tv527886-s1a - block - 19.5339532s
As filed with the Securities and Exchange Commission on September 3, 2019
Registration No. 333-233351
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 1
TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
SPRINGWORKS THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of incorporation or organization)
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2836
(Primary Standard Industrial Classification Code Number)
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83-4066827
(I.R.S. Employer Identification Number)
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100 Washington Blvd
Stamford, CT 06902
(203) 883-9490
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Saqib Islam
Chief Executive Officer
100 Washington Blvd
Stamford, CT 06902
(203) 883-9490
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies of all communications, including communications sent to agent for service, should be sent to:
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Kingsley L. Taft Laurie A. Burlingame Goodwin Procter LLP 100 Northern Ave. Boston, MA 02210 (617) 570-1000
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Brent B. Siler Divakar Gupta Richard Segal Madison A. Jones Cooley LLP 55 Hudson Yards New York, NY 10001 (212) 479-6000
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Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, check the following box. ☐
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large Accelerated Filer ☐ |
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Accelerated Filer ☐ |
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Non-Accelerated Filer ☒ |
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Smaller Reporting Company ☐ |
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Emerging Growth Company ☒ |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act. ☐
CALCULATION OF REGISTRATION FEE
Title of each Class of Securities to be Registered
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Proposed Maximum Aggregate Offering Price(1)(2)
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Amount of Registration Fee(3)
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Common Stock, par value $0.0001 per share
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143,749,994 |
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17,423 |
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(1) Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended.
(2) Includes the offering price of shares that the underwriters may purchase pursuant to an option to purchase additional shares.
(3) Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price. $13,938 of this registration fee was previously paid by the Registrant in connection with the filing of its Registration Statement on Form S-1 on August 16, 2019.
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment that specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until this registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject to completion, dated September 3, 2019
Preliminary prospectus
7,352,941 shares
Common stock
This is an initial public offering of shares of common stock by SpringWorks Therapeutics, Inc. We are offering 7,352,941 shares of our common stock. The initial public offering price is expected to be between $16.00 and $18.00 per share.
Prior to this offering, there has been no public market for our common stock. We have applied to list our common stock on the Nasdaq Global Market under the symbol “SWTX.”
We are an “emerging growth company” as defined under U.S. federal securities laws and will be subject to reduced public company reporting requirements.
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Per share
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Total
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Initial public offering price |
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$
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$ |
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Underwriting discounts and commissions(1) |
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$
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$ |
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Proceeds to SpringWorks Therapeutics, Inc., before expenses |
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$
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$ |
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(1) See “Underwriting” for a description of compensation payable to the underwriters.
We have granted the underwriters an option for a period of up to 30 days to purchase up to 1,102,941 additional shares of our common stock.
Investing in our common stock involves risks. See “Risk factors” beginning on page
13 of this prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities, or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.
The underwriters expect to deliver the shares of common stock to purchasers on or about , 2019.
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J.P. Morgan |
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Goldman Sachs & Co. LLC
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Cowen
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Wedbush PacGrow
, 2019
Table of contents
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F-1
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We and the underwriters have not authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectuses we have prepared. We and the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may provide you. We are offering to sell, and seeking offers to buy, shares of common stock only in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of the common stock.
Through and including , 2019 (the 25th day after the date of this prospectus) all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.
For investors outside of the United States: We have not, and the underwriters have not, done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than the United States. Persons outside of the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of common stock and the distribution of this prospectus outside of the United States.
Prospectus Summary
This summary highlights information contained elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our common stock. Before investing in our common stock, you should carefully read this entire prospectus, including our consolidated financial statements and the related notes included elsewhere in this prospectus. You should also consider, among other things, the matters described in the sections entitled “Risk factors” and “Management’s discussion and analysis of financial condition and results of operations.” As used in this prospectus, unless the context otherwise requires, references to the “company,” “we,” “us” and “our” refer to SpringWorks Therapeutics, Inc. together with its consolidated subsidiaries.
Overview
We are a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. We have a differentiated portfolio of small molecule targeted oncology product candidates and are advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. Our strategic approach and operational excellence in clinical development have enabled us to rapidly advance our two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand our portfolio. From this foundation, we are continuing to build a differentiated global biopharmaceutical company intensely focused on understanding patients and their diseases in order to develop transformative targeted medicines.
Our most advanced product candidate, nirogacestat, is an oral, small molecule gamma secretase inhibitor, or GSI, initially in development for the treatment of desmoid tumors, a rare and often debilitating and disfiguring soft tissue tumor for which there are currently no therapies approved by the U.S. Food and Drug Administration, or FDA. We believe nirogacestat may address the significant limitations associated with existing treatment options and has the potential to become the first therapy approved by the FDA for both newly diagnosed and previously treated desmoid tumors. Since we licensed nirogacestat from Pfizer Inc., or Pfizer, in August 2017, the FDA granted nirogacestat Orphan Drug Designation, Fast Track Designation and Breakthrough Therapy Designation for this indication. In May 2019, we announced the initiation of the DeFi trial, a potentially registrational Phase 3 clinical trial of nirogacestat for patients with desmoid tumors. We expect to provide an update on the DeFi trial in the second half of 2020 ahead of an anticipated top-line data readout in the second or third quarter of 2021.
Our second product candidate is mirdametinib, an oral, small molecule MEK inhibitor initially in development for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas, or NF1-PN, a rare tumor of the peripheral nerve sheath that causes significant pain and disfigurement, and that most often manifests in children. We believe that mirdametinib has the potential to offer a best-in-class profile in order to enable the long-term treatment required for this patient population, as compared to other MEK inhibitors. As with nirogacestat, we licensed mirdametinib from Pfizer in August 2017; since then, the FDA has granted mirdametinib both Orphan Drug Designation and Fast Track Designation for NF1-PN, and the European Commission has granted mirdametinib Orphan Drug Designation for NF1. In the third quarter of 2019, we expect to commence the ReNeu trial, a potentially registrational Phase 2b clinical trial of mirdametinib for patients with NF1-PN. We expect to provide an update on the ReNeu trial between the fourth quarter of 2020 and the first quarter of 2021.
In addition to our late-stage programs in rare oncology indications, we have expanded our portfolio to develop targeted therapies for the treatment of highly prevalent, genetically defined cancers. To advance this strategy, we are taking a precision medicine approach in collaboration with industry leaders, including BeiGene, Ltd., or BeiGene, and GlaxoSmithKline plc, or GSK, to develop combination approaches with nirogacestat and mirdametinib, as well as new standalone medicines. The first of these efforts is our ongoing collaboration with BeiGene, under which patients with advanced or refractory solid tumors harboring RAS mutations, RAF mutations and other MAPK pathway aberrations are being enrolled in a Phase 1b clinical trial evaluating the combination of mirdametinib and BeiGene’s investigational RAF dimer inhibitor lifirafenib. The second of these efforts is our collaboration with GSK, under which patients with relapsed or refractory multiple myeloma will be enrolled in an adaptive Phase 1b clinical trial evaluating the combination of nirogacestat and belantamab mafodotin, GSK’s investigational antibody-drug conjugate, or ADC, targeted to B-cell maturation antigen, or BCMA.
Furthermore, we intend to continue to expand our portfolio by licensing additional programs with strong biological rationales and validated mechanisms of action. We also plan to continue using shared-value partnerships to maximize the potential of our therapies to serve patients. Since our founding, we have invested in building leading clinical development capabilities and have focused on structuring innovative partnerships that seek to align incentives and optimize business outcomes for each party involved. We believe that this approach will continue to allow us to expand our shared-value relationships with innovators, maximize the potential of our existing and future portfolio and ultimately support the building of a scalable and sustainable business focused on the efficient advancement and commercialization of product candidates that hold the potential to transform the lives of patients living with severe rare diseases and cancer.
Our Portfolio
The following table summarizes our current portfolio of product candidates:
(1)
Being developed by MapKure, LLC, or MapKure, a newly formed entity jointly owned by us and BeiGene.
For purposes of this prospectus, when we refer herein to a “potentially registrational trial,” we are referring to a clinical trial to evaluate efficacy and safety of a product candidate to potentially support submission of a marketing application for such product candidate with the applicable regulatory authorities. Such a trial is also sometimes referred to as a Phase 2/3 or Phase 3 clinical trial or a pivotal trial.
Nirogacestat is currently in the potentially registrational Phase 3 DeFi clinical trial for the treatment of desmoid tumors, which are rare and often debilitating and disfiguring soft tissue tumors. Desmoid tumors can aggressively invade surrounding healthy tissues and cause significant morbidities, including severe pain, internal bleeding, incapacitating loss of range of motion and, in rare cases, death. There are currently no therapies approved by the FDA for the treatment of desmoid tumors. Nirogacestat has been generally well tolerated in over 200 subjects and clinical activity was observed in the desmoid tumor patients enrolled in two previous clinical trials, many of whom had been heavily pre-treated. Since then, the FDA has granted nirogacestat Orphan Drug Designation, Fast Track Designation and Breakthrough Therapy Designation for the treatment of desmoid tumors. We are currently conducting the DeFi trial, a double-blind, randomized, placebo-controlled clinical trial in adults with progressing desmoid tumors. We believe that we have designed the DeFi trial such that, if nirogacestat demonstrates clinical activity consistent with that observed in desmoid tumor patients treated to date with nirogacestat, the primary endpoint of this clinical trial should be met. If the results are favorable, we plan to file for marketing approval for nirogacestat in the United States and select international markets. We expect to provide an update on the DeFi trial in the second half of 2020 ahead of an anticipated top-line data readout in the second or third quarter of 2021.
Nirogacestat + belantamab mafodotin is being explored with GSK in patients with relapsed or refractory multiple myeloma, or RRMM. Belantamab mafodotin is the most clinically advanced BCMA ADC, and clinical activity has been observed with belantamab mafodotin as a monotherapy in RRMM patients. We believe that the clinical activity of BCMA directed therapies, including belantamab mafodotin, may be enhanced with the addition of a GSI like nirogacestat. Other than the manufacturing of nirogacestat and certain expenses related to intellectual property rights, GSK will be responsible for the conduct and expenses of the collaboration, which will be governed by a joint development committee with equal representation from each party. We expect GSK to initiate the adaptive Phase 1b clinical trial evaluating the combination by the first quarter of 2020.
Mirdametinib is expected to begin the potentially registrational Phase 2b ReNeu clinical trial for the treatment of NF1-PN in the third quarter of 2019. NF1-PN is a rare tumor of the peripheral nerve sheath that causes significant pain and disfigurement, and that most often manifests in children. There are currently no therapies approved by the FDA for the treatment of NF1-PN. In a previous Phase 2 clinical trial conducted in NF1-PN patients, mirdametinib was observed to be clinically active and generally well tolerated. Since then, the FDA has granted mirdametinib Orphan Drug Designation for the treatment of NF1 and Fast Track Designation for the treatment of NF1-PN, and the European Commission has granted mirdametinib Orphan Drug Designation for NF1. Our upcoming Phase 2b ReNeu trial will be an open-label, single-arm trial that will enroll both pediatric and adult NF1-PN patients. Given the clinical activity and tolerability observed with mirdametinib in the previous NF1-PN clinical trial and informed by our discussions with the FDA, we designed our Phase 2b clinical trial in a manner that we believe has the potential to generate sufficient data to support approval in both pediatric and adult NF1-PN patients. If the results are favorable, we plan to file for marketing approval for mirdametinib in the United States and select international markets.
Mirdametinib + lifirafenib is a combination therapy that we are evaluating with BeiGene in patients with advanced or refractory solid tumors that harbor various oncogenic driver mutations in the mitogen activated protein kinase, or MAPK, pathway, a signaling pathway whose constitutive activation has been reported in approximately 25% of human cancers owing to mutations in genes such as RAS and RAF. Lifirafenib is a RAF dimer inhibitor that was observed to be clinically active in advanced solid tumor patients with RAS and RAF mutations. We believe that lifirafenib’s clinical activity should be enhanced with the addition of a potent and selective MEK
inhibitor like mirdametinib, and potentially provide a promising therapy for cancers whose growth is reliant on MAPK pathway signaling, such as those with mutations in RAS or RAF. In May 2019, we announced the initiation of an adaptive Phase 1b clinical trial that is currently enrolling patients in Australia with advanced or refractory solid tumors harboring relevant genetic mutations in the MAPK pathway. In addition, in July 2019 the FDA cleared the Investigational New Drug application for this combination therapy, thereby allowing for the expansion of this clinical trial to the United States. We intend to provide an update on the dose escalation portion of this trial in 2020, which would precede the selection of specific patient cohorts in which assess the clinical activity of the combination at the selected doses of each compound, which we expect to occur at the end of 2020 or in early 2021.
BGB-3245 is an investigational oral, selective small molecule inhibitor of specific BRAF driver mutations and genetic fusions. BGB-3245 is being advanced via MapKure, a newly formed entity jointly owned by us and BeiGene. BGB-3245 was exclusively licensed to MapKure by BeiGene and is intended to be initially developed as a monotherapy. Preclinical activity has been observed with BGB-3245 in a range of tumor models with BRAF mutations or BRAF fusions that are presently unaddressed with approved BRAF-directed therapies. MapKure expects to initiate an adaptive Phase 1 dose escalation and expansion clinical trial evaluating BGB-3245 in genetically defined solid tumors by the first quarter of 2020.
Our history and team
We were founded in August 2017 and concurrently acquired rights to certain assets from Pfizer, including exclusive worldwide licenses to nirogacestat and mirdametinib. We have raised $228 million from leading strategic and institutional investors. Our strategic investors include Pfizer and GSK, and our institutional investors include OrbiMed, Bain Capital, LifeArc, Perceptive Advisors, Boxer Capital of the Tavistock Group, HBM Healthcare Investments, BVF Partners, Surveyor Capital (a Citadel company), Samsara BioCapital, ArrowMark Partners and other institutional investors.
We are led by biopharmaceutical experts with extensive experience in building and operating organizations that develop and deliver innovative medicines to patients. Our team has broad experience in clinical development, regulatory affairs, manufacturing and commercialization of novel medicines, particularly in rare diseases. Our Chief Executive Officer, Saqib Islam, has more than 25 years of experience in biopharmaceuticals and finance, and has led our key business operations and strategic corporate planning activities since our inception. Members of our management team have held leadership positions at companies that have successfully discovered, acquired, developed and commercialized therapies for a range of devastating rare diseases and cancers. These companies include Alexion Pharmaceuticals, Inc., AstraZeneca plc, Bamboo Therapeutics, Inc., Bristol-Myers Squibb Company, Forest Laboratories, Inc., GSK, Merck & Co., Inc., Moderna, Inc., Pfizer and United Therapeutics Corporation.
Our strategy
Our goal is to continue building a differentiated, global biopharmaceutical company by acquiring, developing and commercializing transformative medicines for underserved patient populations. We aim to be an industry leader in rare diseases and targeted oncology. The key elements of our strategy include:
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Efficiently advance our lead product candidates, nirogacestat and mirdametinib, towards marketing approval in the rare oncology indications in which they are currently being developed.
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Maximize the potential of our portfolio through strategic partnerships in order to access promising therapies for use in combination with our product candidates.
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Commercialize our product candidates, if approved, either alone or in partnership with others, to bring new medicines to underserved patient populations using a focused and efficient approach.
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Deploy our value-driven approach to identifying, acquiring and developing new medicines to further expand our portfolio in our current focus areas of rare diseases and targeted oncology.
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Continue to cultivate a tightly integrated network of patient advocacy groups, key opinion leaders, research institutions and healthcare providers to inform our approach to developing therapies that can transform the lives of patients and their families.
Risks associated with our business
Our business is subject to numerous risks that you should be aware of before making an investment decision. These risks are described more fully in the section entitled “Risk factors.” These risks include, among others:
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We have incurred significant net losses since our inception and anticipate that we will continue to incur net losses in the future.
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We have a limited operating history, which may make it difficult to evaluate our prospects and likelihood of success.
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Even if this offering is successful, we will require additional capital to fund our operations and if we fail to obtain necessary capital, we will not be able to complete the development and commercialization of our product candidates.
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Our business is highly dependent on the success of our lead product candidates, nirogacestat and mirdametinib, as well as other product candidates we may develop. If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize our product candidates, or if we experience delays in doing so, our business will be materially harmed.
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Clinical development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
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We were not involved in the early development of our lead product candidates or in the development of third-party agents used in combination with our product candidates; therefore, we are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical and clinical trials for our product candidates.
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As an organization, we have never successfully completed any clinical trials, and we may be unable to do so for any product candidates we may develop.
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We expect to develop nirogacestat and mirdametinib, and potentially future product candidates, in combination with other therapies, and safety or supply issues with combination use products may delay or prevent development and approval of such product candidates.
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We face significant competition from other biopharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
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Even if any product candidate we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
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We rely on third parties to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for, or commercialize, any potential product candidates.
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Our success depends in part on our ability to protect our intellectual property, and patent terms may be inadequate to protect our competitive position. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
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We depend on intellectual property licensed from third parties, including from Pfizer for our lead product candidates, and termination of any of these licenses could result in the loss of significant rights, which would harm our business.
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Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
Corporate history and information
We were originally formed in Delaware in August 2017 and until March 29, 2019, we conducted our business through SpringWorks Therapeutics, LLC, a Delaware limited liability company. Pursuant to the terms of a corporate reorganization and merger that was completed on March 29, 2019, all of the equity interests in SpringWorks Therapeutics, LLC were exchanged for the same number and class of newly issued securities of SpringWorks Therapeutics, Inc. and, as a result, SpringWorks Therapeutics, LLC became a wholly owned subsidiary of SpringWorks Therapeutics, Inc. See the section titled “Reorganization” for additional information. Our principal executive offices are located at 100 Washington Blvd, Stamford, CT 06902, and our phone number is (203) 883-9490. Our website address is http://www.springworkstx.com. The information contained in or accessible from our website is not incorporated into this prospectus, and you should not consider it part of this prospectus.
We own various U.S. federal trademark applications and unregistered trademarks, including our company name and our logo. All other trademarks or trade names referred to in this prospectus are the property of their respective owners. Solely for convenience, the trademarks and trade names in this prospectus are referred to without the symbols ® and ™, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
Implications of being an emerging growth company
We qualify as an “emerging growth company,” or EGC, as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. As an EGC, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include, but are not limited to:
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being permitted to present only two years of audited financial statements in this prospectus and only two years of related “Management’s discussion and analysis of financial condition and results of operations” in our periodic reports and registration statements, including this prospectus;
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not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended;
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reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements, including in this prospectus; and
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exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
We may take advantage of these exemptions until we are no longer an EGC. We will cease to be an EGC on the date that is the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more; (ii) the last day of 2024; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (iv) the last day of the fiscal year in which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission, or SEC, which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th.
We may choose to take advantage of some but not all of these exemptions. We have taken advantage of reduced reporting requirements in this prospectus. Accordingly, the information contained herein may be different from the information you receive from other public companies in which you hold stock. In addition, the JOBS Act provides that an EGC can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an EGC to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an EGC or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
The Offering
Common stock offered by us
7,352,941 shares
Common stock to be outstanding immediately after this offering
40,235,936 shares (41,338,877 shares if the underwriters exercise their option to purchase additional shares in full)
Option to purchase additional shares
We have granted the underwriters an option for a period of up to 30 days to purchase up to 1,102,941 additional shares of common stock from us at the initial public offering price per share less the underwriting discounts and commissions.
We estimate that the net proceeds from this offering will be approximately $113.0 million, or $130.4 million if the underwriters exercise their option to purchase additional shares in full, assuming an initial public offering price of $17.00 per share, the midpoint of the price range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds from this offering, together with our existing cash and cash equivalents, to (i) advance the clinical development of nirogacestat and mirdametinib; (ii) to fund other research, development and commercial activities, including business development initiatives and growth of our infrastructure to support our expanding operations; and (iii) for working capital and general corporate purposes. For a more complete description of our intended use of the proceeds from this offering, see “Use of proceeds.”
You should carefully read the “Risk factors” section of this prospectus for a discussion of factors that you should consider before deciding to invest in our common stock.
Proposed Nasdaq Global Market symbol
“SWTX”
The number of shares of our common stock to be outstanding after this offering is based on 32,882,995 shares of our common stock (which includes 2,118,689 issued but unvested shares of restricted common stock subject to repurchase) outstanding as of June 30, 2019, and gives effect to the conversion of all outstanding shares of our convertible preferred stock into an aggregate of 29,794,359 shares of our common stock immediately prior to the completion of this offering, and excludes:
•
2,489,778 shares of common stock issuable upon the exercise of stock options outstanding as of June 30, 2019 under our existing stock option and incentive plan, with a weighted average exercise price of $2.24 per share;
•
534,328 shares of common stock issuable upon the exercise of stock options granted subsequent to June 30, 2019 at an exercise price of $9.08 per share;
•
3,537,225 shares of our common stock that will become available for future issuance under our 2019 Stock Option and Equity Incentive Plan, or our 2019 Equity Plan, which will become effective upon the effectiveness of the registration statement of which this prospectus forms a part; and
•
442,153 shares of our common stock that will become available for future issuance under our 2019 Employee Stock Purchase Plan, or our ESPP, which will become effective upon the effectiveness of the registration statement of which this prospectus forms a part.
Unless otherwise indicated, all information in this prospectus reflects or assumes the following:
•
the automatic conversion of all outstanding shares of convertible preferred stock into an aggregate of 29,794,359 shares of common stock immediately prior to the completion of this offering;
•
no exercise of outstanding options after June 30, 2019;
•
a one-for-6.5810 reverse split of our common stock effected on August 30, 2019; and
•
no exercise by the underwriters of their option to purchase up to 1,102,941 additional shares of common stock in this offering.
Summary consolidated financial data
The following tables present summary consolidated financial data for our business. We have derived the summary statement of operations data for the period from August 18, 2017 (inception) to December 31, 2017 and the year ended December 31, 2018 and the summary balance sheet data as of December 31, 2018 from our audited consolidated financial statements included elsewhere in this prospectus. We have derived the summary consolidated statement of operations data for the six months ended June 30, 2018 and 2019 and the summary consolidated balance sheet data as of June 30, 2019 from our unaudited consolidated financial statements included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results that may be expected in the future and the results for the six months ended June 30, 2019 or any other interim period are not necessarily indicative of results to be expected for the full year ending December 31, 2019 or any other period. The consolidated financial statements and selected historical consolidated financial data and other financial information included in this prospectus for periods prior to March 29, 2019 are those of SpringWorks Therapeutics, LLC prior to the Reorganization. You should read this data together with our consolidated financial statements and related notes appearing elsewhere in this prospectus and the information in the sections entitled “Selected consolidated financial data” and “Management’s discussion and analysis of financial condition and results of operations.”
(In thousands, except unit and per unit and share and per share data)
|
|
|
Period from August 18, 2017 (inception) to December 31, 2017
|
|
|
Year Ended December 31, 2018
|
|
|
Six months ended June 30,
|
|
|
2018
|
|
|
2019
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
$ |
2,799 |
|
|
|
|
$ |
9,898 |
|
|
|
|
$ |
2,786 |
|
|
|
|
$ |
19,628 |
|
|
General and administrative
|
|
|
|
|
1,861 |
|
|
|
|
|
8,593 |
|
|
|
|
|
4,028 |
|
|
|
|
|
6,911 |
|
|
Total operating expenses
|
|
|
|
|
4,660 |
|
|
|
|
|
18,491 |
|
|
|
|
|
6,814 |
|
|
|
|
|
26,539 |
|
|
Loss from operations
|
|
|
|
|
(4,660) |
|
|
|
|
|
(18,491) |
|
|
|
|
|
(6,814) |
|
|
|
|
|
(26,539) |
|
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net
|
|
|
|
|
21 |
|
|
|
|
|
678 |
|
|
|
|
|
224 |
|
|
|
|
|
1,283 |
|
|
Total other Income
|
|
|
|
|
21 |
|
|
|
|
|
678 |
|
|
|
|
|
224 |
|
|
|
|
|
1,283 |
|
|
Net loss
|
|
|
|
|
(4,639) |
|
|
|
|
|
(17,813) |
|
|
|
|
|
(6,590) |
|
|
|
|
|
(25,256) |
|
|
Net gain attributable to extinguishment of Series A convertible preferred shares and Junior Series A convertible preferred shares
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
7,729 |
|
|
Net loss attributable to common stockholders
|
|
|
|
$ |
(4,639) |
|
|
|
|
$ |
(17,813) |
|
|
|
|
$ |
(6,590) |
|
|
|
|
$ |
(17,527) |
|
|
Net loss per common unit, basic and diluted(1)
|
|
|
|
|
|
|
|
|
|
$ |
(52.24) |
|
|
|
|
$ |
(37.60) |
|
|
|
|
|
|
|
|
Net loss per common share attributable to common stockholders, basic and diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(22.47) |
|
|
Weighted average common units outstanding, basic and diluted(1)
|
|
|
|
|
|
|
|
|
|
|
341,014 |
|
|
|
|
|
175,291 |
|
|
|
|
|
|
|
|
Weighted average common shares, outstanding, basic and diluted
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
780,066 |
|
|
Pro forma net loss per share, basic and diluted (unaudited)(2)
|
|
|
|
|
|
|
|
|
|
$ |
(2.00) |
|
|
|
|
|
|
|
|
|
|
$ |
(0.79) |
|
|
Pro forma weighted average common shares outstanding, basic and diluted (unaudited)(2)
|
|
|
|
|
|
|
|
|
|
|
8,927,163 |
|
|
|
|
|
|
|
|
|
|
|
22,195,710 |
|
|
(1) As of December 31, 2017, there were no vested common units outstanding. Therefore, net loss per common unit, basic and diluted, is not presented for the period from August 18, 2017 (inception) through December 31, 2017.
(2) See Note 12 to the notes to our consolidated financial statements included elsewhere in this prospectus for an explanation of the method used to calculate the pro forma net loss per share and pro forma weighted average number of common shares outstanding.
|
|
|
As of June 30, 2019
|
|
(in thousands)
|
|
|
Actual
|
|
|
Pro forma(1)
|
|
|
Pro forma as adjusted(2)(3)
|
|
Balance sheet data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$ |
185,291 |
|
|
|
|
$ |
185,291 |
|
|
|
|
$ |
298,277 |
|
|
Working capital(4)
|
|
|
|
|
178,152 |
|
|
|
|
|
178,152 |
|
|
|
|
|
291,138 |
|
|
Total assets
|
|
|
|
|
194,632 |
|
|
|
|
|
194,632 |
|
|
|
|
|
307,618 |
|
|
Convertible preferred shares
|
|
|
|
|
217,290 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Accumulated deficit
|
|
|
|
|
(39,979) |
|
|
|
|
|
(39,979) |
|
|
|
|
|
(39,979) |
|
|
Stockholders’ (deficit) equity
|
|
|
|
|
(33,657) |
|
|
|
|
|
183,633 |
|
|
|
|
|
296,619 |
|
|
(1) Pro forma balance sheet data reflects the automatic conversion of all of our outstanding shares of convertible preferred stock into an aggregate of 29,794,359 shares of common stock upon completion of this offering.
(2) The pro forma as adjusted column gives further effect to the issuance and sale of 7,352,941 shares of common stock in this offering at an assumed initial public offering price of $17.00 per share, the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
(3) The pro forma as adjusted information is illustrative only, and we will depend on the actual initial public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed initial public offering price of $17.00 per share, the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, the pro forma as adjusted amount of each of cash and cash equivalents, working capital, total assets and stockholders’ equity by $6.8 million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. Each increase or decrease of 1,000,000 in the number of shares we are offering would increase or decrease, as applicable, the pro forma as adjusted amount of each of cash and cash equivalents, working capital, total assets and stockholders’ equity by $15.8 million, assuming no change in the assumed initial public offering price per share, the midpoint of the price range set forth on the cover page of this prospectus.
(4) We define working capital as current assets less current liabilities. See our consolidated financial statements and related notes appearing elsewhere in this prospectus for details regarding our current assets and current liabilities.
Reorganization
Prior to March 29, 2019, we conducted our business through SpringWorks Therapeutics, LLC, a Delaware limited liability company. On March 29, 2019, we completed a series of transactions pursuant to which SpringWorks MergerSub, LLC, a wholly owned subsidiary of SpringWorks Therapeutics, Inc., was merged with and into SpringWorks Therapeutics, LLC, or the Reorganization. Following such merger, SpringWorks Therapeutics, LLC survived as a wholly owned subsidiary of SpringWorks Therapeutics, Inc. In connection with the Reorganization:
•
Holders of SpringWorks Therapeutics, LLC Junior Series A convertible preferred units received one share of SpringWorks Therapeutics, Inc. Junior Series A convertible preferred stock for each outstanding Junior Series A convertible preferred unit held immediately prior to the Reorganization, with an aggregate of 6,437,500 shares of SpringWorks Therapeutics, Inc. Junior Series A convertible preferred stock issued in the Reorganization;
•
Holders of SpringWorks Therapeutics, LLC Series A convertible preferred units received one share of SpringWorks Therapeutics, Inc. Series A convertible preferred stock for each outstanding Series A convertible preferred unit held immediately prior to the Reorganization, with an aggregate of 103,000,000 shares of SpringWorks Therapeutics, Inc. Series A convertible preferred stock issued in the Reorganization;
•
Holders of SpringWorks Therapeutics, LLC common units received one share of SpringWorks Therapeutics, Inc. common stock for each outstanding common unit held immediately prior to the Reorganization, which were subject to a subsequent one-for-6.5810 reverse split, with an aggregate of 195,638 shares of common stock issued in the Reorganization; and
•
Holders of SpringWorks Therapeutics, LLC vested and unvested incentive units exchanged such incentive units for an equal number of shares of common stock or restricted common stock, respectively, given that the strike price for all incentive units that had been issued by SpringWorks Therapeutics, LLC was $0.00 per unit, which were subject to a subsequent one-for-6.5810 reverse split. The restricted common stock was issued with the same vesting terms as the unvested incentive units held immediately prior to the Reorganization. An aggregate of 2,892,998 shares of common stock and restricted common stock were issued to the prior holders of incentive units in the Reorganization.
Immediately following the Reorganization, we issued 86,639,279 shares of Series B convertible preferred stock on March 29, 2019.
All outstanding shares of our convertible preferred stock are convertible into shares of common stock at the then-effective conversion ratios.
In connection with the Reorganization, by operation of law, we acquired all assets of SpringWorks Therapeutics, LLC and assumed all of its liabilities and obligations, and we now operate our business through SpringWorks Therapeutics, Inc., which is the issuer in this offering. The purpose of the Reorganization was to reorganize our corporate structure so that SpringWorks Therapeutics, Inc. would continue as a corporation and so that our existing investors would own our capital stock rather than equity interests in a limited liability company. For the convenience of the reader, except as context otherwise requires, all information included in this prospectus is presented giving effect to the Reorganization, the consolidated financial statements and summary and selected historical consolidated financial data and other financial information included in this prospectus for periods prior to March 29, 2019 are those of SpringWorks Therapeutics, LLC prior to the Reorganization.
Risk Factors
Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this prospectus, including our consolidated financial statements and related notes appearing elsewhere in this prospectus and in the section entitled “Management’s discussion and analysis of financial condition and results of operations,” before deciding whether to invest in our common stock. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of our common stock could decline and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.
Risks related to our financial position and need for additional capital
We have incurred significant net losses since our inception and anticipate that we will continue to incur net losses in the future.
We have incurred significant net losses in each reporting period since our inception. To date, we have not generated any revenue and we have financed our operations principally through equity financings. If our product candidates are not successfully developed and approved, we may never generate any revenue. We continue to incur significant research and development and other expenses related to our ongoing operations. As a result, we are not profitable and have incurred losses in each period since our inception. Our net losses were $4.6 million, $17.8 million and $25.3 million for the period from August 18, 2017 (inception) to December 31, 2017, the year ended December 31, 2018 and the six months ended June 30, 2019, respectively. As of December 31, 2018 and June 30, 2019, we had an accumulated deficit of $22.5 million and $40.0 million, respectively. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, our product candidates, including our lead product candidates, nirogacestat and mirdametinib, and any future product candidates.
We anticipate that our expenses will increase substantially if, and as, we:
•
advance the development of our lead product candidates, nirogacestat and mirdametinib, through potentially registrational clinical trials and potentially for other indications;
•
advance our development programs for our other product candidates through clinical development and into later-stage clinical development;
•
seek marketing approvals for any product candidates that successfully complete clinical trials;
•
invest in or in-license other technologies or product candidates for further preclinical and clinical development;
•
hire additional personnel, including clinical, quality control, scientific, medical, business development and finance personnel, and continue to build our infrastructure;
•
expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development, manufacturing and commercialization efforts and our operations as a public company;
•
maintain, expand and protect our intellectual property portfolio; and
•
establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any products for which we may obtain marketing approval and intend to commercialize on our own or jointly with third parties.
To become and remain profitable, we or any potential future collaborators must develop and eventually commercialize products with significant market potential. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials, obtaining marketing approval for product candidates, manufacturing, obtaining reimbursement approval, marketing and selling products for which we may obtain marketing approval and satisfying any post-marketing requirements. We may never succeed in any or all of these activities and, even if we do, we may never generate revenue that is significant or large enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in the value of our company also could cause you to lose all or part of your investment.
Even if we succeed in commercializing one or more of our product candidates, we will continue to incur substantial research and development and other expenditures to develop, register and market additional product candidates. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital.
We have a limited operating history, which may make it difficult to evaluate our prospects and likelihood of success.
We are a clinical-stage biopharmaceutical company with a limited operating history. We were formed in August 2017 and our operations to date have been focused on preparing and executing our clinical trials for our product candidates, building our infrastructure, raising capital and executing partnerships. Consequently, we have limited operations upon which to evaluate our business, and predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing drug products. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate activity or an acceptable safety profile, gain regulatory approval, secure market access and reimbursement and become commercially viable.
Although we announced the initiation of the DeFi trial, a potentially registrational Phase 3 clinical trial of nirogacestat, in May 2019, and expect to commence a potentially registrational Phase 2b clinical trial of mirdametinib, we have not yet demonstrated the ability to successfully enroll or complete clinical trials for any product candidate, we have no products approved for commercial sale and we have not generated any revenue from product sales to date. In addition, as a business with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields.
In addition, we will need to transition at some point from a company with a development focus to a company capable of supporting commercial activities, and may not be successful in such a transition.
Even if this offering is successful, we will require additional capital to fund our operations and if we fail to obtain necessary capital, we will not be able to complete the development and commercialization of our product candidates.
Our operations have consumed substantial amounts of cash since inception. We expect to continue to spend substantial amounts of cash to conduct further research and development and
clinical trials of our product candidates to seek regulatory approvals for our product candidates and to launch and commercialize any products for which we receive regulatory approval. As of June 30, 2019, we had $185.3 million in cash and cash equivalents. Based on our current operating plan, we believe that the net proceeds from this offering, together with existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure requirements through 2022. However, our future capital requirements and the period for which our existing resources will support our operations may vary significantly from what we expect, and we will in any event require additional capital in order to complete clinical development and obtain regulatory approval of our product candidates. Our monthly spending levels will vary based on new and ongoing development and corporate activities. Because the length of time and activities associated with development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities. Our future funding requirements will depend on many factors, including, but not limited to:
•
the initiation, progress, timing, costs and results of clinical trials for our product candidates;
•
the clinical and preclinical development and manufacturing plans we establish for these product candidates;
•
the number and characteristics of product candidates that we develop or in-license;
•
the cost of identifying and evaluating potential product candidates for acquisition or license, including the cost of preclinical activities or clinical activities;
•
the terms of any collaboration or licensing agreements we may choose to enter into;
•
the outcome, timing and cost of meeting regulatory requirements established by the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, and other comparable foreign regulatory authorities;
•
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
•
the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates;
•
the effect of competing technological and market developments;
•
the cost and timing of completion of commercial-scale manufacturing activities; and
•
the cost of establishing medical affairs and sales, marketing and distribution capabilities for any approved product candidates.
If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates or one or more of our other research and development initiatives. Any of the above events could significantly harm our business, prospects, financial condition and results of operations and cause the price of our common stock to decline.
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
We do not have any committed external source of funds or other support for our development efforts and we cannot be certain that additional funding will be available on acceptable terms, or at all. Until we can generate sufficient product or royalty revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic
alliances, licensing arrangements and other marketing or distribution arrangements. If we raise additional funds through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. Further, to the extent that we raise additional capital through the sale of common stock or securities convertible or exchangeable into common stock, your ownership interest will be diluted. In addition, any debt financing may subject us to fixed payment obligations and covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. We also could be required to seek commercial or development partners for our lead products or any future product candidate at an earlier stage than otherwise would be desirable or relinquish our rights to product candidates or technologies that we otherwise would seek to develop or commercialize ourselves.
The amount of our future losses is uncertain and our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
Our quarterly and annual operating results may fluctuate significantly in the future due to a variety of factors, many of which are outside of our control and may be difficult to predict, including the following:
•
the timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;
•
our ability to successfully recruit and retain subjects for clinical trials, and any delays caused by difficulties in such efforts;
•
our ability to obtain marketing approval for our product candidates, and the timing and scope of any such approvals we may receive;
•
the timing and cost of, and level of investment in, research and development activities relating to our product candidates, which may change from time to time;
•
the cost of manufacturing our product candidates, which may vary depending on the quantity of production and the terms of our agreements with manufacturers;
•
our ability to attract, hire and retain qualified personnel;
•
expenditures that we will or may incur to develop additional product candidates;
•
the level of demand for our product candidates should they receive approval, which may vary significantly;
•
the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future therapeutics that compete with our product candidates;
•
the changing and volatile U.S. and global economic environments; and
•
future accounting pronouncements or changes in our accounting policies.
The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. This variability and unpredictability could also
result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially. Such a stock price decline could occur even when we have met any previously publicly stated guidance we may provide.
Risks related to research and development and the biopharmaceutical industry
Our business is highly dependent on the success of our lead product candidates, nirogacestat and mirdametinib, as well as other product candidates we may develop. If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize our product candidates, or if we experience delays in doing so, our business will be materially harmed.
To date, we have not yet completed any clinical trials or development of any product candidates. Our future success and ability to generate revenue from our product candidates, which we do not expect will occur for several years, if ever, is dependent on our ability to successfully develop, obtain regulatory approval for and commercialize one or more product candidates. We are currently enrolling patients in a potentially registrational Phase 3 clinical trial of nirogacestat and we expect to commence a potentially registrational Phase 2b clinical trial of mirdametinib in the third quarter of 2019. If either of our lead product candidates encounter safety or efficacy problems, development delays or regulatory issues or other problems, our development plans and business would be significantly harmed.
All of our other product candidates are in earlier stages of development and will require substantial additional investment for preclinical development, clinical development, regulatory review and approval in one or more jurisdictions.
We may not have the financial resources to continue development of, or to modify existing or enter into new collaborations for, a product candidate if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, our product candidates, including:
•
our inability to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates are safe and effective;
•
insufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;
•
negative or inconclusive results from our preclinical studies, clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional preclinical studies or clinical trials or abandon a program;
•
product-related adverse events experienced by subjects in our clinical trials or by individuals using drugs or therapeutic biologics similar to our product candidates;
•
delays in submitting an Investigational New Drug application, or IND, or comparable foreign applications or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial or a suspension or termination of a clinical trial once commenced;
•
conditions imposed by the FDA, EMA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials;
•
poor effectiveness of our product candidates during clinical trials;
•
better than expected performance of control arms, such as placebo groups, which could lead to negative or inconclusive results from our clinical trials;
•
delays in enrolling subjects in clinical trials;
•
high drop-out rates of subjects from clinical trials;
•
inadequate supply or quality of product candidates or other materials necessary for the conduct of our clinical trials;
•
greater than anticipated clinical trial or manufacturing costs;
•
unfavorable FDA, EMA or comparable regulatory authority inspection and review of a clinical trial site;
•
failure of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all;
•
delays and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our therapies in particular; or
•
varying interpretations of data by the FDA, EMA and comparable foreign regulatory authorities.
Clinical development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
To obtain the requisite regulatory approvals to commercialize any product candidates, we must demonstrate through extensive preclinical studies and clinical trials that our product candidates are safe and effective in humans. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. We may be unable to establish clinical endpoints that applicable regulatory authorities would consider clinically meaningful, and a clinical trial can fail at any stage of testing.
Differences in trial design between early-stage clinical trials and later-stage clinical trials make it difficult to extrapolate the results of earlier clinical trials to later clinical trials. Moreover, clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain marketing approval of their products. Additionally, we plan to conduct some open-label trials, where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved drug or placebo. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in those trials are aware when they are receiving treatment. In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. Where a randomized, placebo-controlled clinical trial is designed to allow enrolled subjects to cross-over from the placebo arm to the treatment arm, there may be a risk of inadvertent unblinding of subjects prior to cross-over, which may limit the clinical meaningfulness of those data and may require the conduct of additional clinical trials.
Successful completion of clinical trials is a prerequisite to submitting a New Drug Application, or NDA, to the FDA, a Marketing Authorization Application, or MAA, to the EMA and similar marketing applications to comparable foreign regulatory authorities for each product candidate and, consequently, the ultimate approval and commercial marketing of any product candidates.
Although we have initiated a potentially registrational clinical trial for nirogacestat and expect to initiate a potentially registrational clinical trial for mirdametinib in the third quarter of 2019, we do not know whether these trials or any of our clinical trials, including trials for our combination therapies using nirogacestat and mirdametinib, will be completed on schedule, if at all, or in some cases whether such clinical trials will begin.
We may experience delays in initiating or completing clinical trials and preparing for regulatory submissions. We also may experience numerous unforeseen events during, or as a result of, any future clinical trials that we could conduct that could delay or prevent our ability to receive marketing approval or commercialize our current product candidates or any future product candidates, including:
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regulators or institutional review boards, or IRBs, or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
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we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective clinical trial sites and prospective contract research organizations, or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;
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clinical trials of any product candidates may fail to show acceptable safety or efficacy, or produce negative or inconclusive results and we may decide, or regulators may require us, to conduct additional preclinical studies or clinical trials or we may decide to abandon product development programs;
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the number of subjects required for clinical trials of any product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate;
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our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators;
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we may elect to, or regulators, IRBs or ethics committees may require, that we or our investigators suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
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the cost of clinical trials of any product candidates may be greater than we anticipate;
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the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be inadequate to initiate or complete a given clinical trial;
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our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators, IRBs or ethics committees to suspend or terminate the clinical trials;
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reports from clinical testing of other therapies may raise safety or efficacy concerns about our product candidates; and
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the FDA, EMA or comparable regulatory authorities may require us to submit additional data, such as long-term toxicology studies, or impose other requirements before permitting us to initiate a clinical trial.
We could also encounter delays if a clinical trial is suspended or terminated by us, the IRBs of the institutions in which such clinical trials are being conducted, or the FDA, EMA or comparable regulatory authorities, or recommended for suspension or termination by the Data Safety Monitoring Board, or DSMB, for such clinical trial. A suspension or termination may be imposed due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or clinical trial site by the FDA, EMA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product or treatment, failure to establish or achieve clinically meaningful trial endpoints, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. Further, the FDA, EMA or comparable foreign regulatory authorities may disagree with our clinical trial design and our interpretation of data from clinical trials, or may change the requirements for approval even after they have reviewed and commented on the design for our clinical trials.
Our costs will increase if we experience delays in clinical testing or marketing approvals. We do not know whether any of our clinical trials will begin as planned, will need to be reassigned or will be completed on schedule, or at all. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates and may allow our competitors to bring products to market before we do, potentially impairing our ability to successfully commercialize our product candidates and harming our business and results of operations. Any delays in our clinical development programs may harm our business, financial condition and results of operations significantly. The clinical trials sponsored by our partners with our product candidates in combination with our partners’ therapies pose the same development risks.
We were not involved in the early development of our lead product candidates or in the development of third-party agents used in combination with our product candidates; therefore, we are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical and clinical trials for our product candidates.
We had no involvement with or control over the preclinical and clinical development of any of our lead product candidates or third-party agents used in combination with our product candidates. We are dependent on third parties having conducted their research and development in accordance with the applicable protocols and legal, regulatory and scientific standards; having accurately reported the results of all preclinical studies and clinical trials conducted with respect to such product candidates; and having correctly collected and interpreted the data from these trials. If these activities were not compliant, accurate or correct, the clinical development, regulatory approval or commercialization of our product candidates will be adversely affected.
If our clinical trials fail to replicate positive results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize our product candidates.
Our preclinical studies or early clinical trials of our product candidates, whether conducted by us or third parties, may not necessarily be predictive of the results of later clinical trials that we
conduct. Similarly, even if we are able to complete our planned clinical trials of our product candidates, positive results from such clinical trials may not be replicated in our subsequent preclinical studies or clinical trials.
Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development, and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported adverse events. For example, we are conducting nonclinical absorption, distribution, metabolism and excretion, or ADME, studies for each of our lead product candidates, and we cannot predict whether findings from these ADME studies will adversely affect our development plans for such product candidates. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA, EMA or comparable foreign regulatory authority approval. Furthermore, the approval policies or regulations of the FDA, EMA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval, which may lead to the FDA, EMA or comparable foreign regulatory authorities delaying, limiting or denying approval of our product candidates.
As an organization, we have never successfully completed any clinical trials, and we may be unable to do so for any product candidates we may develop.
We will need to successfully complete clinical trials in order to obtain the approval of the FDA, EMA or comparable foreign regulatory authorities to market any product candidates. Carrying out clinical trials, including later-stage registrational clinical trials, is a complicated process. As an organization, we have not previously completed any clinical trials. In order to do so, we will need to build and expand our clinical development and regulatory capabilities, and we may be unable to recruit and train qualified personnel. We also expect to continue to rely on third parties to conduct our clinical trials. See “—Risks related to our reliance on third parties—We rely on third parties to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product candidates.” Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to NDA submission and approval of our product candidates. We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approval of any product candidates that we develop. Failure to commence or complete, or delays in, our planned clinical trials, could prevent us from or delay us in commercializing our product candidates.
The successful development of biopharmaceuticals is highly uncertain.
Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control. Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons including:
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clinical trial results may show the product candidates to be less effective than expected (for example, a clinical trial could fail to meet its primary or key secondary endpoint(s)) or to have unacceptable side effects or toxicities;
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failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused by patients who fail the trial screening process, slow enrollment in clinical trials, patients dropping out of trials, patients lost to follow-up,
length of time to achieve trial endpoints, additional time requirements for data analysis or NDA preparation, discussions with the FDA, an FDA request for additional preclinical or clinical data (such as long-term toxicology studies) or unexpected safety or manufacturing issues;
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preclinical study results may show the product candidate to be less effective than desired or to have harmful side effects;
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supply issues, manufacturing costs and formulation issues, including our inability to successfully combine our product candidates with other therapies;
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post-marketing approval requirements; and
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the proprietary rights of others and their competing products and technologies that may prevent our product candidates from being commercialized.
The length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product candidate to the next and from one country to the next, and may be difficult to predict.
Even if we are successful in obtaining marketing approval, commercial success of any approved products will also depend in large part on the availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid programs and managed care organizations in the United States or country specific governmental organizations in foreign countries, which may be affected by existing and future healthcare reform measures designed to reduce the cost of healthcare. Third-party payors could require us to conduct additional studies, including post-marketing studies related to the cost effectiveness of a product, to qualify for reimbursement, which could be costly and divert our resources. If government and other healthcare payors were not to provide coverage and adequate reimbursement for our products once approved, market acceptance and commercial success would be reduced.
In addition, if any of our product candidates receive marketing approval, we will be subject to significant regulatory obligations regarding the submission of safety and other post-marketing information and reports and registration, and will need to continue to comply (or ensure that our third-party providers comply) with current good manufacturing practices, or cGMPs, and good clinical practices, or GCPs, for any clinical trials that we conduct post-approval. In addition, there is always the risk that we, a regulatory authority or a third party might identify previously unknown problems with a product post-approval, such as adverse events of unanticipated severity or frequency. Compliance with these requirements is costly, and any failure to comply or other issues with our product candidates post-approval could adversely affect our business, financial condition and results of operations.
We expect to develop nirogacestat and mirdametinib, and potentially future product candidates, in combination with other therapies, and safety or supply issues with combination use products may delay or prevent development and approval of such product candidates.
We intend to develop nirogacestat and mirdametinib, and likely other future product candidates, in combination with one or more other approved or unapproved rational therapies to treat cancer or other diseases. For example, we are currently evaluating mirdametinib in combination with lifirafenib, BeiGene’s RAF dimer inhibitor, and nirogacestat in combination with belantamab mafodotin, GSK's investigational antibody-drug conjugate, or ADC, targeted to B-cell maturation antigen, or BCMA.
Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA, EMA or comparable foreign regulatory authorities outside of
the United States could revoke approval of the therapy used in combination with our product or that safety, efficacy, manufacturing or supply issues could arise with any of those existing therapies. If the therapies we use in combination with our product candidates are replaced as the standard of care for the indications we choose for any of our product candidates, the FDA, EMA or comparable foreign regulatory authorities may require us to conduct additional clinical trials. The occurrence of any of these risks could result in our own products, if approved, being removed from the market or being less successful commercially.
We also may choose to evaluate nirogacestat or mirdametinib or any other future product candidates in combination with one or more cancer therapies that have not yet been approved for marketing by the FDA, EMA or comparable foreign regulatory authorities. We will not be able to market and sell nirogacestat, mirdametinib or any product candidate we develop in combination with an unapproved cancer therapy for a combination indication if that unapproved cancer therapy does not ultimately obtain marketing approval either alone or in combination with our product. In addition, unapproved cancer therapies face the same risks described with respect to our product candidates currently in development and clinical trials, including the potential for serious adverse effects, delay in their clinical trials and lack of FDA approval.
If the FDA, EMA or comparable foreign regulatory authorities do not approve these other drugs or revoke their approval of, or if safety, efficacy, quality, manufacturing or supply issues arise with, the drugs we choose to evaluate in combination with our product candidate we develop, we may be unable to obtain approval of or market such combination therapy.
Due to our limited resources and access to capital, we must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business.
We may fail to identify and acquire, through purchase or license, viable new product candidates for clinical development for a number of reasons. If we fail to identify and acquire additional product candidates, our business could be materially harmed.
Efforts to identify and pursue new product candidates and disease targets require substantial technical, financial and human resources, regardless of whether they are ultimately successful. We currently rely on third parties, including current and future collaborators, to perform all of our research and preclinical activities. Programs may initially show promise in preclinical studies, yet fail to yield positive results during clinical development for a number of reasons, including:
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the methodology used may not be successful in identifying potential indications and/or product candidates; or
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product candidates may, after further study, be shown to have harmful adverse effects or other characteristics that indicate they are unlikely to be effective products.
Because we have limited financial and human resources, we intend to initially focus on programs and product candidates for a limited set of indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications with our existing product candidates that may later prove to have greater commercial potential or a greater likelihood of success. We may focus our efforts and resources on potential product candidates or other potential programs that ultimately prove to be unsuccessful.
Our future clinical trials or those of our future collaborators may reveal significant adverse events not seen in prior preclinical studies or clinical trials and may result in a safety profile that could inhibit regulatory approval or market acceptance of any of our product candidates.
If significant adverse events or other side effects are observed in any of our clinical trials, we may have difficulty recruiting patients to our clinical trials, patients may drop out of our trials or we
may be required to abandon the trials or our development efforts of one or more product candidates altogether. For example, a prior Phase 2 clinical trial (A4581002) of mirdametinib was terminated and enrollment in the Phase 2 portion of a Phase 1/2 clinical trial (A4581001) was halted as a result of adverse events observed at doses of mirdametinib of 15 mg twice daily, or BID, or above using both intermittent and continuous dosing schedules. These adverse events included ocular disorders (visual disturbances, blurred vision and retinal vein occlusion), nervous system disorders (confusion, slowed ideation, slurred speech and hallucinations), musculoskeletal and connective tissue disorders (general weakness and neck muscle weakness associated with mild and moderate elevations in creatine phosphokinase) and cardiac disorders (decreased left ventricular ejection fraction and congestive heart failure). Although these doses were significantly higher than the maximum allowable dose of 4 mg BID in our planned Phase 2b clinical trial of mirdametinib in NF1-PN, we plan to treat patients in this upcoming trial for a period of up to 24 months, which would be longer than any subjects have been treated with mirdametinib in prior trials. In our planned Phase 2b clinical trial, we may observe adverse events similar to those that were seen at higher doses of mirdametinib in prior clinical trials owing to the potentially increased duration of treatment, or potentially other factors. In addition, the trial will enroll pediatric NF1-PN patients. Patients under 16 years of age have never before been exposed to mirdametinib treatment, and it is possible that there may be unanticipated adverse events observed in this patient population.
If we elect or are required to delay, suspend or terminate any clinical trial of any product candidates that we develop, the commercial prospects of such product candidates will be harmed and our ability to generate product revenues from any of these product candidates will be delayed or eliminated. Serious adverse events or other adverse events, as well as tolerability issues, observed in clinical trials could hinder or prevent market acceptance of the product candidate at issue.
We, the FDA, EMA or comparable foreign regulatory authorities or an IRB may suspend clinical trials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse side effects. Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in early-stage trials have later been found to cause side effects that prevented their further development. Even if the side effects do not preclude the product candidate from obtaining or maintaining marketing approval, restrictions could be imposed on the approval or an approved product could be subject to a “black box” warning, and undesirable side effects may inhibit market acceptance of the approved product due to its tolerability versus other therapies.
If we encounter difficulties enrolling patients in any of our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons, including:
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the patient eligibility and exclusion criteria defined in the protocol;
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the size of the patient population required for analysis of the clinical trial’s primary endpoints;
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the proximity of patients to clinical trial sites;
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the design of the clinical trial;
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our ability to recruit clinical trial investigators with the appropriate competencies and experience, and the ability of these investigators to identify and enroll suitable patients;
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perception of the safety profile of our product candidates;
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our ability to obtain and maintain patient consents; and
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the risk that patients enrolled in clinical trials will drop out of the trials before completion.
For example, we are developing nirogacestat for the treatment of desmoid tumors and mirdametinib for the treatment of NF1-PN, both of which are rare diseases with small patient populations. As a result, we may encounter difficulties enrolling subjects in our clinical trials for these product candidates due, in part, to the small size of these patient populations. In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a clinical trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site. In addition, in the case of mirdametinib, we may face difficulty with enrollment due to physician or patient perception of an adverse tolerability profile.
Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates.
The target patient populations of nirogacestat for the treatment of desmoid tumors and mirdametinib for the treatment of NF1-PN are small and have not been definitively determined, and if our estimates of the number of treatable patients is lower than expected, our potential revenues from sales of our product candidates, if approved, and our ability to achieve profitability would be compromised.
Our estimates of both the number of patients who have the diseases we are targeting, as well as the subset of patients with these diseases in a position to receive our product candidates, if approved, are based on our beliefs and estimates, and these estimates may prove to be incorrect. These estimates have been derived from a variety of sources, including scientific literature, input from physicians that treat patients with the diseases we are targeting, patient foundations and secondary market research databases. Further, new studies may change the estimated incidence or prevalence of these diseases, and any regulatory approvals that we may receive for a product candidate may include limitations for use or contraindications that decrease the addressable patient population. Accordingly, the target patient populations may turn out to be lower than expected, in which case the potential revenues from sales of our product candidates, if approved, would be lower than expected.
We face significant competition from other biopharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
The biopharmaceutical industry is characterized by intense competition and rapid innovation. Our competitors may be able to develop other compounds or drugs that are able to achieve similar or better results. Our potential competitors include major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions. Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations and well-established sales forces. Smaller or early-stage companies may also prove to be significant competitors, particularly as they develop novel approaches to treating disease indications that our product candidates are also focused on treating. Established pharmaceutical companies may also invest heavily to
accelerate discovery and development of novel therapeutics or to in-license novel therapeutics that could make the product candidates that we develop obsolete. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Our competitors, either alone or with collaboration partners, may succeed in developing, acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialized or less costly than our product candidates or may develop proprietary technologies or secure patent protection that we may need for the development of our technologies and products. We believe the key competitive factors that will affect the development and commercial success of our product candidates are efficacy, safety, tolerability, reliability, convenience of use, price and reimbursement.
Even if we obtain regulatory approval of our product candidates, the availability and price of our competitors’ products could limit the demand and the price we are able to charge for our product candidates. We may not be able to implement our business plan if the acceptance of our product candidates is inhibited by price competition or the reluctance of physicians to switch from existing methods of treatment to our product candidates, or if physicians switch to other new drug or biologic products or choose to reserve our product candidates for use in limited circumstances. For additional information regarding our competition, see “Business—Competition.”
Even if any product candidate we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
If any future product candidate we develop receives marketing approval, whether as a single agent or in combination with other therapies, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. If the product candidates we develop do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. The degree of market acceptance of any product candidate, if approved for commercial sale, will depend on a number of factors, including:
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efficacy and potential advantages compared to other treatments;
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the ability to offer our products, if approved, for sale at competitive prices;
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convenience and ease of administration compared to other treatments;
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the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
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the strength of marketing and distribution support;
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the ability to obtain sufficient third-party coverage, market access and adequate reimbursement; and
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the prevalence and severity of any side effects.
Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
As product candidates proceed through preclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these
intended objectives. Any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the materials manufactured using altered processes. Such changes may also require additional testing, including bridging or comparability testing to demonstrate the validity of clinical data obtained in clinical trials following manufacturing changes, FDA notification or FDA approval.
Because all prior clinical trials of nirogacestat and mirdametinib were conducted by third parties, we will need to perform analytical and other tests to demonstrate that any new drug product material is comparable in all respects, including potency, to the product used in such earlier clinical trials. There is no assurance that any such product will pass the required comparability testing, that any other future third-party manufacturer that we engage will be successful in producing our product candidates or that any materials produced by any third-party manufacturer that we engage will have the same effect in patients that we have observed to date with respect to materials used in prior clinical trials.
All of the above could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and jeopardize our ability to commence sales and generate revenue.
Moreover, we have not yet manufactured or processed on a commercial scale and may not be able to do so for any of our product candidates if approved. We may make changes as we work to optimize our manufacturing processes, but we cannot be sure that even minor changes in our processes will result in therapies that are safe and effective and approved for commercial sale.
If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
We face an inherent risk of product liability as a result of testing our product candidates in clinical trials and will face an even greater risk if we commercialize any products. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical trials, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:
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inability to bring a product candidate to the market;
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decreased demand for our products;
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harm to our reputation;
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withdrawal of clinical trial participants and inability to continue clinical trials;
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initiation of investigations by regulators;
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costs to defend the related litigation;
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diversion of management’s time and our resources;
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substantial monetary awards to clinical trial participants or patients who receive an approved product;
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product recalls, withdrawals or labeling, marketing or promotional restrictions;
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loss of revenue;
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exhaustion of any available insurance and of our capital resources;
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the inability to commercialize any product candidate, if approved; and
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a decline in our stock price.
Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop, alone or with collaborators. Even if our agreements with any current or future corporate collaborators entitle us to indemnification against losses, that indemnification may not be available or adequate should any claim arise. Although we currently carry $5.0 million in clinical trial insurance, that amount of insurance coverage may not be adequate, and, in the future, we may be unable to maintain this insurance coverage, or we may not be able to obtain additional or replacement insurance at a reasonable cost, if at all. Our insurance policies also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay those amounts.
Risks related to government regulation
The regulatory approval process for our product candidates in the United States, the European Union and other jurisdictions is currently uncertain and will be lengthy, time-consuming and inherently unpredictable and we may experience significant delays in the clinical development and regulatory approval, if any, of our product candidates.
The research, testing, manufacturing, labeling, approval, selling, import, export, marketing and distribution of drug products are subject to extensive regulation by the FDA in the United States, the EMA in the European Union and comparable foreign regulatory authorities. We are not permitted to market any product in any jurisdiction until we receive marketing approval from the appropriate regulatory authority. We have not previously submitted an NDA to the FDA, an MAA to the EMA or similar marketing application to comparable foreign regulatory authorities. In the United States, an NDA must include extensive preclinical and clinical data and supporting information to establish that the product candidate is safe, pure and potent for each desired indication. An NDA must also include significant information regarding the chemistry, manufacturing and controls for the product, and the manufacturing facilities must complete a successful pre-approval inspection.
The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support approval. The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to obtain approval of any product candidates that we develop based on the completed clinical trials.
In addition, clinical trials can be delayed or terminated for a variety of reasons, including delays or failures related to:
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obtaining regulatory authorization to begin a clinical trial, if applicable;
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the availability of financial resources to begin and complete the planned trials;
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reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;
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obtaining approval at each clinical trial site by an independent IRB or ethics committee;
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recruiting suitable patients to participate in a clinical trial in a timely manner;
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having patients complete a clinical trial or return for post-treatment follow-up;
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clinical trial sites deviating from clinical trial protocol, not complying with GCP requirements or dropping out of a trial;
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addressing any patient safety concerns that arise during the course of a clinical trial;
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addressing any conflicts with new or existing laws or regulations;
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adding new clinical trial sites; or
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manufacturing qualified materials under cGMP regulations for use in clinical trials.
Patient enrollment is a significant factor in the timing of clinical trials and is affected by many factors. Further, a clinical trial may be suspended or terminated by us, the IRBs for the institutions in which such clinical trials are being conducted, or the FDA, EMA or comparable foreign regulatory authorities, or recommended for suspension or termination by the DSMB for such clinical trial, due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or clinical trial sites by the FDA, EMA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If we experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenue will be delayed. In addition, any delays in completing any clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue.
The FDA, EMA or comparable foreign regulatory authorities may disagree with our regulatory plan for our product candidates.
The general approach for FDA approval of a new drug is dispositive data from one or more well-controlled Phase 3 clinical trials of the product candidate in the relevant patient population. Phase 3 clinical trials typically involve a large number of patients, have significant costs and take years to complete.
Our clinical trial results may not support approval of our product candidates. In addition, our product candidates could fail to receive regulatory approval, or regulatory approval could be delayed, for many reasons, including the following:
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the FDA, EMA or comparable foreign regulatory authorities may disagree with the dosing regimen, design or implementation of our clinical trials;
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we may be unable to demonstrate to the satisfaction of the FDA, EMA or comparable foreign regulatory authorities that our product candidates are safe and effective for any of their proposed indications;
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the results of clinical trials may not meet the level of statistical significance required by the FDA, EMA or comparable foreign regulatory authorities for approval;
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we may be unable to demonstrate that our product candidates’ clinical and other benefits outweigh their safety risks;
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the FDA, EMA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
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the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA, EMA or comparable foreign regulatory authorities to support the submission of an NDA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;
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the FDA, EMA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and
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the approval policies or regulations of the FDA, EMA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
We may seek regulatory approval of our product candidates, including nirogacestat, based on an interim analysis conducted of a registrational trial, particularly if the interim analysis is statistically significant for the primary endpoint and the safety data demonstrate an acceptable safety and tolerability profile. The results of any such interim analysis would be discussed with FDA at a pre-NDA meeting to assess the adequacy of the data to support the submission of a NDA; however, if the FDA does not agree that the interim analysis provides a sufficient basis for regulatory approval, we would not submit an NDA until the conclusion of such registrational trial.
Interim “top-line” and preliminary results from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
From time to time, we may publish interim top-line or preliminary results from our clinical trials. Interim results from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or top-line results also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Differences between preliminary or interim data and final data could significantly harm our business prospects and may cause the trading price of our common stock to fluctuate significantly.
We have been granted Orphan Drug Designation for nirogacestat and mirdametinib and may seek Orphan Drug Designation for other product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity.
Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs and therapeutic biologics for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug or therapeutic biologic as an orphan drug if it is a drug or therapeutic biologic intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug or therapeutic biologic will be recovered from sales in the United States. In the United States, Orphan Drug Designation entitles a party to financial incentives such as opportunities for grant funding toward clinical trial costs, tax advantages and user-fee waivers. In addition, if a product that has Orphan Drug Designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications, including a full NDA or Biologics License Application, or BLA, to market the
same product for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or where the manufacturer is unable to assure sufficient product quantity.
In June 2018, the FDA granted Orphan Drug Designation to nirogacestat for the treatment of desmoid tumors. In October 2018, the FDA granted Orphan Drug Designation to mirdametinib for the treatment of NF1 and in July 2019 the European Commission granted mirdametinib Orphan Drug Designation for the treatment of NF1. We may seek Orphan Drug Designations for nirogacestat and mirdametinib for other indications or for our other product candidates. There can be no assurances that we will be able to obtain such designations.
Even if we obtain Orphan Drug Designation for any of our future product candidates in specific indications, we may not be the first to obtain marketing approval of nirogacestat, mirdametinib or any other such product candidates for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.
Further, even if we obtain orphan drug exclusivity in the United States for a product, that exclusivity may not effectively protect the product from competition because different drugs or therapeutic biologics with different active moieties can be approved for the same condition. Even after an orphan product is approved, the FDA can subsequently approve the same drug or therapeutic biologic with the same active moiety for the same condition if the FDA concludes that the later drug or therapeutic biologic is safer, more effective or makes a major contribution to patient care. In Europe, we could be prevented from marketing our products if a similar medicinal product is granted Orphan Drug Designation for the same indications that we are pursuing. Once authorized, with a limited number of exceptions, neither the competent authorities of the EU member states, the EMA or the European Commission are permitted to accept applications or grant marketing authorization for other similar medicinal products with the same therapeutic indication. Marketing authorization could also be granted to a similar medicinal product with the same orphan indication if the latter product is safer, more effective or otherwise clinically superior to the original orphan medicinal product. Further, the composition of matter patents for nirogacestat and mirdametinib expire in 2025 and 2021, respectively, and if orphan drug exclusivity does not protect these products from competition, our business and financial condition could be materially adversely affected. Orphan Drug Designation neither shortens the development time or regulatory review time of a drug or therapeutic biologic nor gives the drug or therapeutic biologic any advantage in the regulatory review or approval process. In addition, while we may seek Orphan Drug Designation for our future product candidates, we may never receive such designations.
Breakthrough Therapy Designation or Fast Track Designation from the FDA may not actually lead to a faster development or regulatory review or approval process.
The FDA has granted Fast Track Designation and Breakthrough Therapy Designation for nirogacestat for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis, and has granted Fast Track Designation for mirdametinib for the treatment of patients at least two years of age with NF1-associated inoperable PN that are progressing or causing significant morbidity. We may seek Breakthrough Therapy Designation or Fast Track Designation for our other product candidates.
If a product is intended for the treatment of a serious or life-threatening condition and the product demonstrates the potential to address unmet medical needs for this condition, the product sponsor may apply for Fast Track Designation. The FDA has broad discretion whether or not to grant this designation, so even if we believe one of our product candidates is eligible for this designation, we cannot assure you that the FDA would decide to grant it. Even if we do receive Fast Track Designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw Fast Track Designation if it believes that the designation is no longer supported by data from our clinical development program.
A breakthrough therapy is defined as a product that is intended, alone or in combination with one or more other products, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For products that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens.
Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe one of our product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a Breakthrough Therapy Designation may not result in a faster development process, review or approval compared to products considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if a product candidate qualifies as a breakthrough therapy, the FDA may later decide that the product no longer meets the conditions for qualification and rescind the Breakthrough Therapy Designation.
The results of clinical trials conducted at clinical trial sites outside the United States might not be accepted by the FDA, and data developed outside of a foreign jurisdiction similarly might not be accepted by such foreign regulatory authority.
Some of the prior clinical trials for our product candidates were conducted outside the United States, and we intend to conduct additional clinical trials outside the United States. Although the FDA, EMA or comparable foreign regulatory authorities may accept data from clinical trials conducted outside the relevant jurisdiction, acceptance of these data is subject to certain conditions. For example, the FDA requires that the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles such as IRB or ethics committee approval and informed consent, the trial population must adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. In addition, while these clinical trials are subject to the applicable local laws, acceptance of the data by the FDA will be dependent upon its determination that the trials were conducted consistent with all applicable U.S. laws and regulations. There can be no assurance that the FDA will accept data from trials conducted outside of the United States as adequate support of a marketing application. Similarly, we must also ensure that any data submitted to foreign regulatory authorities adheres to their standards and requirements for clinical trials and there can be no assurance a comparable foreign regulatory authority would accept data from trials conducted outside of its jurisdiction.
Our relationships with healthcare providers and physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
Healthcare providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical products. Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, or FCA, which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products. In particular, the research of our product candidates, as well as the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials. The applicable federal, state and foreign healthcare laws and regulations that may affect our ability to operate include, but are not limited to:
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the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A person or entity can be found guilty of violating the statute without actual knowledge of the statute or specific intent to violate it. In addition, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution;
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the federal civil and criminal false claims laws and civil monetary penalty laws, including the FCA, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment to, or approval by Medicare, Medicaid or other federal healthcare programs, knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim or an obligation to pay or transmit money to the federal government, or knowingly concealing or knowingly and improperly avoiding or decreasing or concealing an obligation to pay money to the federal government. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The government may deem manufacturers to have “caused” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product off-label. The FCA also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery;
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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or
attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it;
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose, among other things, requirements on certain healthcare providers, health plans and healthcare clearinghouses, known as covered entities, as well as their respective business associates, independent contractors that perform services for covered entities that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions;
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the federal Physician Payments Sunshine Act, created under the Patient Protection and Affordable Care Act, as amended, or ACA, and its implementing regulations, which require some manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the Centers for Medicare & Medicaid Services, or CMS, of the U.S. Department of Health and Human Services, or HHS, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and
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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, and may be broader in scope than their federal equivalents; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or drug pricing; state and local laws that require the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products. Pharmaceutical companies may also be subject to federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.
The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent
and regulations. Federal and state enforcement bodies continue to closely scrutinize interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time and resource-consuming and can divert a company’s attention from the business.
It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in federal and state funded healthcare programs, contractual damages and the curtailment or restricting of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. Any action for violation of these laws, even if successfully defended, could cause a biopharmaceutical manufacturer to incur significant legal expenses and divert management’s attention from the operation of the business. Prohibitions or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way.
Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, the EMA or comparable foreign regulatory authorities must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.
We may also submit marketing applications in other countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.
Even if we receive regulatory approval of any product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
If any of our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities. In addition, we will be subject to continued compliance with cGMP and GCP requirements for any clinical trials that we conduct post-approval.
Manufacturers and manufacturers’ facilities are required to comply with extensive FDA, EMA and comparable foreign regulatory authority requirements, including ensuring that quality control and manufacturing procedures conform to cGMP regulations. As such, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any BLA, other marketing application and previous responses to inspection observations. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.
Any regulatory approvals that we receive for our product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials and surveillance to monitor the safety and efficacy of the product candidate. Certain endpoint data we hope to include in any approved product labeling also may not make it into such labeling, including exploratory or secondary endpoint data such as patient-reported outcome measures. The FDA may also require a risk evaluation and mitigation strategies, or REMS, program as a condition of approval of our product candidates, which could entail requirements for long-term patient follow-up, a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA, EMA or a comparable foreign regulatory authority approves our product candidates, we will have to comply with requirements including submissions of safety and other post-marketing information and reports and registration.
The FDA may impose consent decrees or withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-market studies or clinical trials to assess new safety risks or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:
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restrictions on the marketing or manufacturing of our products, withdrawal of the product from the market or voluntary or mandatory product recalls;
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fines, warning letters or holds on clinical trials;
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refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;
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product seizure or detention or refusal to permit the import or export of our product candidates; and
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injunctions or the imposition of civil or criminal penalties.
The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Products may be promoted only for the approved indications and in accordance with the provisions of the approved label. The policies of the FDA, EMA and comparable foreign regulatory authorities may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.
Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, if approved, which could make it difficult for us to sell any product candidates profitably.
The success of our product candidates, if approved, depends on the availability of coverage and adequate reimbursement from third-party payors. We cannot be sure that coverage and reimbursement will be available for, or accurately estimate the potential revenue from, our product candidates or assure that coverage and reimbursement will be available for any product that we may develop.
Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance.
Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement. Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:
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a covered benefit under its health plan;
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safe, effective and medically necessary;
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appropriate for the specific patient;
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cost-effective; and
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neither experimental nor investigational.
In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. As a result, obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness data for the use of our products on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Additionally, third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of product candidates, once approved. Patients are unlikely to use our product candidates, once approved, unless coverage is provided and reimbursement is adequate
to cover a significant portion of their cost. There is significant uncertainty related to insurance coverage and reimbursement of newly approved products. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.
Payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, the Middle Class Tax Relief and Job Creation Act of 2012 required that CMS, the agency responsible for administering the Medicare program, reduce the Medicare clinical laboratory fee schedule by 2% in 2013, which served as a base for 2014 and subsequent years. In addition, effective January 1, 2014, CMS also began bundling the Medicare payments for certain laboratory tests ordered while a patient received services in a hospital outpatient setting. Additional state and federal healthcare reform measures are expected to be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for certain pharmaceutical products or additional pricing pressures.
Moreover, increasing efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates. There has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drugs. We expect to experience pricing pressures in connection with the sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, cost containment initiatives and additional legislative changes.
At the federal level, the Trump administration’s budget proposals for fiscal years 2019 and 2020 contain further drug price control measures that could be enacted during the legislative session or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid and to eliminate cost sharing for generic drugs for low-income patients. While any proposed measures will require authorization through additional legislation to become effective, Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.
At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.
Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of our products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business.
In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the ACA was passed, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacted the U.S. biopharmaceutical industry. The ACA, among other things, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations, established annual fees and taxes on manufacturers of certain branded prescription drugs and created a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.
Some of the provisions of the ACA have yet to be fully implemented, while certain provisions have been subject to judicial and Congressional challenges, as well as efforts by the Trump administration to repeal or replace certain aspects of the ACA. For example, Congress has considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed repeal legislation, the Tax Reform Act includes a provision that repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” As a result of the individual mandate repeal, subsequent litigation challenged the validity of the ACA. On December 14, 2018, a U.S. District Court judge in the Northern District of Texas ruled that the individual mandate portion of the ACA is an essential and inseverable feature of the ACA, and therefore because the mandate was repealed as part of the Tax Cuts and Jobs Act, or TCJA, the remaining provisions of the ACA are invalid as well. The Trump administration and CMS have both stated that the ruling will have no immediate effect, and on December 30, 2018 the same judge issued an order staying the judgment pending appeal. A Fifth Circuit U.S. Court of Appeals hearing to determine whether certain states and the House of Representatives have standing to appeal the lower court decision was held on July 9, 2019, but it is unclear when the court will render its decision on this hearing, and what effect it will have on the status of the ACA. Litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results. We will continue to evaluate the effect that the ACA and its possible repeal and replacement has on our business.
Since January 2017, President Trump has signed two Executive Orders designed to delay the implementation of certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. Further, the Trump administration has concluded that cost-sharing reduction, or CSR, payments to insurance companies required under the ACA have not received necessary appropriations from Congress and announced that it will discontinue these payments immediately until those appropriations are made. The loss of the CSR payments is expected to increase premiums on certain policies issued by qualified health plans under the ACA. Bipartisan bills to appropriate funds for CSR payments were proposed in 2017 and 2018, but the proposals have not been enacted into law. Multiple state Attorneys General filed suit to stop the administration from terminating the subsidies, but their case was dismissed by a federal judge in California on July 18, 2018. Furthermore, on June 14, 2018, the U.S. Court of Appeals for the Federal Circuit ruled that the federal government was not required to pay more than $12 billion in ACA risk corridor payments to third-party payors who argued were owed to them. The effects of this gap in reimbursement on third-party payors, the viability of the ACA marketplace and providers, and the potential effect on our business, are not yet known.
Additionally, CMS has recently published regulations that would give states greater flexibility starting in 2020 in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces. The Bipartisan Budget Act of 2018, or BBA, also amended the ACA, effective January 1, 2019, by increasing the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D and closing the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.” Moreover, in 2018, CMS published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance issuers under the ACA risk adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses to determine this risk adjustment. On May 23, 2019, CMS finalized a rule that amends the Medicare Advantage and Medicare Part D prescription drug benefit regulations to reduce out-of-pocket costs for plan enrollees and allows Medicare plans to negotiate lower rates for certain drugs. Among other things, the final rule allows Medicare Advantage plans the option to use step therapy, a type of prior authorization, as part of patient-centered care coordination programs for Medicare Part B drugs, beginning January 1, 2020. The proposed rule proposed to change the definition of “negotiated prices,” under which plan sponsors would be required to pass through all pharmacy price concessions at the point of sale; however, CMS is still reviewing comments from stakeholders on this issue. Litigation and legislative efforts to change or repeal the ACA are likely to continue, with unpredictable and uncertain results.
Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. The Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs, including aggregate reductions of Medicare payments to providers of 2% per fiscal year. These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, including the BBA, will remain in effect through 2027, unless additional congressional action is taken. On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
There has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. At the federal level, the Trump administration’s budget for fiscal year 2019 contains further drug price control measures that could be enacted during the 2019 legislative session, or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients. Additionally, the Trump administration released a “Blueprint” to lower drug prices and reduce out-of-pocket costs of drugs that contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and reduce the out-of-pocket costs of drug products paid by consumers. The HHS has already started the process of soliciting feedback on some of these measures and, at the same time, is immediately implementing others under its existing authority. Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or
administrative measures to control drug costs. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
These laws, and future state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.
Off-label use or misuse of our products may harm our reputation in the marketplace or result in injuries that lead to costly product liability suits.
We are developing nirogacestat for the treatment of desmoid tumors and mirdametinib for the treatment of NF1-PN. If our product candidates are approved by the FDA, we may only promote or market our product candidates for their specifically approved indications. We will train our marketing and sales force against promoting our product candidates for uses outside of the approved indications for use, known as “off-label uses.” We cannot, however, prevent a physician from using our products off label, when in the physician’s independent professional medical judgment he or she deems it appropriate. Furthermore, the use of our products for indications other than those approved by the FDA may not effectively treat such conditions. Any such off-label use of our product candidates could harm our reputation in the marketplace among physicians and patients. There may also be increased risk of injury to patients if physicians attempt to use our products for these uses for which they are not approved, which could lead to product liability suits that that might require significant financial and management resources and that could harm our reputation.
Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.
Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, upon completion of this offering and in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
EU drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the European member states.
We intend to seek approval to market our product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign jurisdictions for our product candidates, we will be subject to rules and regulations in those jurisdictions. In some foreign countries, particularly those in the European Union, the pricing of drugs is subject to governmental control and other market regulations which could put pressure on the pricing and usage of our product candidates. In these countries, pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate. In addition, market acceptance and sales of our product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for our product candidates and may be affected by existing and future healthcare reform measures.
Much like the federal Anti-Kickback Statute prohibition in the United States, the provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also prohibited in the European Union. The provision of benefits or advantages to physicians is governed by the national anti-bribery laws of EU Member States, such as the UK Bribery Act 2010. Infringement of these laws could result in substantial fines and imprisonment.
Payments made to physicians in certain EU Member States must be publicly disclosed. Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization and/or the regulatory authorities of the individual EU Member States. These requirements are provided in the national laws, industry codes or professional codes of conduct, applicable in the EU Member States. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.
In addition, in most foreign countries, including the European Economic Area, or EEA, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing and reimbursement vary widely from country to country. For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. Reference pricing used by various EU member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. In some countries, we may be required to conduct a clinical study or other studies that compare the cost-effectiveness of any of our product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval. There can be no assurance that any country that has price controls or reimbursement limitations for biopharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. Historically, products launched in the European Union do not follow price structures of the United States and generally prices tend to be significantly lower. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If pricing is set at unsatisfactory levels or if reimbursement of our products is unavailable or limited in scope or amount, our revenues from sales and the potential profitability of any of our product candidates in those countries would be negatively affected.
We may incur substantial costs in our efforts to comply with evolving global data protection laws and regulations, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations.
The global data protection landscape is rapidly evolving, and we may be or become subject to or affected by numerous federal, state and foreign laws and regulations, as well as regulatory guidance, governing the collection, use, disclosure, transfer, security and processing of personal data, such as information that we collect about participants and healthcare providers in connection with clinical trials. Implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, which may create uncertainty in our business, affect our or our service providers’ ability to operate in certain jurisdictions or to collect, store, transfer use and share personal data, result in liability or impose additional compliance or other costs on us. Any failure or perceived failure by us to comply with federal, state, or foreign laws or self-regulatory standards could result in negative publicity, diversion of management time and effort and proceedings against us by governmental entities or others. For example, California recently passed the California Data Privacy Protection Act, which goes into effect in January 2020 and provides broad rights to California consumers with respect to the collection and use of their information by businesses. The new California law further expands the privacy and process enhancements and commitment of resources in support of compliance with California’s regulatory requirements and may lead to similar laws in other U.S. states or at a national level.
In addition to our operations in the United States, which may be subject to healthcare and other laws relating to the privacy and security of health information and other personal information, may seek to conduct clinical trials in EEA and may become subject to additional European data privacy laws, regulations and guidelines. The General Data Protection Regulation, (EU) 2016/679, or GDPR, became effective on May 25, 2018, and deals with the processing of personal data and on the free movement of such data. The GDPR imposes a broad range of strict requirements on companies subject to the GDPR, including requirements relating to having legal bases for processing personal information relating to identifiable individuals and transferring such information outside the EEA, including to the United States, providing details to those individuals regarding the processing of their personal information, keeping personal information secure, having data processing agreements with third parties who process personal information, responding to individuals’ requests to exercise their rights in respect of their personal information, reporting security breaches involving personal data to the competent national data protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessments and record-keeping. The GDPR increases substantially the penalties to which we could be subject in the event of any non-compliance, including fines of up to 10,000,000 Euros or up to 2% of our total worldwide annual turnover for certain comparatively minor offenses, or up to 20,000,000 Euros or up to 4% of our total worldwide annual turnover for more serious offenses. Given the limited enforcement of the GDPR to date, we face uncertainty as to the exact interpretation of the new requirements on our trials and we may be unsuccessful in implementing all measures required by data protection authorities or courts in interpretation of the new law.
In particular, national laws of member states of the European Union are in the process of being adapted to the requirements under the GDPR, thereby implementing national laws which may partially deviate from the GDPR and impose different obligations from country to country, so that we do not expect to operate in a uniform legal landscape in the EEA. Also, as it relates to processing and transfer of genetic data, the GDPR specifically allows national laws to impose additional and more specific requirements or restrictions, and European laws have historically differed quite substantially in this field, leading to additional uncertainty. Further, the impact of the impending “Brexit”, whereby the United Kingdom is planning to leave the EEA in October of 2019, either with or without a “deal” is uncertain and cannot be predicted at this time.
In the event we commence clinical trials in the EEA, we must also ensure that we maintain adequate safeguards to enable the transfer of personal data outside of the EEA, in particular to the United States, in compliance with European data protection laws. We expect that we will continue to face uncertainty as to whether our efforts to comply with any obligations under European privacy laws will be sufficient. If we are investigated by a European data protection authority, we may face fines and other penalties. Any such investigation or charges by European data protection authorities could have a negative effect on our existing business and on our ability to attract and retain new clients or biopharmaceutical partners. We may also experience hesitancy, reluctance or refusal by European or multi-national clients or biopharmaceutical partners to continue to use our products and solutions due to the potential risk exposure as a result of the current (and, in particular, future) data protection obligations imposed on them by certain data protection authorities in interpretation of current law, including the GDPR. Such clients or biopharmaceutical partners may also view any alternative approaches to compliance as being too costly, too burdensome, too legally uncertain or otherwise objectionable and therefore decide not to do business with us. Any of the forgoing could materially harm our business, prospects, financial condition and results of operations.
Additional laws and regulations governing international operations could negatively impact or restrict our operations.
If we further expand our operations outside of the United States, we must dedicate additional resources to comply with numerous laws and regulations in each jurisdiction in which we plan to operate. The U.S. Foreign Corrupt Practices Act, or FCPA, prohibits any U.S. individual or business from paying, offering, authorizing payment or offering anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.
Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.
Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. If we expand our presence outside of the United States, it will require us to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing or selling certain products and product candidates outside of the United States, which could limit our growth potential and increase our development costs.
The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting. The SEC also may suspend or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions.
We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. We can face serious consequences for violations.
Among other matters, U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations, which are collectively referred to as Trade Laws, prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors and other partners from authorizing, promising, offering, providing, soliciting or receiving, directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. We also expect our non-U.S. activities to increase in time. We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents or partners, even if we do not explicitly authorize or have prior knowledge of such activities.
A portion of our manufacturing of our lead product candidates takes place in China through third-party manufacturers. A significant disruption in the operation of those manufacturers, a trade war or political unrest in China could materially adversely affect our business, financial condition and results of operations.
We currently contract manufacturing operations to third parties, and clinical quantities of our lead product candidates are manufactured by these third parties outside the United States, including in China, and we expect to continue to use such third-party manufacturers for such product candidates. Any disruption in production or inability of our manufacturers in China to produce adequate quantities to meet our needs, whether as a result of a natural disaster or other causes, could impair our ability to operate our business on a day-to-day basis and to continue our development of our product candidates. Furthermore, since these manufacturers are located in China, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in the policies of the United States or Chinese governments, political unrest or unstable economic conditions in China. For example, a trade war could lead to tariffs on the chemical intermediates we use that are manufactured in China. Any of these matters could materially and adversely affect our business and results of operations. Any recall of the manufacturing lots or similar action regarding our product candidates used in clinical trials could delay the trials or detract from the integrity of the trial data and its potential use in future regulatory filings. In addition, manufacturing interruptions or failure to comply with regulatory requirements by any of these manufacturers could significantly delay clinical development of potential products and reduce third-party or clinical researcher interest and support of proposed trials. These interruptions or failures could also impede commercialization of our product candidates and impair our competitive position. Further, we may be exposed to fluctuations in the value of the local currency in China. Future appreciation of the local currency could increase our costs. In addition, our labor costs could continue to rise as wage rates increase due to increased demand for skilled laborers and the availability of skilled labor declines in China.
Risks related to our intellectual property
Our success depends in part on our ability to protect our intellectual property, and patent terms may be inadequate to protect our competitive position. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
Our commercial success will depend in large part on obtaining and maintaining patent, trademark and trade secret protection of our proprietary technologies and our product candidates, their respective components, formulations, combination therapies, methods used to manufacture them and methods of treatment, as well as successfully defending these patents against third-party challenges. Our ability to stop unauthorized third parties from making, using, selling, offering to sell or importing our product candidates is affected by the extent to which we have rights under valid and enforceable patents that cover these activities. If our patents expire, or we are unable to secure and maintain patent protection for any product or technology we develop, or if the scope of the patent protection secured is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to commercialize any product candidates we may develop may be adversely affected.
Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions such as patent term adjustments and/or extensions, may be available, but the life of a patent, and the protection it affords, is limited. Our current composition of matter patents covering nirogacestat and mirdametinib, which we licensed from Pfizer Inc., or Pfizer, in connection with the formation of our company, are expected to expire in 2025 and 2021, respectively, not including any patent term extensions. Our earliest patents may expire before, or soon after, either product candidate achieves marketing approval in the United States or foreign jurisdictions. Upon the expiration of the current patents, we currently intend to rely on orphan drug exclusivity to market our lead products. Once the patent life has expired, we may be open to competition from competitive products, including generics. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. The expiration of the patents covering our lead product candidates, and our inability to secure additional patent protection, could also have a material adverse effect on our business, results of operations, financial condition and prospects.
The patenting process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. In addition, we may not pursue or obtain patent protection in all relevant markets. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from or license to third parties and are reliant on our licensors or licensees.
The strength of patents in the biopharmaceutical field involves complex legal and scientific questions and can be uncertain. The patent applications that we own or in-license now or in the future may fail to result in issued patents with claims that cover our product candidates or uses thereof in the United States or in other foreign countries. Even if the patents do successfully issue, third parties may challenge the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable. Furthermore, even if they are unchallenged, the patents and patent applications covering our product candidates may not adequately protect our intellectual property or prevent others from designing around our claims. If the breadth or strength of protection provided by the patents we hold with respect to our
product candidates is threatened, it could dissuade companies from collaborating with us to develop, and threaten our ability to commercialize, our product candidates. Further, if we encounter delays in our clinical trials, the period of time during which we could market our product candidates under patent protection would be reduced.
Since patent applications in the United States and most other countries are confidential for a period of time after filing, there is no certainty that any patent application related to a product candidate was the first to be filed. Furthermore, for United States applications in which at least one claim is entitled to a priority date before March 16, 2013, an interference proceeding can be provoked by a third party or instituted by the U.S. Patent and Trademark Office, or USPTO, to determine who was the first to invent any of the subject matter covered by the patent claims of an application.
We cannot be certain that we are the first to invent any inventions covered by a pending patent application and, if we are not, we could be subject to priority disputes. We may be required to disclaim part or all of the term of certain patents or all of the term of certain patent applications. There may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim. There also may be prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim. No assurance can be given that if challenged, our patents would be declared by a court to be valid or enforceable or that even if found valid and enforceable, a competitor’s technology or product would be found by a court to infringe our patents. We may analyze patents or patent applications of our competitors that we believe are relevant to our activities, and consider that we are free to operate in relation to our product candidates, but our competitors may achieve issued claims, including in patents we consider to be unrelated, which block our efforts or may potentially result in our product candidates or our activities infringing such claims. The possibility exists that others will develop products which have the same effect as our products on an independent basis which do not infringe our patents or other intellectual property rights, or will design around the claims of patents that we have had issued that cover our products.
Recent or future patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. Under the enacted Leahy-Smith America Invents Act, or America Invents Act, enacted in 2013, the United States moved from a “first-to-invent” to a “first-to-file” system. Under a “first-to-file” system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to a patent on the invention regardless of whether another inventor had made the invention earlier. The America Invents Act includes a number of other significant changes to U.S. patent law, including provisions that affect the way patent applications are prosecuted, redefine prior art and establish a new post-grant review system. The effects of these changes are currently unclear as the USPTO only recently developed new regulations and procedures in connection with the America Invents Act and many of the substantive changes to patent law, including the “first-to-file” provisions, only became effective in March 2013. In addition, the courts have yet to address many of these provisions and the applicability of the act and new regulations on specific patents discussed herein have not been determined and would need to be reviewed. However, the America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of any patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.
The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. For example:
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others may be able to make or use compounds that are similar to the compositions of our product candidates but that are not covered by the claims of our patents;
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the active ingredients in our current product candidates will eventually become commercially available in generic drug products, and no patent protection may be available with regard to formulation or method of use;
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a company or its licensor, as the case may be, may fail to meet its obligations to the U.S. government in regard to any in-licensed patents and patent applications funded by U.S. government grants, leading to the loss of patent rights;
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such company or its licensors, as the case may be, might not have been the first to file patent applications for these inventions;
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others may independently develop similar or alternative technologies or duplicate any of our technologies;
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it is possible that a pending patent applications will not result in issued patents;
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it is possible that there are prior public disclosures that could invalidate our or our licensors’ patents, as the case may be, or parts of our or their patents;
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it is possible that others may circumvent our owned or in-licensed patents;
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it is possible that there are unpublished applications or patent applications maintained in secrecy that may later issue with claims covering our products or technology similar to ours;
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the laws of foreign countries may not protect our or our licensors’, as the case may be, proprietary rights to the same extent as the laws of the United States;
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the claims of our owned or in-licensed issued patents or patent applications, if and when issued, may not cover our product candidates;
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our owned or in-licensed issued patents may not provide us with any competitive advantages, may be narrowed in scope, or be held invalid or unenforceable as a result of legal challenges by third parties;
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the inventors of owned or in-licensed patents or patent applications may become involved with competitors, develop products or processes which design around our patents, or become hostile to us or the patents or patent applications on which they are named as inventors;
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it is possible that owned or in-licensed patents or patent applications omit individual(s) that should be listed as inventor(s) or include individual(s) that should not be listed as inventor(s), which may cause these patents or patents issuing from these patent applications to be held invalid or unenforceable;
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we have engaged in scientific collaborations in the past, and will continue to do so in the future. Such collaborators may develop adjacent or competing products to ours that are outside the scope of our patents;
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we may not develop additional proprietary technologies for which we can obtain patent protection;
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it is possible that product candidates we develop may be covered by third parties’ patents or other exclusive rights; or
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the patents of others may have an adverse effect on our business.
We depend on intellectual property licensed from third parties, including from Pfizer for our lead product candidates, and termination of any of these licenses could result in the loss of significant rights, which would harm our business.
We are dependent on patents, know-how and proprietary technology, both our own and licensed from others. All patents covering nirogacestat and mirdametinib and any combination therapies using our product candidates are licensed from third parties. Any termination of a product license could result in the loss of significant rights and would cause material adverse harm to our ability to commercialize our product candidates. See “Business—License and collaboration agreements” for additional information regarding our license agreements.
Disputes may also arise between us and our licensors regarding intellectual property subject to a license agreement, including:
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the scope of rights granted under the license agreement and other interpretation-related issues;
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whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
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our right to sublicense patent and other rights to third parties under collaborative development relationships;
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our diligence obligations with respect to the use of licensed technology in relation to our development and commercialization of our product candidates and what activities satisfy those diligence obligations; and
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the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners.
If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.
We are generally also subject to all of the same risks with respect to protection of intellectual property that we own, as we are for intellectual property that we license, which are described below. If we or our licensors fail to adequately protect this intellectual property, our ability to commercialize products could materially suffer.
If we fail to comply with our obligations under our patent licenses with third parties, we could lose license rights that are important to our business.
We are a party to license agreements pursuant to which we in-license key patents for our product candidates. At the time we began our operations in August 2017, we entered into four license agreements with Pfizer, including a license agreement for each of our lead product candidates, nirogacestat and mirdametinib. Each of our existing licenses imposes various diligence, milestone payment, royalty, insurance and other obligations on us. If we fail to comply with these obligations, our licensors may have the right to terminate the license, in which event we would not be able to develop or market the products covered by such licensed intellectual property.
We may have limited control over the maintenance and prosecution of these in-licensed rights, activities or any other intellectual property that may be related to our in-licensed intellectual property. For example, we cannot be certain that such activities by these licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents and other intellectual property rights. We have limited control over the
manner in which our licensors initiate an infringement proceeding against a third-party infringer of the intellectual property rights, or defend certain of the intellectual property that is licensed to us. It is possible that the licensors’ infringement proceeding or defense activities may be less vigorous than had we conducted them ourselves.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
In addition to patent protection, we rely heavily upon know-how and trade secret protection, as well as non-disclosure agreements and invention assignment agreements with our employees, consultants and third parties, to protect our confidential and proprietary information, especially where we do not believe patent protection is appropriate or obtainable. In addition to contractual measures, we try to protect the confidential nature of our proprietary information using physical and technological security measures. Such measures may not, for example, in the case of misappropriation of a trade secret by an employee or third party with authorized access, provide adequate protection for our proprietary information. Our security measures may not prevent an employee or consultant from misappropriating our trade secrets and providing them to a competitor, and recourse we take against such misconduct may not provide an adequate remedy to protect our interests fully. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, trade secrets may be independently developed by others in a manner that could prevent legal recourse by us. If any of our confidential or proprietary information, such as our trade secrets, were to be disclosed or misappropriated, or if any such information was independently developed by a competitor, our competitive position could be harmed.
In addition, courts outside the United States are sometimes less willing to protect trade secrets. If we choose to go to court to stop a third party from using any of our trade secrets, we may incur substantial costs. These lawsuits may consume our time and other resources even if we are successful. Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees and consultants, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology.
Thus, we may not be able to meaningfully protect our trade secrets. It is our policy to require our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information concerning our business or financial affairs developed or made known to the individual or entity during the course of the party’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. In the case of employees, the agreements provide that all inventions conceived by the individual, and which are related to our current or planned business or research and development or made during normal working hours, on our premises or using our equipment or proprietary information, are our exclusive property. In addition, we take other appropriate precautions, such as physical and technological security measures, to guard against misappropriation of our proprietary technology by third parties.
Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts.
Our commercial success depends in part on our ability to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. There is a substantial amount of litigation involving patents and other
intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference, derivation, inter partes review, post grant review, and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions. We may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights alleging that our product candidates and/or proprietary technologies infringe their intellectual property rights. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing our product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates may give rise to claims of infringement of the patent rights of others. Moreover, it is not always clear to industry participants, including us, which patents cover various types of drugs, products or their methods of use or manufacture. Thus, because of the large number of patents issued and patent applications filed in our fields, there may be a risk that third parties may allege they have patent rights encompassing our product candidates, technologies or methods.
If a third party claims that we infringe its intellectual property rights, we may face a number of issues, including, but not limited to:
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infringement and other intellectual property claims which, regardless of merit, may be expensive and time-consuming to litigate and may divert our management’s attention from our core business;
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substantial damages for infringement, which we may have to pay if a court decides that the product candidate or technology at issue infringes on or violates the third party’s rights, and, if the court finds that the infringement was willful, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees;
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a court prohibiting us from developing, manufacturing, marketing or selling our product candidates, or from using our proprietary technologies, unless the third party licenses its product rights to us, which it is not required to do;
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if a license is available from a third party, we may have to pay substantial royalties, upfront fees and other amounts, and/or grant cross-licenses to intellectual property rights for our products; and
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redesigning our product candidates or processes so they do not infringe, which may not be possible or may require substantial monetary expenditures and time.
Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations or could otherwise have a material adverse effect on our business, results of operations, financial condition and prospects.
Third parties may assert that we are employing their proprietary technology without authorization. Generally, conducting clinical trials and other development activities in the United States is protected under the Safe Harbor exemption as set forth in 35 U.S.C. §271. If and when any of our product candidates are approved by the FDA, that certain third-party may then seek to enforce its patent by filing a patent infringement lawsuit against us. While we do not believe that any claims of such patent that could otherwise materially adversely affect commercialization of our product candidates, if approved, are valid and enforceable, we may be incorrect in this belief, or we may not be able to prove it in a litigation. In this regard, patents issued in the U.S. by law enjoy a presumption of validity that can be rebutted only with evidence that is “clear and
convincing,” a heightened standard of proof. There may be third-party patents of which we are currently unaware with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our product candidates, constructs or molecules used in or formed during the manufacturing process, or any final product itself, the holders of any such patents may be able to block our ability to commercialize the product candidate unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, the holders of any such patent may be able to block our ability to develop and commercialize the product candidate unless we obtained a license or until such patent expires or is finally determined to be held invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, our ability to commercialize our product candidates may be impaired or delayed, which could in turn significantly harm our business. Even if we obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In addition, if the breadth or strength of protection provided by our patents and any patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.
Parties making claims against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we or our licensors may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research or allow commercialization of our product candidates. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize our product candidates, which could harm our business significantly.
Third parties may assert that our employees, consultants, collaborators or partners have wrongfully used or disclosed confidential information or misappropriated trade secrets.
As is common in the biotechnology and pharmaceutical industries, we employ individuals who were previously employed at universities or other biopharmaceutical or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, and although we try to ensure that our employees and consultants do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of a former employer or other third parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary
damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and, if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. This type of litigation or proceeding could substantially increase our operating losses and reduce our resources available for development activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other intellectual property related proceedings could adversely affect our ability to compete in the marketplace.
We may not be successful in obtaining or maintaining necessary rights to develop any future product candidates on acceptable terms.
Because our programs may involve additional product candidates that may require the use of proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license or use these proprietary rights.
Our product candidates may also require specific formulations to work effectively and efficiently and these rights may be held by others. We may develop products containing our compounds and pre-existing pharmaceutical compounds. We may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify as necessary or important to our business operations. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all, which would harm our business. We may need to cease use of the compositions or methods covered by such third-party intellectual property rights, and may need to seek to develop alternative approaches that do not infringe on such intellectual property rights which may entail additional costs and development delays, even if we were able to develop such alternatives, which may not be feasible. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In that event, we may be required to expend significant time and resources to develop or license replacement technology.
Additionally, we sometimes collaborate with academic institutions to accelerate our preclinical research or development under written agreements with these institutions. In certain cases, these institutions may provide us with an option to negotiate a license to any of the institution’s rights in technology resulting from the collaboration. Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to us. If we are unable to do so, the institution may offer the intellectual property rights to others, potentially blocking our ability to pursue our program. If we are unable to successfully obtain rights to required third-party intellectual property or to maintain the existing intellectual property rights we have, we may have to abandon development of such program and our business and financial condition could suffer.
The licensing and acquisition of third-party intellectual property rights is a competitive area, and companies, which may be more established, or have greater resources than we do, may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider necessary or attractive in order to commercialize our product candidates. More established companies may have a competitive advantage over us due to their size, cash resources
and greater clinical development and commercialization capabilities. There can be no assurance that we will be able to successfully complete such negotiations and ultimately acquire the rights to the intellectual property surrounding the additional product candidates that we may seek to acquire.
We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that one or more of our patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated, held unenforceable or interpreted narrowly and could put any patent applications at risk of not issuing. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.
We may choose to challenge the patentability of claims in a third party’s U.S. patent by requesting that the USPTO review the patent claims in an ex-parte re-exam, inter partes review or post-grant review proceedings. These proceedings are expensive and may consume our time or other resources. We may choose to challenge a third party’s patent in patent opposition proceedings in the European Patent Office, or EPO, or other foreign patent offices. The costs of these opposition proceedings could be substantial and may consume our time or other resources. If we fail to obtain a favorable result at the USPTO, EPO or other patent offices then we may be exposed to litigation by a third party alleging that the patent may be infringed by our product candidates or proprietary technologies.
In addition, because some patent applications in the United States may be maintained in secrecy until the patents are issued, patent applications in the United States and many foreign jurisdictions are typically not published until 18 months after filing, and publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by issued patents or any pending applications, or that we or, if applicable, a licensor were the first to invent the technology. Our competitors also may have filed, and may in the future file, patent applications covering our products or technology similar to ours. Any such patent application may have priority over our patents or any patent applications, which could require us to obtain rights to issued patents covering such technologies. If another party has filed a U.S. patent application on inventions similar to those owned by or in-licensed to us, we or, in the case of in-licensed technology, the licensor may have to participate in an interference proceeding declared by the USPTO to determine priority of invention in the United States. If we or one of our licensors is a party to an interference proceeding involving a U.S. patent application on inventions owned by or in-licensed to us, we may incur substantial costs, divert management’s time and expend other resources, even if we are successful.
Interference proceedings provoked by third parties or brought by the USPTO may be necessary to determine the priority of inventions with respect to our patents or any patent applications or those of our licensors. An unfavorable outcome could result in a loss of our current patent rights and could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Litigation or interference proceedings may result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and
distract our management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of our trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the United States.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during such litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent application process and following the issuance of a patent. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, our competitors might be able to enter the market, which would have a material adverse effect on our business.
Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.
If we or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate, as applicable, is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover our product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to validity, for example, we cannot be certain that there is no invalidating prior art, of which we, our patent counsel and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, or if we are otherwise unable to adequately protect our rights, we would lose at least part, and perhaps all, of the patent protection on our product candidates. Such a loss of patent protection could have a material adverse impact on our business and our ability to commercialize or license our technology and product candidates.
Changes in patent law in the United States and in ex-U.S. jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. We cannot predict how these decisions or any future decisions by the courts, the U.S. Congress or the USPTO may impact the value of our patents. Similarly, any adverse changes in the patent laws of other jurisdictions could have a material adverse effect on our business and financial condition.
We may not be able to protect our intellectual property rights throughout the world.
Filing, prosecuting and defending patents on product candidates in all countries throughout the world is expensive. While our licensed patents, including the patents covering our lead product candidates, have been issued in major markets and other countries, our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection but where enforcement is not as strong as that in the United States. These products may compete with our products in jurisdictions where we do not have any issued patents and our patent claims or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult for us or our licensors to stop the infringement of our patents or marketing of competing products against third parties in violation of our proprietary rights generally. The initiation of proceedings by third parties to challenge the scope or validity of our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and any patent applications at risk of not issuing and could provoke third parties to assert claims against us or our licensors. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.
Depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop, one or more of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering the approved drug, a method for using it or a method for manufacturing it may be extended. However, we may not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If we are unable to obtain patent term extension or term of any such extension is less than we request, our competitors may obtain approval of competing products following our patent expiration, and our business, financial condition, results of operations and prospects could be materially harmed.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names, which we need for name recognition by potential partners or customers in our markets of interest. If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively and our business may be adversely affected.
Risks related to our reliance on third parties
We rely on third parties to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for, or commercialize, any potential product candidates.
We depend upon third parties to conduct certain aspects of our preclinical studies and depend on third parties, including independent investigators, to conduct our clinical trials, under agreements with universities, medical institutions, CROs, strategic partners and others. We expect to negotiate budgets and contracts with such third parties, which may result in delays to our development timelines and increased costs.
We commenced operations in August 2017 and we continue to build our infrastructure and hire personnel necessary to execute our operational plans. We will rely especially heavily on third parties over the course of our clinical trials, and, as a result, may have limited control over the clinical investigators and limited visibility into their day-to-day activities, including with respect to their compliance with the approved clinical protocol. Nevertheless, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities. We and these third parties are required to comply with GCP requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities enforce these GCP requirements through periodic inspections of clinical
trial sponsors, clinical investigators and clinical trial sites. If we or any of these third parties fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to suspend or terminate these trials or perform additional preclinical studies or clinical trials before approving our marketing applications. We cannot be certain that, upon inspection, such regulatory authorities will determine that any of our clinical trials comply with GCP requirements. In addition, our clinical trials must be conducted with product produced under cGMP, requirements and may require a large number of patients.
Our failure or any failure by these third parties to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be adversely affected if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.
Any third parties conducting aspects of our preclinical studies or our clinical trials will not be our employees and, except for remedies that may be available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our preclinical studies and clinical programs. These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other product development activities, which could affect their performance on our behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the preclinical or clinical data they obtain is compromised due to the failure to adhere to our protocols or regulatory requirements or for other reasons, our development timelines, including clinical development timelines, may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed or precluded entirely.
If any of our relationships with these third-party CROs or others terminate, we may not be able to enter into arrangements with alternative CROs or other third parties or to do so on commercially reasonable terms.
Switching or adding additional CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO begins work. As a result, delays may occur, which can materially impact our ability to meet our desired development timelines. Though we endeavor to carefully manage our relationships with our CROs and other third parties, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.
Because we rely on third-party manufacturing and supply partners, our supply of preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality.
We rely on third-party contract manufacturers to manufacture all of our preclinical and clinical trial product supplies. We do not own manufacturing facilities for producing any product supplies. There can be no assurance that our preclinical and clinical development product supplies will not be limited, interrupted, of satisfactory quality or continue to be available at acceptable prices. In particular, any replacement of our manufacturers could require significant effort and expertise because there may be a limited number of qualified replacements.
The manufacturing process for a product candidate is subject to FDA, EMA and comparable foreign regulatory authority review. Suppliers and manufacturers must meet applicable
manufacturing requirements and undergo rigorous facility and process validation tests required by regulatory authorities in order to comply with regulatory standards, such as cGMPs. In the event that any of our manufacturers fails to comply with such requirements or to perform its obligations to us in relation to quality, timing or otherwise, or if our supply of components or other materials becomes limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves, for which we currently do not have the capabilities or resources, or enter into an agreement with another third party, which we may not be able to do on reasonable terms, if at all. In some cases, the technical skills or technology required to manufacture our product candidates may be unique or proprietary to the original manufacturer and we may have difficulty transferring such skills or technology to another third party and a feasible alternative may not exist. These factors would increase our reliance on such manufacturer or require us to obtain a license from such manufacturer in order to have another third party manufacture our product candidates. If we are required to change manufacturers for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. The delays associated with the verification of a new manufacturer could negatively affect our ability to develop product candidates in a timely manner or within budget.
Our or a third party’s failure to execute on our manufacturing requirements and comply with cGMP could adversely affect our business in a number of ways, including:
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an inability to initiate or continue clinical trials of product candidates under development;
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delay in submitting regulatory applications, or receiving regulatory approvals, for product candidates;
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loss of the cooperation of an existing or future collaborator;
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subjecting third-party manufacturing facilities to additional inspections by regulatory authorities;
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requirements to cease distribution or to recall batches of our product candidates; and
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in the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products.
In addition, we contract with packaging providers with the appropriate expertise, facilities and scale to meet our needs. Failure to maintain cGMP can result in a contractor receiving FDA sanctions, which can impact our ability to operate or lead to delays in any clinical development programs. We believe that our current packaging contractors operate in accordance with cGMP, but we can give no assurance that FDA, EMA or comparable foreign regulatory authorities will not conclude that a lack of compliance exists. In addition, any delay in contracting for packaging services, or failure of the contract manufacturer to perform the services as needed, may delay any clinical trials, registration and launches, which could negatively affect our business.
Our product candidates and any drugs that we may develop may compete with other product candidates and drugs for access to manufacturing facilities. There are no assurances we would be able to enter into similar commercial arrangements with other manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us. Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval.
We have not yet manufactured on a commercial scale and expect to rely on third parties to produce and process commercial quantities of our product candidates, if approved.
We expect to continue to rely on third-party manufacturers if we receive regulatory approval for our product candidates. We have not yet entered into any arrangement with a third party for the
manufacture and supply of commercial quantities of our product candidates. To the extent that we enter into future manufacturing arrangements with third parties for commercial supply of our product candidates, if approved, we will depend on these third parties to perform their obligations in a timely manner consistent with contractual and regulatory requirements, including those related to quality control and assurance.
The facilities used by our contract manufacturers to manufacture our product candidates must be approved by the FDA, EMA or comparable foreign regulatory authorities following inspections that will be conducted after we submit an application to the FDA, EMA or comparable foreign regulatory authorities. We do not directly control the manufacturing process of, and will be completely dependent on, our contract manufacturing partners for compliance with cGMP requirements for the manufacture of our product candidates. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA, EMA or comparable foreign regulatory authorities, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. In addition, we have no direct control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA, EMA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.
We are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on one company for the manufacture of the active pharmaceutical ingredient for each of our product candidates.
We currently depend on a small number of suppliers for some of the materials used in, and processes required to develop, our product candidates. We cannot ensure that these suppliers or service providers will remain in business or have sufficient capacity or supply to meet our needs, or that they will not be purchased by one of our competitors or another company that is not interested in continuing to work with us. Our use of a small number of suppliers exposes us to several risks, including disruptions in supply, price increases or late deliveries. There are, in general, relatively few alternative sources of supply for substitute materials. Our current vendors may be unable or unwilling to meet our future demands for our clinical trials or commercial sale. Finding suitable replacement suppliers, materials and processes could take a substantial amount of time and it may be difficult to establish replacement suppliers who meet regulatory requirements. Any disruption or delay in supply could compromise our ability to pursue development and eventual commercialization of our product candidates.
Our existing and future collaborations will be important to our business. If we are unable to maintain our existing collaborations or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected.
An important part of our strategy is to evaluate and, as deemed appropriate, extend our current or enter into additional partnerships in the future, including potentially with major biopharmaceutical companies. We have limited capabilities for product development and do not yet have any capability for commercialization. Accordingly, we have entered into collaborations with other companies to provide us with important technologies in order to more fully develop our product candidates, including mirdametinib, and we may enter into collaborations with other companies to provide us with important technologies or funding for our programs.
Any current or future collaborations we may extend or enter into may pose a number of risks, including the following:
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collaborators have significant discretion in determining the efforts and resources that they will apply;
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collaborators may not perform their obligations as expected;
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collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs or license arrangements based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as a strategic transaction that may divert resources or create competing priorities;
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collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
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collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products and product candidates if the collaborators believe that the competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
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for collaborations involving combination therapies that have not yet been tested together, treatment emergent adverse events may be unforseen and may negatively impact the monotherapy development of our product candidates;
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product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates;
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collaborators may fail to comply with applicable regulatory requirements regarding the development, manufacture, distribution or marketing of a product candidate or product;
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collaborators with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product or products;
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disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or terminations of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;
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collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;
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collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and
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collaborations may be terminated by the collaborator, and, if terminated, we could lose license rights to the applicable product candidates or could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates.
Under our collaboration agreement with BeiGene, the combination of mirdametinib and lifirafenib is being evaluated a Phase 1b clinical trial, and under our collaboration agreement with GSK, the combination of nirogacestat and belantamab mafodotin will be evaluated in a Phase 1b clinical trial that GSK plans to initiate. Under these existing collaboration arrangements, upon completion of the relevant clinical trials, we and our collaboration partner will negotiate in good faith to provide for the expansion of the respective clinical collaboration and the establishment of a commercial relationship. However, our partners have no obligation to continue development of the combination products, regardless of the applicable clinical trial results. We also jointly formed MapKure, LLC, or MapKure, with BeiGene for the development of BGB-3245, and although we will contribute to clinical development and other operational activities, we will not control the development process. MapKure may pursue a development plan that differs from our expectations, which may or may not be successful.
If our collaborations do not result in the successful discovery, development and commercialization of product candidates or if one of our collaborators elects not to enter into collaboration agreements to pursue future development, we may not receive any future funding or milestone or royalty payments under such collaborations. Risks relating to product development, regulatory approval and commercialization described in this prospectus may also apply to the activities of our collaborators.
Additionally, if one of our collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators and our perception in the business and financial communities could be adversely affected.
Furthermore, we face significant competition in seeking appropriate partners for our product candidates and the negotiation process is time-consuming and complex. In order for us to successfully partner our product candidates, potential partners must view our product candidates as economically valuable in markets they determine to be attractive in light of the terms that we are seeking and other available products for licensing by other companies. In addition, there have been a significant number of recent business combinations among large biopharmaceutical companies that have resulted in a reduced number of potential future collaborators. Our ability to reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities or planning, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional expertise or capital, which may not be available to us on acceptable terms, or at all. If we fail to enter into collaborations or do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop our product candidates, bring them to market and generate revenue from sales of drugs or continue to develop our technology, and our business may be materially and adversely affected. Even if we are successful in our efforts to establish new strategic partnerships, the terms that we agree upon may not be favorable to us, and we may not be able to maintain such strategic partnerships if, for example, development or approval of a product candidate is delayed or sales of an approved product are disappointing. Any delay in entering into new strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates and reduce their competitiveness even if they reach the market.
Risks related to managing our business and operations
We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
As of August 15, 2019, we had 52 full-time employees. As our clinical development and commercialization plans and strategies develop, and as we transition into operating as a public company, we expect we will need additional managerial, clinical, manufacturing, medical, regulatory, sales, marketing, financial, legal and other personnel. Future growth would impose significant added responsibilities on members of management, including:
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recruiting, integrating, retaining and motivating additional employees;
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managing our development efforts effectively, including the clinical, manufacturing and quality review process for our product candidates, while complying with our contractual obligations to contractors, collaboration partners and other third parties; and
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improving our operational, financial and management controls, reporting systems and procedures.
Our future financial performance and our ability to commercialize our product candidates, if approved, will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.
We currently rely, and for the foreseeable future will continue to rely, in substantial part on third parties, including independent organizations, advisors and consultants, to provide certain services to support and perform our operations. There can be no assurance that the services of these third parties will continue to be available to us on a timely basis when needed, or that we can find qualified replacements. In addition, if we are unable to effectively manage our outsourced activities or if the quality, accuracy or quantity of the services provided is compromised for any reason, our clinical trials may be delayed or terminated, and we may not be able to obtain, or may be substantially delayed in obtaining, regulatory approval of our product candidates or otherwise advance our business. There can be no assurance that we will be able to manage our existing consultants or find other suitable outside contractors and consultants on economically reasonable terms, or at all.
If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully execute the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our development and commercialization goals.
We have no history of commercializing marketed products. Building our commercialization capabilities will require a significant investment of time and money. There can be no assurance that we will successfully set up our commercialization capabilities.
We are currently in the early stages of building our commercial capabilities to allow us to market our product candidates, if approved, either alone or in combination with others. Establishing commercialization capabilities will require substantial investment of time and money and may divert significant management focus and resources. In addition, we will be competing with larger biopharmaceutical and biotechnology companies with established commercialization and marketing capabilities as we seek to recruit suitable personnel. Accordingly, there can be no assurance that our efforts to set up commercialization capabilities will be successful.
If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to pursue our business strategy will be impaired, could result in loss of markets or market share and could make us less competitive.
Our ability to compete in the highly competitive biopharmaceutical industries depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel. We are highly dependent on our management, scientific and medical personnel, including Saqib Islam, our Chief Executive Officer, Frank Perier, our Chief Financial Officer, Badreddin Edris, our Chief Business Officer, Jens Renstrup, our Chief Medical Officer and L. Mary Smith, our Senior Vice President, Clinical Research and Development. The loss of the services of any of our executive officers, other key employees, and other scientific and medical advisors, and our inability to find suitable replacements for these individuals could harm our business.
Competition for skilled personnel in our industry is intense and may limit our ability to hire and retain highly qualified personnel on acceptable terms, in a timely manner or at all. To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have provided equity incentive awards that vest over time. The value to employees of restricted stock awards and stock options that vest over time may be significantly affected by movements in our stock price that are beyond our control, and may at any time be insufficient to counteract more lucrative offers from other companies. Despite our efforts to retain valuable employees, members of our management, scientific and development teams are at-will employees and may terminate their employment with us on short notice. We do not maintain “key man” insurance policies on the lives of these individuals or the lives of any of our other employees. Given the stage of our programs and our plans to expand operations, our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior personnel across our organization.
We do not have the internal research capabilities required to independently discover new product candidates, and we plan to execute our growth strategy by identifying and in-licensing or acquiring additional product candidates that have been discovered and initially developed by others. We may not be successful in executing our growth strategy or such growth strategy may not deliver the anticipated results.
We do not have an internal discovery and preclinical research and development department to independently discover and initially develop new product candidates. We plan to source new product candidates, including those that may be complementary to our existing product candidates, by in-licensing or acquiring them from other companies, academic institutions or other asset originators. If we are unable to identify, in-license or acquire and integrate product candidates, our ability to pursue our growth strategy would be limited.
Research programs and business development efforts to identify new product candidates require substantial technical, financial and human resources, and we have no immediate plans to develop an internal discovery and preclinical research and development group. In-licensing and acquiring product candidates or development programs often requires significant payments and expenses and may consume valuable resources. We will need to devote a substantial amount of time and personnel to develop and commercialize any in-licensed or acquired technology or product candidate, in addition to doing so for our existing product candidates. Our business development efforts or acquisition or licensing attempts may fail to yield additional complementary or successful product candidates for clinical development and commercialization for a number of reasons, including the following:
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our identification or business development methodology or search criteria and process may be unsuccessful in identifying potential product candidates with a high probability of success for development progression;
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we may not be able or willing to assemble sufficient resources or expertise to identify and in-license or acquire additional product candidates;
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for product candidates we seek to in-license or acquire, we may not be able to agree to acceptable terms with the licensor or owner of those product candidates;
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any product candidates that we do in-license or acquire may not succeed in preclinical studies or clinical trials;
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we may not succeed in formulation or process development of such in-licensed or acquired product candidates;
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such in-licensed or acquired product candidates may be shown to have harmful side effects or may have other characteristics that may make the products unlikely to receive regulatory approval or be unmarketable if approved;
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competitors may develop alternatives that render such in-licensed product candidates obsolete or less attractive;
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in-licensed or acquired product candidates may be covered by third parties’ patents or other exclusive rights that we may not be able to access;
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in-licensed or acquired product candidates that we develop may not allow us to best make use of our expertise and our development and commercial infrastructure as currently expected;
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the market for a product candidate that we in-license or acquire may change during the course of our development of the product candidate so that such product candidate may become unreasonable to continue to develop;
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a product candidate that we in-license or acquire may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and
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a product candidate that we in-license or acquire may not be accepted as safe and effective by patients, the medical community or third-party payors.
If any of these events occur, we may not be successful in executing our growth strategy or our growth strategy may not deliver the anticipated results.
Our internal computer systems, or those used by our vendors, or other contractors or consultants, may fail or suffer security breaches.
Despite the implementation of security measures, our internal computer systems and those of our CROs and other third parties, including our contractors and consultants, are vulnerable to damage from computer viruses and unauthorized access. Like other companies of our size and in our industry, we have been the target of phishing attacks and attacks on our data and systems. While we have not experienced any material system failure or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations. For example, the loss of preclinical or clinical data could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of financial or confidential information, we could incur liability and the further development and commercialization of our product candidates could be delayed.
We could also be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss of information maintained in the information systems and networks of our company and our contractors or consultants. In addition, outside parties may attempt to penetrate our systems or those of our contractors or consultants or fraudulently induce our personnel or the personnel of our contractors or consultants to disclose sensitive information in order to gain access to our data and/or systems. We may experience threats to our data and systems, including malicious codes and viruses, phishing and other cyber-attacks. The number and complexity of these threats continue to increase over time. If a material breach of our information technology systems or those of our contractors or consultants occurs, the market perception of the effectiveness of our security measures could be harmed and our reputation and credibility could be damaged. We could be required to expend significant amounts of money and other resources to repair or replace information systems or networks. In addition, we could be subject to regulatory actions and/or claims made by individuals and groups in private litigation involving privacy issues related to data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive practices. Although we develop and maintain systems and controls designed to prevent these events from occurring, and we have a process to identify and mitigate threats, the development and maintenance of these systems, controls and processes is costly and requires ongoing monitoring and updating as technologies change and efforts to overcome security measures become increasingly sophisticated. Moreover, despite our efforts, the possibility of these events occurring cannot be eliminated entirely. In addition, there can be no assurance that our internal information technology systems or those of our third-party contractors, or our consultants’ efforts to implement adequate security and control measures, will be sufficient to protect us against breakdowns, service disruption, data deterioration or loss in the event of a system malfunction, or prevent data from being stolen or corrupted in the event of a cyberattack, security breach, industrial espionage attacks or insider threat attacks which could result in financial, legal, business or reputational harm.
Our employees, independent contractors, consultants, academic collaborators, partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
We are exposed to the risk of employee fraud or other illegal activity by our employees, independent contractors, consultants, academic collaborators, partners and vendors. Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to comply with the laws of the FDA, EMA and comparable foreign regulatory authorities, provide true, complete and accurate information to the FDA, EMA and comparable foreign regulatory authorities, comply with manufacturing standards we have established, comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws, or report financial information or data accurately or to disclose unauthorized activities to us. If we obtain FDA approval of any of our product candidates and begin commercializing those products in the United States, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws are also likely to increase. These laws may impact, among other things, our current activities with principal investigators and research patients, as well as proposed and future sales, marketing and education programs. In connection with this offering, we will adopt a code of business conduct and ethics, but it is not always possible to identify and deter misconduct by our employees, independent contractors, consultants, academic collaborators, partners and vendors, and the precautions we take to detect and prevent such activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could
result in the imposition of civil, criminal and administrative penalties, damages, monetary fines, imprisonment, disgorgement, possible exclusion from participation in government healthcare programs, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm, diminished profits and future earnings and the curtailment of our operations.
If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
We are subject to numerous environmental, health and safety laws and regulations, including those governing the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our development activities involve the use of biological and hazardous materials and can produce hazardous waste products. We cannot eliminate the risk of contamination or injury from these materials, which could cause an interruption of our commercialization efforts, research and development efforts and business operations, environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. Although we believe that the safety procedures utilized by our third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of certain materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance. In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.
Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries resulting from the use of hazardous materials or other work-related injuries, this insurance may not provide adequate coverage against potential liabilities. We do not carry specific biological waste or hazardous waste insurance coverage, workers compensation or property and casualty and general liability insurance policies that include coverage for damages and fines arising from biological or hazardous waste exposure or contamination.
Our current operations are concentrated in two locations, and we or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
Our current headquarters are located in Stamford, Connecticut. Our development operations are currently located in Durham, North Carolina. We currently outsource our manufacturing operations to third parties, and clinical quantities of our product candidates are manufactured by these third parties outside the United States, including in China and France. Any unplanned event, such as flood, fire, explosion, earthquake, extreme weather condition, medical epidemics, power shortage, telecommunication failure or other natural or manmade accidents or incidents that result in us being unable to fully utilize our facilities, or the manufacturing facilities of our third-party contract manufacturers, may have a material and adverse effect on our ability to operate our business, particularly on a daily basis, and have significant negative consequences on our financial and operating conditions. Loss of access to these facilities may result in increased
costs, delays in the development of our product candidates or interruption of our business operations. Earthquakes or other natural disasters could further disrupt our operations and have a material and adverse effect on our business, financial condition, results of operations and prospects. If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters or our development operations, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible, for us to continue our business for a substantial period of time. Disaster recovery and business continuity plans may prove inadequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a material adverse effect on our business. As part of our risk management approach, we maintain insurance coverage at levels that we believe are appropriate for our business. However, in the event of an accident or incident at these facilities, we cannot assure you that the amounts of insurance will be sufficient to satisfy any damages and losses. If our facilities, or the manufacturing facilities of our third-party contract manufacturers, are unable to operate because of an accident or incident or for any other reason, even for a short period of time, any or all of our research and development programs may be harmed. Any business interruption may have a material and adverse effect on our business, financial condition, results of operations and prospects.
Comprehensive tax reform legislation could adversely affect our business and financial condition.
On December 22, 2017, President Trump signed into law the TCJA that significantly reforms the Internal Revenue Code of 1986, as amended, or the Code. The TCJA, among other things, contains significant changes to corporate taxation, including reduction of the corporate tax rate from 34.0% to a flat rate of 21.0%, limitation of the tax deduction for interest expense to 30.0% of adjusted taxable income (except for certain small businesses), limitation of the deduction for net operating losses arising in taxable years beginning after December 31, 2017 to 80.0% of annual taxable income and elimination of net operating loss carrybacks applying to net operating losses arising in taxable years ending after December 31, 2017, and modifying or repealing many business deductions and credits (including reducing the business tax credit for certain clinical testing expenses incurred in the testing of certain drugs for rare diseases or conditions generally referred to as “orphan drugs”). The effect of the TCJA on our business, whether adverse or favorable, is uncertain and may not become evident for some period of time. We urge investors to consult with their legal and tax advisers regarding the implications of the TCJA on an investment in our common stock.
Our ability to use our net operating loss carryforwards and certain tax credit carryforwards may be subject to limitation.
As of December 31, 2018, we had net operating loss carryforwards for federal, state and city income tax purposes of $14.2 million, $0.6 million and $3.8 million, respectively. Federal net operating loss carryforwards of $4.3 million were recorded in 2017 and the state and city net operating loss carryforwards expire at various dates through 2038. Federal net operating loss carryforwards of $9.9 million recorded in 2018 will be available to offset 80% of taxable income for an indefinite period of time, until fully utilized. As of December 31, 2018, we also had federal tax credits of $0.4 million, which may be used to offset future tax liabilities. These tax credit carryforwards will expire in 2038. Under Section 382 of the Code, changes in our ownership may limit the amount of our net operating loss carryforwards and tax credit carryforwards that could be utilized annually to offset our future taxable income, if any. This limitation would generally apply in the event of a cumulative change in ownership of our company of more than 50%
within a three-year period. Any such limitation may significantly reduce our ability to utilize our net operating loss carryforwards and tax credit carryforwards before they expire. Private placements and other transactions that have occurred since our inception, as well as this offering, may trigger such an ownership change pursuant to Section 382. Any such limitation, whether as the result of this offering, prior private placements, sales of our common stock by our existing stockholders or additional sales of our common stock by us, could have a material adverse effect on our results of operations in future years. The reduction of the corporate tax rate under TCJA may cause a reduction in the economic benefit of our net operating loss carryforwards and other deferred tax assets available to us. Under the TCJA, net operating losses generated in taxable years ending after December 31, 2017 will not be subject to expiration; however, under the TCJA, net operating losses generated in taxable years beginning after December 31, 2017 will be subject to limitation on deduction.
Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. Portions of our future clinical trials may be conducted outside of the United States and unfavorable economic conditions resulting in the weakening of the U.S. dollar would make those clinical trials more costly to operate. Furthermore, the most recent global financial crisis caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to our business, including a reduced ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy or international trade disputes could also strain our suppliers, some of which are located outside of the United States, possibly resulting in supply disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.
Risks related to our common stock and this offering
There has been no prior public market for our common stock, and we do not know whether an active, liquid and orderly trading market will develop for our common stock, or what the market price of our common stock will be, and as a result it may be difficult for you to sell your shares of our common stock.
Prior to this offering there has been no public market for shares of our common stock. Although we have applied to list our common stock on the Nasdaq Global Market, or Nasdaq, an active trading market for our shares may never develop or be sustained following this offering. You may not be able to sell your shares quickly or at the market price if trading in shares of our common stock is not active. The initial public offering price for our common stock will be determined through negotiations with the underwriters, and the negotiated price may not be indicative of the market price of the common stock after the offering. As a result of these and other factors, you may be unable to resell your shares of our common stock at or above the initial public offering price.
Further, an inactive market may also impair our ability to raise capital by selling shares of our common stock and may impair our ability to enter into strategic partnerships or acquire companies or products by using our shares of common stock as consideration.
The price of our stock may be volatile, and you could lose all or part of your investment.
The trading price of our common stock following this offering is likely to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control, including limited trading volume. In addition to the factors discussed in this “Risk factors” section and elsewhere in this prospectus, these factors include:
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the commencement, enrollment or results of our ongoing and planned potentially registrational clinical trials for nirogacestat and mirdametinib;
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any delay in our regulatory filings for our product candidates and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;
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adverse results from or delays in future clinical trials;
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our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;
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adverse regulatory decisions, including failure to receive regulatory approval of our product candidates or any future product candidate;
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changes in laws or regulations applicable to our product candidates or any future product candidate, including but not limited to clinical trial requirements for approvals;
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changes in the structure of healthcare payment systems;
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adverse developments concerning our manufacturers;
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our inability to obtain adequate product supply for any approved product or inability to do so at acceptable prices;
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our inability to establish collaborations or partnerships, if needed;
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our failure to commercialize our product candidates, if approved;
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additions or departures of key medical, scientific or management personnel;
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unanticipated serious safety concerns related to the use of our product candidates;
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introduction of new products or services offered by us or our competitors;
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clinical trial results for other product candidates that could compete with our product candidates;
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announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
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our ability to effectively manage our growth;
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actual or anticipated variations in quarterly operating results;
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our cash position;
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our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;
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publication of research reports about us or our industry, or product candidates in particular, or positive or negative recommendations or withdrawal of research coverage by securities analysts;
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changes in the market valuations of similar companies;
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overall performance of the equity markets;
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sales of our common stock by us or our stockholders in the future;
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trading volume of our common stock;
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changes in accounting practices;
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ineffectiveness of our internal controls;
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disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
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significant lawsuits, including patent or stockholder litigation;
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general political and economic conditions; and
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other events or factors, many of which are beyond our control.
In addition, the stock market in general, and the market for biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. If the market price of our common stock after this offering does not exceed the initial public offering price, you may not realize any return on your investment in us and may lose some or all of your investment. In the past, securities class action litigation has often been instituted against companies following periods of volatility in the market price of a company’s securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources, which would harm our business, operating results or financial condition.
We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Furthermore, future debt or other financing arrangements may contain terms prohibiting or limiting the amount of dividends that may be declared or paid on our common stock. Any return to stockholders will therefore be limited to the appreciation of their stock.
Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
Immediately following the completion of this offering, our executive officers, directors and their affiliates and certain significant stockholders will beneficially hold, in the aggregate, approximately 53% of our outstanding voting stock. Therefore, even after this offering, these stockholders will have the ability to influence us through this ownership position. These stockholders may be able to determine all matters requiring stockholder approval. For example, these stockholders may be able to control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.
If you purchase our common stock in this offering, you will incur immediate and substantial dilution in the book value of your shares.
The initial public offering price will be substantially higher than the pro forma as adjusted net tangible book value per share of our common stock after this offering. Investors purchasing common stock in this offering will pay a price per share that substantially exceeds the pro forma
as adjusted net tangible book value per share after this offering. As a result, investors purchasing common stock in this offering will incur immediate dilution of $9.63 per share, based on an assumed initial public offering price of $17.00 per share, the midpoint of the price range set forth on the cover page of this prospectus, representing the difference between our pro forma as adjusted net tangible book value per share after giving effect to this offering and the assumed initial public offering price. Further, investors purchasing common stock in this offering will contribute approximately 33% of the total amount invested by stockholders since our inception, but will own only approximately 18% of the shares of common stock outstanding after this offering.
This dilution is due to our investors who purchased shares prior to this offering having paid substantially less when they purchased their shares than the price offered to the public in this offering. To the extent outstanding options are exercised, there will be further dilution to new investors. As a result of the dilution to investors purchasing shares in this offering, investors may receive significantly less than the purchase price paid in this offering, if anything, in the event of our liquidation. For a further description of the dilution that you will experience immediately after this offering, see “Dilution.”
We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our common stock less attractive to investors.
We are an emerging growth company, or EGC, as defined in the Jumpstart Our Business Startups Act, or the JOBS Act, enacted in April 2012. For as long as we continue to be an EGC, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not EGCs, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements and exemptions from the requirements of holding nonbinding advisory votes on executive compensation and stockholder approval of any golden parachute payments not previously approved. We could be an EGC for up to five years following the year in which we complete this offering, although circumstances could cause us to lose that status earlier. We will remain an EGC until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary of the completion of this offering, (b) in which we have total annual gross revenue of at least $1.07 billion or (c) in which we are deemed to be a large accelerated filer, which requires the market value of our common stock that is held by non-affiliates to exceed $700.0 million as of the prior June 30th and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
We may choose to take advantage of some, but not all, of the available exemptions. We have taken advantage of reduced reporting burdens in this prospectus. In particular, we have not included all of the executive compensation information that would be required if we were not an EGC. We cannot predict whether investors will find our common stock less attractive if we rely on certain or all of these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.
Under the JOBS Act, EGCs can also delay adopting new or revised accounting standards until such time as those standards apply to private companies, which may make our financial statements less comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
We will incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
As a public company, we will incur significant legal, accounting and other expenses that we did not incur as a private company. We will be subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which will require, among other things, that we file with the SEC, annual, quarterly and current reports with respect to our business and financial condition. In addition, the Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and Nasdaq to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices. Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, was enacted. There are significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional rules and regulations in these areas such as “say on pay” and proxy access. Recent legislation permits EGCs to implement many of these requirements over a longer period and up to five years from the pricing of this offering. Stockholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact the manner in which we operate our business in ways we cannot currently anticipate.
We expect the rules and regulations applicable to public companies to substantially increase our legal and financial compliance costs and to make some activities more time-consuming and costly. If these requirements divert the attention of our management and personnel from other business concerns, they could have an adverse effect on our business. The increased costs will decrease our net income or increase our net loss, and may require us to reduce costs in other areas of our business. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain the same or similar coverage. We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.
Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after the lock-up and other legal restrictions on resale discussed in this prospectus lapse, the trading price of our common stock could decline. Based on shares of common stock outstanding as of June 30, 2019, upon the completion of this offering we will have outstanding a total of 40,235,936 shares of common stock. Of these shares, only the shares of common stock sold in this offering by us, plus any shares sold upon exercise of the underwriters’ option to purchase additional shares, will be freely tradable without restriction in the public market immediately following this offering.
The lock-up agreements pertaining to this offering will expire 180 days from the date of this prospectus, subject to earlier release of all or a portion of the shares subject to such agreements by the representatives of the underwriters in their sole discretion. After the lock-up agreements expire, based upon the number of shares of common stock, on an as-converted basis, outstanding as of the date of this prospectus, up to an additional 32,882,995 shares of common stock will be eligible for sale in the public market. Approximately 71% of these additional shares are held by directors, executive officers and other affiliates and will be subject to certain limitations of Rule 144 under the Securities Act of 1933, as amended, or the Securities Act.
In addition, shares of common stock that are either subject to outstanding options or reserved for future issuance under our existing equity compensation plans will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules, the lock-up agreements and Rule 144 and Rule 701 under the Securities Act. If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline. Additionally, the number of shares of our common stock reserved for issuance under the 2019 Stock Option and Equity Incentive Plan will automatically increase on January 1 of each year, beginning on January 1, 2020 and continuing through and including January 1, 2030, by 5% of the total number of shares of our capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by our board of directors. Unless our board of directors elects not to increase the number of shares available for future grant each year, our stockholders may experience additional dilution.
After the completion of this offering, the holders of 29,794,359 shares of our common stock (including shares issuable upon conversion of our outstanding convertible preferred stock) will be entitled to rights with respect to the registration of their shares under the Securities Act, subject to the 180-day lock-up agreements described above. See “Description of capital stock—Registration rights.” Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares held by affiliates, as defined in Rule 144 under the Securities Act. Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock.
We have broad discretion in the use of our existing cash, cash equivalents and the net proceeds from this offering and may not use them effectively.
Our management will have broad discretion in the application of our existing cash, cash equivalents and the net proceeds from this offering, including for any of the purposes described in the section titled “Use of proceeds,” and you will not have the opportunity as part of your investment decision to assess whether such proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of our existing cash and cash equivalents and the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. Our management might not apply our existing cash and cash equivalents and the net proceeds from this offering in ways that ultimately increase the value of your investment. The failure by our management to apply these funds effectively could harm our business. Pending their use, we may invest the net proceeds from this offering in short-term, investment-grade, interest-bearing securities. These investments may not yield a favorable return to our stockholders. If we do not invest or apply the net proceeds from this offering in ways that enhance stockholder value, we may fail to achieve expected financial results, which could cause our stock price to decline.
Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
Our amended and restated certificate of incorporation and amended and restated bylaws, which are to become effective immediately prior to the completion of this offering, contain provisions that could delay or prevent a change of control of our company or changes in our board of directors that our stockholders might consider favorable. Some of these provisions include:
•
a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at one time;
•
a prohibition on stockholder action through written consent, which requires that all stockholder actions be taken at a meeting of our stockholders;
•
a requirement that special meetings of stockholders be called only by the chairman of the board of directors, the chief executive officer or by a majority of the total number of authorized directors;
•
advance notice requirements for stockholder proposals and nominations for election to our board of directors;
•
a requirement that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to any other vote required by law, upon the approval of not less than two-thirds of all outstanding shares of our voting stock then entitled to vote in the election of directors;
•
a requirement of approval of not less than two-thirds of all outstanding shares of our voting stock to amend any bylaws by stockholder action or to amend specific provisions of our certificate of incorporation; and
•
the authority of the board of directors to issue convertible preferred stock on terms determined by the board of directors without stockholder approval and which convertible preferred stock may include rights superior to the rights of the holders of common stock.
In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock. These anti-takeover provisions and other provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make it more difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-current board of directors and could also delay or impede a merger, tender offer or proxy contest involving our company. These provisions could also discourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing or cause us to take other corporate actions you desire. Any delay or prevention of a change of control transaction or changes in our board of directors could cause the market price of our common stock to decline.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts do not currently, and may never, publish research on our company. If no securities or industry analysts commence coverage of our company, the trading price for our stock would likely be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who covers us downgrades our stock or publishes inaccurate or unfavorable research about our business, our stock price may decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.
If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. In
addition, any testing by us conducted in connection with Section 404, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our stock.
We will be required to disclose changes made in our internal controls and procedures on a quarterly basis and our management will be required to assess the effectiveness of these controls annually. However, for as long as we are an EGC, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404. We could be an EGC for up to five years. An independent assessment of the effectiveness of our internal controls over financial reporting could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal controls over financial reporting could lead to restatements of our financial statements and require us to incur the expense of remediation.
Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
Upon completion of this offering, we will become subject to certain reporting requirements of the Exchange Act. Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated to management, recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements or insufficient disclosures due to error or fraud may occur and not be detected.
Our amended and restated bylaws will designate the Court of Chancery of the State of Delaware as the exclusive forum for certain state law litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to litigate disputes with us in a different judicial forum.
Pursuant to our amended and restated bylaws, as will become effective immediately prior to the completion of this offering, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: (i) any derivative action or proceeding brought on our behalf; (ii) any action asserting a claim of breach of a fiduciary duty or other wrongdoing by any of our directors, officers, employees or agents to us or our stockholders; (iii) any action asserting a claim against us arising pursuant to any provision of the General Corporation Law of the State of Delaware, our amended and restated certificate of incorporation or our amended and restated bylaws; (iv) any action to interpret, apply, enforce or determine the validity of our certificate of incorporation or bylaws; or (v) any action asserting a claim governed by the internal affairs doctrine, in each case subject to the Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein. This exclusive forum provision will not apply to any causes of action arising
under the Securities Act or the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. The forum selection clause in our amended and restated bylaws may limit our stockholders’ ability to litigate disputes with us in a different judicial forum.
Special Note Regarding Forward-looking Statements
This prospectus contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. Some of the statements in the section captioned “Prospectus summary,” “Risk factors,” “Management’s discussion and analysis of financial condition and results of operations,” “Business” and elsewhere in this prospectus contain forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this prospectus, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain.
Forward-looking statements in this prospectus include, but are not limited to, statements about:
•
the success, cost and timing of our product development activities and clinical trials, including statements regarding the timing of our ongoing Phase 3 clinical trial of nirogacestat, the initiation of our planned Phase 2b clinical trial of mirdametinib and the initiation and completion of any other clinical trials and related preparatory work, the expected timing of the availability of results of the clinical trials and the potentially registrational nature of the single Phase 3 clinical trial and the Phase 2b clinical trial;
•
the potential attributes and benefits of our product candidates;
•
our plans to commercialize any of our product candidates that achieve approval either alone or in partnership with others;
•
our ability to obtain funding for our operations, including funding necessary to complete further development of our product candidates, and if approved, commercialization;
•
the period over which we anticipate the proceeds of this offering, together with our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure requirements;
•
the potential for our business development efforts to maximize the potential value of our portfolio;
•
our ability to identify, in-license or acquire additional product candidates;
•
the ability and willingness of our third-party collaborators to continue research and development activities relating to our product candidates that we are developing as combination therapies;
•
our ability to obtain and maintain regulatory approval for our product candidates, and any related restrictions, limitations or warnings in the label of an approved product candidate;
•
the potential benefit of Orphan Drug Designation, Fast Track Designation and Breakthrough Therapy Designation for nirogacestat, mirdametinib and any other of our product candidates that may receive one or more of these designations;
•
our ability to compete with companies currently marketing or engaged in the development of treatments for desmoid tumors or NF1-PN;
•
our expectations regarding our ability to obtain and maintain intellectual property protection or market exclusivity for our product candidates and the direction of such protection;
•
our ability and the potential to successfully manufacture our product candidates for preclinical studies, clinical trials and, if approved, for commercial use, the capacity of our current contract manufacturing organizations, or CMOs, to support clinical supply and commercial-scale production for product candidates and our potential election to pursue additional CMOs for manufacturing supplies of drug substance and finished drug product in the future;
•
the size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in partnership with others;
•
the rate and degree of market acceptance of our product candidates, if approved;
•
regulatory developments in the United States and foreign countries;
•
our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
•
the success of competing products that are or may become available;
•
our ability to attract and retain key scientific, medical, commercial or management personnel;
•
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and
•
our use of the proceeds from this offering.
In addition, you should refer to the “Risk factors” section of this prospectus for a discussion of other important factors that may cause actual results to differ materially from those expressed or implied by the forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this prospectus will prove to be accurate. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this prospectus represent our views as of the date of this prospectus. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this prospectus.
Market and Industry Data and Forecasts
We obtained the industry and market data used throughout this prospectus from our own internal estimates and research, as well as from independent market research, industry and general publications and surveys, governmental agencies and publicly available information in addition to research, surveys and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of our industry and market, which we believe to be reasonable. In some cases, we do not expressly refer to the sources from which this data is derived. In addition, while we believe the industry and market data included in this prospectus is reliable and based on reasonable assumptions, such data involve risks and uncertainties and are subject to change based on various factors, including those discussed in the section entitled “Risk factors.” These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties or by us.
Use of Proceeds
We estimate that the net proceeds to us from the sale of the shares of our common stock in this offering will be approximately $113.0 million, or approximately $130.4 million if the underwriters exercise their option to purchase additional shares in full, based upon an assumed initial public offering price of $17.00 per share, the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
A $1.00 increase or decrease in the assumed initial public offering price of $17.00 per share, the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease the net proceeds to us from this offering by $6.8 million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same. Similarly, an increase or decrease of 1,000,000 in the number of shares offered by us would increase or decrease the net proceeds to us from this offering by $15.8 million, assuming that the assumed initial public offering price remains the same. We do not expect that a change in the initial public offering price or the number of shares by these amounts would have a material effect on our uses of the proceeds from this offering, although it may accelerate the time at which we will need to seek additional capital.
We currently expect to use the net proceeds from this offering, together with our existing cash and cash equivalents, as follows:
•
approximately $60 million to $70 million to fund our ongoing Phase 3 DeFi trial of nirogacestat in patients with desmoid tumors and, if the results from this trial are favorable, to file for regulatory approval in the United States and select international markets;
•
approximately $50 million to $60 million to fund our upcoming Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN and, if the results from this trial are favorable, to file for regulatory approval in the United States and select international markets;
•
approximately $10 million to $15 million to fund our ongoing Phase 1b trial of mirdametinib and lifirafenib and, if initial results are favorable, to fund additional expansion cohorts;
•
approximately $25 million to $35 million to further develop our lead product candidates as standalone or combination therapies in new oncology and rare disease indications; and
•
the remainder, if any, for working capital, general corporate purposes and to continue building our clinical development, medical affairs and commercial infrastructure to support the advancement of our product candidates.
We may also use a portion of the net proceeds to in-license, acquire or invest in new businesses, technology or assets. Although we have no current agreements, commitments or understandings with respect to any such in-license or acquisition, we evaluate such opportunities and engage in related discussions with third parties from time to time.
As of June 30, 2019, we had $185.3 million of cash and cash equivalents on hand. Based on our current plans, we believe our existing cash and cash equivalents, together with the net proceeds from this offering, will be sufficient to fund our operating expenses and capital expenditure requirements through 2022. With our existing cash and cash equivalents and the net proceeds of this offering, we expect to be able to complete our ongoing Phase 3 DeFi clinical trial of nirogacestat in desmoid tumors; complete our planned Phase 2b ReNeu clinical trial of mirdametinib in NF1-PN; complete the ongoing Phase 1b solid tumor combination clinical trial of mirdametinib and lifirafenib; complete the planned Phase 1b multiple myeloma combination clinical trial of nirogacestat and belantamab mafodotin; and via MapKure complete a Phase 1
clinical trial in solid tumors with BGB-3245. We have based these estimates on assumptions that may prove to be incorrect, and we could use our available capital resources sooner than we currently expect. In any event, we may require additional funding to be able to begin commercializing one or more of our product candidates, advance the development of our combination therapies beyond Phase 1b clinical trials and into later-stage trials or conduct additional business development activities; currently, we do not have any committed source of funding for these activities. We may satisfy our future cash needs through the sale of equity securities, debt financings, working capital lines of credit, corporate collaborations or license agreements, grant funding, interest income earned on invested cash balances or a combination of one or more of these sources.
The expected use of net proceeds from this offering represents our intentions based upon our present plans and business conditions. We cannot specify with certainty all of the particular uses for the net proceeds to be received upon the closing of this offering. Due to uncertainties inherent in the product development process, it is difficult to estimate the exact amounts of the net proceeds that will be used for any particular purpose. We may use our existing cash and cash equivalents and the future payments, if any, generated from any future collaboration agreements to fund our operations, either of which may alter the amount of net proceeds used for a particular purpose. In addition, the amount, allocation and timing of our actual expenditures will depend upon numerous factors, including the results of our research and development efforts, the timing and success of clinical trials and the timing of regulatory submissions. Accordingly, we will have broad discretion in using these proceeds.
Pending the uses described above, we plan to invest the net proceeds of this offering in short- and immediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.
Dividend Policy
We have never declared or paid any cash dividends on our capital stock. We do not anticipate paying any dividends on our capital stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business. Investors should not purchase our common stock with the expectation of receiving cash dividends.
Capitalization
The following table sets forth our cash and cash equivalents and our capitalization as of June 30, 2019:
•
on an actual basis;
•
on a pro forma basis to give effect to (i) the automatic conversion of all of our outstanding shares of convertible preferred stock as of June 30, 2019 into an aggregate of 29,794,359 shares of our common stock, as if such conversion had occurred on June 30, 2019, and (ii) the filing and effectiveness of our amended and restated certificate of incorporation immediately prior to the completion of this offering; and
•
on a pro forma as adjusted basis to give further effect to the issuance and sale of 7,352,941 shares of our common stock in this offering at an assumed initial public offering price of $17.00 per share, the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
You should read this information together with our consolidated financial statements and related notes appearing elsewhere in this prospectus and the information set forth in the sections entitled “Selected consolidated financial data” and “Management’s discussion and analysis of financial condition and results of operations.”
|
|
|
As of June 30, 2019
|
|
(in thousands, except per share data)
|
|
|
Actual
|
|
|
Pro Forma
|
|
|
Pro forma as adjusted(1)
|
|
Cash and cash equivalents
|
|
|
|
$ |
185,291 |
|
|
|
|
$ |
185,291 |
|
|
|
|
$ |
298,277 |
|
|
Series A convertible preferred stock, $0.0001 par value; 103,000,000 shares authorized, issued and outstanding, actual; no shares authorized, issued or outstanding, pro forma and pro forma as adjusted
|
|
|
|
$ |
92,700 |
|
|
|
|
$ |
— |
|
|
|
|
$ |
— |
|
|
Series B convertible preferred stock, $0.0001 par value, net of issuance cost; 86,639,279 shares authorized, issued and outstanding, actual; no shares authorized, issued or outstanding, pro forma and pro forma as adjusted
|
|
|
|
|
124,590 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Stockholders’ (deficit) equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Junior Series A convertible preferred stock, $0.0001 par value; 6,437,500 shares authorized, issued and outstanding, actual; no shares authorized, issued or outstanding, pro forma and pro forma as adjusted
|
|
|
|
|
3,882 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Preferred stock, $0.0001 par value; no shares authorized, issued or outstanding, actual; 10,000,000 shares authorized and no shares issued or outstanding, pro forma and pro forma as adjusted
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Common stock, $0.0001 par value, 35,372,778 authorized, 3,088,636 shares issued and outstanding, actual; 150,000,000 shares authorized, pro forma and pro forma as adjusted; 32,882,995 shares issued and outstanding, pro forma; 40,235,936 shares issued and outstanding, pro forma as adjusted
|
|
|
|
|
— |
|
|
|
|
|
3 |
|
|
|
|
|
4 |
|
|
Additional paid-in capital
|
|
|
|
|
2,440 |
|
|
|
|
|
223,609 |
|
|
|
|
|
336,594 |
|
|
Accumulated deficit
|
|
|
|
|
(39,979) |
|
|
|
|
|
(39,979) |
|
|
|
|
|
(39,979) |
|
|
Total stockholders’ (deficit) equity
|
|
|
|
|
(33,657) |
|
|
|
|
|
183,633 |
|
|
|
|
|
296,619 |
|
|
Total capitalization
|
|
|
|
$ |
183,633 |
|
|
|
|
$ |
183,633 |
|
|
|
|
$ |
296,619 |
|
|
(1) The pro forma as adjusted information is illustrative only, and will depend on the actual initial public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed initial public offering price of $17.00 per share, the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, each of pro forma as adjusted cash and cash equivalents, additional paid-in capital, total stockholders’ equity and total capitalization by $6.8 million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same. We may also increase or decrease the number of shares we are offering. Each increase or decrease of 1,000,000 shares in the number of shares we are offering would increase or decrease, as applicable, each of pro forma as adjusted cash and cash equivalents, additional paid-in capital, total stockholders’ equity and total capitalization by $15.8 million, assuming the assumed initial public offering price per share remains the same.
The table above does not include:
•
2,489,778 shares of common stock issuable upon the exercise of stock options outstanding as of June 30, 2019 under our existing stock option and incentive plan, with a weighted average exercise price of $2.24 per share;
•
534,328 shares of common stock issuable upon the exercise of stock options granted subsequent to June 30, 2019 at an exercise price of $9.08 per share;
•
3,537,225 shares of our common stock that will become available for future issuance under our 2019 Equity Plan, which will become effective upon the effectiveness of the registration statement of which this prospectus forms a part; and
•
442,153 shares of our common stock that will become available for future issuance under our ESPP, which will become effective upon the effectiveness of the registration statement of which this prospectus forms a part.
Dilution
If you invest in our common stock in this offering, your ownership interest will be diluted to the extent of the difference between the initial public offering price per share of our common stock and the pro forma as adjusted net tangible book value per share of our common stock immediately after this offering.
Our historical net tangible book value (deficit) was $(37.5) million, or $(12.15) per share, as of June 30, 2019. Our historical net tangible book value (deficit) is equal to our total tangible assets less our total liabilities and convertible preferred stock, and our historical net tangible book value (deficit) per share is that number divided by the number of shares of common stock outstanding as of such date.
Our pro forma net tangible book value as of June 30, 2019 was $183.6 million, or $5.58 per share. Our pro forma net tangible book value per share represents the amount of our total tangible assets reduced by the amount of our total liabilities and divided by the total number of shares of our common stock outstanding as of June 30, 2019, assuming the automatic conversion of all outstanding shares of convertible preferred stock as of June 30, 2019 into an aggregate of 29,794,359 shares of common stock, which conversion will occur immediately prior to the completion of this offering.
After giving effect to our sale of shares of common stock in this offering at an assumed initial public offering price of $17.00 per share, the midpoint of the price range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of June 30, 2019 would have been $296.6 million, or $7.37 per share. This represents an immediate increase in net tangible book value of $1.79 per share to existing stockholders and an immediate dilution in net tangible book value of $9.63 per share to purchasers of common stock in this offering. Dilution per share to new investors represents the difference between the amount per share paid by purchasers of shares of common stock in this offering and the pro forma as adjusted net tangible book value per share of common stock immediately after completion of this offering. The following table illustrates this dilution on a per share basis:
|
Assumed initial public offering price per share
|
|
|
|
|
|
|
|
|
|
$ |
17.00 |
|
|
|
Historical net tangible book value (deficit) per share as of June 30, 2019
|
|
|
|
$ |
(12.15) |
|
|
|
|
|
|
|
|
|
Increase in net tangible book value per share attributable to the pro forma adjustments described above
|
|
|
|
|
17.73 |
|
|
|
|
|
|
|
|
|
Pro forma net tangible book value per share as of June 30, 2019
|
|
|
|
|
5.58 |
|
|
|
|
|
|
|
|
|
Increase in pro forma net tangible book value per share attributable to this offering
|
|
|
|
|
1.79 |
|
|
|
|
|
|
|
|
|
Pro forma as adjusted net tangible book value per share after this offering
|
|
|
|
|
|
|
|
|
|
|
7.37 |
|
|
|
Dilution per share to new investors participating in this offering
|
|
|
|
|
|
|
|
|
|
$ |
9.63 |
|
|
|
The pro forma as adjusted dilution information discussed above is illustrative only and will depend on the actual initial public offering price. Each $1.00 increase or decrease in the assumed public offering price of $17.00 per share, the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, our pro forma as adjusted net tangible book value by $6.8 million, or $0.17 per share, and dilution per share to investors in this offering by $0.83 per share, assuming that the number of shares offered by us, as set forth
on the cover of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. A 1,000,000 share increase in the number of shares offered by us, as set forth on the cover page of this prospectus, would increase the pro forma as adjusted net tangible book value per share by $0.20 and decrease the dilution per share to investors participating in this offering by $0.20, assuming the assumed initial public offering price of $17.00 per share, the midpoint of the price range set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. A 1,000,000 share decrease in the number of shares offered by us, as set forth on the cover page of this prospectus, would decrease the pro forma as adjusted net tangible book value per share after this offering by $0.22 and increase the dilution per share to new investors participating in this offering by $0.22, assuming the assumed initial public offering price of $17.00 per share, the midpoint of the price range set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
If the underwriters’ option to purchase additional shares from us is exercised in full, the pro forma as adjusted net tangible book value per share after this offering would be $7.60 per share, representing an immediate increase in the pro forma as adjusted net tangible book value per share to existing stockholders of $2.02 per share and an immediate dilution to new investors purchasing shares in this offering of $9.40 per share, based on the assumed initial public offering price of $17.00 per share and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
The following table shows, as of June 30, 2019, on the pro forma as adjusted basis described above (but before deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us), the differences between the existing stockholders and the purchasers of shares in this offering with respect to the number of shares purchased from us, the total consideration paid, which includes, in the case of existing stockholders, gross proceeds received from the issuance of common and redeemable convertible preferred stock, cash received from the exercise of stock options, and the value of any stock issued for services, and the average price paid per share (dollars in thousands, except per share amounts):
|
|
|
Shares purchased
|
|
|
Total consideration
|
|
|
Weighted average price per share
|
|
|
|
|
Number
|
|
|
Percent
|
|
|
Amount
|
|
|
Percent
|
|
Existing stockholders before this offering
|
|
|
|
|
32,882,995 |
|
|
|
|
|
82% |
|
|
|
|
$ |
228,003 |
|
|
|
|
|
65% |
|
|
|
|
$ |
7.87 |
|
|
New investors participating in this offering
|
|
|
|
|
7,352,941 |
|
|
|
|
|
18% |
|
|
|
|
$ |
125,000 |
|
|
|
|
|
35% |
|
|
|
|
$ |
17.00 |
|
|
Total
|
|
|
|
|
40,235,936 |
|
|
|
|
|
100% |
|
|
|
|
$ |
353,003 |
|
|
|
|
|
100% |
|
|
|
|
$ |
8.45 |
|
|
The tables and discussion above are based on the number of shares of our common stock outstanding as of June 30, 2019, and exclude:
•
2,489,778 shares of common stock issuable upon the exercise of stock options outstanding as of June 30, 2019 under our existing stock option and incentive plan, with a weighted average exercise price of $2.24 per share;
•
534,328 shares of common stock issuable upon the exercise of stock options granted subsequent to June 30, 2019 at an exercise price of $9.08 per share;
•
3,537,225 shares of our common stock that will become available for future issuance under our 2019 Equity Plan, which will become effective upon the effectiveness of the registration statement of which this prospectus forms a part; and
•
442,153 shares of our common stock that will become available for future issuance under our ESPP, which will become effective upon the effectiveness of the registration statement of which this prospectus forms a part.
To the extent that outstanding stock options are exercised, new stock options or warrants are issued, or we issue additional shares of common stock in the future, there will be further dilution to new investors. In addition, we may choose to raise additional capital because of market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. If we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.
Selected consolidated financial data
You should read the following selected consolidated financial data together with our consolidated financial statements and the related notes appearing at the end of this prospectus and the “Management’s discussion and analysis of financial condition and results of operations” section of this prospectus. We have derived the selected statement of operations data for the period from August 18, 2017 (inception) to December 31, 2017 and the year ended December 31, 2018 and the summary balance sheet data as of December 31, 2017 and 2018 from our audited consolidated financial statements included elsewhere in this prospectus. We have derived the consolidated statement of operations data for the six months ended June 30, 2018 and 2019 and the consolidated balance sheet data as of June 30, 2019 from our unaudited consolidated financial statements included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results that may be expected in the future and the results for the six months ended June 30, 2019 or any other interim period are not necessarily indicative of the results to be expected for the full year ending December 31, 2019 or any other period. The consolidated financial statements and selected historical consolidated financial data and other financial information included in this prospectus for periods prior to March 29, 2019 are those of SpringWorks Therapeutics, LLC prior to the Reorganization.
(in thousands, except unit and per unit and share and per share data)
|
|
|
Period from August 18, 2017 (inception) to December 31, 2017
|
|
|
Year ended December 31, 2018
|
|
|
Six months ended June 30,
|
|
|
2018
|
|
|
2019
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
$ |
2,799 |
|
|
|
|
$ |
9,898 |
|
|
|
|
$ |
2,786 |
|
|
|
|
$ |
19,628 |
|
|
General and administrative
|
|
|
|
|
1,861 |
|
|
|
|
|
8,593 |
|
|
|
|
|
4,028 |
|
|
|
|
|
6,911 |
|
|
Total operating expenses
|
|
|
|
|
4,660 |
|
|
|
|
|
18,491 |
|
|
|
|
|
6,814 |
|
|
|
|
|
26,539 |
|
|
Loss from operations
|
|
|
|
|
(4,660) |
|
|
|
|
|
(18,491) |
|
|
|
|
|
(6,814) |
|
|
|
|
|
(26,539) |
|
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net
|
|
|
|
|
21 |
|
|
|
|
|
678 |
|
|
|
|
|
224 |
|
|
|
|
|
1,283 |
|
|
Total other Income
|
|
|
|
|
21 |
|
|
|
|
|
678 |
|
|
|
|
|
224 |
|
|
|
|
|
1,283 |
|
|
Net loss
|
|
|
|
|
(4,639) |
|
|
|
|
|
(17,813) |
|
|
|
|
|
(6,590) |
|
|
|
|
|
(25,256) |
|
|
Net gain attributable to extinguishment of Series A convertible preferred units and Junior Series A convertible preferred units
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
7,729 |
|
|
Net loss attributable to common stockholders
|
|
|
|
$ |
(4,639) |
|
|
|
|
$ |
(17,813) |
|
|
|
|
$ |
(6,590) |
|
|
|
|
$ |
(17,527) |
|
|
Net loss per common unit, basic and diluted(1)
|
|
|
|
|
|
|
|
|
|
$ |
(52.24) |
|
|
|
|
$ |
(37.60) |
|
|
|
|
|
|
|
|
Net loss per common share attributable to common stockholders, basic and diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(22.47) |
|
|
Weighted average common units outstanding, basic and diluted
|
|
|
|
|
|
|
|
|
|
|
341,014 |
|
|
|
|
|
175,291 |
|
|
|
|
|
— |
|
|
Weighted average common shares outstanding, basic and diluted
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
780,066 |
|
|
Pro forma net loss per share, basic and diluted (unaudited)(2)
|
|
|
|
|
|
|
|
|
|
$ |
(2.00) |
|
|
|
|
|
|
|
|
|
|
$ |
(0.79) |
|
|
Pro forma weighted average common shares outstanding, basic and diluted (unaudited)(2)
|
|
|
|
|
|
|
|
|
|
|
8,927,163 |
|
|
|
|
|
|
|
|
|
|
|
22,195,710 |
|
|
(1) As of December 31, 2017, there were no vested common units outstanding. Therefore, net loss per common unit, basic and diluted, is not presented for the period from August 18, 2017 (inception) through December 31, 2017.
(2) See Note 12 to the notes to our consolidated financial statements included in this prospectus for an explanation of the method used to calculate the pro forma net loss per share and pro forma weighted average number of common shares outstanding.
|
|
|
As of December 31,
|
|
|
As of June 30, 2019
|
|
(in thousands)
|
|
|
2017
|
|
|
2018
|
|
Balance sheet data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$ |
10,271 |
|
|
|
|
$ |
45,648 |
|
|
|
|
$ |
185,291 |
|
|
Working capital(1)
|
|
|
|
|
9,888 |
|
|
|
|
|
43,353 |
|
|
|
|
|
178,152 |
|
|
Total assets
|
|
|
|
|
10,582 |
|
|
|
|
|
48,390 |
|
|
|
|
|
194,632 |
|
|
Series A convertible preferred units and shares
|
|
|
|
|
12,554 |
|
|
|
|
|
62,930 |
|
|
|
|
|
92,700 |
|
|
Series B convertible preferred shares
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
124,590 |
|
|
Accumulated deficit
|
|
|
|
|
(4,639) |
|
|
|
|
|
(22,452) |
|
|
|
|
|
(39,979) |
|
|
Stockholders’ (deficit)
|
|
|
|
|
(2,625) |
|
|
|
|
|
(19,369) |
|
|
|
|
|
(33,657) |
|
|
(1) We define working capital as current assets less current liabilities. See our consolidated financial statements and related notes appearing elsewhere in this prospectus for details regarding our current assets and current liabilities.
Management’s discussion and analysis of financial conditions and results of operations
You should read the following discussion and analysis of our financial condition and results of operations together with the section titled “Selected consolidated financial data” and the consolidated financial statements and related notes included elsewhere in this prospectus. This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those identified below and those discussed in the section titled “Risk factors” and in other parts of this prospectus.
Overview
We are a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. We have a differentiated portfolio of small molecule targeted oncology product candidates and are advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. Our strategic approach and operational excellence in clinical development have enabled us to rapidly advance our two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand our portfolio. From this foundation, we are continuing to build a differentiated, global biopharmaceutical company intensely focused on understanding patients and their diseases in order to develop transformative targeted medicines.
Our most advanced product candidate, nirogacestat, is an oral, small molecule gamma secretase inhibitor, or GSI, initially in development for the treatment of desmoid tumors, a rare and often debilitating and disfiguring soft tissue tumor for which there are currently no therapies approved by the U.S. Food and Drug Administration, or FDA. We believe nirogacestat may address the significant limitations associated with existing treatment options and has the potential to become the first therapy approved by the FDA for both newly diagnosed and previously treated desmoid tumors. Since we licensed nirogacestat from Pfizer Inc., or Pfizer, in August 2017, the FDA has granted nirogacestat Orphan Drug Designation, Fast Track Designation and Breakthrough Therapy Designation for this indication. In May 2019, we announced the initiation of the DeFi trial, a potentially registrational Phase 3 clinical trial of nirogacestat for patients with desmoid tumors. We expect to provide an update on the DeFi trial in the second half of 2020 ahead of an anticipated top-line data readout in the second or third quarter of 2021.
Our second product candidate is mirdametinib, an oral, small molecule MEK inhibitor initially in development for the treatment of NF1-PN, a rare tumor of the peripheral nerve sheath that causes significant pain and disfigurement, and that most often manifests in children. We believe that mirdametinib has the potential to offer a best-in-class combination of tolerability and efficacy to enable the long-term treatment required for this patient population, as compared to other MEK inhibitors. As with nirogacestat, we licensed mirdametinib from Pfizer in August 2017; since then, the FDA has granted mirdametinib both Orphan Drug Designation and Fast Track Designation for NF1-PN, and the European Commission has granted mirdametinib Orphan Drug Designation for NF1. We expect to commence a potentially registrational Phase 2b clinical trial of mirdametinib for patients with NF1-PN in the third quarter of 2019. We expect to provide an update on the ReNeu trial between the fourth quarter of 2020 and the first quarter of 2021.
In addition to our late-stage programs in rare oncology indications, we have expanded our portfolio to develop targeted therapies for the treatment of highly prevalent, genetically defined
cancers. To advance this strategy, we are taking a precision medicine approach in collaboration with industry leaders, including BeiGene, Ltd., or BeiGene and GlaxoSmithKline LLC, or GSK, to develop combination therapies with nirogacestat and mirdametinib, as well as new standalone medicines. The first of these efforts is our ongoing collaboration with BeiGene, under which patients with advanced or refractory solid tumors harboring RAS mutations, RAF mutations or other MAPK pathway aberrations are being enrolled in a Phase 1b clinical trial evaluating the combination of mirdametinib and BeiGene’s RAF dimer inhibitor lifirafenib. We entered into a clinical trial collaboration and supply agreement with GSK, or the GSK Collaboration Agreement, to evaluate nirogacestat in combination with belantamab mafodotin, GSK’s investigational BCMA ADC, in patients with relapsed or refractory multiple myeloma, in an adaptive Phase 1b clinical trial.
Furthermore, we intend to continue to expand our portfolio by licensing additional programs with strong biological rationales and validated mechanisms of action. We also plan to continue using shared-value partnerships to maximize the potential of our therapies to serve patients. Since our founding, we have invested in building leading clinical development capabilities and have focused on structuring innovative partnerships that seek to align incentives and optimize business outcomes for each party involved. We believe that this approach will continue to allow us to expand our shared-value relationships with innovators, maximize the potential of our existing and future portfolio and ultimately support the building of a scalable and sustainable business focused on the efficient advancement and commercialization of product candidates that hold the potential to transform the lives of patients living with severe rare diseases and cancer.
We were originally formed as SpringWorks Therapeutics, LLC, a Delaware limited liability company in August 2017. Concurrent with our formation, we acquired exclusive worldwide licenses to nirogacestat and mirdametinib from Pfizer. In September 2018, we announced that we entered into a global clinical collaboration with BeiGene to evaluate the combination of mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib. From our inception to March 29, 2019, we conducted our business through SpringWorks Therapeutics, LLC and were treated as a partnership for income tax purposes. Pursuant to the terms of a corporate reorganization that was completed on March 29, 2019, all of the equity interests in SpringWorks Therapeutics, LLC were exchanged for the same number and class of newly issued securities of SpringWorks Therapeutics, Inc., or the Reorganization, and, as a result, SpringWorks Therapeutics, LLC became a wholly owned subsidiary of SpringWorks Therapeutics, Inc. Following the Reorganization, we now conduct our business as SpringWorks Therapeutics, Inc. See the section entitled “Reorganization” for more information.
In June 2019, we announced the formation of MapKure, LLC, or MapKure, which is jointly owned by us and BeiGene. BeiGene licensed exclusive rights to MapKure to BGB-3245, and we will contribute to MapKure’s clinical development and other operational activities for BGB-3245.
Since our inception, our operations have been limited to organizing and staffing our company, business planning, raising capital and performing research and development of our product candidates, including nirogacestat for the treatment of desmoid tumors and mirdametinib for the treatment of NF1-PN.
We do not have any products approved for commercial sale and have not generated any revenues. We had cash and cash equivalents of $45.6 million and $185.3 million as of December 31, 2018 and June 30, 2019, respectively. Since inception, we have funded our operations primarily with net proceeds of $102.3 million from the sale of our Series A convertible preferred units prior to the Reorganization and $124.6 million in net proceeds from the sale of
our Series B convertible preferred stock following the Reorganization. We believe that the net proceeds from this offering, together with our existing cash and cash equivalents, will enable us to fund our operating expenses and capital expenditure requirements through 2022.
Since inception, we have incurred significant operating losses. Our net losses were $4.6 million and $17.8 million for the period from August 18, 2017 (inception) to December 31, 2017 and the year ended December 31, 2018, respectively, and were $6.6 million and $25.3 million for the six months ended June 30, 2018 and June 30, 2019, respectively. We had an accumulated deficit of $22.5 million and $40.0 million as of December 31, 2018 and June 30, 2019, respectively. We expect to continue to incur significant expenses and operating losses for the foreseeable future. In addition, we anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:
•
advance our product candidates through clinical development, including our ongoing potentially registrational Phase 3 clinical trial for nirogacestat and planned potentially registrational Phase 2b clinical trial for mirdametinib;
•
advance our other preclinical and clinical development programs, including our combination therapies, into and through clinical development;
•
seek regulatory approvals for any product candidates that successfully complete clinical trials;
•
increase the amount of research and development activities to identify, acquire and develop product candidates;
•
hire additional clinical, quality control, medical, scientific and other technical personnel;
•
expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development, manufacturing, business development and commercialization efforts and our operations as a public company;
•
maintain, expand and protect our intellectual property portfolio;
•
complete commercial-scale outsourced manufacturing activities;
•
establish sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own or jointly with third parties; and
•
invest in or in-license other technologies or product candidates.
We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. In addition, if we obtain regulatory approval for nirogacestat or mirdametinib, we expect to incur significant expenses related to developing our commercialization capabilities to support product sales, marketing and distribution activities, either alone or in collaboration with others.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If
we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Our license and collaboration agreements
Pfizer license agreements
In August 2017, we entered into a license agreement, or the Nirogacestat License Agreement, with Pfizer pursuant to which we acquired exclusive worldwide rights to nirogacestat. We subsequently amended the Nirogacestat License Agreement in July of 2019 with regard to certain provisions relating to intellectual property. Pursuant to the Nirogacestat License Agreement, as amended, we are required to pay Pfizer payments of up to an aggregate of $232.5 million upon achievement of certain commercial milestone events. We will pay Pfizer tiered royalties on sales of nirogacestat at percentages ranging from the mid-single digits to the low 20s, which may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition.
In August 2017, we entered into a license agreement, or the Mirdametinib License Agreement, with Pfizer pursuant to which we acquired exclusive worldwide rights to mirdametinib. We subsequently amended the Mirdametinib License Agreement in August of 2019 with regard to certain provisions relating to intellectual property. Pursuant to the Mirdametinib License Agreement, as amended, we are required to pay Pfizer up to an aggregate of $229.8 million upon achievement of certain commercial milestone events. We will pay Pfizer tiered royalties on sales of mirdametinib at percentages ranging from the mid-single digits to the low 20s, which may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition.
In connection with entering into the Pfizer license agreements, we issued an aggregate of 6,437,500 Junior Series A convertible preferred units to Pfizer, which units were converted into 6,437,500 shares of our Junior Series A convertible preferred stock pursuant to the Reorganization. As of June 30, 2019, we had not made any milestone or royalty payments under the Pfizer license agreements.
BeiGene clinical collaboration agreement
In August 2018, we entered into a clinical collaboration agreement with BeiGene, or the BeiGene Collaboration Agreement, to evaluate the safety, tolerability and preliminary efficacy of combining lifirafenib and mirdametinib, in a Phase 1b clinical trial for patients with advanced or refractory solid tumors. Each party will be solely responsible for its costs associated with manufacturing and supply of its compound for the clinical trial. We and BeiGene will share equally the other costs associated with the clinical trial.
GSK clinical trial collaboration and supply agreement
In June 2019, we entered into the GSK Collaboration Agreement, to evaluate nirogacestat in combination with belantamab mafodotin in patients with relapsed or refractory multiple myeloma, in an adaptive Phase 1b clinical trial. We expect GSK to initiate the adaptive Phase 1b
clinical trial evaluating the combination by the first quarter of 2020. GSK will be responsible for the conduct and expenses of the collaboration, which will be governed by a joint development committee with equal representation from each party.
See “Business—License and collaboration agreements” for more information on our license and collaboration agreements.
Components of our results of operations
Revenue
We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all. If our development efforts for our current product candidates or additional product candidates that we may develop in the future are successful and can be commercialized, we may generate revenue in the future from product sales. Additionally, we may enter into collaboration and license agreements from time to time that provide for certain payments due to us. Accordingly, we may generate revenue from payments from such collaboration or license agreements in the future.
Research and development expenses
Our research and development expenses consist of expenses incurred in connection with the development of our product candidates. These expenses include:
•
employee-related expenses, which include salaries, benefits and stock-based compensation for our research and development personnel;
•
fees paid to consultants for services directly related to our research and development programs;
•
expenses incurred under agreements with third-party contract research organizations, investigative clinical trial sites and consultants that conduct research and development activities on our behalf;
•
costs associated with preclinical studies and clinical trials;
•
costs associated with the manufacture of drug substance and finished drug product for preclinical testing and clinical trials;
•
costs associated with technology and intellectual property licenses; and
•
an allocated portion of facilities and facility-related costs, which include expenses for rent and other facility-related costs and other supplies.
Expenditures for clinical development, including upfront licensing fees and milestone payments associated with our product candidates, are charged to research and development expense as incurred. These expenses consist of expenses incurred in performing development activities, including salaries and benefits, materials and supplies, preclinical expenses, clinical trial and related clinical manufacturing expenses, depreciation of equipment, contract services and other outside expenses. Costs for certain development activities, such as manufacturing and clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using either time-based measures or data such as information provided to us by our vendors on their actual costs incurred.
We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in activities related to developing our product candidates and our preclinical programs and as certain product candidates advance into later stages of development, including our ongoing potentially registrational Phase 3 clinical trial for nirogacestat and
planned potentially registrational Phase 2b clinical trial for mirdametinib. The process of conducting the necessary clinical trials to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
General and administrative expenses
General and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance, corporate and business development and administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters; professional fees for accounting, auditing, tax and administrative consulting services; insurance costs; administrative travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with being a public company.
Other income (expense)
Other income consists primarily of interest income. Interest income consists of interest earned on our cash equivalents, which consist of money market funds. We expect our interest income to increase due to our investment of cash received from the final closing of our last tranche of Series A convertible preferred units in March 2019 prior to the Reorganization and the sale of Series B convertible preferred stock in March 2019, as well as the net proceeds from this offering.
Income taxes
We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or our tax returns. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial statements and tax basis of the assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes.
We recognize deferred tax assets to the extent that we believe that these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies and results of recent operations. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. If management determines that we would be able to realize our deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.
We record uncertain tax positions in accordance with ASC 740 on the basis of a two-step process in which (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions
that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority.
We provide reserves for potential payments of tax to various tax authorities related to uncertain tax positions. These reserves are based on a determination of whether and how much of a tax benefit taken by us in our tax filings or positions is more likely than not to be realized following resolution of any potential contingencies related to the tax benefit. Potential interest related to the underpayment of income taxes will be classified as a component of income tax expense and any related penalties will be classified in income taxes in the statement of operations.
Since our inception, we have not recorded any income tax benefits for the net losses we have incurred in each year or for our research and development tax credits, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credits will not be realized. As of December 31, 2018, we had U.S. federal, state and city net operating loss carryforwards of $14.2 million, $0.6 million and $3.8 million, respectively, which may be available to offset future taxable income. Federal net operating loss carryforwards of $4.3 million were recorded in 2017 and the state and city net operating loss carryforwards expire at various dates through 2038. Federal net operating loss carryforwards of $9.9 million recorded in 2018 will be available to offset 80% of taxable income for an indefinite period of time, until fully utilized. As of December 31, 2018, we also had federal tax credits of $0.4 million, which may be used to offset future tax liabilities. These tax credit carryforwards will expire in 2038. We have recorded a full valuation allowance against our net deferred tax assets at each balance sheet date.
Results of operations
Comparison of the Six Months Ended June 30, 2018 and the Six Months Ended June 30, 2019
The following table summarizes our results of operations for the six months ended June 30, 2018 and June 30, 2019.
(in thousands)
|
|
|
Six months ended June 30,
|
|
|
Change
|
|
|
2018
|
|
|
2019
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
$ |
2,786 |
|
|
|
|
$ |
19,628 |
|
|
|
|
$ |
16,842 |
|
|
General and administrative
|
|
|
|
|
4,028 |
|
|
|
|
|
6,911 |
|
|
|
|
|
2,883 |
|
|
Total operating expenses
|
|
|
|
|
6,814 |
|
|
|
|
|
26,539 |
|
|
|
|
|
19,725 |
|
|
Loss from operations
|
|
|
|
|
(6,814) |
|
|
|
|
|
(26,539) |
|
|
|
|
|
(19,725) |
|
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net
|
|
|
|
|
224 |
|
|
|
|
|
1,283 |
|
|
|
|
|
1,059 |
|
|
Total other income, net
|
|
|
|
|
224 |
|
|
|
|
|
1,283 |
|
|
|
|
|
1,059 |
|
|
Net loss
|
|
|
|
$ |
(6,590) |
|
|
|
|
$ |
(25,256) |
|
|
|
|
$ |
(18,666) |
|
|
Research and development expenses
Research and development expenses were $2.8 million and $19.6 million for the six months ended June 30, 2018 and June 30, 2019, respectively. This increase was primarily related to additional direct costs of $7.0 million; manufacturing and research costs of $5.3 million to further progress the development activities for our product candidates, including clinical trials; and personnel-related costs of $2.6 million and professional and consulting fees of $0.2 million, primarily due to increased headcount and consultant expenses.
We track outsourced development and manufacturing costs as well as personnel costs and other internal costs to specific development of product candidates. These external and internal research and development expenses are summarized by program in the table below:
(in thousands)
|
|
|
Six months ended June 30,
|
|
|
Change
|
|
|
2018
|
|
|
2019
|
|
Nirogacestat
|
|
|
|
$ |
1,665 |
|
|
|
|
$ |
11,935 |
|
|
|
|
$ |
10,270 |
|
|
Mirdametinib
|
|
|
|
|
624 |
|
|
|
|
|
5,881 |
|
|
|
|
|
5,257 |
|
|
Other
|
|
|
|
|
497 |
|
|
|
|
|
1,812 |
|
|
|
|
|
1,315 |
|
|
Total research and development expenses
|
|
|
|
$ |
2,786 |
|
|
|
|
$ |
19,628 |
|
|
|
|
$ |
16,842 |
|
|
General and administrative expenses
(in thousands)
|
|
|
Six months ended June 30,
|
|
|
Change
|
|
|
2018
|
|
|
2019
|
|
Personnel-related
|
|
|
|
$ |
1,636 |
|
|
|
|
$ |
2,770 |
|
|
|
|
$ |
1,134 |
|
|
Equity-based compensation expense
|
|
|
|
|
563 |
|
|
|
|
|
1,060 |
|
|
|
|
|
497 |
|
|
Professional and consulting fees
|
|
|
|
|
1,627 |
|
|
|
|
|
2,090 |
|
|
|
|
|
463 |
|
|
Facility-related and other
|
|
|
|
|
202 |
|
|
|
|
|
991 |
|
|
|
|
|
789 |
|
|
Total general and administrative expenses
|
|
|
|
$ |
4,028 |
|
|
|
|
$ |
6,911 |
|
|
|
|
$ |
2,883 |
|
|
General and administrative expenses were $4.0 million and $6.9 million for the six months ended June 30, 2018 and June 30, 2019, respectively. The increase in personnel-related costs of $1.1 million was primarily due to the hiring of additional personnel in our general and administrative functions as we continued to expand our operations to support the organization. The increase in equity-based compensation expense of $0.5 million was primarily due to incentive units granted. The increase in professional and consulting fees of $0.5 million was primarily due to consulting fees for market research and commercial planning efforts.
Interest income
Interest income was $0.2 million and $1.3 million for the six months ended June 30, 2018, and June 30, 2019, respectively, due to interest earned on higher invested cash balances in 2019.
Comparison of the period from August 18, 2017 (inception) to December 31, 2017 and the year ended December 31, 2018
We commenced operations in August 2017. Accordingly, our consolidated financial statements and results of operations for the period from our inception through December 31, 2017 reflect only approximately three and a half months of operations. For that reason, there is limited comparability of our results of operations for the period from inception through December 31, 2017 with those for the full year 2018.
The following table summarizes our results of operations for the period from August 18, 2017 (inception) to December 31, 2017 and the year ended December 31, 2018:
(in thousands, except unit and per unit data)
|
|
|
Period from August 18, 2017 (inception) to December 31, 2017
|
|
|
Year ended December 31, 2018
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
$ |
2,799 |
|
|
|
|
$ |
9,898 |
|
|
General and administrative
|
|
|
|
|
1,861 |
|
|
|
|
|
8,593 |
|
|
Total operating expenses
|
|
|
|
|
4,660 |
|
|
|
|
|
18,491 |
|
|
Loss from operations
|
|
|
|
|
(4,660) |
|
|
|
|
|
(18,491) |
|
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
21 |
|
|
|
|
|
678 |
|
|
Total other Income
|
|
|
|
|
21 |
|
|
|
|
|
678 |
|
|
Net loss
|
|
|
|
$ |
(4,639) |
|
|
|
|
$ |
(17,813) |
|
|
Research and development expenses
Research and development expenses were $2.8 million and $9.9 million for the period from August 18, 2017 (inception) to December 31, 2017, and for the year ended December 31, 2018, respectively.
This increase was primarily related to additional direct costs of $2.5 million; manufacturing and research costs of $1.8 million to further progress the development activities for our product candidates, including preparations for clinical trials; personnel-related costs of $2.5 million and professional and consulting fees of $1.5 million, primarily due to increased headcount and consultant expenses. These increases were offset by $2.0 million of expenses incurred in 2017 related to the issuance of Junior Series A convertible preferred units in connection with the execution of the Pfizer license agreement.
We track outsourced development and manufacturing costs as well as personnel costs and other internal costs to specific development of product candidates. These external and internal research and development expenses are summarized by program in the table below:
(in thousands)
|
|
|
Period from August 18, 2017 (inception) to December 31, 2017
|
|
|
Year ended December 31, 2018
|
|
Nirogacestat
|
|
|
|
$ |
1,238 |
|
|
|
|
$ |
5,560 |
|
|
Mirdametinib
|
|
|
|
|
1,045 |
|
|
|
|
|
2,675 |
|
|
Other
|
|
|
|
|
516 |
|
|
|
|
|
1,663 |
|
|
Total research and development expenses
|
|
|
|
$ |
2,799 |
|
|
|
|
$ |
9,898 |
|
|
General and administrative expenses
(in thousands)
|
|
|
Period from August 18, 2017 (inception) to December 31, 2017
|
|
|
Year ended December 31, 2018
|
|
Personnel-related
|
|
|
|
$ |
911 |
|
|
|
|
$ |
3,645 |
|
|
Equity-based compensation expense
|
|
|
|
|
— |
|
|
|
|
|
906 |
|
|
Professional and consulting fees
|
|
|
|
|
887 |
|
|
|
|
|
3,235 |
|
|
Facility-related and other
|
|
|
|
|
63 |
|
|
|
|
|
807 |
|
|
Total general and administrative expenses
|
|
|
|
$ |
1,861 |
|
|
|
|
$ |
8,593 |
|
|
General and administrative expenses were $1.9 million and $8.6 million for the period from August 18, 2017 (inception) to December 31, 2017, and for the year ended December 31, 2018.
The increase in personnel-related costs of $2.7 million was primarily due to the hiring of key executives in 2018, including the appointment of our Chief Executive Officer, Chief Business Officer, Chief Medical Officer and General Counsel, as well as additional personnel in our general and administrative functions as we continued to expand our operations to support the organization. The increase in equity-based compensation expense of $0.9 million was primarily due to incentive units granted to certain executives in 2018. The increase in professional and consulting fees of $2.3 million was primarily due to outsourcing various general and administrative activities to third parties.
Interest income
Interest income for the year ended December 31, 2018 was $0.7 million due to interest earned on invested cash balances.
Liquidity and capital resources
Overview
Since inception, we have funded our operations primarily with net proceeds of $102.3 million from the sale of our Series A convertible preferred units prior to the Reorganization and with net proceeds of $124.6 million from the sale of our Series B convertible preferred stock following the Reorganization. At June 30, 2019, we had available cash and cash equivalents of $185.3 million.
We have incurred operating losses and experienced negative operating cash flows since our inception and anticipate that we will continue to incur losses for at least the foreseeable future. Our net loss was $17.8 million and $25.3 million for the year ended December 31, 2018 and for the six months ended June 30, 2019, respectively. We had an accumulated deficit of $22.5 million and $40.0 million at December 31, 2018 and June 30, 2019, respectively.
Funding requirements
Our primary use of cash is to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.
We believe that our net proceeds from this offering, together with our cash and cash equivalents as of June 30, 2019, will be sufficient to to fund our operating expenses and capital expenditure requirements through 2022. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.
Our future funding requirements will depend on many factors, including the following:
•
the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our product candidates, including our ongoing potentially registrational Phase 3 clinical trial for nirogacestat and planned potentially registrational Phase 2b clinical trial for mirdametinib;
•
the clinical development plans we establish for these product candidates;
•
the number and characteristics of product candidates that we develop;
•
the outcome, timing and cost of meeting regulatory requirements established by the FDA, EMA and other comparable foreign regulatory authorities;
•
the terms of our existing and any future license or collaboration agreements we may choose to enter into, including the amount of upfront, milestone and royalty obligations;
•
the other costs associated with in-licensing new technologies, such as any increased costs of research and development and personnel;
•
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
•
the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates;
•
the effect of competing technological and market developments;
•
the cost and timing of completion of commercial-scale outsourced manufacturing activities; and
•
the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own.
We will need additional funds to meet operational needs and capital requirements for clinical trials, other research and development expenditures, and business development activities. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical studies.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Cash flows
The following table summarizes our sources and uses of cash for each of the periods presented:
(in thousands)
|
|
|
Period from August 18, 2017 (inception) to December 31, 2017
|
|
|
Year ended December 31, 2018
|
|
|
Six months ended June 30,
|
|
|
2018
|
|
|
2019
|
|
Cash used in operating activities
|
|
|
|
$ |
(2,239) |
|
|
|
|
$ |
(14,706) |
|
|
|
|
$ |
(4,484) |
|
|
|
|
$ |
(20,268) |
|
|
Cash used in investing activities
|
|
|
|
|
(44) |
|
|
|
|
|
(293) |
|
|
|
|
|
(65) |
|
|
|
|
|
(4,046) |
|
|
Cash provided by financing activities
|
|
|
|
|
12,554 |
|
|
|
|
|
50,376 |
|
|
|
|
|
50,400 |
|
|
|
|
|
163,957 |
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
|
$ |
10,271 |
|
|
|
|
$ |
35,377 |
|
|
|
|
$ |
45,851 |
|
|
|
|
$ |
139,643 |
|
|
Cash flows used in operating activities
Net cash used in operating activities was $2.2 million and $14.7 million for the period from August 18, 2017 (inception) to December 31, 2017, and for the year ended December 31, 2018, respectively.
Cash used in operating activities in the year ended December 31, 2018, was primarily due to our net loss for the year of $17.8 million, adjusted by non-cash charges of $1.1 million and a net change of $2.0 million in our net operating assets and liabilities. The non-cash charges primarily consisted of $1.1 million for equity-based compensation expense. The change in our net operating assets and liabilities was primarily due to an increase of $2.7 million in accounts payable and accrued expenses and a $1.5 million increase in deferred rent, partially offset by a $2.2 million increase of prepaid expenses and other non-current assets.
Cash used in operating activities in the period from August 18, 2017 (inception) to December 31, 2017 was primarily due to our net loss for the year of $4.6 million, adjusted by non-cash charges of $2.0 million and net change of $0.4 million in our net operating assets and liabilities. The non-cash charges primarily consisted of $2.0 million for expenses relating to the issuance of Junior Series A convertible preferred units in connection with the execution of the Pfizer licenses. The change in our net operating assets and liabilities was primarily due to an increase of $0.7 million in accounts payable and accrued expenses and a $0.3 million increase prepaid expenses and in other non-current assets.
Net cash used in operating activities was $4.5 million and $20.3 million for the six months ended June 30, 2018, and June 30, 2019, respectively.
Cash used in operating activities in the six months ended June 30, 2019, was primarily due to our net loss for the six months of $25.3 million, adjusted by non-cash charges of $1.4 million and a net change of $3.6 million in our net operating assets and liabilities. The non-cash charges primarily consisted of $1.4 million for equity-based compensation expense. The change in our net operating assets and liabilities was primarily due to an increase of $6.3 million in accounts payable and accrued expenses and a $0.2 million decrease in deferred rent, partially offset by a $2.6 million increase of other non-current assets.
Cash used in operating activities in the six months ended June 30, 2018, was primarily due to our net loss for the six months of $6.6 million, adjusted by non-cash charges of $0.6 million and a net change of $1.5 million in our net operating assets and liabilities. The non-cash charges primarily consisted of $0.6 million for equity-based compensation expense. The change in our net operating assets and liabilities was primarily due to an increase of $2.0 million in accounts payable and accrued expenses and a $0.5 million increase of other non-current assets.
Cash flows from investing activities
Cash used from investing activities was less than $0.1 million and $0.3 million, during the period from August 18, 2017 (inception) to December 31, 2017 and the year ended December 31, 2018, respectively, primarily related to purchases of property and equipment.
Cash used for investing activities was less than $0.1 million and $4.0 million for the six months ended June 30, 2018, and June 30, 2019, respectively, primarily due to the investment in MapKure and increases in purchases of property and equipment.
Cash flows provided by financing activities
During the period from August 18, 2017 (inception) to December 31, 2017, cash provided by financing activities was $12.6 million from the issuance of Series A convertible preferred units prior to the Reorganization.
During the year ended December 31, 2018, cash provided by financing activities was $50.4 million from the issuance of Series A convertible preferred units prior to the Reorganization.
During the six month period ended June 30, 2018, cash provided by financing activities was $50.4 million from the issuance of Series A convertible preferred units prior to the Reorganization.
During the six month period ended June 30, 2019, cash provided by financing activities was $164.0 million, reflecting $39.4 million in net proceeds received from the issuance of Series A convertible preferred units prior to the Reorganization and $124.6 million in net proceeds received from the issuance of Series B convertible preferred shares following the Reorganization.
Contractual obligations and other commitments
The following table summarizes our contractual obligations as of June 30, 2019 and the effects that such obligations are expected to have on our liquidity and cash flows in future periods:
|
|
|
Payments due by period
|
|
(in thousands)
|
|
|
Total
|
|
|
Remaining 6 months of 2019
|
|
|
1 to 3 years
|
|
|
4 to 5 years
|
|
|
More than 5 years
|
|
Operating lease commitments(1)
|
|
|
|
$ |
4,808 |
|
|
|
|
$ |
660 |
|
|
|
|
$ |
4,013 |
|
|
|
|
$ |
135 |
|
|
|
|
$ |
— |
|
|
Total
|
|
|
|
$ |
4,808 |
|
|
|
|
$ |
660 |
|
|
|
|
$ |
4,013 |
|
|
|
|
$ |
135 |
|
|
|
|
$ |
— |
|
|
(1) Amounts in the table reflect payments due for our facility in Durham, North Carolina and our headquarters in Stamford, Connecticut under two operating lease agreements that expire in August 2023 and November 2022, respectively.
We enter into contracts in the normal course of business with third-party contract research organizations for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore we believe that our non-cancelable obligations under these agreements are not material and they are not included in the table above.
We have not included milestone or royalty payments or other contractual payment obligations in the table above if the timing and amount of such obligations are unknown or uncertain.
We have not recorded any reserves for uncertain tax positions as of December 31, 2017, December 31, 2018 or June 30, 2019.
Off-balance sheet arrangements
We have not entered into any off-balance sheet arrangements and do not have holdings in any variable interest entities.
Quantitative and qualitative disclosures about market risk
The primary objectives of our investment activities are to ensure liquidity and to preserve capital. We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate sensitivities. We had cash and cash equivalents of $10.3 million and $45.6 million as of December 31, 2017 and December 31, 2018, respectively, and $56.1 million and $185.3 million as of June 30, 2018, and June 30, 2019, respectively, which consisted of bank deposits and highly liquid money market funds. Historical fluctuations in interest rates have not been significant for us. We had no outstanding debt as of December 31, 2017, December 31, 2018 and June 30, 2019. Due to the short-term maturities of our cash equivalents, an immediate one percentage point change in interest rates would not have a material effect on the fair market value of our cash equivalents. To minimize the risk in the future, we intend to maintain our portfolio of cash equivalents in institutional market funds that are composed of U.S. Treasury and U.S. Treasury-backed repurchase agreements or short-term U.S. Treasury securities. We do not believe that inflation, interest rate changes or exchange rate fluctuations had a significant impact on our results of operations for any periods presented herein.
Critical accounting policies and estimates
This management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 3 to our consolidated financial statements appearing elsewhere in this prospectus, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our consolidated financial statements.
Accrued research and development costs
We record accrued expenses for estimated costs of our research and development activities conducted by third-party service providers, which include the conduct of clinical trials and preclinical studies. We record the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and include these costs in accrued liabilities in the consolidated balance sheets and within research and development expense in the consolidated statement of operations. These costs are a significant component of our research and development expenses. We record accrued expenses for these costs based on factors such as estimates of the work completed and in accordance with agreements established with these third-party service providers. Any payments made in advance of services provided are recorded as prepaid assets, which are then expensed as the contracted services are performed.
We estimate the amount of work completed based on discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed, the number of patients enrolled and the rate of patient enrollment may vary from our estimates and could result in us reporting amounts that are too high or too low in any particular period. Our accrued expenses are dependent, in part, upon the receipt of timely and accurate reporting from clinical research organizations and other third-party service providers. For the periods presented, we have experienced no material differences between our accrued expenses and actual expenses.
Equity-based compensation
Prior to the Reorganization, our predecessor, SpringWorks Therapeutics, LLC, granted incentive units and unit options, which we accounted for as equity-classified awards. As part of the Reorganization, the incentive units and unit options were exchanged for shares of our common stock, in the case of vested incentive units, and restricted stock, in the case of unvested incentive units. Unit options were exchanged for stock options.
Our predecessor entity measured employee equity-based compensation based on the grant date fair value of the equity-based awards and recognized equity-based compensation expense on a straight-line basis over the requisite service period of the awards, which generally vest over a four-year period with the first 25% vesting following 12 months of employment or service and the remaining incentive units vesting in equal quarterly installments over the following 36 months. For awards subject to performance conditions, we recognize equity-based compensation expense using an accelerated recognition method over the remaining period when we determine that achievement of the milestone is probable. In 2018, our predecessor made an accounting policy election to recognize forfeitures as they occur upon adoption of guidance per Accounting Standard Update, or ASU, No. 2016-09, Compensation—Stock Compensation, or ASU 2016-09. The adoption of ASU 2016-09 did not have a material impact on our consolidated financial statements. The term “forfeitures” is distinct from “cancellations” or “expirations” and represents only the unvested portion of the surrendered equity-based award. Following the Reorganization, we expect to employ the same approach towards equity-based compensation.
We recognize compensation expense for equity-based awards granted to non-employees over the related service period of the award.
We classify equity-based compensation expense in our consolidated statement of operations in the same manner in which the award recipient’s salary and related costs are classified or in which the award recipient’s service payments are classified.
For any incentive units or options that our predecessor entity issued and for any future stock options, we estimate the grant date fair value and the resulting stock-based compensation expense using the Black-Scholes option-pricing model. The grant date fair value of the stock-based awards is recognized on a straight-line basis over the requisite service periods, which are generally the vesting period of the respective awards. Forfeitures are accounted for as they occur.
The grant-date fair value of performance-based awards with market conditions is estimated using a Monte Carlo simulation method that incorporates the probability of the performance conditions being met as of the grant date.
The Black-Scholes option-pricing model requires the use of subjective assumptions which determine the fair value of stock-based awards, including the expected term and the price volatility of the underlying stock. These assumptions include:
•
Fair value of common units—See “Determination of the fair value of equity-based awards” below.
•
Expected term—The expected term represents the period that the equity-based awards are expected to be outstanding. The expected term for our unit options and stock options was calculated based on the weighted average vesting term of the awards and the contract period, or simplified method, as allowed by the SEC.
•
Expected volatility—Since we are not yet a public company and do not have any trading history for our common stock, the expected volatility was estimated based on the average historical volatilities of common stock of comparable publicly traded entities over a period equal to the expected term of the unit options and stock option grants. The comparable companies were chosen based on their size, stage in the life cycle or area of specialty. We will continue to apply this process until enough historical information regarding the volatility of our own stock price becomes available.
•
Risk-free interest rate—The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the expected term of the awards.
•
Expected dividend—We have never paid dividends on our common stock and have no plans to pay dividends on our common stock. Therefore, we used an expected dividend yield of zero.
Determination of the fair value of equity-based awards
As there has been no public market to date for the common units or incentive units of our predecessor entity which operated as a limited liability company, the estimated fair value of our common units and incentive units has been approved by our board of directors, with input from management, as of the date of each award grant, considering our most recently available independent third-party valuations of common units and incentive units and our board of directors assessment, with input from management, of additional objective and subjective factors that we believed were relevant and which may have changed from the date of the most recent valuation through the date of the grant. In addition, following the Reorganization there remains no public market for our common stock to date. The estimated fair value of our common stock has been determined by our board of directors as of the date of each award grant considering our most recently available independent third-party valuations of common stock and our board of directors’ assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent valuation through the date of the grant. These independent third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. We estimated the value of our equity using the market approach, including the guideline public company method and a precedent transaction method which “backsolves” to a preferred price. We allocated equity value to our common units, incentive units and convertible preferred units or to our shares of common stock and shares of our convertible preferred stock, as the case may be, using an option-pricing method, or OPM. The OPM treats common securities and preferred securities as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company’s securities
changes. Under this method, the common and incentive units have value only if the funds available for distribution exceed the value of the convertible preferred units’ liquidation preferences at the time of a liquidity event, such as a strategic sale, merger or initial public offering, or IPO.
As of January 31, 2018, our third-party valuation report estimated a valuation of our common and incentive units of $0.79 per unit. As of April 17, 2018, our third-party valuation report estimated a valuation of our common and incentive units of $1.45 per unit. As of February 28, 2019, our third-party valuation report estimated a valuation of our unit options, common and incentive units of $1.65 per unit. As of March 31, 2019, our third-party valuation report estimated a value of our common stock of $2.30 per share. As of June 30, 2019, our third-party valuation estimated a value of our common stock of $9.08 per share.
In addition to considering the results of these third-party valuations, management considered various objective and subjective factors to determine the fair value of our common units,
incentive units, unit options, stock options and common stock as of each grant date, which may be a date later than the most recent third-party valuation date, including:
•
the prices of our preferred securities sold to or exchanged between outside investors in arm’s length transactions, and the rights, preferences and privileges of our preferred securities as compared to those of our common units, incentive units, unit options, stock options or common stock, including the liquidation preferences of our preferred securities;
•
the progress of our research and development efforts, including the status of preclinical studies and planned clinical trials for our product candidates;
•
our financial position, including cash on hand, and our historical and forecasted performance and operating results;
•
our stage of development and business strategy and the material risks related to our business and industry;
•
the achievement of enterprise milestones, including entering into collaboration and license agreements;
•
the valuation of publicly traded companies in the life sciences and biotechnology sectors, as well as recently completed mergers and acquisitions of peer companies;
•
any external market conditions affecting the biotechnology industry, and trends within the biotechnology industry;
•
the likelihood of achieving a liquidity event for the holders of our common stock, such as an IPO, or a sale of our company, given prevailing market conditions; and
•
the analysis of IPOs and the market performance of similar companies in the biopharmaceutical industry.
The assumptions underlying these valuations represent management’s best estimates, which involve inherent uncertainties and the application of management judgment. As a result, if factors or expected outcomes change and we use significantly different assumptions or estimates, our equity-based compensation expense could be materially different. Following the completion of this offering, the fair value of our common stock will be determined based on the quoted market price of our common stock.
Stock-based compensation expense was $0, $1.1 million and $1.4 million for the period from August 18, 2017 (inception) to December 31, 2017, the year ended December 31, 2018 and six months ended June 30, 2019, respectively.
Recent accounting pronouncements
See Note 3 to our consolidated financial statements “Summary of Significant Accounting Policies—Recently Issued Accounting Pronouncements” for more information.
Emerging growth company status and JOBS Act accounting election
We qualify as an “emerging growth company,” or EGC, as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. As an EGC, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include, but are not limited to:
•
being permitted to present only two years of audited financial statements in this prospectus and only two years of related “Management’s discussion and analysis of financial condition and results of operations” in our periodic reports and registration statements, including this prospectus;
•
not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended;
•
reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements, including in this prospectus; and
•
exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
We may take advantage of these exemptions until we are no longer an EGC. We will cease to be an EGC on the date that is the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more; (ii) the last day of 2024; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (iv) the last day of the fiscal year in which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission, or SEC, which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th. We may choose to take advantage of some but not all of these exemptions. We have taken advantage of reduced reporting requirements in this prospectus. Accordingly, the information contained herein may be different from the information you receive from other public companies in which you hold stock. In addition, the JOBS Act provides that an EGC can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an EGC to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an EGC or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
Business
Overview
We are a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. We have a differentiated portfolio of small molecule targeted oncology product candidates and are advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. Our strategic approach and operational excellence in clinical development have enabled us to rapidly advance our two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand our portfolio. From this foundation, we are continuing to build a differentiated, global biopharmaceutical company intensely focused on understanding patients and their diseases in order to develop transformative targeted medicines.
Our most advanced product candidate, nirogacestat, is an oral, small molecule gamma secretase inhibitor, or GSI, initially in development for the treatment of desmoid tumors, a rare and often debilitating and disfiguring soft tissue tumor for which there are currently no therapies approved by the U.S. Food and Drug Administration, or FDA. We believe nirogacestat may address the significant limitations associated with existing treatment options and has the potential to become the first therapy approved by the FDA for both newly diagnosed and previously treated desmoid tumors. Since we licensed nirogacestat from Pfizer Inc., or Pfizer, in August 2017, the FDA has granted us Orphan Drug Designation, Fast Track Designation and Breakthrough Therapy Designation for this indication. In May 2019, we announced the initiation of the DeFi trial, a potentially registrational Phase 3 clinical trial of nirogacestat for patients with desmoid tumors. We expect to provide an update on the DeFi trial in the second half of 2020 ahead of an anticipated top-line data readout in the second or third quarter of 2021.
Our second product candidate is mirdametinib, an oral, small molecule MEK inhibitor initially in development for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas, or NF1-PN, a rare tumor of the peripheral nerve sheath that causes significant pain and disfigurement, and that most often manifests in children. We believe that mirdametinib has the potential to offer a best-in-class profile in order to enable the long-term treatment required for this patient population, as compared to other MEK inhibitors. As with nirogacestat, we licensed mirdametinib from Pfizer in August 2017; since then, the FDA has granted mirdametinib both Orphan Drug Designation and Fast Track Designation for NF1-PN, and the European Commission has granted mirdametinib Orphan Drug Designation for NF1. In the third quarter of 2019, we expect to commence the ReNeu trial, a potentially registrational Phase 2b clinical trial of mirdametinib for patients with NF1-PN. We expect to provide an update on the ReNeu trial between the fourth quarter of 2020 and the first quarter of 2021.
In addition to our late-stage programs in rare oncology indications, we have expanded our portfolio to develop targeted therapies for the treatment of highly prevalent, genetically defined cancers. To advance this strategy, we are taking a precision medicine approach in collaboration with industry leaders, including BeiGene and GSK, to develop combination approaches with nirogacestat and mirdametinib, as well as new standalone medicines. The first of these efforts is our ongoing collaboration with BeiGene, under which patients with advanced or refractory solid tumors harboring RAS mutations, RAF mutations and other MAPK pathway aberrations are being enrolled in a Phase 1b clinical trial evaluating the combination of mirdametinib and BeiGene’s investigational RAF dimer inhibitor lifirafenib. The second of these efforts is our collaboration with GSK, under which patients with relapsed or refractory multiple myeloma will be enrolled in
an adaptive Phase 1b clinical trial evaluating the combination of nirogacestat and belantamab mafodotin, GSK’s investigational antibody-drug conjugate, or ADC, targeted to B-cell maturation antigen, or BCMA. We expect GSK to initiate the adaptive Phase 1b clinical trial evaluating the combination by the first quarter of 2020.
Furthermore, we intend to continue to expand our portfolio by licensing additional programs with strong biological rationales and validated mechanisms of action. We also plan to continue using shared-value partnerships to maximize the potential of our therapies to serve patients. Since our founding, we have invested in building leading clinical development capabilities and have focused on structuring innovative partnerships that seek to align incentives and optimize business outcomes for each party involved. We believe that this approach will continue to allow us to expand our shared-value relationships with innovators, maximize the potential of our existing and future portfolio and ultimately support the building of a scalable and sustainable business focused on the efficient advancement and commercialization of product candidates that hold the potential to transform the lives of patients living with severe rare diseases and cancer.
The following table summarizes our current portfolio of product candidates:
(1)
Being developed by MapKure, LLC, or MapKure, a newly formed entity jointly owned by us and BeiGene.
For purposes of this prospectus, when we refer herein to a “potentially registrational trial,” we are referring to a clinical trial to evaluate efficacy and safety of a product candidate to potentially support submission of a marketing application for such product candidate with the applicable regulatory authorities. Such a trial is also sometimes referred to as a Phase 2/3 or Phase 3 clinical trial or a pivotal trial.
Nirogacestat is currently in the potentially registrational Phase 3 DeFi clinical trial for the treatment of desmoid tumors, which are rare and often debilitating and disfiguring soft tissue tumors. Desmoid tumors can aggressively invade surrounding healthy tissues and cause significant morbidities, including severe pain, internal bleeding, incapacitating loss of range of motion and, in rare cases, death. There are currently no therapies approved by the FDA for the treatment of desmoid tumors. Nirogacestat has been generally well tolerated in over 200 subjects and clinical activity was observed in the desmoid tumor patients enrolled in two previous clinical trials, many of whom had been heavily pre-treated. Since then, the FDA has granted nirogacestat Orphan Drug Designation, Fast Track Designation and Breakthrough Therapy Designation for the treatment of desmoid tumors. We are currently conducting the DeFi trial, a double-blind, randomized, placebo-controlled clinical trial in adults with progressing desmoid tumors. We
believe that we have designed the DeFi trial such that, if nirogacestat demonstrates clinical activity consistent with that observed in desmoid tumor patients treated to date with nirogacestat, the primary endpoint of this clinical trial should be met. If the results are favorable, we plan to file for marketing approval for nirogacestat in the United States and select international markets. We expect to provide an update on the DeFi trial in the second half of 2020 ahead of an anticipated top-line data readout in the second or third quarter of 2021.
Nirogacestat + belantamab mafodotin is being explored with GSK in patients with relapsed or refractory multiple myeloma, or RRMM. Belantamab mafodotin is the most clinically advanced BCMA ADC and clinical activity has been observed with belantamab mafodotin as a monotherapy in RRMM patients. We believe that the clinical activity of BCMA directed therapies, including belantamab mafodotin, may be enhanced with the addition of a GSI like nirogacestat. Other than the manufacturing of nirogacestat and certain expenses related to intellectual property rights, GSK will be responsible for the conduct and expenses of the trial, which will be governed by a joint development committee with equal representation from each party. We expect GSK to initiate the adaptive Phase 1b clinical trial evaluating the combination by the first quarter of 2020.
Mirdametinib is expected to begin the potentially registrational Phase 2b ReNeu clinical trial for the treatment of NF1-PN in the third quarter of 2019. NF1-PN is a rare tumor of the peripheral nerve sheath that causes significant pain and disfigurement, and that most often manifests in children. There are currently no therapies approved by the FDA for the treatment of NF1-PN. In a previous Phase 2 clinical trial conducted in NF1-PN patients, mirdametinib was observed to be clinically active and generally well tolerated. Since then, the FDA and the European Commission have each granted mirdametinib Orphan Drug Designation for the treatment of NF1 and the FDA has granted mirdametinib Fast Track Designation for the treatment of NF1-PN. The upcoming ReNeu trial will be an open-label, single-arm trial that will enroll both pediatric and adult NF1-PN patients. Given the clinical activity and tolerability observed with mirdametinib in the previous NF1-PN clinical trial and informed by our discussions with the FDA, we designed the ReNeu trial in a manner that we believe has the potential to generate sufficient data to support approval in both pediatric and adult NF1-PN patients. If the results are favorable, we plan to file for marketing approval for mirdametinib in the United States and select international markets.
Mirdametinib + lifirafenib is a combination therapy that we are evaluating with BeiGene in patients with advanced or refractory solid tumors that harbor various oncogenic driver mutations in the mitogen activated protein kinase, or MAPK, pathway, a signaling pathway whose constitutive activation has been reported in approximately 25% of human cancers owing to mutations in genes such as RAS and RAF. Lifirafenib is a RAF dimer inhibitor that was observed to be clinically active in advanced solid tumor patients with RAS and RAF mutations. We believe that lifirafenib’s clinical activity should be enhanced with the addition of a potent and selective MEK inhibitor like mirdametinib, and provide a potentially promising combination therapy for cancers whose growth is reliant on MAPK pathway signaling, such as those with mutations in RAS or RAF. In May 2019, we announced the initiation of an adaptive Phase 1b clinical trial that is currently enrolling patients in Australia with advanced or refractory solid tumors harboring relevant genetic mutations in the MAPK pathway. In addition, in July 2019 the FDA cleared the Investigational New Drug application, or IND, for this combination therapy, thereby allowing for the expansion of this clinical trial to the United States. We intend to provide an update from the dose escalation portion of this trial in 2020, which would precede the selection of specific patient cohorts in which assess the clinical activity of the combination at the selected doses of each compound, which we expect to occur at the end of 2020 or in early 2021.
BGB-3245 is an investigational, oral, selective small molecule inhibitor of specific BRAF driver mutations and genetic fusions. BGB-3245 is being advanced via MapKure, a newly formed entity
jointly owned by us and BeiGene. BGB-3245 was exclusively licensed to MapKure by BeiGene and is intended to be initially developed as a monotherapy. Preclinical activity has been observed with BGB-3245 in a range of tumor models with BRAF mutations and BRAF fusions that are presently unaddressed with approved BRAF-directed therapies. MapKure expects to initiate an adaptive Phase 1 dose escalation and expansion clinical trial evaluating BGB-3245 in genetically defined solid tumors by the first quarter of 2020.
Our history and team
We were founded in August 2017 and concurrently acquired rights to certain assets from Pfizer, including exclusive worldwide licenses to nirogacestat and mirdametinib. We have raised $228 million from leading strategic and institutional investors. Our strategic investors include Pfizer and GlaxoSmithKline, and our institutional investors include OrbiMed, Bain Capital, LifeArc, Perceptive Advisors, Boxer Capital of the Tavistock Group, HBM Healthcare Investments, BVF Partners, Surveyor Capital (a Citadel company), Samsara BioCapital, ArrowMark Partners and other institutional investors.
We are led by biopharmaceutical experts with extensive experience in building and operating organizations that develop and deliver innovative medicines to patients. Our team has broad experience in clinical development, regulatory affairs, manufacturing and commercialization of novel medicines, particularly in rare diseases. Our Chief Executive Officer, Saqib Islam, has more than 25 years of experience in biopharmaceuticals and finance, and has led our key business operations and strategic corporate planning activities since our inception. Members of our management team have held leadership positions at companies that have successfully discovered, acquired, developed and commercialized therapies for a range of devastating rare diseases and cancers. These companies include Alexion Pharmaceuticals, Inc., AstraZeneca plc, Bamboo Therapeutics, Inc., Bristol-Myers Squibb Company, Forest Laboratories, Inc., GlaxoSmithKline plc, Merck & Co., Inc., Moderna, Inc., Pfizer and United Therapeutics Corporation.
Our strategy
Our goal is to continue building a differentiated, global biopharmaceutical company by acquiring, developing and commercializing transformative medicines for underserved patient populations. We aim to be an industry leader in rare diseases and targeted oncology and are advancing a diversified portfolio of programs with the intention of efficiently delivering safe and effective medicines to patients.
The key elements of our strategy include:
•
Efficiently advance our lead product candidates towards marketing approval. We believe that our leading drug development capabilities will enable us to continue efficiently advancing our product candidates towards marketing approval, and we will make use of accelerated regulatory pathways when possible. Since our inception in August 2017, we have made rapid progress advancing two product candidates towards marketing approval. Our first product candidate, nirogacestat, was granted Orphan Drug Designation, Fast Track Designation and Breakthrough Therapy Designation by the FDA for the treatment of desmoid tumors and is currently being evaluated in the potentially registrational DeFi trial; we expect to provide an update on this trial in the second half of 2020. Our second product candidate, mirdametinib, was granted Orphan Drug Designation by both the FDA and the European Commission for the treatment of NF1 and Fast Track Designation by the FDA for the treatment of NF1-PN, and we expect to commence enrollment in the potentially registrational ReNeu trial for the treatment of NF1-PN in the third quarter of 2019.
•
Maximize the potential of our portfolio through strategic partnerships. We have entered into strategic partnerships to develop innovative combination therapies that leverage emerging insights into the fundamental mechanisms that drive cancer. Our strategy is to align incentives among parties by sharing development costs and downstream economics for selected partnered programs. By pursuing this strategy, we believe that we can access promising therapies being developed across the biopharmaceutical industry for which there is scientific and clinical rationale for combinations with our existing product candidates. We have announced collaborations with BeiGene and GSK and we intend to execute additional strategic partnerships in the future.
•
Commercialize our product candidates, if approved, to bring new medicines to underserved patient populations. We intend to market and commercialize our product candidates, if approved, in the United States and select international markets, either alone or in partnership with others. We expect to build our medical affairs organization and commercial infrastructure using a focused and efficient approach, initially establishing market access, sales and marketing capabilities in a targeted manner that is appropriate for the relevant product opportunity. We believe that this approach will allow us to effectively reach the patients and physicians that our product candidates have been developed for and to maximize the commercial potential of our portfolio.
•
Deploy our value-driven approach to identify, acquire and develop new medicines. We follow a scientifically rigorous approach to evaluating new opportunities to broaden our portfolio. When evaluating assets, we consider a variety of factors, including unmet medical need, biological rationale, feasibility of clinical development, potential for regulatory approval, intellectual property position, costs required to achieve both near- and long-term milestones, competitive landscape and commercial potential. Utilizing this strategy, we have continued to expand our reach in targeted oncology by collaborating with BeiGene to jointly form MapKure, a new research-stage company that was recently created to develop precision medicines to treat patients with life-threatening diseases, with an initial focus on cancer. We intend to continue to work closely with our existing partners and other asset originators to further expand our portfolio in our current focus areas of rare diseases and targeted oncology.
•
Continue to cultivate a tightly integrated network of patient advocacy groups, key opinion leaders, research institutions and healthcare providers. We believe that in order to develop our portfolio in an efficient and impactful manner, it is imperative to cultivate a network of key stakeholders. Integrating the experiences and insights from these stakeholders, which include the Desmoid Tumor Research Foundation, the Children’s Tumor Foundation and leading academic physicians and researchers, continues to inform our approach to developing therapies that can transform the lives of patients and their families suffering from devastating rare diseases and cancer.
Our product candidates
Nirogacestat
Overview
Nirogacestat (PF-03084014), our most advanced product candidate, is an oral, selective GSI that we are developing for the treatment of certain oncology indications. Gamma secretase is a protease complex that cleaves numerous transmembrane proteins, including amyloid precursor protein, or APP, Notch, HER4, E-cadherin, N-cadherin, BCMA and CD44. Cleavage of these transmembrane proteins by gamma secretase leads to a variety of signaling events that result from the untethering of the cytoplasmic domains of these proteins. Several of gamma secretase’s
substrates have been implicated in a variety of diseases, including APP in Alzheimer’s disease and Notch in cancer, forming the rationale for evaluating gamma secretase as a therapeutic target. We believe there is significant potential for nirogacestat to address both newly diagnosed and previously treated desmoid tumors and has the potential to be used more broadly in cancer, either alone or in combination with other therapies.
Desmoid tumors are rare, non-metastatic soft tissue tumors that can occur in both children and adults. Depending on tumor size and location, desmoid tumors can cause severe morbidities such as pain, disfigurement, internal bleeding and incapacitating loss of range of motion. We exclusively licensed worldwide rights to nirogacestat from Pfizer in August 2017. In June 2018, the FDA granted nirogacestat Orphan Drug Designation for the treatment of desmoid tumors and in November 2018 the FDA granted nirogacestat Fast Track Designation for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. In addition, in August 2019 the FDA granted nirogacestat Breakthrough Therapy Designation for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.
Nirogacestat has been evaluated in eight clinical trials and over 200 subjects have been exposed to treatment. Nirogacestat’s clinical activity was observed in the two previous clinical trials that enrolled desmoid tumor patients, in which nirogacestat was generally well tolerated. Pfizer conducted a Phase 1 clinical trial of nirogacestat as a treatment for various types of solid tumors. Five of the seven evaluable desmoid tumor patients enrolled in this clinical trial experienced a partial response, or PR, as measured by Response Evaluation Criteria in Solid Tumors v1.0, or RECIST v1.0, a commonly used set of measures for evaluating the response of solid tumors to treatment, yielding a 71% objective response rate, or ORR. In these seven desmoid tumor patients, median progression free survival, or PFS, had not been reached at the time of publication owing to the lack of patients progressing on therapy.
The National Cancer Institute, or NCI, then conducted a Phase 2 clinical trial evaluating nirogacestat as a treatment for desmoid tumors. Of the 17 patients enrolled in this clinical trial, 16 were evaluable for a response, five of whom had a confirmed PR and 11 of whom had stable disease, or SD, yielding a disease control rate of 100%. Furthermore, due to the lack of patients progressing on therapy, at the time of publication median PFS had not been reached.
Nirogacestat has been generally well tolerated in desmoid tumor patients as evidenced by the duration of time on therapy. In the Phase 1 clinical trial, the mean time on therapy was approximately four years. In the Phase 2 clinical trial, 59% of patients remained on therapy for at least two years, and as of August 2019, six patients are continuing to receive nirogacestat, with treatment durations ranging from 50 to 60 months for each of these patients.
Based on these encouraging results, in May 2019, we announced the initiation of the DeFi trial, a potentially registrational Phase 3, double-blind, randomized, placebo-controlled clinical trial. We believe that we have designed the DeFi trial such that if nirogacestat demonstrates clinical activity consistent with that observed in desmoid tumor patients treated to date with nirogacestat, the primary endpoint of this clinical trial, which is PFS, should be met. If the results are favorable, we plan to apply for marketing approval for nirogacestat in the United States and select international markets, although specific countries have not yet been finally determined.
In addition to our monotherapy program in desmoid tumors, in June 2019 we announced that we entered into a clinical collaboration with GSK to explore the combination of nirogacestat with their BCMA targeted ADC, belantamab mafodotin (GSK2857916), in patients with RRMM. Belantamab mafodotin is the most clinically advanced BCMA targeted ADC and clinical activity has been observed with belantamab mafodotin as a monotherapy in heavily pretreated RRMM
patients. We believe that the clinical activity of BCMA directed therapies, including belantamab mafodotin, may be enhanced with the addition of a GSI, like nirogacestat. We expect GSK to initiate the adaptive Phase 1b clinical trial evaluating the combination by the first quarter of 2020. GSK will be responsible for the conduct and expenses of the trial, which will be governed by a joint development committee with equal representation from each party.
Nirogacestat for Treatment of Desmoid Tumors
Disease Background
Desmoid tumors, also referred to as aggressive fibromatosis or desmoid-type fibromatosis, are rare and often debilitating and disfiguring soft tissue tumors characterized by a growth pattern that can invade surrounding healthy tissues, including joints, muscle and viscera. The morbidity of a desmoid tumor is driven by the location of the tumor and the aggressiveness of its growth pattern. Mesentery desmoid tumors, arising in the abdominal cavity, can cause potentially life-threatening abdominal vasculature and bowel obstructions. Similarly, if a desmoid tumor occurs in the head and neck region, it can result in potentially life-threatening impingement on vital structures. When desmoid tumors occur near joints, even small lesions can result in debilitating loss of range of motion, impaired mobility and severe pain. While variable in size, in rare cases, desmoid tumors have been documented to grow in excess of 30 cm in diameter.
Patients with desmoid tumors can experience severe impacts on their quality of life. The French desmoid tumor patient advocacy group, SOS Desmoïde, published a national survey of its members in 2015 to assess pain burden in desmoid tumor patients; out of 102 respondents, 63% noted the presence of pain associated with their disease, 38% of whom characterized their pain as permanent. During the prospective development of patient-reported outcome tools for desmoid tumors, Memorial Sloan Kettering and Quintiles evaluated the impacts of desmoid tumors in 31 patients and found that 81% reported disfigurement, 68% reported range-of-motion impairment and 65% reported a negative impact on their activities of daily living as a result of their tumors.
Desmoid tumors typically occur in patients between the ages of 15 to 60 years and are more commonly diagnosed in the third and fourth decades of life, with a two-to-three times higher prevalence in females. The yearly incidence is estimated to be 1,000 to 1,500 new desmoid tumor patients diagnosed each year in the United States. Most cases of desmoid tumor occur spontaneously and are associated with one of several mutations in the CTNNB1 gene, which encodes for the β-catenin protein. There is also a subset of desmoid tumor patients whose tumors are attributable to germline mutations in the APC gene, which encodes for a protein involved in the degradation of β-catenin. These patients have a syndrome known as familial adenomatous polyposis, or FAP, and the incidence of desmoid tumors is 800 to 1,000 times higher in FAP patients as compared to the general population. When APC or CTNNB1 mutations are present, tissue trauma, including surgery, pregnancy or soft tissue injury, can lead to the formation of desmoid tumors.
The clinical course of desmoid tumors varies across the patient population. Within any given patient, desmoid tumors can alternate between periods of rapid growth and stabilization, and spontaneous regressions have been reported in up to 20% of patients. Desmoid tumors can vary significantly in terms of their morphology and radiographic appearance but are generally routine to diagnose. Desmoid tumors are usually first noted upon physical examination or by using various imaging techniques, such as ultrasound, computed tomography, or CT, or magnetic resonance imaging, or MRI. Histologically, desmoid tumors appear with variable collagen deposition and are not clearly circumscribed. Definitive diagnosis relies upon immunohistochemical stains for nuclear localization of β-catenin. Diagnosis can also be confirmed by screening for mutations in the CTNNB1 and APC genes.
Desmoid tumors, despite being highly morbid, typically have a limited impact on mortality. Due to this limited impact on overall lifespan and current poor treatment options, we believe that there is a sizable prevalent pool of desmoid tumor patients. Existing treatments for desmoid tumors often have low success rates. Up to 70% of patients undergoing surgery will relapse depending on patient age, tumor location and tumor size. Furthermore, based on feedback we have received from interviews and surveys of over 200 physicians, each of whom has treated at least five desmoid tumor patients over the preceding five years, we believe that approximately 50% of patients receiving a given systemic therapy, such as chemotherapy or a tyrosine kinase inhibitor, or a locoregional intervention such as surgery will not have a satisfactory treatment outcome and will require subsequent treatment for their desmoid tumors. Based on this market research, we believe that up to 90% or more of patients will eventually receive an active intervention, and we estimate that, in any given year over the next decade, approximately 5,500 to 7,000 desmoid tumor patients will be actively receiving treatment in the United States.
Current Treatment Landscape for Desmoid Tumors
There are currently no therapies approved by the FDA for the treatment of desmoid tumors. Historically, desmoid tumors were treated with surgical resection, but this approach has become less favored due to an emerging body of evidence showing a post-surgical tumor recurrence rate of up to 70%, which can potentially increase disease burden and require additional intervention. In addition to the high recurrence rates, surgery itself carries risk of complications and can also be highly morbid, occasionally requiring limb amputation. Given the potential morbidities of surgery and the uncertain magnitude and durability of its benefit, physicians now typically adopt a watchful waiting approach for patients who historically may have been candidates for surgery. Despite its limitations, surgery is still used when a desmoid tumor presents significant risk of morbidity or mortality, such as tumors arising in the head and neck. Radiation therapy may also be used alone or in conjunction with surgery but is generally not preferred given the reported risk of developing secondary neoplasms.
In addition to these local treatments, systemic therapies have been used off-label with varying degrees of activity and tolerability. These therapies include chemotherapeutic agents, such as liposomal doxorubicin and vinblastine/methotrexate, non-steroidal anti-inflammatory drugs, anti-hormonal therapies and tyrosine kinase inhibitors, such as sorafenib, imatinib and pazopanib. Of these agents, only sorafenib has been studied in a randomized, double-blind, placebo-controlled clinical trial in patients with desmoid tumors; this Phase 3 clinical trial was investigator-initiated and did not have a biopharmaceutical industry sponsor. Although sorafenib demonstrated a statistically significant improvement in PFS compared to placebo, tolerability was a substantial issue; 20% of treated patients discontinued due to adverse events and an additional 22% of treated patients withdrew consent. At a median follow-up time of 27 months, 61% of the patients receiving sorafenib had discontinued treatment. Overall, we believe that the available off-label systemic therapies are poorly suited for the treatment of desmoid tumors and have not demonstrated an acceptable balance of safety and activity in this population. Therefore, we believe a significant unmet medical need exists for the treatment of desmoid tumors.
Our Solution—Nirogacestat for the Treatment of Desmoid Tumors
Nirogacestat is an oral, small molecule inhibitor of gamma secretase. We believe that nirogacestat can address the significant limitations associated with existing treatment options and has the potential to become the first therapy approved by the FDA for both newly diagnosed and previously treated desmoid tumors. In May 2019, we announced the initiation of our potentially registrational Phase 3 DeFi trial evaluating nirogacestat in patients with desmoid tumors.
Mechanism of Action
Nirogacestat is an oral, potent, selective, reversible, noncompetitive small molecule inhibitor of gamma secretase, an integral protease complex that cleaves numerous functionally important transmembrane proteins, including Notch. Gamma secretase’s cleavage of Notch causes the release of the Notch intracellular domain, or NICD, which shuttles into the nucleus and activates transcription of downstream target genes. Notch signaling is a regulator of cell proliferation and its dysregulation has been implicated in many forms of cancer. In desmoid tumor cell lines, nirogacestat has been observed to significantly decrease NICD release and reduce downstream activity of the Notch signaling pathway and decrease tumor cell migration, invasion and growth.
Clinical Experience with Nirogacestat
Over 200 subjects have been exposed to nirogacestat across eight clinical trials, not including our ongoing DeFi trial in desmoid tumor patients. Nirogacestat’s clinical activity was observed in two previous clinical trials that enrolled desmoid tumor patients. Pfizer conducted a Phase 1 dose-escalation clinical trial in patients with solid tumors (A8641014), a subset of whom had a diagnosis of desmoid tumor. Given the activity of nirogacestat in the desmoid tumor patients treated in this Phase 1 clinical trial, the NCI conducted a Phase 2 clinical trial in desmoid tumor patients (WI180798), which evaluated nirogacestat at 150 mg twice daily, or BID, the same dose being used in our DeFi trial. Nirogacestat was initially intended to be developed as a potential treatment for Alzheimer’s disease, but early clinical trials evaluating its pharmacokinetics and biodistribution did not demonstrate adequate brain exposure to pursue this indication. Given Notch’s role in cancer, nirogacestat was subsequently investigated as a potential antitumor agent. We believe that the peripherally restricted exposure of nirogacestat, as well as the safety and tolerability profile it has demonstrated across clinical trials to date, positions it as a potentially best-in-class GSI for oncology indications.
Nirogacestat was also investigated in three Phase 1 clinical trials conducted in healthy adult subjects to assess the pharmacokinetics and pharmacodynamics of single and multiple doses (A8641001, A8641002 and A8641008). Nirogacestat was further studied in clinical trials in patients with advanced cancers either as a monotherapy or in combination with other agents (A8641016, A8641019 and A8641020). Across all clinical trials, summarized in the table below, the dose range evaluated for nirogacestat was 1 mg once daily, or QD, to 330 mg BID.
Trial Sponsor
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Trial ID (Phase)
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Subjects Exposed
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Agent used in combination
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Pfizer
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A8641001 (Phase 1) |
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26 NHV |
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N/A |
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A8641002 (Phase 1) |
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42 NHV |
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N/A |
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A8641008 (Phase 1) |
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10 NHV |
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N/A |
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A8641014 (Phase 1) |
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64 solid tumor patients, including 7 evaluable with desmoid tumors
8 T-ALL/LBL patients
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N/A |
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A8641016 (Phase 1b) |
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29 metastatic TNBC or locally recurrent/advanced TNBC patients |
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Docetaxel (chemotherapeutic agent) |
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A8641019 (Phase 1/2) |
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3 treatment naïve mPDAC patients
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Nab-paclitaxel and gemcitabine (chemotherapeutic agents) |
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A8641020 (Phase 2) |
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19 metastatic TNBC patients |
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N/A |
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NCI
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WI180798 (Phase 2) |
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17 desmoid tumor patients |
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N/A |
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Abbreviations: normal healthy volunteers (NHV), T-cell acute lymphoblastic leukemia (T-ALL), triple negative breast cancer (TNBC), lymphoblastic leukemia (LBL) and metastatic pancreatic ductal adenocarcinoma (mPDAC).
Phase 1 Dose-Escalation Clinical Trial (A8641014)
In June 2009, Pfizer commenced a Phase 1 dose-escalation clinical trial in patients with various solid tumors. This clinical trial was designed to determine the maximum tolerated dose, or MTD, ascertain the recommended Phase 2 dose and evaluate the safety and tolerability of nirogacestat. Sixty-four patients with solid tumors received doses of nirogacestat and the MTD was determined to be 220 mg BID. The recommended Phase 2 dose was determined to be 150 mg BID, given its comparable pharmacodynamic activity but more tolerable profile as compared to 220 mg BID.
Of the 64 solid tumor patients enrolled, 46 were evaluable for response, seven of whom had desmoid tumors. Of these desmoid tumor patients, five experienced a PR (defined as at least a 30% reduction in the target lesion as measured by RECIST v1.0), yielding a 71% ORR. In the evaluable desmoid tumor patients, median PFS had not been reached at the time of publication owing to the lack of patients progressing on therapy. Patients whose desmoid tumors arose from either germline mutations in APC or spontaneous mutations were enrolled in this clinical trial. Patients with both of these tumor mutational characteristics experienced an objective response. Of the 39 evaluable non-desmoid tumor patients in this clinical trial, whose diagnoses included colon, breast, thyroid, non-small cell lung and pancreatic cancer, only one patient experienced an objective response. The results of this clinical trial were reported in peer-reviewed medical journals in 2014 and 2017.
The following graph shows RECIST v1.0 responses for the seven evaluable desmoid tumor patients enrolled in this Phase 1 clinical trial:
The following chart depicts the treatment course for each of the seven evaluable desmoid tumor patients in the Phase 1 clinical trial. Each bar shows the duration of clinical benefit for all therapies received since the time of diagnosis. Arrows on the right indicate patients who were still free of a new intervention, either on nirogacestat treatment (solid) or off nirogacestat treatment (striped), at the time of publication. As shown in the table below the chart, several of these patients were refractory to a number of previous interventions. The mean treatment duration for these patients was greater than four years, suggesting favorable, long-term tolerability of nirogacestat.
The 64 patients enrolled in the Phase 1 clinical trial received nirogacestat doses ranging from 20 mg BID to 330 BID. The most common treatment-related adverse events (recorded in greater than 10% of patients) were diarrhea (55%), nausea (38%), fatigue (30%), hypophosphatemia (27%), vomiting (23%), rash (20%) and decreased appetite (17%). The majority of adverse events were Grade 1 through 3 and dose reductions due to treatment-related adverse events were infrequent. Treatment-related adverse events that led to temporary discontinuation or dose reduction included diarrhea, hypophosphatemia, rash, nausea, vomiting and fatigue, and most of these subsequently resolved. Seven patients (11%) permanently discontinued treatment due to adverse events. Of these, four patients (6%) discontinued due to a treatment-related adverse event (one for Grade 4 anaphylactic shock, one for Grade 1 visual impairment, one for a Grade 3 drug hypersensitivity reaction and one for Grade 3 rash). The Grade 4 anaphylactic shock adverse event was considered by the trial investigator to be related to intravenous treatment with morphine for pain control, as this adverse event started 25 minutes after morphine administration. However, treatment-related causality could not be excluded because the patient had received their first dose of nirogacestat before intravenous administration of morphine.
Long-term follow-up of the seven evaluable desmoid tumor patients in the Phase 1 clinical trial confirmed that all five patients who achieved a PR continued to maintain their responses between 48 and 73+ months. As of December 2016, four patients (patients 3, 4, 6 and 7) had stopped receiving nirogacestat but continued to be followed and remain free of progression
between 11 and 53+ months after cessation of therapy. In all, the mean duration of clinical benefit observed was greater than 63 months. In addition, two patients continued to receive nirogacestat under a compassionate access protocol beyond the 2017 publication date, and as of November 2018, one of these patients remained on treatment, having received nirogacestat for over nine years. We believe the duration of clinical benefit and the tolerability profile observed in this Phase 1 clinical trial supported the rationale for the NCI’s subsequent clinical investigation of nirogacestat in desmoid tumor patients.
Phase 2 Clinical Trial (WI180798)
The NCI commenced a Phase 2 clinical trial in desmoid tumor patients in November 2014. This clinical trial enrolled 17 desmoid tumor patients, who received nirogacestat every day in three-week cycles at the recommended Phase 2 dose of 150 mg BID. Patients were enrolled irrespective of their underlying mutation, which included germline and spontaneous APC mutations, as well as spontaneous CTNNB1 mutations (T41A and S45F). These patients were heavily pre-treated, having failed a median of four prior treatments (with a range of one to nine), which included various systemic therapies and local interventions, including surgery.
Sixteen patients were evaluable for a response using RECIST v1.1. Five patients had a confirmed PR and eleven patients had SD, yielding a disease control rate of 100% among the evaluable patients. Four of the five patients with a confirmed PR on nirogacestat had previously been treated with tyrosine kinase inhibitors, including sorafenib and imatinib, without a reported response. Median PFS had not been reached at the time of publication owing to the lack of patients progressing on therapy. Clinical benefit was observed independent of underlying mutation, number of previous treatments and type of previous treatments. As of August 2019, six patients are continuing to receive nirogacestat, with treatment durations ranging from 50 to 60 months for each of these patients.
Best responses in the Phase 2 clinical trial, as measured by RECIST v1.1, are shown in the following chart. Dotted lines represent cutoffs for PR (defined as a 30% reduction from baseline) and for progressive disease (defined as a 20% increase from baseline). SD is reflected between the dotted lines. Patient #01 was missing a baseline CT measurement and therefore MRI was used. Patient #14 was not evaluable for response per protocol due to not returning to the clinical trial site for the patient’s first restaging evaluation and subsequently being lost to follow-up.
The following chart depicts treatment duration, clinical response and mutational status of desmoid tumor patients in the Phase 2 clinical trial. Time of PR is denoted using black arrows, and the ten patients continuing on therapy at the time of publication are denoted using gray arrows.
All patients in the Phase 2 clinical trial experienced at least one Grade 1 or Grade 2 adverse event. The most commonly reported adverse events regardless of grade and occurring in at least 30% of patients included diarrhea (76%), hypophosphatemia (76%), maculopapular rash (71%), aspartate aminotransferase increase (59%), nausea (53%), lymphocyte count decrease (53%), dry mouth (41%), alanine aminotransferase increase (35%) and anemia (35%). With the exception of hypophosphatemia, these adverse events were all reported as Grade 1 or Grade 2. The only Grade 3 adverse event occurring in at least 20% of patients was hypophosphatemia (47%), which is a known class effect of GSIs and was reversible with oral phosphate replacement therapy in the trial. Four patients required a dose reduction and one patient discontinued therapy due to Grade 2 urticaria that was not responsive to dose reduction. There were no Grade 4 adverse events reported.
DeFi Trial and Regulatory Pathway for Nirogacestat in Desmoid Tumors
Based upon the degree of clinical benefit for desmoid tumor patients observed in the Phase 1 and Phase 2 clinical trials, as well as our discussions with the FDA, in May 2019, we announced the initiation of our potentially registrational DeFi trial. The DeFi trial is being conducted under our open IND for nirogacestat.
The DeFi trial is a Phase 3, double-blind, randomized, placebo-controlled clinical trial being conducted at clinical sites in North America and Europe. The DeFi trial is designed to evaluate the efficacy, safety and tolerability of nirogacestat compared to placebo in patients with progressing desmoid tumors. This clinical trial will consist of two phases: a double-blind phase and an optional open-label extension, or OLE, phase. This clinical trial is enrolling desmoid tumor patients whose tumors have grown by at least 20% in the last 12 months as measured by RECIST v1.1 and will include both treatment-naïve and relapsed and refractory patients. Given the treatment effect observed in previous clinical trials, patients are eligible for enrollment irrespective of the number and type of previous treatments or the specific underlying mutations in APC or CTNNB1.
Patients are being randomized in a 1:1 ratio to receive 150 mg BID of nirogacestat or placebo every day for 28-day cycles. Eligible patients with confirmed disease progression on trial may enter the optional OLE phase to receive 150 mg BID of nirogacestat. We expect to enroll approximately 115 patients in this clinical trial. The primary PFS endpoint is defined as the time from randomization until the date of assessment of progression as determined using RECIST v1.1, or death by any cause. The documented date of radiographic progression will be determined by blinded independent central review. The FDA has stated that a PFS primary endpoint may support registration in an adequately designed trial with sufficient follow-up. In addition, the DeFi trial has been designed to enable a potential interim analysis. The DeFi trial is currently enrolling patients, and we expect the trial to proceed for approximately two years before top-line data are available; however, as the DeFi trial is an event-driven trial that is designed to measure the difference in PFS between patients receiving nirogacestat at versus those receiving a placebo, the exact timing of the trial’s top-line readout could fluctuate based upon the speed of enrollment and the rate at which tumor progression events are occurring. Therefore, we expect to provide an update on the DeFi trial in 2020, which will be intended to provide information regarding the status of the trial, timing to completion, enrollment status or interim analyses, if any.
The design of the DeFi trial is summarized in the schematic below:
Key secondary endpoints of the DeFi trial include safety and tolerability, ORR, duration of response and change in tumor volume. Patient-reported outcomes will also be key secondary endpoints in the DeFi trial and will be evaluated using several outcome instruments, including the Memorial Sloan Kettering/Desmoid Tumor Research Foundation Desmoid Tumor Impact and Desmoid Tumor Symptom scales, the Patient-Reported Outcomes Measurement Information System Physical Function scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 and the Brief Pain Inventory. These instruments were selected to measure symptoms, impact of symptoms on daily living and outcomes that are most relevant to desmoid tumor patients.
In June 2018, the FDA granted nirogacestat Orphan Drug Designation for the treatment of desmoid tumors and in November 2018 the FDA granted nirogacestat Fast Track Designation for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. In addition, in August 2019 the FDA granted nirogacestat Breakthrough Therapy Designation for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. If the results from the DeFi trial are favorable, we plan to file for marketing approval for nirogacestat in the United States and select international markets, although specific countries have not yet been finally determined.
Nirogacestat in combination with a BCMA-targeted ADC, belantamab mafodotin
BCMA is a cell surface protein universally expressed on MM cells, and the clinical activity of BCMA-targeted agents have been demonstrated in this indication. GSIs have been shown to increase BCMA expression on MM cells. Activity of this combination mechanism has been observed in multiple preclinical models of MM using BCMA-directed therapies in combination
with GSIs, including with nirogacestat. We believe this combination, as compared to BCMA-directed therapies alone, may provide a meaningful clinical benefit to MM patients by improving response rates, prolonging the duration of clinical benefit or reducing the side effect profile by enabling administration at a lower dose.
In June 2019, we announced that we entered a clinical collaboration with GSK to explore the combination of nirogacestat with belantamab mafodotin, a BCMA targeted ADC, in patients with RRMM. Belantamab mafodotin is the most clinically advanced BCMA targeted ADC and clinical activity has been observed with belantamab mafodotin as a monotherapy in heavily pretreated RRMM patients. Other than the manufacturing of nirogacestat and certain expenses related to intellectual property rights, GSK will be responsible for the conduct and expenses of the trial, which will be governed by a joint development committee with equal representation from each party. We expect GSK to initiate the adaptive Phase 1b clinical trial evaluating the combination by the first quarter of 2020.
Disease background – multiple myeloma
Multiple Myeloma, or MM, is a plasma cell neoplasm with substantial morbidity and mortality and is the second most common hematologic malignancy in the United States, accounting for approximately 10% of all hematologic cancers. The NCI surveillance, epidemiology and end results program estimated that in 2016 there were approximately 130,000 patients in the United States living with MM. Of these, approximately 27,000 have relapsed or are refractory to currently available therapies, representing a patient population with few therapeutic options and therefore a significant unmet medical need. It is estimated that approximately 13,000 individuals in the United States will die from MM in 2019.
MM is characterized by the expansion and abnormal accumulation of malignant plasma cells in the bone marrow, which disrupts normal bone marrow function and over time can lead to anemia, hypercalcemia, thrombocytopenia, bone pain, fatigue and weight loss. As the disease progresses, it destroys the surrounding bone marrow and can lead to renal failure, increased susceptibility to infection, skeletal deterioration and neurologic disease.
Current treatment landscape for MM
Treatment of MM has advanced significantly in the past decade driven by a deeper understanding of disease processes and a sequenced or polypharmacy approach. Newly diagnosed patients with MM are treated with either with stem cell transplants or with multiple classes of therapeutic agents, either alone or in combination, to attempt to control their disease progression. These agents include proteasome inhibitors such as bortezomib, immunomodulatory drugs such as lenalidomide, monoclonal antibodies such as daratumumab, histone deacetylase inhibitors such as panobinostat, alkylating agents such as melphalan, anti-inflammatories such as dexamethasone and chemotherapeutic agents such as doxorubicin. Despite these current options, the durability of clinical response and benefit is often brief. As there are no therapies that currently are considered curative, nearly all patients who survive initial treatments are eventually deemed resistant or refractory to available therapies and their disease continues to progress. By the time these heavily pretreated patients reach this advanced state, they are often directed to clinical trials for treatment with experimental agents. Due to the advanced condition of these patients, the refractory nature of their disease and the toll prior treatments have taken on their health, responses to treatment are generally poor.
BCMA-directed agents have emerged as a potentially promising approach for the treatment of RRMM patients due to the restriction of BCMA’s expression solely on the surface of plasmablasts and differentiated plasma cells. Though none are yet approved, we are aware of at least
20 distinct programs in preclinical and clinical development that target BCMA; these programs represent a variety of therapeutics modalities, including monoclonal antibodies, ADCs, autologous chimeric antigen receptor T-cells, or CAR-T cells, and allogeneic CAR-T cells.
We are also aware of at least two efforts to combine a GSI and a BCMA-directed agent to treat RRMM. Juno Therapeutics, Inc., a subsidiary of Celgene Corportation, is currently evaluating an autologous BCMA-directed CAR T-cell therapy in combination with crenigacestat, a GSI licensed from Eli Lilly and Company in December 2017; this combination is currently in Phase 1/2 clinical testing. In December 2018, Novartis licensed the rights to another GSI, AL102, for use in combination with its autologous BCMA-directed CAR-T cell therapy; to our knowledge, this combination has not yet entered clinical testing. Each of crenigacestat and AL102 have been evaluated in Phase 1 clinical trials and a challenging tolerability profile was observed for both of these agents.
Our solution – combination of nirogacestat and belantamab mafodotin
Belantamab mafodotin is the most clinically advanced BCMA ADC and was awarded Breakthrough Therapy Designation from the FDA in 2017. Belantamab mafodotin is delivered via a 60-minute intravenous infusion once every three weeks. Part 2 of GSK’s Phase 1 clinical trial of belantamab mafodotin, after dose selection, enrolled 35 heavily pretreated RRMM patients, 40% of whom had received more than five previous lines of therapy. In Part 2 of this clinical trial, 60% of patients achieved an objective response, median time to first response was 1.2 months, median PFS was 12.0 months and median duration of response was 14.3 months.
At the recommended dose used in Part 2 of this clinical trial, 11% of patients discontinued due to adverse events. Grade 3 or 4 adverse events were reported in 83% of patients, with thrombocytopenia (35%) and anemia (17%) being the most common; there were no Grade 5 adverse events. Other Grade 3 or 4 adverse events that occurred in more than two patients, or in at least six percent of patients, included diarrhea (12%), hypokalemia (9%), lung infection (9%), pneumonia (9%), decreased neutrophil count (9%), back pain (6%), increased aspartate aminotransferase (6%), increased γ-glutamyl transferase (6%), keratitis (6%) and neutropenia (6%). In addition, four Grade 4 events (bacteremia, cholecystitis acute, cholecystitis infective and pericardial effusion) were reported.
The following chart shows the best responses to belantamab mafodotin for the 35 patients in Part 2 of this clinical trial. For patients with measurable serum M-protein, the percentage reduction in serum concentration is shown; for patients with urine-M-protein measurements, the percentage reduction in urine concentrations are shown; and for patients with no available serum or urine M-protein measurements, the percentage reduction in free light-chain concentrations are shown.
We believe that the planned Phase 1b clinical trial of our novel combination of nirogacestat and belantamab mafodotin will be the first clinical trial testing the combination of a GSI with a BCMA targeted ADC for patients with RRMM. We believe that nirogacestat, by maintaining a high level of surface expression of BCMA on MM cells and by reducing peripheral antigen sink resulting from shed BCMA extracellular domain, or ECD, can improve clinical outcomes over belantamab mafodotin alone. In particular, as compared to belantamab mafodotin alone, we believe this combination may improve response rates, prolong the duration of clinical benefit and reduce the side effect profile by enabling administration at a lower dose.
We believe BCMA-targeted therapies will occupy an important role in the future treatment paradigm of MM, with ADCs possessing particular advantages among the modalities being investigated to therapeutically target BCMA. In particular, ADCs possess several attractive features, including convenient infusion schedules and standard pharmaceutical manufacturing, storage and administration processes. In addition, dosing of ADCs can be readily modified throughout the course of treatment. ADCs also allow for the rapid commencement of therapy, which is potentially a key benefit, given how quickly RRMM can progress.
Given our clinical experience with nirogacestat as well as its tolerability profile at doses observed to be active in combination with belantamab mafodotin in preclinical models, we believe that nirogacestat could be a compelling and differentiated GSI for use in combination with a BCMA-directed therapy in MM.
Combination mechanism of action
Gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA ECD from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors. Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in multiple preclinical models of MM.
Belantamab mafodotin’s activity against BCMA-expressing MM cells is attributable to four potential mechanisms: (1) targeted delivery of its cytotoxic payload, (2) antibody-dependent cellular cytotoxicity, (3) BCMA receptor signaling inhibition due to blocking of ligand binding and (4) immunogenic cell death. Belantamab mafodotin is a humanized IgG1 monoclonal antibody targeting BCMA, which is conjugated to a monomethyl auristatin F, or MMAF, payload. Auristatin based cytotoxics have been employed in a variety of investigational ADCs, as well as in the approved agent brentuximab vedotin, a CD30 targeting molecule indicated in several hematologic malignancies.
The following graphic illustrates the effect of GSI on decreasing gamma secretase-mediated cleavage of BCMA, leading to increased density of target (BCMA) on malignant cells and reduced levels of decoy receptors (soluble BCMA ECD).
By increasing surface expression of BCMA, we believe belantamab mafodotin may be better able to target disease-causing MM cells and potentially improve activity and tolerability.
Planned combination therapy future clinical trial
We and GSK have designed an adaptive Phase 1b trial evaluating the combination of nirogacestat and belantamab mafodotin in patients with RRMM. We expect GSK to initiate the adaptive Phase 1b clinical trial by the first quarter of 2020. The dose-escalation portion of this trial will test multiple doses of both nirogacestat and belantamab mafodotin to assess antitumor activity, safety and tolerability of the combination. Following the selection of a recommended dose for each agent, an additional expansion cohort of patients is intended to be treated with the combination therapy.
Mirdametinib
Overview
Mirdametinib (PD-0325901) is an oral, small molecule inhibitor of MEK1 and MEK2. MEK proteins occupy a pivotal position in the MAPK pathway, a key signaling network that regulates cell growth and survival, and that plays a central role in multiple oncology and rare disease indications.
We are initially investigating mirdametinib as a monotherapy for the treatment of patients with NF1-PN, a rare disorder characterized by mutations in the MAPK pathway that lead to the growth of peripheral nerve sheath tumors, which cause significant pain, disfigurement and morbidity. NF1-PN are most often diagnosed in the first two decades of life and are characterized by aggressive tumor growth, which is typically more rapid during childhood. In August 2017, we exclusively licensed worldwide rights to mirdametinib from Pfizer. In October 2018, the FDA granted mirdametinib Orphan Drug Designation for the treatment of NF1, and in May 2019, the FDA granted mirdametinib Fast Track Designation for the treatment of NF1-PN.
Mirdametinib has been evaluated in eight Phase 1 and 2 clinical trials, with over 200 subjects having been exposed to treatment. A Phase 2 clinical trial was conducted by the
Neurofibromatosis Clinical Trial Consortium, which evaluated mirdametinib in 19 NF1-PN patients. In this clinical trial, 42% of patients experienced an objective response (defined as at least a 20% volumetric reduction in their target PN tumor) by 12 months of treatment. Based on the strength of these data and our interactions with the FDA, we expect to initiate our potentially registrational single-arm, open-label Phase 2b ReNeu clinical trial of mirdametinib in NF1-PN patients in the third quarter of 2019. The primary endpoint for the ReNeu trial will be ORR, with an objective response defined as at least a 20% reduction in tumor volume from baseline as determined by volumetric MRI assessment. If the results of this clinical trial are favorable, we plan to file for marketing approval for mirdametinib in the United States and select international markets, although specific countries have not yet been finally determined.
In addition to our monotherapy program in NF1-PN, we believe that mirdametinib holds promise for use in multiple targeted combination therapies in oncology. Our first such effort is evaluating mirdametinib in combination with BeiGene’s RAF dimer inhibitor, lifirafenib (BGB-283). In May 2019, we announced the initiation of an adaptive Phase 1b clinical trial of this combination that is being conducted by BeiGene. This trial is currently enrolling patients in Australia with advanced or refractory solid tumors harboring relevant genetic mutations in the MAPK pathway.
Overview of the MAPK Pathway
The MAPK pathway, which relies upon the RAS-RAF-MEK-ERK signaling cascade, represents a central biological pathway in all human cells that is responsible for helping to regulate cellular transcription, proliferation and survival. The general structure of the pathway consists of RAS, a small GTPase, and three downstream protein kinases, RAF, MEK and ERK. In addition, at the level of RAS, the pathway is negatively regulated by several proteins, including neurofibromin, the protein encoded by the NF1 gene. Given its direct regulation of ERK, which directly controls downstream signaling through the MAPK pathway, MEK occupies a pivotal position in this signaling cascade and represents a rational therapeutic target for addressing indications where overactivation of the MAPK pathway contributes significantly to disease onset and/or progression.
Constitutive activation of the MAPK pathway has been reported in approximately 25% of human cancers, including colon, lung, breast, pancreatic, ovarian and renal tumors. The cause of pathway activation is varied and tissue-specific, but is driven by one or more of the following mechanisms, each of which is depicted in the illustration below: (i) upstream activation of one or more receptor tyrosine kinases, such as EGFR, (ii) mutations in a RAS isoform, such as KRAS and (iii) other mutations or aberrations within the pathway, such as in BRAF and NF1.
Mirdametinib for treatment of NF1-PN
Disease background
NF1 is a rare, autosomal dominant tumor predisposition disorder that arises from mutations in the NF1 gene, which encodes for neurofibromin, a key negative regulator of the MAPK pathway. NF1 is the most common form of neurofibromatosis, with an estimated global birth incidence of approximately 1 in 3,000 individuals. We estimate that there are approximately 100,000 patients living with NF1 in the United States. NF1 is clinically heterogeneous and manifests in a variety of symptoms across numerous organ systems, including abnormal pigmentation, skeletal deformities, tumor growth and neurological complications, such as cognitive impairment. Patients with NF1 have a 15-year mean reduction in their life expectancy compared to the general population.
NF1 patients have an approximately 30% to 50% lifetime risk of developing plexiform neurofibromas, or PN, which are tumors that grow in an infiltrative pattern along the peripheral nerve sheath and that can cause severe disfigurement, pain and functional impairment; in rare cases, NF1-PN may be fatal. NF1-PN are most often diagnosed in the first two decades of life and can be confirmed using routine imaging techniques. These tumors are characterized by aggressive growth, which is typically more rapid during childhood. NF1-PN typically do not spontaneously regress. In a study published in 2012 examining the natural growth dynamics of NF1-PN, 95 NF1-PN patients had the volumes of individual PN lesions monitored over time. Of
these 95 patients, 69 were older than 16 years of age at the time of the initial assessment; these 69 patients had a total of 146 NF1-PN lesions monitored. At an average follow-up time of 2.4 years (range 1.05 to 4.10 years), six lesions (4.1%) were documented to have had a volumetric decrease of at least 20%.
While NF1-PN are benign, these tumors can undergo malignant transformation, leading to malignant peripheral nerve sheath tumors, or MPNST. NF1 patients have an 8% to 15% lifetime risk of developing MPNST, a diagnosis that carries with it a 12-month survival rate of under 50%. In addition to MPNST, NF1 patients are at an increased risk of developing other malignancies, including breast cancer and gliomas.
Current Treatment Landscape for NF1-PN
There are currently no therapies approved by the FDA for NF1-PN. The only definitive treatment for NF1-PN is surgical resection with wide margins, an outcome that can rarely be achieved in NF1-PN patients. This is because NF1-PN arise from nerve cells and grow in an infiltrative pattern, making it challenging to successfully resect tumors without severe comorbidities, such as permanent nerve damage and disfigurement. Patients that are ineligible for surgery or those who have had a recurrence post-surgery are often treated with a variety of off-label therapies. Among these off-label therapies are various systemic treatments, such as chemotherapy and immunotherapy, which have not been shown to consistently confer a clinical benefit.
The inadequacy of surgery and currently available off-label therapies highlights the need for improved systemic therapies. Given that NF1-PN is driven by overactivation of the MAPK pathway, MEK inhibitors have emerged as a class of therapies that hold significant promise for the treatment of NF1-PN, and we believe that MEK inhibitors have the potential to become the standard of care.
We are aware of at least three other MEK inhibitors in Phase 2 clinical trials for this indication, including a MEK inhibitor approved for other oncology indications that is sometimes used off-label in NF1-PN patients. Given the lifelong and devastating nature of NF1-PN, as well as the need to begin treating patients at a young age, we believe that the optimal MEK inhibitor is one that will have a tolerability profile suitable for long-term dosing while simultaneously arresting or reversing tumor growth.
Our Solution — mirdametinib for the treatment of NF1-PN
Mirdametinib is an oral, small molecule inhibitor of MEK1 and MEK2, which we are developing as a monotherapy in NF1-PN. Based on results from prior clinical trials, we believe that mirdametinib, using the dose and schedule from the NF1-PN Phase 2 clinical trial, has the potential to offer a potentially best-in-class profile in order to enable the long-term treatment required for this patient population, as compared to other MEK inhibitors. Given the clinical activity and tolerability profile observed with mirdametinib in the previous NF1-PN clinical trial, and following our discussions with the FDA, we designed our potentially registrational Phase 2b clinical trial in a manner that we believe has the potential to generate sufficient data to support approval in both pediatric and adult NF1-PN patients. We intend to initiate this Phase 2b clinical trial in the third quarter of 2019. If the results are favorable, we plan to file for marketing approval for mirdametinib in the United States and select international markets, although specific countries have not yet been finally determined.
Mechanism of action
Neurofibromin is a critical repressor of RAS signaling and is impaired in patients with a mutated NF1 gene, resulting in constitutive activation of the MAPK pathway. MEK inhibitors can reduce MAPK pathway activity and therefore arrest or reverse NF1-PN growth, which has been observed clinically with several MEK inhibitors, including mirdametinib.
Clinical experience with mirdametinib
Over 200 subjects have been exposed to mirdametinib across eight clinical trials. Mirdametinib has shown clinical activity in a previous Phase 2 clinical trial conducted by the Neurofibromatosis Clinical Trial Consortium that enrolled adolescent and adult NF1-PN patients (WI176190). Given the activity and tolerability of mirdametinib in this clinical trial, we are utilizing the same dose and schedule in our potentially registrational Phase 2b ReNeu trial. Furthermore, based on discussions with the FDA, we will be enrolling pediatric NF1-PN patients, in addition to adolescent and adult patients.
Mirdametinib has been investigated in a Phase 1 clinical trial conducted in healthy adult subjects to assess the pharmacokinetics and pharmacodynamics of single and multiple doses (A4581004). Mirdametinib was further studied in additional clinical trials in patients with advanced cancers either as a monotherapy or in combination with other agents (A4581001, A4581002, B1271002, 13-506, M13DAP and MErCuRIC1). The table below summarizes these clinical trials.
Trial sponsor
|
|
|
Trial ID (Phase)
|
|
|
Subjects exposed
|
|
|
Agent Used in Combination
|
|
Pfizer
|
|
|
A4581004 (Phase 1) |
|
|
23 NHV |
|
|
N/A |
|
|
|
|
A4581001 (Phase 1/2)
|
|
|
79 solid tumor patients |
|
|
N/A |
|
|
|
|
A4581002 (Phase 2) |
|
|
34 advanced NSCLC patients |
|
|
N/A |
|
|
|
|
B1271002 (Phase 2) |
|
|
7 KRAS/BRAF-mutant solid tumor patients 36 KRAS-mutant CRC patients |
|
|
N/A |
|
Dana-Farber Cancer Institute
|
|
|
13-506 (Phase 1/2) |
|
|
60 KRAS-mutant NSCLC and solid tumor patients |
|
|
Palbociclib (CDK 4/6 inhibitor) |
|
Netherlands Cancer Institute
|
|
|
M13DAP (Phase 1/2) |
|
|
36 KRAS-mutant CRC, NSCLC, PDAC patients |
|
|
Dacomitinib (EGFR inhibitor) |
|
University of Oxford
|
|
|
MErCuRIC1 (Phase 1)
|
|
|
~25 RAS mutant and RAS wild type/aberrant cMET CRC patients |
|
|
Crizotinib (ALK/cMET inhibitor) |
|
University of Alabama at Birmingham (via Neurofibromatosis Clinical Trial Consortium) |
|
|
WI176190 (Phase 2)
|
|
|
19 NF1-PN patients
|
|
|
N/A
|
|
Abbreviations: normal healthy volunteer (NHV), non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC).
In the monotherapy clinical trials, mirdametinib was tested across a broad dose range (from 1 mg QD to 30 mg BID), with the initial MTD determined to be 15 mg BID and the recommended Phase 2 dose determined to be 10 mg BID administered on a five days-on, two days-off schedule.
Post-treatment biopsies taken in the A4581001 clinical trial showed a pharmacodynamic effect at doses as low as 1 mg QD, as measured by a greater than 90% decrease in levels of phosphorylated ERK from baseline, demonstrating inhibition of the MAPK pathway. Furthermore, in the Phase 2 clinical trial in NF1-PN patients, clinical activity was observed at doses of 4 mg BID and below. These pharmacodynamic and clinical activity data at doses below the MTD formed the rationale for continuing to advance mirdametinib in NF1-PN and in genetically defined solid tumors, either alone or in combination.
To date, the safety profile of monotherapy mirdametinib in patients with advanced cancers at doses lower than 10 mg BID using an intermittent schedule has been characterized by mostly manageable and reversible toxicities. The most frequently reported of these adverse events have been rash, nausea, vomiting, diarrhea and fatigue.
Other adverse events have been reported at a lower frequency, though these adverse events primarily occurred in patients who received doses above 10 mg and up to 30 mg BID. These adverse events included ocular disorders (visual disturbances, blurred vision and retinal vein occlusion), nervous system disorders (confusion, slowed ideation, slurred speech and hallucinations), musculoskeletal and connective tissue disorders (general weakness and neck muscle weakness associated with mild and moderate elevations in creatine kinase) and cardiac disorders (decreased left ventricular ejection fraction and congestive heart failure). Due to the adverse events observed, a prior Phase 2 clinical trial (A4581002) was terminated and enrollment in the Phase 2 portion of a Phase 1/2 clinical trial (A4581001) was halted. In each of these trials, mirdametinib at doses of 15 mg BID or above was being evaluated using both intermittent and continuous dosing schedules. These doses were significantly higher than the maximum allowable dose of 4 mg BID in the Phase 2 NF1-PN trial described below, in which mirdametinib was observed to be generally well tolerated. Our potentially registrational Phase 2b ReNeu trial in NF1-PN will have this same maximum allowable dose of 4 mg BID.
Phase 2 Clinical Trial in NF1-PN (WI176190)
The Phase 2 clinical trial evaluating mirdametinib in adolescents and adults with NF1-PN enrolled 19 patients between 16 and 39 years of age. This clinical trial commenced in June 2014 and preliminary results were presented in 2017 at a conference organized by the Children’s Tumor Foundation. Patients received an oral dose of 2 mg/m2 BID with a maximum dose of 4 mg BID on a four-week cycle of three weeks-on, one week-off. Eight patients (42%) achieved an objective response by cycle 12, prospectively defined as a volumetric reduction in their target PN of at least 20%.
The protocol specified that patients were to be removed from the clinical trial if they did not achieve at least a 15% volumetric reduction in their target PN by cycle eight of treatment, corresponding to approximately eight months on therapy. Patients achieving at least a 15% reduction in their target PN by cycle eight of treatment, but who did not achieve at least a 20% reduction in their target PN by cycle 12 of treatment, were also removed from the trial. Importantly, it has been observed in subsequent clinical trials of other MEK inhibitors that some NF1-PN patients achieved their first objective response to therapy 12 months or more following the start of treatment. Therefore, we believe that the design of this clinical trial was not optimized to demonstrate the full potential of mirdametinib’s antitumor activity in the NF1-PN patients that were enrolled, a consideration that we have aimed to address in our upcoming potentially registrational Phase 2b ReNeu trial by allowing patients to remain on treatment for up to 24 months.
Mirdametinib was generally well tolerated in this trial. There were no Grade 4 adverse events reported. Related treatment-emergent Grade 2 and Grade 3 adverse events occurring in at least 20% of patients included acneiform rash (53%), fatigue (26%) and nausea (21%). The only Grade
3 treatment-related adverse event reported was pain. Five patients (26%) had dose reductions due to adverse events, including two patients for Grade 2 rash, one patient for Grade 2 nausea, one patient for Grade 2 fatigue and one patient for Grade 2 pain. Two patients permanently discontinued mirdametinib in this trial, both at cycle four; one of these discontinuations was due to noncompliance with the trial protocol and other was due to a Grade 2 rash.
Mirdametinib Planned Future Clinical Trial in NF1-PN and Regulatory Pathway
Given the degree of clinical benefit observed in patients with NF1-PN in the previous Phase 2 clinical trial of mirdametinib, and informed by our discussions with the FDA, we expect to initiate the potentially registrational ReNeu clinical trial in the third quarter of 2019. The ReNeu trial will be conducted under our IND for mirdametinib that became effective in April 2019, and will be a Phase 2b, longitudinal, open-label clinical trial designed to evaluate the efficacy, safety and tolerability of mirdametinib in patients at least two years of age with an inoperable NF1-PN that is causing significant morbidity or major deformity. The ReNeu trial will be conducted at clinical sites in North America. As in the previous Phase 2 clinical trial in NF1-PN patients, mirdametinib will be administered orally at a 2 mg/m2 BID dose with a maximum dose of 4 mg BID. Dosing will occur on a four-week cycle with a three weeks-on, one week-off schedule. The intervention period will last for up to 24 cycles. In contrast to the previous Phase 2 clinical trial, we have designed our ReNeu trial with an intervention period that we believe is optimized to demonstrate the full antitumor activity of mirdametinib in NF1-PN patients.
We anticipate enrolling approximately 100 patients in the Phase 2b ReNeu trial, roughly half of whom will be pediatric patients. The primary endpoint will be ORR measured using three-dimensional MRI volumetric analysis. As in the previous Phase 2 clinical trial, an objective response will be defined as a decrease of at least 20% in the target NF1-PN using central review. Key secondary endpoints will include the duration of response and health-related quality-of-life measurements.
In October 2018, the FDA granted mirdametinib Orphan Drug Designation for the treatment of NF1, in May 2019, the FDA granted mirdametinib Fast Track Designation for the treatment of patients at least two years of age with NF1-associated inoperable PN that are progressing or causing significant morbidity and in July 2019, the European Commission granted mirdametinib Orphan Drug Designation for the treatment of NF1. If the results of the Phase 2b clinical trial are favorable, we plan to file for marketing approval for mirdametinib in the United States and select international markets.
Mirdametinib in combination with a RAF dimer inhibitor (lifirafenib)
Overview
In September 2018, we announced that we entered into a global clinical collaboration with BeiGene to evaluate the combination of mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in patients with advanced or refractory solid tumors harboring RAS mutations, RAF mutations or other MAPK pathway aberrations. Lifirafenib has been observed to potently inhibit BRAF, CRAF and ARAF across all homodimeric and heterodimeric conformations of these proteins that have been evaluated. Furthermore, monotherapy lifirafenib has shown activity in tumors harboring RAS and RAF mutations in a multicenter, open-label Phase 1 clinical trial conducted by BeiGene. We believe that lifirafenib’s clinical activity can be enhanced with the addition of a potent and selective MEK inhibitor like mirdametinib, and provide a potentially promising combination therapy for cancers whose growth is reliant on MAPK pathway signaling, such as those with mutations in RAS or RAF. In May 2019, we announced the initiation of an adaptive Phase 1b clinical trial being conducted by BeiGene that is currently enrolling patients in Australia with advanced or refractory solid tumors harboring relevant genetic mutations in the MAPK pathway. In addition, in July 2019 the FDA cleared the IND for the combination of mirdametinib with lifirafenib, thereby allowing for the expansion of this clinical trial to the United States.
Disease Background
RAS Mutations
RAS mutations are one of the most common genetic aberrations found in human cancers and these driver mutations are found in approximately 25% of all solid tumors, representing over 200,000 new patients diagnosed in the United States each year. RAS proteins, which are comprised of the KRAS, HRAS and NRAS isoforms, are central to the transduction of receptor tyrosine kinase signaling and lead to downstream activation of the canonical RAF-MEK-ERK signaling cascade of the MAPK pathway.
The following table illustrates the reported prevalence of KRAS and NRAS mutations in selected types of solid tumors.
We believe that effective therapies for patients harboring RAS mutations represent a significant clinical need. To date, MEK or RAF inhibitors used as monotherapies have generally demonstrated only limited clinical activity in patients whose tumors harbor RAS mutations. These tumors are generally poorly responsive to targeted therapies and RAS mutations typically confer poor prognosis, although outcomes can vary across different cancer types with RAS mutations.
RAF Mutations
RAF mutations have been reported in up to 7% of all solid tumors, with the most widely described being the BRAF V600 mutations, commonly found in patients with metastatic melanoma. While there are approved MEK-RAF targeted combination therapies for patients with BRAF V600 mutations, patients eventually progress on these therapies representing a significant unmet clinical need.
In addition, there have been numerous non-V600 BRAF mutations described, which are not responsive to the currently approved therapies, and the use of the existing therapies has been shown to paradoxically increase the ability of tumor cells with these non-V600 BRAF mutations to proliferate.
Other MAPK Aberrations
Patients with mutations and aberrations in the MAPK pathway aside from RAS and RAF mutations also represent a substantial unmet clinical need owing to a lack of approved therapies. Such tumors include malignant cancers driven by NF1 mutations, such as MPNST.
Current Treatment Landscape
We are not aware of any therapies currently approved by the FDA specifically for the treatment of cancers harboring RAS mutations. There are several approved therapies in indications where RAS mutations are frequent, though these therapies are not specifically designed to address RAS mutations. There are multiple programs in clinical development today for RAS-mutant solid tumors that are evaluating various mechanisms of action.
For RAF mutations, we are not aware of any therapies currently approved by the FDA for treatment of patients harboring non-V600 BRAF mutations. There are several approved therapies in indications where RAF mutations are frequent, though none are designed to address RAF mutations aside from those therapies targeting BRAF V600 mutations, and even for these an unmet medical need exists because patients eventually progress on these therapies.
For patients whose tumors harbor other MAPK aberrations, we are not aware of any therapies currently approved by the FDA. There are several approved therapies in indications where we believe such MAPK pathway aberrations are frequent, though these therapies are not specifically designed to address these aberrations.
Our Solution—Combination of mirdametinib and Lifirafenib
We believe that the biological rationale and the differentiated pharmacological properties of mirdametinib in combination with lifirafenib support the potential to provide significant clinical benefit in these large genetically defined tumor populations with significant unmet medical need. Our ongoing Phase 1b clinical trial of the novel combination of mirdametinib and lifirafenib is among the first clinical trials evaluating vertical inhibition of the MAPK pathway using a RAF dimer inhibitor and a MEK inhibitor. We believe this combination has the potential to provide meaningful clinical benefit in patients with solid tumors harboring RAS mutations, RAF mutations and other MAPK pathway aberrations.
Preclinical and Clinical Experience
Preclinical data with the combination of mirdametinib and lifirafenib demonstrating antitumor activity in RAS mutant cancer models were presented at the 2015 American Association for Cancer Research Conference. A variety of MEK inhibitors were evaluated in combination with lifirafenib in this preclinical study, and mirdametinib was observed to be among the MEK inhibitors with the highest synergy and the most potent antitumor activity in combination.
While mirdametinib and lifirafenib have not previously been clinically tested in combination, each compound has been evaluated in clinical trials as a monotherapy. Lifirafenib has been tested by BeiGene in one completed and one ongoing clinical trial. A Phase 1 open-label, multiple-dose, dose-escalation clinical trial (BGB-283-AU-001), which was initiated in Australia in November 2013, investigated the preliminary antitumor activity, safety, tolerability and pharmacokinetics of lifirafenib in patients with RAS and RAF mutated solid tumors. A second Phase 1 clinical trial (BGB-283-CN-001) was initiated in October 2015 in China and is ongoing.
In the BGB-283-AU-001 clinical trial, lifirafenib was observed to be generally well tolerated; treatment-related adverse events were mostly Grade 1 and Grade 2 in severity and included fatigue, thrombocytopenia, dysphonia, decreased appetite and palmar-plantar
erythrodysesthesia syndrome. The MTD was determined to be 40 mg QD and 30 mg QD was selected as the recommended Phase 2 dose. Evidence of antitumor activity was observed in patients with certain types of RAS-mutant tumors, non-V600 BRAF-mutant tumors and treatment-naïve and treatment-refractory BRAF-mutant V600 tumors. The following chart shows the best objective responses in KRAS mutant cancers.
*
Represents patient that remained on treatment as of September 2016.
Combination Mechanism of Action
Given lifirafenib’s activity profile, we believe that it is among the most promising RAF inhibitors. In particular, lifirafenib has been observed to inhibit both dimeric and monomeric forms of RAF, which we believe should overcome the paradoxical MAPK pathway activation seen with several other RAF inhibitors. Furthermore, lifirafenib has shown potent inhibition in preclinical studies across all RAF isoforms tested. We believe these two attributes are primarily responsible for the monotherapy activity data observed with this compound in its Phase 1 clinical trial.
Currently approved RAF inhibitors were designed to address tumors whose growth is reliant upon signaling via monomeric forms of BRAF, such as those with BRAF V600 mutations, a subset of MAPK aberrations commonly found in metastatic melanoma. In this setting, the addition of a MEK inhibitor to a BRAF V600 inhibitor showed significant clinical activity beyond monotherapy BRAF inhibition. By targeting both monomeric and dimeric forms of RAF, RAF dimer inhibitors, such as lifirafenib, are designed to work in tumors beyond just those harboring BRAF V600 mutations and therefore have the potential to address a much broader range of genetically defined patient populations. This includes RAS-mutant cancers, which predominantly signal through hetero- and homodimeric RAF; both of these conformations are potentially addressed by lifirafenib.
The following illustration depicts how the combination of mirdametinib and lifirafenib is intended to vertically inhibit the MAPK pathway to prevent the proliferation and survival of cancer cells reliant upon this pathway.
We believe that by vertically inhibiting two key, adjacent constituents of the MAPK pathway, the combination of mirdametinib and lifirafenib can potentially address the resistance mechanisms and feedback loops that have prevented development of therapies for many devastating cancers harboring MAPK pathway gene mutations, such as those in RAS, RAF and NF1. In particular we believe that the Phase 1 clinical data demonstrated lifirafenib’s activity across both monomeric and dimeric forms of RAF, as well as mirdametinib’s observed clinical pharmacodynamic activity at low doses, provide the opportunity for a leading combination therapy to address tumors with aberrant MAPK signaling.
Combination of mirdametinib and Lifirafenib Clinical Trial
In May 2019, we announced the initiation of an adaptive Phase 1b clinical trial evaluating the combination of mirdametinib and lifirafenib. This clinical trial is enrolling patients with advanced or refractory solid tumors harboring relevant genetic mutations in the MAPK pathway. This clinical trial is being conducted by BeiGene in collaboration with us under an open Clinical Trial Application in Australia. In addition, in July 2019 the FDA cleared the IND for the combination of mirdametinib with lifirafenib, thereby allowing for the expansion of this clinical trial to the United States. The clinical trial is comprised of two stages. In the first stage, we intend to determine the MTD and recommended Phase 2 dose of the combination therapy; we will be evaluating doses of mirdametinib between 2 mg QD and 8 mg QD and doses of lifirafenib between 15 mg QD and 25 mg QD. In the second stage, the trial is expected to enroll cohorts of
approximately 15 patients each in tumor types of interest, which may include non-small cell lung cancer and endometrial cancer with KRAS mutations, to assess antitumor efficacy, safety and tolerability of the combination therapy at the recommended Phase 2 dose. We expect to provide an update on this clinical trial at the end of 2020 or in early 2021.
BGB-3245 in Genetically Defined BRAF-Mutant Solid Tumors
In June 2019, we announced the formation of MapKure, which is jointly owned by us and BeiGene. BeiGene licensed to MapKure exclusive rights to BGB-3245, a novel, oral, selective small molecule inhibitor of specific BRAF driver mutations and BRAF fusions. MapKure intends to advance BGB-3245 into clinical development for solid tumor patients harboring BRAF driver mutations and BRAF fusions that were observed to be sensitive to the compound in preclinical studies. MapKure expects to initiate an adaptive Phase 1 dose-escalation and expansion clinical trial by the first quarter of 2020.
In addition to our significant, but non-controlling equity ownership in MapKure, we have one seat on each of MapKure’s joint steering committee and its board of directors. We also expect to contribute to some of the clinical development of BGB-3245 and other operational activities through a service agreement with MapKure.
Based on preclinical data, we believe that BGB-3245 may be unique in its BRAF binding and disassociation properties, potentially enabling differentiated antitumor activity as compared to other known RAF inhibitors. We believe this may better position BGB-3245 for clinical development as a monotherapy in certain biomarker defined patient populations. These biomarkers include de novo Class 2 BRAF mutations, de novo BRAF fusions and BRAF resistance mutations following treatment with BRAF V600 inhibitors.
To date, approximately 200 unique mutant BRAF alleles have been identified in human tumors. Activating BRAF mutations have been categorized into three classes: Class 1 mutants, comprised of constitutively active monomers, such as V600E mutations, Class 2 mutants, comprised of constitutively active dimers, and Class 3 mutants, which are kinase-impaired or kinase-dead. Today, only Class 1 BRAF mutations have any approved targeted therapeutic options, such as vemurafenib, dabrafenib and encorafenib for the treatment of BRAF V600E/K-mutant metastatic melanoma. The following table summarizes the distribution of BRAF mutations that have been described in the scientific literature as of 2017.
Despite the clinical activity of approved BRAF inhibitors in patients with Class 1 BRAF mutations, emerging evidence suggests that resistance commonly develops via mutations that enable ligand independent signaling by dimerization of the protein, such as p61 BRAF V600E and BRAF V600E/L514V, which represent an area of unmet medical need. BGB-3245 has demonstrated preclinical activity against these mutations.
Furthermore, BRAF fusion proteins have recently been described as drivers of cancer cell growth, and patients can now be screened for such fusions in the clinical setting. Recent literature suggests that these mutations may account for 0.3% of all human cancers, with 20 novel BRAF fusions now identified across 12 distinct tumor types, with enrichment in specific cancers. We believe that BGB-3245 may also address patients with these BRAF fusions.
License and collaboration agreements
Pfizer License Agreements
We were originally conceived by Pfizer as an innovative way to advance investigational therapies that may hold significant promise for underserved patients, and Freda Lewis-Hall, M.D., DFAPA the Executive Vice President and Chief Patient Officer of Pfizer, is a member of our board of directors. Pfizer initially made an equity investment and also contributed royalty- and milestone-bearing product licenses, including for our two lead product candidates, nirogacestat and mirdametinib.
Further, Pfizer has agreed to provide us, once per calendar year until October 2020, with a list of compounds that are available for license or acquisition from Pfizer. As of June 1, 2019, we have not licensed or acquired any additional compounds from Pfizer.
A description of each of our license agreements with Pfizer is set forth below:
Nirogacestat License Agreement
In August 2017, we entered into a license agreement, or the Nirogacestat License Agreement, with Pfizer pursuant to which we acquired exclusive (including as to Pfizer) worldwide
sublicensable rights to research, develop and manufacture nirogacestat for the treatment, diagnosis and prevention of all diseases and commercialize nirogacestat for the treatment, diagnosis and prevention of all diseases other than Alzheimer’s disease, breast cancer and prostate cancer. Additionally, Pfizer agreed that, for ten years, it would not conduct a clinical trial of a gamma secretase inhibitor for desmoid tumors. Pfizer retained rights to commercialize nirogacestat for the treatment of Alzheimer’s disease, breast cancer and prostate cancer. We subsequently amended the Nirogacestat License Agreement in July 2019 with regard to certain provisions relating to intellectual property.
Pursuant to the Nirogacestat License Agreement, as amended, we are obligated to use commercially reasonable efforts to develop and seek regulatory approval for at least one product in the United States and if regulatory approval is obtained, to commercialize such product in the United States. If, following regulatory approval in the United States, we reasonably anticipate that the product will receive a certain level of reimbursement in certain countries, then we are obligated to use commercially reasonable efforts to develop and seek regulatory approval for the product in such country and if regulatory approval is obtained, to commercialize such product in such country.
Until the earlier of (i) an initial public offering, (ii) the sale of all or substantially all of the assets that relate to nirogacestat, (iii) a change of control of our company or (iv) the first filing of an NDA for a product in a major market (as defined in the Nirogacestat License Agreement), Pfizer has an exclusive right of first negotiation if we grant an exclusive license to a third party to commercialize a product containing nirogacestat in certain specified countries.
We are required to pay Pfizer payments of up to an aggregate of $232.5 million upon achievement of certain commercial milestone events.
We will pay Pfizer tiered royalties on sales of nirogacestat at percentages ranging from the mid-single digits to the low 20s, that may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition.
Unless earlier terminated, the Nirogacestat License Agreement will expire upon the expiration of all royalty obligations. The royalty period will expire on a country-by-country basis upon the later of (i) ten years from the first commercial sale, (ii) the expiration of all regulatory or data exclusivity and (iii) the expiration of the last-to-expire valid patent claim. We have the right to terminate the Nirogacestat License Agreement for convenience upon thirty (30) days’ prior written notice. Pfizer may not terminate the agreement for convenience. Either we or Pfizer may terminate the Nirogacestat License Agreement if the other party is in material breach and such breach is not cured within the specified cure period. In addition, either we or Pfizer may terminate the Nirogacestat License Agreement in the event of specified insolvency events involving the other party. If Pfizer terminates the agreement as a result of our uncured material breach or our insolvency, Pfizer retains its license with respect to targets for which it has exercised an option (unless Pfizer elects otherwise), subject to reduced payment obligations.
Mirdametinib License Agreement
In August 2017, we entered into a license agreement, or the Mirdametinib License Agreement with Pfizer pursuant to which we acquired exclusive (including as to Pfizer) worldwide sublicensable rights to research, develop, manufacture and commercialize mirdametinib for the treatment of all diseases. Additionally, Pfizer agreed, that for ten years, it will not conduct a clinical trial with a MEK inhibitor for NF1, but excluding a MEK inhibitor owned or controlled by a third party that acquires, or is acquired by, Pfizer. We subsequently amended the Mirdametinib License Agreement in August 2019 with regard to certain provisions relating to intellectual property.
Pursuant to the Mirdametinib License Agreement, as amended, we are obligated to use commercially reasonable efforts to develop and seek regulatory approval for at least one product in the United States and if regulatory approval is obtained, to commercialize such product in the United States. If, following regulatory approval in the United States, we reasonably anticipate that the product will receive a certain level of reimbursement in certain countries, then we will use commercially reasonable efforts to develop and seek regulatory approval for the product in such country and if regulatory approval is obtained, to commercialize such product in such country.
Until the earlier of (i) an initial public offering, (ii) the sale of all or substantially all of the assets that relate to mirdametinib, (iii) a change of control of us or (iv) the first filing of an NDA for a product in a major market, Pfizer has an exclusive right of first negotiation if we wish to grant an exclusive license to a third party to commercialize a product in certain countries.
We are required to pay Pfizer up to an aggregate of $229.8 million upon achievement of certain commercial milestone events.
We will pay Pfizer tiered royalties on sales of mirdametinib at percentages ranging from the mid-single digits to the low 20s, that may be subject to deductions for expiration of valid claims, amounts due under third party licenses and generic competition.
Unless earlier terminated, the Mirdametinib License Agreement will expire upon the expiration of all royalty obligations. The royalty period will expire on a country-by-country basis upon the later of (i) ten years from the first commercial sale, (ii) the expiration of all regulatory or data exclusivity and (iii) the expiration of the last-to-expire valid patent claim. We have the right to terminate the Mirdametinib License Agreement for convenience upon thirty (30) days’ prior written notice. Pfizer may not terminate the agreement for convenience. Either we or Pfizer may terminate the Mirdametinib License Agreement if the other party is in material breach and such breach is not cured within the specified cure period. In addition, either we or Pfizer may terminate the Mirdametinib License Agreement in the event of specified insolvency events involving the other party. If Pfizer terminates the agreement as a result of our uncured material breach or our insolvency, Pfizer retains its license with respect to targets for which it has exercised an option (unless Pfizer elects otherwise), subject to reduced payment obligations.
BeiGene Clinical Collaboration Agreement
In August 2018, we entered into a clinical collaboration agreement with BeiGene, or the BeiGene Collaboration Agreement, to evaluate the safety, tolerability and preliminary efficacy of combining BeiGene’s investigational RAF dimer inhibitor, lifirafenib (BGB-283), and mirdametinib, in a Phase 1b clinical trial for patients with advanced or refractory solid tumors.
We and BeiGene are obligated to use commercially reasonable efforts to complete our respective activities for the clinical trial. BeiGene is responsible for administering the clinical trial and we are responsible for performing the fixed dose formulation activities at our cost. Each party will be solely responsible for its costs associated with manufacturing and supply of its compound for the clinical trial. Upon completion of the clinical trial, if the parties agree that certain pre-defined criteria have been satisfied, the parties will negotiate in good faith a definitive agreement to provide for the expansion of the clinical collaboration and a commercial relationship based on specified principles, provided that neither party is obligated to enter into such definitive agreement.
We will share with BeiGene equally the costs associated with the clinical trial. The collaboration is managed by a joint steering committee of equal representation from us and BeiGene.
During a specified exclusivity period, neither party will develop or commercialize the other party’s compound. Further, for a certain period following the effective date of the agreement, neither party will clinically develop (or prepare to clinically develop) or commercialize the combination of certain inhibitors in any form, or any products containing any such combination, except as permitted by the BeiGene Collaboration Agreement.
Unless earlier terminated, the BeiGene Collaboration Agreement will expire on the one-year anniversary of the date that BeiGene provides the final clinical trial report for the clinical trial to us. Either party may terminate the BeiGene Collaboration Agreement as follows: (i) either party entirely ceases all development of its compound, (ii) either party reasonably concludes that there is a patient safety issue or (iii) if a regulatory authority withdraws approval for either party’s compound or the clinical trial. Either party may also terminate the BeiGene Collaboration Agreement if the other party is in material breach and such breach is not cured within the specified cure period.
GlaxoSmithKline clinical collaboration agreement
In June 2019, we entered into a clinical trial collaboration and supply agreement with GSK, or the GSK Collaboration Agreement, to evaluate nirogacestat in combination with belantamab mafodotin, GSK's investigational BCMA ADC, in patients with relapsed or refractory multiple myeloma in an adaptive Phase 1b clinical trial.
GSK is responsible for administering the clinical trial and is responsible for all costs associated with the direct conduct of the clinical trial, other than the manufacture and supply of nirogacestat and certain expenses related to intellectual property rights. The collaboration is managed by a joint development committee of equal representation by us and GSK. Following completion of the clinical trial, within a specified period of time, either party may propose new agreements for the purpose of performing one or more additional clinical trials of the combination therapy for the treatment of relapsed and refractory multiple myeloma. If a party proposes to conduct an additional clinical trial, the parties will negotiate in good faith, without obligation, the details of a definitive agreement to provide for the expansion of the clinical collaboration. If the parties do not reach an agreement, and only one party wishes to proceed with an additional clinical trial, it may do so if the other party does not object to the protocol based on safety concerns.
During a specified period following the effective date of the GSK Collaboration Agreement, we will not conduct preclinical studies or clinical trials or supply or license nirogacestat for the development or commercialization of any combination therapy using an agent that binds to a BCMA. Unless earlier terminated, the GSK Collaboration Agreement will expire upon completion of the analyses contemplated by the clinical trial. Either party may terminate the GSK Collaboration Agreement as follows: (i) if either party commits a material breach of the GSK Collaboration Agreement that is not cured within a certain time period, (ii) either party files a petition in bankruptcy, insolvency or similar proceedings and such proceedings are not dismissed within a certain time period, (iii) due to regulatory action that prevents a party from supplying its compound or if a party, in its own discretion, determined to discontinue the manufacture or development of its compound for medical, scientific or legal reasons, (iv) either party concludes in good faith that there is a Material Safety Issue, as defined in the GSK Collaboration Agreement, or (v) if a clinical hold with respect to either party's compound arises during the term of the GSK Collaboration Agreement.
Manufacturing
We rely on third parties to manufacture nirogacestat and mirdametinib. We have entered into agreements with Asymchem Laboratories Inc and Patheon Inc., or Patheon, to produce drug substance for the nirogacestat and mirdametinib programs, respectively, and with Patheon to produce drug product for both programs.
We require all of our contract manufacturing organizations, or CMOs, to conduct manufacturing activities in compliance with current good manufacturing practice, or cGMP, requirements. We currently rely solely on these CMOs for scale-up and process development work and to produce sufficient quantities of our product candidates for use in preclinical studies and clinical trials. We anticipate that these CMOs will have the capacity to support both clinical supply and commercial-scale production, but we do not have any formal agreements at this time to cover commercial production. We may also elect to enter into agreements with other CMOs to manufacture supplies of drug substance and finished drug product.
Sales and marketing
If any of our product candidates are approved, we intend to market and commercialize them in the United States and select international markets, either alone or in partnership with others.
Many desmoid tumor and NF1-PN patients are managed by specialist physicians, including oncologists, medical geneticists and neurologists, and therefore we believe can be reached with a targeted sales force.
We actively collaborate with desmoid tumor and NF1-PN constituents through a number of initiatives, including participation in patient meetings and educational initiatives. Examples of such constituents include the Desmoid Tumor Research Foundation, Children’s Oncology Group and Children’s Tumor Foundation. We undertake these activities in order to better understand the burdens and unmet needs these patients face so that we can more effectively facilitate their access to our product candidates, if approved. In each of these disease areas we will support disease awareness and diagnosis and subsequent treatment of identified patients, by providing information, increasing physician awareness and creating more efficient referral pathways.
For our product candidates being explored in combination with other agents or in highly prevalent diseases, we intend to establish commercialization strategies for each in collaboration with our partner as we approach potential marketing approval, and will share responsibilities in a manner that takes into account our respective commercial infrastructures, competencies and country-specific expertise.
Competition
The pharmaceutical industry is characterized by rapid evolution of technologies and intense competition. While we believe that our product candidates, technology, knowledge, experience and scientific resources provide us with competitive advantages, we face competition from major pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private research institutions, among others.
Any product candidates that we successfully develop and commercialize will compete with approved treatment options, including off-label therapies, and new therapies that may become available in the future. Key considerations that would impact our ability to effectively compete with other therapies include the efficacy, safety, method of administration, cost, level of promotional activity and intellectual property protection of our products. Many of the companies
against which we may compete have significantly greater financial resources and expertise than we do in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products.
For our program in desmoid tumors, where there are no therapies currently approved by the FDA, we are aware that other companies are, or may be, developing products for this indication, including Ayala Pharmaceuticals, Inc., Bayer Corporation, Cellestia Biotech AG and Iterion Therapeutics, Inc. We are also aware of several therapies, some of which are generic, that are used off-label for the treatment of desmoid tumors. These therapies include chemotherapeutic agents, such as liposomal doxorubicin and vinblastine/methotrexate, non-steroidal anti-inflammatory drugs, anti-hormonal therapies and tyrosine kinase inhibitors, such as sorafenib, imatinib and pazopanib.
For our program in NF1-PN, where there are also no therapies currently approved by the FDA, we are aware that other companies are, or may be, developing products for this indication, including Array BioPharma Inc., AstraZeneca Plc, Daiichi Sankyo Co., Ltd., Exelixis, Inc., F. Hoffmann-La Roche Ltd, Infixion Bioscience, Inc., NFlection Therapeutics, Inc., Novartis International AG and Teton Therapeutics LLC. We are also aware of several therapies, some of which are generic, that are used off-label for the treatment of NF1-PN. These therapies include radiotherapy and various systemic treatments, such as chemotherapy and immunotherapy.
For our targeted oncology portfolio, we are aware that other oncology focused companies are or may be developing products for the treatment of solid tumors with RAS mutations, RAF mutations and other MAPK aberrations, including Amgen Inc., AstraZeneca PLC, Basilea Pharmaceutica Ltd., Chugai Pharmaceutical Co Ltd, Daiichi Sankyo Co., Ltd., Eli Lilly and Company, F. Hoffmann-La Roche Ltd., Hanmi Pharmaceutical Co., Ltd., Merck & Co., Inc., Mirati Therapeutics, Inc., Moderna Inc., Novartis International AG, Pfizer, Revolution Medicines, Inc., Takeda Pharmaceutical Company Limited, TheRas, Inc. and Wellspring Biosciences, Inc. There may be additional companies with programs suitable for addressing these patient populations that could be competitive with our efforts but that have not yet disclosed specific clinical development plans. In addition we are aware that other oncology focused companies are or may be developing products targeting BCMA for the treatment of multiple myeloma patients, including AbbVie Inc., Allogene Therapeutics, Amgen Inc, AstraZeneca PLC, Autolus Therapeutics plc, Cartesian Therapeutics, Inc., Celgene Corporation, CRISPR Therapeutics AG, Johnson and Johnson, Heidelberg Pharma GmbH, Novartis International AG, Pfizer Inc., Poseida Therapeutics, Inc., Precision BioSciences, Inc., Regeneron Pharmaceuticals and Seattle Genetics.
Smaller or early-stage companies, including oncology-focused therapeutics companies, may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These companies may also compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites, enrolling patients in clinical trials and acquiring technologies complementary to, or necessary for, our programs.
The availability of reimbursement from government and private payors will also significantly impact the pricing and competitiveness of our products. Our competitors may obtain FDA or other regulatory approvals for their products more rapidly than we may obtain approvals for our product candidates, which could result in our competitors establishing a strong market position before we are able to commercialize our product candidates.
Intellectual property
Our success depends in part on our ability to obtain and maintain proprietary protection for our product candidates, manufacturing and process discoveries and other know-how, to operate
without infringing the proprietary rights of others, and to prevent others from infringing our proprietary rights. We plan to protect our proprietary position using a variety of methods, which include pursuit of U.S. and foreign patent applications related to proprietary technology, inventions and improvements, such as compositions of matter and methods-of-use, that we determine are important to the development and implementation of our business. For example, we, our licensors, or our collaborators currently have, or are pursuing, patents covering the composition of matter for our product candidates and we plan to generally pursue patent protection covering methods-of-use for one or more clinical programs. We also rely on trade secrets, trademarks, know-how, continuing technological innovation and potential in-licensing opportunities to develop and maintain our proprietary position.
Patents
At the time we were formed in August 2017, we entered into license agreements with Pfizer for our lead product candidates, pursuant to which we acquired exclusive worldwide rights under Pfizer patents and know-how to develop, manufacture and commercialize our lead product candidates.
We have exclusive licenses under the Nirogacestat License Agreement to patent rights in the United States and numerous foreign jurisdictions relating to nirogacestat. As of June 30, 2019, the patent rights in-licensed under the Nirogacestat License Agreement include three granted patents in the United States and more than 25 patents granted in foreign jurisdictions including Australia, Canada, China, France, Germany, Spain, United Kingdom and Japan. A U.S. patent covering nirogacestat as a composition of matter has a statutory expiration date in 2025, not including patent term adjustment or any patent term extension, and relevant foreign counterparts are expected to expire in 2025, in each case, not including any patent term extensions. If we are successful in obtaining regulatory approval of nirogacestat for the treatment of desmoid tumors, we expect to rely on orphan drug exclusivity, which generally grants seven years of marketing exclusivity in the United States and 10 years of marketing exclusivity in Europe. See “License and collaboration agreements—Pfizer license agreements” above for additional information on our rights under the Nirogacestat License Agreement. Nirogacestat received Orphan Drug Designation in the United States for the treatment of desmoid tumors.
We have exclusive licenses under the Mirdametinib License Agreement to patent rights in the United States and numerous foreign jurisdictions relating to mirdametinib. As of June 30, 2019, the patent rights in-licensed under the Mirdametinib License Agreement include two granted patents in the United States and more than 45 patents granted in foreign jurisdictions including Australia, Canada, China, France, Germany, Spain, United Kingdom and Japan. A U.S. patent covering mirdametinib as a composition of matter has a statutory expiration date in 2021, not including patent term adjustment or patent term extension, and relevant foreign counterparts are expected to expire in 2021, in each case, not including any patent term extensions. With patent term adjustments, the U.S. patent expires in 2022. If we are successful in obtaining regulatory approval of mirdametinib for the treatment of NF1, we expect to rely on orphan drug exclusivity, which generally grants seven years of marketing exclusivity in the United States and 10 years of marketing exclusivity in Europe. See “License and collaboration agreements—Pfizer license agreements” above for additional information on our rights under the Mirdametinib License Agreement. The FDA has granted mirdametinib Orphan Drug Designation for NF1-PN, and the European Commission has granted mirdametinib Orphan Drug Designation for NF1.
For combination therapeutics involving nirogacestat or mirdametinib, there may be opportunities to enhance our patent estate, which we will explore. There can be no assurance that patents will issue from any of these efforts.
Trade secrets
In addition to patents, we rely on trade secrets and know-how to develop and maintain our competitive position. We typically rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection. We protect trade secrets and know-how by establishing confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and partners. These agreements generally provide that all confidential information developed or made known during the course of an individual or entity’s relationship with us must be kept confidential during and after the relationship. These agreements also generally provide that all inventions resulting from work performed for us or relating to our business and conceived or completed during the period of employment or assignment, as applicable, shall be our exclusive property. In addition, we take other appropriate precautions, such as physical and technological security measures, to guard against misappropriation of our proprietary information by third parties.
Coverage, pricing and reimbursement
Successful commercialization of new drug products depends in part on the extent to which reimbursement for those drug products will be available from government health administration authorities, private health insurers and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drug products they will pay for and establish reimbursement levels. The availability and extent of reimbursement by governmental and private payors is essential for most patients to be able to afford a drug product. Sales of drug products depend substantially, both domestically and abroad, on the extent to which the costs of drugs products are paid for by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors.
A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular drug products. In many countries, the prices of drug products are subject to varying price control mechanisms as part of national health systems. In general, the prices of drug products under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices for drug products, but monitor and control company profits. Accordingly, in markets outside the United States, the reimbursement for drug products may be reduced compared with the United States. In the United States, the principal decisions about reimbursement for new drug products are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the Department of Health and Human Services, or HHS. CMS decides whether and to what extent a new drug product will be covered and reimbursed under certain federal governmental healthcare programs, such as Medicare, and private payors tend to follow CMS to a substantial degree. However, no uniform policy of coverage and reimbursement for drug products exists among third-party payors and coverage and reimbursement levels for drug products can differ significantly from payor to payor. In the United States, the process for determining whether a third-party payor will provide coverage for a biological product typically is separate from the process for setting the price of such product or for establishing the reimbursement rate that the payor will pay for the product once coverage is approved. With respect to biologics, third-party payors may limit coverage to specific products on an approved list, also known as a formulary, which might not include all of the FDA-approved products for a particular indication, or place products at certain formulary levels that result in lower reimbursement levels and higher cost sharing obligation imposed on patients. A decision by a third-party payor not to cover our
product candidates could reduce physician utilization of a product. Moreover, a third-party payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Adequate third-party reimbursement may not be available to enable a manufacturer to maintain price levels sufficient to realize an appropriate return on its investment in product development. Additionally, coverage and reimbursement for products can differ significantly from payor to payor. One third-party payor’s decision to cover a particular medical product does not ensure that other payors will also provide coverage for the medical product, or will provide coverage at an adequate reimbursement rate. As a result, the coverage determination process usually requires manufacturers to provide scientific and clinical support for the use of their products to each payor separately and is a time-consuming process.
Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. Third-party payors are increasingly challenging the prices charged for medical products and services, examining the medical necessity and reviewing the cost-effectiveness of pharmaceutical products, in addition to questioning safety and efficacy. If third-party payors do not consider a product to be cost-effective compared to other available therapies, they may not cover that product after FDA approval or, if they do, the level of payment may not be sufficient to allow a manufacturer to sell its product at a profit.
In addition, in many foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing and reimbursement vary widely from country to country. In the European Union, governments influence the price of products through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed to by the government. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular product to currently available therapies. Other member states allow companies to fix their own prices for medicines, but monitor and control company profits. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. The downward pressure on healthcare costs in general, particularly prescription products, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross border imports from low-priced markets exert a commercial pressure on pricing within a country.
Government Regulation
Government authorities in the United States at the federal, state and local level and in other countries and jurisdictions, including the European Union, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of drug products, such as nirogacestat, mirdametinib and our other product candidates. Generally, before a new drug can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific for each regulatory authority and submitted for review and approved by the regulatory authority.
Clinical Trials
The clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by, or under control of, the trial sponsor, in accordance with Good Clinical Practices, or GCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria and the parameters to be used to monitor subject safety and assess efficacy. Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical trial must be reviewed and approved by an Institutional Review Board, or IRB, for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative, and must monitor the clinical trial until completed. There also are requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries. Information about most clinical trials must be submitted within specific timeframes for publication on the www.clinicaltrials.gov website. Information related to the product, patient population, phase of investigation, trial sites and investigators and other aspects of the clinical trial is made public as part of the registration of the clinical trial. Sponsors are also obligated to discuss the results of their clinical trials after completion. Disclosure of the results of these trials can be delayed in some cases for up to two years after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs. Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined:
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Phase 1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, side effect tolerability and safety of the drug.
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Phase 2 clinical trials involve studies in disease-affected patients to determine the dose required to produce the desired benefits. At the same time, safety and further pharmacokinetic an pharmacodynamic information is collected, possible adverse effects and safety risks are identified and a preliminary evaluation of efficacy is conducted.
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Phase 3 clinical trials generally involve a larger number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an adequate basis for product approval. These trials may include comparisons with placebo and/or other comparator treatments. The duration of treatment is often extended to mimic the actual use of a product during marketing.
A registrational trial is a clinical trial that adequately meets regulatory agency requirements for the evaluation of a drug candidate’s efficacy and safety such that it can be used to justify the approval of the drug. Generally, registrational trials are Phase 3 trials but may be Phase 2 trials if the trial design provides a reliable assessment of clinical benefit, particularly in situations where there is an unmet medical need.
Post-approval trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow up. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of a Biologics License Application, or BLA.
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. The FDA or the sponsor may suspend or terminate a clinical trial at any time or the FDA may impose other sanctions on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the requirements of the IRB or if the drug has been associated with unexpected serious harm to patients. There are also requirements related to registration and reporting of certain clinical trials and completed clinical trial results to public registries.
United States—FDA regulation
Approval Process
In the United States, pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug, and Cosmetic Act, or the FDC Act, and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending NDAs, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution.
Pharmaceutical product development for a new product or certain changes to an approved product in the United States typically involves preclinical laboratory and animal tests, the submission to the FDA of an IND, which must become effective before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought. Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.
Preclinical tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product. The conduct of the preclinical tests must comply with federal regulations and requirements, including good laboratory practices. The results of preclinical testing are submitted to the FDA as part of an IND along with other information, including information about product chemistry, manufacturing and controls and a proposed clinical trial protocol. Long term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.
A 30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has neither commented on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.
Clinical trials involve the administration of the investigational new drug to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials must be conducted: (i) in compliance with federal regulations; (ii) in compliance with GCP, an international standard
meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators, and monitors; as well as (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part of the IND.
The FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. The Trial protocol and informed consent information for patients in clinical trials must also be submitted to an IRB for approval. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements, or may impose other conditions. Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In Phase 1, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics, pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence on effectiveness. Phase 2 usually involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance and optimum dosage, and to identify common adverse effects and safety risks. If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug. In most cases FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug. A single Phase 3 trial with other confirmatory evidence may be sufficient in rare instances where the Trial is a large multi-center trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible.
Pursuant to the 21st Century Cures Act, which was enacted on December 13, 2016, the manufacturer of an investigational drug for a serious or life-threatening disease is required to make available, such as by posting on its website, its policy on evaluating and responding to requests for expanded access. This requirement applies on the later of 60 days after the date of enactment or the first initiation of a Phase 2 or Phase 3 trial of the investigational drug. After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the United States. The NDA must include the results of all preclinical, clinical and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture and controls. The cost of preparing and submitting an NDA is substantial. The submission of most NDAs is additionally subject to a substantial application user fee, currently $2,588,478 for Fiscal Year 2019, and the manufacturer and/or sponsor under an approved NDA are also subject to annual program fees for eligible products, which are currently $309,915 for Fiscal Year 2019.
The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. The FDA has agreed to certain performance goals in the review of new drug applications. Most such applications for standard review drug products are reviewed within ten to twelve months; most applications for priority review drugs are reviewed in six to eight months. Priority review can be applied to drugs that the FDA determines offer major advances in
treatment or provide a treatment where no adequate therapy exists. The review process for both standard and priority review may be extended by FDA for three additional months to consider certain late-submitted information, or information intended to clarify information already provided in the submission.
The FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an advisory committee—typically a panel that includes clinicians and other experts—for review, evaluation and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. FDA will not approve the product unless compliance with cGMP is satisfactory and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied.
After FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information, in order for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included.
An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. As a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy, or REMS, to help ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals and elements to assure safe use, or ETASU. ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability of the drug. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing.
Changes to some of the conditions established in an approved application, including changes in indications, labeling or manufacturing processes or facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing NDAs.
Exclusivity
Upon NDA approval of a new chemical entity, or NCE, which is a drug that contains no active moiety that has been approved by FDA in any other NDA, that drug receives five years of marketing exclusivity during which FDA cannot receive any Abbreviated New Drug Application, or ANDA, seeking approval of a generic version of that drug. Certain changes to a drug, such as the addition of a new indication to the package insert, are associated with a three-year period of exclusivity during which FDA cannot approve an ANDA for a generic drug that includes the change.
An ANDA may be submitted one year before NCE exclusivity expires if a Paragraph IV certification is filed. If there is no listed patent in the Orange Book, there may not be a Paragraph IV certification, and, thus, no ANDA may be filed before the expiration of the exclusivity period.
Patent Term Extension
After NDA approval, owners of relevant drug patents may apply for up to a five-year patent extension for one patent. The allowable patent term extension is calculated as half of the drug’s testing phase—the time between IND application and NDA submission—and all of the review phase—the time between NDA submission and approval up to a maximum of five years. The time can be shortened if FDA determines that the applicant did not pursue approval with due diligence. The total patent term after the extension may not exceed 14 years from approval.
For patents that might expire during the application phase, the patent owner may request an interim patent extension. An interim patent extension increases the patent term by one year and may be renewed up to four times. For each interim patent extension granted, the post-approval patent extension is reduced by one year. The director of the United States Patent and Trademark Office must determine that approval of the drug covered by the patent for which a patent extension is being sought is likely. Interim patent extensions are not available for a drug for which an NDA has not been submitted.
Orphan Drugs
Under the Orphan Drug Act, the FDA may grant Orphan Drug Designation to drugs intended to treat a rare disease or condition—generally a disease or condition that affects fewer than 200,000 individuals in the U.S. Orphan Drug Designation must be requested before submitting an NDA. After the FDA grants Orphan Drug Designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan Drug Designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. The first NDA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA Orphan Drug Designation is entitled to a seven-year exclusive marketing period in the U.S. for that product, for that indication. During the seven-year exclusivity period, the FDA may not approve any other applications to market the same drug for the same disease, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan drug exclusivity does not prevent FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or condition. Among the other benefits of Orphan Drug Designation are tax credits for certain research and a waiver of the NDA application user fee.
Fast Track Designation and Accelerated Approval
FDA is required to facilitate the development, and expedite the review, of drugs that are intended for the treatment of a serious or life-threatening disease or condition for which there is no effective treatment, and which demonstrate the potential to address unmet medical needs for the condition. Under the fast track program, the sponsor of a new drug candidate may request that FDA designate the drug candidate for a specific indication as a fast track drug concurrent with, or after, the filing of the IND for the drug candidate. FDA must determine if the drug candidate qualifies for Fast Track Designation within 60 days of receipt of the sponsor’s request.
Under the fast track program and FDA’s accelerated approval regulations, FDA may approve a drug for a serious or life-threatening illness that provides meaningful therapeutic benefit to patients over existing treatments based upon a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible
morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments.
In clinical trials, a surrogate endpoint is a measurement of laboratory or clinical signs of a disease or condition that substitutes for a direct measurement of how a patient feels, functions or survives. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. A drug candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies, or confirm a clinical benefit during post-marketing studies, will allow FDA to withdraw the drug from the market on an expedited basis. All promotional materials for product candidates approved under accelerated regulations are subject to prior review by FDA.
In addition to other benefits such as the ability to use surrogate endpoints and engage in more frequent interactions with FDA, FDA may initiate review of sections of a fast track drug’s NDA before the application is complete. This rolling review is available if the applicant provides, and FDA approves, a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, FDA’s time period goal for reviewing an application does not begin until the last section of the NDA is submitted. Additionally, the Fast Track Designation may be withdrawn by FDA if FDA believes that the designation is no longer supported by data emerging in the clinical trial process.
Breakthrough Therapy Designation
Breakthrough Therapy Designation by the FDA provides more extensive development consultation opportunities with FDA senior staff, allows for the rolling review of the drug’s application for approval and indicates that the product could be eligible for priority review if supported by clinical data at the time of application submission for drugs that are intended to treat a serious or life-threatening disease or condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Under the breakthrough therapy program, the sponsor of a new drug candidate may request that FDA designate the drug candidate for a specific indication as a breakthrough therapy concurrent with, or after, the filing of the IND for the drug candidate. FDA must determine if the drug candidate qualifies for Breakthrough Therapy Designation within 60 days of receipt of the sponsor’s request.
Disclosure of Clinical Trial Information
Sponsors of clinical trials of FDA regulated products, including drugs, are required to register and disclose certain clinical trial information. Information related to the product, patient population, phase of investigation, Trial sites and investigators and other aspects of the clinical trial is then made public as part of the registration. Sponsors are also obligated to discuss the results of their clinical trials after completion. Disclosure of the results of these trials can be delayed in certain circumstances for up to two years after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.
European Union regulation
In the European Union, our product candidates also may be subject to extensive regulatory requirements. As in the United States, medicinal products can be marketed only if a marketing authorization from the competent regulatory agencies has been obtained.
Similar to the United States, the various phases of preclinical and clinical research in the European Union are subject to significant regulatory controls.
The Clinical Trials Directive 2001/20/EC, the Directive 2005/28/EC on GCP, and the related national implementing provisions of the individual EU Member States govern the system for the approval of clinical trials in the European Union. Under this system, an applicant must obtain prior approval from the competent national authority of the EU Member States in which the clinical trial is to be conducted. Furthermore, the applicant may only start a clinical trial at a specific Trial site after the competent ethics committee has issued a favorable opinion. The clinical trial application must be accompanied by, among other documents, an IMPD (the Common Technical Document) with supporting information prescribed by Directive 2001/20/EC, Directive 2005/28/EC, where relevant the implementing national provisions of the individual EU Member States and further detailed in applicable guidance documents. All suspected unexpected serious adverse reactions to the investigated drug that occur during the clinical trial have to be reported to the competent national authority and the Ethics Committee of the Member State where they occurred.
In April 2014, the new Clinical Trials Regulation, (EU) No 536/2014 was adopted. The regulation is anticipated to come into application in 2019. The Clinical Trials Regulation will be directly applicable in all the EU Member States, repealing the current Clinical Trials Directive 2001/20/EC. Conduct of all clinical trials performed in the European Union will continue to be bound by currently applicable provisions until the new Clinical Trials Regulation becomes applicable. The extent to which ongoing clinical trials will be governed by the Clinical Trials Regulation will depend on when the Clinical Trials Regulation becomes applicable and on the duration of the individual clinical trial. If a clinical trial continues for more than three years from the day on which the Clinical Trials Regulation becomes applicable the Clinical Trials Regulation will at that time begin to apply to the clinical trial.
The new Clinical Trials Regulation aims to simplify and streamline the approval of clinical trials in the European Union. The main characteristics of the regulation include: a streamlined application procedure via a single-entry point, the “EU portal”; a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors; and a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is assessed by the competent authorities of all EU Member States in which an application for authorization of a clinical trial has been submitted (Member States concerned). Part II is assessed separately by each Member State concerned. Strict deadlines have been established for the assessment of clinical trial applications. The role of the relevant ethics committees in the assessment procedure will continue to be governed by the national law of the concerned EU Member State. However, overall related timelines will be defined by the Clinical Trials Regulation.
To obtain a marketing authorization of a drug in the European Union, we may submit Marketing Authorization Applications, or MAA, either under the so-called centralized or national authorization procedures.
Centralized Procedure
The centralized procedure provides for the grant of a single marketing authorization following a favorable opinion by the European Medicines Agency, or EMA, that is valid in all EU Member States, as well as Iceland, Liechtenstein and Norway. The centralized procedure is compulsory for medicines produced by specified biotechnological processes, products designated as orphan medicinal products, advanced therapy medicines (such as gene-therapy, somatic cell-therapy or tissue-engineered medicines) and products with a new active substance indicated for the
treatment of specified diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative disorders or autoimmune diseases and other immune dysfunctions and viral diseases. The centralized procedure is optional for products that represent a significant therapeutic, scientific or technical innovation, or whose authorization would be in the interest of public health. Under the centralized procedure the maximum timeframe for the evaluation of an MAA by the EMA is 210 days, excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the Committee of Medicinal Products for Human Use, or the CHMP. Accelerated assessment might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a major public health interest, particularly from the point of view of therapeutic innovation. The timeframe for the evaluation of an MAA under the accelerated assessment procedure is of 150 days, excluding stop-clocks.
National Authorization Procedures
There are also two other possible routes to authorize medicinal products in several EU countries, which are available for investigational medicinal products that fall outside the scope of the centralized procedure:
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Decentralized procedure. Using the decentralized procedure, an applicant may apply for simultaneous authorization in more than one EU country of medicinal products that have not yet been authorized in any EU country and that do not fall within the mandatory scope of the centralized procedure.
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Mutual recognition procedure. In the mutual recognition procedure, a medicine is first authorized in one EU Member State, in accordance with the national procedures of that country. Following this, further marketing authorizations can be sought from other EU countries in a procedure whereby the countries concerned agree to recognize the validity of the original, national marketing authorization.
Under the above described procedures, before granting an MAA, the EMA or the competent authorities of the Member States of the European Economic Area, or EEA, make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.
European Union Regulatory Exclusivity
In the European Union, new products authorized for marketing (i.e., reference products) qualify for eight years of data exclusivity and an additional two years of market exclusivity upon marketing authorization. The data exclusivity period prevents generic applicants from relying on the preclinical and clinical trial data contained in the dossier of the reference product when applying for a generic marketing authorization in the European Union during a period of eight years from the date on which the reference product was first authorized in the European Union. The market exclusivity period prevents a successful generic applicant from commercializing its product in the European Union until ten years have elapsed from the initial authorization of the reference product in the European Union. The ten-year market exclusivity period can be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
European Union Orphan Designation and Exclusivity
The criteria for designating an orphan medicinal product in the European Union, are similar in principle to those in the United States. Under Article 3 of Regulation (EC) 141/2000, a medicinal product may be designated as orphan if (i) it is intended for the diagnosis, prevention or
treatment of a life-threatening or chronically debilitating condition; (ii) either (a) such condition affects no more than five in 10,000 persons in the European Union when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the European Union to justify investment; and (iii) there exists no satisfactory method of diagnosis, prevention or treatment of such condition authorized for marketing in the European Union, or if such a method exists, the product will be of significant benefit to those affected by the condition, as defined in Regulation (EC) 847/2000. Orphan medicinal products are eligible for financial incentives such as reduction of fees or fee waivers and are, upon grant of a marketing authorization, entitled to ten years of market exclusivity for the approved therapeutic indication. The application for orphan designation must be submitted before the application for marketing authorization. The applicant will receive a fee reduction for the marketing authorization application if the orphan designation has been granted, but not if the designation is still pending at the time the marketing authorization is submitted. Orphan designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
The ten-year market exclusivity in the European Union may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, for example, if the product is sufficiently profitable not to justify maintenance of market exclusivity. Additionally, marketing authorization may be granted to a similar product for the same indication at any time if:
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the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior;
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the applicant consents to a second orphan medicinal product application; or
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the applicant cannot supply enough orphan medicinal product.
Rest of the world regulation
For other countries outside of the European Union and the United States, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from jurisdiction to jurisdiction. Additionally, the clinical trials must be conducted in accordance with cGCP requirements and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
Other Healthcare Laws
Manufacturing, sales, promotion and other activities following product approval are also subject to regulation by numerous regulatory authorities in the United States in addition to the FDA, including CMS, the HHS Office of Inspector General and HHS Office for Civil Rights, other divisions of the HHS and the Department of Justice.
Healthcare providers, physicians, and third-party payors will play a primary role in the recommendation and prescription of any products for which we obtain marketing approval. Our current and future arrangements with third-party payors, healthcare providers and physicians may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we
market, sell and distribute any drugs for which we obtain marketing approval. In the United States, these laws include, without limitation, state and federal anti-kickback, false claims, physician transparency, and patient data privacy and security laws and regulations, including but not limited to those described below.
The U.S. federal Anti-Kickback Statute, or AKS, prohibits, among other things, any person or entity from knowingly and willfully offering, paying, soliciting, receiving or providing any remuneration, directly or indirectly, overtly or covertly, to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any good, facility, item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federal healthcare programs. The term “remuneration” has been broadly interpreted to include anything of value. The AKS has been interpreted to apply to arrangements between pharmaceutical and medical device manufacturers on the one hand and prescribers, purchasers, formulary managers and beneficiaries on the other hand. Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the AKS. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all its facts and circumstances. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute has been violated. In addition, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Moreover, a claim including items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.
Although we would not submit claims directly to payors, drug manufacturers can be held liable under the federal False Claims Act, which imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities (including manufacturers) for, among other things, knowingly presenting, or causing to be presented to federal programs (including Medicare and Medicaid) claims for items or services, including drugs, that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services. The government may deem manufacturers to have “caused” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product off-label. Several biopharmaceutical, medical device and other healthcare companies have been prosecuted under federal false claims and civil monetary penalty laws for, among other things, allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of products for unapproved (e.g., or off-label), and thus non-covered, uses. In addition, the civil monetary penalties statute imposes penalties against any person who is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent. Claims which include items or services resulting from a violation of the federal AKS are false or fraudulent claims for purposes of the False Claims Act.
Our future marketing and activities relating to the reporting of wholesaler or estimated retail prices for our products, if approved, the reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state and third-party reimbursement for our products, and the sale and marketing of our product candidates, are subject to scrutiny under these laws.
The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created additional federal criminal statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
In addition, there has been a recent trend of increased federal and state regulation of payments made to physicians and certain other healthcare providers. The Affordable Care Act, or the ACA, imposed, among other things, new annual reporting requirements through the Physician Payments Sunshine Act for covered manufacturers for certain payments and “transfers of value” provided to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Failure to submit timely, accurately and completely the required information for all payments, transfers of value and ownership or investment interests may result in civil monetary penalties. Covered manufacturers must submit reports by the 90th day of each subsequent calendar year and the reported information is publicly made available on a searchable website.
We may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their respective implementing regulations, including the Final HIPAA Omnibus Rule published on January 25, 2013, impose specified requirements relating to the privacy, security and transmission of individually identifiable health information held by covered entities and their business associates. Among other things, HITECH made HIPAAs security standards directly applicable to “business associates,” defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity, although it is unclear that we would be considered a “business associate” in the normal course of our business. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same requirements, thus complicating compliance efforts.
Similar state and foreign fraud and abuse laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services. Such laws are generally broad and are enforced by various state agencies and private actions. Also, many states have similar fraud and abuse statutes or regulations that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs. Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant federal government compliance guidance, and require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or drug pricing.
In order to distribute products commercially, we must comply with state laws that require the registration of manufacturers and wholesale distributors of drug and biological products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state. Some states also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution, including some states that require manufacturers and others to adopt new technology capable of tracking and tracing product as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing practices. All of our activities are potentially subject to federal and state consumer protection and unfair competition laws.
The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, imprisonment, exclusion of drugs from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, any of which could adversely affect our ability to operate our business and our financial results. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource consuming and can divert a company’s attention from the business.
European Data Collection
The collection and use of personal health data in the European Union are governed by the provisions of the Data Protection Directive, and, as of May 2018, the General Data Protection Regulation, or GDPR. This directive imposes several requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals, notification of data processing obligations to the competent national data protection authorities and the security and confidentiality of the personal data. The Data Protection Directive and GDPR also impose strict rules on the transfer of personal data out of the European Union, or the European Union, to the United States. Failure to comply with the requirements of the Data Protection Directive, the GDPR and the related national data protection laws of the EU Member States may result in fines and other administrative penalties. The GDPR introduces new data protection requirements in the European Union and substantial fines for breaches of the data
protection rules. The GDPR regulations may impose additional responsibility and liability in relation to personal data that we process, including in respect of clinical trials, and we may be required to put in place additional mechanisms ensuring compliance with the new data protection rules. This may be onerous and adversely affect our business, financial condition, results of operations and prospects.
Current and Future Legislation
In the United States and foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval. We expect that current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and additional downward pressure on the price that we, or any collaborators, may receive for any approved products.
The ACA, for example, contains provisions that subject biological products to potential competition by lower-cost biosimilars and may reduce the profitability of drug products through increased rebates for drugs reimbursed by Medicaid programs, extend Medicaid rebates to Medicaid managed care plans, provide for mandatory discounts for certain Medicare Part D beneficiaries and annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs. With the President Trump administration and current Congress, there will likely be additional administrative or legislative changes, including modification, repeal or replacement of all, or certain provisions of the ACA, which may impact reimbursement for drugs and biologics. On January 20, 2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay the implementation of any provision of the ACA that would impose a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices. On October 13, 2017, President Trump signed an Executive Order terminating the cost-sharing subsidies that reimburse insurers under the ACA. Several state Attorneys General filed suit to stop the administration from terminating the subsidies, but their lawsuit was dismissed by a federal judge in California on July 18, 2018. In addition, CMS has recently finalized regulations that would give states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces. Further, each chamber of Congress has put forth multiple bills, and may do so again in the future, designed to repeal or repeal and replace portions of the ACA.
While Congress has not passed repeal legislation, the Tax Reform Act includes a provision that repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” Further, the Bipartisan Budget Act of 2018, or the BBA, among other things, amended the ACA, effective January 1, 2019, to increase from 50 percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D and to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.” Congress may consider other legislation to repeal and replace elements of the ACA. On December 14, 2018, a U.S. District Court judge in the Northern District of Texas ruled that the individual mandate portion of the ACA is an essential and inseverable feature of the ACA, and therefore because the mandate was repealed as part of the Tax Cuts and Jobs Act, the remaining provisions of the ACA are invalid as well. The Trump administration and CMS have both stated that the ruling will have no immediate effect, and on December 30, 2018 the same judge issued an order staying the judgment pending
appeal. A Fifth Circuit U.S. Court of Appeals hearing to determine whether certain states and the House of Representatives have standing to appeal the lower court decision was held on July 9, 2019, but it is unclear when a Court will render its decision on this hearing, and what effect it will have on the status of the ACA. Litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results.
Additionally, other federal health reform measures have been proposed and adopted in the United States since the ACA was enacted:
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The Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. These changes included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments to the statute, including the BBA, will remain in effect through 2027, unless additional Congressional action is taken.
•
The American Taxpayer Relief Act of 2012, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
•
The Middle Class Tax Relief and Job Creation Act of 2012 required that CMS reduce the Medicare clinical laboratory fee schedule by 2% in 2013, which served as a base for 2014 and subsequent years. In addition, effective January 1, 2014, CMS also began bundling the Medicare payments for certain laboratory tests ordered while a patient received services in a hospital outpatient setting.
Further, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which have resulted in several recent Congressional inquiries and proposed and enacted bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. In addition, the U.S. government, state legislatures, and foreign governments have shown significant interest in implementing cost containment programs, including price-controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs to limit the growth of government paid healthcare costs. For example, the U.S. government has passed legislation requiring pharmaceutical manufacturers to provide rebates and discounts to certain entities and governmental payors to participate in federal healthcare programs. Further, Congress and the current administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs, and the current administration recently released a “Blueprint”, or plan, to reduce the cost of drugs. The Blueprint contains certain measures that the U.S. Department of Health and Human Services is already working to implement. For example, in May 2019, CMS issued a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was effective January 1, 2019. Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. Individual states in the United States have also been increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
Employees
As of August 15, 2019, we had 52 full-time employees. Of these employees, 31 are engaged in product development and clinical activities. None of our employees are represented by a labor union or covered by a collective bargaining agreement. We consider our relationship with our employees to be good.
Facilities
Our headquarters are based in Stamford, Connecticut, where we have leased approximately 24,000 square feet of office space under a lease that expires in November 2022. Our development operations are based in Durham, North Carolina, where we have leased approximately 10,350 square feet of office space under a lease that expires in 2023, with two five-year renewal options. We believe that our office spaces are sufficient for our current needs.
Legal proceedings
We are not currently a party to any material legal proceedings.
Management
The following table sets forth certain information concerning our executive officers who, subject to rights pursuant to any employment agreements, serve at the pleasure of our board of directors:
Name
|
|
|
Age
|
|
|
Position
|
|
Saqib Islam, J.D.
|
|
|
|
|
50 |
|
|
|
Chief Executive Officer and Director |
|
Francis I. Perier, Jr., M.B.A.
|
|
|
|
|
59 |
|
|
|
Chief Financial Officer |
|
Jens Renstrup, M.D., M.B.A.
|
|
|
|
|
54 |
|
|
|
Chief Medical Officer |
|
Badreddin Edris, Ph.D.
|
|
|
|
|
32 |
|
|
|
Chief Business Officer |
|
L. Mary Smith, Ph.D.
|
|
|
|
|
52 |
|
|
|
Senior Vice President, Clinical Research and Development |
|
Michael V. Greco, J.D.
|
|
|
|
|
48 |
|
|
|
General Counsel and Secretary |
|
The following is a biographical summary of the experience of our executive officers.
Executive officers
Saqib Islam, J.D., has served as our Chief Executive Officer and a member of our board of directors since August 2018. Previously, Mr. Islam served as our Chief Financial Officer and Chief Business Officer since our formation in August 2017. Prior to joining SpringWorks, Mr. Islam served as Chief Business Officer at Moderna Therapeutics, Inc. from February 2016 to August 2017. Prior to Moderna Therapeutics, Inc., Mr. Islam was Executive Vice President, Chief Strategy and Portfolio Officer at Alexion Pharmaceuticals, Inc. from February 2013 to February 2016, where he was responsible for executing the company’s corporate growth strategies and contributed to its assessment and management of global operations. Prior to joining Alexion, Mr. Islam worked for more than 25 years in international business management with a focus on business development, strategic decision-making and planning and capital markets, previously holding Managing Director positions at Morgan Stanley and Credit Suisse. Mr. Islam holds a J.D. from Columbia Law School, where he was a Harlan Fiske Scholar, and a Bachelor’s degree from McGill University where he was a Faculty and University Scholar. We believe that Mr. Islam is qualified to serve on our board of directors based on his experience and expertise in operations management and executive leadership at various biopharmaceutical companies.
Francis (Frank) I. Perier, Jr., M.B.A., has served as our Chief Financial Officer since August 2019. Prior to joining SpringWorks, Mr. Perier was retired following the 2014 acquisition of Forest Laboratories, Inc. by Actavis. From September 2004 to October 2014, Mr. Perier served as Chief Financial Officer of Forest Laboratories, Inc. Prior to Forest, Mr. Perier was with Bristol-Myers Squibb from 1995 to 2004, where he worked in corporate and operations executive finance capacities of increasing responsibilities, including Vice President of Finance and Operations Planning—Americas Medicines Group, the company’s largest business unit at that time. Before joining Bristol-Myers Squibb, Mr. Perier served as an accounting and auditing partner at Deloitte, where he worked for approximately 15 years. Mr. Perier also served as a member of the board of directors of Concordia International, Inc., a specialty pharmaceutical company from May 2017 until September 2018. Mr. Perier received an M.B.A. from the Stern School of Business, New York University and a Bachelor’s degree in Accountancy from Villanova University. He is a Certified Public Accountant (inactive) and a member of the New Jersey Society of Certified Public Accountants and the American Institute of Certified Public Accountants.
Jens Renstrup, M.D., M.B.A., has served as our Chief Medical Officer since July 2018. From June 2015 to April 2018, Dr. Renstrup was Senior Vice President and Head of Global Medical Affairs at Alexion Pharmaceuticals, Inc. Prior to Alexion, Dr. Renstrup served as Head of Global Medical Affairs at GlaxoSmithKline from May 2010 to June 2015 and held various medical director positions at Merck & Co. from 2002 to 2010. Dr. Renstrup holds an M.D. from the University of Copenhagen and a graduate diploma in marketing from Copenhagen Business School.
Badreddin Edris, Ph.D., has served as our Chief Business Officer since September 2018. Prior to joining us, Dr. Edris was an investment and operating professional on the private equity team at OrbiMed Advisors LLC, a healthcare investment firm, from June 2014 to November 2018. During his tenure at OrbiMed, Dr. Edris focused on investing in private and public biopharmaceutical companies, and also co-founded and held operating roles at two OrbiMed portfolio companies, Silverback Therapeutics, Inc., where he was Chief Business Officer from April 2016 to September 2018, and Edgewise Therapeutics, Inc. where he was Chief Operating Officer from May 2017 until March 2018. Before OrbiMed, Dr. Edris was a management consultant in the healthcare practice at Bain & Co Inc. Dr. Edris holds a Ph.D. in Genetics from Stanford University School of Medicine, where he was a National Science Foundation Graduate Research Fellow, an M.S. in Biology from Stanford University and a Bachelor’s degree in Microbiology from Weber State University.
L. Mary Smith, Ph.D., has served as our Senior Vice President, Clinical Research and Development since August 2017. Prior to joining us, Dr. Smith was the Executive Vice President of Clinical Development at Bamboo Therapeutics, Inc., a wholly owned subsidiary of Pfizer, from June 2016 to August 2017. Prior to joining Bamboo, Dr. Smith held positions of increasing responsibility in the research and development department at United Therapeutics Corporation from 2005 to 2016, most recently as Vice President of Product Development from December 2014 to June 2016. She earned a B.S. in biochemistry and a Ph.D. in microbiology from the University of New Hampshire, and she received her postdoctoral training at Emory University.
Michael V. Greco, J.D., has served as our General Counsel and Secretary since June 2018. Prior to joining us, Mr. Greco held positions of increasing responsiblity in the legal department at Alexion Pharmaceuticals, Inc. from February 2007 until June 2018, most recently as Senior Vice President of Law and Corporate Secretary from August 2015 to June 2018. Prior to Alexion, he was a corporate and transactional attorney at Wiggin and Dana LLP from May 2005 to February 2007 and Bingham McCutchen LLP (now Morgan, Lewis & Bockius LLP) from September 1999 to May 2005. Prior to attending law school, Mr. Greco served in the U.S. Army Corps of Engineers. He received a J.D. from Suffolk University Law School and a B.S. from the United States Military Academy, West Point.
Non-employee directors
The following table sets forth certain information concerning our non-employees who serve on our board of directors:
Name
|
|
|
Age
|
|
|
Position
|
|
Daniel S. Lynch, M.B.A.(1)(2)
|
|
|
61
|
|
|
Chairman of the Board |
|
Alan Fuhrman(1)(3)
|
|
|
63
|
|
|
Director |
|
Carl L. Gordon, Ph.D., CFA*
|
|
|
54
|
|
|
Director |
|
Freda Lewis-Hall, M.D., DFAPA(3)
|
|
|
64
|
|
|
Director |
|
Deval L. Patrick, J.D.*
|
|
|
63
|
|
|
Director |
|
Jeffrey Schwartz, M.B.A.(1)(2)
|
|
|
40
|
|
|
Director |
|
Stephen Squinto, Ph.D.(2)(3)
|
|
|
62
|
|
|
Director and Acting Head of Research and Development |
|
(1) Member of audit committee.
(2) Member of compensation committee.
(3) Member of nominating and corporate governance committee.
* Each of Dr. Gordon and Mr. Patrick has indicated that he will resign as a director contingent upon, and effective immediately following, the pricing of this offering.
The following is a biographical summary of the experience of our non-employee directors.
Daniel S. Lynch, M.B.A., has served as our Chairman since August 2019, and served as our Executive Chairman from August 2017 to August 2019. Additionally, from February 2018 to July 2018, Mr. Lynch served as our interim Chief Executive Officer. Mr. Lynch has served as chairman of the board of directors of Blueprint Medicines Corporation since September 2012. Mr. Lynch served as a venture partner at Third Rock from May 2013 to December 2016 and served as an entrepreneur-in-residence at Third Rock from May 2011 to May 2013 and interim Chief Executive Officer of Surface Oncology, Inc., from September 2017 to January 2018. From April 2001 to November 2005, Mr. Lynch served as the Chief Financial Officer and then the Chief Executive Officer of ImClone Systems, Inc. Mr. Lynch has served as chairman of the board of directors and chairman of the compensation committee of Surface Oncology, Inc. since December 2016, chairman of the boards of directors of bluebird bio, Inc. since May 2011 and Blueprint Medicines Corp. since September 2012 and as a member of the board of directors of Translate Bio, Inc. (formerly RaNa Therapeutics, Inc.) since June 2012 (including as chairman of the board of directors since March 2015). Mr. Lynch served as a member of the board of directors of DNIB Unwind, Inc. (formerly BIND Therapeutics, Inc.) from October 2012 to July 2016. Mr. Lynch received a B.A. in mathematics from Wesleyan University and an M.B.A. from the Darden Graduate School of Business Administration at the University of Virginia. We believe that Mr. Lynch is qualified to serve on our board of directors based on his experience as the Chief Executive Officer and Chief Financial Officer of a public pharmaceutical company and as executive chairman and director for many other life science companies.
Alan Fuhrman, has served as a member of our board of directors since August 2019. Since December 2017, Mr. Fuhrman has served as chief financial officer of Amplyx Pharmaceuticals, Inc. Prior to Amplyx, Mr. Fuhrman served as chief financial officer of Mirna Therapeutics, Inc. from September 2015 to August 2017. Mr. Fuhrman also served as chief financial officer of Ambit Biosciences Corporation from October 2010 to November 2014, chief financial officer of Naviscan, Inc. from November 2008 to September 2010 and chief financial officer of Sonus Pharmaceuticals, Inc. from September 2004 to August 2008. Mr. Fuhrman has served on the board of directors of Checkmate Pharmaceuticals, Inc. since June 2019 and as a member of the board of directors and chairman of the audit committee of Loxo Oncology, Inc. from January 2015 to February 2019. Mr. Fuhrman received B.S. degrees in business administration and agricultural economics from Montana State University and practiced as a CPA with Coopers and Lybrand. We believe that Mr. Fuhrman is qualified to serve on our board of directors based on his experience as the chief financial officer of pharmaceutical companies, his prior service on the board of a public biotechnology company and his financial expertise and experience with public company accounting.
Carl Gordon, Ph.D., CFA, has served as a member of our board of directors since August 2017. In addition, Dr. Gordon is a member at OrbiMed Advisors, LLC, which he co-founded in January 1998. Dr. Gordon currently serves on the boards of directors of several private companies and has served as a member of the board of directors of Turning Point Therapeutics, Inc. since May 2017, Alector, Inc. since 2013 and Prevail Therapeutics, Inc. since August 2017. Previously, he also served on the boards of directors of various publicly traded companies including Acceleron Pharma Inc. from 2006 to 2013, ARMO BioSciences, Inc. from December 2012 to May 2018, Intellia Therapeutics, Inc. from August 2015 to July 2017, Selecta BioSciences Inc. from 2010 to June 2017
and X4 Pharmaceuticals, Inc. (formerly Arsanis Inc.) from September 2010 to March 2019. Prior to OrbiMed, he was a senior biotechnology analyst at Mehta and Isaly Assets Management, Inc. from 1995 to 1997. He was a Fellow at The Rockefeller University from 1993 to 1995. Dr. Gordon received a Ph.D. in Molecular Biology from the Massachusetts Institute of Technology and a B.A. in Chemistry from Harvard College. Dr. Gordon has indicated that he will resign as a director contingent upon, and effective immediately following, the pricing of this offering.
Freda Lewis-Hall, M.D., DFAPA., has served as a member of our board of directors since August 2017. Since January 2019, Dr. Lewis-Hall has served as Chief Patient Officer and Executive Vice President of Pfizer Inc., a pharmaceutical company, where she is responsible for Pfizer’s office of patient affairs, centers of excellence on pediatric care, clinical trial diversity and healthy aging, its enterprise benefit-risk communications and its worldwide compassionate access program. Prior to January 2019, Dr. Lewis-Hall served as Pfizer’s Chief Medical Officer from 2009 to January 2019. Prior to joining Pfizer in 2009, Dr. Lewis-Hall held various senior leadership positions including Chief Medical Officer and Executive Vice President, Medicines Development at Vertex Pharmaceuticals Incorporated from June 2008 to May 2009, Senior Vice President, U.S. Pharmaceuticals, Medical Affairs for Bristol-Myers Squibb Company from 2003 until May 2008, and Product Team Leader at Pharmacia and Eli Lilly and Company from 1998 to 2002. Dr. Lewis-Hall holds an M.D. from Howard University Hospital and College of Medicine and a B.A. in natural sciences from Johns Hopkins University. We believe Dr. Lewis-Hall is qualified to serve on our board of directors based on her expertise and experience in the biopharmaceutical industry and her leadership experience as a senior executive at various biopharmaceutical companies.
Deval L. Patrick, J.D., has served as a member of our board of directors since August 2017. In April 2015, Mr. Patrick joined Bain Capital Double Impact, LP where he serves as managing director. From January 2007 to January 2015, Mr. Patrick served as the governor of Massachusetts. Prior to his tenure in government, from 2000 to 2004, Mr. Patrick served as the Executive Vice President and General Counsel at The Coca-Cola Company. Prior to that, he served as Vice President and General Counsel at Texaco Inc., from 1998 to 1999. Mr. Patrick has served on the board of directors of Global Blood Therapeutics, Inc. since April 2015 and currently serves on the boards of directors of a number of private companies. He was a partner in two Boston law firms and, from 1994 to 1997, served as the Assistant Attorney General of the United States for Civil Rights in the Department of Justice. Mr. Patrick received an A.B. in English and American Literature from Harvard College and a J.D. from Harvard Law School. Mr. Patrick has indicated that he will resign as a director contingent upon, and effective immediately following, the pricing of this offering.
Jeffrey Schwartz, M.B.A., has served as a member of board of directors since August 2017. Mr. Schwartz currently serves as a managing director of Bain Capital Life Sciences, LP, where he is a founding member. Prior to founding Bain Capital Life Sciences, LP in 2016, he was a leader within the healthcare vertical of Bain Capital Private Equity, LP. Mr. Schwartz has served on the boards of directors of several private companies. Mr. Schwartz holds an M.B.A. from the Wharton School at the University of Pennsylvania, where he was a Palmer Scholar, and holds a B.A. in economics from Yale University. We believe Mr. Schwartz is qualified to serve on our board of directors based on his significant experience investing in and advising healthcare companies.
Stephen Squinto, Ph.D., has served as a member of our board of directors since August 2017 and is currently our acting Head of Research and Development. Dr. Squinto has been an Executive Partner at OrbiMed Advisors LLC since January 2015. Previously, Dr. Squinto co-founded Alexion Pharmaceuticals, Inc. and served as its Executive Vice President and Chief Global Operations Officer from 2012 to January 2015 and as its Global Head of Research and Development from 2007 to 2012. Dr. Squinto also previously served as a member of the board of directors of Arvinas, Inc. from October 2015 to September 2018 and Audentes Therapeutics, Inc. from April 2015 to
January 2018. Dr. Squinto holds a Ph.D. in biochemistry and biophysics and a B.A. in chemistry from Loyola University of Chicago. We believe Dr. Squinto is qualified to serve on our board of directors based on his experience in the biopharmaceutical industry, including his operational experience in drug discovery and development.
Our Board of Directors
Upon effectiveness of the registration statement of which this prospectus forms a part, our board of directors will consist of eight members, all of whom other than Alan Fuhrman is a member pursuant to the board composition provisions of our existing certificate of incorporation and agreements with our stockholders. These board composition provisions will terminate upon the completion of this offering. Upon the termination of these provisions, there will be no further contractual obligations regarding the election of our directors. Contingent upon, and effective immediately following the pricing of this offering, Dr. Gordon and Mr. Patrick will resign from our board of directors and our board will consist of six members. Our nominating and corporate governance committee and our board of directors may therefore consider a broad range of factors relating to the qualifications and background of nominees. Our nominating and corporate governance committee’s and our board of directors’ priority in selecting board members is the identification of persons who will further the interests of our stockholders through their established record of professional accomplishment, the ability to contribute positively to the collaborative culture among board members, knowledge of our business, understanding of the competitive landscape and professional and personal experiences and expertise relevant to our growth strategy. Our directors hold office until their successors have been elected and qualified or until the earlier of their resignation or removal. Our amended and restated certificate of incorporation and amended and restated bylaws that will become effective immediately prior to the completion of this offering also provide that our directors may be removed only for cause by the affirmative vote of the holders of at least two-thirds of the votes that all our stockholders would be entitled to cast in an annual election of directors, and that any vacancy on our board of directors, including a vacancy resulting from an enlargement of our board of directors, may be filled only by vote of a majority of our directors then in office.
Director independence
Our board of directors has determined that all members of the board of directors, except Mr. Islam and Dr. Squinto, are independent directors, including for purposes of the rules of the Nasdaq Global Market, or Nasdaq and the Securities and Exchange Commission, or SEC. In making such independence determination, our board of directors considered the relationships that each non-employee director has with us and all other facts and circumstances that our board of directors deemed relevant in determining their independence, including the beneficial ownership of our capital stock by each non-employee director. In considering the independence of the directors listed above, our board of directors considered the association of our directors with the holders of more than 5% of our common stock. Upon the completion of this offering, we expect that the composition and functioning of our board of directors and each of our committees will comply with all applicable requirements of Nasdaq and the rules and regulations of the SEC. There are no family relationships among any of our directors or executive officers. Mr. Islam is not an independent director because he has served as one of our executive officers within the last three years and Dr. Squinto is not independent because he has served as our Acting Head of Research and Development for a period of longer than one year.
Staggered board
In accordance with the terms of our amended and restated certificate of incorporation and amended and restated bylaws that will become effective immediately prior to the completion of
this offering, our board of directors will be divided into three staggered classes of directors and each director will be assigned to one of the three classes. At each annual meeting of the stockholders, a class of directors will be elected for a three-year term to succeed the directors of the same class whose terms are then expiring. The terms of the directors will expire upon the election and qualification of successor directors at the annual meeting of stockholders to be held during the years 2020 for Class I directors, 2021 for Class II directors and 2022 for Class III directors.
•
Our Class I directors will be Saqib Islam and Stephen Squinto;
•
Our Class II directors will be Freda Lewis-Hall and Jeffrey Schwartz; and
•
Our Class III directors will be Alan Fuhrman and Daniel S. Lynch.
Our amended and restated certificate of incorporation and amended and restated bylaws that will become effective immediately prior to the completion of this offering will provide that the number of directors shall be fixed from time to time by a resolution of the majority of our board of directors.
The division of our board of directors into three classes with staggered three-year terms may delay or prevent stockholder efforts to effect a change of our management or a change in control.
Board leadership structure and board’s role in risk oversight
Daniel S. Lynch is the current Chairman of our board of directors and Saqib Islam is our current Chief Executive Officer, hence the roles of Chairman of our board of directors and Chief Executive Officer are separated. We believe that separating these positions allows our Chief Executive Officer to focus on our day-to-day business, while allowing our Chairman to lead the board of directors in its fundamental role of providing advice to and independent oversight of management. Our board of directors recognizes the time, effort and energy that the Chief Executive Officer is required to devote to his position in the current business environment, as well as the commitment required to serve as our Chairman, particularly as the board of directors’ oversight responsibilities continue to grow. While our amended and restated bylaws and corporate governance guidelines do not require that our Chairman and Chief Executive Officer positions be separate, our board of directors believes that having separate positions is the appropriate leadership structure for us at this time and demonstrates our commitment to good corporate governance.
Risk is inherent with every business, and how well a business manages risk can ultimately determine its success. We face a number of risks, including risks relating to our financial condition, development and commercialization activities, operations, strategic direction and intellectual property as more fully discussed in the section entitled “Risk factors” appearing elsewhere in this prospectus. Management is responsible for the day-to-day management of risks we face, while our board of directors, as a whole and through its committees, has responsibility for the oversight of risk management. In its risk oversight role, our board of directors has the responsibility to satisfy itself that the risk management processes designed and implemented by management are adequate and functioning as designed.
The role of the board of directors in overseeing the management of our risks is conducted primarily through committees of the board of directors, as disclosed in the descriptions of each of the committees below and in the charters of each of the committees. The full board of directors (or the appropriate board committee in the case of risks that are under the purview of a particular committee) discusses with management our major risk exposures, their potential impact on us, and the steps we take to manage them. When a board committee is responsible for
evaluating and overseeing the management of a particular risk or risks, the chairman of the relevant committee reports on the discussion to the full board of directors during the committee reports portion of the next board meeting. This enables the board of directors and its committees to coordinate the risk oversight role, particularly with respect to risk interrelationships.
Committees of our Board of Directors
Our board of directors has established an audit committee, a compensation committee and a nominating and corporate governance committee, each of which will operate pursuant to a charter adopted by our board of directors and will be effective upon the effectiveness of the registration statement of which this prospectus forms a part. At such time, the composition and functioning of all of our committees will comply with all applicable requirements of the Sarbanes-Oxley Act of 2002, Nasdaq and SEC rules and regulations.
Audit committee
Effective upon the effectiveness of the registration statement of which this prospectus forms a part, Alan Fuhrman, Daniel S. Lynch and Jeffrey Schwartz will serve on the audit committee, which will be chaired by Mr. Fuhrman. Our board of directors has determined each of Alan Fuhrman and Jeffrey Schwartz is “independent” for audit committee purposes as that term is defined in the rules of the SEC and the applicable Nasdaq rules, and each has sufficient knowledge in financial and auditing matters to serve on the audit committee. Our board of directors has determined that Mr. Schwartz is independent even though he falls outside the “safe harbor” definition set forth in Rule 10A-3(e)(1)(ii) under the Exchange Act because he is a manager of Bain Capital Life Sciences Investors, LLC, which is the general partner of BCSW, L.P., which, owns in excess of 10% of our common stock. Among other things, our board of directors considered Mr. Schwartz’s history of service and the percentage of common stock held by others, and it determined that he is not an “affiliated person” of the Company who would be ineligible to serve on our audit committee. Mr. Lynch is not “independent” for purposes of serving on the audit committee and we are relying on the phase-in schedules set forth in Nasdaq listing rule 5615(b)(1) with respect to Mr. Lynch’s service on the audit committee. Pursuant to the phase-in schedules, we must have all members of the audit committee be independent within one year of listing. Our board of directors has designated each of Messrs. Fuhrman and Schwartz as an “audit committee financial expert,” as defined under the applicable rules of the SEC. The audit committee’s responsibilities include:
•
appointing, approving the compensation of and assessing the independence of our independent registered public accounting firm;
•
pre-approving auditing and permissible non-audit services, and the terms of such services, to be provided by our independent registered public accounting firm;
•
reviewing the overall audit plan with our independent registered public accounting firm and members of management responsible for preparing our financial statements;
•
reviewing and discussing with management and our independent registered public accounting firm our annual and quarterly financial statements and related disclosures as well as critical accounting policies and practices used by us;
•
coordinating the oversight and reviewing the adequacy of our internal control over financial reporting;
•
establishing policies and procedures for the receipt and retention of accounting-related complaints and concerns;
•
recommending based upon the audit committee’s review and discussions with management and our independent registered public accounting firm whether our audited financial statements shall be included in our Annual Report on Form 10-K;
•
monitoring the integrity of our financial statements and our compliance with legal and regulatory requirements as they relate to our financial statements and accounting matters;
•
preparing the audit committee report required by SEC rules to be included in our annual proxy statement;
•
reviewing all related person transactions for potential conflict of interest situations and approving all such transactions; and
•
reviewing quarterly earnings releases.
Compensation committee
Effective upon the effectiveness of the registration statement of which this prospectus forms a part, Daniel S. Lynch, Jeffrey Schwartz and Stephen Squinto will serve on the compensation committee, which will be chaired by Mr. Lynch. Our board of directors has determined that each of Messrs. Lynch and Schwartz is “independent” as defined in the applicable Nasdaq rules for purposes of serving on the compensation committee. Dr. Squinto is not “independent” and we are relying on the phase-in schedules set forth in Nasdaq listing rule 5615(b)(1) with respect to Dr. Squinto’s service on the compensation committee. Pursuant to the phase-in schedules, we must have all members of the compensation committee be independent within one year of listing. The compensation committee’s responsibilities include:
•
annually reviewing and recommending to the board of directors the corporate goals and objectives relevant to the compensation of our Chief Executive Officer;
•
evaluating the performance of our Chief Executive Officer in light of such corporate goals and objectives and based on such evaluation: (i) recommending to the board of directors the cash compensation of our Chief Executive Officer and (ii) recommending grants and awards to our Chief Executive Officer under equity-based plans;
•
reviewing and approving or recommending to the board of directors the cash and equity compensation of our other executive officers;
•
reviewing and establishing our overall management compensation, philosophy and policy;
•
overseeing and administering our compensation and similar plans;
•
evaluating and assessing potential and current compensation advisors in accordance with the independence standards identified in the applicable Nasdaq rules;
•
reviewing and approving our policies and procedures for the grant of equity-based awards;
•
reviewing and recommending to the board of directors the compensation of our directors;
•
preparing the compensation committee report required by SEC rules, if and when required, to be included in our annual proxy statement; and
•
reviewing and approving the retention, termination or compensation of any consulting firm or outside advisor to assist in the evaluation of compensation matters.
Nominating and corporate governance committee
Effective upon the effectiveness of the registration statement of which this prospectus forms a part, Freda Lewis-Hall, Alan Fuhrman and Stephen Squinto will serve on the nominating and corporate governance committee, which will be chaired by Dr. Lewis-Hall. Pursuant to the phase-in schedules, we must have all members of the nominating and corporate governance committee be independent within one year of listing. Our board of directors has determined that Dr. Lewis-Hall and Mr. Fuhrman are “independent” as defined in the applicable Nasdaq rules for purposes of serving on the nominating and corporate governance committee. Dr. Squinto is not “independent” and we are relying on the phase-in schedules set forth in Nasdaq listing rule 5615(b)(1) with respect to Dr. Squinto’s service on the nominating and corporate governance committee. The nominating and corporate governance committee’s responsibilities include:
•
developing and recommending to the board of directors criteria for board and committee membership;
•
establishing procedures for identifying and evaluating board of director candidates, including nominees recommended by stockholders;
•
reviewing the composition of the board of directors to ensure that it is composed of members containing the appropriate skills and expertise to advise us;
•
identifying individuals qualified to become members of the board of directors;
•
recommending to the board of directors the persons to be nominated for election as directors and to each of the board’s committees;
•
developing and recommending to the board of directors a code of business conduct and ethics and a set of corporate governance guidelines; and
•
overseeing the evaluation of our board of directors and management.
Our board of directors may from time to time establish other committees.
Compensation committee interlocks and insider participation
None of the members of our compensation committee has at any time during the prior three years been one of our officers or employees. None of our executive officers currently serves, or in the past fiscal year has served, as a member of the board of directors or compensation committee of any entity that has one or more executive officers serving on our board of directors or compensation committee.
Corporate governance
We have adopted a written code of business conduct and ethics, which will become effective upon the effectiveness of the registration statement of which this prospectus forms a part, that applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. Following the effectiveness of the registration statement of which this prospectus forms a part, a current copy of the code will be posted on the investor relations section of our website, which is located at http://www.springworkstx.com. If we make any substantive amendments to, or grant any waivers from, the code of business conduct and ethics for any officer or director, we will disclose the nature of such amendment or waiver on our website or in a current report on Form 8-K.
Executive Compensation
Executive compensation overview
Historically, our executive compensation program has reflected our continued growth and development-oriented focus. To date, the compensation of our executive officers identified in the 2018 Summary Compensation Table below, who we refer to as our named executive officers, has consisted of a combination of base salary, incentive bonuses and long-term incentive compensation. Our named executive officers who are full-time employees, like all other full-time employees, are eligible to participate in our retirement, health and welfare benefit plans. As we transition from a private company to a publicly traded company, the compensation committee of our board of directors will evaluate our compensation values and philosophy and compensation plans and arrangements as circumstances require. At a minimum, the compensation committee expects to review executive compensation annually with input from a compensation consultant. As part of this review process, we expect the compensation committee to apply our values and philosophy, while considering the compensation levels needed to ensure our executive compensation program remains competitive. We will also review whether we are meeting our retention objectives and the potential cost of replacing a key employee.
2018 summary compensation table
The following table presents information regarding the total compensation awarded to, earned by, and paid to our named executive officers for services rendered to us in all capacities in 2018.
Name and Principal Position
|
|
|
Year
|
|
|
Salary ($)
|
|
|
Non-equity incentive plan compensation ($)(6)
|
|
|
Stock Awards ($)(7)
|
|
|
All Other Compensation ($)
|
|
|
Total ($)
|
|
|
Saqib Islam, J.D. Chief Executive Officer(1)
|
|
|
|
|
2018 |
|
|
|
|
|
406,510 |
|
|
|
|
|
180,000 |
|
|
|
|
|
1,181,322 |
|
|
|
|
|
— |
|
|
|
|
|
1,767,832 |
|
|
|
Daniel S. Lynch
Chairman and Former Interim Chief Executive Officer (2)
|
|
|
|
|
2018 |
|
|
|
|
|
150,000 |
|
|
|
|
|
— |
|
|
|
|
|
309,000 |
|
|
|
|
|
— |
|
|
|
|
|
459,000 |
|
|
|
Jens Renstrup, M.D. Chief Medical Officer(3)
|
|
|
|
|
2018 |
|
|
|
|
|
170,625 |
|
|
|
|
|
51,288 |
|
|
|
|
|
353,882 |
|
|
|
|
|
— |
|
|
|
|
|
575,795 |
|
|
|
|
|
Badreddin Edris, Ph.D. Chief Business Officer(4)
|
|
|
|
|
2018 |
|
|
|
|
|
112,500 |
|
|
|
|
|
33,140 |
|
|
|
|
|
339,900 |
|
|
|
|
|
37,735(8) |
|
|
|
|
|
523,275 |
|
|
|
Lara S. Sullivan, M.D. Former President(5)
|
|
|
|
|
2018 |
|
|
|
|
|
176,458 |
|
|
|
|
|
60,914 |
|
|
|
|
|
703,671 |
|
|
|
|
|
324,809(9) |
|
|
|
|
|
1,265,852 |
|
|
|
(1) Mr. Islam served as Chief Business Officer and Chief Financial Officer from September 1, 2017 until July 30, 2018 and was appointed Chief Executive Officer on July 31, 2018. His base salary increased from $375,000 to $450,000 in 2018.
(2) Mr. Lynch served as Executive Chairman from September 2017 to August 2019, and served as interim Chief Executive Officer from February 1, 2018 until July 30, 2018. In August 2019, Mr. Lynch ceased to serve as our executive chairman, but will continue to serve as the Chairman of our board of directors. See “Executive Compensation—Employment arrangements and severance agreements with our named executive officers” and “Certain relationships and related party transactions—Employment agreement with Daniel Lynch” for further information regarding the termination of Mr. Lynch’s employment arrangements.
(3) Dr. Renstrup commenced employment on July 24, 2018. His annualized base salary for 2018 was $390,000, and the 2018 salary reported reflects the pro rata portion of Dr. Renstrup’s annual salary earned from commencement of his employment through December 31, 2018.
(4) Dr. Edris commenced employment on September 10, 2018. His annualized base salary for 2018 was $360,000, and the 2018 salary reported reflects the pro rata portion of Dr. Edris’ annual salary earned from commencement of his employment through December 31, 2018.
(5) Dr. Sullivan’s employment terminated in June 2018. The 2018 salary reflects Dr. Sullivan’s base salary earned as our President through that date. In connection with the termination of her employment, we entered into a separation agreement with Dr. Sullivan pursuant to which we agreed to provide Dr. Sullivan with the following payments and benefits: (i) nine months of base salary continuation, (ii) the same portion of premiums that we pay for active employees for the same level of group medical coverage as in effect for her prior to her termination of employment for up to nine months following termination, (iii) attorney’s fees of up to $7,500 relating to the completion of her separation agreement, (iv) up to $21,000 for executive coaching services and (v) accelerated vesting of 165,884 incentive units held by Dr. Sullivan as of the date of termination, which such amounts are reflected in the “All other compensation” column.
(6) The amounts reported represent bonuses awarded based upon 100% achievement of corporate performance objectives for the year ended December 31, 2018, which were paid in March 2019. Bonus payments were pro-rated to reflect each named executive officer’s start date.
(7) The amounts reported represent the aggregate grant-date fair value of incentive unit awards of our predecessor granted in 2018, calculated in accordance with Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 718. Such grant-date fair value does not take into account any estimated forfeitures related to service-vesting conditions. In addition, the amount reported for Dr. Sullivan includes the incremental fair value of $240,171 associated with the acceleration of vesting of 165,884 incentive units, calculated in accordance with FASB ASC Topic 718. The assumptions used in calculating the grant-date fair value are set forth in Note 3 of our notes to consolidated financial statements included elsewhere in this prospectus. In March 2019, in connection with the Reorganization, incentive unit awards were exchanged for an equal number of shares of restricted stock or vested common stock, as applicable, under the Company’s 2019 Stock Option and Incentive Plan, or the 2019 Stock Plan.
(8) The amount reported represents commuting expense reimbursements.
(9) The amount reported represents (i) the following amounts payable to Dr. Sullivan pursuant to the terms of her separation agreement with us: (A) $288,750 in cash severance payments, (B) $6,934 for nine months of premiums of medical coverage, (C) $7,500 in attorney’s fees related to the completion of her separation agreement and (D) $12,000 for executive coaching services, and (ii) $9,625 in accrued but unused vacation paid upon the termination of her employment.
Employment arrangements with our named and other executive officers
We have entered into offer letters and severance agreements with each of our named executive officers and other executive officers who are our current employees, which are described below. In connection with this offering, we intend to enter into employment agreements with these named executive officers that will become effective upon the closing of this offering and will provide for specified payments and benefits in connection with a termination of employment in certain circumstances. Our goal in providing these severance and change in control payments and benefits is to offer sufficient cash continuity protection such that the named executive officers who are our employees will focus their full time and attention on the requirements of the business rather than the potential implications for their respective positions. We prefer to have certainty regarding the potential severance amounts payable to the named executive officers, rather than negotiating severance at the time that a named executive officer’s employment terminates. We have also determined that accelerated vesting provisions with respect to outstanding equity awards in connection with a qualifying termination of employment in certain circumstances are appropriate because they encourage our named executive officers to stay focused on the business in those circumstances, rather than focusing on the potential implications for them personally. The employment agreements with our named executive officers require the named executive officers to execute a separation agreement containing a general release of claims in favor of us to receive any severance payments and benefits.
Saqib Islam
Under the offer letter with Mr. Islam, he serves as our Chief Executive Officer on an at-will basis. Mr. Islam currently receives a base salary of $465,750 per year, which is subject to periodic review and adjustment. Mr. Islam is also eligible for an annual performance bonus targeted at 40% of his base salary and is eligible to participate in the employee benefit plans generally available to our employees, subject to the terms of those plans.
The severance agreement with Mr. Islam, or the Islam Severance Agreement, provides that if his employment is terminated by us without Cause (as defined in the Islam Severance Agreement) or
Mr. Islam resigns for Good Reason (as defined in the Islam Severance Agreement), subject to Mr. Islam signing of a separation agreement, containing, among other things, a general release of claims in favor of the Company, he will be entitled to receive: (i) base salary continuation for 12 months following termination, (ii) a pro-rata payment of his target annual bonus and, (iii) if Mr. Islam is enrolled in our group health plan immediately prior to the date of termination and properly elects and remains eligible to receive the Consolidated Omnibus Budget Reconciliation Act, or COBRA, benefits, a monthly cash payment for 12 months or Mr. Islam’s COBRA health continuation period, whichever ends earlier, in an amount equal to our normal rate of contribution for employees for coverage at the level in effect immediately prior to the date of termination. Payment of the base salary continuation and pro-rated bonus described in clauses (i) and (ii) of the preceding sentence shall immediately cease if Mr. Islam breaches the terms of the restrictive covenants agreement between him and us. In addition, if such termination occurs within seven to 18 months following July 31, 2018, the equity award granted to Mr. Islam in July 2018 will accelerate and become vested as to the portion that would have been vested if Mr. Islam had remained employed through January 31, 2020.
In lieu of the severance payments and benefits set forth above, in the event Mr. Islam’s employment is terminated by us without Cause or he resigns for Good Reason, in either case within 18 months following a Change in Control (as defined in the Islam Severance Agreement), and subject to the signing of a separation agreement, containing, among other thing, a general release of claims in favor of the Company, he will be entitled to receive: (i) an amount equal to 12 months of his base salary, (ii) a pro-rata payment of his target annual bonus, (iii) if Mr. Islam is enrolled in our group health plan immediately prior to the date of termination and properly elects to receive COBRA benefits, a monthly cash payment for 12 months or Mr. Islam’s COBRA health continuation period, whichever ends earlier, in an amount equal to our normal rate of contribution for employees for coverage at the level in effect immediately prior to the date of termination, and (iv) 12 months of accelerated vesting of his time-based equity awards.
Jens Renstrup
Under the offer letter with Dr. Renstrup, he serves as our Chief Medical Officer on an at-will basis. Dr. Renstrup currently receives a base salary of $403,650 per year, which is subject to periodic review and adjustment. Dr. Renstrup is also eligible for an annual performance bonus targeted at 30% of his base salary and is eligible to participate in the employee benefit plans generally available to our employees, subject to the terms of those plans.
The severance agreement with Dr. Renstrup, or the Renstrup Severance Agreement, provides that if his employment is terminated by us without Cause (as defined in the Renstrup Severance Agreement) or Dr. Renstrup resigns for Good Reason (as defined in the Renstrup Severance Agreement), subject to the signing of a separation agreement, containing, among other things, a general release of claims in favor of the Company, he will be entitled to receive: (i) base salary continuation for nine months following termination, (ii) a pro-rata payment of his target annual bonus, and (iii) if Dr. Renstrup is enrolled in our group health plan immediately prior to the date of termination and properly elects and remains eligible to receive COBRA benefits, a monthly cash payment for nine months or Dr. Renstrup’s COBRA health continuation period, whichever ends earlier, in an amount equal to our normal rate of contribution for employees for coverage at the level in effect immediately prior to the date of termination. Payment of the base salary continuation and pro-rated bonus described in clauses (i) and (ii) of the preceding sentence shall immediately cease if Dr. Renstrup breaches the terms of the restrictive covenants set forth in the Renstrup Severance Agreement. In addition, if such termination occurs within seven to 18 months following July 16, 2018, the equity award granted to Dr. Renstrup will accelerate and become vested as to the portion that would have been vested if Dr. Renstrup had remained employed through January 16, 2020.
In lieu of the severance payments and benefits set forth above, in the event that Dr. Renstrup’s employment is terminated by us without Cause or he resigns for Good Reason, in either case within 18 months following a Change in Control (as defined in the Renstrup Severance Agreement), and subject to the signing of a separation agreement, containing, among other things, a general release of claims in favor of the Company, he will be entitled to receive: (i) an amount equal to nine months of his base salary, (ii) a pro-rata payment of his target annual bonus, (iii) except as otherwise provided in the applicable option or stock-based award agreement, accelerated vesting of 100% of all unvested stock options and other stock-based awards held by Dr. Renstrup, and (iv) if Dr. Renstrup is enrolled in our group health plan immediately prior to the date of termination and properly elects to receive COBRA benefits, a monthly cash payment for nine months or Dr. Renstrup’s COBRA health continuation period, whichever ends earlier, in an amount equal to our normal rate of contribution for employees for coverage at the level in effect immediately prior to the date of termination.
Badreddin Edris
Under the offer letter with Dr. Edris, he serves as our Chief Business Officer on an at-will basis. Dr. Edris currently receives a base salary of $372,600 per year, which is subject to periodic review and adjustment. Dr. Edris is also eligible for an annual performance bonus targeted at 30% of his base salary and is eligible to participate in the employee benefit plans generally available to our employees, subject to the terms of those plans.
The severance agreement with Dr. Edris, or the Edris Severance Agreement, provides that if his employment is terminated by us without Cause (as defined in the Edris Severance Agreement) or Dr. Edris resigns for Good Reason (as defined in the Edris Severance Agreement), subject to the signing of a separation agreement, containing, among other things, a general release of claims in favor of the Company, he will be entitled to receive: (i) base salary continuation for nine months following termination, (ii) a pro-rata payment of his target annual bonus, and (iii) if Dr. Edris is enrolled in our group health plan immediately prior to the date of termination and properly elects and remains eligible to receive COBRA benefits, a monthly cash payment for nine months or Dr. Edris’ COBRA health continuation period, whichever ends earlier, in an amount equal to our normal rate of contribution for employees for coverage at the level in effect immediately prior to the date of termination. Payment of the base salary continuation and pro-rated bonus described in clauses (i) and (ii) of the preceding sentence shall immediately cease if Dr. Edris breaches the terms of the restrictive covenants set forth in the Edris Severance Agreement. In addition, if such termination occurs within seven to 18 months following September 10, 2018, the equity award granted to Dr. Edris will accelerate and become vested as to the portion that would have been vested if Dr. Edris had remained employed through March 10, 2020.
In lieu of the severance payments and benefits set forth above, in the event that Dr. Edris’ employment is terminated by us without Cause or he resigns for Good Reason, in either case within 18 months following a Change in Control (as defined in the Edris Severance Agreement), and subject to the signing of a separation agreement, containing, among other things, a general release of claims in favor of the Company, he will be entitled to receive: (i) an amount equal to nine months of his base salary, (ii) a pro-rata payment of his target annual bonus, (iii) except as otherwise provided in the applicable option or stock-based award agreement, accelerated vesting of 100% of all unvested stock options and other stock-based awards held by Dr. Edris, and (iv) if Dr. Edris is enrolled in our group health plan immediately prior to the date of termination and properly elects to receive COBRA benefits, a monthly cash payment for nine months or Dr. Edris’ COBRA health continuation period, whichever ends earlier, in an amount equal to our normal rate of contribution for employees for coverage at the level in effect immediately prior to the date of termination.
Frank Perier
Under the offer letter with Mr. Perier, he serves as our Chief Financial Officer on an at-will basis. Mr. Perier currently receives a base salary of $370,000 per year, which is subject to periodic review and adjustment. Mr. Perier is also eligible for an annual performance bonus targeted at 35% of his base salary, which we have guaranteed for the year 2019, prorated based on the portion of 2019 during which he is employed with us. Mr. Perier is also eligible to participate in the employee benefit plans generally available to our employees, subject to the terms of those plans.
The severance agreement with Mr. Perier, or the Perier Severance Agreement, provides that if his employment is terminated by us without Cause (as defined in the Perier Severance Agreement) or Mr. Perier resigns for Good Reason (as defined in the Perier Severance Agreement), subject to the signing of a separation agreement, containing, among other things, a general release of claims in favor of the Company, he will be entitled to receive: (i) base salary continuation for nine months following termination, (ii) a pro-rata payment of his target annual bonus, and (iii) if Mr. Perier is enrolled in our group health plan immediately prior to the date of termination and properly elects and remains eligible to receive COBRA benefits, a monthly cash payment for nine months or Mr. Perier’s COBRA health continuation period, whichever ends earlier, in an amount equal to our normal rate of contribution for employees for coverage at the level in effect immediately prior to the date of termination. Payment of the base salary continuation and pro-rated bonus described in clauses (i) and (ii) of the preceding sentence shall immediately cease if Mr. Perier breaches the terms of the restrictive covenants set forth in the Perier Severance Agreement.
In addition, if (i) such termination occurs within six months following August 15, 2019, the equity award granted to Mr. Perier shall be subject to 12-month vesting from August 15, 2019, from August 15, 2019 (without regard to the actual period of time Mr. Perier provided services to the Company); (ii) such termination occurs within seven to 12 months following August 15, 2019, the equity award granted to Mr. Perier shall be subject to 18-month vesting from August 15, 2019 (without regard to the actual period of time Mr. Perier provided services to the Company); and (iii) such termination occurs 19 months or later after August 15, 2019, the equity award granted to Mr. Perier shall be subject to vesting equal to the number of months that have elapsed from the August 15, 2019 to the date of termination Trigger Event (without regard to the actual period of time Mr. Perier provided services to the Company).
In lieu of the severance payments and benefits set forth above, in the event that Mr. Perier’s employment is terminated by us without Cause or he resigns for Good Reason, in either case within 18 months following a Change in Control (as defined in the Perier Severance Agreement), and subject to the signing of a separation agreement, containing, among other things, a general release of claims in favor of the Company, he will be entitled to receive: (i) an amount equal to nine months of his base salary, (ii) a pro-rata payment of his target annual bonus, (iii) except as otherwise provided in the applicable option or stock-based award agreement, accelerated vesting of 100% of all unvested stock options and other stock-based awards held by Mr. Perier, and (iv) if Mr. Perier is enrolled in our group health plan immediately prior to the date of termination and properly elects to receive COBRA benefits, a monthly cash payment for nine months or Mr. Perier’s COBRA health continuation period, whichever ends earlier, in an amount equal to our normal rate of contribution for employees for coverage at the level in effect immediately prior to the date of termination.
Other agreements
We have also entered into employee confidentiality, inventions, non-solicitation and non-competition agreements with each of our named executive officers. Under such agreements, each named executive officer has agreed (i) not to compete with us during his or her
employment and for a period of one year after the termination of such employment, (ii) not to solicit our employees during his or her employment and for a period of one year after the termination of such employment, (iii) to protect our confidential and proprietary information and (iv) to assign to us related intellectual property developed during the course of his or her employment.
Outstanding equity awards at 2018 fiscal year-end
The following table sets forth information concerning outstanding equity awards held by each of our named executive officers as of December 31, 2018.
|
|
|
Stock Awards(1)
|
|
Name
|
|
|
Number of shares or units of stock that have not vested (#)
|
|
|
Market value of shares or units of stock that have not vested ($)(2)
|
|
Saqib Islam, J.D.
|
|
|
|
|
276,304(3) |
|
|
|
|
|
400,039 |
|
|
|
|
|
|
|
629,185(4) |
|
|
|
|
|
910,947 |
|
|
Daniel S. Lynch
|
|
|
|
|
310,743(5) |
|
|
|
|
|
449,899 |
|
|
|
|
|
Stock Awards(1)
|
|
Name
|
|
|
Number of shares or units of stock that have not vested (#)
|
|
|
Market value of shares or units of stock that have not vested ($)(2)
|
|
Jens Renstrup, M.D.
|
|
|
|
|
244,424(6) |
|
|
|
|
|
353,882 |
|
|
Badreddin Edris, Ph.D.
|
|
|
|
|
234,766(7) |
|
|
|
|
|
339,899 |
|
|
Lara S. Sullivan, M.D.
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
(1) The awards set forth in the table represent incentive units granted under our predecessor’s 2018 Equity Incentive Plan. In connection with the Reorganization, these incentive units were exchanged for an equivalent number of shares of our restricted stock under the 2019 Stock Plan. The vesting terms applicable to the incentive unit awards apply to the restricted stock awards for which the incentive unit awards were substituted.
(2) Represents the market value of the restricted stock award as of December 31, 2018, based on an assumed fair market value of our common units of $1.45 per unit on December 31, 2018.
(3) These incentive units were (and the substituted restricted stock award is) subject to the following vesting schedule: 25% on September 1, 2018, and the remainder in equal monthly installments through the fourth anniversary thereafter, subject to continued service through the applicable vesting date.
(4) These incentive units were (and the substituted restricted stock award is) subject to the following vesting schedule: 25% on July 31, 2019, then in equal monthly installments through the fourth anniversary thereafter, subject to continued service through the applicable vesting date.
(5) These incentive units were (and the substituted restricted stock award is) subject to the following vesting schedule: 25% on August 18, 2018, then in equal monthly installments through the fourth anniversary thereafter, subject to continued service through the applicable vesting date.
(6) These incentive units were (and the substituted restricted stock award is) subject to the following vesting schedule: 25% on July 16, 2019, then in equal monthly installments through the fourth anniversary thereafter, subject to continued service through the applicable vesting date.
(7) These incentive units were (and the substituted restricted stock award is) subject to the following vesting schedule: 25% on September 10, 2019, then in equal monthly installments through the fourth anniversary thereafter, subject to continued service through the applicable vesting date.
Compensation risk assessment
We believe that although a portion of the compensation provided to our executive officers and other employees is performance-based, our executive compensation program does not encourage
excessive or unnecessary risk taking. This is primarily due to the fact that our compensation programs are designed to encourage our executive officers and other employees to remain focused on both short-term and long-term strategic goals, in particular in connection with our pay-for-performance compensation philosophy. As a result, we do not believe that our compensation programs are reasonably likely to have a material adverse effect on us.
Employee benefit and equity compensation plans
2019 Stock Option and Incentive Plan
Our 2019 Stock Plan was approved by our board of directors and our stockholders on March 29, 2019. Under our 2019 Stock Plan, we have reserved for issuance an aggregate of 6,700,197 shares of our common stock, which number is subject to adjustment in the event of a reorganization, recapitalization, stock dividend, stock split or other similar change in our capital stock.
The shares we issue under our 2019 Stock Plan are authorized but unissued shares or shares we reacquire. The shares of common stock underlying any awards that are forfeited, cancelled, reacquired by us prior to vesting, satisfied without the issuance of common stock or otherwise terminated (other than by exercise) under our 2019 Stock Plan are currently added to the shares of common stock available for issuance under our 2019 Stock Plan. Following this offering, such shares will be added to the shares available under our 2019 Equity Plan.
Our compensation committee has acted as administrator of our 2019 Stock Plan. The administrator has full power to select, from among the individuals eligible for awards, the individuals to whom awards will be granted, and to determine the specific terms and conditions of each award, subject to the provisions of our 2019 Stock Plan. Persons eligible to participate in our 2019 Stock Plan are our full or part time officers, employees, directors, consultants and other key persons as selected from time to time by the administrator in its discretion.
Our 2019 Stock Plan permits the granting of (1) options to purchase common stock intended to qualify as incentive stock options under Section 422 of the Code and (2) options that do not so qualify. The option exercise price of each option is determined by the administrator but may not be less than 100% of the fair market value of the common stock on the date of grant. The term of each option is fixed by the administrator and may not exceed ten years from the date of grant. The administrator determines at what time or times each option may be exercised. In addition, our 2019 Stock Plan permits the granting of restricted shares of common stock, restricted stock units and unrestricted stock.
Our 2019 Stock Plan provides that upon the occurrence of a “sale event,” as defined in our 2019 Stock Plan, all outstanding stock options will terminate at the effective time of such sale event, unless the parties to the sale event agree that such awards will be assumed or continued by the successor entity. In the event of a termination of our 2019 Stock Plan and all options issued thereunder in connection with a sale event, optionees will be provided an opportunity to exercise options that are then exercisable or will become exercisable as of the effective time of the sale event prior to the consummation of the sale event. In addition, we have the right to provide for cash payment to holders of options, in exchange for the cancellation thereof, in an amount per share equal to the difference between the value of the consideration payable per share of common stock in the sale event and the per share exercise price of such options. In the event of and subject to the consummation of a sale event, restricted stock and restricted stock units (other than those becoming vested as a result of the sale event) will be forfeited immediately prior to the effective time of a sale event unless such awards are assumed or continued by the successor entity. In the event that shares of restricted stock are forfeited in connection with a sale event, such shares of restricted stock shall be repurchased at a price per share equal to the lower of the
original per share purchase price and the fair market value of such shares. We have the right to provide for cash payment to holders of restricted stock or restricted stock units, in exchange for the cancellation thereof, in an amount per share equal to the value of the consideration payable per share of common stock in the sale event.
Our board of directors may amend the 2019 Stock Plan but no such action may adversely affect the rights of an award holder without such holder’s consent. Approval by our stockholders of amendments to the 2019 Plan must be obtained if required by law.
No awards may be granted under our 2019 Stock Plan after the date that is ten years from the date our 2019 Stock Plan was adopted by the board of directors. Our board of directors has determined not to make any further awards under our 2019 Equity Plan following the closing of this offering.
2019 Equity Incentive Plan
Our 2019 Equity Incentive Plan, or our 2019 Equity Plan, was adopted by our board of directors in August 2019, approved by our stockholders in August 2019 and will become effective upon the effectiveness of the registration statement of which this prospectus forms a part declared effective by the SEC. Our 2019 Equity Plan will replace our 2019 Stock Plan as our board of directors has determined not to make additional awards under that plan following the consummation of our initial public offering. Our 2019 Equity Plan allows us to make equity-based incentive awards to our officers, employees, directors and consultants.
We have initially reserved 3,537,225 shares of our common stock, or the Initial Limit, for the issuance of awards under our 2019 Equity Plan (which includes 783,034 unused shares reserved for issuance under our 2019 Stock Plan that will become available under our 2019 Equity upon the completion of this offering). This limit is subject to adjustment in the event of a stock split, stock dividend or other change in our capitalization. Our 2019 Equity Plan provides that the number of shares reserved and available for issuance thereunder will automatically increase on January 1, 2020 and each January 1 thereafter by 5% of the number of shares of common stock outstanding on the immediately preceding December 31 or such lesser number of shares determined by the compensation committee, or the Annual Increase.
The shares we issue under our 2019 Equity Plan will be authorized but unissued shares or shares that we reacquire. The shares of common stock underlying any awards that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by us prior to vesting, satisfied without the issuance of stock, expire or are otherwise terminated (other than by exercise) under our 2019 Equity Plan and our 2019 Stock Plan will be added back to the shares of common stock available for issuance under our 2019 Equity Plan.
The maximum number of shares that may be issued as incentive stock options may not exceed the Initial Limit, cumulatively increased on January 1, 2020 and on each January 1 thereafter by the lesser of the Annual Increase, or 3,537,225 shares. The grant date fair value of all awards made under our 2019 Equity Plan and all other cash compensation paid by us to any non-employee director in any calendar year shall not exceed $500,000; provided, however, that such amount shall be $1,000,000 for the calendar year in which the applicable non-employee director is initially elected or appointed to the board.
Our 2019 Equity Plan will be administered by our compensation committee. Our compensation committee has full power to select, from among the individuals eligible for awards, the individuals to whom awards will be granted, to make any combination of awards to participants, and to determine the specific terms and conditions of each award, subject to the provisions of
our 2019 Equity Plan. Persons eligible to participate in our 2019 Equity Plan will be those full or part-time officers, employees, non-employee directors, and consultants as selected from time to time by our compensation committee in its discretion.
Our 2019 Equity Plan permits the granting of both options to purchase common stock intended to qualify as incentive stock options under Section 422 of the Code and options that do not so qualify. The exercise price of each option will be determined by our compensation committee but may not be less than 100% of the fair market value of our common stock on the date of grant. The term of each option will be fixed by our compensation committee and may not exceed ten years from the date of grant. Our compensation committee will determine at what time or times each option may be exercised.
Our compensation committee may award stock appreciation rights subject to such conditions and restrictions as it may determine. Stock appreciation rights entitle the recipient to cash or shares of common stock equal to the value of the appreciation in our stock price over the exercise price. The exercise price may not be less than 100% of the fair market value of our common stock on the date of grant. The term of each stock appreciation right will be fixed by our compensation committee and may not exceed ten years from the date of grant. Our compensation committee will determine at what time or times each stock appreciation right may be exercised.
Our compensation committee may award restricted shares of common stock and restricted stock units to participants subject to such conditions and restrictions as it may determine. These conditions and restrictions may include the achievement of certain performance goals and/or continued employment with us through a specified vesting period. Our compensation committee may also grant shares of common stock that are free from any restrictions under our 2019 Equity Plan. Unrestricted stock may be granted to participants in recognition of past services or for other valid consideration and may be issued in lieu of cash compensation due to such participant.
Our compensation committee may grant cash bonuses under our 2019 Equity Plan to participants, subject to the achievement of certain performance goals.
Our 2019 Equity Plan provides that upon the effectiveness of a “sale event,” as defined in our 2019 Equity Plan, an acquirer or successor entity may assume, continue or substitute outstanding awards under our 2019 Equity Plan. To the extent that awards granted under our 2019 Equity Plan are not assumed or continued or substituted by the successor entity, except as may be otherwise provided in the relevant award certificate, all awards with time-based vesting, conditions or restrictions shall become fully vested and nonforfeitable as of the effective time of the sale event, and all awards with conditions and restrictions relating to the attainment of performance goals may become vested and nonforfeitable in connection with a sale event in the compensation committee’s discretion or to the extent specified in the relevant award certificate. Upon the effective time of the sale event, all outstanding awards granted under our 2019 Equity Plan shall terminate. In the event of such termination, individuals holding options and stock appreciation rights will be permitted to exercise such options and stock appreciation rights (to the extent exercisable) within a specified period of time prior to the sale event. In addition, in connection with the termination of our 2019 Equity Plan upon a sale event, we may make or provide for a payment, in cash or in kind, to participants holding vested and exercisable options and stock appreciation rights equal to the difference between the per share cash consideration payable to stockholders in the sale event and the exercise price of the options or stock appreciation rights and we may make or provide for a payment, in cash or in kind, to participants holding other vested awards.
Our board of directors may amend or discontinue our 2019 Equity Plan and our compensation committee may amend or cancel outstanding awards for purposes of satisfying changes in law or any other lawful purpose, but no such action may adversely affect rights under an award without the holder’s consent. Certain amendments to our 2019 Equity Plan require the approval of our stockholders.
No awards may be granted under our 2019 Equity Plan after the date that is ten years from the effective date of our 2019 Equity Plan. No awards under our 2019 Equity Plan have been made prior to the date hereof.
2019 Employee Stock Purchase Plan
Our 2019 Employee Stock Purchase Plan, or our ESPP, was adopted by our board in August 2019, approved by our stockholders in August 2019 and will become effective upon the effectiveness of registration statement of which this prospectus forms a part. Our ESPP initially reserves and authorizes the issuance of up to a total of 442,153 shares of common stock to participating employees. Our ESPP provides that the number of shares reserved and available for issuance will automatically increase on each January 1, beginning on January 1, 2020 and ending on January 1, 2029, by the least of (i) 663,229 shares of common stock, (ii) 1% of the outstanding shares of common stock on the immediately preceding December 31 or (iii) such lesser number of shares as determined by the administrator of our ESPP. This number is subject to adjustment in the event of a stock split, stock dividend or other change in our capitalization.
All employees are eligible to participate in our ESPP. Any employee who owns five percent or more of the voting power or value of our shares of common stock is not eligible to purchase shares under our ESPP.
We may make one or more offerings each year to our employees to purchase shares under our ESPP. Offerings will usually begin on each May 1 and November 1 and will continue for six-month periods, referred to as offering periods. Each eligible employee may elect to participate in any offering by submitting an enrollment form at least 15 days before the relevant offering date.
Each employee who is a participant in our ESPP may purchase shares by authorizing payroll deductions of up to 15% of his or her eligible compensation during an offering period. Unless the participating employee has previously withdrawn from the offering, his or her accumulated payroll deductions will be used to purchase shares of common stock on the last business day of the offering period at a price equal to 85% of the fair market value of the shares on the first business day or the last business day of the offering period, whichever is lower, provided that no more than the lowest of (i) a number of shares of common stock determined by dividing such employee's accumulated payroll deductions on such date by the Option Price, (ii) the number of shares determined by dividing $25,000 by the fair market value of the common stock on such date or (iii) such other lesser maximum number of shares determined by the administrator in advance of the offering may be purchased by any one employee during each offering period. Under applicable tax rules, an employee may purchase no more than $25,000 worth of shares of common stock, valued at the start of the purchase period, under our ESPP in any calendar year.
The accumulated payroll deductions of any employee who is not a participant on the last day of an offering period will be refunded. An employee’s rights under our ESPP terminate upon voluntary withdrawal from the plan or when the employee ceases employment with us for any reason.
Our ESPP may be terminated or amended by our board at any time. An amendment that increases the number of shares of common stock authorized under our ESPP and certain other amendments require the approval of our stockholders.
Senior Executive Cash Incentive Bonus Plan
On August 7, 2019, our board adopted the Senior Executive Cash Incentive Bonus Plan, or the Bonus Plan, which will become effective upon the effectiveness of the registration statement of which this prospectus forms a part. Our Bonus Plan provides for bonus payments based upon the attainment of performance targets established by our compensation committee. The payment targets will be related to financial and operational measures or objectives with respect to our company, or the Corporate Performance Goals, as well as individual performance objectives.
Our compensation committee may select corporate performance goals (as defined in the Bonus Plan) including, but not limited to the following: cash flow (including, but not limited to, operating cash flow and free cash flow); revenue; corporate revenue; earnings before interest, taxes, depreciation and amortization; net income (loss) (either before or after interest, taxes, depreciation and/or amortization); changes in the market price of our common stock; economic value-added; development, clinical, regulatory or commercial milestones; acquisitions or strategic transactions; operating income (loss); return on capital, assets, equity, or investment; stockholder returns; return on sales; gross or net profit levels; productivity; expense efficiency; margins; operating efficiency; customer satisfaction; working capital; earnings (loss) per share of our common stock; bookings, new bookings or renewals; sales or market shares; number of customers; number of new customers or customer references; operating income and/or net annual recurring revenue, any of which may be measured in absolute terms, as compared to any incremental increase, in terms of growth, as compared to results of a peer group, against the market as a whole, compared to applicable market indices and/or measured on a pre-tax or post-tax basis.
Each executive officer who is selected to participate in our Bonus Plan will have a target bonus opportunity set for each performance period. The bonus formulas will be adopted in each performance period by the compensation committee and communicated to each executive officer. The Corporate Performance Goals will be measured at the end of each performance period after our financial reports have been published. If the Corporate Performance Goals and individual performance objectives are met, payments will be made as soon as practicable following the end of each performance period. Subject to the rights contained in any agreement between the executive officer and us, an executive officer must be employed by us on the bonus payment date to be eligible to receive a bonus payment. Our Bonus Plan also permits the compensation committee to approve additional bonuses to executive officers in its sole discretion.
401(k) Plan
We maintain a tax-qualified retirement plan, or the 401(k) Plan, that provides eligible U.S. employees with an opportunity to save for retirement on a tax advantaged basis. Eligible employees are able to defer eligible compensation subject to applicable annual Code limits. Employees’ pre-tax or Roth contributions are allocated to each participant’s individual account and are then invested in selected investment alternatives according to the participants’ directions. Employees are immediately and fully vested in their contributions. Our 401(k) Plan is intended to be qualified under Section 401(a) of the Code with our 401(k) Plan’s related trust intended to be tax exempt under Section 501(a) of the Code. As a tax-qualified retirement plan, contributions to our 401(k) Plan and earnings on those contributions are not taxable to the employees until distributed from our 401(k) Plan.
Director Compensation
The following table presents the total compensation for each person who served as a non-employee member of our board of directors during the year ended December 31, 2018. Other than as set forth in the table and described more fully below, we did not pay any compensation, make any equity awards or non-equity awards to, or pay any other compensation to any of the non-employee members of our board of directors in 2018. The compensation received by Mr. Islam, our Chief Executive Officer, and Mr. Lynch, our Chairman and former interim Chief Executive Officer, for their service in their respective roles during 2018 is presented above in the “2018 summary compensation table” above.
Name(1)
|
|
|
Fees Paid or Earned in Cash ($)
|
|
|
All Other Compensation ($)
|
|
|
Total ($)
|
|
Carl L. Gordon, Ph.D., CFA
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Peter Keen(2)
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Freda Lewis-Hall, M.D., DFAPA
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Deval Patrick, J.D.
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Jeffrey Schwartz, M.B.A.
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Stephen Squinto, Ph.D.(3)
|
|
|
|
|
20,000 |
|
|
|
|
|
80,000 |
|
|
|
|
|
100,000 |
|
|
(1) As of December 31, 2018, Dr. Squinto held 116,528 unvested incentive units. None of the other non-employee directors held outstanding equity awards as of December 31, 2018.
(2) Mr. Keen resigned from our board of directors in August 2019.
(3) Dr. Squinto received $20,000 per year for his services as a member of the board of directors and $80,000 per year for his services as acting head of research and development.
Non-employee director compensation policy
In connection with this offering, our board of directors adopted a non-employee director compensation policy, to be effective upon effectiveness of the registration statement of which this prospectus forms a part, that is designed to enable us to attract and retain, on a long-term basis, highly qualified non-employee directors. Under the policy, each director who is not an employee will be paid cash compensation from and after the completion of this offering, as set forth below:
|
|
|
Member annual fee
|
|
|
Chairman additional annual fee
|
|
Board of directors
|
|
|
|
$ |
35,000 |
|
|
|
|
$ |
65,000 |
|
|
Audit committee
|
|
|
|
|
7,500 |
|
|
|
|
|
15,000 |
|
|
Compensation committee
|
|
|
|
|
5,000 |
|
|
|
|
|
10,000 |
|
|
Nominating and corporate governance committee
|
|
|
|
|
4,000 |
|
|
|
|
|
8,000 |
|
|
In addition, subject to board discretion, upon initial election or appointment each non-employee director will receive an option to purchase that number of shares that has a value equivalent to $336,819, with value determined in accordance with the reasonable assumptions and methodologies for calculating the fair value of options under ASC 718 on the date of such director’s election or appointment to the board of directors, which will vest annually over three years, subject to continued service through such vesting dates. On the date of each annual meeting of stockholders of our company, each non-employee director will also receive an option to purchase that number of shares that has a value equivalent to $168,410, with value
determined in accordance with the reasonable assumptions and methodologies for calculating the fair value of options under ASC 718, which will vest in full of the earlier to occur of the first anniversary of the date of grant or the next annual meeting, subject to continued service as a director through such vesting date.
Certain Relationships and Related Party Transactions
Other than the compensation agreements and other arrangements described under “Executive compensation” and “Director compensation” in this prospectus and the transactions described below, since our inception on August 18, 2017, there has not been and there is not currently proposed, any transaction or series of similar transactions to which:
•
we were, or will be, a participant;
•
the amount involved exceeded, or will exceed, $120,000; and
•
in which any director, executive officer, holder of 5% or more of any class of our capital stock or any member of the immediate family of, or entities affiliated with, any of the foregoing persons, had, or will have, a direct or indirect material interest.
License Agreements with Pfizer
On August 18, 2017, we entered into license agreements with Pfizer, a holder of 5% of our capital stock, for our lead product candidates, pursuant to which we acquired exclusive worldwide rights under Pfizer patents and know-how to develop, manufacture and commercialize nirogacestat and mirdametinib. We subsequently amended these license agreements on July 31, 2019 and August 7, 2019, respectively. See “Business—License and collaboration agreements—Pfizer license agreements” for additional details on our license agreements with Pfizer. As of December 31, 2018, we had not made any milestone or royalty payments under the Pfizer license agreements.
In connection with entry into the Pfizer license agreements, we issued Pfizer the Junior Series A convertible preferred units described below.
Junior Series A Convertible Preferred Units
On August 18, 2017, concurrently with entering into the license agreements described above, we issued an aggregate of 6,437,500 Junior Series A convertible preferred units to Pfizer, in connection with our entering into certain License Agreements therewith. Each Junior Series A convertible preferred unit was exchanged for one share of Junior Series A convertible preferred stock in the Reorganization. Following the reverse split of our common stock in August 2019, every 6.5810 shares of Junior Series A convertible preferred stock will automatically convert into one share of common stock upon completion of this offering. Freda Lewis-Hall, M.D., DFAPA, one of our directors, is the Chief Patient Officer and Executive Vice President of Pfizer.
Series A Convertible Preferred Unit financing
At closings held from August 18, 2017 through March 4, 2019, we sold an aggregate of 103,000,000 Series A convertible preferred units at a purchase price of $1.00 per unit, pursuant to a unit purchase agreement entered into with certain of our investors. Each Series A convertible preferred unit was exchanged for one share of Series A convertible preferred stock in the Reorganization. Following the reverse split of our common stock in August 2019, every 6.5810 shares of Series A convertible preferred stock will automatically convert into one share of common stock upon completion of this offering. The following table summarizes purchases of our Series A convertible preferred units by related persons:
5% Stockholder
|
|
|
Series A Convertible Preferred Units (#)
|
|
|
Total Purchase Price ($)
|
|
Entities affiliated with Pfizer(1)
|
|
|
|
|
20,000,000 |
|
|
|
|
|
20,000,000 |
|
|
BC SW, LP(2)
|
|
|
|
|
40,000,000 |
|
|
|
|
|
40,000,000 |
|
|
OrbiMed Private Investments VI, LP(3)
|
|
|
|
|
40,000,000 |
|
|
|
|
|
40,000,000 |
|
|
(1) Pfizer Ventures (US) LLC is an affiliate fund of Pfizer Inc. Together these affiliated entities are a holder of 5% or more of our capital stock. Dr. Freda Lewis-Hall, Executive Vice President and Chief Patient Officer at Pfizer Inc., is a member of our board of directors.
(2) BC SW, LP is a holder of 5% or more of our capital stock. Jeffrey Schwartz and Deval Patrick are managing directors of Bain Capital Life Sciences, LP and Bain Capital Double Impact, L.P., respectively, and are members of our board of directors.
(3) OrbiMed Private Investments VI, LP (“OPI VI”) is a holder of 5% or more of our capital stock. OrbiMed Capital GP VI LLC (“OrbiMed GP VI”) is the sole general partner of OPI VI and OrbiMed Advisors LLC (“OrbiMed Advisors”), a registered investment advisor under the Investment Advisors Act of 1940, as amended, is the sole managing member of OrbiMed GP VI. By virtue of such relationships, OrbiMed GP VI and OrbiMed Advisors may be deemed to have voting and investment power over the securities held by OPI VI and as a result may be deemed to have beneficial ownership over such securities. Dr. Carl L. Gordon is the Founding Partner and Co-Head of Global Private Equity at OrbiMed Advisors LLC and Dr. Stephen Squinto is an Executive Partner at OrbiMed Advisors LLC. Both Dr. Gordon and Dr. Squinto are members of our board of directors.
Series B Convertible Preferred Stock financing
On March 29, 2019, immediately following the Reorganization, we sold an aggregate of 86,639,279 shares of our Series B convertible preferred stock at a purchase price of $1.4428 per share, pursuant to a stock purchase agreement entered into with certain of our investors. Following the reverse split of our common stock in August 2019, every 6.5810 shares of Series B convertible preferred stock will automatically convert into one share of common stock upon completion of this offering. The following table summarizes purchases of our Series B convertible preferred stock by related persons:
5% Stockholder
|
|
|
Series B Preferred Stock (#)
|
|
|
Total Purchase Price ($)
|
|
Entities affiliated with Pfizer(1)
|
|
|
|
|
3,465,571 |
|
|
|
|
|
5,000,125 |
|
|
BC SW, LP(2)
|
|
|
|
|
6,931,142 |
|
|
|
|
|
10,000,251 |
|
|
OrbiMed Private Investments VI, LP(3)
|
|
|
|
|
6,931,142 |
|
|
|
|
|
10,000,251 |
|
|
Perceptive Life Sciences Master Fund Ltd(4)
|
|
|
|
|
13,862,285 |
|
|
|
|
|
20,000,504 |
|
|
(1) Pfizer Ventures (US) LLC is an affiliate fund of Pfizer Inc. Together these affiliated entities are a holder of 5% or more of our capital stock. Dr. Freda Lewis-Hall, Executive Vice President and Chief Patient Officer at Pfizer Inc., is a member of our board of directors.
(2) BC SW, LP is a holder of 5% or more of our capital stock. Jeffrey Schwartz and Deval Patrick are managing directors of Bain Capital Life Sciences, LP and Bain Capital Double Impact, L.P., respectively, and are members of our board of directors.
(3) OrbiMed Private Investments VI, LP (“OPI VI”) is a holder of 5% or more of our capital stock. OrbiMed Capital GP VI LLC (“OrbiMed GP VI”) is the sole general partner of OPI VI and OrbiMed Advisors LLC (“OrbiMed Advisors”), a registered investment advisor under the Investment Advisors Act of 1940, as amended, is the sole managing member of OrbiMed GP VI. By virtue of such relationships, OrbiMed GP VI and OrbiMed Advisors may be deemed to have voting and investment power over the securities held by OPI VI and as a result may be deemed to have beneficial ownership over such securities. Dr. Carl L. Gordon is the Founding Partner and Co-Head of Global Private Equity at OrbiMed Advisors LLC and Dr. Stephen Squinto is an Executive Partner at OrbiMed Advisors LLC. Both Dr. Gordon and Dr. Squinto are members of our board of directors.
(4) Perceptive Life Sciences Master Fund Ltd is a holder of 5% or more of our capital stock.
Consulting arrangement with Stephen Squinto
We entered into a consulting arrangement in November 2017 with Stephen Squinto, Ph.D., a member of our board of directors, to serve as our acting Head of Research and Development. Dr. Squinto receives an annual consulting fee equal to $80,000 for his service as our acting Head of Research and Development, payable twice monthly, along with $20,000 for his service as a member of our board of directors. This fee for service on our board of directors will terminate upon consummation of this offering. In addition, Dr. Squinto received incentive units and options to purchase common units prior to the Reorganization (which have since been exchanged for restricted stock awards and options to purchase common stock). During the period from August 18, 2017 (inception) through December 31, 2017 and the year ended December 31, 2018, we have paid $31,016 and $100,000, respectively, for Dr. Squinto’s services.
Employment agreement with Daniel Lynch
On February 1, 2018, we entered into an Employment Agreement with Mr. Lynch, or the Lynch Agreement, pursuant to which (i) Mr. Lynch served as the Executive Chairman of our board of directors and (ii) from February 1, 2018 until July 31, 2018, he served as our interim Chief Executive Officer, in each case on an at-will basis. On August 16, 2019, we entered into a letter agreement, or the Termination Letter, with Mr. Lynch, pursuant to which the parties agreed that the Lynch Agreement would terminate effective immediately. Following such termination, Mr. Lynch will no longer serve as Executive Chairman, and will serve as the Chairman of our board of directors.
The Termination Letter provides that all of the rights and obligations of the parties accrued as of the date thereof will survive the termination of the Lynch Agreement. In addition, the Termination Letter provides for the treatment of outstanding stock options and restricted stock awards held by Mr. Lynch as of the date of the Termination Letter.
Pursuant to the Termination Letter, upon a Sale of the Company (as defined in the Termination Letter), all equity awards held by Mr. Lynch as of the date of the Termination Letter shall be accelerated in full.
Additionally, if Mr. Lynch ceases to serve as our Chairman, other than due to his voluntary resignation or removal for Cause (as defined in the Termination Letter) or Mr. Lynch fails to be nominated by our board of directors for election as a director at a meeting of our stockholders at or prior to the expiration of his then current term, then any portion of equity awards held by Mr. Lynch as of the date of the Termination Letter that would have vested during the Applicable Period following the date Mr. Lynch ceases to serve as our Chairman, if not for Mr. Lynch’s termination or failure to be nominated for reelection, shall immediately vest as of the date Mr. Lynch ceases to serve as our Chairman. For purposes of the Termination Letter, Applicable Period means a period of 12 months plus two additional months for each full year of service provided by Mr. Lynch to the Company (including service as a director), measured from February 1, 2018, up to a maximum aggregate period of eighteen (18) months.
Indemnification agreements
In connection with this offering, we intend to enter into agreements to indemnify our directors and executive officers. These agreements will, among other things, require us to indemnify these individuals for certain expenses (including attorneys’ fees), judgments, fines and settlement amounts reasonably incurred by such person in any action or proceeding, including any action by or in our right, on account of any services undertaken by such person on behalf of our company or that person’s status as a member of our board of directors to the maximum extent allowed under Delaware law.
Investors’ rights agreement
In connection with our Series B convertible preferred stock financing, we entered into an investors’ rights agreement with certain of our significant stockholders, including entities related to Pfizer, Bain, OrbiMed and Perceptive. The investors’ rights agreement, among other things:
•
grants such stockholders certain registration rights with respect to shares of our common stock, including shares of common stock issued or issuable upon conversion of our convertible preferred stock;
•
obligates us to deliver periodic financial statements to any stockholder who holds at least 2,500,000 shares of our convertible preferred stock, which we refer to as “majority investors;”
•
grants a right of first offer with respect to sales of our shares by us, subject to specified exclusions (which exclusions include the sale of the shares in connection with this offering), to qualified holders; and
•
requires us to reimburse certain legal expenses of the investors in connection with future financings or a liquidation event.
For more information regarding the registration rights provided in this agreement, please refer to the section of this prospectus titled “Description of capital stock—Registration rights.”
Certain provisions of this agreement, including the covenants described above, but not the registration rights, will terminate automatically upon completion of this offering. This is not a complete description of the investors’ rights agreement and is qualified by the full text of the investors’ rights agreement filed as an exhibit to the registration statement of which this prospectus forms a part.
Voting agreement
In connection with our Series B convertible preferred stock financing, we entered into a voting agreement with certain of our significant stockholders, including entities related to Pfizer, Bain, OrbiMed and Perceptive Life Sciences Master Fund Ltd. The voting agreement among other things provides the terms for the voting of shares with respect to the constituency of our directors. Pursuant to the terms of the voting agreement, the following directors were elected to serve as members on our board of directors and, as of the date of this prospectus, continue to so serve: Daniel S. Lynch, Saqib Islam, Carl L. Gordon, Freda Lewis-Hall, Deval L. Patrick, Jeffrey Schwartz and Stephen Squinto. Mr. Lynch was selected to serve on our board of directors as our Chairman, Mr. Islam was selected to serve on our board of directors as our Chief Executive Officer, Dr. Gordon was selected to serve on our board of directors as designated by OrbiMed, Dr. Lewis-Hall was selected to serve on our board of directors by Pfizer, Mr. Schwartz was selected to serve on our board of directors by Bain. Mr. Patrick and Dr. Squinto were selected to serve on our board of directors as directors who are not affiliated with any investor, possess relevant industry experience and were selected by the unanimous consent of the other members of our board of directors. Perceptive received the right to designate a director pursuant to the voting agreement but has not elected a director to date.
This voting agreement will terminate automatically upon the completion of this offering and members previously elected to our board of directors pursuant to this agreement will continue to serve as directors until they resign, are removed or their successors are duly elected by the holders of our common stock.
Right of first refusal and co-sale agreement
In connection with our Series B convertible preferred stock financing, we entered into a right of first refusal and co-sale agreement with certain of our significant stockholders, including entities related to Pfizer, Bain, OrbiMed and Perceptive. The right of first refusal and co-sale agreement, among other things:
•
grants our investors certain rights of first refusal and co-sale with respect to proposed transfers of our securities by certain stockholders; and
•
grants us certain rights of first refusal with respect to proposed transfers of our securities by certain stockholders.
The right of first refusal and co-sale agreement will terminate automatically upon the completion of this offering.
Policies for approval of related party transactions
Our board of directors reviews and approves transactions with directors, officers and holders of five percent or more of our voting securities and their affiliates, each a related party. Prior to this offering, the material facts as to the related party’s relationship or interest in the transaction are disclosed to our board of directors prior to their consideration of such transaction, and the transaction is not considered approved by our board of directors unless a majority of the directors who are not interested in the transaction approve the transaction. Further, when stockholders are entitled to vote on a transaction with a related party, the material facts of the related party’s relationship or interest in the transaction are disclosed to the stockholders, who must approve the transaction in good faith.
In connection with this offering, we adopted a written related party transactions policy that such transactions must be approved by our audit committee. This policy will become effective on the date on which the registration statement of which this prospectus forms a part is declared effective by the SEC. Pursuant to this policy, the audit committee has the primary responsibility for reviewing and approving or disapproving “related party transactions,” which are transactions between us and related persons in which the aggregate amount involved exceeds or may be expected to exceed $120,000 and in which a related person has or will have a direct or indirect material interest. For purposes of this policy, a related person will be defined as a director, executive officer, nominee for director, or greater than 5% beneficial owner of our common stock, in each case since the beginning of the most recently completed year, and their immediate family members.
Principal Stockholders
The following table sets forth certain information known to us regarding beneficial ownership of our capital stock as of September 1, 2019 as adjusted to reflect the sale of common stock offered by us in this offering, for:
•
each person or group of affiliated persons known by us to be the beneficial owner of more than 5% of our capital stock;
•
each of our named executive officers;
•
each of our directors; and
•
all of our executive officers and directors as a group.
Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. Under those rules, beneficial ownership includes any shares as to which the individual or entity has sole or shared voting power or investment power, and includes securities that the individual or entity has the right to acquire, such as through the exercise of stock options, within 60 days of September 1, 2019. Except as noted by footnote, and subject to community property laws where applicable, we believe, based on the information provided to us, that the persons and entities named in the table below have sole voting and investment power with respect to all common stock shown as beneficially owned by them.
The percentage of beneficial ownership prior to this offering in the table below is based on shares of common stock deemed to be outstanding as of September 1, 2019, assuming the conversion of all outstanding shares of our convertible preferred stock immediately prior to the completion of this offering into an aggregate of 29,794,359 shares of common stock upon the completion of this offering, and the percentage of beneficial ownership at this offering in the table below is based on shares of common stock assumed to be outstanding after the completion of the offering. The table below assumes that the underwriters do not exercise their option to purchase additional shares. Shares of common stock subject to options that are currently exercisable or exercisable within 60 days of September 1, 2019 are considered outstanding and beneficially owned by the person holding the options for the purpose of computing the percentage ownership of that person but are not treated as outstanding for the purpose of computing the percentage ownership of any other person. Unless otherwise indicated below, the address of each individual listed below is c/o SpringWorks Therapeutics, Inc., 100 Washington Blvd, Stamford, Connecticut 06902.
Name and Address of Beneficial Owner
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Number of Shares Beneficially Owned Prior to Offering
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Percentage of Shares Beneficially Owned
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Before Offering
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After Offering
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5% Stockholders: |
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Entities affiliated with Pfizer(1)
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4,543,847 |
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13.82% |
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11.29% |
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Entities affiliated with Bain(2)
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7,131,307 |
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21.69% |
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17.72% |
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OrbiMed Private Investments VI, LP(3)
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7,131,307 |
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21.69% |
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17.72% |
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Perceptive Life Sciences Master Fund Ltd.(4)
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2,106,410 |
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6.41% |
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5.24% |
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Named Executive Officers and Directors: |
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Saqib Islam, J.D.(5)
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1,067,778 |
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3.24% |
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2.65% |
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Jens Renstrup, M.D., M.B.A.(6)
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256,212 |
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* |
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* |
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Badreddin Edris, Ph.D.(7)
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253,450 |
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* |
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* |
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Daniel S. Lynch, M.B.A.(8)
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517,147 |
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1.57% |
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1.28% |
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Name and Address of Beneficial Owner
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Number of Shares Beneficially Owned Prior to Offering
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Percentage of Shares Beneficially Owned
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Before Offering
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After Offering
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Carl L. Gordon, Ph.D., CFA(3)
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7,131,307 |
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21.69% |
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17.72% |
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Alan Fuhrman
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— |
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— |
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— |
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Freda Lewis-Hall, M.D., DFAPA(1)
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4,543,847 |
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13.82% |
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11.29% |
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Deval L. Patrick, J.D.
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— |
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— |
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— |
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Jeffrey Schwartz, M.B.A.(2)
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7,131,307 |
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21.69% |
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17.72% |
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Stephen Squinto, Ph.D.(9)
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7,278,035 |
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22.13% |
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18.09% |
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All executive officers and directors as a group (12 persons)
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21,411,265 |
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64.58% |
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53.21% |
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* Represents beneficial ownership of less than 1%.
(1) Represents (i) 978,194 shares of common stock issuable upon the conversion of shares of our Junior Series A convertible preferred stock held by Pfizer Inc., or Pfizer, (ii) 3,039,051 shares of common stock issuable upon the conversion of shares of our Series A convertible preferred stock held by Pfizer and (iii) 526,602 shares of common stock issuable upon the conversion of shares of our Series B convertible preferred stock held by Pfizer Ventures (US) Holdings, or Pfizer Ventures, a wholly-owned subsidiary of Pfizer. Freda Lewis-Hall, a member of our board of directors, is employed by Pfizer. Dr. Lewis-Hall has no voting or dispositive power over the shares held by Pfizer or Pfizer Ventures and disclaims beneficial ownership of all such shares. The address of Pfizer is 235 East 42nd Street, New York, New York 10017.
(2) Consists of (i) 6,078,103 shares of common stock issuable upon conversion of shares of our Series A convertible preferred stock held directly by BC SW, L.P., or BCSW and (ii) 1,053,204 shares of common stock issuable upon conversion of shares of our Series B preferred stock held directly by BCSW. Bain Capital Life Sciences Investors, LLC, whose managers are Jeffrey Schwartz and Adam Koppel, is the general partner of BCSW. As a result, each of Bain Capital Life Sciences Investors, LLC, Mr. Schwartz and Dr. Koppel may be deemed to share voting and dispositive power with respect to the shares held by BCSW. The address of BCSW is c/o Bain Capital Life Sciences, L.P., 200 Clarendon Street, Boston, Massachusetts 02116.
(3) Consists of (i) 6,078,103 shares of common stock issuable upon conversion of shares of our Series A convertible preferred stock held directly by OrbiMed Capital GP VI LLC, or GP VI, and (ii) 1,053,204 shares of common stock issuable upon conversion of shares of our Series B preferred stock held directly by GP VI. GP VI, is the general partner of OrbiMed Private Investments VI, LP, or OrbiMed VI. OrbiMed Advisors LLC, or OrbiMed Advisors, is the managing member of GP VI. OrbiMed Advisors exercises investment and voting power through a management committee comprised of Carl Gordon, Ph.D., C.F.A., Sven H. Borho and Jonathan T. Silverstein. By virtue of such relationships, GP VI, OrbiMed Advisors and Dr. Gordon may be deemed to have voting and investment power with respect to the shares held by OrbiMed VI and as a result may be deemed to have beneficial ownership of these shares. Each of GP VI, OrbiMed Advisors, Messrs. Borho and Silverstein and Dr. Gordon disclaims beneficial ownership of the shares held by OrbiMed VI, except to the extent of its or his pecuniary interest therein, if any. OrbiMed Advisors’ mailing address is 601 Lexington Avenue, 54th Floor, New York, New York 10022.
(4) Consists of shares of common stock issuable upon conversion of shares of our Series B preferred stock held directly held by Perceptive Life Sciences Master Fund Ltd., or Perceptive. Perceptive Advisors LLC is the advisor of Perceptive, and Joseph Edelman is the managing member of Perceptive Advisors LLC. Perceptive Advisors LLC and Mr. Edelman may be deemed to beneficially own the shares held by Perceptive. The address of Perceptive is 51 Astor Place, 10th Floor, New York, NY 10003.
(5) Consists of (i) 971,552 shares of common stock (which includes 637,097 unvested shares of restricted stock subject to time-based vesting) and (ii) 96,226 shares of common stock underlying options exercisable within 60 days of September 1, 2019 held by Mr. Islam.
(6) Consists of (i) 244,424 shares of common stock (which includes 178,226 unvested shares of restricted stock subject to time-based vesting) and (ii) 11,788 shares of common stock underlying options exercisable within 60 days of September 1, 2019 held by Dr. Renstrup.
(7) Consists of (i) 234,766 shares of common stock, (all of which are unvested shares of restricted stock subject to time-based vesting) and (ii) 18,684 shares of common stock underlying options exercisable within 60 days of September 1, 2019 held by Dr. Edris.
(8) Consists of (i) 391,277 shares of common stock (which includes 195,639 unvested shares of restricted stock subject to time-based vesting) and (ii) 125,870 shares of common stock underlying options exercisable within 60 days of September 1, 2019 held by Mr. Lynch.
(9) Consists of (i) 146,728 shares of common stock (which includes 73,365 unvested shares of restricted stock subject to time-based vesting) held by Dr. Squinto directly and (ii) the shares described in note (3) above. Dr. Squinto is an Executive Partner at OrbiMed Advisors and may be deemed the indirect beneficial owner of such shares. Dr. Squinto disclaims beneficial ownership of such shares except to the extent of any pecuniary interest therein.
Description of Capital Stock
The following descriptions are summaries of the material terms of our amended and restated certificate of incorporation, and amended and restated bylaws, which will be effective immediately prior to the completion of this offering. The descriptions of the common stock and convertible preferred stock give effect to changes to our capital structure that will occur immediately prior to the completion of this offering.
General
Upon completion of this offering, our authorized capital stock will consist of 150,000,000 shares of common stock, par value $0.0001 per share, and 10,000,000 shares of convertible preferred stock, par value $0.0001 per share, all of which shares of convertible preferred stock will be undesignated.
As of June 30, 2019, 3,088,636 shares of our common stock (which includes 2,118,689 shares of unvested restricted stock) and 196,076,779 shares of convertible preferred stock were outstanding and held by 72 stockholders of record. This amount does not take into account the conversion of all outstanding shares of our convertible preferred stock into common stock immediately prior to the completion of this offering.
Common stock
The holders of our common stock are entitled to one vote for each share held on all matters submitted to a vote of the stockholders. The holders of our common stock do not have any cumulative voting rights. Holders of our common stock are entitled to receive ratably any dividends declared by our board of directors out of funds legally available for that purpose, subject to any preferential dividend rights of any outstanding convertible preferred stock. Our common stock has no preemptive rights, conversion rights or other subscription rights or redemption or sinking fund provisions.
In the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in all assets remaining after payment of all debts and other liabilities and any liquidation preference of any outstanding convertible preferred stock. The shares to be issued by us in this offering will be, when issued and paid for, validly issued, fully paid and non-assessable.
Convertible preferred stock
Upon the completion of this offering, all outstanding shares of our convertible preferred stock will be converted into shares of our common stock. Upon the consummation of this offering, our board of directors will have the authority, without further action by our stockholders, to issue up to 10,000,000 shares of convertible preferred stock in one or more series and to fix the rights, preferences, privileges and restrictions thereof. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting, or the designation of, such series, any or all of which may be greater than the rights of common stock. The issuance of our convertible preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon our liquidation. In addition, the issuance of convertible preferred stock could have the effect of delaying, deferring or preventing a change in control of our company or other corporate action. Immediately after consummation of this offering, no shares of convertible preferred stock will be outstanding, and we have no present plan to issue any shares of convertible preferred stock.
Stock options
As of June 30, 2019, options to purchase 2,489,778 shares of our common stock were outstanding under our 2019 Plan, of which 147,397 were exercisable as of that date. For additional information regarding the terms of this plan, see “Executive compensation—Employee benefit and equity compensation plans—2019 Stock Option and Incentive Plan.”
Registration rights
Upon the completion of this offering, the holders of 29,794,359 shares of our common stock, including those issuable upon the conversion of convertible preferred stock, which shares we refer to as “registrable securities,” will be entitled to rights with respect to the registration of these registrable securities under the Securities Act. These rights are provided under the terms of an investors’ rights agreement between us and holders of our convertible preferred stock. The investors’ rights agreement includes demand registration rights, short-form registration rights and piggyback registration rights. All fees, costs and expenses of underwritten registrations under this agreement will be borne by us and all selling expenses, including underwriting discounts and selling commissions, will be borne by the holders of the shares being registered.
Demand registration rights
Beginning 180 days after the effective date of this registration statement, the holders of registrable securities are entitled to demand registration rights under certain conditions. Under the terms of the investors’ rights agreement, we will be required, upon the written request of holders of at least 20% of these registrable securities that would result in an aggregate offering price of that would exceed $5,000,000, to file a registration statement and use best efforts to effect the registration of all or a portion of these registrable securities for public resale. We are required to effect only two registrations pursuant to this provision of the investors’ rights agreement.
Short-form registration rights
Pursuant to the investors’ rights agreement, if we are eligible to file a registration statement on Form S-3, upon the written request of holders of at least 20% of these registrable securities that would result in an aggregate offering price of at least $2,000,000, we will be required to effect a registration of such registrable securities. We are required to effect only two registrations in any twelve-month period pursuant to this provision of the investors’ rights agreement. The right to have such shares registered on Form S-3 is further subject to other specified conditions and limitations.
Piggyback registration rights
Pursuant to the investors’ rights agreement, if we register any of our securities either for our own account or for the account of other security holders, subject to certain exceptions, the holders of these shares are entitled to include their shares in the registration. Subject to certain exceptions contained in the investors’ rights agreement, we and the underwriters may limit the number of shares included in the underwritten offering to the number of shares which we and the underwriters determine in our sole discretion will not jeopardize the success of the offering. The holders of a majority of the Preferred Stock have waived all registration rights with respect to the registrable securities they hold in connection with this offering.
Indemnification
Our investors’ rights agreement contains customary cross-indemnification provisions, under which we are obligated to indemnify holders of registrable securities in the event of material
misstatements or omissions in the registration statement attributable to us, and they are obligated to indemnify us for material misstatements or omissions attributable to them.
Expiration of registration rights
The demand registration rights and short form registration rights granted to any holder of registrable securities under the investors’ rights agreement will terminate upon the earliest to occur of (i) immediately prior to the closing of a deemed liquidation event (as defined in our certificate of incorporation) or (ii) the fourth anniversary of the completion of this offering.
Anti-takeover effects of our amended and restated certificate of incorporation and amended and restated bylaws and Delaware Law
Our amended and restated certificate of incorporation and amended and restated bylaws which will become effective immediately prior to the completion of this offering include a number of provisions that may have the effect of delaying, deferring or preventing another party from acquiring control of us and encouraging persons considering unsolicited tender offers or other unilateral takeover proposals to negotiate with our board of directors rather than pursue non-negotiated takeover attempts. These provisions include the items described below.
Board composition and filling vacancies
Our amended and restated certificate of incorporation which will become effective immediately prior to the completion of this offering provides for the division of our board of directors into three classes serving staggered three-year terms, with one class being elected each year. Our amended and restated certificate of incorporation also provides that directors may be removed only for cause and then only by the affirmative vote of the holders of two-thirds or more of the shares then entitled to vote at an election of directors. Furthermore, any vacancy on our board of directors, however occurring, including a vacancy resulting from an increase in the size of our board, may only be filled by the affirmative vote of a majority of our directors then in office even if less than a quorum. The classification of directors, together with the limitations on removal of directors and treatment of vacancies, has the effect of making it more difficult for stockholders to change the composition of our board of directors.
No written consent of stockholders
Our amended and restated certificate of incorporation which will become effective immediately prior to the completion of this offering provides that all stockholder actions are required to be taken by a vote of the stockholders at an annual or special meeting, and that stockholders may not take any action by written consent in lieu of a meeting. This limit may lengthen the amount of time required to take stockholder actions and would prevent the amendment of our amended and restated bylaws or removal of directors by our stockholders without holding a meeting of stockholders.
Meetings of stockholders
Our amended and restated certificate of incorporation and amended and restated bylaws which will become effective immediately prior to the completion of this offering provide that only a majority of the members of our board of directors then in office may call special meetings of stockholders and only those matters set forth in the notice of the special meeting may be considered or acted upon at a special meeting of stockholders. Our amended and restated bylawslimit the business that may be conducted at an annual meeting of stockholders to those matters properly brought before the meeting.
Advance notice requirements
Our amended and restated bylaws establish advance notice procedures with regard to stockholder proposals relating to the nomination of candidates for election as directors or new business to be brought before meetings of our stockholders. These procedures provide that notice of stockholder proposals must be timely given in writing to our corporate secretary prior to the meeting at which the action is to be taken. Generally, to be timely, notice must be received at our principal executive offices not less than 90 days nor more than 120 days prior to the first anniversary date of the annual meeting for the preceding year. Our bylaws specify the requirements as to form and content of all stockholders’ notices. These requirements may preclude stockholders from bringing matters before the stockholders at an annual or special meeting.
Amendment to amended and restated certificate of incorporation and amended and restated bylaws
Any amendment of our amended and restated certificate of incorporation must first be approved by a majority of our board of directors, and if required by law or our amended and restated certificate of incorporation, must thereafter be approved by a majority of the outstanding shares entitled to vote on the amendment and a majority of the outstanding shares of each class entitled to vote thereon as a class, except that the amendment of the provisions relating to stockholder action, board composition, limitation of liability and the amendment of our bylawsand certificate of incorporation must be approved by not less than two-thirds of the outstanding shares entitled to vote on the amendment, and not less than two-thirds of the outstanding shares of each class entitled to vote thereon as a class. Our amended and restated bylaws may be amended by the affirmative vote of a majority of the directors then in office, subject to any limitations set forth in the amended and restated bylaws, and may also be amended by the affirmative vote of at least two-thirds of the outstanding shares entitled to vote on the amendment, or, if our board of directors recommends that the stockholders approve the amendment, by the affirmative vote of the majority of the outstanding shares entitled to vote on the amendment, in each case voting together as a single class.
Undesignated preferred stock
Our amended and restated certificate of incorporation, which will become effective immediately prior to the completion of this offering provides for 10,000,000 authorized shares of preferred stock. The existence of authorized but unissued shares of convertible preferred stock may enable our board of directors to discourage an attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise. For example, if in the due exercise of its fiduciary obligations, our board of directors were to determine that a takeover proposal is not in the best interests of our stockholders, our board of directors could cause shares of convertible preferred stock to be issued without stockholder approval in one or more private offerings or other transactions that might dilute the voting or other rights of the proposed acquirer or insurgent stockholder or stockholder group. In this regard, our amended and restated certificate of incorporation grants our board of directors broad power to establish the rights and preferences of authorized and unissued shares of convertible preferred stock. The issuance of shares of convertible preferred stock could decrease the amount of earnings and assets available for distribution to holders of shares of common stock. The issuance may also adversely affect the rights and powers, including voting rights, of these holders and may have the effect of delaying, deterring or preventing a change in control of us.
Choice of forum
Our amended and restated bylaws, which will become effective immediately prior to the closing of this offering, will provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for any state law claim for: (i) any derivative action or proceeding brought on our behalf; (ii) any action asserting a claim of breach of a fiduciary duty or other wrongdoing by any of our directors, officers, employees or agents to us or our stockholders; (iii) any action asserting a claim against us arising pursuant to any provision of the Delaware General Corporation Law or our certificate of incorporation or bylaws; (iv) any action to interpret, apply, enforce or determine the validity of our certificate of incorporation or bylaws or (v) any action asserting a claim governed by the internal affairs doctrine. The choice of forum provision does not apply to any actions arising under the Securities Act or the Exchange Act.
Section 203 of the Delaware General Corporation Law
Upon completion of this offering, we will be subject to the provisions of Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits a publicly held Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a three-year period following the time that this stockholder becomes an interested stockholder, unless the business combination is approved in a prescribed manner. Under Section 203, a business combination between a corporation and an interested stockholder is prohibited unless it satisfies one of the following conditions:
•
before the stockholder became interested, our board of directors approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;
•
upon consummation of the transaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding, shares owned by persons who are directors and also officers, and employee stock plans, in some instances, but not the outstanding voting stock owned by the interested stockholder; or
•
at or after the time the stockholder became interested, the business combination was approved by our board of directors and authorized at an annual or special meeting of the stockholders by the affirmative vote of at least two-thirds of the outstanding voting stock which is not owned by the interested stockholder.
Section 203 defines a business combination to include:
•
any merger or consolidation involving the corporation and the interested stockholder;
•
any sale, transfer, lease, pledge or other disposition involving the interested stockholder of 10% or more of the assets of the corporation;
•
subject to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;
•
subject to exceptions, any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; and
•
the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.
In general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation and any entity or person affiliated with or controlling or controlled by the entity or person.
Nasdaq Global Market listing
We have applied to list our common stock on the Nasdaq Global Market under the trading symbol “SWTX.”
Transfer agent and registrar
The transfer agent and registrar for our common stock is Computershare Trust Company, N.A. The transfer agent and registrar’s address is 250 Royall Street, Canton, Massachusetts 02021.
Shares Eligible for Future Sale
Prior to this offering, there has been no public market for our shares. Future sales of our common stock in the public market, or the availability of such shares for sale in the public market, could adversely affect market prices prevailing from time to time. As described below, only a limited number of shares will be available for sale shortly after this offering due to contractual and legal restrictions on resale. Nevertheless, sales of our common stock in the public market after such restrictions lapse, or the perception that those sales may occur, could adversely affect the prevailing market price at such time and our ability to raise equity capital in the future.
Based on the number of shares outstanding as of June 30, 2019, upon the completion of this offering, 40,235,936 shares of our common stock will be outstanding. Of the outstanding shares, all of the shares sold in this offering will be freely tradable, except that any shares held by our affiliates, as that term is defined in Rule 144 under the Securities Act, may only be sold in compliance with the limitations described below. All remaining shares of common stock held by existing stockholders immediately prior to the completion of this offering will be “restricted securities” as such term is defined in Rule 144. These restricted securities were issued and sold by us, or will be issued and sold by us, in private transactions and are eligible for public sale only if registered under the Securities Act or if they qualify for an exemption from registration under the Securities Act, including the exemptions provided by Rule 144 or Rule 701, summarized below.
Rule 144
In general, a person who has beneficially owned restricted stock for at least six months would be entitled to sell their securities provided that (i) such person is not deemed to have been one of our affiliates at the time of, or at any time during the 90 days preceding, a sale and (ii) we are subject to the Securities Exchange Act of 1934, as amended, or the Exchange Act, periodic reporting requirements for at least 90 days before the sale. Persons who have beneficially owned restricted shares for at least six months but who are our affiliates at the time of, or any time during the 90 days preceding, a sale, would be subject to additional restrictions, by which such person would be entitled to sell within any three-month period only a number of securities that does not exceed the greater of either of the following:
•
1% of the number of shares then outstanding, which will equal approximately 402,359 shares immediately after this offering, assuming no exercise of the underwriters’ option to purchase additional shares, based on the number of shares outstanding as of June 30, 2019; or
•
the average weekly trading volume of our common stock on the Nasdaq Global Market during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale; provided, in each case, that we are subject to the Exchange Act periodic reporting requirements for at least 90 days before the sale. Such sales both by affiliates and by non-affiliates must also comply with the manner of sale, current public information and notice provisions of Rule 144.
Rule 701
Rule 701 under the Securities Act, as in effect on the date of this prospectus, permits resales of shares in reliance upon Rule 144 but without compliance with certain restrictions of Rule 144, including the holding period requirement. Most of our employees, executive officers or directors who purchased shares under a written compensatory plan or contract may be entitled to rely on the resale provisions of Rule 701, but all holders of Rule 701 shares are required to wait until 90 days after the date of this prospectus before selling their shares.
However, substantially all Rule 701 shares are subject to lock-up agreements as described below and under “Underwriting” included elsewhere in this prospectus and will become eligible for sale upon the expiration of the restrictions set forth in those agreements.
Lock-up agreements
We, our directors and executive officers and holders of substantially all of our common stock have signed lock-up agreements that prevent us and them from selling any of our common stock or any securities convertible into or exercisable or exchangeable for common stock for a period of not less than 180 days from the date of this prospectus without the prior written consent of the Underwriters, subject to certain exceptions. See the section entitled “Underwriters” appearing elsewhere in this prospectus for more information.
Registration rights
Upon completion of this offering, certain holders of our securities will be entitled to various rights with respect to registration of their shares under the Securities Act. Registration of these shares under the Securities Act would result in these shares becoming fully tradable without restriction under the Securities Act immediately upon the effectiveness of the registration. See the section entitled “Description of capital stock—Registration rights” appearing elsewhere in this prospectus for more information.
Equity incentive plans
We intend to file one or more registration statements on Form S-8 under the Securities Act to register our shares issued or reserved for issuance under our equity incentive plans. The first such registration statement is expected to be filed soon after the date of this prospectus and will automatically become effective upon filing with the SEC. Accordingly, shares registered under such registration statement will be available for sale in the open market, unless such shares are subject to vesting restrictions with us or the lock-up restrictions described above. As of June 30, 2019, we estimate that such registration statement on Form S-8 will cover 5,382,776 shares.
Certain Material U.S. Federal Income and Estate Tax consequences for non-U.S. Holders
The following discussion is a summary of the material U.S. federal income tax consequences applicable to non-U.S. holders (as defined below) with respect to their ownership and disposition of shares of our common stock issued pursuant to this offering. For purposes of this discussion, a non-U.S. holder means a beneficial owner of our common stock that is not a “U.S. person” or a partnership (including any entity or arrangement treated as a partnership and the equity holders therein) for U.S. federal income tax purposes. A U.S. person is any of the following:
•
an individual citizen or resident of the United States;
•
a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created or organized under the laws of the United States, any state thereof or the District of Columbia;
•
an estate, the income of which is subject to U.S. federal income tax regardless of its source; or
•
a trust (i) whose administration is subject to the primary supervision of a U.S. court and which has one or more U.S. persons who have the authority to control all substantial decisions of the trust, or (ii) that has a valid election in effect under applicable Treasury Regulations to be treated as a U.S. person.
This discussion does not address the tax treatment of partnerships or other entities or arrangements that are classified as partnerships or other pass-through entities for U.S. federal income tax purposes or persons that hold their common stock through partnerships or other pass-through entities for U.S. federal income tax purposes. A partner in a partnership or other pass-through entity that will hold our common stock should consult his, her or its tax advisor regarding the tax consequences of holding and disposing of our common stock through a partnership or other pass-through entity, as applicable.
This discussion is based on current provisions of the Internal Revenue Code of 1986, as amended, or the Code, existing and proposed U.S. Treasury Regulations promulgated thereunder, current administrative rulings and judicial decisions, all as in effect as of the date of this prospectus and, all of which are subject to change or to differing interpretation, possibly with retroactive effect. Any such change or differing interpretation could alter the tax consequences to non-U.S. holders described in this prospectus. There can be no assurance that the Internal Revenue Service, which we refer to as the IRS, will not challenge one or more of the tax consequences described herein. We assume in this discussion that a non-U.S. holder holds shares of our common stock as a capital asset within the meaning of Section 1221 of the Code, generally property held for investment.
This discussion does not address all aspects of U.S. federal income taxation that may be relevant to a particular non-U.S. holder in light of that non-U.S. holder’s individual circumstances including the alternative minimum tax, or the Medicare tax on net investment income, the timing of income accruals required under Section 451(b) of the Code, the rules regarding qualified small business stock within the meaning of Section 1202 of the Code and any election to apply Section 1400Z-2 of the Code to gains recognized with respect to shares of our common stock. This discussion also does not address any U.S. state, local or non-U.S. taxes, any estate tax or any other aspect of any U.S. federal tax other than the income tax. This discussion also does not consider any specific facts or circumstances that may apply to a non-U.S. holder and does not address the special tax rules applicable to particular non-U.S. holders, such as:
•
insurance companies;
•
tax-exempt or governmental organizations;
•
financial institutions;
•
brokers or dealers in securities;
•
regulated investment companies;
•
pension plans;
•
“controlled foreign corporations,” “passive foreign investment companies,” and corporations that accumulate earnings to avoid U.S. federal income tax;
•
“qualified foreign pension funds,” or entities wholly owned by a “qualified foreign pension fund”;
•
partnerships or other entities or arrangements treated as partnerships for U.S. federal income tax purposes (and partners and investors therein);
•
persons deemed to sell our common stock under the constructive sale provisions of the Code;
•
persons that hold our common stock as part of a straddle, hedge, conversion transaction, synthetic security or other integrated investment;
•
persons who have elected to mark securities to market;
•
persons who have a functional currency other than the U.S. dollar;
•
persons that own, or have owned, actually or constructively, more than 5% of our common stock;
•
persons who hold or receive our common stock pursuant to the exercise of any employee stock option or otherwise as compensation; and
•
certain U.S. expatriates.
This discussion is for general information only and is not tax advice. Accordingly, all prospective non-U.S. holders of our common stock should consult their tax advisors with respect to the U.S. federal, state, local and non-U.S. tax consequences of the purchase, ownership and disposition of our common stock.
Distributions on our common stock
Distributions, if any, on our common stock will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. If a distribution exceeds our current and accumulated earnings and profits, the excess will be treated as a tax-free return of the non-U.S. holder’s investment, up to such holder’s tax basis in the common stock. Any remaining excess will be treated as capital gain, subject to the tax treatment described below in “Gain on sale or other taxable disposition of our common stock.” Any such distributions will also be subject to the discussions below under the sections titled “Backup withholding and information reporting” and “Withholding and information reporting requirements—FATCA.”
Subject to the discussion in the following two paragraphs in this section, dividends paid to a non-U.S. holder generally will be subject to withholding of U.S. federal income tax at a 30% rate or such lower rate as may be specified by an applicable income tax treaty between the United States and such holder’s country of residence. If we or another withholding agent apply over-withholding or if a non-U.S. holder does not timely provide us with the required certification, the non-U.S. holder may be entitled to a refund or credit of any excess tax withheld by timely filing an appropriate claim with the IRS.
Dividends that are treated as effectively connected with a trade or business conducted by a non-U.S. holder within the United States and, if an applicable income tax treaty so provides, that are attributable to a permanent establishment or a fixed base maintained by the non-U.S. holder within the United States, are generally exempt from the 30% withholding tax if the non-U.S. holder satisfies applicable certification and disclosure requirements. To claim the exemption, the
non-U.S. holder must generally furnish to the applicable withholding agent a properly executed IRS Form W-8ECI (or applicable successor form). However, such U.S. effectively connected income, net of specified deductions and credits, is taxed at the same graduated U.S. federal income tax rates applicable to U.S. persons (as defined in the Code). Any U.S. effectively connected income received by a non-U.S. holder that is a corporation may also, under certain circumstances, be subject to an additional “branch profits tax” at a 30% rate or such lower rate as may be specified by an applicable income tax treaty between the United States and such holder’s country of residence.
A non-U.S. holder who claims the benefit of an applicable income tax treaty between the United States and such holder’s country of residence generally will be required to provide a properly executed IRS Form W-8BEN or W-8BEN-E (or successor form) to the applicable withholding agent and satisfy applicable certification and other requirements. This certification must be provided to the withholding agent prior to the payment of dividends and must be updated periodically. If the non-U.S. holder holds the stock through a financial institution or other agent acting on the non-U.S. holder’s behalf, the non-U.S. holder will be required to provide appropriate documentation to the agent, which then will be required to provide certification to us or our paying agent, either directly or through other intermediaries. Non-U.S. holders are urged to consult their tax advisors regarding their entitlement to benefits under a relevant income tax treaty. Non-U.S. holders that do not timely provide the required certification, but that qualify for a reduced treaty rate, may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for refund with the IRS.
Gain on sale or other taxable disposition of our common stock
Subject to the discussions below under “Backup withholding and information reporting” and “Withholding and information reporting requirements—FATCA,” a non-U.S. holder generally will not be subject to any U.S. federal income tax on any gain realized upon such holder’s sale or other taxable disposition of shares of our common stock unless:
•
the gain is effectively connected with the non-U.S. holder’s conduct of a U.S. trade or business and, if an applicable income tax treaty so provides, is attributable to a permanent establishment or a fixed-base maintained by such non-U.S. holder in the United States, in which case the non-U.S. holder generally will be taxed on a net income basis at the U.S. federal income tax rates applicable to United States persons (as defined in the Code) and, if the non-U.S. holder is a foreign corporation, the branch profits tax described above in “Distributions on our common stock” also may apply;
•
the non-U.S. holder is a nonresident alien individual who is present in the United States for 183 days or more in the taxable year of the disposition and certain other conditions are met, in which case the non-U.S. holder will be subject to a 30% tax (or such lower rate as may be specified by an applicable income tax treaty between the United States and such holder’s country of residence) on the gain derived from the disposition, which may be offset by certain U.S. source capital losses of the non-U.S. holder, if any (even though the individual is not considered a resident of the United States), provided that the non-U.S. holder has timely filed U.S. federal income tax returns with respect to such losses; or
•
we are, or have been, at any time during the five-year period preceding such sale of other taxable disposition (or the non-U.S. holder’s holding period, if shorter) a “U.S. real property holding corporation,” unless our common stock is regularly traded on an established securities market and the non-U.S. holder holds no more than 5% of our outstanding common stock, directly or indirectly, during the shorter of the 5-year period ending on the date of the disposition or the period that the non-U.S. holder held our common stock. Generally, a corporation is a U.S. real property holding corporation only if the fair market value of its U.S.
real property interests equals or exceeds 50% of the sum of the fair market value of its worldwide real property interests plus its other assets used or held for use in a trade or business. Although there can be no assurance, we do not believe that we are, or have been, a U.S. real property holding corporation, or that we are likely to become one in the future. No assurance can be provided that our common stock will be regularly traded on an established securities market for purposes of the rules described above. If we are a U.S. real property holding corporation and either our common stock is not regularly traded on an established securities market or a non-U.S. holder holds, or is treated as holding, more than 5% of our outstanding common stock, directly or indirectly, during the applicable testing period, such non-U.S. holder will generally be taxed on any gain in the same manner as gain that is effectively connected with the conduct of a U.S. trade or business, except that the branch profits tax generally will not apply. If we are a U.S. real property holding corporation and our common stock is not regularly traded on an established securities market, a non-U.S. holder’s proceeds received on the disposition of shares will also generally be subject to withholding at a rate of 15%. Prospective investors are encouraged to consult their own tax advisors regarding the possible consequences to them if we are, or were to become, a U.S. real property holding corporation.
Backup withholding and information reporting
We must report annually to the IRS and to each non-U.S. holder the gross amount of the distributions on our common stock paid to such holder and the tax withheld, if any, with respect to such distributions. Non-U.S. holders may have to comply with specific certification procedures to establish that the holder is not a U.S. person (as defined in the Code) in order to avoid backup withholding at the applicable rate with respect to dividends on our common stock. Dividends paid to non-U.S. holders subject to withholding of U.S. federal income tax, as described above in “Distributions on our common stock,” generally will be exempt from U.S. backup withholding.
Information reporting and backup withholding will generally apply to the proceeds of a disposition of our common stock by a non-U.S. holder effected by or through the U.S. office of any broker, U.S. or foreign, unless the holder certifies its status as a non-U.S. holder and satisfies certain other requirements, or otherwise establishes an exemption. Generally, information reporting and backup withholding will not apply to a payment of disposition proceeds to a non-U.S. holder where the transaction is effected outside the United States through a non-U.S. office of a broker. However, for information reporting purposes, dispositions effected through a non-U.S. office of a broker with substantial U.S. ownership or operations generally will be treated in a manner similar to dispositions effected through a U.S. office of a broker. Non-U.S. holders should consult their tax advisors regarding the application of the information reporting and backup withholding rules to them. Copies of information returns may be made available to the tax authorities of the country in which the non-U.S. holder resides or is incorporated under the provisions of a specific treaty or agreement. Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules from a payment to a non-U.S. holder can be refunded or credited against the non-U.S. holder’s U.S. federal income tax liability, if any, provided that an appropriate claim is filed with the IRS in a timely manner.
Withholding and information reporting requirements—FATCA
Provisions of the Code commonly referred to as the Foreign Account Tax Compliance Act, or FATCA, generally imposes a U.S. federal withholding tax at a rate of 30% on payments of dividends on our common stock paid to a foreign entity unless (i) if the foreign entity is a “foreign financial institution,” such foreign entity undertakes certain due diligence, reporting, withholding, and certification obligations, (ii) if the foreign entity is not a “foreign financial institution,” such foreign entity identifies certain of its U.S. investors, if any, or (iii) the foreign entity is otherwise exempt under FATCA. Under applicable U.S. Treasury regulations, withholding under FATCA currently applies to payments of dividends on our common stock. Proposed U.S. Treasury Regulations provide that FATCA withholding does not apply to gross proceeds from the disposition of property of a type that can produce U.S. source dividends or interest; however, the current version of the rules subjects gross proceeds to FATCA withholding. In its preamble to such proposed U.S. Treasury Regulations, the U.S. Treasury stated that taxpayers (including withholding agents) can currently rely on the proposed Treasury Regulations. Under certain circumstances, a non-U.S. holder may be eligible for refunds or credits of this withholding tax. An intergovernmental agreement between the United States and an applicable foreign country may modify the requirements described in this paragraph. Non-U.S. holders should consult their tax advisors regarding the possible implications of this legislation on their investment in our common stock and the entities through which they hold our common stock, including, without limitation, the process and deadlines for meeting the applicable requirements to prevent the imposition of the 30% withholding tax under FATCA.
Underwriting
We are offering the shares of common stock described in this prospectus through a number of underwriters. J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Cowen and Company, LLC are acting as joint book-running managers of the offering and as representatives of the underwriters. We have entered into an underwriting agreement with the underwriters. Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to the underwriters, and each underwriter has severally agreed to purchase, at the public offering price less the underwriting discounts and commissions set forth on the cover page of this prospectus, the number of shares of common stock listed next to its name in the following table:
Name
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|
|
Number of shares
|
|
J.P. Morgan Securities LLC
|
|
|
|
|
Goldman Sachs & Co. LLC
|
|
|
|
|
Cowen and Company, LLC
|
|
|
|
|
Wedbush Securities Inc.
|
|
|
|
|
Total
|
|
|
|
|
The underwriters are committed to purchase all the common shares offered by us if they purchase any shares. The underwriting agreement also provides that if an underwriter defaults, the purchase commitments of non-defaulting underwriters may also be increased or the offering may be terminated. The offering of the shares by the underwriters is subject to receipt and acceptance and subject to the underwriters’ right to reject any order in whole or in part.
The underwriters propose to offer the common stock directly to the public at the initial public offering price set forth on the cover page of this prospectus and to certain dealers at that price less a concession not in excess of $ per share. After the initial offering of the shares to the public, if all of the shares of common stock are not sold at the initial public offering price, the underwriters may change the offering price and the other selling terms.
The underwriters have an option to buy up to 1,102,941 additional shares of common stock from us to cover sales of shares by the underwriters which exceed the number of shares specified in the table above. The underwriters have 30 days from the date of this prospectus to exercise this option to purchase additional shares. If any shares are purchased with this option to purchase additional shares, the underwriters will purchase shares in approximately the same proportion as shown in the table above. If any additional shares of common stock are purchased, the underwriters will offer the additional shares on the same terms as those on which the shares are being offered.
The underwriting discount is equal to the public offering price per share of common stock less the amount paid by the underwriters to us per share of common stock. The underwriting discount is $ per share. The following table shows the per share and total underwriting discounts and commissions to be paid to the underwriters assuming both no exercise and full exercise of the underwriters’ option to purchase additional shares.
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|
|
Without exercise of option to purchase additional shares
|
|
|
With full exercise of option to purchase additional shares
|
|
Per Share
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
|
Total
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
|
We estimate that the total expenses of this offering, including registration, filing and listing fees, printing fees and legal and accounting expenses, but excluding the underwriting discounts and commissions, will be approximately $3.3 million. We have also agreed to reimburse the underwriters for certain of their expenses.
A prospectus in electronic format may be made available on the websites maintained by one or more underwriters, or selling group members, if any, participating in the offering. The underwriters may agree to allocate a number of shares to underwriters and selling group members for sale to their online brokerage account holders. Internet distributions will be allocated by the representatives to underwriters and selling group members that may make Internet distributions on the same basis as other allocations.
We have agreed that, subject to certain limited exceptions, we will not (1) offer, pledge, announce the intention to sell, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase or otherwise dispose of, directly or indirectly, or file with, or submit to, the Securities and Exchange Commission a registration statement under the Securities Act relating to, any shares of our common stock or securities convertible into or exchangeable or exercisable for any shares of our common stock, or publicly disclose the intention to make any offer, sale, pledge, disposition, submission or filing, or (2) enter into any swap or other arrangement that transfers all or a portion of the economic consequences associated with the ownership of any shares of common stock or any such other securities (regardless of whether any of these transactions are to be settled by the delivery of shares of common stock or such other securities, in cash or otherwise), in each case without the prior written consent of J.P. Morgan Securities LLC and Goldman Sachs & Co. LLC for a period of 180 days after the date of this prospectus.
Our directors and executive officers, and substantially all of our securityholders have entered into lock-up agreements with the underwriters prior to the commencement of this offering pursuant to which each of these persons or entities, with limited exceptions, for a period of 180 days after the date of this prospectus, may not, without the prior written consent of the representatives, (1) offer, pledge, announce the intention to sell, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares of our common stock or any securities convertible into or exercisable or exchangeable for our common stock (including, without limitation, common stock or such other securities which may be deemed to be beneficially owned by such directors, executive officers, managers and members in accordance with the rules and regulations of the SEC and securities which may be issued upon exercise of a stock option or warrant); or (2) enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the common stock or such other securities, whether any such transaction described in clause (1) or (2) above is to be settled by delivery of common stock or such other securities, in cash or otherwise; or (3) make any demand for or exercise any right with respect to the registration of any shares of our common stock or any security convertible into or exercisable or exchangeable for our common stock.
The restrictions described in the immediately preceding paragraph do not apply to, subject to certain limitations:
•
transfers of shares of common stock or any security convertible into common stock as a bona fide gift or gifts, or to a charitable organization or educational institution in a transaction not involving a disposition for value;
•
transfers, distributions or dispositions of shares of common stock to members or stockholders of the transferor, any member of the immediate family of the transferor or any trust for the direct or indirect benefit of the transferor or the immediate family of the transferor in a transaction not involving a disposition for value;
•
transactions relating to shares of common stock or other securities acquired in the public offering of the securities offered by this prospectus (other than any issuer-directed shares of common stock purchased in the public offering of the securities offered by this prospectus by an officer or director of the company) or in open market transactions after the pricing of the public offering of the securities offered by this prospectus;
•
transfers or dispositions of shares of common stock or other securities to any corporation, partnership, limited liability company or other entity, in each case, all of the beneficial ownership interests of which are held by the transferor or the immediate family of the transferor in a transaction not involving a disposition for value;
•
transfers or dispositions of shares of common stock or other securities (x) by will, other testamentary document or intestate succession to the legal representative, heir, beneficiary or a member of the immediate family of the transferor upon the death of the transferor, or (y) by operation of law pursuant to a domestic order or negotiated divorce settlement;
•
transfers or dispositions of common stock or any security convertible into or exercisable or exchangeable for common stock to us pursuant to any contractual arrangement in effect on the date of such lock-up agreement that provides for the repurchase of the transferor’s common stock or other securities by us or in connection with the termination of the transferor’s employment with or service to us;
•
transfers or dispositions of shares of common stock or other securities to us in connection with the conversion of any convertible preferred stock into, or the exercise of any option or warrant for, shares of common stock;
•
transfers or dispositions of shares of common stock or other securities to a nominee or custodian of a person or entity to whom a disposition or transfer would be permissible under the seven preceding paragraphs;
•
the establishment of a trading plan pursuant to Rule 10b5-1 under the Exchange Act for the transfer of shares of common stock; or
•
transfers or dispositions of shares of common stock or such other securities pursuant to a bona fide tender offer for shares of our capital stock, merger, consolidation or other similar transaction made to all holders of our securities involving a change of control (as defined in the lock-up agreement) of us (including, without limitation, the entering into of any lock-up, voting or similar agreement pursuant to which the transferor may agree to transfer, sell, tender or otherwise dispose of shares of common stock or other securities in connection with such transaction) that has been approved by our board of directors.
We have agreed to indemnify the underwriters against certain liabilities, including liabilities under the Securities Act.
We have applied to list our common stock on the Nasdaq Global Market under the symbol “SWTX.”
In connection with this offering, the underwriters may engage in stabilizing transactions, which involves making bids for, purchasing and selling shares of common stock in the open market for the purpose of preventing or retarding a decline in the market price of the common stock while this offering is in progress. These stabilizing transactions may include making short sales of the common stock, which involves the sale by the underwriters of a greater number of shares of common stock than they are required to purchase in this offering, and purchasing shares of
common stock on the open market to cover positions created by short sales. Short sales may be “covered” shorts, which are short positions in an amount not greater than the underwriters’ option to purchase additional shares referred to above, or may be “naked” shorts, which are short positions in excess of that amount. The underwriters may close out any covered short position either by exercising their option to purchase additional shares, in whole or in part, or by purchasing shares in the open market. In making this determination, the underwriters will consider, among other things, the price of shares available for purchase in the open market compared to the price at which the underwriters may purchase shares through the option to purchase additional shares. A naked short position is more likely to be created if the underwriters are concerned that there may be downward pressure on the price of the common stock in the open market that could adversely affect investors who purchase in this offering. To the extent that the underwriters create a naked short position, they will purchase shares in the open market to cover the position.
The underwriters have advised us that, pursuant to Regulation M of the Securities Act, they may also engage in other activities that stabilize, maintain or otherwise affect the price of the common stock, including the imposition of penalty bids. This means that if the representatives of the underwriters purchase common stock in the open market in stabilizing transactions or to cover short sales, the representatives can require the underwriters that sold those shares as part of this offering to repay the underwriting discount received by them.
These activities may have the effect of raising or maintaining the market price of the common stock or preventing or retarding a decline in the market price of the common stock, and, as a result, the price of the common stock may be higher than the price that otherwise might exist in the open market. If the underwriters commence these activities, they may discontinue them at any time. The underwriters may carry out these transactions on the Nasdaq Global Market, in the over-the-counter market or otherwise.
Prior to this offering, there has been no public market for our common stock. The initial public offering price will be determined by negotiations between us and the representatives of the underwriters. In determining the initial public offering price, we and the representatives of the underwriters expect to consider a number of factors including:
•
the information set forth in this prospectus and otherwise available to the representatives;
•
our prospects and the history and prospects for the industry in which we compete;
•
an assessment of our management;
•
our prospects for future earnings;
•
the general condition of the securities markets at the time of this offering;
•
the recent market prices of, and demand for, publicly traded common stock of generally comparable companies; and
•
other factors deemed relevant by the underwriters and us.
Neither we nor the underwriters can assure investors that an active trading market will develop for our common stock, or that the shares will trade in the public market at or above the initial public offering price.
Other relationships
The underwriters and their respective affiliates are full service financial institutions engaged in various activities, which may include sales and trading, commercial and investment banking, advisory, investment management, investment research, principal investment, hedging, market making, brokerage and other financial and non-financial activities and services. Certain of the underwriters and their respective affiliates have provided, and may in the future provide, a variety of these services to the issuer and to persons and entities with relationships with the issuer, for which they received or will receive customary fees and expenses.
In the ordinary course of their various business activities, the underwriters and their respective affiliates, officers, directors and employees may purchase, sell or hold a broad array of investments and actively traded securities, derivatives, loans, commodities, currencies, credit default swaps and other financial instruments for their own account and for the accounts of their customers, and such investment and trading activities may involve or relate to assets, securities and/or instruments of the issuer (directly, as collateral securing other obligations or otherwise) and/or persons and entities with relationships with the issuer. The underwriters and their respective affiliates may also communicate independent investment recommendations, market color or trading ideas and/or publish or express independent research views in respect of such assets, securities or instruments and may at any time hold, or recommend to clients that they should acquire, long and/or short positions in such assets, securities and instruments.
Selling restrictions
Other than in the United States, no action has been taken by us or the underwriters that would permit a public offering of the securities offered by this prospectus in any jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in connection with the offer and sale of any such securities be distributed or published in any jurisdiction, except under circumstances that will result in compliance with the applicable rules and regulations of that jurisdiction. Persons into whose possession this prospectus comes are advised to inform themselves about and to observe any restrictions relating to the offering and the distribution of this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities offered by this prospectus in any jurisdiction in which such an offer or a solicitation is unlawful.
Notice to prospective investors in the European Economic Area
In relation to each Member State of the European Economic Area (each, a “Relevant Member State”), no offer of shares may be made to the public in that Relevant Member State other than:
A.
to any legal entity which is a qualified investor as defined in the Prospectus Directive;
B.
to fewer than 150, natural or legal persons (other than qualified investors as defined in the Prospectus Directive), subject to obtaining the prior consent of the representatives; or
C.
in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided that no such offer of shares shall require the company or the representatives to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive and each person who initially acquires any shares or to whom any offer is made will be deemed to have represented, acknowledged and agreed to and with each of the underwriters and the Company that it is a “qualified investor” within the meaning of the law in that Relevant Member State implementing Article 2(1)(e) of the Prospectus Directive.
In the case of any shares being offered to a financial intermediary as that term is used in Article 3(2) of the Prospectus Directive, each such financial intermediary will be deemed to have represented, acknowledged and agreed that the shares acquired by it in the offer have not been acquired on a non-discretionary basis on behalf of, nor have they been acquired with a view to their offer or resale to, persons in circumstances which may give rise to an offer of any shares to the public other than their offer or resale in a Relevant Member State to qualified investors as so defined or in circumstances in which the prior consent of the representatives has been obtained to each such proposed offer or resale.
For the purpose of the above provisions, the expression “an offer to the public” in relation to any shares in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the shares to be offered so as to enable an investor to decide to purchase or subscribe the shares, as the same may be varied in the Relevant Member State by any measure implementing the Prospectus Directive in the Relevant Member State and the expression “Prospectus Directive” means Directive 2003/71/EC (including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member States) and includes any relevant implementing measure in the Relevant Member State and the expression “2010 PD Amending Directive” means Directive 2010/73/EU.
Notice to prospective investors in the United Kingdom
In addition, in the United Kingdom, this document is being distributed only to, and is directed only at, and any offer subsequently made may only be directed at persons who are “qualified investors” (as defined in the Prospectus Directive) (1) who have professional experience in matters relating to investments falling within Article 19 (5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) and/or (2) who are high net worth companies (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”) or otherwise in circumstances which have not resulted and will not result in an offer to the public of the shares in the United Kingdom within the meaning of the Financial Services and Markets Act 2000.
Any person in the United Kingdom that is not a relevant person should not act or rely on the information included in this document or use it as basis for taking any action. In the United Kingdom, any investment or investment activity that this document relates to may be made or taken exclusively by relevant persons. Any person in the United Kingdom that is not a relevant person should not act or rely on this document or any of its contents.
Notice to prospective investors in Canada
The shares may be sold only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale of the shares must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of applicable securities laws.
Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory for particulars of these rights or consult with a legal advisor.
Pursuant to section 3A.3 of National Instrument 33-105 Underwriting Conflicts, or NI 33-105, the underwriters are not required to comply with the disclosure requirements of NI 33-105 regarding underwriter conflicts of interest in connection with this offering.
Notice to prospective investors in Switzerland
The shares may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange, or the SIX, or on any other stock exchange or regulated trading facility in Switzerland. This document has been prepared without regard to the disclosure standards for issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this document nor any other offering or marketing material relating to the shares or the offering may be publicly distributed or otherwise made publicly available in Switzerland.
Neither this document nor any other offering or marketing material relating to this offering, our Company, or the shares have been or will be filed with or approved by any Swiss regulatory authority. In particular, this document will not be filed with, and the offer of shares will not be supervised by, the Swiss Financial Market Supervisory Authority, and the offer of shares has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes, or CISA. The investor protection afforded to acquirers of interests in collective investment schemes under the CISA does not extend to acquirers of shares.
Notice to prospective investors in the Dubai International Financial Centre
This prospectus relates to an Exempt Offer in accordance with the Offered Securities Rules of the Dubai Financial Services Authority, or DFSA. This prospectus is intended for distribution only to persons of a type specified in the Offered Securities Rules of the DFSA. It must not be delivered to, or relied on by, any other person. The DFSA has no responsibility for reviewing or verifying any documents in connection with Exempt Offers. The DFSA has not approved this prospectus nor taken steps to verify the information set forth herein and has no responsibility for this prospectus. The shares to which this prospectus relates may be illiquid and/or subject to restrictions on their resale. Prospective purchasers of the shares offered should conduct their own due diligence on the shares. If you do not understand the contents of this prospectus you should consult an authorized financial advisor.
Notice to prospective investors in the United Arab Emirates
The shares have not been, and are not being, publicly offered, sold, promoted or advertised in the United Arab Emirates (including the Dubai International Financial Centre) other than in compliance with the laws of the United Arab Emirates (and the Dubai International Financial Centre) governing the issue, offering and sale of securities. Further, this prospectus does not constitute a public offer of securities in the United Arab Emirates (including the Dubai International Financial Centre) and is not intended to be a public offer. This prospectus has not been approved by or filed with the Central Bank of the United Arab Emirates, the Securities and Commodities Authority or the Dubai Financial Services Authority.
Notice to prospective investors in Australia
This prospectus:
•
does not constitute a product disclosure document or a prospectus under Chapter 6D.2 of the Corporations Act 2001 (Cth), or the Corporations Act;
•
has not been, and will not be, lodged with the Australian Securities and Investments Commission, or ASIC, as a disclosure document for the purposes of the Corporations Act and does not purport to include the information required of a disclosure document under Chapter 6D.2 of the Corporations Act;
•
does not constitute or involve a recommendation to acquire, an offer or invitation for issue or sale, an offer or invitation to arrange the issue or sale, or an issue or sale, of interests to a “retail client” (as defined in section 761G of the Corporations Act and applicable regulations) in Australia; and
•
may only be provided in Australia to select investors who are able to demonstrate that they fall within one or more of the categories of investors, or Exempt Investors, available under section 708 of the Corporations Act.
The shares may not be directly or indirectly offered for subscription or purchased or sold, and no invitations to subscribe for or buy the shares may be issued, and no draft or definitive offering memorandum, advertisement or other offering material relating to any shares may be distributed in Australia, except where disclosure to investors is not required under Chapter 6D of the Corporations Act or is otherwise in compliance with all applicable Australian laws and regulations. By submitting an application for the shares, you represent and warrant to us that you are an Exempt Investor.
As any offer of shares under this document will be made without disclosure in Australia under Chapter 6D.2 of the Corporations Act, the offer of those securities for resale in Australia within 12 months may, under section 707 of the Corporations Act, require disclosure to investors under Chapter 6D.2 if none of the exemptions in section 708 applies to that resale. By applying for the shares you undertake to us that you will not, for a period of 12 months from the date of issue of the shares, offer, transfer, assign or otherwise alienate those securities to investors in Australia except in circumstances where disclosure to investors is not required under Chapter 6D.2 of the Corporations Act or where a compliant disclosure document is prepared and lodged with ASIC.
Notice to prospective investors in Japan
The shares have not been and will not be registered pursuant to Article 4, Paragraph 1 of the Financial Instruments and Exchange Act. Accordingly, none of the shares nor any interest therein may be offered or sold, directly or indirectly, in Japan or to, or for the benefit of, any “resident” of Japan (which term as used herein means any person resident in Japan, including any corporation or other entity organized under the laws of Japan), or to others for re-offering or resale, directly or indirectly, in Japan or to or for the benefit of a resident of Japan, except pursuant to an exemption from the registration requirements of, and otherwise in compliance with, the Financial Instruments and Exchange Act and any other applicable laws, regulations and ministerial guidelines of Japan in effect at the relevant time.
Notice to prospective investors in Hong Kong
The shares have not been offered or sold, and will not be offered or sold, in Hong Kong, by means of any document, other than (a) to “professional investors” as defined in the SFO (Cap. 571) of Hong Kong and any rules made under that Ordinance; or (b) in other circumstances which do not result in the document being a “prospectus” as defined in the Companies Ordinance (Cap. 32) of Hong Kong or which do not constitute an offer to the public within the meaning of that Ordinance. No advertisement, invitation or document relating to the shares has been or may be issued or has been or may be in the possession of any person for the purposes of issue, whether in Hong Kong or elsewhere, which is directed at, or the contents of which are likely to be accessed or read by, the public of Hong Kong (except if permitted to do so under the
securities laws of Hong Kong) other than with respect to shares which are or are intended to be disposed of only to persons outside Hong Kong or only to “professional investors” as defined in the SFO and any rules made under that Ordinance.
Notice to prospective investors in Singapore
This prospectus has not been registered as a prospectus with the MAS. Accordingly, this prospectus and any other document or material in connection with the offer or sale, or invitation for subscription or purchase, of shares may not be circulated or distributed, nor may the shares be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore other than (i) to an institutional investor under Section 274 of the SFA, Chapter 289 of Singapore, or the SFA, (ii) to a relevant person pursuant to Section 275(1), or any person pursuant to Section 275(1A), and in accordance with the conditions specified in Section 275, of the SFA, or (iii) otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the SFA.
Where the shares are subscribed or purchased under Section 275 of the SFA by a relevant person which is:
(a)
a corporation (which is not an accredited investor (as defined in Section 4A of the SFA)) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor; or
(b)
a trust (where the trustee is not an accredited investor) whose sole purpose is to hold investments and each beneficiary of the trust is an individual who is an accredited investor, securities (as defined in Section 239(1) of the SFA) of that corporation or the beneficiaries’ rights and interest (howsoever described) in that trust shall not be transferred within six months after that corporation or that trust has acquired the shares pursuant to an offer made under Section 275 of the SFA except:
(a)
to an institutional investor or to a relevant person defined in Section 275(2) of the SFA, or to any person arising from an offer referred to in Section 275(1A) or Section 276(4)(i)(B) of the SFA;
(b)
where no consideration is or will be given for the transfer;
(c)
where the transfer is by operation of law;
(d)
as specified in Section 276(7) of the SFA; or
(e)
as specified in Regulation 32 of the Securities and Futures (Offers of Investments) (Shares and Debentures) Regulations 2005 of Singapore.
Notice to prospective investors in Bermuda
Shares may be offered or sold in Bermuda only in compliance with the provisions of the Investment Business Act of 2003 of Bermuda which regulates the sale of securities in Bermuda. Additionally, non-Bermudian persons (including companies) may not carry on or engage in any trade or business in Bermuda unless such persons are permitted to do so under applicable Bermuda legislation.
Notice to prospective investors in Saudi Arabia
This document may not be distributed in the Kingdom of Saudi Arabia except to such persons as are permitted under the Offers of Securities Regulations as issued by the board of the Saudi Arabian Capital Market Authority, or the CMA, pursuant to resolution number 2-11-2004 dated
4 October 2004 as amended by resolution number 1-28-2008, as amended, or the CMA Regulations. The CMA does not make any representation as to the accuracy or completeness of this document and expressly disclaims any liability whatsoever for any loss arising from, or incurred in reliance upon, any part of this document. Prospective purchasers of the securities offered hereby should conduct their own due diligence on the accuracy of the information relating to the securities. If you do not understand the contents of this document, you should consult an authorized financial adviser.
Notice to prospective investors in the British Virgin Islands
The shares are not being, and may not be offered to the public or to any person in the British Virgin Islands for purchase or subscription by or on behalf of the Company. The Company may be offered to companies incorporated under the BVI Business Companies Act, 2004 (British Virgin Islands), but only where the offer will be made to, and received by, the relevant BVI Company entirely outside of the British Virgin Islands. This prospectus has not been, and will not be, registered with the Financial Services Commission of the British Virgin Islands. No registered prospectus has been or will be prepared in respect of the shares for the purposes of the Securities and Investment Business Act, 2010 or the Public Issuers Code of the British Virgin Islands.
Notice to prospective investors in China
This prospectus does not constitute a public offer of shares, whether by sale or subscription, in the People’s Republic of China, or the PRC. The shares are not being offered or sold directly or indirectly in the PRC to or for the benefit of, legal or natural persons of the PRC.
Further, no legal or natural persons of the PRC may directly or indirectly purchase any of the shares or any beneficial interest therein without obtaining all prior PRC’s governmental approvals that are required, whether statutorily or otherwise. Persons who come into possession of this document are required by the issuer and its representatives to observe these restrictions.
Notice to prospective investors in Korea
The shares have not been and will not be registered under the Financial Investments Services and Capital Markets Act of Korea and the decrees and regulations thereunder, or the FSCMA, and the shares have been and will be offered in Korea as a private placement under the FSCMA. None of the shares may be offered, sold or delivered directly or indirectly, or offered or sold to any person for re-offering or resale, directly or indirectly, in Korea or to any resident of Korea except pursuant to the applicable laws and regulations of Korea, including the FSCMA and the Foreign Exchange Transaction Law of Korea and the decrees and regulations thereunder, or the FETL. Furthermore, the purchaser of the shares shall comply with all applicable regulatory requirements (including but not limited to requirements under the FETL) in connection with the purchase of the shares. By the purchase of the shares, the relevant holder thereof will be deemed to represent and warrant that if it is in Korea or is a resident of Korea, it purchased the shares pursuant to the applicable laws and regulations of Korea.
Notice to prospective investors in Malaysia
No prospectus or other offering material or document in connection with the offer and sale of the shares has been or will be registered with the Securities Commission of Malaysia, or the Commission, for the Commission’s approval pursuant to the Capital Markets and Services Act 2007. Accordingly, this prospectus and any other document or material in connection with the offer or sale, or invitation for subscription or purchase, of the shares may not be circulated or distributed, nor may the shares be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Malaysia other than
(1) a closed end fund approved by the Commission, (2) a holder of a Capital Markets Services License, (3) a person who acquires the shares, as principal, if the offer is on terms that the shares may only be acquired at a consideration of not less than RM250,000 (or its equivalent in foreign currencies) for each transaction, (4) an individual whose total net personal assets or total net joint assets with his or her spouse exceeds RM3 million (or its equivalent in foreign currencies), excluding the value of the primary residence of the individual, (5) an individual who has a gross annual income exceeding RM300,000 (or its equivalent in foreign currencies) per annum in the preceding 12 months, (6) an individual who, jointly with his or her spouse, has a gross annual income of RM400,000 (or its equivalent in foreign currencies), per annum in the preceding 12 months, (7) a corporation with total net assets exceeding RM10 million (or its equivalent in a foreign currencies) based on the last audited accounts, (8) a partnership with total net assets exceeding RM10 million (or its equivalent in foreign currencies), (9) a bank licensee or insurance licensee as defined in the Labuan Financial Services and Securities Act 2010, (10) an Islamic bank licensee or takaful licensee as defined in the Labuan Financial Services and Securities Act 2010, and (11) any other person as may be specified by the Commission; provided that, in the each of the preceding categories (1) to (11), the distribution of the shares is made by a holder of a Capital Markets Services Licence who carries on the business of dealing in securities. The distribution in Malaysia of this prospectus is subject to Malaysian laws. This prospectus does not constitute and may not be used for the purpose of public offering or an issue, offer for subscription or purchase, invitation to subscribe for or purchase any securities requiring the registration of a prospectus with the Commission under the Capital Markets and Services Act 2007.
Notice to prospective investors in Taiwan
The shares have not been and will not be registered with the Financial Supervisory Commission of Taiwan pursuant to relevant securities laws and regulations and may not be sold, issued or offered within Taiwan through a public offering or in circumstances which constitutes an offer within the meaning of the Securities and Exchange Act of Taiwan that requires a registration or approval of the Financial Supervisory Commission of Taiwan. No person or entity in Taiwan has been authorized to offer, sell, give advice regarding or otherwise intermediate the offering and sale of the shares in Taiwan.
Notice to prospective investors in South Africa
Due to restrictions under the securities laws of South Africa, the shares are not offered, and the offer shall not be transferred, sold, renounced or delivered, in South Africa or to a person with an address in South Africa, unless one or other of the following exemptions applies:
(1)
the offer, transfer, sale, renunciation or delivery is to:
(a)
persons whose ordinary business is to deal in securities, as principal or agent;
(b)
the South African Public Investment Corporation;
(c)
persons or entities regulated by the Reserve Bank of South Africa;
(d)
authorized financial service providers under South African law;
(e)
financial institutions recognized as such under South African law;
(f)
a wholly owned subsidiary of any person or entity contemplated in (c), (d) or (e), acting as agent in the capacity of an authorized portfolio manager for a pension fund or collective investment scheme (in each case duly registered as such under South African law); or
(g)
any combination of the person in (a) to (f); or
(2)
the total contemplated acquisition cost of the securities, for any single addressee acting as principal is equal to or greater than ZAR1,000,000.
No “offer to the public” (as such term is defined in the South African Companies Act, No. 71 of 2008 (as amended or re-enacted), or the South African Companies Act, in South Africa is being made in connection with the issue of the shares. Accordingly, this document does not, nor is it intended to, constitute a “registered prospectus” (as that term is defined in the South African Companies Act) prepared and registered under the South African Companies Act and has not been approved by, and/or filed with, the South African Companies and Intellectual Property Commission or any other regulatory authority in South Africa. Any issue or offering of the shares in South Africa constitutes an offer of the shares in South Africa for subscription or sale in South Africa only to persons who fall within the exemption from “offers to the public” set out in section 96(1)(a) of the South African Companies Act. Accordingly, this document must not be acted on or relied on by persons in South Africa who do not fall within section 96(1)(a) of the South African Companies Act (such persons being referred to as “SA Relevant Persons”). Any investment or investment activity to which this document relates is available in South Africa only to SA Relevant Persons and will be engaged in South Africa only with SA relevant persons.
Notice to prospective investors in Israel
In the State of Israel this prospectus shall not be regarded as an offer to the public to purchase shares of common stock under the Israeli Securities Law, 5728 – 1968, which requires a prospectus to be published and authorized by the Israel Securities Authority, if it complies with certain provisions of Section 15 of the Israeli Securities Law, 5728 – 1968, including, inter alia, if: (i) the offer is made, distributed or directed to not more than 35 investors, subject to certain conditions (the “Addressed Investors”); or (ii) the offer is made, distributed or directed to certain qualified investors defined in the First Addendum of the Israeli Securities Law, 5728 – 1968, subject to certain conditions (the “Qualified Investors”). The Qualified Investors shall not be taken into account in the count of the Addressed Investors and may be offered to purchase securities in addition to the 35 Addressed Investors. The company has not and will not take any action that would require it to publish a prospectus in accordance with and subject to the Israeli Securities Law, 5728 – 1968. We have not and will not distribute this prospectus or make, distribute or direct an offer to subscribe for our common stock to any person within the State of Israel, other than to Qualified Investors and up to 35 Addressed Investors.
Qualified Investors may have to submit written evidence that they meet the definitions set out in of the First Addendum to the Israeli Securities Law, 5728 – 1968. In particular, we may request, as a condition to be offered common stock, that Qualified Investors will each represent, warrant and certify to us and/or to anyone acting on our behalf: (i) that it is an investor falling within one of the categories listed in the First Addendum to the Israeli Securities Law, 5728 – 1968; (ii) which of the categories listed in the First Addendum to the Israeli Securities Law, 5728 – 1968 regarding Qualified Investors is applicable to it; (iii) that it will abide by all provisions set forth in the Israeli Securities Law, 5728 – 1968 and the regulations promulgated thereunder in connection with the offer to be issued common stock; (iv) that the shares of common stock that it will be issued are, subject to exemptions available under the Israeli Securities Law, 5728 – 1968: (a) for its own account; (b) for investment purposes only; and (c) not issued with a view to resale within the State of Israel, other than in accordance with the provisions of the Israeli Securities Law,
5728 – 1968; and (v) that it is willing to provide further evidence of its Qualified Investor status. Addressed Investors may have to submit written evidence in respect of their identity and may have to sign and submit a declaration containing, inter alia, the Addressed Investor’s name, address and passport number or Israeli identification number.
Legal Matters
The validity of the shares of common stock offered by this prospectus will be passed upon for us by Goodwin Procter LLP, Boston, Massachusetts. Cooley LLP, New York, New York, is acting as counsel to the underwriters in connection with this offering.
Experts
The consolidated financial statements of SpringWorks Therapeutics, LLC at December 31, 2017 and 2018, and for the period from August 18, 2017 (inception) through December 31, 2017 and the year ended December 31, 2018, appearing in this Prospectus and Registration Statement have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon appearing elsewhere herein, and are included in reliance upon such report given on the authority of such firm as experts in accounting and auditing.
Where You can Find More Information
We have filed with the SEC a registration statement on Form S-1 (File Number 333-233351) under the Securities Act with respect to the common stock we are offering by this prospectus. This prospectus does not contain all of the information included in the registration statement. For further information pertaining to us and our common stock, you should refer to the registration statement and to its exhibits. Whenever we make reference in this prospectus to any of our contracts, agreements or other documents, the references are not necessarily complete, and you should refer to the exhibits attached to the registration statement for copies of the actual contract, agreement or other document.
Upon the completion of the offering, we will be subject to the informational requirements of the Exchange Act and will file annual, quarterly and current reports, proxy statements and other information with the SEC. You can read our SEC filings, including the registration statement, at the SEC’s website at www.sec.gov. We also maintain a website at http://www.springworkstx.com. Upon completion of the offering, you may access, free of charge, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendment to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC.
Index to Consolidated Financial Statements
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F-2
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F-3
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F-4
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F-5
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F-6
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F-7
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|
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Report of independent registered public accounting firm
To the Stockholders and the Board of Directors of SpringWorks Therapeutics, Inc. (formerly SpringWorks Therapeutics, LLC)
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of SpringWorks Therapeutics, LLC and Subsidiaries (“the Company”) as of December 31, 2018 and 2017, the related consolidated statements of operations and comprehensive loss, convertible preferred units and members’ deficit and cash flows for the year ended December 31, 2018 and for the period from August 18, 2017 (inception) through December 31, 2017, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2018 and 2017, and the results of its operations and its cash flows for the year ended December 31, 2018 and for the period from August 18, 2017 (inception) through December 31, 2017 in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risk of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2018.
New York, New York
June 7, 2019, except for the section entitled “Reverse stock split” in Note 16, as to which the date is September 3, 2019
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Consolidated Balance Sheets
|
|
|
December 31,
|
|
|
June 30, 2019
|
|
|
Pro Forma June 30, 2019
|
|
(in thousands, except share, unit, per-share and per-unit data)
|
|
|
2017
|
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$ |
10,271 |
|
|
|
|
$ |
45,648 |
|
|
|
|
$ |
185,291 |
|
|
|
|
$ |
185,291 |
|
|
Prepaid expenses and other current assets
|
|
|
|
|
270 |
|
|
|
|
|
1,382 |
|
|
|
|
|
2,888 |
|
|
|
|
|
2,888 |
|
|
Total current assets
|
|
|
|
|
10,541 |
|
|
|
|
|
47,030 |
|
|
|
|
|
188,179 |
|
|
|
|
|
188,179 |
|
|
Property and equipment, net
|
|
|
|
|
41 |
|
|
|
|
|
317 |
|
|
|
|
|
799 |
|
|
|
|
|
799 |
|
|
Equity investment in MapKure
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
3,500 |
|
|
|
|
|
3,500 |
|
|
Other assets
|
|
|
|
|
— |
|
|
|
|
|
1,043 |
|
|
|
|
|
2,154 |
|
|
|
|
|
2,154 |
|
|
Total assets
|
|
|
|
$ |
10,582 |
|
|
|
|
$ |
48,390 |
|
|
|
|
$ |
194,632 |
|
|
|
|
$ |
194,632 |
|
|
Liabilities, Convertible Preferred Stock and Stockholders’ (Deficit) Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
|
$ |
283 |
|
|
|
|
$ |
774 |
|
|
|
|
$ |
2,144 |
|
|
|
|
$ |
2,144 |
|
|
Accrued expenses
|
|
|
|
|
370 |
|
|
|
|
|
2,568 |
|
|
|
|
|
7,534 |
|
|
|
|
|
7,534 |
|
|
Deferred rent
|
|
|
|
|
— |
|
|
|
|
|
335 |
|
|
|
|
|
349 |
|
|
|
|
|
349 |
|
|
Total current liabilities
|
|
|
|
|
653 |
|
|
|
|
|
3,677 |
|
|
|
|
|
10,027 |
|
|
|
|
|
10,027 |
|
|
Long-term portion of deferred rent
|
|
|
|
|
— |
|
|
|
|
|
1,152 |
|
|
|
|
|
972 |
|
|
|
|
|
972 |
|
|
Non-current liabilities
|
|
|
|
|
— |
|
|
|
|
|
1,152 |
|
|
|
|
|
972 |
|
|
|
|
|
972 |
|
|
Total liabilities
|
|
|
|
|
653 |
|
|
|
|
|
4,829 |
|
|
|
|
|
10,999 |
|
|
|
|
|
10,999 |
|
|
Commitments and contingencies (Note 8) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible preferred stock |
|
|
|
|
|
Series A convertible preferred units, no par value, net of issuance costs; authorized 103,000,000 units at December 31, 2017 and December 31, 2018; issued and outstanding 13,200,001 and 63,600,000 units at December 31, 2017 and December 31, 2018, respectively; no units authorized, issued and outstanding at June 30, 2019
|
|
|
|
|
12,554 |
|
|
|
|
|
62,930 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Series A convertible preferred stock, $0.0001 par value; no shares authorized, issued or outstanding at December 31, 2017 and December 31, 2018; 103,000,000 shares authorized, issued and outstanding at June 30, 2019; no shares authorized, issued or outstanding at June 30, 2019, pro forma
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
92,700 |
|
|
|
|
|
— |
|
|
Series B Convertible preferred stock, $0.0001 par value, net of issuance costs; no shares authorized, issued or outstanding of December 31, 2017 or December 31, 2018; 86,639,279 shares authorized, issued and outstanding at June 30, 2019; no shares authorized, issued or outstanding at June 30, 2019, pro forma
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
124,590 |
|
|
|
|
|
— |
|
|
Stockholders’ (deficit) equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Junior Series A convertible preferred units, no par value; authorized 6,437,500 units at December 31, 2017 and December 31, 2018; issued and outstanding 6,437,500 units at December 31, 2017 and December 31, 2018; no units authorized, issued and outstanding at June 30, 2019
|
|
|
|
|
2,014 |
|
|
|
|
|
2,014 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Junior Series A convertible preferred stock, $0.0001 par value; no shares authorized, issued or outstanding at December 31, 2017 and December 31, 2018; 6,437,500 shares authorized, issued and outstanding at June 30, 2019; no shares authorized, issued or outstanding at June 30, 2019, pro forma
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
3,882 |
|
|
|
|
|
— |
|
|
Common units, no par value; 195,638 units authorized at December 31, 2017 and December 31, 2018; no units issued and outstanding at December 31, 2017; 195,638 units issued and outstanding at December 31, 2018; no units authorized, issued and outstanding at June 30, 2019
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Common stock, $0.0001 par value, no shares authorized, issued or outstanding at December 31, 2017 and December 31, 2018; 35,372,778 shares authorized, 3,088,636 shares issued and outstanding, at June 30, 2019; 32,882,995 shares authorized, 32,882,995 shares issued and outstanding, pro forma at June 30, 2019
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
3 |
|
|
Additional paid-in capital
|
|
|
|
|
— |
|
|
|
|
|
1,069 |
|
|
|
|
|
2,440 |
|
|
|
|
|
223,609 |
|
|
Accumulated deficit
|
|
|
|
|
(4,639) |
|
|
|
|
|
(22,452) |
|
|
|
|
|
(39,979) |
|
|
|
|
|
(39,979) |
|
|
Total stockholders’ (deficit) equity
|
|
|
|
|
(2,625) |
|
|
|
|
|
(19,369) |
|
|
|
|
|
(33,657) |
|
|
|
|
|
183,633 |
|
|
Total liabilities, convertible preferred stock and stockholders’ (deficit) equity
|
|
|
|
$ |
10,582 |
|
|
|
|
$ |
48,390 |
|
|
|
|
$ |
194,632 |
|
|
|
|
$ |
194,632 |
|
|
|
See accompanying notes to consolidated financial statements.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except unit and share data)
|
|
|
Period from August 18, 2017 (Inception) to December 31, 2017
|
|
|
Year Ended December 31, 2018
|
|
|
Six Months Ended June 30,
|
|
|
2018
|
|
|
2019
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
$ |
2,799 |
|
|
|
|
$ |
9,898 |
|
|
|
|
$ |
2,786 |
|
|
|
|
$ |
19,628 |
|
|
General and administrative
|
|
|
|
|
1,861 |
|
|
|
|
|
8,593 |
|
|
|
|
|
4,028 |
|
|
|
|
|
6,911 |
|
|
Total operating expenses
|
|
|
|
|
4,660 |
|
|
|
|
|
18,491 |
|
|
|
|
|
6,814 |
|
|
|
|
|
26,539 |
|
|
Loss from operations
|
|
|
|
|
(4,660) |
|
|
|
|
|
(18,491) |
|
|
|
|
|
(6,814) |
|
|
|
|
|
(26,539) |
|
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net
|
|
|
|
|
21 |
|
|
|
|
|
678 |
|
|
|
|
|
224 |
|
|
|
|
|
1,283 |
|
|
Total other Income
|
|
|
|
|
21 |
|
|
|
|
|
678 |
|
|
|
|
|
224 |
|
|
|
|
|
1,283 |
|
|
Net loss
|
|
|
|
$ |
(4,639) |
|
|
|
|
$ |
(17,813) |
|
|
|
|
$ |
(6,590) |
|
|
|
|
$ |
(25,256) |
|
|
Reconciliation of net loss to net loss attributable to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$ |
(4,639) |
|
|
|
|
$ |
(17,813) |
|
|
|
|
$ |
(6,590) |
|
|
|
|
$ |
(25,256) |
|
|
Net gain attributable to extinguishment of Series A convertible preferred and Junior Series A convertible preferred shares
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
7,729 |
|
|
Net loss attributable to common stockholders – basic and diluted
|
|
|
|
$ |
(4,639) |
|
|
|
|
$ |
(17,813) |
|
|
|
|
$ |
(6,590) |
|
|
|
|
$ |
(17,527) |
|
|
Net loss per common unit, basic and diluted
|
|
|
|
|
— |
|
|
|
|
$ |
(52.24) |
|
|
|
|
$ |
(37.60) |
|
|
|
|
|
|
|
|
Net loss per common share attributable to common stockholders, basic and diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(22.47) |
|
|
Weighted average common units outstanding, basic and diluted
|
|
|
|
|
— |
|
|
|
|
|
341,014 |
|
|
|
|
|
175,291 |
|
|
|
|
|
|
|
|
Weighted average common shares outstanding, basic and diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
780,066 |
|
|
Pro forma net loss per share, basic and diluted (unaudited)
|
|
|
|
|
|
|
|
|
|
$ |
(2.00) |
|
|
|
|
|
|
|
|
|
|
$ |
(0.79) |
|
|
Pro forma weighted average common shares outstanding, basic and diluted (unaudited)
|
|
|
|
|
|
|
|
|
|
|
8,927,163 |
|
|
|
|
|
|
|
|
|
|
|
22,195,710 |
|
|
|
See accompanying notes to consolidated financial statements.
SpringWorks Therapeutics, Inc. and Subsidiaries (formerly SpringWorks Therapeutics, LLC)
Consolidated Statement of Convertible Preferred Unit/Stock and Members’/Stockholders’ Deficit
|
|
|
Series A convertible preferred
|
|
|
Series A and B convertible preferred
|
|
|
|
Junior Series A convertible preferred
|
|
|
Junior Series A convertible preferred
|
|
|
Common
|
|
|
Common
|
|
|
Additional Paid-In Capital
|
|
|
Accumulated Deficit
|
|
|
Total
|
|
(in thousands, except unit, share, per-unit and per-share data)
|
|
|
Units
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
|
Units
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Units
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
Balance at August 18, 2017 (Inception)
|
|
|
|
|
— |
|
|
|
|
$ |
— |
|
|
|
|
|
— |
|
|
|
|
$ |
— |
|
|
|
|
|
|
— |
|
|
|
|
$ |
— |
|
|
|
|
|
— |
|
|
|
|
$ |
— |
|
|
|
|
|
— |
|
|
|
|
$ |
— |
|
|
|
|
|
— |
|
|
|
|
$ |
— |
|
|
|
|
$ |
— |
|
|
|
|
$ |
— |
|
|
|
|
$ |
— |
|
|
Issuance of Series A convertible preferred units, net of issuance costs
|
|
|
|
|
13,200,001 |
|
|
|
|
|
12,554 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Issuance of Junior Series A convertible preferred units
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
6,437,500 |
|
|
|
|
|
2,014 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
2,014 |
|
|
Net Loss
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(4,639) |
|
|
|
|
|
(4,639) |
|
|
Balance at December 31, 2017
|
|
|
|
|
13,200,001 |
|
|
|
|
|
12,554 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
6,437,500 |
|
|
|
|
|
2,014 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(4,639) |
|
|
|
|
|
(2,625) |
|
|
Issuance of Series A convertible preferred units, net
|
|
|
|
|
50,399,999 |
|
|
|
|
|
50,376 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Issuance of common units to founders
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
195,638 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
154 |
|
|
|
|
|
— |
|
|
|
|
|
154 |
|
|
Issuance of incentive units
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
2,905,572 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
915 |
|
|
|
|
|
— |
|
|
|
|
|
915 |
|
|
Net loss
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(17,813) |
|
|
|
|
|
(17,813) |
|
|
Balance at December 31, 2018
|
|
|
|
|
63,600,000 |
|
|
|
|
|
62,930 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
6,437,500 |
|
|
|
|
|
2,014 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
3,101,210 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,069 |
|
|
|
|
|
(22,452) |
|
|
|
|
|
(19,369) |
|
|
Issuance of Series A convertible preferred shares
|
|
|
|
|
39,400,000 |
|
|
|
|
|
39,367 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Effects of Reorganization
|
|
|
|
|
(103,000,000) |
|
|
|
|
|
(102,297) |
|
|
|
|
|
103,000,000 |
|
|
|
|
|
102,297 |
|
|
|
|
|
|
(6,437,500) |
|
|
|
|
|
(2,014) |
|
|
|
|
|
6,437,500 |
|
|
|
|
|
2,014 |
|
|
|
|
|
(3,088,636) |
|
|
|
|
|
— |
|
|
|
|
|
3,088,636 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Issuance of Series B convertible preferred units, net of $413,063 in legal costs
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
86,639,279 |
|
|
|
|
|
124,590 |
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Series A convertible preferred extinguishment
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(9,597) |
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
9,597 |
|
|
|
|
|
9,597 |
|
|
Junior Series A convertible preferred extinguishment
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,868 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(1,868) |
|
|
|
|
|
— |
|
|
Stock compensation expense, net of forfeiture
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(12,570) |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,371 |
|
|
|
|
|
— |
|
|
|
|
|
1,371 |
|
|
Net Income (loss)
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(25,256) |
|
|
|
|
|
(25,256) |
|
|
Balance at June 30, 2019 .
|
|
|
|
|
— |
|
|
|
|
$ |
— |
|
|
|
|
|
189,639,279 |
|
|
|
|
$ |
217,290 |
|
|
|
|
|
|
— |
|
|
|
|
$ |
— |
|
|
|
|
|
6,437,500 |
|
|
|
|
$ |
3,882 |
|
|
|
|
|
— |
|
|
|
|
$ |
— |
|
|
|
|
|
3,088,636 |
|
|
|
|
$ |
— |
|
|
|
|
$ |
2,440 |
|
|
|
|
$ |
(39,979) |
|
|
|
|
$ |
(33,657) |
|
|
|
See accompanying notes to consolidated financial statements.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Consolidated Statements of Cash Flows
(in thousands, except unit and per-unit data)
|
|
|
Period from August 18, 2017 (Inception) to December 31, 2017
|
|
|
Year Ended December 31, 2018
|
|
|
Six Months Ended June 30,
|
|
|
2018
|
|
|
2019
|
|
Operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$ |
(4,639) |
|
|
|
|
$ |
(17,813) |
|
|
|
|
$ |
(6,590) |
|
|
|
|
$ |
(25,256) |
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense
|
|
|
|
|
3 |
|
|
|
|
|
17 |
|
|
|
|
|
6 |
|
|
|
|
|
64 |
|
|
Stock compensation expense
|
|
|
|
|
— |
|
|
|
|
|
1,069 |
|
|
|
|
|
609 |
|
|
|
|
|
1,371 |
|
|
Non-cash license expense
|
|
|
|
|
2,014 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Changes in operating assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
|
|
(270) |
|
|
|
|
|
(1,112) |
|
|
|
|
|
35 |
|
|
|
|
|
(1,506) |
|
|
Other assets
|
|
|
|
|
— |
|
|
|
|
|
(1,043) |
|
|
|
|
|
(503) |
|
|
|
|
|
(1,111) |
|
|
Accounts payable
|
|
|
|
|
283 |
|
|
|
|
|
491 |
|
|
|
|
|
871 |
|
|
|
|
|
1,370 |
|
|
Accrued expenses
|
|
|
|
|
370 |
|
|
|
|
|
2,198 |
|
|
|
|
|
1,088 |
|
|
|
|
|
4,966 |
|
|
Deferred rent
|
|
|
|
|
— |
|
|
|
|
|
1,487 |
|
|
|
|
|
— |
|
|
|
|
|
(166) |
|
|
Net cash used in operating activities
|
|
|
|
|
(2,239) |
|
|
|
|
|
(14,706) |
|
|
|
|
|
(4,484) |
|
|
|
|
|
(20,268) |
|
|
Investing activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
|
|
(44) |
|
|
|
|
|
(293) |
|
|
|
|
|
(65) |
|
|
|
|
|
(546) |
|
|
Investment in MapKure
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(3,500) |
|
|
Net cash used in investing activities
|
|
|
|
|
(44) |
|
|
|
|
|
(293) |
|
|
|
|
|
(65) |
|
|
|
|
|
(4,046) |
|
|
Financing activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of Series A convertible preferred units, net of issuance costs
|
|
|
|
|
12,554 |
|
|
|
|
|
50,376 |
|
|
|
|
|
50,400 |
|
|
|
|
|
39,367 |
|
|
Junior Series A convertible preferred units
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Proceeds from issuance of Series B convertible preferred units, net of issuance costs
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
124,590 |
|
|
Net cash provided by financing activities
|
|
|
|
|
12,554 |
|
|
|
|
|
50,376 |
|
|
|
|
|
50,400 |
|
|
|
|
|
163,957 |
|
|
Net increase in cash and cash equivalents
|
|
|
|
|
10,271 |
|
|
|
|
|
35,377 |
|
|
|
|
|
45,851 |
|
|
|
|
|
139,643 |
|
|
Cash and cash equivalents, beginning of period
|
|
|
|
|
— |
|
|
|
|
|
10,271 |
|
|
|
|
|
10,271 |
|
|
|
|
|
45,648 |
|
|
Cash and cash equivalents, end of period
|
|
|
|
$ |
10,271 |
|
|
|
|
$ |
45,648 |
|
|
|
|
$ |
56,122 |
|
|
|
|
$ |
185,291 |
|
|
|
See accompanying notes to consolidated financial statements.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
1. Nature of Operations
SpringWorks Therapeutics, Inc. was formed in Delaware on August 18, 2017 (“Inception”).
Prior to March 29, 2019, the Company conducted its business through SpringWorks Therapeutics, LLC, a Delaware limited liability company. On March 29, 2019, it completed a series of transactions pursuant to which SpringWorks MergerSub LLC, a wholly owned subsidiary of SpringWorks Therapeutics, Inc., merged with SpringWorks Therapeutics, LLC, with SpringWorks Therapeutics, LLC surviving the merger as a wholly owned subsidiary of SpringWorks Therapeutics, Inc. (the “Reorganization”).
As part of the Reorganization, each issued and outstanding convertible preferred and common unit of SpringWorks Therapeutics, LLC outstanding immediately prior to the Reorganization was exchanged for the same class and/or series of shares of SpringWorks Therapeutics, Inc. on a one-for-one basis. Previously outstanding units option and vested and unvested incentive units were exchanged for an equal number of shares of common stock or restricted common stock, respectively. The restricted stock was issued with the same vesting terms as the unvested incentive units held immediately prior to the Reorganization. For purposes of these consolidated financial statements, the “Company” refers to SpringWorks Therapeutics, LLC prior to the Reorganization, and SpringWorks Therapeutics, Inc. after the Reorganization (see Note 7).
Upon consummation of the Reorganization, the historical consolidated financial statements of SpringWorks Therapeutics, LLC became the historical consolidated financial statements of SpringWorks Therapeutics, Inc., the entity whose shares are being offered in this offering.
The Company is a clinical-stage biopharmaceutical company focused on identifying, developing and commercializing therapies for underserved patient populations suffering from severe rare diseases and cancer. The Company has a pipeline of product candidates across various stages of development, currently focused on rare disease and oncology conditions. Two of the medicines are late stage clinical product candidates: nirogacestat and mirdametinib.
2. Risks and Liquidity
The Company has incurred losses and negative operating cash flows since Inception and had an accumulated deficit of $22.5 million and $40.0 million and working capital of $43.4 million and $178.2 million at December 31, 2018 and June 30, 2019 (unaudited), respectively. The Company is subject to those risks associated with any biopharmaceutical company that has substantial expenditures for development. There can be no assurance that the Company’s development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees, advisors, and consultants.
The Company had cash and cash equivalents of $45.6 million and $185.3 million as of December 31, 2018, and June 30, 2019, (unaudited), respectively. This increase in the cash balance of approximately $139.7 million was due to the net proceeds of $39.4 million from the issuance of Series A convertible preferred units in March 2019, plus the net proceeds of $124.6 million from the issuance of Series B convertible preferred stock in March 2019 (see Note 6), net of loss
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
from operation for the six month period ended June 30, 2019. Management estimates that its cash and cash equivalents will enable it to meet operational expenses through at least twelve months after the date that the financial statements were available to be issued.
3. Summary of Significant Accounting Policies
Basis of Presentation
These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The consolidated financial statements include the accounts of the Company and all subsidiaries. All intercompany accounts and transactions have been eliminated.
Principles of Consolidation
In conjunction with the formation of the Company, five public benefit corporation (“PBC”) subsidiaries were also formed; SpringWorks Therapeutics Operating Company, PBC (“Operating Subsidiary”), SpringWorks Subsidiary 1, PBC, SpringWorks Subsidiary 2, PBC, SpringWorks Subsidiary 3, PBC, and SpringWorks Subsidiary 4, PBC, all wholly owned Delaware public benefit corporations (collectively, including the Operating Subsidiary, the “Subsidiaries”). The purpose of the Operating Subsidiary is to manage, account for and report on the operations of the Company and the Subsidiaries. The purpose for each of the other Subsidiaries is to account for the expenditures related to the development of a specific compound licensed from Pfizer Inc. (“Pfizer”), (see Note 7). The Company’s consolidated financial statements include the accounts of the Company and the Subsidiaries. In connection with the Reorganization, each of the Subsidiaries was converted from a Delaware public benefit corporation into a Delaware corporation.
The Company does not have any components of other comprehensive income recorded within its consolidated financial statements, and, therefore, does not separately present a statement of comprehensive income in its consolidated financial statements.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, accrued expenses and the valuation of equity-based awards, which includes common and incentive units, common stock, restricted stock and stock options. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions.
The Company utilizes significant estimates and assumptions in determining the fair value of its common and incentive units, common stock, restricted stock and stock options. The Company has utilized various valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately Held
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
Company Equity Securities Issued as Compensation (the “Practice Aid”) to estimate the fair value of its common units and common stock. Each valuation methodology includes estimates and assumptions that require the Company’s judgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold preferred units and convertible preferred stock, the rights and preferences of securities senior to the Company’s common and incentive units, and common stock and restricted stock at the time of, and the likelihood of, achieving a liquidity event, such as an initial public offering or sale. Significant changes to the key assumptions used in the valuations could result in different fair values at each valuation date.
Unaudited Interim Financial Information
The accompanying balance sheet as of June 30, 2019, the related statements of operations and cash flows for the six months ended June 30, 2018 and June 30, 2019 and the statements of convertible preferred stock and stockholders’ deficit for the six months ended June 30, 2019 and related footnote disclosures are unaudited. The accompanying unaudited interim financial information has been prepared from the books and records of the Company in accordance with U.S. GAAP. All adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the accompanying balance sheets, statements of operations, changes in convertible preferred stock and stockholders’ deficit and cash flows have been made. The results for the six months ended June 30, 2018 and June 30, 2019 and related footnote disclosures are unaudited and are not necessarily indicative of results to be expected for the year ending December 31, 2019, any other interim periods or any future year or period.
Unaudited Pro Forma Information
The accompanying unaudited pro forma consolidated balance sheet as of June 30, 2019 gives effect to the automatic conversion of all outstanding shares of preferred stock into 29,794,359 shares of the Company’s common stock and the resulting reclassification of the carrying value of the convertible preferred stock to stockholders’ deficit upon completion of the Company’s planned Initial Public Offering (“IPO”). The shares of common stock issuable and the proceeds expected to be received in the proposed IPO are excluded from such pro forma financial information.
The unaudited pro forma basic and diluted net loss per share in the accompanying consolidated statement of operations and comprehensive loss gives effect to the automatic conversion of all outstanding convertible preferred stock into common shares, and was computed using the weighted average number of shares of common stock outstanding, including the pro forma effect of the conversion of all outstanding shares of convertible preferred stock into shares of common stock, as if the Company’s proposed IPO had occurred on the later of January 1, 2018 or the original issuance dates of the convertible preferred stock. The unaudited pro forma net loss per share does not include the shares expected to be sold or related proceeds to be received in the proposed IPO.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
Segment Information
Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment operating exclusively in the United States.
Fair Value of Financial Instruments
Management believes that the carrying amounts of the Company’s financial instruments, including accounts payable and accrued expenses, approximate fair value due to the short-term nature of those instruments. The Company follows the provisions of Financial Accounting Standards Board (“FASB”) ASC Topic 820, “Fair Value Measurements and Disclosures” (ASC 820), for financial assets and liabilities measured on a recurring basis. This pronouncement defines fair value, establishes a framework for measuring fair value under GAAP and requires expanded disclosures about fair value measurements. The guidance requires that fair value measurements be classified in one of the following three categories:
Level 1 — Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets, or liabilities.
Level 2 — Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the instrument.
Level 3 — Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
Cash and cash equivalents of $185.3 million as of June 30, 2019 (unaudited) consist of money market funds and are measured at fair value at the reporting date using quoted prices in active markets for identical assets (Level 1). The Company has no other financial assets or liabilities that are measured at fair value on a recurring basis.
Cash and Cash Equivalents
The Company considers all highly liquid instruments that have maturities of three months or less when acquired to be cash equivalents. The Company had cash and cash equivalents at June 30, 2019 of $185.3 million (unaudited). The Company maintains its bank accounts at one major financial institution.
Concentration of Credit Risk
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains each of its cash and cash equivalent balances with high quality, financial institutions and, accordingly, such funds are not exposed to significant credit risk. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
Property and Equipment
Property and equipment consist of computer equipment, furniture and leasehold improvements and are recorded at cost. Property and equipment are depreciated on a straight-line basis over their estimated useful lives. The Company uses a life of three years for computer equipment and five years for furniture, and leasehold improvements are amortized over their estimated life or lease term, whichever is shorter.
Convertible Preferred Units and Convertible Preferred Stock
The Company has classified the Series A convertible preferred units as temporary equity in the accompanying balance sheets because, upon certain change in control events that are outside of the Company’s control, including sale or transfer of control of the Company (“Change of Control Event”), holders of the Series A convertible preferred units could cause redemption of the units. The Company does not accrete the carrying values of the Series A convertible preferred units to the redemption values, regardless of the probability that a Change of Control Event could occur, since a liquidation event is not considered probable to occur. Subsequent adjustments of the carrying values to the ultimate redemption values will be made only if it becomes probable that such a liquidation event will occur.
The Company has determined that Series B convertible preferred stock should be classified as temporary equity in the accompanying balance sheets because a deemed liquidation event is outside the Company’s control. The holders of Series B convertible preferred stock are entitled to receive a dividend; however, it is contingent upon a liquidation event that is not considered probable to occur. Therefore, accretion is not required to bring the value of Series B convertible preferred stock at issuance to a redemption value inclusive of dividends until such a dividend is declared.
Research and Development
In accordance with FASB ASC Topic 730 10 55, “Research and Development”, expenditures for clinical development, including upfront licensing fees and milestone payments associated with products that have not yet been approved by the FDA, are charged to research and development expense as incurred. These expenses consist of expenses incurred in performing development activities, including salaries and benefits, unit-based compensation expenses, materials and supplies, preclinical expenses, clinical trial and related clinical manufacturing expenses, depreciation of equipment, contract services and other outside expenses. Costs for certain development activities, such as manufacturing and clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using either time-based measures or data such as information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued development expenses. Nonrefundable advance payments for goods or services to be received in the future for use in development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. As of December 31, 2018 and June 30, 2019, the Company had made payments of $0.5 million and $1.2 million, respectively, for services to be received in the future. These payments are recorded as other assets in the balance sheet as of June 30, 2019 (unaudited).
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
General and Administrative
General and administrative expenses consist primarily of payroll and related costs, benefits, rent and utilities, unit-based compensation, infrastructure, corporate insurance, office expenses, professional fees, as well as travel, meal, and entertainment costs.
Equity-based compensation expense
The Company accounts for employee equity-based compensation in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic (“ASC”) 718, Compensation — Stock Compensation. ASC 718 requires all equity-based awards to employees and non-employee directors to be recognized as expense in the statement of operations based on the grant date fair value of the common and incentive unit, unit option, restricted stock and stock option awards. Equity-based awards vest over a four-year period. Generally, onboarding equity-based awards vest with the first 25% vesting following 12 months of employment or service and the remaining vesting in equal quarterly installments over the following 36 months. Certain restricted stock and stock options are subject to performance conditions and/or market conditions.
Stock compensation expense is recognized using the straight-line method, based on the grant date fair value, over the requisite service period of the award, which is generally the vesting term.
For awards subject to performance conditions, as well as awards containing both market and performance conditions, the Company recognizes equity award compensation expense using an accelerated recognition method over the remaining service period when management determines that achievement of the milestone is probable. Management evaluates when the achievement of a performance-based milestone is probable based on the expected satisfaction of the performance conditions as of the reporting date.
The Company recognizes forfeitures at the time of the actual forfeiture event in accordance with the adoption of the guidance per Accounting Standard Update (“ASU”) No. 2016-09.
The grant-date fair value of performance-based awards with market conditions is estimated using a Monte Carlo simulation method that incorporates the probability of the performance conditions being met as of the grant date.
The Company estimates the fair value of equity awards granted using the special case of the market approach, including the guideline public company method and precedent transaction method which is known as a backsolve method. This option pricing model was utilized to solve for the implied total equity value that is consistent with the Company’s Series A convertible preferred units “backsolves” to a preferred share price. The backsolve method derives the implied equity value for one type of equity security from a contemporaneous transaction involving another type of security to calculate the equity value. The use of these valuation approaches requires management to make assumptions with respect to the expected volatility of its units and stock, time until a liquidity event and risk-free interest rates. Equity value was allocated to the common, incentive and convertible preferred units, and common, restricted and convertible
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
preferred stock using an option-pricing method. Under this method, the common and incentive units and common stock have value only if the funds available for distribution exceed the value of the convertible preferred units’ liquidation preferences at the time of a liquidity event, such as a strategic sale, merger or IPO.
For stock options issued, the Company estimates the grant date fair value and the resulting stock-based compensation expense using the Black-Scholes option-pricing model.
The Black-Scholes option-pricing model requires the use of subjective assumptions which determine the fair value of stock-based awards, including the expected term and the price volatility of the underlying stock. These assumptions include:
•
Fair value of common stock — See section above.
•
Expected term — The expected term represents the period that the equity-based awards are expected to be outstanding. The expected term for our stock options was calculated based on the weighted average vesting term of the awards and the contract period, or simplified method.
•
Expected volatility — The Company lacks Company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until it has adequate historical data regarding the volatility of its own traded stock.
•
Risk-free interest rate — The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the expected term of the awards.
•
Expected dividend — The Company has never paid dividends on its common units or stock and has no plans to pay dividends on its common stock. Therefore, the expected dividend yield is zero.
Net Loss per Unit and Share
Basic net loss per unit and per share is computed by dividing net loss by the weighted average number of common units and shares outstanding for the period. Diluted net loss per unit and share excludes the potential impact of convertible preferred units, unvested incentive units, convertible preferred stock, unvested restricted stock and stock options because their effect would be anti-dilutive due to the Company’s net loss. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common unit and share are the same.
Income Taxes
Income taxes are accounted for using the asset-and-liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized as income in the period that includes the enactment date. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
The Company recognizes deferred tax assets to the extent that we believe that these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies and results of recent operations. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.
The Company records uncertain tax positions in accordance with ASC 740 on the basis of a two-step process in which (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority.
The Company provides reserves for potential payments of tax to various tax authorities related to uncertain tax positions. These reserves are based on a determination of whether and how much of a tax benefit taken by the Company in its filings or positions is more likely than not to be realized following resolution of any potential contingencies related to the tax benefit. Potential interest related to the underpayment of income taxes will be classified as a component of income tax expense and any related penalties will be classified in income tax expenses in the statement of operations.
Recently Adopted Accounting Pronouncements
In March 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”). ASU 2016-09 simplified several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. The Company adopted ASU 2016-09 effective for the year ended December 31, 2018 and has elected to account for forfeitures when they occur instead of estimating the number of awards that are expected to vest. The adoption of ASU 2016-09 did not have a material impact on the Company’s financial statements.
In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes (“ASU 2015-17”), which simplifies the presentation of deferred income taxes. The amendment eliminates the requirement that entities separate deferred income tax liabilities and assets into current and noncurrent amounts and now requires that deferred tax liabilities and assets be classified as noncurrent in a classified balance sheet. This ASU is effective for annual periods beginning after December 15, 2017. The adoption of ASU 2015-17 on January 1, 2018 did not have a material effect on the Company’s financial position, results of operations or cash flows.
Recently Issued Accounting Pronouncements
In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”). ASU No. 2014-09 eliminated transaction- and industry-specific
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
revenue recognition guidance under FASB ASC Subtopic 605-15, Revenue Recognition-Products and replaced it with a principle-based approach for determining revenue recognition. The new standard requires a company to recognize revenue upon transfer of goods or services to a customer at an amount that reflects the expected consideration to be received in exchange for those goods or services. ASU 2014-09 defines a five-step approach for recognizing revenue, which may require a company to use more judgment and make more estimates than under the current guidance. The standard is effective for annual periods beginning after December 15, 2018. The Company is currently evaluating the impact that ASU 2014-09 will have, if any, on its financial position, results of operations or cash flows.
In February 2016, the FASB issued ASU 2016-02 “Leases (Topic 842).” This standard requires entities that lease assets to recognize on the balance sheet the assets and liabilities of the rights and obligations created by those leases. The standard is effective for annual periods beginning after December 15, 2019 and interim periods within annual periods beginning after December 15, 2020. Early adoption is permitted. The Company is currently assessing the impact of the adoption of this authoritative guidance on its consolidated financial statements.
In August 2016, the FASB issued ASU 2016-15 “Statement of Cash Flows (Topic 230) — Classification of Certain Cash Receipts and Cash Payments.” This standard requires entities that must present a statement of cash flows under Topic 230 to classify certain cash receipts and cash payments using a standardized method. The standard is effective for annual periods beginning after December 15, 2018 and the interim periods within annual periods beginning after December 15, 2019. The guidance is required to be applied by the retrospective transition approach. Early adoption is permitted. The Company is currently assessing the impact of the adoption of this authoritative guidance on its consolidated financial statements.
4. Property and Equipment
Property and equipment, net consisted of the following:
|
|
|
December 31,
|
|
|
June 30, 2019 (unaudited)
|
|
(in thousands)
|
|
|
2017
|
|
|
2018
|
|
Leasehold improvements
|
|
|
|
$ |
— |
|
|
|
|
$ |
293 |
|
|
|
|
$ |
731 |
|
|
Computer equipment
|
|
|
|
|
26 |
|
|
|
|
|
27 |
|
|
|
|
|
121 |
|
|
Furniture
|
|
|
|
|
18 |
|
|
|
|
|
18 |
|
|
|
|
|
31 |
|
|
|
|
|
|
|
44 |
|
|
|
|
|
338 |
|
|
|
|
|
883 |
|
|
Less accumulated depreciation
|
|
|
|
|
(3) |
|
|
|
|
|
(21) |
|
|
|
|
|
(84) |
|
|
|
|
|
|
$ |
41 |
|
|
|
|
$ |
317 |
|
|
|
|
$ |
799 |
|
|
|
Depreciation expense was $3,182 and $17,328 for the period of August 18, 2017 (inception) to December 31, 2017 and for the year ended December 31, 2018, respectively. Depreciation expense (unaudited) was $6,216 and $63,899 for the six months ended June 30, 2018 and June 30, 2019, respectively.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
5. Accrued Expenses
Accrued expenses consisted of the following:
|
|
|
December 31,
|
|
|
June 30, 2019 (unaudited)
|
|
(in thousands)
|
|
|
2017
|
|
|
2018
|
|
Accrued professional fees
|
|
|
|
$ |
129 |
|
|
|
|
$ |
1,040 |
|
|
|
|
$ |
802 |
|
|
Accrued compensation and benefits
|
|
|
|
|
189 |
|
|
|
|
|
1,178 |
|
|
|
|
|
1,118 |
|
|
Accrued other
|
|
|
|
|
52 |
|
|
|
|
|
350 |
|
|
|
|
|
5,614 |
|
|
|
|
|
|
$ |
370 |
|
|
|
|
$ |
2,568 |
|
|
|
|
$ |
7,534 |
|
|
|
6. Convertible Preferred Units and Members’ Deficit prior to Reorganization
Series A convertible preferred
In August 2017, the Company authorized the sale and issuance of up to 103,000,000 units of Series A convertible preferred units at $1.00 per unit for a total of $103 million of proceeds. The Series A convertible preferred financing was structured to close in three tranches.
The first tranche closed in August 2017, resulting in the issuance of 13,200,001 units of Series A convertible preferred units for gross cash proceeds of $13.2 million. Issuance costs totaled $0.6 million. The Company determined that the right of the investors to purchase Series A convertible preferred units in the second and third tranches does not meet the definition of a freestanding financial instrument because the right to purchase Series A convertible preferred units in the second and third tranches was not separable from the Series A convertible preferred units issued in the first tranche. In April 2018, the second tranche of 50,399,999 units of Series A convertible preferred were issued at $1.00 per unit, or $50.4 million in gross proceeds. Issuance costs totaled $24,372. In March 2019, the third tranche of 39,400,000 units of Series A convertible preferred units were issued at $1.00 per unit, or $39.4 million in gross proceeds. Issuance costs totaled $32,694.
Junior Series A convertible preferred
In August 2017 and in conjunction with the formation of the Company and the License Agreements (see Note 9), the Company authorized and issued 6,437,500 units of Junior Series A convertible preferred units in exchange for four license agreements for the development and commercialization of products based on the inventions of Pfizer’s researchers. No cash was received by the Company for these units. The Company determined the fair value of Junior Series A convertible preferred units in aggregate was $2.0 million based on the calculated enterprise value and the distribution preferences. The fair value of the Junior Series A convertible preferred units was then allocated across the four licenses relative to the present value of estimated discrete cash flows and recorded as research and development expense in the period from August 18, 2017 (inception) to December 31, 2017.
Common Units
Common units mean the Company interests designated as common units (“common units”). In August 2017, the Company authorized 195,638 common units. As of December 31, 2017, no common units had been issued. On January 30, 2018, the Company issued 195,638 common units
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
to certain employees, for which the Company recorded unit-based compensation expense of $0.2 million for the twelve months ended December 31, 2018. The number of common units issued and outstanding was 195,638 at December 31, 2018.
The rights and preferences of Series A convertible preferred units, Junior Series A convertible preferred units and common units are summarized below.
Conversion
Following the reverse split of our common stock in August 2019, every 6.5810 units of Series A convertible preferred and Junior Series A convertible preferred is convertible into one common unit at the option of the holder, subject to certain anti-dilution adjustments. The Series A convertible preferred units and Junior Series A convertible preferred units are mandatorily convertible in the event of an initial public offering, as defined. If a Series A convertible preferred unitholder did not acquire its entire portion in a future tranche closing, then all of its Series A convertible preferred units would automatically convert into common units at the rate of 65.81 Series A convertible preferred units to one common unit (after giving effect to the reverse stock split). Effective March 2019, upon the issuance of the third tranche of Series A convertible preferred units, this conversion feature no longer applies.
Voting
Holders of Series A convertible preferred units hold the number of votes equal to the number of common units into which their Series A convertible preferred units are convertible. Holders of the Series A convertible preferred units, voting as a class, are entitled to designate four of the nine members of the Board. Approval of holders of 55% of the Series A convertible preferred units is required for certain significant corporate events. The holders of common units and Series A convertible preferred units vote together on all other matters for which a vote of members is required, with each Series A convertible preferred unit holder entitled to the number of votes equal to the number of common units into which the holder’s Series A convertible preferred units are convertible, and each holder of common units entitled to one vote for each common unit held by such holder. There are no voting rights associated with the Junior Series A convertible preferred units.
Liquidation
Holders of Series A convertible preferred units are entitled to an initial liquidation preference equal to $1.00 per unit. If proceeds are insufficient to cover the initial Series A convertible preferred liquidation preference, proceeds are distributed ratably among the holders of the Series A convertible preferred units in proportion to the full preferential amount each such holder is otherwise entitled to receive. Following payment to the Series A convertible preferred unitholders of their initial liquidation preference, the holders of Series A convertible preferred units and Junior Series A convertible preferred units are entitled to liquidation preferences equal to $1.00. If proceeds are insufficient to cover the Series A convertible preferred and Junior Series A convertible preferred liquidation preferences, proceeds are distributed ratably among the holders of the Series A convertible preferred units and Junior Series A convertible preferred units in proportion to the full preferential amount each such holder is otherwise entitled to receive. Following payment to the Series A convertible preferred units and Junior Series A convertible
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
preferred unitholders, holders of common units and incentive units are entitled to a liquidation preference equal to $1.00. After all preferences have been paid, any remaining assets would be distributed to all unit holders as if converted to common units. Series A convertible preferred units and common units shall vote together as a single class to approve liquidation.
7. Reorganization
As part of the Reorganization:
Holders of Series A convertible preferred Units of SpringWorks Therapeutics, LLC received one share of Series A convertible preferred stock of SpringWorks Therapeutics, Inc. for each Series A convertible preferred unit held immediately prior to the Reorganization;
Holders of Junior Series A convertible preferred units of SpringWorks Therapeutics, LLC received one share of Junior Series A convertible preferred stock of Parent for each Junior Series A convertible preferred unit held immediately prior to the Reorganization;
Holders of common units received one share of common stock of SpringWorks Therapeutics, Inc. for each common unit held immediately prior to the Reorganization;
Each outstanding incentive unit converted into one share of common stock of SpringWorks Therapeutics, Inc. for each incentive unit held immediately prior to the Reorganization, and such common stock is subject to vesting in accordance with the vesting schedule applicable to such incentive units; and
Holders of options exercisable to purchase common units (“unit options”) of SpringWorks Therapeutics, LLC received one stock option exercisable to purchase common stock of the Company for each unit option held immediately prior to the Reorganization, at the same exercise price of such unit option immediately prior to the Reorganization. Such stock options continue to be subject to vesting in accordance with the vesting schedule applicable to such unit options.
In evaluating the Reorganization, the Company considered that there were no changes to the ownership interest held by each unit/stockholder as a result of the Reorganization, there was no consideration exchanged to effect the exchange, and the significant terms of the preferred units, common units, incentive units and options units were substantially the same before and after the Reorganization. Based on these considerations, the Company determined that the exchange of units for shares occurring in the Reorganization did not have an impact on the financial statements as of June 30, 2019.
8. Convertible preferred stock and common stock
Series B convertible preferred
In March 2019, following the Reorganization, the Company authorized the sale and issuance of up to 86,639,279 shares of Series B convertible preferred stock. The Series B convertible preferred financing was closed in a single tranche at the original price of $1.4428 per share for gross proceeds of $125 million. Issuance costs totaled $0.4 million.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
The liquidation preference terms of each of the Series A convertible preferred stock and Junior Series A convertible preferred stock changed in connection with the issuance of Series B convertible preferred. Specifically, after receiving one times its original issue price, the Series A convertible preferred does not participate in the distribution with the Junior Series A convertible preferred prior to final distribution to all stockholders, and the Junior Series A convertible preferred does not participate with all other stockholders in the final distribution. The Company concluded that the changes in the Series A convertible preferred and Junior Series A convertible preferred liquidation preferences are a significant change in the economics of those instruments and therefore were accounted for as an extinguishment. Immediately following the extinguishment of Series A convertible preferred and Junior Series A convertible preferred, the same number of shares was reissued at fair value. As a result, the difference between (1) the fair value of the consideration transferred to the holders of the preferred stock and (2) the carrying amount of the extinguished instruments (net of issuance costs) was recorded to retained earnings.
The rights and preferences of Series A convertible preferred, Junior Series A convertible preferred, Series B convertible preferred and common shares are summarized below.
Conversion
Following the reverse split of our common stock in August 2019, every 6.5810 shares of Series A convertible preferred, Junior Series A convertible preferred and Series B convertible preferred is convertible into one common share at the option of the holder, subject to certain anti-dilution adjustments. The Series A convertible preferred, Junior Series A convertible preferred and Series B convertible preferred are mandatorily convertible in the event of an initial public offering, as defined.
Voting
Holders of Series B convertible preferred, Series A convertible preferred and common stock act as a single voting class on an as-converted basis. An affirmative vote of the holders of at a least a majority of the Series B convertible preferred and Series A convertible preferred is required for any changes to the Certificate of Incorporation. There are no voting rights associated with the Junior Series A convertible preferred.
Liquidation
Holders of Series B convertible preferred are entitled to an initial liquidation preference equal to $1.4428 per share plus any accrued and unpaid dividends. If proceeds are insufficient to cover the initial Series B convertible preferred liquidation preference, proceeds are distributed ratably among the holders of the Series B convertible preferred in proportion to the full preferential amount each such holder is otherwise entitled to receive. Following payment to the Series B convertible preferred holders of their initial liquidation preference, the holders of Series A convertible preferred and Junior Series A convertible preferred are entitled to liquidation preferences equal to $1.00.
If proceeds are insufficient to cover the Series A convertible preferred and Junior Series A convertible preferred liquidation preferences, proceeds are distributed ratably among the holders of the Series A convertible preferred and Junior Series A convertible preferred in proportion to
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
the full preferential amount each such holder is otherwise entitled to receive. Following payment to the Series A convertible preferred and Junior Series A convertible preferred shareholders and holders of common stock are entitled to a liquidation preference equal to $1.00. After all preferences have been paid, any remaining assets would be distributed to all stockholders as if converted to common stock. Holders of Series A convertible preferred, Series B convertible preferred and common stock shall vote together as a single class to approve liquidation.
Dividends
Series B convertible preferred stock carries an annual cumulative, non-compounding dividend of 8% of the Series B convertible preferred original issue price, payable upon a liquidation event, or earlier when and if declared by the Board. No dividend is payable on the Series A convertible preferred stock unless and until, prior to any payment of dividends on such stock, the Series B convertible preferred dividend is declared and paid.
Equity Based Compensation
Prior to the Reorganization, the Company’s operating agreement provided for the granting of incentive units to employees, officers, and directors under the 2018 Equity Incentive Plan (the “2018 Equity Plan”), as determined by the Board of Directors.
2018 Equity Plan
In January 2018, the Company adopted the 2018 Equity Incentive Plan (“2018 Equity Plan”). There were 2,738,929 incentive units (“incentive units”) initially available for issuance under the 2018 Equity Plan. The 2018 Plan was increased by 269,716 units for an aggregate of 3,008,645 as of December 31, 2018.
Holders of incentive units have no voting power and are not entitled to vote on any matter except as otherwise required by applicable law. Holders of incentive units will participate in distributions subject to certain limitations.
Per the Company’s Operating Agreement, holders of incentive units will share in the distribution with holders of common units (after the preferred units have received all of their preferences) until the amount distributed equals the Junior Series A convertible preferred original issue price of $1.00 per share. Thereafter, holders of incentive units will share the distribution with all unit holders as if converted to common units.
The Company issued 3,290,929 and cancelled 385,361 incentive units during the twelve months ended December 31, 2018. There were 103,077 incentive units available for issuance at December 31, 2018.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
A summary of the changes in the Company’s incentive units through the Reorganization:
|
|
|
Number of Units
|
|
|
Weighted Average Grant Date Fair Value
|
|
Outstanding at December 31, 2017
|
|
|
|
|
— |
|
|
|
|
$ |
— |
|
|
Granted
|
|
|
|
|
3,290,929 |
|
|
|
|
|
1.12 |
|
|
Vested
|
|
|
|
|
(401,824) |
|
|
|
|
|
1.05 |
|
|
Forfeited
|
|
|
|
|
(385,361) |
|
|
|
|
|
0.92 |
|
|
Unvested and outstanding at December 31, 2018
|
|
|
|
|
2,503,744 |
|
|
|
|
|
1.25 |
|
|
Vested
|
|
|
|
|
(228,209) |
|
|
|
|
|
0.81 |
|
|
Forfeited
|
|
|
|
|
(12,570) |
|
|
|
|
|
1.45 |
|
|
Unvested and outstanding at March 29, 2019 (unaudited)
|
|
|
|
|
2,262,965 |
|
|
|
|
|
1.24 |
|
|
|
The assumptions used in determining the fair value of incentive units during 2018 included a risk-free interest rate of 2.58%, expected dividend yield of 0.00%, expected term (years to liquidity) of 3.75 and expected volatility of 73%.
The total unrecognized compensation related to unvested incentive units granted was $2.5 million and $1.8 million at December 31, 2018 and March 29, 2019, respectively, which the Company expects to recognize over a period of approximately 3.5 years.
On March 19, 2019, the Company modified its Operating Agreement to allow for the award of unit options.
A summary of the changes in the Company’s unit options through the Reorganization:
|
|
|
Number of Award
|
|
|
Weighted Average Exercise Price
|
|
Outstanding at December 31, 2017 and December 31, 2018
|
|
|
|
|
— |
|
|
|
|
$ |
— |
|
|
Granted
|
|
|
|
|
148,415 |
|
|
|
|
|
1.65 |
|
|
Forfeited
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Outstanding at March 29, 2019 (unaudited)
|
|
|
|
|
148,415 |
|
|
|
|
|
1.65 |
|
|
|
2019 Equity Plan
On March 29, 2019, the Company adopted the 2019 Stock Option and Incentive Plan (“2019 Equity Plan”) in connection with the Reorganization. The 2019 Equity Plan originally had 5,292,355 shares available for issuance. In connection with the adoption of the 2019 Equity Plan, the unit options granted on March 19, 2019 were modified into stock options, and incentive units granted in 2018 were modified into restricted stock, with all vesting terms previously existing transferring, with no modification triggered. On May 28, 2019, the shares available for issuance under the 2019 Equity Plan was increased to 5,382,828 shares. In July 2019, the number of shares available for issuance under the 2019 Equity Plan was increased to 6,700,197.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
Holders of restricted stock participate with holders of common stock in a distribution (after the holders of convertible preferred stock receive all of their preferences).
The Company issued 2,341,363 stock options under the 2019 Equity Plan. There are no stock options available for issuance at June 30, 2019.
A summary of the changes in the Company’s restricted stock during the period from the Reorganization through June 30, 2019:
|
|
|
Number of Shares
|
|
|
Weighted Average Grant Date Fair Value
|
|
Unvested and outstanding at March 29, 2019 (unaudited)
|
|
|
|
|
2,262,965 |
|
|
|
|
$ |
1.24 |
|
|
Granted
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Vested
|
|
|
|
|
(144,276) |
|
|
|
|
|
1.11 |
|
|
Forfeited
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Unvested and outstanding at June 30, 2019 (unaudited)
|
|
|
|
|
2,118,689 |
|
|
|
|
|
1.25 |
|
|
|
A summary of the changes in the Company’s stock options during the period from the Reorganization through June 30, 2019 (unaudited):
|
|
|
Number of Award
|
|
|
Weighted Average Exercise Price
|
|
|
Weighted Average Remaining Contractual Life (Years)
|
|
|
Aggregate Intrinsic Value
|
|
Outstanding at March 29, 2019 (unaudited)
|
|
|
|
|
148,415 |
|
|
|
|
$ |
1.65 |
|
|
|
|
|
|
|
|
|
|
$ |
— |
|
|
Granted
|
|
|
|
|
2,341,363 |
|
|
|
|
|
2.30 |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
Cancelled/Forfeited
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Outstanding at June 30, 2019 (unaudited)
|
|
|
|
|
2,489,778 |
|
|
|
|
|
2.24 |
|
|
|
|
|
9.8 |
|
|
|
|
|
17,034,513 |
|
|
Exercisable, June 30, 2019 (unaudited)
|
|
|
|
|
147,397 |
|
|
|
|
|
2.30 |
|
|
|
|
|
9.8 |
|
|
|
|
|
999,614 |
|
|
Vested and expected to vest, June 30, 2019 (unaudited)
|
|
|
|
|
2,489,778 |
|
|
|
|
|
2.24 |
|
|
|
|
|
9.8 |
|
|
|
|
|
17,034,513 |
|
|
Assumptions used in determining the fair value of the stock options granted in 2019 include risk-free interest rate 1.95% – 2.47%, expected dividend yield of 0.00%, expected Life in years of 6.25 and expected volatility of 68.1%.
At June 30, 2019, the total unrecognized compensation related to unvested restricted stock and stock options was $4.7 million, which the Company expects to recognize over a period of approximately 3.83 years.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
The Company recorded equity-based compensation expense related to incentive units, unit options, restricted stock and stock options for the periods presented as follows (in thousands):
|
|
|
Period from August 18, 2017 (inception) to December 31, 2017
|
|
|
Year Ended December 31, 2018
|
|
|
Six Months Ended June 30,
|
|
|
2018
|
|
|
2019
|
|
Research and development
|
|
|
|
$ |
— |
|
|
|
|
$ |
164 |
|
|
|
|
$ |
46 |
|
|
|
|
$ |
311 |
|
|
General and administrative
|
|
|
|
|
— |
|
|
|
|
|
751 |
|
|
|
|
|
408 |
|
|
|
|
|
1,060 |
|
|
Total equity compensation expenses
|
|
|
|
$ |
— |
|
|
|
|
$ |
915 |
|
|
|
|
$ |
454 |
|
|
|
|
$ |
1,371 |
|
|
|
2019 CEO Performance Award
In June 2019, our CEO received an award of 176,411 stock options (the “2019 CEO Performance Award”) at an exercise price of $2.30 per share. The 2019 CEO Performance Award can vest over 48 monthly installments based on four years of service, a performance condition (a liquidity event, such as an IPO) and market conditions, assuming continued employment and service through each vesting date. During the vesting period of four years, the 2019 CEO Performance Award is not earned unless the market condition is achieved on each vesting date. If the market condition is not achieved on a vesting date, but is achieved on a future vesting date, the award is earned for the entire period since the last date that such market condition was achieved. All or a portion of the award can be earned following the initial four year service period if the market condition is next achieved after such four year service period and Mr. Islam remains in continuous service. The market condition and performance condition are satisfied when the Company’s common stock is listed on a U.S. national securities exchange and achieves a 60-trading day average closing price of at least $28.49 per share (as adjusted for stock splits, recapitalizations, and similar events).
As of June 30, 2019, the Company had $1.4 million (unaudited) of total unrecognized stock-based compensation expense.
The Company has not recorded stock compensation expense related to this award as of June 30, 2019 as the related performance condition was not considered probable.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
9. License and Collaboration Agreements
Pfizer Inc.
In August and October 2017, the Subsidiaries entered into four license agreements with Pfizer for rights to certain technologies (the “License Agreements”). Under the License Agreements, the Company obtained from Pfizer the right to use research, develop, manufacture and commercialize certain products, including nirogacestat and mirdametinib. In connection with the License Agreements, the Company issued 6,437,500 units of Junior Series A convertible preferred units to Pfizer (see Note 6). No cash was received by the Company for these units.
The Company is required to pay Pfizer milestones payments of up to an aggregate of $232.5 million for nirogacestat and up to an aggregate of $229.8 million for mirdametinib, each upon achievement of certain commercial milestone events. Royalties are also payable under each License Agreement based on a specified percentage of net sales ranging from mid-single digit percentages to the low 20s, Royalty payments under each License Agreement continue until the expiration of the last to expire licensed patent applicable to such product, but not less than ten years after the first commercial sale on a country-by-country basis.
BeiGene, Ltd. (“BeiGene”)
In August 2018, the Company entered into a clinical collaboration agreement with BeiGene to conduct a clinical study of the combination of mirdametinib and a BeiGene compound designated as lifirafenib. In accordance with the terms of the agreement, the Company and BeiGene share equally the costs associated with the clinical study. BeiGene is required to supply the BeiGene compound and the Company is required to supply mirdametinib to conduct the clinical study. The collaboration is guided by a joint steering committee. Specified areas of development require unanimous agreement among all members of the joint steering committee.
The Company recorded $0.4 million and $0.6 million (unaudited) as of December 31, 2018 and the six months ended June 30, 2019, respectively, in connection with this collaboration agreement, which are classified as research and development expenses in the Company’s statement of operations.
GSK clinical collaboration agreement (“GSK”)
In June 2019, the Company entered into a clinical collaboration agreement with GlaxoSmithKline (“GSK”) (the “GSK Collaboration Agreement”), to evaluate the safety, tolerability and preliminary efficacy of nirogacestat and belantamab mafodotin. Under the terms of the GSK Collaboration Agreement, GSK will sponsor and conduct the adaptive Phase 1b study of nirogacestat, in combination with GSK’s BCMA antibody-drug conjugate, belantamab mafodotin, in patients with relapsed or refractory multiple myeloma. GSK will assume all development costs associated with the study. The Company agreed to manufacture and supply the Company compound for purposes of the study.
Pursuant to the GSK Collaboration Agreement, GSK is responsible for administering the clinical trial and is responsible for all costs associated with the direct conduct of the clinical trial, other than the manufacture and supply of nirogacestat and certain expenses related to intellectual property rights. The collaboration is managed by a joint development committee of equal
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
representation by the Company and GSK. Following completion of the clinical trial, within a specified period of time, either party may propose new agreements for the purpose of performing one or more additional clinical trials of the combination therapy for the treatment of relapsed and refractory multiple myeloma. If a party proposes to conduct an additional clinical trial, the parties will negotiate in good faith, without obligation, the details of a definitive agreement to provide for the expansion of the clinical collaboration. If the parties do not reach an agreement, and only one party wishes to proceed with an additional clinical trial, it may do so if the other party does not object to the protocol based on safety concerns.
The Company has not incurred any expense under the GSK Collaboration Agreement as of June 30, 2019 (unaudited).
10. Commitments and Contingencies
Leases
In August 2018, the Company entered into a five-year operating lease in Durham, NC (the location of the Company’s clinical development operations), with two five-year renewal options. Rental payments under the renewal period will be at current market rates for the premises. The Company established a security deposit of $40,467 presented in other assets.
In October 2018, the Company entered into a lease for its corporate headquarters in Stamford, CT. The lease expires in November 2022. The Company received $1.5 million from the previous tenant in connection with the assumption of the lease. The Company recognizes rent expense for the office it currently occupies and records a deferred rent obligation representing the cumulative difference between actual rent payments, incentive received and rent expense recognized ratably over the lease period. The Company established a security deposit of $0.5 million in the form of a letter-of-credit, recorded in other noncurrent assets.
The Company’s future minimum lease obligations as of June 30, 2019 (unaudited) are:
(in thousands)
|
|
|
Premises Operating Leases
|
|
Remainder of 2019
|
|
|
|
$ |
660 |
|
|
2020
|
|
|
|
|
1,344 |
|
|
2021
|
|
|
|
|
1,372 |
|
|
2022
|
|
|
|
|
1,297 |
|
|
2023
|
|
|
|
|
135 |
|
|
Total obligations
|
|
|
|
$ |
4,808 |
|
|
|
The Company recorded rent expense aggregating $42,000, $0.2 million and $0.5 million for the period from August 18, 2017 (Inception) to December 31, 2017, the year ended December 31, 2018 and the six months ended June 30, 2019 (unaudited), respectively. For the six months ended June 30, 2019 (unaudited), the Company recorded $0.5 million.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
Contingencies
From time to time, the Company may be involved in disputes or regulatory inquiries that arise in the ordinary course of business. When the Company determines that a loss is both probable and reasonably estimable, a liability is recorded and disclosed if the amount is material to the financial statements taken as a whole. When a material loss contingency is only reasonably possible, the Company does not record a liability, but instead discloses the nature and the amount of the claim, and an estimate of the loss or range of loss, if such an estimate can reasonably be made.
As of December 31, 2018, there was no litigation or contingency with at least a reasonable possibility of a material loss.
11. Income Taxes
Prior to the Reorganization, SpringWorks Therapeutics, LLC elected to be treated under the partnership provisions of the Internal Revenue Service code. However, its five wholly owned subsidiaries, SpringWorks Operating Company, SpringWorks Subsidiary 1, SpringWorks Subsidiary 2, SpringWorks Subsidiary 3, and SpringWorks Subsidiary 4, (“Combined Subsidiaries”) are taxable corporations. The following discussion of income tax, before the Reorganization, represents the combined tax attributes of Combined Subsidiaries.
Subsequent to the Reorganization, SpringWorks Therapeutics, Inc. became the 100% owner of SpringWorks Therapeutics, LLC, creating a new ultimate parent company, and a consolidated group for income tax reporting. The Reorganization and change in tax status of the reporting entity did not have an impact on the consolidated tax provision.
For the period from August 18, 2017 (Inception) to December 31, 2017 and for the year ended December 31, 2018, the Company did not have a current or deferred income tax expense or benefit as the Company is a flow-through entity not subject to tax at the entity level. Additionally, the Combined Subsidiaries have incurred losses since inception.
As of December 31, 2018, the Combined Subsidiaries had federal, state and city net operating loss carryforwards of $14.2 million, $0.6 million and $3.8 million, respectively, which are available to reduce future taxable income. Federal net operating loss carryforwards of $4.3 million were reported in 2017 and the state and city net operating loss carryforwards expire at various dates through 2038. Federal net operating loss carryforwards of $9.9 million reported in 2018 will be available to offset 80% of taxable income for an indefinite period of time, until fully utilized. The Combined Subsidiaries also have federal tax credits of $0.4 million, which may be used to offset future tax liabilities. These tax credit carryforwards will expire in 2038.
The net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Net operating loss and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant unitholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code, respectively, as well as similar state provisions and other provisions within the Internal Revenue Code. This could limit
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years.
The Company has not recorded any reserves for uncertain tax positions as of December 31, 2017, December 31, 2018 or June 30, 2019 (unaudited). The Company has not conducted a study of research and development credit carryforwards. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed, and any adjustment is known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the balance sheets or statements of operations and comprehensive loss if an adjustment were required.
Interest and penalty charges, if any, related to unrecognized tax benefits will be classified as income tax expense in the accompanying statements of operations and comprehensive loss. As of December 31, 2018 or June 30, 2019 (unaudited), the Company had no accrued interest or penalties related to uncertain tax positions.
Since the Company is in a loss carryforward position, it is generally subject to examination by the U.S. federal, state and local income tax authorities for all tax years in which a loss carryforward is available. The Company is not currently under examination by the Internal Revenue Service or any other jurisdictions for any tax years.
In December 2015, the Protecting Americans from Tax Hikes (PATH) Act of 2015 was signed into law, which created several new research and development (“R&D”) tax credit provisions, including allowing qualified small businesses to utilize the R&D tax credit against the employer’s portion of payroll tax up to a maximum of $0.3 million per year. This provision is available for R&D tax credits generated in tax years beginning after 2015. The Company qualified as a small business under PATH and has elected to apply the $0.1 million and maximum $0.3 million for both 2017 and 2018, respectively, for each of the 2017 R&D tax credit and the 2018 R&D tax credit generated against future employer payroll tax liabilities. The $0.1 million and $0.3 million benefit was recorded as a reduction of research and development costs for the period from August 18, 2017 (Inception) to December 31, 2017 and the year ended December 31, 2018, respectively.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
The principal components of the Subsidiaries deferred tax assets are as follows:
|
|
|
As of December 31,
|
|
(in thousands)
|
|
|
2017
|
|
|
2018
|
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards
|
|
|
|
$ |
1,413 |
|
|
|
|
$ |
3,342 |
|
|
Research and development credits
|
|
|
|
|
53 |
|
|
|
|
|
403 |
|
|
Deferred rent
|
|
|
|
|
— |
|
|
|
|
|
312 |
|
|
Accrued expenses
|
|
|
|
|
92 |
|
|
|
|
|
46 |
|
|
Section 195 startup costs
|
|
|
|
|
— |
|
|
|
|
|
1,270 |
|
|
Total deferred tax assets
|
|
|
|
|
1,558 |
|
|
|
|
|
5,373 |
|
|
Deferred tax liability
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Valuation allowance
|
|
|
|
|
(1,558) |
|
|
|
|
|
(5,373) |
|
|
Net deferred tax assets
|
|
|
|
$ |
— |
|
|
|
|
$ |
— |
|
|
ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After consideration of all the evidence, both positive and negative, the Company has recorded a full valuation allowance against its deferred tax assets at December 31, 2017, December 31, 2018 or June 30, 2018 (unaudited) and June 30, 2019 (unaudited) because the Company’s management has determined that it is more likely than not that these assets will not be realized. The increase in the valuation allowance of $3.8 million in 2018 primarily relates to the net loss incurred by the Company.
In accordance with this guidance, the Company has adopted a policy under which, if required to be recognized in the future, interest related to the underpayment of income taxes will be classified as a component of income tax expense and any related penalties will be classified in operating expenses in the statements of operations.
The Tax Cuts and Jobs Act (“the Act”) was enacted in December 2017. The Act includes a number of changes to then-existing U.S. tax laws that impact the Company, most notably a reduction of the U.S. federal corporate tax rate from a maximum of 35% to a flat 21%, effective January 1, 2018. As a result of the new law, as of December 31, 2017, the Company remeasured its deferred tax assets based on the rates at which they are expected to reverse in the future, resulting in a reduction in the deferred tax asset balance of $225,558, which was offset by a reduction in the valuation allowance by a corresponding amount.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
The effective tax rate for the Company for the years ended December 31, 2017 and December 31, 2018 and for the six months ended June 30, 2018 (unaudited) and June 30, 2019 (unaudited), was zero percent. A reconciliation of the income tax expense at the federal statutory tax rate to the Combined Subsidiaries effective income tax rate follows:
|
|
|
Period from August 18, 2017 (inception) to December 31, 2017
|
|
|
Year Ended December 31, 2018
|
|
Statutory tax rate
|
|
|
|
|
34.00% |
|
|
|
|
|
21.00% |
|
|
State tax expense, net of federal benefit
|
|
|
|
|
9.17 |
|
|
|
|
|
0.00 |
|
|
Revaluation of deferred tax assets
|
|
|
|
|
(10.46) |
|
|
|
|
|
0.00 |
|
|
Federal and state return to provision adjustments
|
|
|
|
|
0.00 |
|
|
|
|
|
(1.08) |
|
|
Research and development credit
|
|
|
|
|
0.76 |
|
|
|
|
|
2.02 |
|
|
Other
|
|
|
|
|
(0.04) |
|
|
|
|
|
(0.04) |
|
|
Change in valuation allowance
|
|
|
|
|
(33.43) |
|
|
|
|
|
(21.90) |
|
|
Effective tax rate
|
|
|
|
|
0.00% |
|
|
|
|
|
0.00% |
|
|
12. 401(k) Plan
In 2017, the Company adopted a tax-qualified employee savings and retirement plan (the “401(k) Plan”) that covers all of its full-time employees who are at least 21 years of age. Pursuant to the 401(k) Plan, participants may elect to contribute up to the federally allowed maximum limits of their pretax earnings to the 401(k) Plan. As of December 31, 2017, December 31, 2018 and June 30, 2019 (unaudited), the Company had not made any matching contributions.
13. Related Party Transactions
The Company entered into agreements with two of its board members to provide consulting and Board of Director (“BOD”) services to the Company. For the period from August 18, 2017 (inception) to December 31, 2017, the Company recorded consulting and BOD expenses totaling $89,168. For the year ended December 31, 2018, the Company recorded consulting and BOD expenses totaling $287,079. The Company recorded consulting and BOD expenses totaling $125,000 and $152,458, for the six months ended June 30, 2018 (unaudited) and June 30, 2019 (unaudited), respectively.
Pfizer is a significant shareholder of the Company and a Pfizer employee is a member of the Board of Directors. See Note 9 for further details on transactions entered into with Pfizer.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
14. Net Loss per Unit and Share and Unaudited Pro Forma Net Loss per Share
Basic and diluted net loss per unit is calculated as follows:
(in thousands except for units and per-unit data)
|
|
|
Period from August 18, 2017 (inception) to December 31, 2017
|
|
|
Year Ended December 31, 2018
|
|
Net loss
|
|
|
|
$ |
(4,639) |
|
|
|
|
$ |
(17,813) |
|
|
Weighted average common units outstanding, basic and diluted
|
|
|
|
|
— |
|
|
|
|
|
341,014 |
|
|
Net loss per common unit, basic and diluted
|
|
|
|
$ |
— |
|
|
|
|
$ |
(52.24) |
|
|
Basic and diluted net loss per share is calculated as follows:
(in thousands except for shares and per unit data)
|
|
|
Six Months Ended June 30,
|
|
|
2018
|
|
|
2019
|
|
Net loss
|
|
|
|
$ |
(6,590) |
|
|
|
|
$ |
(25,256) |
|
|
Net gain attributable to extinguishment of Series A convertible preferred and Junior Series A convertible preferred shares
|
|
|
|
|
— |
|
|
|
|
|
7,729 |
|
|
Net loss attributable to common stockholders – basic and diluted
|
|
|
|
$ |
(6,590) |
|
|
|
|
$ |
(17,527) |
|
|
Weighted average common units and shares outstanding, basic and diluted
|
|
|
|
|
175,291 |
|
|
|
|
|
780,066 |
|
|
Net loss per common unit and share, basic and diluted
|
|
|
|
$ |
(37.60) |
|
|
|
|
$ |
(22.47) |
|
|
As of December 31, 2017, there were no vested common units outstanding. Therefore, net loss per unit attributable to common unitholders, basic and diluted, is not presented for the period from August 18, 2017 (inception) through December 31, 2017.
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
The table below provides potential common units not included in the calculation of the diluted net loss per unit and share because to do so would be anti-dilutive:
|
|
|
Period from August 18, 2017 (inception) to December 31, 2017
|
|
|
Year Ended December 31, 2018
|
|
|
Six Months Ended June 30, 2019 (unaudited)
|
|
Series A convertible preferred units and shares
|
|
|
|
|
2,005,774 |
|
|
|
|
|
9,664,183 |
|
|
|
|
|
15,651,114 |
|
|
Series B convertible preferred shares
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
13,165,051 |
|
|
Junior Series A convertible preferred units and shares
|
|
|
|
|
978,194 |
|
|
|
|
|
978,194 |
|
|
|
|
|
978,194 |
|
|
Unvested incentive units and restricted shares
|
|
|
|
|
— |
|
|
|
|
|
2,503,744 |
|
|
|
|
|
2,118,689 |
|
|
Stock options issued and outstanding
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
2,489,778 |
|
|
Total
|
|
|
|
|
2,983,968 |
|
|
|
|
|
13,146,121 |
|
|
|
|
|
34,402,826 |
|
|
Unaudited Pro Forma Basic and Diluted Net Loss Per Share
The following table summarizes the Company’s unaudited pro forma net loss per share:
(in thousands except share and per share data)
|
|
|
Year Ended December 31, 2018
|
|
|
Six Months Ended June 30, 2019 (unaudited)
|
|
Numerator |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$ |
(17,813) |
|
|
|
|
$ |
(25,256) |
|
|
Less net Income attributable to Extinguishment
|
|
|
|
|
— |
|
|
|
|
|
7,729 |
|
|
Net loss attributable to common stockholders
|
|
|
|
$ |
(17,813) |
|
|
|
|
$ |
(17,527) |
|
|
Denominator |
|
|
|
|
|
|
|
|
|
|
|
|
|
Units and shares used to compute net loss per unit and share, basic and diluted
|
|
|
|
|
341,014 |
|
|
|
|
|
780,066 |
|
|
Pro forma adjustments to reflect assumed weighted average effect of conversion of convertible preferred stock
|
|
|
|
|
8,586,149 |
|
|
|
|
|
21,415,644 |
|
|
Shares used to compute pro forma net loss per share, basic and diluted
|
|
|
|
|
8,927,163 |
|
|
|
|
|
22,195,710 |
|
|
Pro forma net loss per share, basic and diluted
|
|
|
|
$ |
(2.00) |
|
|
|
|
$ |
(0.79) |
|
|
15. Investment and Variable Interest Entity
MapKure
June 2019, the Company announced the formation of MapKure, an entity jointly owned by the Company and BeiGene. BeiGene licensed to MapKure exclusive rights to BGB-3245, an oral, small
SpringWorks Therapeutics, Inc. and Subsidiaries
(formerly SpringWorks Therapeutics, LLC)
Notes to Consolidated Financial Statements
molecule selective inhibitor of specific BRAF driver mutations and genetic fusions. MapKure intends to advance BGB-3245 into clinical development for solid tumor patients harboring BRAF driver mutations and genetic fusions that were observed to be sensitive to the compound in preclinical studies. In addition to the Company’s equity ownership in MapKure, the Company has appointed a member to each of MapKure's joint steering committee and board of directors. The Company will also contribute to clinical development and other operational activities for BGB-3245 through a service agreement with MapKure.
The Company purchased 3,500,000 Series A preferred units of MapKure, or a 25% ownership interest, of the outstanding unit for $3.5 million, and BeiGene received 10,000,000 Series A preferred units as payment for its contributed intellectual property, or a 71.4% ownership interest. Two individuals each purchased 250,000 Series A preferred units, or 1.8% ownership interest each.
Upon the first anniversary of the initial closing (the “Second Closing”), MapKure is obligated to sell another 4,000,000 Series A preferred units to the same two individuals and the Company. At the Second Closing, the Company is obligated to purchase 3,500,000 Series A preferred units, which will increase the Company’s ownership to 38.9%.
The Company determined that MapKure is a variable interest entity, but the Company is not the primary beneficiary. The Company does not have the power to direct the activities that most significantly impact the economic performance of MapKure. Accordingly, the Company does not consolidate the financial statements of this entity and accounts for this investment using equity method accounting.
The Company did not recognize any equity income or losses for the six months ended June 30, 2019 (unaudited) because MapKure did not have any activity since inception. The Company’s ownership interest in MapKure is included in “Equity method investments” in the Consolidated Balance Sheet as of June 30, 2019 (unaudited). The balance of the Company’s investment was $3.5 million at June 30, 2019 (unaudited), representing the maximum exposure to loss as a result of the Company’s involvement with MapKure.
16. Reverse Stock Split
In August 2019, the Company’s Board of Directors and stockholders approved a one-for-6.5810 reverse stock split of the Company’s common stock. The reverse stock split became effective on August 30, 2019. Stockholders entitled to a fractional share as a result of the reverse stock split will receive a cash payment in lieu of the fractional shares at the initial public offering price.
All common stock share and per share amounts in the consolidated financial statements and notes thereto have been retroactively adjusted, where applicable for all periods presented to give effect to the reverse stock split. The shares of common stock retained a par value of $0.0001 per share.
17. Subsequent Events
The Company has evaluated subsequent events through August 16, 2019, the date on which the financial statements were available to be issued.
7,352,941 shares
Common stock
Prospectus
J.P. MorganGoldman Sachs & Co. LLCCowen
Wedbush PacGrow
, 2019
Part II
Information not Required in Prospectus
Item 13. Other Expenses of Issuance and Distribution.
The following table sets forth the fees and expenses, other than underwriting discounts and commissions, payable in connection with the registration of the common stock hereunder. All amounts are estimates except the SEC registration fee, the FINRA filing fee and listing fee.
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Amount to be paid
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SEC registration fee
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$ |
17,423 |
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|
FINRA filing fee
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|
|
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22,063 |
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Nasdaq Global Market listing fee
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|
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150,000 |
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Printing and mailing
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|
|
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200,000 |
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|
Legal fees and expenses
|
|
|
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1,700,000 |
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|
Accounting fees and expenses
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|
|
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1,050,000 |
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Transfer agent and registrar fees and expenses
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25,000 |
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Miscellaneous
|
|
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100,000 |
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Total
|
|
|
|
$ |
3,264,486 |
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Item 14. Indemnification of Directors and Officers.
Section 145 of the Delaware General Corporation Law, or the DGCL, authorizes a corporation to indemnify its directors and officers against liabilities arising out of actions, suits and proceedings to which they are made or threatened to be made a party by reason of the fact that they have served or are currently serving as a director or officer to a corporation. The indemnity may cover expenses (including attorneys’ fees) judgments, fines and amounts paid in settlement actually and reasonably incurred by the director or officer in connection with any such action, suit or proceeding. Section 145 permits corporations to pay expenses (including attorneys’ fees) incurred by directors and officers in advance of the final disposition of such action, suit or proceeding. In addition, Section 145 provides that a corporation has the power to purchase and maintain insurance on behalf of its directors and officers against any liability asserted against them and incurred by them in their capacity as a director or officer, or arising out of their status as such, whether or not the corporation would have the power to indemnify the director or officer against such liability under Section 145.
We have adopted provisions in our amended and restated certificate of incorporation and amended and restated bylaws to be in effect immediately prior to the completion of this offering that limit or eliminate the personal liability of our directors to the fullest extent permitted by the DGCL, as it now exists or may in the future be amended. Consequently, a director will not be personally liable to us or our stockholders for monetary damages or breach of fiduciary duty as a director, except for liability for:
•
any breach of the director’s duty of loyalty to us or our stockholders; any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; any unlawful payments related to dividends or unlawful stock purchases, redemptions or other distributions; or any transaction from which the director derived an improper personal benefit.
These limitations of liability do not alter director liability under the federal securities laws and do not affect the availability of equitable remedies such as an injunction or rescission.
In addition, our bylaws provide that:
•
we will indemnify our directors, officers and, in the discretion of our board of directors, certain employees to the fullest extent permitted by the DGCL, as it now exists or may in the future be amended; and
•
we will advance reasonable expenses, including attorneys’ fees, to our directors and, in the discretion of our board of directors, to our officers and certain employees, in connection with legal proceedings relating to their service for or on behalf of us, subject to limited exceptions.
We have entered into indemnification agreements with each of our directors and intend to enter into such agreements with certain of our executive officers. These agreements provide that we will indemnify each of our directors, certain of our executive officers and, at times, their affiliates to the fullest extent permitted by Delaware law. We will advance expenses, including attorneys’ fees (but excluding judgments, fines and settlement amounts), to each indemnified director, executive officer or affiliate in connection with any proceeding in which indemnification is available and we will indemnify our directors and officers for any action or proceeding arising out of that person’s services as a director or officer brought on behalf of us or in furtherance of our rights. Additionally, certain of our directors or officers may have certain rights to indemnification, advancement of expenses or insurance provided by their affiliates or other third parties, which indemnification relates to and might apply to the same proceedings arising out of such director’s or officer’s services as a director referenced herein. Nonetheless, we have agreed in the indemnification agreements that our obligations to those same directors or officers are primary and any obligation of such affiliates or other third parties to advance expenses or to provide indemnification for the expenses or liabilities incurred by those directors are secondary.
We also maintain general liability insurance which covers certain liabilities of our directors and officers arising out of claims based on acts or omissions in their capacities as directors or officers, including liabilities under the Securities Act of 1933, as amended, or the Securities Act.
The underwriting agreement filed as Exhibit 1.1 to this registration statement provides for indemnification of us and our directors and officers by the underwriters against certain liabilities under the Securities Act and the Securities Exchange Act of 1934.
Item 15. Recent Sales of Unregistered Securities.
In the three years preceding the filing of this registration statement, we have issued the following securities that were not registered under the Securities Act:
(a) Reorganization
In connection with the Reorganization:
•
Holders of SpringWorks Therapeutics, LLC Junior Series A convertible preferred units received one share of SpringWorks Therapeutics, Inc. Junior Series A convertible preferred stock for each outstanding Junior Series A convertible preferred unit held immediately prior to the Reorganization, with an aggregate of 6,437,500 shares of SpringWorks Therapeutics, Inc. Junior Series A convertible preferred stock issued in the Reorganization;
•
Holders of SpringWorks Therapeutics, LLC Series A convertible preferred units received one share of SpringWorks Therapeutics, Inc. Series A convertible preferred stock for each outstanding Series A convertible preferred unit held immediately prior to the Reorganization, with an aggregate of 103,000,000 shares of SpringWorks Therapeutics, Inc. Series A convertible preferred stock issued in the Reorganization;
•
Holders of SpringWorks Therapeutics, LLC common units received one share of SpringWorks Therapeutics, Inc. common stock for each outstanding common unit held immediately prior to the Reorganization, which were subject to a subsequent one-for-6.5810 reverse split, with an aggregate of 195,638 shares of common stock issued in the Reorganization; and
•
Holders of SpringWorks Therapeutics, LLC vested and unvested incentive units exchanged such incentive units for an equal number of shares of common stock or restricted common stock, respectively, given that the strike price for all incentive units that had been issued by SpringWorks Therapeutics, LLC was $0.00 per unit which were subject to a subsequent one-for-6.5810 reverse split. The restricted common stock was issued with the same vesting terms as the unvested incentive units held immediately prior to the Reorganization. An aggregate of 2,892,998 shares of common stock and restricted common stock were issued to the prior holders of incentive units in the Reorganization.
(b) Issuances of Capital Stock
In August 2017, our predecessor issued 156,511 common units to one of our founders and 39,127 common units to a former employee of ours. All common units issued converted on a one-to-one basis for common stock in connection with the Reorganization.
In August 2017, our predecessor issued an aggregate of 6,437,500 Junior Series A convertible preferred units to Pfizer in connection with our entering into certain License Agreements therewith. All Junior Series A convertible preferred units issued converted on a one-to-one basis for Junior Series A convertible preferred stock in connection with the Reorganization.
In August 2017, our predecessor issued and sold an aggregate of 13,200,001 Series A convertible preferred units at a purchase price of $1.00 per unit, for an aggregate consideration of approximately $13.2 million to OrbiMed, Bain, Pfizer and LifeArc. All Series A convertible preferred units sold converted on a one-to-one basis for Series A convertible preferred stock in connection with the Reorganization.
In April 2018, in a second closing, our predecessor issued and sold an aggregate of 50,399,999 convertible preferred units at a purchase price of $1.00 per unit, for an aggregate consideration of approximately $50.4 million to OrbiMed, Bain, Pfizer and LifeArc. All Series A convertible preferred units sold converted on a one-to-one basis for Series A convertible preferred stock in connection with the Reorganization.
In March 2019, in a third and final closing, our predecessor issued and sold an aggregate of 39,400,000 convertible preferred units at a purchase price of $1.00 per unit, for an aggregate consideration of approximately $39.4 million to OrbiMed, Bain, Pfizer and LifeArc. All Series A convertible preferred units sold converted on a one-to-one basis for Series A convertible preferred stock in connection with the Reorganization.
In March 2019, we issued and sold to investors in a private placement an aggregate of 86,639,279 shares of our Series B Preferred Stock at a purchase price of $1.4428 per share, for aggregate consideration of approximately $125 million.
No underwriters were involved in the foregoing sales of securities. Unless otherwise stated, the sales of securities described above were deemed to be exempt from registration pursuant to Section 4(a)(2) of the Securities Act, including Regulation D and Rule 506 promulgated
thereunder, as transactions by an issuer not involving a public offering. All of the purchasers in these transactions represented to us in connection with their purchase that they were acquiring the securities for investment and not distribution, that they could bear the risks of the investment and could hold the securities for an indefinite period of time. Such purchasers received written disclosures that the securities had not been registered under the Securities Act and that any resale must be made pursuant to a registration or an available exemption from such registration. All of the foregoing securities are deemed restricted securities for the purposes of the Securities Act.
(c) Grants and Exercises of Stock Options
Prior to the Reorganization, our predecessor issued an aggregate of 2,892,998 incentive units and 148,415 options to purchase common units. Upon consummation of the Reorganization, all incentive units were exchanged for shares of restricted stock under our 2019 Plan with identical vesting terms and options to purchase common units were exchanged for options to purchase shares of our common stock with identical vesting terms. Such shares of restricted stock and options were subject to a subsequent one-for-6.5810 reverse split.
Following the Reorganization, we have granted stock options to purchase an aggregate of 2,875,691 shares of our common stock, with exercise prices ranging from $1.65, $2.30 and $9.08 per share, to employees, directors and consultants pursuant to the 2019 Plan. No shares of common stock have been issued upon the exercise of stock options pursuant to the 2019 Plan.
The issuances of the securities described above were deemed to be exempt from registration pursuant to Section 4(a)(2) of the Securities Act or Rule 701 promulgated under the Securities Act as transactions pursuant to compensatory benefit plans. The shares of common stock issued upon the exercise of options are deemed to be restricted securities for purposes of the Securities Act.
Item 16. Exhibits and Financial Statement Schedules.
(a) Exhibits.
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Exhibit No.
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Description
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1
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.1
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Form of Underwriting Agreement.
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3
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.1
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Amended and Restated Certificate of Incorporation, as amended, of the Registrant, as currently in effect.
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3
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.2*
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Form of Amended and Restated Certificate of Incorporation of the Registrant, to be in effect immediately prior to the completion of the offering.
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3
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.3*
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Bylaws of the Registrant, as currently in effect.
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3
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.4
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Form of Amended and Restated Bylaws of the Registrant, to be in effect immediately prior to the completion of the offering.
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4
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.1*
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Specimen Common Stock Certificate of the Registrant.
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4
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.2
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Amended and Restated Investors’ Rights Agreement by and among the Registrant and certain of its stockholders, dated August 30, 2019.
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5
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.1
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Opinion of Goodwin Procter LLP.
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10
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.1#*
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2019 Stock Option and Incentive Plan and forms of award agreements thereunder.
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10
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.2#
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2019 Stock Option and Equity Incentive Plan and forms of award agreements thereunder.
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10
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.3#
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2019 Employee Stock Purchase Plan.
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10
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.4#*
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Senior Executive Cash Incentive Bonus Plan.
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10
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.5#*
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Non-Employee Director Compensation Policy.
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10
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.6*
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Form of Indemnification Agreement, by and between the Registrant and each of its Directors.
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10
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.7*
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Form of Indemnification Agreement, by and between the Registrant and each of its Officers.
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Exhibit No.
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Description
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10
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.8†*
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Amended and Restated License Agreement by and among the Registrant, Pfizer Inc., SpringWorks Subsidiary 2, Inc. and Pfizer Products, Inc., dated July 31, 2019.
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10
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.9†*
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Amended and Restated License Agreement by and among the Registrant, Pfizer Inc., SpringWorks Subsidiary 3, Inc. and Warner-Lambert Company LLC, dated August 7, 2019.
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10
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.10†*
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Clinical Collaboration Agreement by and among SpringWorks Subsidiary 3, PBC and BeiGene, Ltd., dated August 16, 2018.
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10
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.11†*
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Clinical Trial Collaboration and Supply Agreement by and between the Registrant and GlaxoSmithKline LLC, dated June 25, 2019.
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10
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.12*
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Assignment and Assumption of Lease, dated as of October 10, 2018, by and between R&D Subsidiary and Structured Portfolio Management LLC.
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10
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.13#*
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Form of Employment Agreement for Executive Officers.
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10
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.14#
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Termination Letter by and between SpringWorks Therapeutics Operating Company, Inc. and Daniel S. Lynch, dated August 16, 2019.
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21
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.1*
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Subsidiaries of the Registrant.
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23
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.1
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Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm.
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23
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.2
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Consent of Goodwin Procter LLP (included in Exhibit 5.1).
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24
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.1*
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Power of Attorney (included on signature page).
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* Previously filed.
† Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit.
# Represents management compensation plan, contract or arrangement.
(b) Financial statement schedules.
None.
Item 17. Undertakings.
Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended, or the Act, may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is therefore unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
The Registrant hereby undertakes that:
(a)
The Registrant will provide to the underwriter at the closing as specified in the underwriting agreement, certificates in such denominations and registered in such names as required by the underwriter to permit prompt delivery to each purchaser.
(b)
For purposes of determining any liability under the Securities Act of 1933, as amended, the information omitted from a form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in the form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act of 1933, as amended, shall be deemed to be part of this registration statement as of the time it was declared effective.
(c)
For the purpose of determining any liability under the Securities Act of 1933, as amended, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
Signatures
Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this Registration Statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Boston, Massachusetts, on the 3rd day of September, 2019.
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SPRINGWORKS THERAPEUTICS, INC. |
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By: |
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/s/ Saqib Islam |
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Name: Saqib Islam, J.D. |
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Title: Chief Executive Officer and Director |
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Power of Attorney and Signatures
Each individual whose signature appears below hereby constitutes and appoints Saqib Islam as such person’s true and lawful attorney-in-fact and agent with full power of substitution and resubstitution, for such person in such person’s name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this Registration Statement (or any Registration Statement for the same offering that is to be effective upon filing pursuant to Rule 462(b) under the Securities Act of 1933), and to file the same, with all exhibits thereto, and all documents in connection therewith, with the Securities and Exchange Commission granting unto said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as such person might or could do in person, hereby ratifying and confirming all that such attorney-in-fact and agent, or any substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration Statement and Power of Attorney has been signed by the following person in the capacities and on the date indicated.
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Name
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Title
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Date
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/s/ Saqib Islam
Saqib Islam, J.D.
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Chief Executive Officer and Director (Principal Executive Officer) |
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September 3, 2019
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/s/ Francis I. Perier, Jr
Francis I. Perier, Jr.
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Chief Financial Officer (Principal Financial and Accounting Officer) |
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September 3, 2019
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*
Daniel S. Lynch, M.B.A.
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Chairman |
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September 3, 2019
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/s/ Alan Fuhrman
Alan Fuhrman
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Director |
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September 3, 2019
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*
Carl L. Gordon, Ph.D.
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Director |
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September 3, 2019
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*
Freda Lewis-Hall, M.D., DFAPA
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Director |
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September 3, 2019
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Name
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Title
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Date
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*
Deval Patrick, J.D.
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Director |
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September 3, 2019
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*
Jeffrey Schwartz, M.B.A.
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Director |
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September 3, 2019
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*
Stephen Squinto, Ph.D.
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Director |
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September 3, 2019
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*By:
/s/ Saqib Islam
Saqib Islam, J.D.
Attorney-in-fact
Exhibit 1.1
SpringWorks Therapeutics, Inc.
[ ] Shares of Common Stock
Underwriting Agreement
[ ], 2019
J.P. Morgan Securities LLC
Goldman Sachs & Co. LLC
Cowen and Company, LLC
As Representatives of the
several Underwriters listed
in Schedule 1 hereto
c/o J.P. Morgan Securities LLC
383 Madison Avenue
New York, New York 10179
c/o Goldman Sachs & Co. LLC
200 West Street
New York, New York 10282
c/o Cowen and Company, LLC
599 Lexington Avenue
New York, New York 10022
Ladies and Gentlemen:
SpringWorks Therapeutics, Inc., a Delaware
corporation (the “Company”), proposes to issue and sell to the several underwriters listed in Schedule 1 hereto (the
“Underwriters”), for whom you are acting as representatives (the “Representatives”), an aggregate of [·]
shares of common stock, par value $0.0001 per share (“Common Stock”), of the Company (the “Underwritten Shares”)
and, at the option of the Underwriters, up to an additional [·] shares of Common Stock of the Company (the “Option
Shares”). The Underwritten Shares and the Option Shares are herein referred to as the “Shares”. The shares of
Common Stock of the Company to be outstanding after giving effect to the sale of the Shares are referred to herein as the “Stock”.
The Company hereby confirms its agreement
with the several Underwriters concerning the purchase and sale of the Shares, as follows:
1. Registration
Statement. The Company has prepared and filed with the Securities and Exchange Commission (the “Commission”) under
the Securities Act of 1933, as amended, and the rules and regulations of the Commission thereunder (collectively, the “Securities
Act”), a registration statement (File No. 333-233351), including a prospectus, relating to the Shares. Such registration
statement, as amended at the time it became effective, including the information, if any, deemed pursuant to Rule 430A, 430B or
430C under the Securities Act to be part of the registration statement at the time of its effectiveness (“Rule 430 Information”),
is referred to herein as the “Registration Statement”; and as used herein, the term “Preliminary Prospectus”
means each prospectus included in such registration statement (and any amendments thereto) before effectiveness, any prospectus
filed with the Commission pursuant to Rule 424(a) under the Securities Act and the prospectus included in the Registration Statement
at the time of its effectiveness that omits Rule 430 Information, and the term “Prospectus” means the prospectus in
the form first used (or made available upon request of purchasers pursuant to Rule 173 under the Securities Act) in connection
with confirmation of sales of the Shares. If the Company has filed an abbreviated registration statement pursuant to Rule 462(b)
under the Securities Act (the “Rule 462 Registration Statement”), then any reference herein to the term “Registration
Statement” shall be deemed to include such Rule 462 Registration Statement. Capitalized terms used but not defined herein
shall have the meanings given to such terms in the Registration Statement and the Prospectus.
At or prior to the Applicable Time (as defined
below), the Company had prepared the following information (collectively with the pricing information set forth on Annex A, the
“Pricing Disclosure Package”): a Preliminary Prospectus dated [ ], 2019 and each “free-writing prospectus”
(as defined pursuant to Rule 405 under the Securities Act) listed on Annex A hereto.
“Applicable Time” means [ ]
[A/P].M., New York City time, on [ ], 2019.
2. Purchase
of the Shares.
(a) The
Company agrees to issue and sell the Underwritten Shares to the several Underwriters as provided in this underwriting agreement
(this “Agreement”), and each Underwriter, on the basis of the representations, warranties and agreements set forth
herein and subject to the conditions set forth herein, agrees, severally and not jointly, to purchase at a price per share of $[·]
(the “Purchase Price”) from the Company the respective number of Underwritten Shares set forth opposite such Underwriter’s
name in Schedule 1 hereto.
In addition, the Company agrees to issue
and sell the Option Shares to the several Underwriters as provided in this Agreement, and the Underwriters, on the basis of the
representations, warranties and agreements set forth herein and subject to the conditions set forth herein, shall have the option
to purchase, severally and not jointly, from the Company the Option Shares at the Purchase Price less an amount per share equal
to any dividends or distributions declared by the Company and payable on the Underwritten Shares but not payable on the Option
Shares.
If any Option Shares are to be purchased,
the number of Option Shares to be purchased by each Underwriter shall be the number of Option Shares which bears the same ratio
to the aggregate number of Option Shares being purchased as the number of Underwritten Shares set forth opposite the name of such
Underwriter in Schedule 1 hereto (or such number increased as set forth in Section 10 hereof) bears to the aggregate number of
Underwritten Shares being purchased from the Company by the several Underwriters, subject, however, to such adjustments to eliminate
any fractional Shares as the Representatives in their sole discretion shall make.
The Underwriters may exercise the option
to purchase Option Shares at any time in whole, or from time to time in part, on or before the thirtieth day following the date
of the Prospectus, by written notice from the Representatives to the Company. Such notice shall set forth the aggregate number
of Option Shares as to which the option is being exercised and the date and time when the Option Shares are to be delivered and
paid for, which may be the same date and time as the Closing Date (as hereinafter defined) but shall not be earlier than the Closing
Date nor later than the tenth full business day (as hereinafter defined) after the date of such notice (unless such time and date
are postponed in accordance with the provisions of Section 10 hereof). Any such notice shall be given at least two business days
prior to the date and time of delivery specified therein, provided that if such date and
time of delivery are the same as the Closing Date, such notice may be given one business day prior to such date and time of delivery.
(b) The
Company understands that the Underwriters intend to make a public offering of the Shares, and initially to offer the Shares on
the terms set forth in the Pricing Disclosure Package. The Company acknowledges and agrees that the Underwriters may offer and
sell Shares to or through any affiliate of an Underwriter.
(c) Payment
for the Shares shall be made by wire transfer in immediately available funds to the account specified by the Company to the Representatives
in the case of the Underwritten Shares, at the offices of Cooley LLP, counsel for the Underwriters, at 55 Hudson Yards, New York,
NY 10001, at 10:00 A.M. New York City time on [·], 2019, or at such other time or place on the same or such other date,
not later than the fifth business day thereafter, as the Representatives and the Company may agree upon in writing or, in the case
of the Option Shares, on the date and at the time and place specified by the Representatives in the written notice of the Underwriters’
election to purchase such Option Shares. The time and date of such payment for the Underwritten Shares is referred to herein as
the “Closing Date,” and the time and date for such payment for the Option Shares, if other than the Closing Date, is
herein referred to as the “Additional Closing Date”.
Payment for the Shares to be purchased on
the Closing Date or the Additional Closing Date, as the case may be, shall be made against delivery to the Representatives for
the respective accounts of the several Underwriters of the Shares to be purchased on such date in book-entry form registered in
such names and in such denominations as the Representatives shall request in writing not later than two full business days prior
to the Closing Date or the Additional Closing Date, as the case may be, with any transfer taxes payable in connection with the
sale of such Shares duly paid by the Company. Delivery of the Shares shall be made through the facilities of The Depository Trust
Company (“DTC”) unless the Representatives shall otherwise instruct.
(d) The
Company acknowledges and agrees that the Representatives and the other Underwriters are acting solely in the capacity of an arm’s
length contractual counterparty to the Company with respect to the offering of Shares contemplated hereby (including in connection
with determining the terms of the offering) and not as a financial advisor or a fiduciary to, or an agent of, the Company or any
other person. Additionally, neither the Representatives nor any other Underwriter is advising the Company or any other person as
to any legal, tax, investment, accounting or regulatory matters in any jurisdiction. The Company shall consult with its own advisors
concerning such matters and shall be responsible for making its own independent investigation and appraisal of the transactions
contemplated hereby, and neither the Representatives nor the other Underwriters shall have any responsibility or liability to the
Company with respect thereto. Any review by the Representatives and the other Underwriters of the Company, the transactions contemplated
hereby or other matters relating to such transactions will be performed solely for the benefit of the Underwriters and shall not
be on behalf of the Company.
3. Representations
and Warranties of the Company. The Company represents and warrants to each Underwriter that:
(a) Preliminary
Prospectus. No order preventing or suspending the use of any Preliminary Prospectus has been issued by the Commission, and
each Preliminary Prospectus included in the Pricing Disclosure Package, at the time of filing thereof, complied in all material
respects with the applicable requirements of the Securities Act, and no Preliminary Prospectus, at the time of filing thereof,
contained any untrue statement of a material fact or omitted to state a material fact necessary in order to make the statements
therein, in the light of the circumstances under which they were made, not misleading; provided that the Company makes no
representation or warranty with respect to any statements or omissions made in reliance upon and in conformity with information
relating to any Underwriter furnished to the Company in writing by such Underwriter through the Representatives expressly for use
in any Preliminary Prospectus, it being understood and agreed that the only such information furnished by any Underwriter consists
of the information described as such in Section 7(b) hereof.
(b) Pricing
Disclosure Package. The Pricing Disclosure Package as of the Applicable Time did not, and as of the Closing Date and as of
the Additional Closing Date, as the case may be, will not, contain any untrue statement of a material fact or omit to state a material
fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading;
provided that the Company makes no representation or warranty with respect to any statements or omissions made in reliance
upon and in conformity with information relating to any Underwriter furnished to the Company in writing by such Underwriter through
the Representatives expressly for use in such Pricing Disclosure Package, it being understood and agreed that the only such information
furnished by any Underwriter consists of the information described as such in Section 7(b) hereof. No statement of material fact
included in the Prospectus has been omitted from the Pricing Disclosure Package and no statement of material fact included in the
Pricing Disclosure Package that is required to be included in the Prospectus has been omitted therefrom.
(c) Issuer
Free Writing Prospectus. Other than the Registration Statement, the Preliminary Prospectus and the Prospectus, the Company
(including its agents and representatives, other than the Underwriters in their capacity as such) has not prepared, made, used,
authorized, approved or referred to and will not prepare, make, use, authorize, approve or refer to any “written communication”
(as defined in Rule 405 under the Securities Act) that constitutes an offer to sell or solicitation of an offer to buy the Shares
(each such communication by the Company or its agents and representatives (other than a communication referred to in clause (i)
below) an “Issuer Free Writing Prospectus”) other than (i) any document not constituting a prospectus pursuant to Section
2(a)(10)(a) of the Securities Act or Rule 134 under the Securities Act or (ii) the documents listed on Annex A hereto, each electronic
road show and any other written communications approved in writing in advance by the Representatives, such approval not to be unreasonably
withheld or delayed. Each such Issuer Free Writing Prospectus complied, or will comply, in all material respects with the Securities
Act, has been or will be (within the time period specified in Rule 433) filed in accordance with the Securities Act (to the extent
required thereby) and (except as expressly set forth in such Issuer Free Writing Prospectus) does not conflict with the information
contained in the Registration Statement or the Pricing Disclosure Package, and, when taken together with any other Issuer Free
Writing Prospectus(es) and the Preliminary Prospectus accompanying, or delivered prior to delivery of, such Issuer Free Writing
Prospectus, did not, and as of the Closing Date and as of the Additional Closing Date, as the case may be, will not, contain any
untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the
light of the circumstances under which they were made, not misleading; provided that the Company makes no representation
or warranty with respect to any statements or omissions made in each such Issuer Free Writing Prospectus or Preliminary Prospectus
in reliance upon and in conformity with information relating to any Underwriter furnished to the Company in writing by such Underwriter
through the Representatives expressly for use in such Issuer Free Writing Prospectus or Preliminary Prospectus, it being understood
and agreed that the only such information furnished by any Underwriter consists of the information described as such in Section
7(b) hereof.
(d) Emerging
Growth Company. From the time of initial confidential submission of the Registration Statement to the Commission (or, if earlier,
the first date on which the Company engaged directly or through any person authorized to act on its behalf in any Testing-the-Waters
Communication (as defined below)) through the date hereof, the Company has been and is an “emerging growth company,”
as defined in Section 2(a) of the Securities Act (an “Emerging Growth Company”). “Testing-the-Waters Communication”
means any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the Securities Act.
(e) Testing-the-Waters
Materials. The Company (i) has not alone engaged in any Testing-the-Waters Communications other than Testing-the-Waters Communications
with the consent of the Representatives with entities that are qualified institutional buyers within the meaning of Rule 144A under
the Securities Act or institutions that are accredited investors within the meaning of Rule 501 under the Securities Act and (ii)
has not authorized anyone other than the Representatives to engage in Testing-the-Waters Communications. The Company reconfirms
that the Representatives have been authorized to act on its behalf in undertaking Testing-the-Waters Communications by virtue of
a writing substantially in the form of Exhibit A hereto. The Company has not distributed or approved for distribution any Written
Testing-the-Waters Communications other than those listed on Annex B hereto. “Written Testing-the-Waters Communication”
means any Testing-the-Waters Communication that is a written communication within the meaning of Rule 405 under the Securities
Act. Any individual Written Testing-the-Waters Communication does not conflict with the information contained in the Registration
Statement or the Pricing Disclosure Package, complied in all material respects with the applicable requirements of the Securities
Act, and when taken together with the Pricing Disclosure Package as of the Applicable Time, did not, and as of the Closing Date
and as of the Additional Closing Date, as the case may be, will not, contain any untrue statement of a material fact or omit to
state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were
made, not misleading.
(f) Registration
Statement and Prospectus. The Registration Statement has been declared effective by the Commission. No order suspending the
effectiveness of the Registration Statement has been issued by the Commission, and no proceeding for that purpose or pursuant to
Section 8A of the Securities Act against the Company or related to the offering of the Shares has been initiated or, to the knowledge
of the Company, threatened by the Commission; as of the applicable effective date of the Registration Statement and any post-effective
amendment thereto, the Registration Statement and any such post-effective amendment complied and will comply in all material respects
with the applicable requirements of the Securities Act, and did not and will not contain any untrue statement of a material fact
or omit to state a material fact required to be stated therein or necessary in order to make the statements therein not misleading;
and as of the date of the Prospectus and any amendment or supplement thereto and as of the Closing Date and as of the Additional
Closing Date, as the case may be, the Prospectus will comply in all material respects with the applicable requirements of the Securities
Act and will not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the
statements therein, in the light of the circumstances under which they were made, not misleading; provided that the Company
makes no representation or warranty with respect to any statements or omissions made in reliance upon and in conformity with information
relating to any Underwriter furnished to the Company in writing by such Underwriter through the Representatives expressly for use
in the Registration Statement and the Prospectus and any amendment or supplement thereto, it being understood and agreed that the
only such information furnished by any Underwriter consists of the information described as such in Section 7(b) hereof.
(g) Financial
Statements. The financial statements (including the related notes thereto) of the Company and its consolidated subsidiaries
included in the Registration Statement, the Pricing Disclosure Package and the Prospectus comply in all material respects with
the applicable requirements of the Securities Act and present fairly the financial position of the Company and its consolidated
subsidiaries as of the dates indicated and the results of their operations and the changes in their cash flows for the periods
specified; such financial statements have been prepared in conformity with generally accepted accounting principles (“GAAP”)
in the United States applied on a consistent basis throughout the periods covered thereby, except in the case of unaudited financial
statements, which are subject to normal year end adjustment and do not contain certain footnotes as permitted by the applicable
rules of the Commission, and any supporting schedules included in the Registration Statement present fairly in all material respects
the information required to be stated therein; and the other financial information included in the Registration Statement, the
Pricing Disclosure Package and the Prospectus has been derived from the accounting records of the Company and its consolidated
subsidiaries and presents fairly in all material respects the information shown thereby; all disclosures included in the Registration
Statement, the Pricing Disclosure Package and the Prospectus regarding “non-GAAP financial measures” (as such term
is defined by the rules and regulations of Commission) comply in all material respects with Regulation G of the Exchange Act and
Item 10 of Regulation S-K of the Securities Act, to the extent applicable.
(h) No
Material Adverse Change. Since the date of the most recent financial statements of the Company included in the Registration
Statement, the Pricing Disclosure Package and the Prospectus, (i) there has not been any change in the capital stock (other than
the issuance of shares of Common Stock upon exercise of stock options and warrants described as outstanding in, and the grant of
options and awards under existing equity incentive plans described in, the Registration Statement, the Pricing Disclosure Package
and the Prospectus), short-term debt or long-term debt of the Company or any of its subsidiaries, or any dividend or distribution
of any kind declared, set aside for payment, paid or made by the Company on any class of capital stock, or any material adverse
change, or any development that would reasonably be expected to result in a material adverse change, in or affecting the business,
properties, management, financial position, stockholders’ equity, results of operations or prospects of the Company and its
subsidiaries taken as a whole; (ii) neither the Company nor any of its subsidiaries has entered into any transaction or agreement
(whether or not in the ordinary course of business) that is material to the Company and its subsidiaries taken as a whole or incurred
any liability or obligation, direct or contingent, that is material to the Company and its subsidiaries taken as a whole; and (iii)
neither the Company nor any of its subsidiaries has sustained any loss or interference with its business that is material to the
Company and its subsidiaries taken as a whole and that is either from fire, explosion, flood or other calamity, whether or not
covered by insurance, or from any labor disturbance or dispute or any action, order or decree of any court or arbitrator or governmental
or regulatory authority, except in each case as otherwise disclosed in the Registration Statement, the Pricing Disclosure Package
and the Prospectus.
(i) Organization
and Good Standing. The Company and each of its subsidiaries have been duly organized and are validly existing and in good standing
under the laws of their respective jurisdictions of organization, are duly qualified to do business and are in good standing in
each jurisdiction in which their respective ownership or lease of property or the conduct of their respective businesses requires
such qualification, and have all power and authority necessary to own or hold their respective properties and to conduct the businesses
in which they are engaged, except where the failure to be so qualified or in good standing or have such power or authority would
not, individually or in the aggregate, have a material adverse effect on the business, properties, management, financial position,
stockholders’ equity, results of operations or prospects of the Company and its subsidiaries taken as a whole or on the performance
by the Company of its obligations under this Agreement (a “Material Adverse Effect”). The Company does not own or control,
directly or indirectly, any corporation, association or other entity other than the subsidiaries listed in Exhibit 21 to the Registration
Statement. The subsidiaries listed in Schedule 2 to this Agreement are the only significant subsidiaries of the Company.
(j) Capitalization.
The Company has an authorized capitalization as set forth in the Registration Statement, the Pricing Disclosure Package and the
Prospectus under the heading “Capitalization” and “Description of Capital Stock”; all the outstanding shares
of capital stock of the Company have been duly and validly authorized and issued and are fully paid and non-assessable and are
not subject to any pre-emptive or similar rights; except as described in or expressly contemplated by the Registration Statement,
the Pricing Disclosure Package and the Prospectus, there are no outstanding rights (including, without limitation, pre-emptive
rights), warrants or options to acquire, or instruments convertible into or exchangeable for, any shares of capital stock or other
equity interest in the Company or any of its subsidiaries, or any contract, commitment, agreement, understanding or arrangement
of any kind relating to the issuance of any capital stock of the Company or any such subsidiary, any such convertible or exchangeable
securities or any such rights, warrants or options; the capital stock of the Company conforms in all material respects to the description
thereof contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and all the outstanding shares
of capital stock or other equity interests of each subsidiary owned, directly or indirectly, by the Company have been duly and
validly authorized and issued, are fully paid and non-assessable and are owned directly or indirectly by the Company, free and
clear of any lien, charge, encumbrance, security interest, restriction on voting or transfer or any other claim of any third party.
(k) Stock
Options. With respect to the stock options (the “Stock Options”) granted pursuant to the stock-based compensation
plans of the Company and its subsidiaries (the “Company Stock Plans”), (i) each Stock Option intended to qualify as
an “incentive stock option” under Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”)
so qualifies, (ii) each grant of a Stock Option was duly authorized no later than the date on which the grant of such Stock Option
was by its terms to be effective (the “Grant Date”) by all necessary corporate action, including, as applicable, approval
by the board of directors of the Company (or a duly constituted and authorized committee thereof) and any required stockholder
approval by the necessary number of votes or written consents, and the award agreement governing such grant (if any) was duly executed
and delivered by each party thereto, (iii) each such grant was made in all material respects in accordance with the terms of the
Company Stock Plans and (iv) each such grant was properly accounted for in accordance with GAAP in the financial statements
(including the related notes) of the Company. Each Company Stock Plan is accurately described in all material respects in the Registration
Statement, the Pricing Disclosure Package and the Prospectus. The Company has not knowingly granted, and there is no and has been
no policy or practice of the Company of granting, Stock Options prior to, or otherwise coordinating the grant of Stock Options
with, the release or other public announcement of material information regarding the Company or its subsidiaries or their results
of operations or prospects.
(l) Due
Authorization. The Company has full right, power and authority to execute and deliver this Agreement and to perform its obligations
hereunder; and all action required to be taken for the due and proper authorization, execution and delivery by it of this Agreement
and the consummation by it of the transactions contemplated hereby has been duly and validly taken.
(m) Underwriting
Agreement. This Agreement has been duly authorized, executed and delivered by the Company.
(n) The
Shares. The Shares to be issued and sold by the Company hereunder have been duly authorized by the Company and, when issued
and delivered and paid for as provided herein, will be duly and validly issued, will be fully paid and nonassessable and will conform
in all material respects to the descriptions thereof in the Registration Statement, the Pricing Disclosure Package and the Prospectus;
and the issuance of the Shares is not subject to any preemptive or similar rights that have not been duly and validly waived or
satisfied.
(o) Listing.
The Shares have been approved for listing on the Nasdaq Global [Select] Market (the “Nasdaq Market”), subject to
notice of issuance.
(p) Description
of the Underwriting Agreement. This Agreement conforms in all material respects to the description thereof contained in the
Registration Statement, the Pricing Disclosure Package and the Prospectus.
(q) No
Violation or Default. Neither the Company nor any of its subsidiaries is (i) in violation of its charter or by-laws or
similar organizational documents; (ii) in default, and no event has occurred that, with notice or lapse of time or both, would
constitute such a default, in the due performance or observance of any term, covenant or condition contained in any indenture,
mortgage, deed of trust, loan agreement or other agreement or instrument to which the Company or any of its subsidiaries is a party
or by which the Company or any of its subsidiaries is bound or to which any property or asset of the Company or any of its subsidiaries
is subject; or (iii) in violation of any law or statute or any judgment, order, rule or regulation of any court or arbitrator or
governmental or regulatory authority, except, in the case of clauses (ii) and (iii) above, for any such default or violation that
would not, individually or in the aggregate, have a Material Adverse Effect.
(r) No
Conflicts. The execution, delivery and performance by the Company of this Agreement, the issuance and sale of the Shares by
the Company and the consummation by the Company of the transactions contemplated by this Agreement or the Pricing Disclosure Package
and the Prospectus will not (i) conflict with or result in a breach or violation of any of the terms or provisions of, or constitute
a default under, result in the termination, modification or acceleration of, or result in the creation or imposition of any lien,
charge or encumbrance upon any property, right or asset of the Company or any of its subsidiaries pursuant to, any indenture, mortgage,
deed of trust, loan agreement or other agreement or instrument to which the Company or any of its subsidiaries is a party or by
which the Company or any of its subsidiaries is bound or to which any property, right or asset of the Company or any of its subsidiaries
is subject, (ii) result in any violation of the provisions of the charter or by-laws or similar organizational documents of the
Company or any of its subsidiaries or (iii) result in the violation of any law or statute or any judgment, order, rule or regulation
of any court or arbitrator or governmental or regulatory authority, except, in the case of clauses (i) and (iii) above, for any
such conflict, breach, violation, default, lien, charge or encumbrance that would not, individually or in the aggregate, have a
Material Adverse Effect.
(s) No
Consents Required. No consent, approval, authorization, order, registration or qualification of or with any court or arbitrator
or governmental or regulatory authority is required for the execution, delivery and performance by the Company of this Agreement,
the issuance and sale of the Shares and the consummation of the transactions contemplated by this Agreement, except for the registration
of the Shares under the Securities Act and such consents, approvals, authorizations, orders and registrations or qualifications
as may be required by the Financial Industry Regulatory Authority, Inc. (“FINRA”), the Nasdaq Market and under applicable
state securities laws in connection with the purchase and distribution of the Shares by the Underwriters.
(t) Legal
Proceedings. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, there are
no legal, governmental or regulatory investigations, actions, demands, claims, suits, arbitrations, inquiries or proceedings (“Actions”)
pending to which the Company or any of its subsidiaries is or may be a party or to which any property of the Company or any of
its subsidiaries is or may be the subject that, individually or in the aggregate, if determined adversely to the Company or any
of its subsidiaries, would reasonably be expected to have a Material Adverse Effect; no such Actions are threatened or, to the
knowledge of the Company, contemplated by any governmental or regulatory authority or threatened by others; and (i) there are no
current or pending Actions that are required under the Securities Act to be described in the Registration Statement, the Pricing
Disclosure Package or the Prospectus that are not so described in the Registration Statement, the Pricing Disclosure Package and
the Prospectus and (ii) there are no statutes, regulations or contracts or other documents that are required under the Securities
Act to be filed as exhibits to the Registration Statement or described in the Registration Statement, the Pricing Disclosure Package
or the Prospectus that are not so filed as exhibits to the Registration Statement or described in the Registration Statement, the
Pricing Disclosure Package and the Prospectus.
(u) Independent
Accountants. Ernst & Young LLP , who have certified certain financial statements of the Company and its subsidiaries is
an independent registered public accounting firm with respect to the Company and its subsidiaries within the applicable rules and
regulations adopted by the Commission and the Public Company Accounting Oversight Board (United States) and as required by the
Securities Act.
(v) Title
to Real and Personal Property. The Company and its subsidiaries have good and marketable title in fee simple to, or have valid
rights to lease or otherwise use, all items of real and personal property that are material to the respective businesses of the
Company and its subsidiaries, in each case free and clear of all liens, encumbrances, claims and defects and imperfections of title
except those that (i) do not materially interfere with the use made and proposed to be made of such property by the Company and
its subsidiaries or (ii) would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.
(w) Title
to Intellectual Property. The Company and its subsidiaries own, have valid and enforceable license to, or otherwise have the
right to use, all material patents, patent applications, trademarks, service marks, trade names, trademark registrations, service
mark registrations, trade dress, designs, data, database rights, Internet domain names, copyrights, works of authorship, licenses,
proprietary information and know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential
information, systems or procedures), and all other intellectual property and proprietary rights, including registrations and applications
for registration thereof (collectively, “Intellectual Property”) necessary for the conduct of their respective businesses
as currently conducted and as proposed to be conducted, or which are described in the Registration Statement, the Pricing Disclosure
Package and the Prospectus as being owned by or licensed to the Company or its subsidiaries. To the knowledge of the Company and
its subsidiaries, the Company and its subsidiaries’ conduct of their respective businesses does not and will not infringe,
misappropriate or otherwise violate in any material respect with any Intellectual Property of any third party The Intellectual
Property of the Company has not been adjudged by a court of competent jurisdiction to be invalid or unenforceable, in whole or
in part, and the Company is unaware of any facts which would form a reasonable basis for any such adjudication. The Company and
its subsidiaries have not received any notice of any claim of infringement, misappropriation or conflict with any intellectual
property rights of another, and the Company is unaware of any facts which would form a reasonable basis for any such notice or
claim. To the Company’s knowledge, there are no third parties who have rights to any Intellectual Property, except for customary
reversionary rights of third-party licensors with respect to Intellectual Property that is disclosed in the Registration Statement,
the Pricing Disclosure Package and the Prospectus as owned by or licensed to the Company or its subsidiaries. Except as disclosed
in the Registration Statement, the Pricing Disclosure Package and the Prospectus, there is no pending or, to the Company’s
knowledge, threatened action, suit, proceeding or claim by others: (A) challenging the Company’s rights in or to any Intellectual
Property, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or
claim; (B) challenging the validity, enforceability or scope of any Intellectual Property, and the Company is unaware of any facts
which would form a reasonable basis for any such action, suit, proceeding or claim; or (C) asserting that the Company or its subsidiaries
infringe, misappropriate, or otherwise violate, or would, upon the commercialization of any product or service described in the
Disclosure Documents as under development, infringe, misappropriate, or otherwise violate, any intellectual property rights of
others, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim.
The Company and its subsidiaries have complied with the terms of each agreement pursuant to which Intellectual Property has been
licensed to the Company or its subsidiaries, and all such agreements are in full force and effect. To the Company’s knowledge,
there are no material defects in any of the patents or patent applications included in the Intellectual Property. The Company and
its subsidiaries have taken all reasonable steps to protect, maintain and safeguard their Intellectual Property, including the
execution of appropriate nondisclosure, confidentiality agreements and invention assignment agreements and invention assignments
with their employees. To the Company’s knowledge, no employee of the Company is in or has been in violation of any term of
any employment contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation
agreement, nondisclosure agreement, or any restrictive covenant to or with a former employer where the basis of such violation
relates to such employee’s employment with the Company. The duty of candor and good faith as required by the United States
Patent and Trademark Office during the prosecution of the United States patents and patent applications within the Intellectual
Property have been complied with; and in all foreign offices having similar requirements, all such requirements have been complied
with. None of the Company owned Intellectual Property or technology (including information technology and outsourced arrangements)
employed by the Company or its subsidiaries has been obtained or is being used by the Company or its subsidiary in violation of
any contractual obligation binding on the Company or its subsidiaries or any of their respective officers, directors or employees
or otherwise in violation of the rights of any persons.
(x) Trade
Secrets. The Company and its subsidiaries have taken reasonable and customary actions to protect their rights in and prevent
the unauthorized use and disclosure of material trade secrets and confidential business information (including confidential source
code, ideas, research and development information, know-how, formulas, compositions, technical data, designs, drawings, specifications,
research records, records of inventions, test information, financial, marketing and business data, customer and supplier lists
and information, pricing and cost information, business and marketing plans and proposals) owned by the Company and its subsidiaries,
and, to the knowledge of the Company, there has been no unauthorized use or disclosure.
(y) IT
Assets. Except as could not reasonably be expected to have a Material Adverse Effect (i) the computers, software, servers,
networks, data communications lines, and other information technology systems owned, licensed, leased or otherwise used by the
Company or its subsidiaries (excluding any public networks) (collectively, the “IT Assets”) operate and perform as
is necessary for the operation of the business of the Company and its subsidiaries as currently conducted and as proposed to be
conducted as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, and (ii) such IT
Assets are not infected by viruses, disabling code or other harmful code. The Company and its subsidiaries have at all times implemented
and maintained all reasonably necessary controls, policies, procedures, and safeguards to maintain and protect their confidential
information and the integrity, continuous operation, redundancy and security of all IT Assets and data (including all Personal
Data (defined below) sensitive, confidential or regulated data (“Confidential Data”) used in connection with their
businesses, and there have been no breaches, violations, outages or unauthorized uses of or accesses to same, except for those
that have been remedied without material cost or liability or the duty to notify any other person, nor any incidents under internal
review or investigations relating to the same.
(z) Data
Privacy and Security Laws. The Company and its subsidiaries are, and at all prior times were, in material compliance with all
applicable state and federal data privacy and security laws and regulations, including without limitation the Health Insurance
Portability and Accountability Act of 1996 (“HIPAA”) as amended by the Health Information Technology for Economic and
Clinical Health Act (the “HITECH Act”); and the Company and its subsidiaries have taken commercially reasonable actions
to prepare to comply with, and since May 25, 2018, have been and currently are in compliance with, the European Union General Data
Protection Regulation (“GDPR”) (EU 2016/679) (collectively, the “Privacy Laws”). To ensure compliance with
the Privacy Laws, the Company and its subsidiaries have in place, comply with, and take appropriate steps reasonably designed to
ensure compliance in all material respects with their policies and procedures relating to data privacy and security and the collection,
storage, use, disclosure, handling, and analysis of Personal Data (the “Policies”). “Personal Data” means
(i) a natural person’s name, street address, telephone number, e-mail address, photograph, social security number or
tax identification number, driver’s license number, passport number, credit card number, bank information, or customer or
account number; (ii) any information which would qualify as “personally identifying information” under the Federal
Trade Commission Act, as amended; (iii) Protected Health Information as defined by HIPAA; (iv) “personal data” as defined
by GDPR; and (v) any other piece of information that allows the identification of such natural person, or his or her family, or
permits the collection or analysis of any data related to an identified person’s health or sexual orientation. The Company
and its subsidiaries have at all times made all disclosures to users or customers required by applicable laws and regulatory rules
or requirements, and none of such disclosures made or contained in any Policy have, to the knowledge of the Company, been inaccurate
or in violation of any applicable laws and regulatory rules or requirements in any material respect. The Company further certifies
that neither it nor any subsidiary: (i) has received notice of any actual or potential liability under or relating to, or actual
or potential violation of, any of the Privacy Laws, and has no knowledge of any event or condition that would reasonably be expected
to result in any such notice; (ii) is currently conducting or paying for, in whole or in part, any investigation, remediation,
or other corrective action pursuant to any Privacy Law; or (iii) is a party to any order, decree, or agreement that imposes any
obligation or liability under any Privacy Law.
(aa) No Complaints.
There is no complaint to or audit, proceeding, investigation (formal or informal) or claim currently pending against the Company
or its subsidiaries, or to the knowledge of the Company, any of its customers (specific to the customer’s use of the products
or services of the Company) by the Federal Trade Commission, the U.S. Department of Health and Human Services and any office contained
therein (“HHS”), or any similar authority in any jurisdiction other than the United States or any other governmental
entity, or by any person in respect of the collection, use or disclosure of Personal Data by the Company or its subsidiaries, and,
to the knowledge of the Company, no such complaint, audit, proceeding, investigation or claim is threatened.
(bb) FDA Compliance.
The Company: (A) is and at all times has been in material compliance with all statutes, rules or regulations of the FDA and other
comparable governmental entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution,
marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured
or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, notice of adverse finding,
warning letter, untitled letter or other correspondence or notice from the FDA or any governmental entity alleging or asserting
material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations,
permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses
all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation
of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement,
investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation
or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental
entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has
not received notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify
or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action;
and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims,
submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents,
forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on
the date filed (or were corrected or supplemented by a subsequent submission).
(cc) Tests and Preclinical
and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge,
on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental
protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable
Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder
and current Good Clinical Practices and Good Laboratory Practices and any applicable rules, regulations and policies of the jurisdiction
in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained
in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate
and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent
disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies,
tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described
or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which
such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement,
the Pricing Disclosure Package or the Prospectus, the Company has not received any notices or correspondence from the FDA or any
governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by
or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design
and implementation of such trials, copies of which communications have been made available to you.
(dd) Compliance with Health
Care Laws. The Company and its subsidiaries are, and at all times have been, in compliance in all material respects with all
Health Care Laws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic
Act and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse
laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims
Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)),
18 U.S.C. Sections 286, 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance
Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the
civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), laws governing
government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and
Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010, as amended
by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under
applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational
and foreign laws, relating to the regulation of the Company or its subsidiaries, and (vii) the directives and regulations promulgated
pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, any
of its subsidiaries, nor any of their respective officers, directors, employees or agents have engaged
in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its
subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration
or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation
or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding,
hearing, enforcement, investigation, arbitration or other action threatened. The Company, and to the Company’s knowledge,
its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims,
submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices,
applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material
respects (or were corrected or supplemented by a subsequent submission). Neither the Company, any of its subsidiaries, nor, to
the Company’s knowledge, any of their respective employees, officers, directors, or agents is a party to any corporate integrity
agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental
or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective employees, officers,
directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human
clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other
similar action that could reasonably be expected to result in debarment, suspension, or exclusion.
(ee) No Undisclosed Relationships.
No relationship, direct or indirect, exists between or among the Company or any of its subsidiaries, on the one hand, and the directors,
officers, stockholders, customers, suppliers or other affiliates of the Company or any of its subsidiaries, on the other, that
is required by the Securities Act to be described in each of the Registration Statement and the Prospectus and that is not so described
in such documents and in the Pricing Disclosure Package.
(ff) Investment Company
Act. The Company is not and, after giving effect to the offering and sale of the Shares and the application of the proceeds
thereof as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, will not be required to
register as an “investment company” or an entity “controlled” by an “investment company” within
the meaning of the Investment Company Act of 1940, as amended, and the rules and regulations of the Commission thereunder (collectively,
the “Investment Company Act”).
(gg) Taxes. The Company
and its subsidiaries have paid all federal, state, local and foreign taxes and filed all tax returns required to be paid or filed
through the date hereof, except for taxes being contested in good faith and for which reserves in accordance with GAAP have been
taken; and except as otherwise disclosed in each of the Registration Statement, the Pricing Disclosure Package and the Prospectus,
or where the failure to pay or file any such taxes would not have a Material Adverse Effect, there is no tax deficiency that has
been, or would reasonably be expected to be, asserted against the Company or any of its subsidiaries or any of their respective
properties or assets and which could reasonably be expected to result in a Material Adverse Effect.
(hh) Licenses and Permits.
To the Company’s knowledge, the Company and its subsidiaries possess all licenses, sub-licenses, certificates, permits and
other authorizations issued by, and have made all declarations and filings with, the appropriate and applicable federal, state,
local or foreign governmental or regulatory authorities that are necessary for the ownership or lease of their respective properties
or the conduct of their respective businesses as described in each of the Registration Statement, the Pricing Disclosure Package
and the Prospectus, except where the failure to possess or make the same would not, individually or in the aggregate, have a Material
Adverse Effect; and except as described in each of the Registration Statement, the Pricing Disclosure Package and the Prospectus,
neither the Company nor any of its subsidiaries has received notice of any revocation or modification of any such license, sub-license,
certificate, permit or authorization or has any reason to believe that any such license, sub-license, certificate, permit or authorization
will not be renewed in the ordinary course. To the Company’s knowledge, no party granting any such licenses, certificates,
permits and other authorizations has taken any action to limit, suspend or revoke the same in any material respect, except where
such modification or revocation would not have a Material Adverse Effect. The Company and its subsidiaries have filed, obtained,
maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements
or amendments as required and that all such reports, documents, forms, notices, applications, records, claims, submissions and
supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent
submission) as required for maintenance of their licenses, certificates, permits and other authorizations that are necessary for
the conduct of their respective businesses.
(ii) No
Labor Disputes. No labor disturbance by or dispute with employees of the Company or any of its subsidiaries exists or, to the
knowledge of the Company, is contemplated or threatened, and the Company is not aware of any existing or imminent labor disturbance
by, or dispute with, the employees of any of its or its subsidiaries’ principal suppliers, contractors or customers, except
as would not have a Material Adverse Effect. Neither the Company nor any of its subsidiaries has received any notice of cancellation
or termination with respect to any collective bargaining agreement to which it is a party.
(jj) Certain Environmental
Matters. (i) The Company and its subsidiaries (x) are in compliance with all, and have not violated any, applicable federal,
state, local and foreign laws (including common law), rules, regulations, requirements, decisions, judgments, decrees, orders and
other legally enforceable requirements relating to pollution or the protection of human health or safety, the environment, natural
resources, hazardous or toxic substances or wastes, pollutants or contaminants (collectively, “Environmental Laws”);
(y) have received and are in compliance with all, and have not violated any, permits, licenses, certificates or other authorizations
or approvals required of them under any Environmental Laws to conduct their respective businesses; and (z) have not received notice
of any actual or potential liability or obligation under or relating to, or any actual or potential violation of, any Environmental
Laws, including for the investigation or remediation of any disposal or release of hazardous or toxic substances or wastes, pollutants
or contaminants, and have no knowledge of any event or condition that would reasonably be expected to result in any such notice,
and (ii) there are no costs or liabilities associated with Environmental Laws of or relating to the Company or its subsidiaries,
except in the case of each of (i) and (ii) above, for any such matter as would not, individually or in the aggregate, reasonably
be expected to have a Material Adverse Effect; and (iii) except as described in each of the Registration Statement, Pricing Disclosure
Package and the Prospectus, (x) there is no proceeding that is pending, or to the Company’s knowledge, contemplated, against
the Company or any of its subsidiaries under any Environmental Laws in which a governmental entity is also a party, other than
such proceeding regarding which it is reasonably believed no monetary sanctions of $100,000 or more will be imposed, (y) the Company
and its subsidiaries are not aware of any facts or issues regarding compliance with Environmental Laws, or liabilities or other
obligations under Environmental Laws or concerning hazardous or toxic substances or wastes, pollutants or contaminants, that would
reasonably be expected to have a material effect on the capital expenditures, earnings or competitive position of the Company and
its subsidiaries, and (z) none of the Company or its subsidiaries anticipates material capital expenditures relating to any Environmental
Laws.
(kk) Hazardous Materials.
There has been no storage, generation, transportation, use, handling, treatment, Release or threat of Release of Hazardous Materials
by, relating to or caused by the Company or any of its subsidiaries (or, to the knowledge of the Company and its subsidiaries,
any other entity (including any predecessor) for whose acts or omissions the Company or any of its subsidiaries is or could reasonably
be expected to be liable) at, on, under or from any property or facility now or previously owned, operated or leased by the Company
or any of its subsidiaries, or at, on, under or from any other property or facility, in violation of any Environmental Laws or
in a manner or amount or to a location that could reasonably be expected to result in any liability under any Environmental Law,
except for any violation or liability which would not, individually or in the aggregate, reasonably be expected to have a Material
Adverse Effect. “Hazardous Materials” means any material, chemical, substance ,waste, pollutant, contaminant, compound,
mixture, or constituent thereof, in any form or amount, including petroleum (including crude oil or any fraction thereof) and petroleum
products, natural gas liquids, asbestos and asbestos containing materials, naturally occurring radioactive materials, brine, and
drilling mud, regulated or which can give rise to liability under any Environmental Law. “Release” means any spilling,
leaking, seepage, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, disposing, depositing,
dispersing, or migrating in, into or through the environment, or in, into from or through any building or structure.
(ll) Compliance with ERISA.
(i) Each employee benefit plan, within the meaning of Section 3(3) of the Employee Retirement Income Security Act of 1974, as amended
(“ERISA”), for which the Company or any member of its “Controlled Group” (defined as any entity, whether
or not incorporated, that is under common control with the Company within the meaning of Section 4001(a)(14) of ERISA or any entity
that would be regarded as a single employer with the Company under Section 414(b),(c),(m) or (o) of the Code) would have any liability
(each, a “Plan”) has been maintained in compliance with its terms and the requirements of any applicable statutes,
orders, rules and regulations, including but not limited to ERISA and the Code; (ii) no prohibited transaction, within the meaning
of Section 406 of ERISA or Section 4975 of the Code, has occurred with respect to any Plan, excluding transactions effected pursuant
to a statutory or administrative exemption; (iii) for each Plan that is subject to the funding rules of Section 412 of the Code
or Section 302 of ERISA, no Plan has failed (whether or not waived), or is reasonably expected to fail, to satisfy the minimum
funding standards (within the meaning of Section 302 of ERISA or Section 412 of the Code) applicable to such Plan; (iv) no Plan
is, or is reasonably expected to be, in “at risk status” (within the meaning of Section 303(i) of ERISA) and no Plan
that is a “multiemployer plan” within the meaning of Section 4001(a)(3) of ERISA is in “endangered status”
or “critical status” (within the meaning of Sections 304 and 305 of ERISA); (v) the fair market value of the assets
of each Plan exceeds the present value of all benefits accrued under such Plan (determined based on those assumptions used to fund
such Plan); (vi) no “reportable event” (within the meaning of Section 4043(c) of ERISA and the regulations promulgated
thereunder) has occurred or is reasonably expected to occur; (vii) each Plan that is intended to be qualified under Section 401(a)
of the Code is so qualified, and nothing has occurred, whether by action or by failure to act, which would cause the loss of such
qualification; (viii) neither the Company nor any member of the Controlled Group has incurred, nor reasonably expects to incur,
any liability under Title IV of ERISA (other than contributions to the Plan or premiums to the Pension Benefit Guarantee Corporation,
in the ordinary course and without default) in respect of a Plan (including a “multiemployer plan” within the meaning
of Section 4001(a)(3) of ERISA); and (ix) none of the following events has occurred or is reasonably likely to occur: (A) a material
increase in the aggregate amount of contributions required to be made to all Plans by the Company or its Controlled Group affiliates
in the current fiscal year of the Company and its Controlled Group affiliates compared to the amount of such contributions made
in the Company’s and its Controlled Group affiliates’ most recently completed fiscal year; or (B) a material increase
in the Company and its subsidiaries’ “accumulated post-retirement benefit obligations” (within the meaning of
Accounting Standards Codification Topic 715-60) compared to the amount of such obligations in the Company and its subsidiaries’
most recently completed fiscal year, except in each case with respect to the events or conditions set forth in (i) through (ix)
hereof, as would not, individually or in the aggregate, have a Material Adverse Effect.
(mm) Disclosure Controls.
The Company and its subsidiaries maintain an effective system of “disclosure controls and procedures” (as defined in
Rule 13a-15(e) of the Exchange Act) that complies with the applicable requirements of the Exchange Act and that has been designed
to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms, including
controls and procedures designed to ensure that such information is accumulated and communicated to the Company’s management
as appropriate to allow timely decisions regarding required disclosure.
(nn) Accounting Controls.
The Company and its subsidiaries maintain systems of “internal control over financial reporting” (as defined in Rule
13a-15(f) of the Exchange Act) designed to comply with the applicable requirements of the Exchange Act and have been designed by,
or under the supervision of, their respective principal executive and principal financial officers, or persons performing similar
functions, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with GAAP, including internal accounting controls sufficient to provide reasonable assurance
that (i) transactions are executed in accordance with management’s general or specific authorizations; (ii) transactions
are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability;
(iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the
recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken
with respect to any differences. There are no material weaknesses in the Company’s internal controls. The Company’s
auditors and the Audit Committee of the Board of Directors of the Company have been advised of: (i) all significant deficiencies
and material weaknesses in the design or operation of internal controls over financial reporting which have adversely affected
or are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information;
and (ii) to the best knowledge of the Company, any fraud, whether or not material, that involves management or other employees
who have a significant role in the Company’s internal controls over financial reporting.
(oo) Insurance.
The Company and its subsidiaries have insurance covering their respective properties, operations, personnel and businesses,
including business interruption insurance, which insurance is in amounts and insures against such losses and risks as are generally
maintained by similarly situated companies and which the Company believes are reasonably adequate to protect the Company and its
subsidiaries and their respective businesses; and neither the Company nor any of its subsidiaries has (i) received notice from
any insurer or agent of such insurer that capital improvements or other expenditures are required or necessary to be made in order
to continue such insurance or (ii) knowledge of any events that have occurred, or circumstances that exist, with respect to the
Company that would cause it to be unable to renew its existing insurance coverage as and when such coverage expires or to obtain
similar coverage at reasonable cost from similar insurers as may be necessary to continue its business.
(pp) No Unlawful Payments.
Neither the Company nor any of its subsidiaries nor any director, officer or employee of the Company or any of its subsidiaries
nor, to the knowledge of the Company, any agent, affiliate or other person associated with or acting on behalf of the Company or
any of its subsidiaries has (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense
relating to political activity; (ii) made or taken an act in furtherance of an offer, promise or authorization of any direct or
indirect unlawful payment or benefit to any foreign or domestic government or regulatory official or employee, including of any
government-owned or controlled entity or of a public international organization, or any person acting in an official capacity for
or on behalf of any of the foregoing, or any political party or party official or candidate for political office; (iii) violated
or is in violation of any provision of the Foreign Corrupt Practices Act of 1977, as amended, or any applicable law or regulation
implementing the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions, or committed
an offence under the Bribery Act 2010 of the United Kingdom or any other applicable anti-bribery or anti-corruption law; or (iv)
made, offered, agreed, requested or taken an act in furtherance of any unlawful bribe or other unlawful benefit, including, without
limitation, any rebate, payoff, influence payment, kickback or other unlawful or improper payment or benefit. The Company and its
subsidiaries have instituted, maintain and enforce, and will continue to maintain and enforce policies and procedures designed
to promote and ensure compliance with all applicable anti-bribery and anti-corruption laws.
(qq) Compliance with Anti-Money
Laundering Laws. The operations of the Company and its subsidiaries are and have been conducted at all times in compliance
with financial recordkeeping and reporting requirements applicable to such entities, including those of the Currency and Foreign
Transactions Reporting Act of 1970, as amended, the applicable money laundering statutes of all jurisdictions where the Company
or any of its subsidiaries conducts business, the rules and regulations thereunder and any related or similar rules, regulations
or guidelines applicable to such entities issued, administered or enforced by any governmental agency (collectively, the “Anti-Money
Laundering Laws”) and no action, suit or proceeding by or before any court or governmental agency, authority or body or any
arbitrator involving the Company or any of its subsidiaries with respect to the Anti-Money Laundering Laws is pending or, to the
knowledge of the Company, threatened.
(rr) No Conflicts with Sanctions
Laws. Neither the Company nor any of its subsidiaries, directors, officers, or employees, nor, to the knowledge of the Company,
any agent, affiliate or other person associated with or acting on behalf of the Company or any of its subsidiaries is currently
the subject or the target of any sanctions administered or enforced by the U.S. government, (including, without limitation, the
Office of Foreign Assets Control of the U.S. Department of the Treasury (“OFAC”) or the U.S. Department of State and
including, without limitation, the designation as a “specially designated national” or “blocked person”),
the United Nations Security Council (“UNSC”), the European Union, Her Majesty’s Treasury (“HMT”)
or other relevant sanctions authority (collectively, “Sanctions”), nor is the Company or any of its subsidiaries located,
organized or resident in a country or territory that is the subject or target of Sanctions, including, without limitation, Crimea,
Cuba, Iran, North Korea and Syria (each, a “Sanctioned Country”); and the Company will not directly or indirectly use
the proceeds of the offering of the Shares hereunder, or lend, contribute or otherwise make available such proceeds to any subsidiary,
joint venture partner or other person or entity (i) to fund or facilitate any activities of or business with any person that, at
the time of such funding or facilitation, is the subject or target of Sanctions, (ii) to fund or facilitate any activities of or
business in any Sanctioned Country or (iii) in any other manner that will result in a violation by any person (including any person
participating in the transaction, whether as underwriter, advisor, investor or otherwise) of Sanctions. For the past five years,
the Company and its subsidiaries have not knowingly engaged in and are not now knowingly engaged in any dealings or transactions
with any person that at the time of the dealing or transaction is or was the subject or the target of Sanctions or with any Sanctioned
Country.
(ss) No Restrictions on
Subsidiaries. No subsidiary of the Company is currently prohibited, directly or indirectly, under any agreement or other instrument
to which it is a party or is subject, from paying any dividends to the Company, from making any other distribution on such subsidiary’s
capital stock or similar ownership interest, from repaying to the Company any loans or advances to such subsidiary from the Company
or from transferring any of such subsidiary’s properties or assets to the Company or any other subsidiary of the Company.
(tt) No Broker’s Fees.
Neither the Company nor any of its subsidiaries is a party to any contract, agreement or understanding with any person (other than
this Agreement) that would give rise to a valid claim against any of them or any Underwriter for a brokerage commission, finder’s
fee or like payment in connection with the offering and sale of the Shares.
(uu) No Registration Rights.
Except as described in the Registration Statement, the Pricing Disclosure Packages and the Prospectus, no person has the right
to require the Company or any of its subsidiaries to register any securities for sale under the Securities Act by reason of the
filing of the Registration Statement with the Commission or the issuance and sale of the Shares by the Company, except for those
rights that have been duly and validly waived.
(vv) No Stabilization.
Neither the Company nor any of its subsidiaries or, to the knowledge of the Company, its affiliates, has taken, directly or
indirectly, any action designed to or that could reasonably be expected to cause or result in any stabilization or manipulation
of the price of the Shares.
(ww) Margin Rules. Neither
the issuance, sale and delivery of the Shares nor the application of the proceeds thereof by the Company as described in each of
the Registration Statement, the Pricing Disclosure Package and the Prospectus will violate Regulation T, U or X of the Board of
Governors of the Federal Reserve System or any other regulation of such Board of Governors.
(xx) Forward-Looking
Statements. No forward-looking statement (within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange
Act) included in the Registration Statement, the Pricing Disclosure Package or the Prospectus has been made or reaffirmed without
a reasonable basis or has been disclosed other than in good faith.
(yy) Statistical and Market
Data. Nothing has come to the attention of the Company that has caused the Company to believe that the statistical and market-related
data included in each of the Registration Statement, the Pricing Disclosure Package and the Prospectus is not based on or derived
from sources that are reliable and accurate in all material respects.
(zz) Sarbanes-Oxley Act.
There is and has been no failure on the part of the Company or, to the knowledge of the Company, any of the Company’s directors
or officers, in their capacities as such, to comply with any applicable provision of the Sarbanes-Oxley Act of 2002, as amended
and the rules and regulations promulgated in connection therewith (the “Sarbanes-Oxley Act”), including Section 402
related to loans and Sections 302 and 906 related to certifications.
(aaa) Status under the Securities
Act. At the time of filing the Registration Statement and any post-effective amendment thereto, at the earliest time thereafter
that the Company or any offering participant made a bona fide offer (within the meaning of Rule 164(h)(2) under the Securities
Act) of the Shares and at the date hereof, the Company was not and is not an “ineligible issuer,” as defined in Rule
405 under the Securities Act. The Company has paid the registration fee for this offering pursuant to Rule 456(b)(1) under the
Securities Act or will pay such fee within the time period required by such rule (without giving effect to the proviso therein)
and in any event prior to the Closing Date.
(bbb) No
Ratings. There are (and prior to the Closing Date, will be) no debt securities, convertible securities or preferred stock
issued or guaranteed by the Company or any of its subsidiaries that are rated by a “nationally recognized statistical rating
organization”, as such term is defined in Section 3(a)(62) under the Exchange Act.
(ccc) Cybersecurity.
The Company and its subsidiaries’ information technology assets and equipment, computers, systems, networks, hardware, software,
websites, applications, and databases (collectively, “IT Systems”) are adequate for, and operate and perform in all
material respects as required in connection with the operation of the business of the Company and the Subsidiaries as currently
conducted, free and clear of all material bugs, errors, defects, Trojan horses, time bombs, malware and other corruptants. The
Company and its subsidiaries have implemented and maintained commercially reasonable controls, policies, procedures, and safeguards
to maintain and protect their material confidential information and the integrity, continuous operation, redundancy and security
of all IT Systems and data (including all personal, personally identifiable, sensitive, confidential or regulated data (“Personal
Data”)) used in connection with their businesses, and, to the Company’s knowledge, there have been no breaches, violations,
outages or unauthorized uses of or accesses to same, except for those that have been remedied without material cost or liability
or the duty to notify any other person, nor any incidents under internal review or investigations relating to the same. The Company
and its subsidiaries are presently in material compliance with all applicable laws or statutes and all judgments, orders, rules
and regulations of any court or arbitrator or governmental or regulatory authority, internal policies and contractual obligations,
in each case relating to the privacy and security of IT Systems and Personal Data and to the protection of such IT Systems and
Personal Data from unauthorized use, access, misappropriation or modification.
4. Further
Agreements of the Company. The Company covenants and agrees with each Underwriter that:
(a) Required
Filings. The Company will file the final Prospectus with the Commission within the time periods specified by Rule 424(b) and
Rule 430A, 430B or 430C under the Securities Act, will file any Issuer Free Writing Prospectus to the extent required by Rule 433
under the Securities Act; and the Company will furnish copies of the Prospectus and each Issuer Free Writing Prospectus (to the
extent not previously delivered) to the Underwriters in New York City prior to 10:00 A.M., New York City time, on the business
day next succeeding the date of this Agreement in such quantities as the Representatives may reasonably request.
(b) Delivery
of Copies. The Company will deliver, without charge, (i) to the Representatives, two signed copies of the Registration Statement
as originally filed and each amendment thereto, in each case including all exhibits and consents filed therewith; and (ii) to each
Underwriter (A) a conformed copy of the Registration Statement as originally filed and each amendment thereto (without exhibits)
and (B) during the Prospectus Delivery Period (as defined below), as many copies of the Prospectus (including all amendments and
supplements thereto and each Issuer Free Writing Prospectus) as the Representatives may reasonably request. As used herein, the
term “Prospectus Delivery Period” means such period of time after the first date of the public offering of the Shares
as in the opinion of counsel for the Underwriters a prospectus relating to the Shares is required by law to be delivered (or required
to be delivered but for Rule 172 under the Securities Act) in connection with sales of the Shares by any Underwriter or dealer.
(c) Amendments
or Supplements, Issuer Free Writing Prospectuses. Before making, preparing, using, authorizing, approving, referring to or
filing any Issuer Free Writing Prospectus, and before filing any amendment or supplement to the Registration Statement, the Pricing
Disclosure Package or the Prospectus, the Company will furnish to the Representatives and counsel for the Underwriters a copy of
the proposed Issuer Free Writing Prospectus, amendment or supplement for review and will not make, prepare, use, authorize, approve,
refer to or file any such Issuer Free Writing Prospectus or file any such proposed amendment or supplement to which the Representatives
reasonably object.
(d) Notice
to the Representatives. The Company will advise the Representatives promptly, and confirm such advice in writing (which confirmation
may be delivered by electronic mail), (i) when the Registration Statement has become effective; (ii) when any amendment to the
Registration Statement has been filed or becomes effective; (iii) when any supplement to the Pricing Disclosure Package, the Prospectus,
any Issuer Free Writing Prospectus, any Written Testing-the-Waters Communication or any amendment to the Prospectus has been filed
or distributed; (iv) of any request by the Commission for any amendment to the Registration Statement or any amendment or supplement
to the Prospectus or the receipt of any comments from the Commission relating to the Registration Statement or any other request
by the Commission for any additional information including, but not limited to, any request for information concerning any Testing-the-Waters
Communication; (v) of the issuance by the Commission or any other governmental or regulatory authority of any order suspending
the effectiveness of the Registration Statement or preventing or suspending the use of any Preliminary Prospectus, any of the Pricing
Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication or the initiation or, to the Company’s
knowledge, threatening of any proceeding for that purpose or pursuant to Section 8A of the Securities Act; (vi) of the occurrence
of any event or development within the Prospectus Delivery Period as a result of which the Prospectus, any of the Pricing Disclosure
Package, any Issuer Free Writing Prospectus or any Written Testing-the-Waters Communication as then amended or supplemented would
include any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein,
in the light of the circumstances existing when the Prospectus, the Pricing Disclosure Package, or any such Issuer Free Writing
Prospectus or any Written Testing-the-Waters Communication is delivered to a purchaser, not misleading; and (vii) of the receipt
by the Company of any notice with respect to any suspension of the qualification of the Shares for offer and sale in any jurisdiction
or the initiation or, to the Company’s knowledge, threatening of any proceeding for such purpose; and the Company will use
its reasonable best efforts to prevent the issuance of any such order suspending the effectiveness of the Registration Statement,
preventing or suspending the use of any Preliminary Prospectus, any of the Pricing Disclosure Package or the Prospectus or any
Written Testing-the-Waters Communication or suspending any such qualification of the Shares and, if any such order is issued, will
use its reasonable best efforts to obtain as soon as possible the withdrawal thereof.
(e) Ongoing
Compliance. (1) If during the Prospectus Delivery Period (i) any event or development shall occur or condition shall exist
as a result of which the Prospectus as then amended or supplemented would include any untrue statement of a material fact or omit
to state any material fact necessary in order to make the statements therein, in the light of the circumstances existing when the
Prospectus is delivered to a purchaser, not misleading or (ii) it is necessary to amend or supplement the Prospectus to comply
with applicable law, the Company will promptly notify the Underwriters thereof and forthwith prepare and, subject to paragraph
(c) above, file with the Commission and furnish to the Underwriters and to such dealers as the Representatives may designate such
amendments or supplements to the Prospectus as may be necessary so that the statements in the Prospectus as so amended or supplemented
will not, in the light of the circumstances existing when the Prospectus is delivered to a purchaser, be misleading or so that
the Prospectus will comply with applicable law and (2) if at any time prior to the Closing Date (i) any event or development shall
occur or condition shall exist as a result of which the Pricing Disclosure Package as then amended or supplemented would include
any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in
the light of the circumstances existing when the Pricing Disclosure Package is delivered to a purchaser, not misleading or (ii)
it is necessary to amend or supplement the Pricing Disclosure Package to comply with applicable law, the Company will promptly
notify the Underwriters thereof and forthwith prepare and, subject to paragraph (c) above, file with the Commission (to the extent
required) and furnish to the Underwriters and to such dealers as the Representatives may designate such amendments or supplements
to the Pricing Disclosure Package as may be necessary so that the statements in the Pricing Disclosure Package as so amended or
supplemented will not, in the light of the circumstances existing when the Pricing Disclosure Package is delivered to a purchaser,
be misleading or so that the Pricing Disclosure Package will comply with applicable law.
(f) Blue
Sky Compliance. The Company will qualify the Shares for offer and sale under the securities or Blue Sky laws of such jurisdictions
as the Representatives shall reasonably request and will continue such qualifications in effect so long as required for distribution
of the Shares; provided that the Company shall not be required to (i) qualify as a foreign corporation or other entity or
as a dealer in securities in any such jurisdiction where it would not otherwise be required to so qualify, (ii) file any general
consent to service of process in any such jurisdiction or (iii) subject itself to taxation in any such jurisdiction if it is not
otherwise so subject.
(g) Earning
Statement. The Company will make generally available to its security holders and the Representatives as soon as practicable
an earning statement that satisfies the provisions of Section 11(a) of the Securities Act and Rule 158 of the Commission promulgated
thereunder covering a period of at least twelve months beginning with the first fiscal quarter of the Company occurring after the
“effective date” (as defined in Rule 158) of the Registration Statement; provided that the Company will be deemed
to have furnished such statements to its security holders and the Representatives to the extent they are filed on the Commission’s
Electronic Data Gathering Analysis and Retrieval system (“EDGAR”) or any successor system.
(h) Clear
Market. For a period of 180 days after the date of the Prospectus, the Company will not (i) offer, pledge, sell, contract to
sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase,
lend, or otherwise transfer or dispose of, directly or indirectly, or submit to, or file with, the Commission a registration statement
under the Securities Act relating to, any shares of Stock or any securities convertible into or exercisable or exchangeable for
Stock, or publicly disclose the intention to undertake any of the foregoing, or (ii) enter into any swap or other agreement that
transfers, in whole or in part, any of the economic consequences of ownership of the Stock or any such other securities, whether
any such transaction described in clause (i) or (ii) above is to be settled by delivery of Stock or such other securities, in cash
or otherwise, without the prior written consent of J.P. Morgan Securities LLC and Goldman Sachs & Co. LLC, other than (A) the
Shares to be sold hereunder, (B) any shares of Stock of the Company issued upon the conversion of preferred stock outstanding on
the date of this Agreement in connection with the offering contemplated by this Agreement and as described in the Registration
Statement, the Pricing Disclosure Package and the Prospectus, (C) any shares of Stock of the Company issued upon the exercise of
options granted under Company Stock Plans, (D) the filing by the Company of any registration statement on Form S-8 or a successor
form thereto relating to a Company Stock Plan described in the Registration Statement, the Pricing Disclosure Package and the Prospectus
and (E) shares of Stock or other securities issued in connection with a transaction with an unaffiliated third party that includes
a bona fide commercial relationship (including joint ventures, marketing or distribution arrangements, collaboration agreements,
intellectual property license agreements, or lending agreements or arrangements) or any acquisition of assets or acquisition of
equity of another entity, provided that the aggregate number of shares issued pursuant to this clause (E) shall not exceed five
percent (5%) of the total number of outstanding shares of Stock immediately following the issuance and sale of the Underwritten
Shares pursuant hereto; provided, further, that, in the case of clauses (B), (D) and (E), (x) the Company shall cause each recipient
of such shares of Stock or other securities of the Company to execute and deliver, on or prior to the issuance of such shares,
a lock-up agreement on substantially the same terms as the lock-up agreements described in Section 6(l) hereof to the extent and
for the duration that such terms remain in effect at the time of the transfer, and (y) the Company shall authorize its transfer
agent to decline to make any transfer of such shares in violation of such lock-up agreements.
If J.P. Morgan Securities LLC and
Goldman Sachs & Co. LLC, in their sole discretion, agree to release or waive the restrictions set forth in a lock-up letter
described in Section 6(l) hereof for an officer or director of the Company and provide the Company with notice of the impending
release or waiver substantially in the form of Exhibit B hereto at least three business days before the effective date of the release
or waiver, the Company agrees to announce the impending release or waiver by a press release substantially in the form of Exhibit
C hereto through a major news service or as otherwise permitted under FINRA Rule 5131 at least two business days before the effective
date of the release or waiver.
(i) Use
of Proceeds. The Company will apply the net proceeds from the sale of the Shares as described in each of the Registration Statement,
the Pricing Disclosure Package and the Prospectus under the heading “Use of Proceeds”.
(j) No
Stabilization. Neither the Company nor its subsidiaries or, to the knowledge of the Company, its affiliates, will take, directly or indirectly,
any action designed to or that could reasonably be expected to cause or result in any stabilization or manipulation of the
price of the Stock.
(k) Exchange
Listing. The Company will use its reasonable best efforts to list, subject to notice of issuance, the Shares on the Nasdaq
Market.
(l) Reports.
For a period of two years from the date of this Agreement, so long as the Shares are outstanding, the Company will furnish to the
Representatives, as soon as commercially reasonable after the date on which they are available, copies of all reports or other
communications (financial or other) furnished to holders of the Shares, and copies of any reports and financial statements furnished
to or filed with the Commission or any national securities exchange or automatic quotation system; provided the Company
will be deemed to have furnished such reports and financial statements to the Representatives to the extent they are filed on EDGAR
or any successor.
(m) Record
Retention. The Company will, pursuant to reasonable procedures developed in good faith, retain copies of each Issuer Free Writing
Prospectus that is not filed with the Commission in accordance with Rule 433 under the Securities Act.
(n) Filings.
The Company will file with the Commission such reports as may be required by Rule 463 under the Securities Act.
(o) Emerging
Growth Company. The Company will promptly notify the Representatives if the Company ceases to be an Emerging Growth Company
at any time prior to the later of (i) completion of the distribution of Shares within the meaning of the Securities Act and (ii)
completion of the 180-day restricted period referred to in Section 4(h) hereof.
(p) Certification
Regarding Beneficial Ownership. The Company will deliver to each Underwriter (or its agent), on the date of execution of this
Agreement, a properly completed and executed Certification Regarding Beneficial Owners of Legal Entity Customers, together with
copies of identifying documentation, and the Company undertakes to provide such additional supporting documentation as each Underwriter
may reasonably request with the verification of the foregoing Certification.
5. Certain Agreements of the Underwriters.
Each Underwriter hereby represents and agrees that:
(a) It
has not and will not use, authorize use of, refer to or participate in the planning for use of, any “free writing prospectus”,
as defined in Rule 405 under the Securities Act (which term includes use of any written information furnished to the Commission
by the Company and not incorporated by reference into the Registration Statement and any press release issued by the Company) other
than (i) a free writing prospectus that contains no “issuer information” (as defined in Rule 433(h)(2) under the Securities
Act) that was not included (including through incorporation by reference) in the Preliminary Prospectus or a previously filed Issuer
Free Writing Prospectus, (ii) any Issuer Free Writing Prospectus listed on Annex A or prepared pursuant to Section 3(c) or Section
4(c) above (including any electronic road show approved in advance by the Company), or (iii) any free writing prospectus prepared
by such underwriter and approved by the Company in advance in writing (each such free writing prospectus referred to in clauses
(i) or (iii), an “Underwriter Free Writing Prospectus”).
(b) It
has not and will not, without the prior written consent of the Company, use any free writing prospectus that contains the final
terms of the Shares unless such terms have previously been included in a free writing prospectus filed with the Commission; provided
that Underwriters may use a term sheet substantially in the form of Annex C hereto without the consent of the Company; provided
further that any Underwriter using such term sheet shall notify the Company, and provide a copy of such term sheet to the Company,
prior to, or substantially concurrently with, the first use of such term sheet.
(c) It
is not subject to any pending proceeding under Section 8A of the Securities Act with respect to the offering (and will promptly
notify the Company if any such proceeding against it is initiated during the Prospectus Delivery Period).
6. Conditions
of Underwriters’ Obligations. The obligation of each Underwriter to purchase the Underwritten Shares on the Closing Date
or the Option Shares on the Additional Closing Date, as the case may be, as provided herein is subject to the performance by the
Company of its covenants and other obligations hereunder and to the following additional conditions:
(a) Registration
Compliance; No Stop Order. No order suspending the effectiveness of the Registration Statement shall be in effect, and no proceeding
for such purpose or pursuant to Section 8A under the Securities Act shall be pending before or threatened by the Commission; the
Prospectus and each Issuer Free Writing Prospectus shall have been timely filed with the Commission under the Securities Act (in
the case of an Issuer Free Writing Prospectus, to the extent required by Rule 433 under the Securities Act) and in accordance with
Section 4(a) hereof; and all requests by the Commission for additional information shall have been complied with to the reasonable
satisfaction of the Representatives.
(b) Representations
and Warranties. The representations and warranties of the Company contained herein shall be true and correct on the date hereof
and on and as of the Closing Date or the Additional Closing Date, as the case may be; and the statements of the Company and its
officers made in any certificates delivered pursuant to this Agreement shall be true and correct on and as of the Closing Date
or the Additional Closing Date, as the case may be.
(c) No
Material Adverse Change. No event or condition of a type described in Section 3(h) hereof shall have occurred or shall exist,
which event or condition is not described in the Pricing Disclosure Package (excluding any amendment or supplement thereto) and
the Prospectus (excluding any amendment or supplement thereto) and the effect of which in the judgment of the Representatives makes
it impracticable or inadvisable to proceed with the offering, sale or delivery of the Shares on the Closing Date or the Additional
Closing Date, as the case may be, on the terms and in the manner contemplated by this Agreement, the Pricing Disclosure Package
and the Prospectus.
(d) Officer’s
Certificate. The Representatives shall have received on and as of the Closing Date or the Additional Closing Date, as the case
may be, a certificate of the chief financial officer or chief accounting officer of the Company and one additional senior executive
officer of the Company who is satisfactory to the Representatives (i) confirming that such officers have carefully reviewed the
Registration Statement, the Pricing Disclosure Package and the Prospectus and, to the knowledge of such officers, the representations
of the Company set forth in Sections 3(b) and 3(d) hereof are true and correct, (ii) confirming that the other representations
and warranties of the Company in this Agreement are true and correct and that the Company has complied with all agreements and
satisfied all conditions on its part to be performed or satisfied hereunder at or prior to the Closing Date or the Additional Closing
Date, as the case may be, and (iii) to the effect set forth in paragraphs (a) and (c) above.
(e) Comfort
Letters and CFO Certificates. (i) On the date of this Agreement and on the Closing Date or the Additional Closing Date, as
the case may be, Ernst & Young LLP shall have furnished to the Representatives, at the request of the Company, letters, dated
the respective dates of delivery thereof and addressed to the Underwriters, in form and substance reasonably satisfactory to the
Representatives, containing statements and information of the type customarily included in accountants’ “comfort letters”
to underwriters with respect to the financial statements and certain financial information contained in each of the Registration
Statement, the Pricing Disclosure Package and the Prospectus; provided, that the letter delivered on the Closing Date or the Additional
Closing Date, as the case may be, shall use a “cut-off” date no more than two business days prior to such Closing Date
or such Additional Closing Date, as the case may be.
(ii) On the date of this Agreement
and on the Closing Date or the Additional Closing Date, as the case may be, the Company shall have furnished to the Representatives
a certificate, dated the respective dates of delivery thereof and addressed to the Underwriters, of its chief financial officer
with respect to certain financial data contained in the Pricing Disclosure Package and the Prospectus, providing “management
comfort” with respect to such information, in form and substance reasonably satisfactory to the Representatives.
(f) Opinion
and 10b-5 Statement of Counsel for the Company. Goodwin Procter LLP, counsel for the Company, shall have furnished to the Representatives,
at the request of the Company, their written opinion and 10b-5 statement, dated the Closing Date or the Additional Closing Date,
as the case may be, and addressed to the Underwriters, in form and substance reasonably satisfactory to the Representatives, to
the effect set forth in Annex D-1 hereto.
(g) Opinion
of Intellectual Property Counsel for the Company. Sterne, Kessler, Goldstein & Fox P.L.L.C., intellectual property counsel
for the Company, shall have furnished to the Representatives, at the request of the Company, their written opinion, dated the Closing
Date or the Additional Closing Date, as the case may be, and addressed to the Underwriters, in form and substance reasonably satisfactory
to the Representatives, to the effect set forth in Annex D-2 hereto.
(h) Opinion
and 10b-5 Statement of Counsel for the Underwriters. The Representatives shall have received on and as of the Closing Date
or the Additional Closing Date, as the case may be, an opinion and 10b-5 statement, addressed to the Underwriters, of Cooley LLP,
counsel for the Underwriters, with respect to such matters as the Representatives may reasonably request, and such counsel shall
have received such documents and information as they may reasonably request to enable them to pass upon such matters.
(i) No
Legal Impediment to Issuance and Sale. No action shall have been taken and no statute, rule, regulation or order shall have
been enacted, adopted or issued by any federal, state or foreign governmental or regulatory authority that would, as of the Closing
Date or the Additional Closing Date, as the case may be, prevent the issuance or sale of the Shares by the Company; and no injunction
or order of any federal, state or foreign court shall have been issued that would, as of the Closing Date or the Additional Closing
Date, as the case may be, prevent the issuance or sale of the Shares by the Company.
(j) Good
Standing. The Representatives shall have received on and as of the Closing Date or the Additional Closing Date, as the case
may be, satisfactory evidence of the good standing of the Company and its subsidiaries in their respective jurisdictions of organization
and their good standing in such other jurisdictions as the Representatives may reasonably request, in each case in writing or any
standard form of telecommunication from the appropriate governmental authorities of such jurisdictions.
(k) Exchange
Listing. The Shares to be delivered on the Closing Date or the Additional Closing Date, as the case may be, shall have been
approved for listing on the Nasdaq Market, subject to official notice of issuance.
(l) Lock-up
Agreements. The “lock-up” agreements, each substantially in the form of Exhibit D hereto, between you and substantially
all of the securityholders, officers and directors of the Company relating to sales and certain other dispositions of shares of
Stock or certain other securities, delivered to you on or before the date hereof, shall be in full force and effect on the Closing
Date or the Additional Closing Date, as the case may be.
(m) Additional
Documents. On or prior to the Closing Date or the Additional Closing Date, as the case may be, the Company shall have furnished
to the Representatives such further certificates and documents as the Representatives may reasonably request.
All opinions, letters, certificates and
evidence mentioned above or elsewhere in this Agreement shall be deemed to be in compliance with the provisions hereof only if
they are in form and substance reasonably satisfactory to counsel for the Underwriters.
7. Indemnification
and Contribution.
(a) Indemnification
of the Underwriters. The Company agrees to indemnify and hold harmless each Underwriter, its affiliates, directors and officers
and each person, if any, who controls such Underwriter within the meaning of Section 15 of the Securities Act or Section 20 of
the Exchange Act, from and against any and all losses, claims, damages and liabilities (including, without limitation, reasonable
and documented legal fees and other expenses reasonably incurred in connection with any suit, action or proceeding or any claim
asserted, as such fees and expenses are incurred), joint or several, that arise out of, or are based upon, (i) any untrue statement
or alleged untrue statement of a material fact contained in the Registration Statement or caused by any omission or alleged omission
to state therein a material fact required to be stated therein or necessary in order to make the statements therein, not misleading,
or (ii) any untrue statement or alleged untrue statement of a material fact contained in the Prospectus (or any amendment or supplement
thereto), any Preliminary Prospectus, any Issuer Free Writing Prospectus, any “issuer information” filed or required
to be filed pursuant to Rule 433(d) under the Securities Act, any Written Testing-the-Waters Communication, any road show as defined
in Rule 433(h) under the Securities Act (a “road show”) or any Pricing Disclosure Package (including any Pricing Disclosure
Package that has subsequently been amended), or caused by any omission or alleged omission to state therein a material fact necessary
in order to make the statements therein, in light of the circumstances under which they were made, not misleading, in each case
except insofar as such losses, claims, damages or liabilities arise out of, or are based upon, any untrue statement or omission
or alleged untrue statement or omission made in reliance upon and in conformity with any information relating to any Underwriter
furnished to the Company in writing by such Underwriter through the Representatives expressly for use therein, it being understood
and agreed that the only such information furnished by any Underwriter consists of the information described as such in paragraph
(b) below.
(b) Indemnification
of the Company. Each Underwriter agrees, severally and not jointly, to indemnify and hold harmless the Company, its directors,
its officers who signed the Registration Statement and each person, if any, who controls the Company within the meaning of Section
15 of the Securities Act or Section 20 of the Exchange Act to the same extent as the indemnity set forth in paragraph (a) above,
but only with respect to any losses, claims, damages or liabilities (including, without limitation, reasonable and documented legal
fees and other expenses incurred in connection with any suit, action, or proceeding or any claim asserted, as such fees and expenses
are incurred) that arise out of, or are based upon, any untrue statement or omission or alleged untrue statement or omission made
in reliance upon and in conformity with any information relating to such Underwriter furnished to the Company in writing by such
Underwriter through the Representatives expressly for use in the Registration Statement, the Prospectus (or any amendment or supplement
thereto), any Preliminary Prospectus, any Issuer Free Writing Prospectus, any Written Testing-the-Waters Communication, any road
show or any Pricing Disclosure Package (including any Pricing Disclosure Package that has subsequently been amended), it being
understood and agreed upon that the only such information furnished by any Underwriter consists of the following information in
the Prospectus furnished on behalf of each Underwriter: the concession and reallowance figures appearing in the _______ paragraph
under the caption “Underwriting” and the information contained in the ________ paragraph under the caption “Underwriting.”
(c) Notice
and Procedures. If any suit, action, proceeding (including any governmental or regulatory investigation), claim or demand shall
be brought or asserted against any person in respect of which indemnification may be sought pursuant to the preceding paragraphs
of this Section 7, such person (the “Indemnified Person”) shall promptly notify the person against whom such indemnification
may be sought (the “Indemnifying Person”) in writing; provided that the failure to notify the Indemnifying Person
shall not relieve it from any liability that it may have under the preceding paragraphs of this Section 7 except to the extent
that it has been materially prejudiced (through the forfeiture of substantive rights or defenses) by such failure; and provided,
further, that the failure to notify the Indemnifying Person shall not relieve it from any liability that it may have to
an Indemnified Person otherwise than under the preceding paragraphs of this Section 7. If any such proceeding shall be brought
or asserted against an Indemnified Person and it shall have notified the Indemnifying Person thereof, the Indemnifying Person shall
retain counsel reasonably satisfactory to the Indemnified Person (who shall not, without the consent of the Indemnified Person,
be counsel to the Indemnifying Person) to represent the Indemnified Person and any others entitled to indemnification pursuant
to this Section that the Indemnifying Person may designate in such proceeding and shall pay the reasonably incurred and documented
fees and expenses in such proceeding and shall pay the reasonably incurred and documented fees and expenses of such counsel related
to such proceeding, as incurred. In any such proceeding, any Indemnified Person shall have the right to retain its own counsel,
but the fees and expenses of such counsel shall be at the expense of such Indemnified Person unless (i) the Indemnifying Person
and the Indemnified Person shall have mutually agreed to the contrary; (ii) the Indemnifying Person has failed within a reasonable
time to retain counsel reasonably satisfactory to the Indemnified Person; (iii) the Indemnified Person shall have reasonably concluded
that there may be legal defenses available to it that are different from or in addition to those available to the Indemnifying
Person; or (iv) the named parties in any such proceeding (including any impleaded parties) include both the Indemnifying Person
and the Indemnified Person and representation of both parties by the same counsel would be inappropriate due to actual or potential
differing interests between them. It is understood and agreed that the Indemnifying Person shall not, in connection with any proceeding
or related proceeding in the same jurisdiction, be liable for the fees and expenses of more than one separate firm (in addition
to any local counsel) for all Indemnified Persons, and that all such fees and expenses shall be paid or reimbursed as they are
incurred. Any such separate firm for any Underwriter, its affiliates, directors and officers and any control persons of such Underwriter
shall be designated in writing by J.P. Morgan Securities LLC and any such separate firm for the Company, its directors, its officers
who signed the Registration Statement and any control persons of the Company shall be designated in writing by the Company. The
Indemnifying Person shall not be liable for any settlement of any proceeding effected without its written consent, but if settled
with such consent or if there be a final judgment for the plaintiff, the Indemnifying Person agrees to indemnify each Indemnified
Person from and against any loss or liability by reason of such settlement or judgment. Notwithstanding the foregoing sentence,
if at any time an Indemnified Person shall have requested that an Indemnifying Person reimburse the Indemnified Person for fees
and expenses of counsel as contemplated by this paragraph, the Indemnifying Person shall be liable for any settlement of any proceeding
effected without its written consent if (i) such settlement is entered into more than 30 days after receipt by the Indemnifying
Person of such request and (ii) the Indemnifying Person shall not have reimbursed the Indemnified Person in accordance with such
request prior to the date of such settlement. No Indemnifying Person shall, without the written consent of the Indemnified Person,
effect any settlement of any pending or threatened proceeding in respect of which any Indemnified Person is or could have been
a party and indemnification could have been sought hereunder by such Indemnified Person, unless such settlement (x) includes an
unconditional release of such Indemnified Person, in form and substance reasonably satisfactory to such Indemnified Person, from
all liability on claims that are the subject matter of such proceeding and (y) does not include any statement as to or any admission
of fault, culpability or a failure to act by or on behalf of any Indemnified Person.
(d) Contribution.
If the indemnification provided for in paragraphs (a) and (b) above is unavailable to an Indemnified Person or insufficient in
respect of any losses, claims, damages or liabilities referred to therein, then each Indemnifying Person under such paragraph,
in lieu of indemnifying such Indemnified Person thereunder, shall contribute to the amount paid or payable by such Indemnified
Person as a result of such losses, claims, damages or liabilities (i) in such proportion as is appropriate to reflect the relative
benefits received by the Company, on the one hand, and the Underwriters on the other, from the offering of the Shares or (ii) if
the allocation provided by clause (i) is not permitted by applicable law, in such proportion as is appropriate to reflect not only
the relative benefits referred to in clause (i) but also the relative fault of the Company, on the one hand, and the Underwriters
on the other, in connection with the statements or omissions that resulted in such losses, claims, damages or liabilities, as well
as any other relevant equitable considerations. The relative benefits received by the Company, on the one hand, and the Underwriters
on the other, shall be deemed to be in the same respective proportions as the net proceeds (before deducting expenses) received
by the Company from the sale of the Shares and the total underwriting discounts and commissions received by the Underwriters in
connection therewith, in each case as set forth in the table on the cover of the Prospectus, bear to the aggregate offering price
of the Shares. The relative fault of the Company, on the one hand, and the Underwriters on the other, shall be determined by reference
to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to
state a material fact relates to information supplied by the Company or by the Underwriters and the parties’ relative intent,
knowledge, access to information and opportunity to correct or prevent such statement or omission.
(e) Limitation
on Liability. The Company and the Underwriters agree that it would not be just and equitable if contribution pursuant to paragraph
(d) above were determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose)
or by any other method of allocation that does not take account of the equitable considerations referred to in paragraph (d) above.
The amount paid or payable by an Indemnified Person as a result of the losses, claims, damages and liabilities referred to in paragraph
(d) above shall be deemed to include, subject to the limitations set forth above, any documented legal or other expenses reasonably
incurred by such Indemnified Person in connection with any such action or claim. Notwithstanding the provisions of paragraphs (d)
and (e), in no event shall an Underwriter be required to contribute any amount in excess of the amount by which the total underwriting
discounts and commissions received by such Underwriter with respect to the offering of the Shares exceeds the amount of any damages
that such Underwriter has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged
omission. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be
entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. The Underwriters’ obligations
to contribute pursuant to paragraphs (d) and (e) are several in proportion to their respective purchase obligations hereunder and
not joint.
(f) Non-Exclusive
Remedies. The remedies provided for in paragraphs (a) through (e) are not exclusive and shall not limit any rights or remedies
which may otherwise be available to any Indemnified Person at law or in equity.
8. Effectiveness
of Agreement. This Agreement shall become effective as of the date first written above upon the execution and delivery hereof
by the parties hereto.
9. Termination.
This Agreement may be terminated in the absolute discretion of the Representatives, by notice to the Company, if after the execution
and delivery of this Agreement and on or prior to the Closing Date or, in the case of the Option Shares, prior to the Additional
Closing Date (i) trading generally shall have been suspended or materially limited on or by any of the New York Stock Exchange
or The Nasdaq Stock Market; (ii) trading of any securities issued or guaranteed by the Company shall have been suspended on any
exchange or in any over-the-counter market; (iii) a general moratorium on commercial banking activities shall have been declared
by federal or New York State authorities; or (iv) there shall have occurred any outbreak or escalation of hostilities or any change
in financial markets or any calamity or crisis, either within or outside the United States, that, in the judgment of the Representatives,
is material and adverse and makes it impracticable or inadvisable to proceed with the offering, sale or delivery of the Shares
on the Closing Date or the Additional Closing Date, as the case may be on the terms and in the manner contemplated by this Agreement,
the Pricing Disclosure Package and the Prospectus.
10. Defaulting
Underwriter.
(a) If,
on the Closing Date or the Additional Closing Date, as the case may be, any Underwriter defaults on its obligation to purchase
the Shares that it has agreed to purchase hereunder on such date, the non-defaulting Underwriters may in their discretion arrange
for the purchase of such Shares by other persons satisfactory to the Company on the terms contained in this Agreement. If, within
36 hours after any such default by any Underwriter, the non-defaulting Underwriters do not arrange for the purchase of such Shares,
then the Company shall be entitled to a further period of 36 hours within which to procure other persons satisfactory to the non-defaulting
Underwriters to purchase such Shares on such terms. If other persons become obligated or agree to purchase the Shares of a defaulting
Underwriter, either the non-defaulting Underwriters or the Company may postpone the Closing Date or the Additional Closing Date,
as the case may be, for up to five full business days in order to effect any changes that in the opinion of counsel for the Company
or counsel for the Underwriters may be necessary in the Registration Statement and the Prospectus or in any other document or arrangement,
and the Company agrees to promptly prepare any amendment or supplement to the Registration Statement and the Prospectus that effects
any such changes. As used in this Agreement, the term “Underwriter” includes, for all purposes of this Agreement unless
the context otherwise requires, any person not listed in Schedule 1 hereto that, pursuant to this Section 10, purchases Shares
that a defaulting Underwriter agreed but failed to purchase.
(b) If,
after giving effect to any arrangements for the purchase of the Shares of a defaulting Underwriter or Underwriters by the non-defaulting
Underwriters and the Company as provided in paragraph (a) above, the aggregate number of Shares that remain unpurchased on the
Closing Date or the Additional Closing Date, as the case may be, does not exceed one-eleventh of the aggregate number of Shares
to be purchased on such date, then the Company shall have the right to require each non-defaulting Underwriter to purchase the
number of Shares that such Underwriter agreed to purchase hereunder on such date plus such Underwriter’s pro rata share (based
on the number of Shares that such Underwriter agreed to purchase on such date) of the Shares of such defaulting Underwriter or
Underwriters for which such arrangements have not been made.
(c) If,
after giving effect to any arrangements for the purchase of the Shares of a defaulting Underwriter or Underwriters by the non-defaulting
Underwriters and the Company as provided in paragraph (a) above, the aggregate number of Shares that remain unpurchased on the
Closing Date or the Additional Closing Date, as the case may be, exceeds one-eleventh of the aggregate amount of Shares to be purchased
on such date, or if the Company shall not exercise the right described in paragraph (b) above, then this Agreement or, with respect
to any Additional Closing Date, the obligation of the Underwriters to purchase Shares on the Additional Closing Date, as the case
may be, shall terminate without liability on the part of the non-defaulting Underwriters. Any termination of this Agreement pursuant
to this Section 10 shall be without liability on the part of the Company, except that the Company will continue to be liable for
the payment of expenses as set forth in Section 11 hereof (other than with respect to the defaulting underwriter(s)) and except
that the provisions of Section 7 hereof shall not terminate and shall remain in effect.
(d) Nothing
contained herein shall relieve a defaulting Underwriter of any liability it may have to the Company or any non-defaulting Underwriter
for damages caused by its default.
11. Payment
of Expenses.
(a) Whether
or not the transactions contemplated by this Agreement are consummated or this Agreement is terminated, the Company will pay or
cause to be paid all costs and expenses incident to the performance of its obligations hereunder, including without limitation,
(i) the costs incident to the authorization, issuance, sale, preparation and delivery of the Shares and any taxes payable
in that connection; (ii) the costs incident to the preparation, printing and filing under the Securities Act of the Registration
Statement, the Preliminary Prospectus, any Issuer Free Writing Prospectus, any Pricing Disclosure Package and the Prospectus (including
all exhibits, amendments and supplements thereto) and the distribution thereof; (iii) the fees and expenses of the Company’s
counsel and independent accountants; (iv) the reasonable and documented fees and expenses incurred in connection with the registration
or qualification and determination of eligibility for investment of the Shares under the laws of such jurisdictions as the Representatives
may designate and the preparation, printing and distribution of a Blue Sky Memorandum (including the related reasonable and documented
fees and expenses of counsel for the Underwriters); (v) the cost of preparing stock certificates; (vi) the costs and
charges of any transfer agent and any registrar; (vii) all expenses and application fees incurred in connection with any filing
with, and clearance of the offering by, FINRA [(including the related reasonable fees and expenses of counsel for the Underwriters)];
(viii) all expenses incurred by the Company in connection with any “road show” presentation to potential investors[,
provided however, that the Underwriters will pay all of the travel, lodging and other expenses of the Underwriters or any of their
employees incurred by them in connection with the “road show”, and provided, further, that the Company and the Underwriters
will each pay 50% of the cost of any aircraft chartered to be used in connection with such road show by both the Company and the
Underwriters]; and (ix) all expenses and application fees related to the listing of the Shares on the Nasdaq Market.
(b) If
(i) this Agreement is terminated pursuant to Section 9, (ii) the Company for any reason fails to tender the Shares for delivery
to the Underwriters (other than by reason of a default by any Underwriter) or (iii) the Underwriters decline to purchase the Shares
for any reason permitted under this Agreement, the Company agrees to reimburse the Underwriters for all out-of-pocket costs and
expenses (including the fees and expenses of their counsel) reasonably incurred by the Underwriters in connection with this Agreement
and the offering contemplated hereby. For the avoidance of doubt, it is understood that the Company shall not pay or reimburse
any costs, fees or expenses incurred by any Underwriter that defaults on its obligation to purchase the Shares.
12. Persons
Entitled to Benefit of Agreement. This Agreement shall inure to the benefit of and be binding upon the parties hereto and their
respective successors and the officers and directors and any controlling persons referred to herein, and the affiliates of each
Underwriter referred to in Section 7 hereof. Nothing in this Agreement is intended or shall be construed to give any other person
any legal or equitable right, remedy or claim under or in respect of this Agreement or any provision contained herein. No purchaser
of Shares from any Underwriter shall be deemed to be a successor merely by reason of such purchase.
13. Survival.
The respective indemnities, rights of contribution, representations, warranties and agreements of the Company and the Underwriters
contained in this Agreement or made by or on behalf of the Company or the Underwriters pursuant to this Agreement or any certificate
delivered pursuant hereto shall survive the delivery of and payment for the Shares and shall remain in full force and effect, regardless
of any termination of this Agreement or any investigation made by or on behalf of the Company or the Underwriters or the directors,
officers, controlling persons or affiliates referred to in Section 7 hereof.
14. Certain
Defined Terms. For purposes of this Agreement, (a) except where otherwise expressly provided, the term “affiliate”
has the meaning set forth in Rule 405 under the Securities Act; (b) the term “business day” means any day other than
a day on which banks are permitted or required to be closed in New York City; (c) the term “subsidiary” has the meaning
set forth in Rule 405 under the Securities Act; and (d) the term “significant subsidiary” has the meaning set forth
in Rule 1-02 of Regulation S-X under the Exchange Act. In the event that the Company has only one subsidiary, then all references
herein to “subsidiaries” of the Company shall be deemed to refer to such single subsidiary, mutatis mutandis.
15. Compliance
with USA Patriot Act. In accordance with the requirements of the USA Patriot Act (Title III of Pub. L. 107-56 (signed into
law October 26, 2001)), the Underwriters are required to obtain, verify and record information that identifies their respective
clients, including the Company, which information may include the name and address of their respective clients, as well as other
information that will allow the Underwriters to properly identify their respective clients.
16. Miscellaneous.
(a) Notices.
All notices and other communications hereunder shall be in writing and shall be deemed to have been duly given if mailed or transmitted
and confirmed by any standard form of telecommunication. Notices to the Underwriters shall be given to the Representatives c/o
J.P. Morgan Securities LLC, 383 Madison Avenue, New York, New York 10179 (fax: (212) 622-8358); Attention Equity Syndicate Desk,
c/o Goldman Sachs & Co. LLC, 200 West Street, New York, New York 10282, Attention Control Room; c/o Cowen and Company, LLC,
599 Lexington Avenue, New York, New York 10022, Attention: Bradley Friedman, with a copy to the Legal Department. Notices to the
Company shall be given to it at SpringWorks Therapeutics, Inc., 100 Washington Blvd., Stamford, Connecticut 06902; Attention: Saqib Islam, with a copy to Kingsley Taft, Goodwin Procter LLP, 100 Northern Avenue, Boston, Massachusetts 02210.
(b) Governing
Law. This Agreement and any claim, controversy or dispute arising under or related to this Agreement shall be governed by and
construed in accordance with the laws of the State of New York.
(c) Waiver
of Jury Trial. Each of the parties hereto hereby waives any right to trial by jury in any suit or proceeding arising out of
or relating to this Agreement or the transactions contemplated hereby.
(d) Recognition
of the U.S. Special Resolution Regimes.
(i) In the event that any Underwriter
that is a Covered Entity becomes subject to a proceeding under a U.S. Special Resolution Regime, the transfer from such Underwriter
of this Agreement, and any interest and obligation in or under this Agreement, will be effective to the same extent as the transfer
would be effective under the U.S. Special Resolution Regime if this Agreement, and any such interest and obligation, were governed
by the laws of the United States or a state of the United States.
(ii) In the event that any Underwriter
that is a Covered Entity or a BHC Act Affiliate of such Underwriter becomes subject to a proceeding under a U.S. Special Resolution
Regime, Default Rights under this Agreement that may be exercised against such Underwriter are permitted to be exercised to no
greater extent than such Default Rights could be exercised under the U.S. Special Resolution Regime if this Agreement were governed
by the laws of the United States or a state of the United States.
As used in this Section 16(g):
“BHC Act Affiliate” has
the meaning assigned to the term “affiliate” in, and shall be interpreted in accordance with, 12 U.S.C. § 1841(k).
“Covered Entity” means
any of the following:
(i) a “covered entity”
as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 252.82(b);
(ii) a “covered bank”
as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 47.3(b); or
(iii) a “covered FSI”
as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 382.2(b).
“Default Right” has the
meaning assigned to that term in, and shall be interpreted in accordance with, 12 C.F.R. §§ 252.81, 47.2 or 382.1, as
applicable.
“U.S. Special Resolution Regime”
means each of (i) the Federal Deposit Insurance Act and the regulations promulgated thereunder and (ii) Title II of the Dodd-Frank
Wall Street Reform and Consumer Protection Act and the regulations promulgated thereunder.
(h) Counterparts.
This Agreement may be signed in counterparts (which may include counterparts delivered by any standard form of telecommunication),
each of which shall be an original and all of which together shall constitute one and the same instrument.
(i) Amendments
or Waivers. No amendment or waiver of any provision of this Agreement, nor any consent or approval to any departure therefrom,
shall in any event be effective unless the same shall be in writing and signed by the parties hereto.
(j) Headings.
The headings herein are included for convenience of reference only and are not intended to be part of, or to affect the meaning
or interpretation of, this Agreement.
If the foregoing is in accordance with your
understanding, please indicate your acceptance of this Agreement by signing in the space provided below.
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Very truly yours, |
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SPRINGWORKS THERAPEUTICS, INC. |
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By: |
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Name: |
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Title: |
Accepted: As of the date first written above
J.P. MORGAN SECURITIES LLC
For itself and on behalf of the
several Underwriters listed
in Schedule 1 hereto.
GOLDMAN SACHS & CO. LLC |
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For itself and on behalf of the |
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several Underwriters listed |
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in Schedule 1 hereto. |
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By: |
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Authorized Signatory |
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COWEN AND COMPANY, LLC |
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For itself and on behalf of the |
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several Underwriters listed |
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in Schedule 1 hereto. |
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By: |
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Authorized Signatory |
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Schedule 1
Underwriter | |
Number of Shares | |
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| | |
J.P. Morgan Securities LLC | |
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Goldman Sachs & Co. LLC | |
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Cowen and Company, LLC | |
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Wedbush Securities Inc. | |
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Total | |
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Schedule 2
Significant Subsidiaries
SpringWorks Therapeutics, LLC, a Delaware Limited Liability Company
SpringWorks Subsidiary 1, Inc. a Delaware Corporation
SpringWorks Subsidiary 2, Inc. a Delaware Corporation
SpringWorks Subsidiary 3, Inc. a Delaware Corporation
SpringWorks Subsidiary 4, Inc. a Delaware Corporation
SpringWorks Therapeutics Operating Company, Inc., a Delaware Corporation
Annex A
| a. | Pricing Disclosure Package |
| | [List each Issuer
Free Writing Prospectus to be included in the Pricing Disclosure Package] |
| b. | Pricing Information Provided Orally by Underwriters |
| | [Set out key information
included in script that will be used by Underwriters to confirm sales] |
Annex B
Written Testing-the-Waters Communications
[None]
Annex C
SpringWorks Therapeutics, Inc.
Pricing Term Sheet
[To come]
Annex D-1
Form of Opinion of Counsel for the Company
[Circulated separately]
Annex D-2
Form of Opinion of Intellectual Property
Counsel for the Company
[Circulated separately]
Exhibit A
Testing the Waters Authorization
In reliance on Section 5(d) of the Securities Act of 1933, as amended
(the “Act”), SpringWorks Therapeutics, Inc. (the “Issuer”) hereby authorizes J.P. Morgan Securities LLC
(“J.P. Morgan”), Goldman Sachs & Co. LLC (“Goldman”) and Cowen and Company, LLC (“Cowen”
and, together with J.P. Morgan and Goldman, the “Representatives”) and their affiliates and their respective employees,
to engage on behalf of the Issuer in oral and written communications with potential investors that are “qualified institutional
buyers”, as defined in Rule 144A under the Act, or institutions that are “accredited investors”, as defined in
Regulation D under the Act, to determine whether such investors might have an interest in the Issuer’s contemplated initial
public offering (“Testing-the-Waters Communications”). A “Written Testing-the Waters Communication” means
any Testing-the-Waters Communication that is a written communication within the meaning of Rule 405 under the Act. Any Written
Testing-the-Waters Communication shall be subject to prior approval by the Issuer's Chief Executive Officer or Chief Operating
Officer prior to its dissemination to a potential investor, provided, however, that no such approval shall be required for any
written communication that is administrative in nature (i.e., scheduling meetings) or that solely contains information already
contained in a communication previously approved by the Issuer.
The Issuer represents that it is an “emerging growth company”
as defined in Section 2(a)(19) of the Act (“Emerging Growth Company”) and agrees to promptly notify the Representatives
in writing if the Issuer hereafter ceases to be an Emerging Growth Company while this authorization is in effect. If at any time
following the distribution of any Written Testing-the-Waters Communication there occurs an event or development as a result of
which such Written Testing-the-Waters Communication included or would include an untrue statement of a material fact or omitted
or would omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances existing
at that subsequent time, not misleading, the Issuer will promptly notify the Representatives and will promptly amend or supplement,
at its own expense, such Written Testing-the-Waters Communication to eliminate or correct such untrue statement or omission.
Nothing in this authorization is
intended to limit or otherwise affect the ability of the Representatives and their affiliates and their respective employees,
to engage in communications in which they could otherwise lawfully engage in the absence of this authorization, including, without
limitation, any written communication containing only one or more of the statements specified under Rule 134(a) under the Act.
This authorization shall remain in effect until the Issuer has provided to the Representatives a written notice revoking this
authorization. All notices as described herein shall be sent by email to the attention of David Ke (david.ke@jpmorgan.com)
at J.P. Morgan, Jack Bannister (jack.bannister@gs.com) at Goldman and Jason Fenton (Jason.Fenton@cowen.com)
at Cowen.
Exhibit B
Form of Waiver of Lock-up
J.P. MORGAN SECURITIES LLC |
GOLDMAN SACHS & CO. LLC |
SpringWorks Therapeutics, Inc.
Public Offering of Common Stock
, 20__
[Name and Address of
Officer or Director
Requesting Waiver]
Dear Mr./Ms. [Name]:
This letter is being delivered to you in connection
with the offering by SpringWorks Therapeutics, Inc. (the “Company”) of ______ shares of common stock, $___ par value
(the “Common Stock”), of the Company and the lock-up letter dated__________________, 2019 (the “Lock-up Letter”),
executed by you in connection with such offering, and your request for a [waiver] [release] dated__________________, 20__, with
respect to ______ shares of Common Stock (the “Shares”).
J.P. Morgan Securities LLC and Goldman Sachs
& Co. hereby agree to [waive] [release] the transfer restrictions set forth in the Lock-up Letter, but only with respect to
the Shares, effective __________________, 20__ ; provided, however, that such [waiver] [release] is conditioned on
the Company announcing the impending [waiver] [release] by press release through a major news service at least two business days
before effectiveness of such [waiver] [release]. This letter will serve as notice to the Company of the impending [waiver] [release].
Except as expressly [waived] [released]
hereby, the Lock-up Letter shall remain in full force and effect.
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Yours very truly, |
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J.P. MORGAN SECURITIES LLC |
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By: |
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Name: |
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Title: |
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GOLDMAN SACHS & CO. LLC |
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By: |
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Name: |
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Title: |
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cc: Company
Exhibit C
Form of Press Release
SpringWorks Therapeutics, Inc.
[Date]
SpringWorks Therapeutics, Inc. (the “Company”) announced
today that J.P. Morgan Securities LLC and Goldman Sachs & Co. LLC, the lead book-running managers in the Company’s recent
public sale of shares of common stock, is [waiving] [releasing] a lock-up restriction with respect to shares of the Company’s
common stock held by [certain officers or directors] [an officer or director] of the Company. The [waiver] [release] will take
effect on ____________________, 20__, and the shares may be sold on or after such date.
This press release is not an offer for sale of the securities
in the United States or in any other jurisdiction where such offer is prohibited, and such securities may not be offered or sold
in the United States absent registration or an exemption from registration under the United States Securities Act of 1933, as amended.
Exhibit D
Form of Lock-Up Agreement
,
2019
J.P. MORGAN SECURITIES LLC
GOLDMAN SACHS & CO. LLC
COWEN AND COMPANY, LLC
As Representatives of
the several Underwriters listed in
Schedule 1 to the Underwriting
Agreement referred to below
c/o J.P. Morgan Securities LLC
383 Madison Avenue
New York, NY 10179
c/o Goldman Sachs & Co. LLC
200 West Street
New York, NY 10282
c/o Cowen and Company, LLC
599 Lexington Avenue
New York, NY 10022
Re: SpringWorks Therapeutics, Inc.
-- Initial Public Offering
Ladies and Gentlemen:
The undersigned understands that you, as
Representatives of the several Underwriters, propose to enter into an underwriting agreement (the “Underwriting Agreement”)
with SpringWorks Therapeutics, Inc., a Delaware corporation (the “Company”), providing for the public offering (the
“Public Offering”) by the several Underwriters named in Schedule 1 to the Underwriting Agreement (the “Underwriters”),
of any shares of common stock, par value $0.0001 per share (“Common Stock”), of the Company (the “Securities”).
Capitalized terms used herein and not otherwise defined shall have the meanings set forth in the Underwriting Agreement.
In consideration of the Underwriters’
agreement to purchase and make the Public Offering of the Securities, and for other good and valuable consideration receipt of
which is hereby acknowledged, the undersigned hereby agrees that, without the prior written consent of J.P. Morgan Securities LLC
and Goldman Sachs & Co. LLC on behalf of the Underwriters, the undersigned will not, during the period beginning on the date
of this letter agreement (this “Letter Agreement”) and ending 180 days after the date of the prospectus relating to
the Public Offering (the “Prospectus”) (such period, the “Restricted Period”), (1) offer, pledge, sell,
contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or
warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any shares of Common Stock or any securities
convertible into or exercisable or exchangeable for Common Stock (including without limitation, Common Stock or such other securities
which may be deemed to be beneficially owned by the undersigned in accordance with the rules and regulations of the Securities
and Exchange Commission and securities which may be issued upon exercise of a stock option or warrant), or publicly disclose the
intention to undertake any of the foregoing, (2) enter into any swap or other agreement that transfers, in whole or in part, any
of the economic consequences of ownership of the Common Stock or such other securities, whether any such transaction described
in clause (1) or (2) above is to be settled by delivery of Common Stock or such other securities, in cash or otherwise or (3) make
any demand for or exercise any right with respect to the registration of any shares of Common Stock or any security convertible
into or exercisable or exchangeable for Common Stock.
The undersigned acknowledges and agrees
that the foregoing precludes the undersigned from engaging in any hedging or other transactions designed or intended, or which
could reasonably be expected to lead to or result in, a sale or disposition of any shares of Common Stock, or securities convertible
into or exercisable or exchangeable for Common Stock, even if any such sale or disposition transaction or transactions would be
made or executed by or on behalf of someone other than the undersigned. Notwithstanding the foregoing, the terms of
this Letter Agreement shall not apply to or prohibit:
| (A) | the Securities to be sold by the undersigned pursuant to the Underwriting Agreement; |
| (B) | sales or transfers of shares of Common Stock acquired in the Public Offering (other than any issuer-directed shares of Common
Stock purchased in the Public Offering by an officer or director of the Company) or in open market transactions after the consummation
of the Public Offering; |
| (C) | (i) transfers of shares of Common Stock or any security convertible into Common Stock as a bona fide gift or gifts or
to a charitable organization or educational institution in a transaction not involving a disposition for value; (ii) by
will, other testamentary document or intestate succession to the legal representative, heir, beneficiary or a member of the immediate
family of the undersigned or (iii) by operation of law, such as pursuant to a qualified domestic order or as required by a divorce
settlement; |
| (D) | if the undersigned is an individual, transfers of shares of Common Stock or any security directly or indirectly convertible
into Common Stock in a transaction not involving a disposition for value to any trust for the direct or indirect benefit of the
undersigned or the immediate family of the undersigned, or limited partnerships the partners of which are the undersigned and/or
the immediate family members of the undersigned, in each case for estate planning purposes; |
| (E) | if the undersigned is a trust, distributions of shares of Common Stock or any security directly or indirectly convertible into
Common Stock to its beneficiaries in a transaction not involving a disposition for value; |
| (F) | if the undersigned is a corporation, limited liability company, partnership (whether general, limited or otherwise) or other
entity, distribution of shares of Common Stock or any security directly or indirectly convertible into Common Stock to members,
stockholders, limited partners, general partners, subsidiaries or affiliates (as defined in Rule 405 promulgated under the Securities
Act of 1933, as amended) of the undersigned or to any investment fund or other entity that controls or manages the undersigned
(including, for the avoidance of doubt, a fund managed by the same manager or managing member or general partner or management
company or by an entity controlling, controlled by, or under common control with such manager or managing member or general partner
or management company as the undersigned or who shares a common investment advisor with the undersigned) in a transaction not involving
a disposition for value; |
| (G) | transfers of shares of Common Stock to the Company in connection with the exercise of options, warrants or other rights to
acquire Common Stock or any security convertible into or exercisable for Common Stock of the Company by way of net exercise and/or
to cover withholding tax obligations in connection with such exercise pursuant to an employee benefit plan, option, warrant or
other right disclosed in the prospectus for the Public Offering, provided that any such shares issued upon exercise of such
option, warrant or other right shall be subject to the restrictions set forth herein; provided, further, that no
public report or filing required to be made under Section 16(a) of the Securities Exchange Act of 1934, as amended, (the “Exchange
Act”) or other public filing, report or announcement shall be required or shall be voluntarily made during the Restricted
Period in connection with any such transfers or dispositions (other than any Form 4 or Form 5 required to be filed under the Exchange
Act if the undersigned is subject to Section 16 reporting with respect to the Company under the Exchange Act, which may not be
made during the period beginning on the date hereof and continuing to and including the date that is 30 days after the date of
the Prospectus (the “30 Day Period”), and after the 30 Day Period, if required, any public filing or Form 4 or Form
5 required to be filed under the Exchange Act shall clearly indicate by footnote disclosure or otherwise the nature of the transfer
or disposition and that no Common Stock was sold by the undersigned and that the Common Stock so received is subject to this Letter
Agreement with the underwriters of the Public Offering); and provided, further, that this clause (G) shall only apply
to such options, warrants and other rights to acquire Common Stock or securities convertible into or exercisable for Common Stock
that shall expire or terminate during the Restricted Period; |
provided that in the case of any transfer or distribution
pursuant to clause (C), (D), (E), (F) or (G), each donee or distributee shall execute and deliver to the Representative a lock-up
letter in the form of this paragraph; and provided, further, that in the case of any transfer or distribution pursuant
to clause (B), (C), (D), (E), or (F), no filing by any party (donor, donee, transferor or transferee) under the Exchange Act, or
other public announcement shall be required or shall be made voluntarily in connection with such transfer or distribution (other
than a filing on a Form 5 and any required Schedule 13F, 13G or 13G/A made after the expiration of the Restricted Period referred
to above);
| (H) | transfers or dispositions of shares of Common Stock or other securities to the Company in connection with the conversion of
any convertible preferred stock into, or the exercise of any option or warrant for, shares of Common Stock; provided that
(i) any such shares of Common Stock received by the undersigned shall be subject to the terms of this Letter Agreement and
(ii) no filing by any party under the Exchange Act or other public announcement shall be required or shall be made voluntarily
during the Restricted Period (other than a filing on a Form 4 that reports such disposition under the transaction code “F”); |
| (I) | the establishment of a trading plan pursuant to Rule 10b5-1 under the Exchange Act
for the transfer of shares of Common Stock, provided that (i) such plan does not provide for the transfer
of Common Stock during the Restricted Period and (ii) no filing by any party under the Exchange Act or other public announcement
shall be required or shall be made voluntarily by or on behalf of the undersigned or the Company in connection with the establishment
of such plan; |
| (J) | transfers or dispositions of Common Stock or any security convertible into or exercisable or exchangeable for Common Stock
to the Company pursuant to any contractual arrangement in effect on the date of this Letter Agreement that provides for the repurchase
of the undersigned’s Common Stock or other securities by the Company or in connection with the termination of the undersigned’s
employment with or service to the Company, provided that no filing by any party under the Exchange Act or other
public announcement reporting a reduction in beneficial ownership of shares of Common Stock, shall be required or shall be voluntarily
made during the Restricted Period in connection with any such transfers or dispositions (other than any Form 4 or Form 5
required to be filed under the Exchange Act if the undersigned is subject to Section 16 reporting with respect to the Company
under the Exchange Act and indicating by footnote disclosure or otherwise the nature of the transfer or disposition); and |
| (K) | transfers of shares of Common Stock to a bona fide third party pursuant to a merger, consolidation, tender offer or other similar
transaction made to all holders of Common Stock and involving a “Change of Control” of the Company after the Public
Offering and approved by the Company’s Board of Directors (with “Change of Control” meaning the transfer of the
Company’s voting securities in one transaction or a series of related transactions to any “person” (as defined
in Section 13(d)(3) of the Exchange Act) or group of affiliated persons if, after such transfer, such person or group of affiliated
persons would hold more than 75% of the outstanding voting securities of the Company (or the surviving entity)), provided
that in the event that such transaction is not completed, the shares of Common Stock held by the undersigned shall remain subject
to the restrictions contained in this Letter Agreement, and provided further that in the event any shares of Common Stock not transferred
in the Change of Control shall remain subject to the restrictions contained in this Letter Agreement. |
If the undersigned is an officer or director
of the Company, the undersigned further agrees that the foregoing provisions shall be equally applicable to any Company-directed
Securities the undersigned may purchase in the Public Offering.
For purposes of this Letter Agreement,
“immediate family” shall mean any relationship by blood, marriage or adoption, not more remote than first cousin.
In the event that a release is granted
to any Major Holder (as defined below) other than the undersigned relating to the lock-up restrictions set forth above for shares
of the Company’s Common Stock, the same percentage of shares of the Company’s Common Stock held by the undersigned
(the “Pro-rata Release”) shall be immediately and fully released on the same terms from any remaining lock-up restrictions
set forth herein; provided, however, that such Pro-rata Release shall not be applied in the event of releases
granted from such lockup restrictions to any individual party or parties (other than shareholders subject to Section 16 reporting
with respect to the Company under the Exchange Act) to sell or otherwise transfer or dispose of shares of the Company’s Common
Stock or other securities in an amount up to an aggregate of $2,500,000. In the event that any percentage of such Common
Stock released from the lock-up restrictions are subject to any restrictions of the type set forth in clause (1) or (2) of
the second paragraph of this agreement, the same restrictions shall be applicable to the release of the same percentage of the
Company’s Common Stock held by the undersigned. In the event that the undersigned is released from any of its obligations
under this agreement or, by virtue of this agreement, becomes entitled to offer, pledge, sell, contract to sell, or otherwise dispose
of any Common Stock (or any securities convertible into Common Stock) prior to the date that is 180 days after the date of the
Prospectus, J.P. Morgan Securities LLC and Goldman Sachs & Co. LLC shall use their commercially reasonable efforts to provide
notification of such to the undersigned within three business days thereof; provided that the failure to provide
such notice shall not give rise to any claim or liability against the J.P. Morgan Securities LLC and Goldman Sachs & Co. LLC
or the Underwriters. For purposes of this agreement, each of the following persons is a “Major Holder”: each
officer and director of the Company and each record or beneficial owner, as of the date hereof, of more than 1% of the outstanding
shares of securities of the Company (for purposes of determining record or beneficial ownership of a stockholder, all shares of
securities held by investment funds affiliated with such stockholder shall be aggregated).
The undersigned represents and warrants
that the undersigned is not, and has not caused or directed any of its affiliates to be or become, currently a party to any agreement
or arrangement that is designed to or which reasonably could be expected to lead to or result in any activity prohibited by this
Letter Agreement during the Restricted Period.
The undersigned represents and warrants
that no single natural person, entity or “group” (within the meaning of Section 13(d)(3) of the Exchange Act)
beneficially owns, directly or indirectly, 50% or more of the common equity interests, or 50% or more of the voting power, in the
undersigned.
If the undersigned is an officer or director
of the Company, (i) J.P. Morgan Securities LLC and Goldman Sachs & Co. on behalf of the Underwriters agree that, at least three
business days before the effective date of any release or waiver of the foregoing restrictions in connection with a transfer of
shares of Common Stock, J.P. Morgan Securities LLC and Goldman Sachs & Co. LLC on behalf of the Underwriters will notify the
Company of the impending release or waiver, and (ii) the Company has agreed in the Underwriting Agreement to announce the impending
release or waiver by press release through a major news service at least two business days before the effective date of the release
or waiver. Any release or waiver granted by J.P. Morgan Securities LLC and Goldman Sachs & Co. LLC on behalf of the Underwriters
hereunder to any such officer or director shall only be effective two business days after the publication date of such press release.
The provisions of this paragraph will not apply if (a) the release or waiver is effected solely to permit a transfer not for consideration
and (b) the transferee has agreed in writing to be bound by the same terms described in this letter to the extent and for the duration
that such terms remain in effect at the time of the transfer.
In furtherance of the foregoing, the
Company, and any duly appointed transfer agent for the registration or transfer of the securities described herein, are hereby
authorized to decline to make any transfer of securities if such transfer would constitute a violation or breach of this Letter
Agreement.
The undersigned hereby represents and
warrants that the undersigned has full power and authority to enter into this Letter Agreement. All authority herein conferred
or agreed to be conferred and any obligations of the undersigned shall be binding upon the successors, assigns, heirs or personal
representatives of the undersigned.
The undersigned understands that, if
the Underwriting Agreement does not become effective by December 31, 2019, or if the Underwriting Agreement (other than the provisions
thereof which survive termination) shall terminate or be terminated prior to payment for and delivery of the Common Stock to be
sold thereunder, the undersigned shall be released from all obligations under this Letter Agreement. The undersigned understands
that the Underwriters are entering into the Underwriting Agreement and proceeding with the Public Offering in reliance upon this
Letter Agreement.
This Letter Agreement and any claim,
controversy or dispute arising under or related to this Letter Agreement shall be governed by and construed in accordance with
the laws of the State of New York.
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Very truly yours, |
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[NAME OF STOCKHOLDER] |
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Exhibit 3.1
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION OF
SPRINGWORKS
THERAPEUTICS, INC.
(Pursuant to Sections 241 and 245 of the
General Corporation Law of the State of Delaware)
SpringWorks Therapeutics,
Inc., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of
Delaware (the “General Corporation Law”),
DOES HEREBY CERTIFY:
1. That
the name of this corporation is SpringWorks Therapeutics, Inc., and that this corporation was originally incorporated pursuant
to the General Corporation Law on March 20, 2019 under the name SpringWorks Therapeutics, Inc.
2. That
the corporation’s Board of Directors duly adopted this Amended and Restated Certificate of Incorporation.
3. Pursuant
to Sections 241 and 245 of the General Corporation Law, this Amended and Restated Certificate of Incorporation restates, integrates
and further amends this corporation’s original certificate of incorporation, and this corporation has not received payment
for any shares of its capital stock.
RESOLVED, that
the Certificate of this corporation be amended and restated in its entirety to read as follows:
FIRST: The name
of this corporation is SpringWorks Therapeutics, Inc. (the “Corporation”).
SECOND: The address
of the registered office of the Corporation in the State of Delaware is 1209 Orange Street, in the City of Wilmington, County of
New Castle, Zip Code 19801. The name of its registered agent at such address is The Corporation Trust Company.
THIRD: The nature
of the business or purposes to be conducted or promoted is to engage in any lawful act or activity for which corporations may be
organized under the General Corporation Law.
FOURTH: The total
number of shares of all classes of stock which the Corporation shall have authority to issue is (i) 232,193,269 shares of Common
Stock, $0.0001 par value per share (“Common Stock”) and (ii) 196,076,779 shares of Preferred Stock, $0.0001
par value per share (the “Preferred Stock”), of which 6,437,500 shares are hereby designated as “Junior
Series A Preferred Stock,” 103,000,000 shares are hereby designated as “Series A Preferred Stock”
and 86,639,279 shares are hereby designated as “Series B Preferred Stock”.
The following is a
statement of the designations and the powers, privileges and rights, and the qualifications, limitations or restrictions thereof
in respect of each class of capital stock of the Corporation.
1. General.
The voting, dividend and liquidation rights of the holders of the Common Stock are subject to and qualified by the rights, powers
and preferences of the holders of the Preferred Stock set forth herein.
2. Voting.
The holders of the Common Stock are entitled to one vote for each share of Common Stock held at all meetings of stockholders (and
written actions in lieu of meetings); provided, however, that, except as otherwise required by law, holders of Common Stock, as
such, shall not be entitled to vote on any amendment to this Amended and Restated Certificate of Incorporation (the “Certificate
of Incorporation”) that relates solely to the terms of one or more outstanding series of Preferred Stock if the holders
of such affected series are entitled, either separately or together with the holders of one or more other such series, to vote
thereon pursuant to this Certificate of or pursuant to the General Corporation Law. The number of authorized shares of Common Stock
may be increased or decreased (but not below the number of shares thereof then outstanding) by (in addition to any vote of the
holders of one or more series of Preferred Stock that may be required by the terms of the Certificate of Incorporation) the affirmative
vote of the holders of shares of capital stock of the Corporation representing a majority of the votes represented by all outstanding
shares of capital stock of the Corporation entitled to vote, irrespective of the provisions of Section 242(b)(2) of the General
Corporation Law.
The Junior
Series A Preferred Stock, Series A Preferred Stock and Series B Preferred Stock shall have the following rights, preferences, powers,
privileges and restrictions, qualifications and limitations. Unless otherwise indicated, references to “sections” or
“subsections” in this Part B of this Article Fourth refer to sections and subsections of Part B of this Article Fourth.
1.1 Series
B Dividends. From and after the date of the issuance of any shares of Series B Preferred Stock, dividends at the rate per annum
of eight percent (8%) (non-compounding) times the Series B Original Issue Price (as defined below) shall accrue on such shares
of Series B Preferred Stock (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or
other similar recapitalization with respect to the Series B Preferred Stock) (the “Series B Dividends”). The
Corporation shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Corporation
(other than dividends on shares of Common Stock payable in shares of Common Stock) unless (in addition to the obtaining of any
consents required elsewhere in the Certificate of Incorporation) the holders of the Series B Preferred Stock then outstanding shall
first receive, or simultaneously receive, a dividend on each outstanding share of Series B Preferred Stock in an amount at least
equal to the greater of (i) the amount of the aggregate Series B Dividends then accrued on such share of Series B Preferred Stock
and not previously paid and (ii) (A) in the case of a dividend on Common Stock or any class or series that is convertible into
Common Stock, that dividend per share of Series B Preferred Stock as would equal the product of (1) the dividend payable on each
share of such class or series determined, if applicable, as if all shares of such class or series had been converted into Common
Stock and (2) the number of shares of Common Stock issuable upon conversion of a share of Series B Preferred Stock, in each case
calculated on the record date for determination of holders entitled to receive such dividend or (B) in the case of a dividend on
any class or series that is not convertible into Common Stock, at a rate per share of Series B Preferred Stock determined by (1)
dividing the amount of the dividend payable on each share of such class or series of capital stock by the original issuance price
of such class or series of capital stock (subject to appropriate adjustment in the event of any stock dividend, stock split, combination
or other similar recapitalization with respect to such class or series) and (2) multiplying such fraction by an amount equal to
the Series B Original Issue Price (as defined below); provided that if the Corporation declares, pays or sets aside, on
the same date, a dividend on shares of more than one class or series of capital stock of the Corporation, the dividend payable
to the holders of Series B Preferred Stock pursuant to this Section 1.1 shall be calculated based upon the dividend on the
class or series of capital stock that would result in the highest Series B Preferred Stock dividend. The Series B Dividends shall
accrue from day to day, whether or not declared, and shall be cumulative; provided, however, that except as otherwise
set forth in this Section 1 or in Section 2, such Series B Dividends shall be payable only when, as, and if declared
by the Board of Directors and the Corporation shall be under no obligation to pay such Series B Dividends.
1.2 Series
A Dividends. The Corporation shall not declare, pay or set aside any dividends on shares of any other class or series of capital
stock of the Corporation (other than the Series B Dividends as provided in Section 1.1 or dividends on shares of Common
Stock payable in shares of Common Stock) unless (in addition to the obtaining of any consents required elsewhere in the Certificate
of Incorporation) the holders of the Series A Preferred Stock then outstanding shall first receive, or simultaneously receive,
a dividend on each outstanding share of Series A Preferred Stock in an amount at least equal to (i) in the case of a dividend on
Common Stock or any class or series that is convertible into Common Stock, that dividend per share of Series A Preferred Stock
as would equal the product of (1) the dividend payable on each share of such class or series determined, if applicable, as if all
shares of such class or series had been converted into Common Stock and (2) the number of shares of Common Stock issuable upon
conversion of a share of Series A Preferred Stock, in each case calculated on the record date for determination of holders entitled
to receive such dividend or (ii) in the case of a dividend on any class or series that is not convertible into Common Stock, at
a rate per share of Series A Preferred Stock determined by (1) dividing the amount of the dividend payable on each share of such
class or series of capital stock by the original issuance price of such class or series of capital stock (subject to appropriate
adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to such
class or series) and (2) multiplying such fraction by an amount equal to the Series A Original Issue Price (as defined below);
provided that if the Corporation declares, pays or sets aside, on the same date, a dividend on shares of more than one class
or series of capital stock of the Corporation, the dividend payable to the holders of Series A Preferred Stock pursuant to this
Section 1.2 shall be calculated based upon the dividend on the class or series of capital stock that would result in the
highest Series A Preferred Stock dividend.
1.3 Junior
Series A Dividends. The Corporation shall not declare, pay or set aside any dividends on shares of any other class or series
of capital stock of the Corporation (other than the Series B Dividends and any dividends paid to the Series A Preferred Stock as
provided in Sections 1.1 and 1.2 or dividends on shares of Common Stock payable in shares of Common Stock) unless
(in addition to the obtaining of any consents required elsewhere in the Certificate of Incorporation) the holders of the Junior
Series A Preferred Stock then outstanding shall first receive, or simultaneously receive, a dividend on each outstanding share
of Junior Series A Preferred Stock in an amount at least equal to (i) in the case of a dividend on Common Stock or any class or
series that is convertible into Common Stock, that dividend per share of Junior Series A Preferred Stock as would equal the product
of (1) the dividend payable on each share of such class or series determined, if applicable, as if all shares of such class or
series had been converted into Common Stock and (2) the number of shares of Common Stock issuable upon conversion of a share of
Junior Series A Preferred Stock, in each case calculated on the record date for determination of holders entitled to receive such
dividend or (ii) in the case of a dividend on any class or series that is not convertible into Common Stock, at a rate per share
of Junior Series A Preferred Stock determined by (1) dividing the amount of the dividend payable on each share of such class or
series of capital stock by the original issuance price of such class or series of capital stock (subject to appropriate adjustment
in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to such class or series)
and (2) multiplying such fraction by an amount equal to the Junior Series A Original Issue Price (as defined below); provided
that if the Corporation declares, pays or sets aside, on the same date, a dividend on shares of more than one class or series of
capital stock of the Corporation, the dividend payable to the holders of Junior Series A Preferred Stock pursuant to this Section
1.3 shall be calculated based upon the dividend on the class or series of capital stock that would result in the highest Junior
Series A Preferred Stock dividend.
1.4 The
(a) “Series B Original Issue Price” shall mean $1.4428 per share, (b) “Series A Original Issue
Price” shall mean $1.00 per share, and (c) “Junior Series A Original Issue Price” shall mean
$1.00 per share; in each case, subject to appropriate adjustment in the event of any stock dividend, stock split, combination
or other similar recapitalization with respect to the Series B Preferred Stock, Series A Preferred Stock, or Junior Series A Preferred
Stock, as applicable.
| 2. | Liquidation, Dissolution or Winding Up; Certain Mergers,
Consolidations and Asset Sales. |
2.1 Preferential
Payments to Holders of Series B Preferred Stock, Series A Preferred Stock, Junior Series A Preferred Stock, and Distribution of
Remaining Assets. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Corporation or
Deemed Liquidation Event, subject to Subsection 2.2:
(a) the
holders of shares of Series B Preferred Stock then outstanding shall be entitled to be paid out of the assets of the Corporation
available for distribution to its stockholders before any payment shall be made to the holders of shares of any other class of
stock, including the Series A Preferred Stock, Junior Series A Preferred Stock, and the Common Stock by reason of their ownership
thereof, an amount per share equal to the Series B Original Issue Price, plus any Series B Dividends accrued but unpaid thereon,
whether or not declared, together with any other dividends declared but unpaid thereon;
(b) after
the payment of all the amounts required to be paid to the holders of shares of Series B Preferred Stock under Subsection 2.1(a),
the holders of shares of the Series A Preferred Stock then outstanding shall be entitled to be paid out of the assets of the Corporation
available for distribution to its stockholders, and before any payment shall be made to the holders of Junior Series A Preferred
Stock or Common Stock by reason of their ownership thereof, an amount per share equal to the Series A Original Issue Price, together
with any other dividends declared but unpaid thereon; and
(c) after
the payment of all the amounts required to be paid to the holders of Series B Preferred Stock and Series A Preferred Stock pursuant
to the Subsections 2.1(a) and (b), the holders of shares of the Junior Series A Preferred Stock then outstanding shall be entitled
to be paid out of the assets of the Corporation available for distribution to its stockholders, before any payment shall be made
to the holders of the Common Stock, an amount equal to the greater of (i) the Junior Series A Preferred Original Issue Price, plus
any dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had each such share of Junior
Series A Preferred Stock and all other Preferred Stock converted into Common Stock pursuant to Section 4 immediately prior to such
liquidation, dissolution or winding up; and
(d) after
the payment of all the amounts required to be paid to the holders of shares of Series B Preferred Stock, Series A Preferred Stock,
and Junior Series A Preferred Stock, under Subsections 2.1(a), (b) and (c), the remaining assets of the Corporation
available for distribution to its stockholders shall be distributed among the holders of the shares of Series B Preferred Stock,
Series A Preferred Stock, and Common Stock, pro rata based on the number of shares held by each such holder, treating for
this purpose all such securities as if they had been converted to Common Stock pursuant to the terms of the Certificate of Incorporation
immediately prior to such liquidation, dissolution or winding up of the Corporation.
The aggregate amount
which a holder of a share of Series B Preferred Stock, a holder of a share of Series A Preferred Stock, and a holder of a share
of Junior Series A Preferred Stock, respectively, is entitled to receive under Subsections 2.1(a), (b) and (c),
respectively, is hereinafter referred to as the “Series B Liquidation Amount,” the “Series A Liquidation
Amount,” and the “Junior Series A Liquidation Amount”, respectively.
| 2.2 | Deemed Liquidation Events. |
2.2.1 Definition.
Each of the following events shall be considered a “Deemed Liquidation Event” unless the holders of more than
50% of the then outstanding shares of Series B Preferred Stock and Series A Preferred Stock, voting together as a single class
on an as-converted to Common Stock basis (the “Required Preferred Majority”), elect otherwise by written notice
sent to the Corporation at least ten (10) days prior to the effective date of any such event:
(a) a
merger or consolidation in which:
(i) the
Corporation is a constituent party; or
(ii) a
subsidiary of the Corporation is a constituent party and the Corporation issues shares of its capital stock pursuant to such merger
or consolidation,
except any such merger or consolidation
involving the Corporation or a subsidiary in which the shares of capital stock of the Corporation outstanding immediately prior
to such merger or consolidation continue to represent, or are converted into or exchanged for shares of capital stock that represent,
or the holders of shares of capital stock of the Corporation outstanding immediately prior to such merger or consolidation otherwise
hold, directly or indirectly, immediately following such merger or consolidation, at least a majority, by voting power, of the
capital stock or other equity interests of (1) the surviving or resulting corporation; or (2) if the surviving or resulting corporation
is a wholly owned subsidiary of another corporation immediately following such merger or consolidation, the parent corporation
of such surviving or resulting corporation; or
(b) the
sale, lease, transfer, exclusive license or other disposition, in a single transaction or series of related transactions, by the
Corporation or any subsidiary of the Corporation of all or substantially all the assets of the Corporation and its subsidiaries
taken as a whole, or the sale or disposition (whether by merger, consolidation or otherwise, and whether in a single transaction
or series of transactions) of one or more subsidiaries of the Corporation if substantially all of the assets of the Corporation
and its subsidiaries taken as a whole are held by such subsidiary or subsidiaries, except where such sale, lease, transfer, exclusive
license or other disposition is to a wholly owned subsidiary of the Corporation.
2.2.2
Effecting a Deemed Liquidation Event.
(a) The
Corporation shall not have the power to effect a Deemed Liquidation Event referred to in Subsection 2.2.1 (a)(i) unless
the agreement or plan of merger or consolidation for such transaction (the “Merger Agreement”) provides that
the consideration payable to the stockholders of the Corporation in such Deemed Liquidation Event shall be allocated among the
holders of capital stock of the Corporation in accordance with Subsection 2.1.
(b) In
the event of a Deemed Liquidation Event referred to in Subsection 2.2.1 (a)(ii) or 2.2.1 (b), if the Corporation
does not effect a dissolution of the Corporation under the General Corporation Law within ninety (90) days after such Deemed Liquidation
Event, then (i) the Corporation shall send a written notice to each holder of Preferred Stock no later than the ninetieth (90th)
day after the Deemed Liquidation Event advising such holders of their right (and the requirements to be met to secure such right)
pursuant to the terms of the following clause; (ii) to require the redemption of such shares of Preferred Stock,
and (iii) if the Required Preferred Majority so request in a written instrument delivered to the Corporation not later than one
hundred twenty (120) days after such Deemed Liquidation Event, the Corporation shall use the consideration received by the Corporation
for such Deemed Liquidation Event (net of any retained liabilities associated with the assets sold or technology licensed, as determined
in good faith by the Board of Directors), together with any other assets of the Corporation available for distribution to its stockholders,
all to the extent permitted by Delaware law governing distributions to stockholders (the “Available Proceeds”),
on the one hundred fiftieth (150th) day after such Deemed Liquidation Event, to redeem all outstanding shares of Series B Preferred
Stock at a price per share equal to the Series B Liquidation Amount, the shares of Series A Preferred Stock at a price per share
equal to the Series A Liquidation Amount and the shares of Junior Series A Preferred Stock at a price per share equal to the Junior
Series A Liquidation Amount. Notwithstanding the foregoing, in the event of a redemption pursuant to the preceding sentence, if
the Available Proceeds are not sufficient to redeem all outstanding shares of Preferred Stock, the Corporation shall redeem a pro
rata portion (i) first, each holder’s shares of Series B Preferred Stock to the fullest extent of such Available Proceeds
(in payment of the Series B Liquidation Amount, ratably among the holders of the shares of Series B Preferred Stock) based
on the respective amounts which would otherwise be payable in respect of the shares to be redeemed if the Available Proceeds were
sufficient to redeem all such shares and shall redeem the remaining shares as soon as it may lawfully do so under Delaware law
governing distributions to stockholders, (ii) second, each holder’s shares of Series A Preferred Stock to the fullest extent
of any remaining Available Proceeds (in payment of the Series A Liquidation Amount, ratably among the holders of the shares of
Series A Preferred Stock) based on the respective amounts which would otherwise be payable in respect of the shares to be redeemed
if the Available Proceeds were sufficient to redeem all such shares and shall redeem the remaining shares as soon as it may lawfully
do so under Delaware law governing distributions to stockholders and (iii) third, each holder’s shares of Junior Series A
Preferred Stock to the fullest extent of any remaining Available Proceeds (in payment of the Junior Series A Liquidation Amount,
ratably among the holders of the shares of Junior Series A Preferred Stock) based on the respective amounts which would otherwise
be payable in respect of the shares to be redeemed if the Available Proceeds were sufficient to redeem all such shares and shall
redeem the remaining shares as soon as it may lawfully do so under Delaware Law governing distributions to stockholders. Prior
to the distribution or redemption provided for in this Subsection 2.2.2 (b), the Corporation shall not expend or dissipate
the consideration received for such Deemed Liquidation Event, except to discharge expenses incurred in connection with such Deemed
Liquidation Event, or as approved by the Board, including the Required Preferred Directors (as such term is defined in the Investors’
Rights Agreement, dated on or about the date of this Certificate of Incorporation, by and between the Corporation and certain of
its stockholders that are parties thereto), in the ordinary course of business.
2.2.3 Amount
Deemed Paid or Distributed. The amount deemed paid or distributed to the holders of capital stock of the Corporation upon any
such merger, consolidation, sale, transfer, exclusive license, other disposition or redemption shall be the cash or the value of
the property, rights or securities paid or distributed to such holders by the Corporation or the acquiring person, firm or other
entity pursuant to the Deemed Liquidation Event. The value of such property, rights or securities shall be determined in good faith
by the Board of Directors.
2.2.4 Allocation
of Escrow and Contingent Consideration. In the event of a Deemed Liquidation Event pursuant to Subsection 2.2.1(a)(i),
if any portion of the consideration payable to the stockholders of the Corporation is payable only upon satisfaction of contingencies
(the “Additional Consideration”), the Merger Agreement shall provide that (a) the portion of such consideration
that is not Additional Consideration (such portion, the “Initial Consideration”) shall be allocated among the
holders of capital stock of the Corporation in accordance with Subsection 2.1 as if the Initial Consideration were the only
consideration payable in connection with such Deemed Liquidation Event; and (b) any Additional Consideration which becomes payable
to the stockholders of the Corporation upon satisfaction of such contingencies shall be allocated among the holders of capital
stock of the Corporation in accordance with Subsection 2.1 after taking into account the previous payment of the Initial
Consideration as part of the same transaction. For the purposes of this Subsection 2.2.4, consideration placed into escrow
or retained as holdback to be available for satisfaction of indemnification or similar obligations in connection with such Deemed
Liquidation Event shall be deemed to be Additional Consideration.
3.1 General.
On any matter presented to the stockholders of the Corporation for their action or consideration at any meeting of stockholders
of the Corporation (or by written consent of stockholders in lieu of meeting), each holder of outstanding shares of Preferred Stock
shall be entitled to cast the number of votes equal to the number of whole shares of Common Stock into which the shares of Preferred
Stock held by such holder are convertible as of the record date for determining stockholders entitled to vote on such matter. Except
as provided by law or by the other provisions of the Certificate of Incorporation, holders of Preferred Stock shall vote together
with the holders of Common Stock as a single class on an as-converted basis.
| 3.2 | Election of Directors. |
3.2.1 The
holders of record of the shares of Series B Preferred Stock, exclusively and as a separate class, shall be entitled to elect one
(1) director of the Corporation (the “Series B Director”) and the holders of record of the shares of Series
A Preferred Stock exclusively and as a separate class, shall be entitled to elect four (4) directors of the Corporation (the “Series
A Directors”). Any director elected as provided in the preceding sentence may be removed without cause by, and only by,
the affirmative vote of the holders of the shares of the class or series of capital stock entitled to elect such director or directors,
given either at a special meeting of such stockholders duly called for that purpose or pursuant to a written consent of stockholders.
If the holders of shares of Series B Preferred Stock or Series A Preferred Stock, as the case may be, fail to elect a sufficient
number of directors to fill all directorships for which they are respectively entitled to elect directors, voting exclusively and
as a separate class, pursuant to the first sentence of this Subsection 3.2, then any directorship not so filled shall remain
vacant until such time as the holders of the Series B Preferred Stock or Series A Preferred Stock, as the case may be, elect a
person to fill such directorship by vote or written consent in lieu of a meeting; and no such directorship may be filled by stockholders
of the Corporation other than by the stockholders of the Corporation that are entitled to elect a person to fill such directorship,
voting exclusively and as a separate class.
3.2.2 The
holders of record of the shares of Common Stock and of any other class or series of voting stock (including the Series B Preferred
Stock, Series A Preferred Stock and Junior Series A Preferred Stock), exclusively and voting together as a single class, shall
be entitled to elect the balance of the total number of directors of the Corporation.
3.2.3 At
any meeting held for the purpose of electing a director, the presence in person or by proxy of the holders of a majority of the
outstanding shares of the class or series entitled to elect such director shall constitute a quorum for the purpose of electing
such director.
3.2.4 Except
as otherwise provided in this Subsection 3.2, a vacancy in any directorship filled by the holders of any class or series
shall be filled only by vote or written consent in lieu of a meeting of the holders of such class or series or by any remaining
director or directors elected by the holders of such class or series pursuant to this Subsection 3.2.
3.3 Preferred
Stock Protective Provisions. At any time when shares of Series A Preferred Stock or Series B Preferred Stock are outstanding,
the Corporation shall not, either directly or indirectly by amendment, merger, consolidation or otherwise, do any of the following,
or permit or cause any of its subsidiaries to do any of the following, without (in addition to any other vote required by law or
the Certificate of Incorporation) the written consent or affirmative vote of the Required Preferred Majority, and any such act
or transaction entered into without such consent or vote shall be null and void ab initio, and of no force or effect.
3.3.1 liquidate,
dissolve or wind-up the business and affairs of the Corporation, effect any merger or consolidation or any other Deemed Liquidation
Event or change of control of the Corporation, or public offering of the Corporation’s stock, or consent to any of the foregoing;
3.3.2 amend,
alter or repeal any provision of the Certificate of Incorporation or Bylaws of the Corporation;
3.3.3 create,
or authorize the creation of, or issue or obligate itself to issue shares of, any additional class or series of capital stock (or
any security convertible into or exchangeable for capital stock) unless the same ranks junior to the Series B Preferred Stock and
Series A Preferred Stock with respect to the distribution of assets on the liquidation, dissolution or winding up of the Corporation,
the payment of dividends and rights of redemption, or increase the authorized number of shares of Preferred Stock or other class
or series of Stock unless the same ranks junior to the Series B Preferred Stock and Series A Preferred Stock with respect to the
distribution of assets on the liquidation, dissolution or winding up of the Corporation, the payment of dividends and rights of
redemption;
3.3.4 (i)
reclassify, alter or amend any existing security of the Corporation that is pari passu with the Series A Preferred Stock and/or
Series B Preferred Stock in respect of the distribution of assets on the liquidation, dissolution or winding up of the Corporation,
the payment of dividends or rights of redemption, if such reclassification, alteration or amendment would render such other security
senior to the Series B Preferred Stock and/or Series A Preferred Stock in respect of any such right, preference, or privilege or
(ii) reclassify, alter or amend any existing security of the Corporation that is junior to the Series B Preferred Stock and/or
Series A Preferred Stock in respect of the distribution of assets on the liquidation, dissolution or winding up of the Corporation,
the payment of dividends or rights of redemption, if such reclassification, alteration or amendment would render such other security
senior to or pari passu with the Series B Preferred Stock and/or Series A Preferred Stock in respect of any such right, preference
or privilege;
3.3.5 purchase
or redeem (or permit any subsidiary to purchase or redeem) or pay or declare any dividend or make any distribution on, any shares
of capital stock of the Corporation prior to the Series B Preferred Stock (subject to all preferences and priorities of the Series
B Preferred Stock in this Article Fourth), or following the Series B Preferred Stock, but prior to the Series A Preferred
Stock (subject to all preferences and priorities of the Series A Preferred Stock in this Article Fourth) other than (i)
redemptions of or dividends or distributions on the Preferred Stock as expressly authorized herein, (ii) dividends or other distributions
payable on the Common Stock solely in the form of additional shares of Common Stock and (iii) repurchases of stock from former
employees, officers, directors, consultants or other persons who performed services for the Corporation or any subsidiary in connection
with the cessation of such employment or service at the lower of the original purchase price or the then-current fair market value
thereof;
3.3.6 create,
or authorize the creation of, or issue, or authorize the issuance of any debt security or create any lien or security interest
(except for purchase money liens or statutory liens of landlords, mechanics, materialmen, workmen, warehousemen and other similar
persons arising or incurred in the ordinary course of business) or incur other indebtedness for borrowed money, including but not
limited to obligations and contingent obligations under guarantees, or permit any subsidiary to take any such action with respect
to any debt security, lien, security interest or other indebtedness for borrowed money, if the aggregate indebtedness of the Corporation
and its subsidiaries for borrowed money (other than equipment leases, bank lines of credit or trade payables incurred in the ordinary
course of business) following such action would exceed $1,000,000;
3.3.7 create,
or hold capital stock or other equity interests in, any subsidiary that is not wholly owned (either directly or through one or
more other subsidiaries) by the Corporation, or permit any subsidiary to create, or authorize the creation of, or issue or obligate
itself to issue, any shares of any class or series of capital stock or other equity interests, or sell, transfer or otherwise dispose
of any capital stock or other equity interests of any direct or indirect subsidiary of the Corporation, or permit any direct or
indirect subsidiary to sell, lease, transfer, exclusively license or otherwise dispose (in a single transaction or series of related
transactions) of all or substantially all of the assets of such subsidiary;
3.3.8 increase
or decrease the authorized number of directors constituting the Board of Directors;
3.3.9 enter
into any transaction with any affiliate of the Company or any individual in the role of senior management of the Company, except
for compensatory agreements entered into in the ordinary course of business; or
3.3.10 change
the business in which the Company is presently engaged.
3.4 Series
B Preferred Stock Protective Provisions. At any time when any shares of Series B Preferred Stock are outstanding, the Corporation
shall not, either directly or indirectly by amendment, merger, consolidation or otherwise, do any of the following without (in
addition to any other vote required by law or the Certificate of Incorporation) the written consent or affirmative vote of the
holders of more than 50% of the then outstanding shares of Series B Preferred Stock, given in writing or by vote at a meeting,
consenting or voting (as the case may be) separately as a class, and any such act or transaction entered into without such
consent or vote shall be null and void ab initio, and of no force or effect:
3.4.1 amend,
alter or repeal any provision of the Certificate of Incorporation or Bylaws of the Corporation in a manner that adversely affects
the powers, preferences or rights of the Series B Preferred Stock; provided that the same does not also affect all of the Preferred
Stock in substantially the same manner; or
3.4.2 increase
or decrease the number of authorized shares of Series B Preferred Stock.
3.5 Series
A Preferred Stock Protective Provisions. At any time when any shares of Series A Preferred Stock are outstanding, the Corporation
shall not, either directly or indirectly by amendment, merger, consolidation or otherwise, do any of the following without (in
addition to any other vote required by law or the Certificate of Incorporation) the written consent or affirmative vote of the
holders of at least 55% of the then outstanding shares of Series A Preferred Stock, given in writing or by vote at a meeting, consenting
or voting (as the case may be) separately as a class, and any such act or transaction entered into without such consent or
vote shall be null and void ab initio, and of no force or effect:
3.5.1 amend,
alter or repeal any provision of the Certificate of Incorporation or Bylaws of the Corporation in a manner that adversely affects
the powers, preferences or rights of the Series A Preferred Stock; provided that the same does not also affect all of the Preferred
Stock in substantially the same manner; or
3.5.2 increase
or decrease the number of authorized shares of Series A Preferred Stock.
3.6 Junior
Series A Preferred Stock Protective Provisions. At any time when any shares of Junior Series A Preferred Stock are outstanding,
the Corporation shall not, either directly or indirectly by amendment, merger, consolidation or otherwise, do any of the following
without (in addition to any other vote required by law or the Certificate of Incorporation) the written consent or affirmative
vote of the holders of more than 50% of the then outstanding shares of Junior Series A Preferred Stock, given in writing or by
vote at a meeting, consenting or voting (as the case may be) separately as a class, and any such act or transaction entered
into without such consent or vote shall be null and void ab initio, and of no force or effect:
3.6.1 amend,
alter or repeal any provision of the Certificate of Incorporation or Bylaws of the Corporation in a manner that adversely affects
the powers, preferences or rights of the Junior Series A Preferred Stock; provided that the same does not also affect all of the
Preferred Stock in substantially the same manner; or
3.6.2 increase
or decrease the number of authorized shares of Junior Series A Preferred Stock.
4.1 Right
to Convert. The holders of Preferred Stock shall have conversion rights as follows (the “Conversion Rights”):
4.1.1 Conversion
Ratio. Each share of Series B Preferred Stock shall be convertible, at the option of the holder thereof, at any time and from
time to time, and without the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable
shares of Common Stock as is determined by dividing the Series B Original Issue Price by the Series B Conversion Price (as defined
in Section 4.4.1) in effect at the time of conversion. Each share of Series A Preferred Stock shall be convertible, at the
option of the holder thereof, at any time and from time to time, and without the payment of additional consideration by the holder
thereof, into such number of fully paid and non-assessable shares of Common Stock as is determined by dividing the Series A Original
Issue Price by the Series A Conversion Price (as defined in Section 4.4.1) in effect at the time of conversion. Each share of Junior
Series A Preferred Stock shall be convertible, at the option of the holder thereof, at any time and from time to time, and without
the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable shares of Common
Stock as is determined by dividing the Junior Series A Original Issue Price by the Junior Series A Conversion Price (as defined
in Section 4.4.1) in effect at the time of conversion.
4.1.2 Termination
of Conversion Rights. In the event of a liquidation, dissolution or winding up of the Corporation or a Deemed Liquidation Event,
the Conversion Rights shall terminate at the close of business on the last full day preceding the date fixed for the payment of
any such amounts distributable on such event to the holders of Preferred Stock.
4.2 Fractional
Shares. No fractional shares of Common Stock shall be issued upon conversion of Preferred Stock. In lieu of any fractional
shares to which the holder would otherwise be entitled, the Corporation shall pay cash equal to such fraction multiplied by the
fair market value of a share of Common Stock as determined in good faith by the Board of Directors. Whether or not fractional shares
would be issuable upon such conversion shall be determined on the basis of the total number of shares of Preferred Stock the holder
is at the time converting into Common Stock and the aggregate number of shares of Common Stock issuable upon such conversion.
| 4.3 | Mechanics of Conversion. |
4.3.1 Notice
of Conversion. In order for a holder of Preferred Stock to voluntarily convert shares of Preferred Stock into shares of Common
Stock, such holder shall (a) provide written notice to the Corporation’s transfer agent at the office of the transfer agent
for the Preferred Stock (or at the principal office of the Corporation if the Corporation serves as its own transfer agent) that
such holder elects to convert all or any number of such holder’s shares of Preferred Stock and, if applicable, any event
on which such conversion is contingent and (b), if such holder’s shares are certificated, surrender the certificate or certificates
for such shares of Preferred Stock (or, if such registered holder alleges that such certificate has been lost, stolen or destroyed,
a lost certificate affidavit and agreement reasonably acceptable to the Corporation to indemnify the Corporation against any claim
that may be made against the Corporation on account of the alleged loss, theft or destruction of such certificate), at the office
of the transfer agent for the Preferred Stock (or at the principal office of the Corporation if the Corporation serves as its own
transfer agent). Such notice shall state such holder’s name or the names of the nominees in which such holder wishes the
shares of Common Stock to be issued. If required by the Corporation, any certificates surrendered for conversion shall be endorsed
or accompanied by a written instrument or instruments of transfer, in form satisfactory to the Corporation, duly executed by the
registered holder or his, her or its attorney duly authorized in writing. The close of business on the date of receipt by the transfer
agent (or by the Corporation if the Corporation serves as its own transfer agent) of such notice and, if applicable, certificates
(or lost certificate affidavit and agreement) shall be the time of conversion (the “Conversion Time”), and the
shares of Common Stock issuable upon conversion of the specified shares shall be deemed to be outstanding of record as of such
date. The Corporation shall, as soon as practicable after the Conversion Time, (i) issue and deliver to such holder of Preferred
Stock, or to his, her or its nominees, a certificate or certificates for the number of full shares of Common Stock issuable upon
such conversion in accordance with the provisions hereof and a certificate for the number (if any) of the shares of Preferred Stock
represented by the surrendered certificate that were not converted into Common Stock, (ii) pay in cash such amount as provided
in Subsection 4.2 in lieu of any fraction of a share of Common Stock otherwise issuable upon such conversion and (iii) pay
all declared but unpaid dividends on the shares of Preferred Stock converted.
4.3.2
Reservation of Shares. The Corporation shall at all times when the Preferred Stock shall be outstanding, reserve and keep
available out of its authorized but unissued capital stock, for the purpose of effecting the conversion of the Preferred Stock,
such number of its duly authorized shares of Common Stock as shall from time to time be sufficient to effect the conversion of
all outstanding Preferred Stock; and if at any time the number of authorized but unissued shares of Common Stock shall not be sufficient
to effect the conversion of all then outstanding shares of the Preferred Stock, the Corporation shall take such corporate action
as may be necessary to increase its authorized but unissued shares of Common Stock to such number of shares as shall be sufficient
for such purposes, including, without limitation, engaging in best efforts to obtain the requisite stockholder approval of any
necessary amendment to the Certificate of Incorporation. Before taking any action which would cause an adjustment reducing the
Conversion Price below the then par value of the shares of Common Stock issuable upon conversion of the Preferred Stock, the Corporation
will take any corporate action which may, in the opinion of its counsel, be necessary in order that the Corporation may validly
and legally issue fully paid and non-assessable shares of Common Stock at such adjusted Conversion Price.
4.3.3 Effect
of Conversion. All shares of Preferred Stock which shall have been surrendered for conversion as herein provided shall no longer
be deemed to be outstanding and all rights with respect to such shares shall immediately cease and terminate at the Conversion
Time, except only the right of the holders thereof to receive shares of Common Stock in exchange therefor, to receive payment in
lieu of any fraction of a share otherwise issuable upon such conversion as provided in Subsection 4.2 and to receive payment
of any dividends declared but unpaid thereon. Any shares of Preferred Stock so converted shall be retired and cancelled and may
not be reissued as shares of such series, and the Corporation may thereafter take such appropriate action (without the need for
stockholder action) as may be necessary to reduce the authorized number of shares of Preferred Stock accordingly.
4.3.4 No
Further Adjustment. Upon any such conversion, no adjustment to the Conversion Price shall be made for any declared but unpaid
dividends on the Preferred Stock surrendered for conversion or on the Common Stock delivered upon conversion.
4.3.5 Taxes.
The Corporation shall pay any and all issue and other similar taxes that may be payable in respect of any issuance or delivery
of shares of Common Stock upon conversion of shares of Preferred Stock pursuant to this Section 4. The Corporation shall
not, however, be required to pay any tax which may be payable in respect of any transfer involved in the issuance and delivery
of shares of Common Stock in a name other than that in which the shares of Preferred Stock so converted were registered, and no
such issuance or delivery shall be made unless and until the person or entity requesting such issuance has paid to the Corporation
the amount of any such tax or has established, to the satisfaction of the Corporation, that such tax has been paid.
4.4 Adjustments
to Series B Conversion Price, Series A Conversion Price, and Junior Series A Conversion Price for Diluting Issues.
4.4.1 Definitions.
For the purposes of this Article Fourth, the following terms shall have the following meanings:
(a) “Additional
Shares of Common Stock” shall mean all shares of Common Stock issued (or, pursuant to Subsection 4.4.3 below,
deemed to be issued) by the Corporation after the Series B Original Issue Date, other than (1) the following shares of Common Stock
and (2) shares of Common Stock deemed issued pursuant to the following Options and Convertible Securities (clauses (1) and (2),
collectively, “Exempted Securities”):
(i) shares
of Common Stock, Options or Convertible Securities issued as a dividend or distribution on Series B Preferred Stock, Series A Preferred
Stock, or Junior Series A Preferred Stock;
(ii) shares
of Common Stock, Options or Convertible Securities issued by reason of a dividend, stock split, split-up or other distribution
on shares of Common Stock that is covered by Subsection 4.5, 4.6, 4.7 or 4.8;
(iii) shares
of Common Stock or Options issued to employees or directors of, or consultants or advisors to, the Corporation or any of its subsidiaries
pursuant to a plan, agreement or arrangement approved by the Board of Directors; shares of Common Stock or Convertible Securities
actually issued upon the exercise of Options or shares of Common Stock actually issued upon the conversion or exchange of Convertible
Securities, in each case provided such issuance is pursuant to the terms of such Option or Convertible Security;
(iv) shares
of Common Stock, Options or Convertible Securities issued to suppliers or third party service providers in connection with the
provision of goods or services pursuant to transactions approved by the Board of Directors; or
(v) shares
of Common Stock, Options or Convertible Securities issued to banks, equipment lessors or other financial institutions, or to real
property lessors, pursuant to a debt financing, equipment leasing or real property leasing transaction approved by the Board of
Directors, including the Required Preferred Directors;
(vi) shares
of Common Stock, Options or Convertible Securities issued in connection with sponsored research, collaboration, technology license,
development, marketing or other similar agreements or strategic partnerships approved by the Board of Directors; and
(vii) shares
of Common Stock, Options or Convertible Securities issued as acquisition consideration pursuant to the acquisition of another corporation
by the Corporation by merger, purchase of substantially all of the assets or other reorganization or to a joint venture agreement,
provided that such issuances are approved by the Board of Directors, including the Required Preferred Directors.
(b) “Conversion
Price” means the Series B Conversion Price, Series A Conversion Price or Junior Series A Conversion Price, as applicable.
(c) “Convertible
Securities” shall mean any evidence of indebtedness, shares or other securities directly or indirectly convertible
into or exchangeable for Common Stock, but excluding Options.
(d) “Junior
Series A Conversion Price” shall initially be equal to $1.00. Such initial Junior Series A Conversion Price, and
the rate at which shares of Junior Series A Preferred Stock may pursuant to this Section 4 or shall pursuant to Section 5 be converted
into shares of Common Stock, shall be subject to adjustment as provided below.
(e) “Option”
shall mean rights, options or warrants to subscribe for, purchase or otherwise acquire Common Stock or Convertible Securities.
(f)
“Series A Conversion Price” shall initially be equal to $1.00. Such initial Series A Conversion Price,
and the rate at which shares of Series A Preferred Stock may pursuant to this Section 4 or shall pursuant to Section 5 be converted
into shares of Common Stock, shall be subject to adjustment as provided below.
(g) “Series
B Conversion Price” shall initially be equal to $1.4428. Such initial Series B Conversion Price, and the rate
at which shares of Series B Preferred Stock may pursuant to this Section 4 or shall pursuant to Section 5 be converted into shares
of Common Stock, shall be subject to adjustment as provided below.
(h) “Series
B Original Issue Date” shall mean the date on which the first share of Series B Preferred Stock was issued.
4.4.2 No
Adjustment of Conversion Price.
(a) No
adjustment in the Series B Conversion Price shall be made as the result of the issuance or deemed issuance of Additional Shares
of Common Stock if the Corporation receives written notice from the holders of more than 50% of the then outstanding shares of
Series B Preferred Stock agreeing that no such adjustment shall be made as the result of the issuance or deemed issuance of such
Additional Shares of Common Stock.
(b) No
adjustment in the Series A Conversion Price shall be made as the result of the issuance or deemed issuance of Additional Shares
of Common Stock if the Corporation receives written notice from the holders of at least 55% of the then outstanding shares of Series
A Preferred Stock agreeing that no such adjustment shall be made as the result of the issuance or deemed issuance of such Additional
Shares of Common Stock.
(c) No
adjustment in the Junior Series A Conversion Price shall be made as the result of the issuance or deemed issuance of Additional
Shares of Common Stock if the Corporation receives written notice from the holders of more than 50% of the then outstanding shares
of Junior Series A Preferred Stock agreeing that no such adjustment shall be made as the result of the issuance or deemed issuance
of such Additional Shares of Common Stock.
4.4.3 Deemed
Issue of Additional Shares of Common Stock.
(a) If
the Corporation at any time or from time to time after the Series B Original Issue Date shall issue any Options or Convertible
Securities (excluding Options or Convertible Securities which are themselves Exempted Securities) or shall fix a record date for
the determination of holders of any class of securities entitled to receive any such Options or Convertible Securities, then the
maximum number of shares of Common Stock (as set forth in the instrument relating thereto, assuming the satisfaction of any conditions
to exercisability, convertibility or exchangeability but without regard to any provision contained therein for a subsequent adjustment
of such number) issuable upon the exercise of such Options or, in the case of Convertible Securities and Options therefor, the
conversion or exchange of such Convertible Securities, shall be deemed to be Additional Shares of Common Stock issued as of the
time of such issue or, in case such a record date shall have been fixed, as of the close of business on such record date.
(b) If
the terms of any Option or Convertible Security, the issuance of which resulted in an adjustment to the Conversion Price pursuant
to the terms of Subsection 4.4.4, are revised as a result of an amendment to such terms or any other adjustment pursuant
to the provisions of such Option or Convertible Security (but excluding automatic adjustments to such terms pursuant to anti-dilution
or similar provisions of such Option or Convertible Security) to provide for either (1) any increase or decrease in the number
of shares of Common Stock issuable upon the exercise, conversion and/or exchange of any such Option or Convertible Security or
(2) any increase or decrease in the consideration payable to the Corporation upon such exercise, conversion and/or exchange, then,
effective upon such increase or decrease becoming effective, the Conversion Price computed upon the original issue of such Option
or Convertible Security (or upon the occurrence of a record date with respect thereto) shall be readjusted to such Conversion Price
as would have obtained had such revised terms been in effect upon the original date of issuance of such Option or Convertible Security.
Notwithstanding the foregoing, no readjustment pursuant to this clause (b) shall have the effect of increasing the Conversion
Price to an amount which exceeds the lower of (i) the Conversion Price in effect immediately prior to the original adjustment made
as a result of the issuance of such Option or Convertible Security, or (ii) Conversion Price that would have resulted from any
issuances of Additional Shares of Common Stock (other than deemed issuances of Additional Shares of Common Stock as a result of
the issuance of such Option or Convertible Security) between the original adjustment date and such readjustment date.
(c) If
the terms of any Option or Convertible Security (excluding Options or Convertible Securities which are themselves Exempted Securities),
the issuance of which did not result in an adjustment to the Conversion Price pursuant to the terms of Subsection 4.4.4
(either because the consideration per share (determined pursuant to Subsection 4.4.5) of the Additional Shares of Common
Stock subject thereto was equal to or greater than the Conversion Price then in effect, or because such Option or Convertible Security
was issued before the Series B Original Issue Date), are revised after the Series B Original Issue Date as a result of an amendment
to such terms or any other adjustment pursuant to the provisions of such Option or Convertible Security (but excluding automatic
adjustments to such terms pursuant to anti-dilution or similar provisions of such Option or Convertible Security) to provide for
either (1) any increase in the number of shares of Common Stock issuable upon the exercise, conversion or exchange of any such
Option or Convertible Security or (2) any decrease in the consideration payable to the Corporation upon such exercise, conversion
or exchange, then such Option or Convertible Security, as so amended or adjusted, and the Additional Shares of Common Stock subject
thereto (determined in the manner provided in Subsection 4.4.3 shall be deemed to have been issued effective upon such increase
or decrease becoming effective.
(d) Upon
the expiration or termination of any unexercised Option or unconverted or unexchanged Convertible Security (or portion thereof)
which resulted (either upon its original issuance or upon a revision of its terms) in an adjustment to the Conversion Price pursuant
to the terms of Subsection 4.4.4, the Conversion Price shall be readjusted to such Conversion Price as would have obtained
had such Option or Convertible Security (or portion thereof) never been issued.
(e) If
the number of shares of Common Stock issuable upon the exercise, conversion and/or exchange of any Option or Convertible Security,
or the consideration payable to the Corporation upon such exercise, conversion and/or exchange, is calculable at the time such
Option or Convertible Security is issued or amended but is subject to adjustment based upon subsequent events, any adjustment to
the Conversion Price provided for in this Subsection 4.4.3 shall be effected at the time of such issuance or amendment based
on such number of shares or amount of consideration without regard to any provisions for subsequent adjustments (and any subsequent
adjustments shall be treated as provided in clauses (b) and (c) of this Subsection 4.4.3). If the number of shares
of Common Stock issuable upon the exercise, conversion and/or exchange of any Option or Convertible Security, or the consideration
payable to the Corporation upon such exercise, conversion and/or exchange, cannot be calculated at all at the time such Option
or Convertible Security is issued or amended, any adjustment to the Conversion Price that would result under the terms of this
Subsection 4.4.3 at the time of such issuance or amendment shall instead be effected at the time such number of shares and/or
amount of consideration is first calculable (even if subject to subsequent adjustments), assuming for purposes of calculating such
adjustment to the Conversion Price that such issuance or amendment took place at the time such calculation can first be made.
4.4.4 Adjustment
of Conversion Price Upon Issuance of Additional Shares of Common Stock. In the event the Corporation shall at any time after
the Series B Original Issue Date issue Additional Shares of Common Stock (including Additional Shares of Common Stock deemed to
be issued pursuant to Subsection 4.4.3), without consideration or for a consideration per share less than the applicable
Conversion Price of any series of Preferred Stock in effect immediately prior to such issue, then the applicable Conversion Price
of such series of Preferred Stock shall be reduced, concurrently with such issue, to a price (calculated to the nearest one- hundredth
of a cent) determined in accordance with the following formula:
CP2 =
CP1* (A + B) ÷ (A + C).
For purposes of the foregoing
formula, the following definitions shall apply:
(a) “CP2”
shall mean the Conversion Price in effect immediately after such issuance or deemed issuance of Additional Shares of Common Stock
(b) “CP1”
shall mean the Conversion Price in effect immediately prior to such issuance or deemed issuance of Additional Shares of Common
Stock;
(c) “A”
shall mean the number of shares of Common Stock outstanding immediately prior to such issuance or deemed issuance of Additional
Shares of Common Stock (treating for this purpose as outstanding all shares of Common Stock issuable upon exercise of Options outstanding
immediately prior to such issuance or deemed issuance or upon conversion or exchange of Convertible Securities (including the Preferred
Stock) outstanding (assuming exercise of any outstanding Options therefor) immediately prior to such issue;
(d) “B”
shall mean the number of shares of Common Stock that would have been issued if such Additional Shares of Common Stock had been
issued or deemed issued at a price per share equal to CP1 (determined by dividing the aggregate
consideration received by the Corporation in respect of such issue by CP1); and
(e) “C”
shall mean the number of such Additional Shares of Common Stock issued in such transaction.
4.4.5 Determination
of Consideration. For purposes of this Subsection 4.4, the consideration received by the Corporation for the issuance
or deemed issuance of any Additional Shares of Common Stock shall be computed as follows:
(a) Cash
and Property: Such consideration shall:
(i) insofar
as it consists of cash, be computed at the aggregate amount of cash received by the Corporation, excluding amounts paid or payable
for accrued interest;
(ii) insofar
as it consists of property other than cash, be computed at the fair market value thereof at the time of such issue, as determined
in good faith by the Board of Directors of the Corporation; and
(iii) in
the event Additional Shares of Common Stock are issued together with other shares or securities or other assets of the Corporation
for consideration which covers both, be the proportion of such consideration so received, computed as provided in clauses (i)
and (ii) above, as determined in good faith by the Board of Directors of the Corporation.
(b) Options
and Convertible Securities. The consideration per share received by the Corporation for Additional Shares of Common Stock deemed
to have been issued pursuant to Subsection 4.4.3, relating to Options and Convertible Securities, shall be determined by
dividing:
(i) the
total amount, if any, received or receivable by the Corporation as consideration for the issue of such Options or Convertible Securities,
plus the minimum aggregate amount of additional consideration (as set forth in the instruments relating thereto, without regard
to any provision contained therein for a subsequent adjustment of such consideration) payable to the Corporation upon the exercise
of such Options or the conversion or exchange of such Convertible Securities, or in the case of Options for Convertible Securities,
the exercise of such Options for Convertible Securities and the conversion or exchange of such Convertible Securities; by
(ii) the
maximum number of shares of Common Stock (as set forth in the instruments relating thereto, without regard to any provision contained
therein for a subsequent adjustment of such number) issuable upon the exercise of such Options or the conversion or exchange of
such Convertible Securities, or in the case of Options for Convertible Securities, the exercise of such Options for Convertible
Securities and the conversion or exchange of such Convertible Securities.
4.4.6 Multiple
Closing Dates. In the event the Corporation shall issue on more than one date Additional Shares of Common Stock that are a
part of one transaction or a series of related transactions and that would result in an adjustment to any Conversion Price pursuant
to the terms of Subsection 4.4.4, and such issuance dates occur within a period of no more than ninety (90) days from the
first such issuance to the final such issuance, then, upon the final such issuance, the applicable Conversion Price(s) shall be
readjusted to give effect to all such issuances as if they occurred on the date of the first such issuance (and without giving
effect to any additional adjustments as a result of any such subsequent issuances within such period).
4.5 Adjustment
for Stock Splits and Combinations. If the Corporation shall at any time or from time to time after the Series B Original Issue
Date effect a subdivision of the outstanding Common Stock, the Conversion Prices in effect immediately before that subdivision
shall be proportionately decreased so that the number of shares of Common Stock issuable on conversion of each share of such series
shall be increased in proportion to such increase in the aggregate number of shares of Common Stock outstanding. If the Corporation
shall at any time or from time to time after the Series B Original Issue Date combine the outstanding shares of Common Stock, the
Conversion Prices in effect immediately before the combination shall be proportionately increased so that the number of shares
of Common Stock issuable on conversion of each share of such series shall be decreased in proportion to such decrease in the aggregate
number of shares of Common Stock outstanding. Any adjustment under this subsection shall become effective at the close of business
on the date the subdivision or combination becomes effective.
4.6 Adjustment
for Certain Dividends and Distributions. In the event the Corporation at any time or from time to time after the Series B Original
Issue Date shall make or issue, or fix a record date for the determination of holders of Common Stock entitled to receive, a dividend
or other distribution payable on the Common Stock in additional shares of Common Stock, then and in each such event the Conversion
Prices in effect immediately before such event shall be decreased as of the time of such issuance or, in the event such a record
date shall have been fixed, as of the close of business on such record date, by multiplying the Conversion Prices then in effect
by a fraction:
(i) the
numerator of which shall be the total number of shares of Common Stock issued and outstanding immediately prior to the time of
such issuance or the close of business on such record date, and
(ii) the
denominator of which shall be the total number of shares of Common Stock issued and outstanding immediately prior to the time of
such issuance or the close of business on such record date plus the number of shares of Common Stock issuable in payment of such
dividend or distribution.
Notwithstanding the foregoing, (a) if such
record date shall have been fixed and such dividend is not fully paid or if such distribution is not fully made on the date fixed
therefor, the Conversion Prices shall be recomputed accordingly as of the close of business on such record date and thereafter
the Conversion Prices shall be adjusted pursuant to this subsection as of the time of actual payment of such dividends or distributions;
and (b) no such adjustment shall be made to the Series B Conversion Price, Series A Conversion Price or Junior Series A Conversion
Price, as applicable, if the holders of Series B Preferred Stock, Series A Preferred Stock or Junior Series A Preferred Stock,
as applicable, simultaneously receive a dividend or other distribution of shares of Common Stock in a number equal to the number
of shares of Common Stock as they would have received if all outstanding shares of such series of Preferred Stock had been converted
into Common Stock on the date of such event.
4.7 Adjustments
for Other Dividends and Distributions. In the event the Corporation at any time or from time to time after the Series B Original
Issue Date shall make or issue, or fix a record date for the determination of holders of Common Stock entitled to receive, a dividend
or other distribution payable in securities of the Corporation (other than a distribution of shares of Common Stock in respect
of outstanding shares of Common Stock) or in other property and the provisions of Section 1 do not apply to such dividend
or distribution, then in each such event the holders of Preferred Stock shall receive, simultaneously with the distribution to
the holders of Common Stock, a dividend or other distribution of such securities or other property in an amount equal to the amount
of such securities or other property as they would have received if all outstanding shares of Preferred Stock had been converted
into Common Stock on the date of such event.
4.8 Adjustment
for Merger or Reorganization, etc. Subject to the provisions of Subsection 2.2, if there shall occur any reorganization,
recapitalization, reclassification, consolidation or merger involving the Corporation in which the Common Stock (but not the Series
B Preferred Stock, Series A Preferred Stock, and/or Junior Series A Preferred Stock) is converted into or exchanged for securities,
cash or other property (other than a transaction covered by Subsections 4.4, 4.6 or 4.7), then, following any such
reorganization, recapitalization, reclassification, consolidation or merger, each share of Preferred Stock shall thereafter be
convertible in lieu of the Common Stock into which it was convertible prior to such event into the kind and amount of securities,
cash or other property which a holder of the number of shares of Common Stock of the Corporation issuable upon conversion of one
share of Series B Preferred Stock, Series A Preferred Stock or Junior Series A Preferred Stock (as applicable) immediately prior
to such reorganization, recapitalization, reclassification, consolidation or merger would have been entitled to receive pursuant
to such transaction; and, in such case, appropriate adjustment (as determined in good faith by the Board of Directors of the Corporation)
shall be made in the application of the provisions in this Section 4 with respect to the rights and interests thereafter
of the holders of such Preferred Stock, to the end that the provisions set forth in this Section 4 (including provisions
with respect to changes in and other adjustments of the applicable Conversion Price) shall thereafter be applicable, as nearly
as reasonably may be, in relation to any securities or other property thereafter deliverable upon the conversion of such Preferred
Stock.
4.9 Certificate
as to Adjustments. Upon the occurrence of each adjustment or readjustment of any Conversion Price pursuant to this Section
5, the Corporation at its expense shall, as promptly as reasonably practicable but in any event not later than 10 days thereafter,
compute such adjustment or readjustment in accordance with the terms hereof and furnish to each holder of Preferred Stock a certificate
setting forth such adjustment or readjustment (including the kind and amount of securities, cash or other property into which the
Preferred Stock is convertible) and showing in detail the facts upon which such adjustment or readjustment is based. The Corporation
shall, as promptly as reasonably practicable after the written request at any time of any holder of Preferred Stock (but in any
event not later than 10 days thereafter), furnish or cause to be furnished to such holder a certificate setting forth (i) the applicable
Conversion Price then in effect with respect to such series of Preferred Stock, and (ii) the number of shares of Common Stock and
the amount, if any, of other securities, cash or property which then would be received upon the conversion of Preferred Stock.
| 4.10 | Notice of Record Date. In the event: |
(a) the
Corporation shall take a record of the holders of its Series B Preferred Stock, Series A Preferred Stock, Junior Series A Preferred
Stock, and/or Common Stock (or other capital stock or securities at the time issuable upon conversion of any Preferred Stock) for
the purpose of entitling or enabling them to receive any dividend or other distribution, or to receive any right to subscribe for
or purchase any shares of capital stock of any class or any other securities, or to receive any other security; or
(b) of
any capital reorganization of the Corporation, any reclassification of the Common Stock of the Corporation, or any Deemed Liquidation
Event;
(c) of
the voluntary or involuntary dissolution, liquidation or winding-up of the Corporation,
then, in each such case, the Corporation
will send or cause to be sent to the holders of Preferred Stock a notice specifying, as the case may be, (i) the record date for
such dividend, distribution or right, and the amount and character of such dividend, distribution or right, or (ii) the effective
date on which such reorganization, reclassification, consolidation, merger, transfer, dissolution, liquidation or winding-up is
proposed to take place, and the time, if any is to be fixed, as of which the holders of record of Common Stock (or such other capital
stock or securities at the time issuable upon the conversion of the Preferred Stock) shall be entitled to exchange their shares
of Common Stock (or such other capital stock or securities) for securities or other property deliverable upon such reorganization,
reclassification, consolidation, merger, transfer, dissolution, liquidation or winding-up, and the amount per share and character
of such exchange applicable to the Preferred Stock and the Common Stock. Such notice shall be sent at least ten (10) days prior
to the record date or effective date for the event specified in such notice.
5.1 Trigger
Events. Upon either (a) the closing of the sale of shares of Common Stock to the public in a firm-commitment underwritten public
offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, in which (1) the price of
the Common Stock to the public in such offering, multiplied by the total number of shares of Common Stock outstanding at the time
the registration statement for such offering becomes effective (including the shares of Common Stock issuable upon conversion or
exercise of any Options or Convertible Securities then outstanding), is no less than $350,000,000, and (2) such offering results
in at least $75,000,000 of gross proceeds to the Corporation, and in connection with such offering the Common Stock is listed for
trading on the Nasdaq Stock Market's National Market, the New York Stock Exchange or another exchange or marketplace approved the
Board of Directors, or (b) the date and time, or the occurrence of an event, specified by vote or written consent of the holders
of (1) more than 50% of the then outstanding shares of Series B Preferred Stock and (2) at least 55% of the then outstanding shares
of Series A Preferred Stock (the time of such closing or the date and time specified or the time of the event specified in such
vote or written consent is referred to herein as the “Mandatory Conversion Time”), (i) all outstanding shares
of Series B Preferred Stock, Series A Preferred Stock and Junior Series A Preferred Stock shall automatically be converted into
shares of Common Stock, at the then effective conversion rate applicable thereto as calculated pursuant to Subsection 4.1.1 and
(ii) such shares may not be reissued by the Corporation.
5.2 Procedural
Requirements. All holders of record of shares of Preferred Stock shall be sent written notice of the Mandatory Conversion Time
and the place designated for mandatory conversion of all such shares of Preferred Stock pursuant to this Section 5. Such
notice need not be sent in advance of the occurrence of the Mandatory Conversion Time. Upon receipt of such notice, each holder
of shares of Preferred Stock in certificated form shall surrender his, her or its certificate or certificates for all such shares
(or, if such holder alleges that such certificate has been lost, stolen or destroyed, a lost certificate affidavit and agreement
reasonably acceptable to the Corporation to indemnify the Corporation against any claim that may be made against the Corporation
on account of the alleged loss, theft or destruction of such certificate) to the Corporation at the place designated in such notice.
If so required by the Corporation, any certificates surrendered for conversion shall be endorsed or accompanied by written instrument
or instruments of transfer, in form satisfactory to the Corporation, duly executed by the registered holder or by his, her or its
attorney duly authorized in writing. All rights with respect to the Series B Preferred Stock, Series A Preferred Stock or
Junior Series A Preferred Stock converted pursuant to Subsection 5.1, including the rights, if any, to receive notices and
vote (other than as a holder of Common Stock), will terminate at the Mandatory Conversion Time (notwithstanding the failure of
the holder or holders thereof to surrender any certificates at or prior to such time), except only the rights of the holders thereof,
upon surrender of any certificate or certificates of such holders (or lost certificate affidavit and agreement) therefor, to receive
the items provided for in the next sentence of this Subsection 5.2. As soon as practicable after the Mandatory Conversion
Time and, if applicable, the surrender of any certificate or certificates (or lost certificate affidavit and agreement) for Series
B Preferred Stock, Series A Preferred Stock or Junior Series A Preferred Stock, the Corporation shall (a) issue and deliver to
such holder, or to his, her or its nominees, a certificate or certificates for the number of full shares of Common Stock issuable
on such conversion in accordance with the provisions hereof and (b) pay cash as provided in Subsection 4.2 in lieu of any
fraction of a share of Common Stock otherwise issuable upon such conversion and the payment of any declared but unpaid dividends
on the shares of Series B Preferred Stock, Series A Preferred Stock or Junior Series A Preferred Stock converted. Such converted
Series B Preferred Stock, Series A Preferred Stock and Junior Series A Preferred Stock shall be retired and cancelled and may not
be reissued as shares of such series, and the Corporation may thereafter take such appropriate action (without the need for stockholder
action) as may be necessary to reduce the authorized number of shares of Series B Preferred Stock, Series A Preferred Stock or
Junior Series A Preferred Stock accordingly.
6. Redeemed
or Otherwise Acquired Shares. Any shares of Series B Preferred Stock, Series A Preferred Stock or Junior Series A Preferred
Stock that are redeemed or otherwise acquired by the Corporation or any of its subsidiaries shall be automatically and immediately
cancelled and retired and shall not be reissued, sold or transferred. Neither the Corporation nor any of its subsidiaries may exercise
any voting or other rights granted to the holders of Series B Preferred Stock, Series A Preferred Stock or Junior Series A Preferred
Stock following redemption.
7. Waiver.
Except to the extent stated to the contrary in this Certificate of Incorporation, any of the rights, powers, preferences and other
terms of the Preferred Stock set forth herein may be waived on behalf of all holders of Preferred Stock by the Required Preferred
Majority, provided, however, that, unless such waiver applies to all series of Preferred Stock in the same fashion,
the rights, powers, preferences and other terms of the Preferred Stock set forth herein may not be waived with respect to any series
of Preferred Stock, without the written consent of the holders of as applicable, (1) more than 50% of the then outstanding shares
of Series B Preferred Stock, with respect to the Series B Preferred Stock; (2) at least 55% of the then outstanding shares of Series
A Preferred Stock, with respect to the Series A Preferred Stock; and (3) more than 50% of the then outstanding shares of Junior
Series A Preferred Stock, with respect to the Junior Series A Preferred Stock.
8. Notices.
Any notice required or permitted by the provisions hereof to be given to a holder of shares of Series B Preferred Stock, Series
A Preferred Stock or Junior Series A Preferred Stock shall be mailed, postage prepaid, to the post office address last shown on
the records of the Corporation, or given by electronic communication in compliance with the provisions of the General Corporation
Law, and shall be deemed sent upon such mailing or electronic transmission.
FIFTH: Subject
to any additional vote required by the Certificate of Incorporation or Bylaws, in furtherance and not in limitation of the powers
conferred by statute, the Board of Directors is expressly authorized to make, repeal, alter, amend and rescind any or all of the
Bylaws of the Corporation.
SIXTH: Subject
to any additional vote required by the Certificate of Incorporation, the number of directors of the Corporation shall be determined
in the manner set forth in the Bylaws of the Corporation.
SEVENTH: Elections
of directors need not be by written ballot unless the Bylaws of the Corporation shall so provide.
EIGHTH: Meetings
of stockholders may be held within or without the State of Delaware, as the Bylaws of the Corporation may provide. The books of
the Corporation may be kept outside the State of Delaware at such place or places as may be designated from time to time by the
Board of Directors or in the Bylaws of the Corporation.
NINTH: To the
fullest extent permitted by law, a director of the Corporation shall not be personally liable to the Corporation or its stockholders
for monetary damages for breach of fiduciary duty as a director. If the General Corporation Law or any other law of the State of
Delaware is amended after approval by the stockholders of this Article Ninth to authorize corporate action further eliminating
or limiting the personal liability of directors, then the liability of a director of the Corporation shall be eliminated or limited
to the fullest extent permitted by the General Corporation Law as so amended.
Any repeal or modification
of the foregoing provisions of this Article Ninth by the stockholders of the Corporation shall not adversely affect any right or
protection of a director of the Corporation existing at the time of, or increase the liability of any director of the Corporation
with respect to any acts or omissions of such director occurring prior to, such repeal or modification.
TENTH: To the
fullest extent permitted by applicable law, the Corporation is authorized to provide indemnification of (and advancement of expenses
to) directors, officers and agents of the Corporation (and any other persons to which General Corporation Law permits the Corporation
to provide indemnification) through Bylaw provisions, agreements with such agents or other persons, vote of stockholders or disinterested
directors or otherwise, in excess of the indemnification and advancement otherwise permitted by Section 145 of the General
Corporation Law.
Any amendment, repeal
or modification of the foregoing provisions of this Article Tenth shall not adversely affect any right or protection of any director,
officer or other agent of the Corporation existing at the time of such amendment, repeal or modification or increase the liability
of any director of the Corporation with respect to any acts or omissions of such director occurring prior to, such amendment, repeal
or modification.
ELEVENTH: The
Corporation renounces, to the fullest extent permitted by law, any interest or expectancy of the Corporation in, or in being offered
an opportunity to participate in, any Excluded Opportunity. An “Excluded Opportunity” is any matter, transaction
or interest that is presented to, or acquired, created or developed by, or which otherwise comes into the possession of (i) any
director of the Corporation who is not an employee of the Corporation or any of its subsidiaries, or (ii) any holder of Series
A Preferred Stock or any partner, member, director, stockholder, employee, affiliate or agent of any such holder, other than someone
who is an employee of the Corporation or any of its subsidiaries (collectively, “Covered Persons”), unless such
matter, transaction or interest is presented to, or acquired, created or developed by, or otherwise comes into the possession of,
a Covered Person expressly and solely in such Covered Person’s capacity as a director of the Corporation while such Covered
Person is performing services in such capacity. Any repeal or modification of this Article Eleventh will only be prospective and
will not affect the rights under this Article Eleventh in effect at the time of the occurrence of any actions or omissions to act
giving rise to liability.
* *
*
IN WITNESS WHEREOF, this Amended
and Restated Certificate of Incorporation has been executed by a duly authorized officer of this corporation on this 29th
day of March, 2019.
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By: |
/s/ Saqib Islam |
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Name: Saqib Islam |
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Title: Chief Executive Officer |
CERTIFICATE OF AMENDMENT TO
AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
OF
SPRINGWORKS THERAPEUTICS, INC.
SpringWorks Therapeutics, Inc. (the “Corporation”),
a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “DGCL”),
does hereby certify:
1. Pursuant
to Section 242 of the DGCL, this Certificate of Amendment to Amended and Restated Certificate of Incorporation (this “Amendment”)
amends the provisions of the Amended and Restated Certificate of Incorporation of the Corporation, dated as of March 29, 2019 (the
“Certificate”).
2. This
Amendment has been approved and duly adopted by the Corporation’s Board of Directors and written consent of the stockholders
has been given in accordance with the provisions of Sections 228 and 242 of the DGCL, and the provisions of the Certificate.
3. The
Certificate is hereby amended as follows:
The first
paragraph of Article FOURTH is hereby amended and restated in its entirety to read as set forth below:
“The
total number of shares of all classes of stock which the Corporation shall have authority to issue is (i) 232,788,672 shares of
Common Stock, $0.0001 par value per share (“Common Stock”) and (ii) 196,076,779 shares of Preferred Stock, $0.0001
par value per share (“Preferred Stock”), of which 6,437,500 shares are hereby designated as “Junior
Series A Preferred Stock,” 103,000,000 shares are hereby designated as “Series A Preferred Stock”
and 86,639,279 shares are hereby designated as “Series B Preferred Stock”.”
* - * - * - *
IN WITNESS WHEREOF, the undersigned
authorized officer of the Corporation has executed this Certificate of Amendment to Amended and Restated Certificate of Incorporation
as of June 4, 2019.
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SPRINGWORKS THERAPEUTICS, INC. |
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By: |
/s/ Saqib Islam |
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Saqib Islam |
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Chief Executive Officer |
AMENDMENT NO. 2 TO
AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
OF
SPRINGWORKS THERAPEUTICS, INC.
SpringWorks Therapeutics, Inc. (the “Corporation”),
a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “DGCL”),
does hereby certify:
1. Pursuant
to Section 242 of the DGCL, this Amendment No. 2 to Amended and Restated Certificate of Incorporation (this “Amendment”)
amends the provisions of the Amended and Restated Certificate of Incorporation of the Corporation, dated as of March 29, 2019 (as
such has been amended, the “Certificate”).
2. This
Amendment has been approved and duly adopted by the Corporation’s Board of Directors and written consent of the stockholders
has been given in accordance with the provisions of Sections 228 and 242 of the DGCL, and the provisions of the Certificate.
3. The
Certificate is hereby amended as follows:
The first
paragraph of Article FOURTH is hereby amended and restated in its entirety to read as set forth below:
“The
total number of shares of all classes of stock which the Corporation shall have authority to issue is (i) 241,458,276 shares of
Common Stock, $0.0001 par value per share (“Common Stock”) and (ii) 196,076,779 shares of Preferred Stock, $0.0001
par value per share (“Preferred Stock”), of which 6,437,500 shares are hereby designated as “Junior
Series A Preferred Stock,” 103,000,000 shares are hereby designated as “Series A Preferred Stock”
and 86,639,279 shares are hereby designated as “Series B Preferred Stock”.”
* - * - * - *
IN WITNESS WHEREOF, the undersigned
authorized officer of the Corporation has executed this Certificate of Amendment to Amended and Restated Certificate of Incorporation
as of July 29, 2019.
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SPRINGWORKS THERAPEUTICS, INC. |
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By: |
/s/ Saqib Islam |
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Saqib Islam |
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Chief Executive Officer |
AMENDMENT NO. 3
TO
AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
OF
SPRINGWORKS THERAPEUTICS, INC.
SpringWorks Therapeutics, Inc. (the “Corporation”),
a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “DGCL”),
does hereby certify
1.
Pursuant to Section 242 of the DGCL, this Amendment No. 3 to Amended and Restated Certificate of Incorporation (this “Amendment”)
amends the provisions of the Amended and Restated Certificate of Incorporation of the Corporation, dated as of March 29, 2019 (as
such has been amended, the “Certificate”).
2.
This Amendment has been approved and duly adopted by the Corporation’s Board of Directors and written consent of the
stockholders has been given in accordance with the provisions of Sections 228 and 242 of the DGCL, and the provisions of the Certificate.
3.
The Certificate is hereby amended as follows:
The following
is hereby inserted into Article FOURTH immediately before the first sentence therein:
“Effective upon the filing of
this Certificate of Amendment of the Amended and Restated Certificate of Incorporation with the Secretary of State of the State
of Delaware (the “Effective Time”), every 6.5810 shares of Common Stock then issued and outstanding or held
in the treasury of the Corporation immediately prior to the Effective Time shall automatically be combined into one (1) share of
Common Stock, without any further action by the holders of such shares (the “Reverse Stock Split”). The Reverse
Stock Split will be effected on a certificate-by-certificate basis, and any fractional shares resulting from such combination shall
be rounded down to the nearest whole share on a certificate-by-certificate basis. No fractional shares shall be issued in connection
with the Reverse Stock Split. In lieu of any fractional shares to which a holder would otherwise be entitled, the Corporation shall
pay cash equal to such fraction multiplied by the fair market value of a share of Common Stock as determined in good faith by the
Corporation’s Board of Directors. The Reverse Stock Split shall occur automatically without any further action by the holders
of the shares of Common Stock and Preferred Stock affected thereby. All rights, preferences and privileges of the Common Stock
and the Preferred Stock shall be appropriately adjusted to reflect the Reverse Stock Split in accordance with this Amended and
Restated Certificate of Incorporation.”
* - * - * - *
[Signature Page to Follow]
IN WITNESS WHEREOF, the undersigned authorized
officer of the Corporation has executed this Certificate of Amendment to Amended and Restated Certificate of Incorporation as of
August 30, 2019.
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SPRINGWORKS THERAPEUTICS, INC. |
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By: |
/s/ Saqib Islam |
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Saqib Islam |
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Chief Executive Officer |
Exhibit 3.4
AMENDED AND RESTATED
BY-LAWS
OF
SPRINGWORKS THERAPEUTICS, INC.
(the “Corporation”)
ARTICLE I
Stockholders
SECTION 1. Annual Meeting. The annual
meeting of stockholders (any such meeting being referred to in these By-laws as an “Annual Meeting”) shall be held
at the hour, date and place within or without the United States which is fixed by the Board of Directors, which time, date and
place may subsequently be changed at any time by vote of the Board of Directors. If no Annual Meeting has been held for a period
of thirteen (13) months after the Corporation’s last Annual Meeting, a special meeting in lieu thereof may be held, and
such special meeting shall have, for the purposes of these By-laws or otherwise, all the force and effect of an Annual Meeting.
Any and all references hereafter in these By-laws to an Annual Meeting or Annual Meetings also shall be deemed to refer to any
special meeting(s) in lieu thereof.
SECTION 2. Notice of Stockholder Business
and Nominations.
(a) Annual
Meetings of Stockholders.
(1) Nominations
of persons for election to the Board of Directors of the Corporation and the proposal of other business to be considered by the
stockholders may be brought before an Annual Meeting (i) by or at the direction of the Board of Directors or (ii) by any stockholder
of the Corporation who was a stockholder of record at the time of giving of notice provided for in this By-law, who is entitled
to vote at the meeting, who is present (in person or by proxy) at the meeting and who complies with the notice procedures set forth
in this By-law as to such nomination or business. For the avoidance of doubt, the foregoing clause (ii) shall be the exclusive
means for a stockholder to bring nominations or business properly before an Annual Meeting (other than matters properly brought
under Rule 14a-8 (or any successor rule) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)),
and such stockholder must comply with the notice and other procedures set forth in Article I, Section 2(a)(2) and (3) of this By-law
to bring such nominations or business properly before an Annual Meeting. In addition to the other requirements set forth in this
By-law, for any proposal of business to be considered at an Annual Meeting, it must be a proper subject for action by stockholders
of the Corporation under Delaware law.
(2) For
nominations or other business to be properly brought before an Annual Meeting by a stockholder pursuant to clause (ii) of Article
I, Section 2(a)(1) of this By-law, the stockholder must (i) have given Timely Notice (as defined below) thereof in writing to the
Secretary of the Corporation, (ii) have provided any updates or supplements to such notice at the times and in the forms required
by this By-law and (iii) together with the beneficial owner(s), if any, on whose behalf the nomination or business proposal
is made, have acted in accordance with the representations set forth in the Solicitation Statement (as defined below) required
by this By-law. To be timely, a stockholder’s written notice shall be received by the Secretary at the principal executive
offices of the Corporation not later than the close of business on the ninetieth (90th) day nor earlier than the close of business
on the one hundred twentieth (120th) day prior to the one-year anniversary of the preceding year’s Annual Meeting; provided,
however, that in the event the Annual Meeting is first convened more than thirty (30) days before or more than sixty (60)
days after such anniversary date, or if no Annual Meeting were held in the preceding year, notice by the stockholder to be timely
must be received by the Secretary of the Corporation not later than the close of business on the later of the ninetieth (90th)
day prior to the scheduled date of such Annual Meeting or the tenth (10th) day following the day on which public announcement of
the date of such meeting is first made (such notice within such time periods shall be referred to as “Timely Notice”).
Notwithstanding anything to the contrary provided herein, for the first Annual Meeting following the initial public offering of
common stock of the Corporation, a stockholder’s notice shall be timely if received by the Secretary at the principal executive
offices of the Corporation not later than the close of business on the later of the ninetieth (90th) day prior to the scheduled
date of such Annual Meeting or the tenth (10th) day following the day on which public announcement of the date of such Annual Meeting
is first made or sent by the Corporation. Such stockholder’s Timely Notice shall set forth:
(A) as
to each person whom the stockholder proposes to nominate for election or reelection as a director, (i) the name, age, business
address and residence address of the nominee, (ii) the principal occupation or employment of the nominee, (iii) the class and number
of shares of the Corporation that are held of record or are beneficially owned by the nominee and any derivative positions held
or beneficially held by the nominee, (iv) whether and the extent to which any hedging or other transaction or series of transactions
has been entered into by or on behalf of the nominee with respect to any securities of the Corporation, and a description of any
other agreement, arrangement or understanding (including any short position or any borrowing or lending of shares), the effect
or intent of which is to mitigate loss to, or to manage the risk or benefit of share price changes for, or to increase or decrease
the voting power of the nominee, (v) a description of all arrangements or understandings between or among the stockholder and each
nominee and any other person or persons (naming such person or persons) pursuant to which the nominations are to be made by the
stockholder or concerning the nominee’s potential service on the Board of Directors, (vi) a written statement executed by
the nominee acknowledging that as a director of the corporation, the nominee will owe fiduciary duties under Delaware law with
respect to the Corporation and its stockholders, and (vii) all information relating to such person that is required to be disclosed
in solicitations of proxies for election of directors in an election contest, or is otherwise required, in each case pursuant to
Regulation 14A under the Exchange Act (including such person’s written consent to being named in the proxy statement as a
nominee and to serving as a director if elected);
(B) as
to any other business that the stockholder proposes to bring before the meeting, a brief description of the business desired to
be brought before the meeting, the reasons for conducting such business at the meeting, the text, if any, of any resolutions or
By-law amendment proposed for adoption, and any material interest in such business of each Proposing Person (as defined below);
(C) (i)
the name and address of the stockholder giving the notice, as they appear on the Corporation’s books, and the names and addresses
of the other Proposing Persons (if any) and (ii) as to each Proposing Person, the following information: (a) the class or series
and number of all shares of capital stock of the Corporation which are, directly or indirectly, owned beneficially or of record
by such Proposing Person or any of its affiliates or associates (as such terms are defined in Rule 12b-2 promulgated under the
Exchange Act), including any shares of any class or series of capital stock of the Corporation as to which such Proposing Person
or any of its affiliates or associates has a right to acquire beneficial ownership at any time in the future, (b) all Synthetic
Equity Interests (as defined below) in which such Proposing Person or any of its affiliates or associates, directly or indirectly,
holds an interest including a description of the material terms of each such Synthetic Equity Interest, including without limitation,
identification of the counterparty to each such Synthetic Equity Interest and disclosure, for each such Synthetic Equity Interest,
as to (x) whether or not such Synthetic Equity Interest conveys any voting rights, directly or indirectly, in such shares to such
Proposing Person, (y) whether or not such Synthetic Equity Interest is required to be, or is capable of being, settled through
delivery of such shares and (z) whether or not such Proposing Person and/or, to the extent known, the counterparty to such Synthetic
Equity Interest has entered into other transactions that hedge or mitigate the economic effect of such Synthetic Equity Interest,
(c) any proxy (other than a revocable proxy given in response to a public proxy solicitation made pursuant to, and in accordance
with, the Exchange Act), agreement, arrangement, understanding or relationship pursuant to which such Proposing Person has or shares
a right to, directly or indirectly, vote any shares of any class or series of capital stock of the Corporation, (d) any rights
to dividends or other distributions on the shares of any class or series of capital stock of the Corporation, directly or indirectly,
owned beneficially by such Proposing Person that are separated or separable from the underlying shares of the Corporation, and
(e) any performance-related fees (other than an asset based fee) that such Proposing Person, directly or indirectly, is entitled
to based on any increase or decrease in the value of shares of any class or series of capital stock of the Corporation or any Synthetic
Equity Interests (the disclosures to be made pursuant to the foregoing clauses (a) through (e) are referred to, collectively, as
“Material Ownership Interests”) and (iii) a description of the material terms of all agreements, arrangements or understandings
(whether or not in writing) entered into by any Proposing Person or any of its affiliates or associates with any other person for
the purpose of acquiring, holding, disposing or voting of any shares of any class or series of capital stock of the Corporation;
(D) (i)
a description of all agreements, arrangements or understandings by and among any of the Proposing Persons, or by and among any
Proposing Persons and any other person (including with any proposed nominee(s)), pertaining to the nomination(s), or other business
proposed to be brought before the meeting of stockholders (which description shall identify the name of each other person who is
party to such an agreement, arrangement or understanding), and (ii) identification of the names and addresses of other stockholders
(including beneficial owners) known by any of the Proposing Persons to support such nominations or other business proposal(s),
and to the extent known the class and number of all shares of the Corporation’s capital stock owned beneficially or of record
by such other stockholder(s) or other beneficial owner(s); and
(E) a
statement whether or not the stockholder giving the notice and/or the other Proposing Person(s), if any, will deliver a proxy statement
and form of proxy to holders of, in the case of a business proposal, at least the percentage of voting power of all of the shares
of capital stock of the Corporation required under applicable law to approve the proposal or, in the case of a nomination or nominations,
at least the percentage of voting power of all of the shares of capital stock of the Corporation reasonably believed by such Proposing
Person to be sufficient to elect the nominee or nominees proposed to be nominated by such stockholder (such statement, the “Solicitation
Statement”).
For purposes of this Article I
of these By-laws, the term “Proposing Person” shall mean the following persons: (i) the stockholder of record providing
the notice of nominations or business proposed to be brought before a stockholders’ meeting, and (ii) the beneficial
owner(s), if different, on whose behalf the nominations or business proposed to be brought before a stockholders’ meeting
is made. For purposes of this Section 2 of Article I of these By-laws, the term “Synthetic Equity Interest” shall
mean any transaction, agreement or arrangement (or series of transactions, agreements or arrangements), including, without limitation,
any derivative, swap, hedge, repurchase or so-called “stock borrowing” agreement or arrangement, the purpose or effect
of which is to, directly or indirectly: (a) give a person or entity economic benefit and/or risk similar to ownership of shares
of any class or series of capital stock of the Corporation, in whole or in part, including due to the fact that such transaction,
agreement or arrangement provides, directly or indirectly, the opportunity to profit or avoid a loss from any increase or decrease
in the value of any shares of any class or series of capital stock of the Corporation, (b) mitigate loss to, reduce the economic
risk of or manage the risk of share price changes for, any person or entity with respect to any shares of any class or series of
capital stock of the Corporation, (c) otherwise provide in any manner the opportunity to profit or avoid a loss from any decrease
in the value of any shares of any class or series of capital stock of the Corporation, or (d) increase or decrease the voting power
of any person or entity with respect to any shares of any class or series of capital stock of the Corporation.
(3) A
stockholder providing Timely Notice of nominations or business proposed to be brought before an Annual Meeting shall further update
and supplement such notice, if necessary, so that the information (including, without limitation, the Material Ownership Interests
information) provided or required to be provided in such notice pursuant to this By-law shall be true and correct as of the record
date for the meeting and as of the date that is ten (10) business days prior to such Annual Meeting, and such update and supplement
shall be received by the Secretary at the principal executive offices of the Corporation not later than the close of business on
the fifth (5th) business day after the record date for the Annual Meeting (in the case of the update and supplement required to
be made as of the record date), and not later than the close of business on the eighth (8th) business day prior to the date of
the Annual Meeting (in the case of the update and supplement required to be made as of ten (10) business days prior to the meeting).
(4) Notwithstanding
anything in the second sentence of Article I, Section 2(a)(2) of this By-law to the contrary, in the event that the number
of directors to be elected to the Board of Directors of the Corporation is increased and there is no public announcement naming
all of the nominees for director or specifying the size of the increased Board of Directors made by the Corporation at least ten
(10) days before the last day a stockholder may deliver a notice of nomination in accordance with the second sentence of Article
I, Section 2(a)(2), a stockholder’s notice required by this By-law shall also be considered timely, but only with respect
to nominees for any new positions created by such increase, if it shall be received by the Secretary of the Corporation not later
than the close of business on the tenth (10th) day following the day on which such public announcement is first made by the Corporation.
(b) General.
(1) Only
such persons who are nominated in accordance with the provisions of this By-law shall be eligible for election and to serve as
directors and only such business shall be conducted at an Annual Meeting as shall have been brought before the meeting in accordance
with the provisions of this By-law or in accordance with Rule 14a-8 under the Exchange Act. The Board of Directors or a designated
committee thereof shall have the power to determine whether a nomination or any business proposed to be brought before the meeting
was made in accordance with the provisions of this By-law. If neither the Board of Directors nor such designated committee makes
a determination as to whether any stockholder proposal or nomination was made in accordance with the provisions of this By-law,
the presiding officer of the Annual Meeting shall have the power and duty to determine whether the stockholder proposal or nomination
was made in accordance with the provisions of this By-law. If the Board of Directors or a designated committee thereof or the presiding
officer, as applicable, determines that any stockholder proposal or nomination was not made in accordance with the provisions of
this By-law, such proposal or nomination shall be disregarded and shall not be presented for action at the Annual Meeting.
(2) Except
as otherwise required by law, nothing in this Article I, Section 2 shall obligate the Corporation or the Board of Directors to
include in any proxy statement or other stockholder communication distributed on behalf of the Corporation or the Board of Directors
information with respect to any nominee for director or any other matter of business submitted by a stockholder.
(3) Notwithstanding
the foregoing provisions of this Article I, Section 2, if the nominating or proposing stockholder (or a qualified representative
of the stockholder) does not appear at the Annual Meeting to present a nomination or any business, such nomination or business
shall be disregarded, notwithstanding that proxies in respect of such vote may have been received by the Corporation. For purposes
of this Article I, Section 2, to be considered a qualified representative of the proposing stockholder, a person must be authorized
by a written instrument executed by such stockholder or an electronic transmission delivered by such stockholder to act for such
stockholder as proxy at the meeting of stockholders and such person must produce such written instrument or electronic transmission,
or a reliable reproduction of the written instrument or electronic transmission, to the presiding officer at the meeting of stockholders.
(4) For
purposes of this By-law, “public announcement” shall mean disclosure in a press release reported by the Dow Jones News
Service, Associated Press or comparable national news service or in a document publicly filed by the Corporation with the Securities
and Exchange Commission pursuant to Section 13, 14 or 15(d) of the Exchange Act.
(5) Notwithstanding
the foregoing provisions of this By-law, a stockholder shall also comply with all applicable requirements of the Exchange Act and
the rules and regulations thereunder with respect to the matters set forth in this By-law. Nothing in this By-law shall be deemed
to affect any rights of (i) stockholders to have proposals included in the Corporation’s proxy statement pursuant to Rule
14a-8 (or any successor rule), as applicable, under the Exchange Act and, to the extent required by such rule, have such proposals
considered and voted on at an Annual Meeting or (ii) the holders of any series of Undesignated Preferred Stock to elect directors
under specified circumstances.
(c) Notwithstanding
anything herein to the contrary, the affirmative vote of not less than two thirds (2/3) of the outstanding shares of capital stock
entitled to vote thereon, and the affirmative vote of not less than two thirds (2/3) of the outstanding shares of each class entitled
to vote thereon as a class, shall be required to amend or repeal any provision of this Article I, Section 2; provided, however,
that if the Board of Directors recommends that stockholders approve such amendment or repeal at such meeting of stockholders, such
amendment or repeal shall only require the affirmative vote of a majority of the outstanding shares entitled to vote on such amendment
or repeal, voting together as a single class.
SECTION 3. Special Meetings. Except
as otherwise required by statute and subject to the rights, if any, of the holders of any series of Undesignated Preferred Stock,
special meetings of the stockholders of the Corporation may be called only by the Board of Directors acting pursuant to a resolution
approved by the affirmative vote of a majority of the Directors then in office. The Board of Directors may postpone or reschedule
any previously scheduled special meeting of stockholders. Only those matters set forth in the notice of the special meeting may
be considered or acted upon at a special meeting of stockholders of the Corporation. Nominations of persons for election to the
Board of Directors of the Corporation and stockholder proposals of other business shall not be brought before a special meeting
of stockholders to be considered by the stockholders unless such special meeting is held in lieu of an annual meeting of stockholders
in accordance with Article I, Section 1 of these By-laws, in which case such special meeting in lieu thereof shall be deemed an
Annual Meeting for purposes of these By-laws and the provisions of Article I, Section 2 of these By-laws shall govern such special
meeting.
Notwithstanding anything herein to the contrary,
the affirmative vote of not less than two thirds (2/3) of the outstanding shares of capital stock entitled to vote thereon, and
the affirmative vote of not less than two thirds (2/3) of the outstanding shares of each class entitled to vote thereon as a class,
shall be required to amend or repeal any provision of this Article I, Section 3; provided, however, that if the Board
of Directors recommends that stockholders approve such amendment or repeal at such meeting of stockholders, such amendment or repeal
shall only require the affirmative vote of a majority of the outstanding shares entitled to vote on such amendment or repeal, voting
together as a single class.
SECTION 4. Notice
of Meetings; Adjournments.
(a) A
notice of each Annual Meeting stating the hour, date and place, if any, of such Annual Meeting and the means of remote communication,
if any, by which stockholders and proxyholders may be deemed to be present in person and vote at such meeting, shall be given not
less than ten (10) days nor more than sixty (60) days before the Annual Meeting, to each stockholder entitled to vote thereat by
delivering such notice to such stockholder or by mailing it, postage prepaid, addressed to such stockholder at the address of such
stockholder as it appears on the Corporation’s stock transfer books. Without limiting the manner by which notice may otherwise
be given to stockholders, any notice to stockholders may be given by electronic transmission in the manner provided in Section
232 of the Delaware General Corporation Law (“DGCL”).
(b) Unless
otherwise required by the DGCL, notice of all special meetings of stockholders shall be given in the same manner as provided for
Annual Meetings, except that the notice of all special meetings shall state the purpose or purposes for which the meeting has been
called.
(c) Notice
of an Annual Meeting or special meeting of stockholders need not be given to a stockholder if a waiver of notice is executed, or
waiver of notice by electronic transmission is provided, before or after such meeting by such stockholder or if such stockholder
attends such meeting, unless such attendance is for the express purpose of objecting at the beginning of the meeting to the transaction
of any business because the meeting was not lawfully called or convened.
(d) The
Board of Directors may postpone and reschedule any previously scheduled Annual Meeting or special meeting of stockholders and any
record date with respect thereto, regardless of whether any notice or public disclosure with respect to any such meeting has been
sent or made pursuant to Section 2 of this Article I of these By-laws or otherwise. In no event shall the public announcement
of an adjournment, postponement or rescheduling of any previously scheduled meeting of stockholders commence a new time period
for the giving of a stockholder’s notice under this Article I of these By-laws.
(e) When
any meeting is convened, the presiding officer may adjourn the meeting if (i) no quorum is present for the transaction of
business, (ii) the Board of Directors determines that adjournment is necessary or appropriate to enable the stockholders to
consider fully information which the Board of Directors determines has not been made sufficiently or timely available to stockholders,
or (iii) the Board of Directors determines that adjournment is otherwise in the best interests of the Corporation. When any Annual
Meeting or special meeting of stockholders is adjourned to another hour, date or place, notice need not be given of the adjourned
meeting other than an announcement at the meeting at which the adjournment is taken of the hour, date and place, if any, to which
the meeting is adjourned and the means of remote communications, if any, by which stockholders and proxyholders may be deemed to
be present in person and vote at such adjourned meeting; provided, however, that if the adjournment is for more than thirty (30)
days from the meeting date, or if after the adjournment a new record date is fixed for the adjourned meeting, notice of the adjourned
meeting and the means of remote communications, if any, by which stockholders and proxyholders may be deemed to be present in person
and vote at such adjourned meeting shall be given to each stockholder of record entitled to vote thereat and each stockholder who,
by law or under the Certificate of Incorporation of the Corporation (as the same may hereafter be amended and/or restated, the
“Certificate”) or these By-laws, is entitled to such notice.
SECTION 5. Quorum. A majority
of the outstanding shares entitled to vote, present in person or represented by proxy, shall constitute a quorum at any meeting
of stockholders. If less than a quorum is present at a meeting, the holders of voting stock representing a majority of the voting
power present at the meeting or the presiding officer may adjourn the meeting from time to time, and the meeting may be held as
adjourned without further notice, except as provided in Section 4 of this Article I. At such adjourned meeting at which
a quorum is present, any business may be transacted which might have been transacted at the original meeting. The stockholders
present at a duly constituted meeting may continue to transact business until adjournment, notwithstanding the withdrawal of enough
stockholders to leave less than a quorum.
SECTION 6. Voting and Proxies.
Stockholders shall have one vote for each share of stock entitled to vote owned by them of record according to the stock ledger
of the Corporation as of the record date, unless otherwise provided by law or by the Certificate. Stockholders may vote either
(i) in person, (ii) by written proxy or (iii) by a transmission permitted by Section 212(c) of the DGCL. Any copy, facsimile
telecommunication or other reliable reproduction of the writing or transmission permitted by Section 212(c) of the DGCL may be
substituted for or used in lieu of the original writing or transmission for any and all purposes for which the original writing
or transmission could be used, provided that such copy, facsimile telecommunication or other reproduction shall be a complete reproduction
of the entire original writing or transmission. Proxies shall be filed in accordance with the procedures established for the meeting
of stockholders. Except as otherwise limited therein or as otherwise provided by law, proxies authorizing a person to vote at a
specific meeting shall entitle the persons authorized thereby to vote at any adjournment of such meeting, but they shall not be
valid after final adjournment of such meeting. A proxy with respect to stock held in the name of two or more persons shall be valid
if executed by or on behalf of any one of them unless at or prior to the exercise of the proxy the Corporation receives a specific
written notice to the contrary from any one of them.
SECTION 7. Action at Meeting.
When a quorum is present at any meeting of stockholders, any matter before any such meeting (other than an election of a director
or directors) shall be decided by a majority of the votes properly cast for and against such matter, except where a larger vote
is required by law, by the Certificate or by these By-laws. Any election of directors by stockholders shall be determined by a
plurality of the votes properly cast on the election of directors.
SECTION 8. Stockholder Lists.
The Secretary or an Assistant Secretary (or the Corporation’s transfer agent or other person authorized by these By-laws
or by law) shall prepare and make, at least ten (10) days before every Annual Meeting or special meeting of stockholders, a complete
list of the stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the address of each stockholder
and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder,
for a period of at least ten (10) days prior to the meeting as provided in the manner, and subject to the terms, set forth in Section
219 of the DGCL (or any successor provision). The list shall also be open to the examination of any stockholder during the whole
time of the meeting as provided by law.
SECTION 9. Presiding Officer.
The Board of Directors shall designate a representative to preside over all Annual Meetings or special meetings of stockholders,
provided that if the Board of Directors does not so designate such a presiding officer, then the Chairman of the Board, if one
is elected, shall preside over such meetings. If the Board of Directors does not so designate such a presiding officer and there
is no Chairman of the Board or the Chairman of the Board is unable to so preside or is absent, then the Chief Executive Officer,
if one is elected, shall preside over such meetings, provided further that if there is no Chief Executive Officer or the Chief
Executive Officer is unable to so preside or is absent, then the President shall preside over such meetings. The presiding officer
at any Annual Meeting or special meeting of stockholders shall have the power, among other things, to adjourn such meeting at any
time and from time to time, subject to Sections 4 and 5 of this Article I. The order of business and all other matters
of procedure at any meeting of the stockholders shall be determined by the presiding officer.
SECTION 10. Inspectors of Elections.
The Corporation shall, in advance of any meeting of stockholders, appoint one or more inspectors to act at the meeting and make
a written report thereof. The Corporation may designate one or more persons as alternate inspectors to replace any inspector who
fails to act. If no inspector or alternate is able to act at a meeting of stockholders, the presiding officer shall appoint one
or more inspectors to act at the meeting. Any inspector may, but need not, be an officer, employee or agent of the Corporation.
Each inspector, before entering upon the discharge of his or her duties, shall take and sign an oath faithfully to execute the
duties of inspector with strict impartiality and according to the best of his or her ability. The inspectors shall perform such
duties as are required by the DGCL, including the counting of all votes and ballots. The inspectors may appoint or retain other
persons or entities to assist the inspectors in the performance of the duties of the inspectors. The presiding officer may review
all determinations made by the inspectors, and in so doing the presiding officer shall be entitled to exercise his or her sole
judgment and discretion and he or she shall not be bound by any determinations made by the inspectors. All determinations by the
inspectors and, if applicable, the presiding officer, shall be subject to further review by any court of competent jurisdiction.
ARTICLE II
Directors
SECTION 1. Powers. The business
and affairs of the Corporation shall be managed by or under the direction of the Board of Directors except as otherwise provided
by the Certificate or required by law.
SECTION 2. Number and Terms. The
number of directors of the Corporation shall be fixed solely and exclusively by resolution duly adopted from time to time by the
Board of Directors. The directors shall hold office in the manner provided in the Certificate.
SECTION 3. Qualification. No director
need be a stockholder of the Corporation.
SECTION 4. Vacancies. Vacancies
in the Board of Directors shall be filled in the manner provided in the Certificate.
SECTION 5. Removal. Directors
may be removed from office only in the manner provided in the Certificate.
SECTION 6. Resignation. A director
may resign at any time by electronic transmission or by giving written notice to the Chairman of the Board, if one is elected,
the President or the Secretary. A resignation shall be effective upon receipt, unless the resignation otherwise provides.
SECTION 7. Regular Meetings. The
regular annual meeting of the Board of Directors shall be held, without notice other than this Section 7, on the same date and
at the same place as the Annual Meeting following the close of such meeting of stockholders. Other regular meetings of the Board
of Directors may be held at such hour, date and place as the Board of Directors may by resolution from time to time determine and
publicize by means of reasonable notice given to any director who is not present at the meeting at which such resolution is adopted.
SECTION 8. Special Meetings. Special
meetings of the Board of Directors may be called, orally or in writing, by or at the request of a majority of the directors, the
Chairman of the Board, if one is elected, or the President. The person calling any such special meeting of the Board of Directors
may fix the hour, date and place thereof.
SECTION 9. Notice of Meetings.
Notice of the hour, date and place of all special meetings of the Board of Directors shall be given to each director by the Secretary
or an Assistant Secretary, or in case of the death, absence, incapacity or refusal of such persons, by the Chairman of the Board,
if one is elected, or the President or such other officer designated by the Chairman of the Board, if one is elected, or the President.
Notice of any special meeting of the Board of Directors shall be given to each director in person, by telephone, or by facsimile,
electronic mail or other form of electronic communication, sent to his or her business or home address, at least twenty-four (24)
hours in advance of the meeting, or by written notice mailed to his or her business or home address, at least forty-eight (48)
hours in advance of the meeting. Such notice shall be deemed to be delivered when hand-delivered to such address, read to such
director by telephone, deposited in the mail so addressed, with postage thereon prepaid if mailed, dispatched or transmitted if
sent by facsimile transmission or by electronic mail or other form of electronic communications. A written waiver of notice signed
or electronically transmitted before or after a meeting by a director and filed with the records of the meeting shall be deemed
to be equivalent to notice of the meeting. The attendance of a director at a meeting shall constitute a waiver of notice of such
meeting, except where a director attends a meeting for the express purpose of objecting at the beginning of the meeting to the
transaction of any business because such meeting is not lawfully called or convened. Except as otherwise required by law, by the
Certificate or by these By-laws, neither the business to be transacted at, nor the purpose of, any meeting of the Board of Directors
need be specified in the notice or waiver of notice of such meeting.
SECTION 10. Quorum. At any meeting
of the Board of Directors, a majority of the total number of directors shall constitute a quorum for the transaction of business,
but if less than a quorum is present at a meeting, a majority of the directors present may adjourn the meeting from time to time,
and the meeting may be held as adjourned without further notice. Any business which might have been transacted at the meeting as
originally noticed may be transacted at such adjourned meeting at which a quorum is present. For purposes of this section, the
total number of directors includes any unfilled vacancies on the Board of Directors.
SECTION 11. Action at Meeting.
At any meeting of the Board of Directors at which a quorum is present, the vote of a majority of the directors present shall constitute
action by the Board of Directors, unless otherwise required by law, by the Certificate or by these By-laws.
SECTION 12. Action by Consent.
Any action required or permitted to be taken at any meeting of the Board of Directors may be taken without a meeting if all members
of the Board of Directors consent thereto in writing or by electronic transmission and the writing or writings or electronic transmission
or transmissions are filed with the records of the meetings of the Board of Directors. Such filing shall be in paper form if the
minutes are maintained in paper form and shall be in electronic form if the minutes are maintained in electronic form. Such consent
shall be treated as a resolution of the Board of Directors for all purposes.
SECTION 13. Manner of Participation.
Directors may participate in meetings of the Board of Directors by means of conference telephone or other communications equipment
by means of which all directors participating in the meeting can hear each other, and participation in a meeting in accordance
herewith shall constitute presence in person at such meeting for purposes of these By-laws.
SECTION 14. Presiding Director.
The Board of Directors shall designate a representative to preside over all meetings of the Board of Directors, provided that if
the Board of Directors does not so designate such a presiding director or such designated presiding director is unable to so preside
or is absent, then the Chairman of the Board, if one is elected, shall preside over all meetings of the Board of Directors. If
both the designated presiding director, if one is so designated, and the Chairman of the Board, if one is elected, are unable to
preside or are absent, the Board of Directors shall designate an alternate representative to preside over a meeting of the Board
of Directors.
SECTION 15. Committees. The Board
of Directors, by vote of a majority of the directors then in office, may elect one or more committees, including, without limitation,
a Compensation Committee, a Nominating & Corporate Governance Committee and an Audit Committee, and may delegate thereto some
or all of its powers except those which by law, by the Certificate or by these By-laws may not be delegated. Except as the Board
of Directors may otherwise determine, any such committee may make rules for the conduct of its business, but unless otherwise provided
by the Board of Directors or in such rules, its business shall be conducted so far as possible in the same manner as is provided
by these By-laws for the Board of Directors. All members of such committees shall hold such offices at the pleasure of the Board
of Directors. The Board of Directors may abolish any such committee at any time. Any committee to which the Board of Directors
delegates any of its powers or duties shall keep records of its meetings and shall report its action to the Board of Directors.
SECTION 16. Compensation of Directors.
Directors shall receive such compensation for their services as shall be determined by a majority of the Board of Directors, or
a designated committee thereof, provided that directors who are serving the Corporation as employees and who receive compensation
for their services as such, shall not receive any salary or other compensation for their services as directors of the Corporation.
ARTICLE III
Officers
SECTION 1. Enumeration. The officers
of the Corporation shall consist of a President, a Treasurer, a Secretary and such other officers, including, without limitation,
a Chairman of the Board of Directors, a Chief Executive Officer and one or more Vice Presidents (including Executive Vice Presidents
or Senior Vice Presidents), Assistant Vice Presidents, Assistant Treasurers and Assistant Secretaries, as the Board of Directors
may determine.
SECTION 2. Election. At the regular
annual meeting of the Board of Directors following the Annual Meeting, the Board of Directors shall elect the President, the Treasurer
and the Secretary. Other officers may be elected by the Board of Directors at such regular annual meeting of the Board of Directors
or at any other regular or special meeting.
SECTION 3. Qualification. No officer
need be a stockholder or a director. Any person may occupy more than one office of the Corporation at any time.
SECTION 4. Tenure. Except as otherwise
provided by the Certificate or by these By-laws, each of the officers of the Corporation shall hold office until the regular annual
meeting of the Board of Directors following the next Annual Meeting and until his or her successor is elected and qualified or
until his or her earlier resignation or removal.
SECTION 5. Resignation. Any officer
may resign by delivering his or her written or electronically transmitted resignation to the Corporation addressed to the President
or the Secretary, and such resignation shall be effective upon receipt, unless the resignation otherwise provides.
SECTION 6. Removal. Except as
otherwise provided by law or by resolution of the Board of Directors, the Board of Directors may remove any officer with or without
cause by the affirmative vote of a majority of the directors then in office.
SECTION 7. Absence or Disability.
In the event of the absence or disability of any officer, the Board of Directors may designate another officer to act temporarily
in place of such absent or disabled officer.
SECTION 8. Vacancies. Any vacancy
in any office may be filled for the unexpired portion of the term by the Board of Directors.
SECTION 9. President. The President
shall, subject to the direction of the Board of Directors, have such powers and shall perform such duties as the Board of Directors
may from time to time designate.
SECTION 10. Chairman of the Board.
The Chairman of the Board, if one is elected, shall have such powers and shall perform such duties as the Board of Directors may
from time to time designate.
SECTION 11. Chief Executive Officer.
The Chief Executive Officer, if one is elected, shall have such powers and shall perform such duties as the Board of Directors
may from time to time designate.
SECTION 12. Vice Presidents and Assistant
Vice Presidents. Any Vice President (including any Executive Vice President or Senior Vice President) and any Assistant Vice
President shall have such powers and shall perform such duties as the Board of Directors or the Chief Executive Officer may from
time to time designate.
SECTION 13. Treasurer and Assistant
Treasurers. The Treasurer shall, subject to the direction of the Board of Directors and except as the Board of Directors or
the Chief Executive Officer may otherwise provide, have general charge of the financial affairs of the Corporation and shall cause
to be kept accurate books of account. The Treasurer shall have custody of all funds, securities, and valuable documents of the
Corporation. He or she shall have such other duties and powers as may be designated from time to time by the Board of Directors
or the Chief Executive Officer. Any Assistant Treasurer shall have such powers and perform such duties as the Board of Directors
or the Chief Executive Officer may from time to time designate.
SECTION 14. Secretary and Assistant
Secretaries. The Secretary shall record all the proceedings of the meetings of the stockholders and the Board of Directors
(including committees of the Board of Directors) in books kept for that purpose. In his or her absence from any such meeting, a
temporary secretary chosen at the meeting shall record the proceedings thereof. The Secretary shall have charge of the stock ledger
(which may, however, be kept by any transfer or other agent of the Corporation). The Secretary shall have custody of the seal of
the Corporation, and the Secretary, or an Assistant Secretary shall have authority to affix it to any instrument requiring it,
and, when so affixed, the seal may be attested by his or her signature or that of an Assistant Secretary. The Secretary shall have
such other duties and powers as may be designated from time to time by the Board of Directors or the Chief Executive Officer. In
the absence of the Secretary, any Assistant Secretary may perform his or her duties and responsibilities. Any Assistant Secretary
shall have such powers and perform such duties as the Board of Directors or the Chief Executive Officer may from time to time designate.
SECTION 15. Other Powers and Duties.
Subject to these By-laws and to such limitations as the Board of Directors may from time to time prescribe, the officers of the
Corporation shall each have such powers and duties as generally pertain to their respective offices, as well as such powers and
duties as from time to time may be conferred by the Board of Directors or the Chief Executive Officer.
ARTICLE IV
Capital Stock
SECTION 1. Certificates
of Stock. Each stockholder shall be entitled to a certificate of the capital stock of the Corporation in such form as may
from time to time be prescribed by the Board of Directors. Such certificate shall be signed by any two authorized officers of
the Corporation. The Corporation seal and the signatures by the Corporation’s officers, the transfer agent or the registrar
may be facsimiles. In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed
on such certificate shall have ceased to be such officer, transfer agent or registrar before such certificate is issued, it may
be issued by the Corporation with the same effect as if he or she were such officer, transfer agent or registrar at the time of
its issue. Every certificate for shares of stock which are subject to any restriction on transfer and every certificate issued
when the Corporation is authorized to issue more than one class or series of stock shall contain such legend with respect thereto
as is required by law. Notwithstanding anything to the contrary provided in these Bylaws, the Board of Directors of the Corporation
may provide by resolution or resolutions that some or all of any or all classes or series of its stock shall be uncertificated
shares (except that the foregoing shall not apply to shares represented by a certificate until such certificate is surrendered
to the Corporation), and by the approval and adoption of these Bylaws the Board of Directors has determined that all classes or
series of the Corporation’s stock may be uncertificated, whether upon original issuance, re-issuance, or subsequent transfer.
SECTION 2. Transfers. Subject
to any restrictions on transfer and unless otherwise provided by the Board of Directors, shares of stock that are represented by
a certificate may be transferred on the books of the Corporation by the surrender to the Corporation or its transfer agent of the
certificate theretofore properly endorsed or accompanied by a written assignment or power of attorney properly executed, with transfer
stamps (if necessary) affixed, and with such proof of the authenticity of signature as the Corporation or its transfer agent may
reasonably require. Shares of stock that are not represented by a certificate may be transferred on the books of the Corporation
by submitting to the Corporation or its transfer agent such evidence of transfer and following such other procedures as the Corporation
or its transfer agent may require.
SECTION 3. Record Holders. Except
as may otherwise be required by law, by the Certificate or by these By-laws, the Corporation shall be entitled to treat the record
holder of stock as shown on its books as the owner of such stock for all purposes, including the payment of dividends and the right
to vote with respect thereto, regardless of any transfer, pledge or other disposition of such stock, until the shares have been
transferred on the books of the Corporation in accordance with the requirements of these By-laws.
SECTION 4. Record Date. In order
that the Corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment
thereof or entitled to receive payment of any dividend or other distribution or allotment of any rights, or entitled to exercise
any rights in respect of any change, conversion or exchange of stock or for the purpose of any other lawful action, the Board of
Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date
is adopted by the Board of Directors, and which record date: (a) in the case of determination of stockholders entitled to vote
at any meeting of stockholders, shall, unless otherwise required by law, not be more than sixty (60) nor less than ten (10) days
before the date of such meeting and (b) in the case of any other action, shall not be more than sixty (60) days prior to such other
action. If no record date is fixed: (i) the record date for determining stockholders entitled to notice of or to vote at a meeting
of stockholders shall be at the close of business on the day next preceding the day on which notice is given, or, if notice is
waived, at the close of business on the day next preceding the day on which the meeting is held; and (ii) the record date for determining
stockholders for any other purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution
relating thereto.
SECTION 5. Replacement of Certificates.
In case of the alleged loss, destruction or mutilation of a certificate of stock of the Corporation, a duplicate certificate may
be issued in place thereof, upon such terms as the Board of Directors may prescribe.
ARTICLE V
Indemnification
SECTION 1. Definitions. For purposes
of this Article:
(a) “Corporate
Status” describes the status of a person who is serving or has served (i) as a Director of the Corporation, (ii) as an Officer
of the Corporation, (iii) as a Non-Officer Employee of the Corporation, or (iv) as a director, partner, trustee, officer, employee
or agent of any other corporation, partnership, limited liability company, joint venture, trust, employee benefit plan, foundation,
association, organization or other legal entity which such person is or was serving at the request of the Corporation. For purposes
of this Section 1(a), a Director, Officer or Non-Officer Employee of the Corporation who is serving or has served as a director,
partner, trustee, officer, employee or agent of a Subsidiary shall be deemed to be serving at the request of the Corporation. Notwithstanding
the foregoing, “Corporate Status” shall not include the status of a person who is serving or has served as a director,
officer, employee or agent of a constituent corporation absorbed in a merger or consolidation transaction with the Corporation
with respect to such person’s activities prior to said transaction, unless specifically authorized by the Board of Directors
or the stockholders of the Corporation;
(b) “Director”
means any person who serves or has served the Corporation as a director on the Board of Directors of the Corporation;
(c)
“Disinterested Director” means, with respect to each Proceeding in respect of which indemnification is sought hereunder,
a Director of the Corporation who is not and was not a party to such Proceeding;
(d) “Expenses”
means all attorneys’ fees, retainers, court costs, transcript costs, fees of expert witnesses, private investigators and
professional advisors (including, without limitation, accountants and investment bankers), travel expenses, duplicating costs,
printing and binding costs, costs of preparation of demonstrative evidence and other courtroom presentation aids and devices, costs
incurred in connection with document review, organization, imaging and computerization, telephone charges, postage, delivery service
fees, and all other disbursements, costs or expenses of the type customarily incurred in connection with prosecuting, defending,
preparing to prosecute or defend, investigating, being or preparing to be a witness in, settling or otherwise participating in,
a Proceeding;
(e) “Liabilities”
means judgments, damages, liabilities, losses, penalties, excise taxes, fines and amounts paid in settlement;
(f) “Non-Officer
Employee” means any person who serves or has served as an employee or agent of the Corporation, but who is not or was not
a Director or Officer;
(g) “Officer”
means any person who serves or has served the Corporation as an officer of the Corporation appointed by the Board of Directors
of the Corporation;
(h) “Proceeding”
means any threatened, pending or completed action, suit, arbitration, alternate dispute resolution mechanism, inquiry, investigation,
administrative hearing or other proceeding, whether civil, criminal, administrative, arbitrative or investigative; and
(i) “Subsidiary”
shall mean any corporation, partnership, limited liability company, joint venture, trust or other entity of which the Corporation
owns (either directly or through or together with another Subsidiary of the Corporation) either (i) a general partner, managing
member or other similar interest or (ii) (A) fifty percent (50%) or more of the voting power of the voting capital equity interests
of such corporation, partnership, limited liability company, joint venture or other entity, or (B) fifty percent (50%) or more
of the outstanding voting capital stock or other voting equity interests of such corporation, partnership, limited liability company,
joint venture or other entity.
SECTION 2. Indemnification
of Directors and Officers.
(a) Subject
to the operation of Section 4 of this Article V of these By-laws, each Director and Officer shall be indemnified and held harmless
by the Corporation to the fullest extent authorized by the DGCL, as the same exists or may hereafter be amended (but, in the case
of any such amendment, only to the extent that such amendment permits the Corporation to provide broader indemnification rights
than such law permitted the Corporation to provide prior to such amendment), and to the extent authorized in this Section 2.
(1) Actions,
Suits and Proceedings Other than By or In the Right of the Corporation. Each Director and Officer shall be indemnified and
held harmless by the Corporation against any and all Expenses and Liabilities that are incurred or paid by such Director or Officer
or on such Director’s or Officer’s behalf in connection with any Proceeding or any claim, issue or matter therein (other
than an action by or in the right of the Corporation), which such Director or Officer is, or is threatened to be made, a party
to or participant in by reason of such Director’s or Officer’s Corporate Status, if such Director or Officer acted
in good faith and in a manner such Director or Officer reasonably believed to be in or not opposed to the best interests of the
Corporation and, with respect to any criminal proceeding, had no reasonable cause to believe his or her conduct was unlawful.
(2) Actions,
Suits and Proceedings By or In the Right of the Corporation. Each Director and Officer shall be indemnified and held harmless
by the Corporation against any and all Expenses that are incurred by such Director or Officer or on such Director’s or Officer’s
behalf in connection with any Proceeding or any claim, issue or matter therein by or in the right of the Corporation, which such
Director or Officer is, or is threatened to be made, a party to or participant in by reason of such Director’s or Officer’s
Corporate Status, if such Director or Officer acted in good faith and in a manner such Director or Officer reasonably believed
to be in or not opposed to the best interests of the Corporation; provided, however, that no indemnification shall be made under
this Section 2(a)(2) in respect of any claim, issue or matter as to which such Director or Officer shall have been finally adjudged
by a court of competent jurisdiction to be liable to the Corporation, unless, and only to the extent that, the Court of Chancery
or another court in which such Proceeding was brought shall determine upon application that, despite adjudication of liability,
but in view of all the circumstances of the case, such Director or Officer is fairly and reasonably entitled to indemnification
for such Expenses that such court deems proper.
(3) Survival
of Rights. The rights of indemnification provided by this Section 2 shall continue as to a Director or Officer after he or
she has ceased to be a Director or Officer and shall inure to the benefit of his or her heirs, executors, administrators and personal
representatives.
(4) Actions
by Directors or Officers. Notwithstanding the foregoing, the Corporation shall indemnify any Director or Officer seeking indemnification
in connection with a Proceeding initiated by such Director or Officer only if such Proceeding (including any parts of such Proceeding
not initiated by such Director or Officer) was authorized in advance by the Board of Directors of the Corporation, unless such
Proceeding was brought to enforce such Officer’s or Director’s rights to indemnification or, in the case of Directors,
advancement of Expenses under these By-laws in accordance with the provisions set forth herein.
SECTION 3. Indemnification of Non-Officer
Employees. Subject to the operation of Section 4 of this Article V of these By-laws, each Non-Officer Employee may, in the
discretion of the Board of Directors of the Corporation, be indemnified by the Corporation to the fullest extent authorized by
the DGCL, as the same exists or may hereafter be amended, against any or all Expenses and Liabilities that are incurred by such
Non-Officer Employee or on such Non-Officer Employee’s behalf in connection with any threatened, pending or completed Proceeding,
or any claim, issue or matter therein, which such Non-Officer Employee is, or is threatened to be made, a party to or participant
in by reason of such Non-Officer Employee’s Corporate Status, if such Non-Officer Employee acted in good faith and in a manner
such Non-Officer Employee reasonably believed to be in or not opposed to the best interests of the Corporation and, with respect
to any criminal proceeding, had no reasonable cause to believe his or her conduct was unlawful. The rights of indemnification provided
by this Section 3 shall exist as to a Non-Officer Employee after he or she has ceased to be a Non-Officer Employee and shall inure
to the benefit of his or her heirs, personal representatives, executors and administrators. Notwithstanding the foregoing, the
Corporation may indemnify any Non-Officer Employee seeking indemnification in connection with a Proceeding initiated by such Non-Officer
Employee only if such Proceeding was authorized in advance by the Board of Directors of the Corporation.
SECTION 4. Determination. Unless
ordered by a court, no indemnification shall be provided pursuant to this Article V to a Director, to an Officer or to a Non-Officer
Employee unless a determination shall have been made that such person acted in good faith and in a manner such person reasonably
believed to be in or not opposed to the best interests of the Corporation and, with respect to any criminal Proceeding, such person
had no reasonable cause to believe his or her conduct was unlawful. Such determination shall be made by (a) a majority vote
of the Disinterested Directors, even though less than a quorum of the Board of Directors, (b) a committee comprised of Disinterested
Directors, such committee having been designated by a majority vote of the Disinterested Directors (even though less than a quorum),
(c) if there are no such Disinterested Directors, or if a majority of Disinterested Directors so directs, by independent legal
counsel in a written opinion, or (d) by the stockholders of the Corporation.
SECTION 5. Advancement
of Expenses to Directors Prior to Final Disposition.
(a) The
Corporation shall advance all Expenses incurred by or on behalf of any Director in connection with any Proceeding in which such
Director is involved by reason of such Director’s Corporate Status within thirty (30) days after the receipt by the Corporation
of a written statement from such Director requesting such advance or advances from time to time, whether prior to or after final
disposition of such Proceeding. Such statement or statements shall reasonably evidence the Expenses incurred by such Director and
shall be preceded or accompanied by an undertaking by or on behalf of such Director to repay any Expenses so advanced if it shall
ultimately be determined that such Director is not entitled to be indemnified against such Expenses. Notwithstanding the foregoing,
the Corporation shall advance all Expenses incurred by or on behalf of any Director seeking advancement of expenses hereunder in
connection with a Proceeding initiated by such Director only if such Proceeding (including any parts of such Proceeding not initiated
by such Director) was (i) authorized by the Board of Directors of the Corporation, or (ii) brought to enforce such Director’s
rights to indemnification or advancement of Expenses under these By-laws.
(b) If
a claim for advancement of Expenses hereunder by a Director is not paid in full by the Corporation within thirty (30) days after
receipt by the Corporation of documentation of Expenses and the required undertaking, such Director may at any time thereafter
bring suit against the Corporation to recover the unpaid amount of the claim and if successful in whole or in part, such Director
shall also be entitled to be paid the expenses of prosecuting such claim. The failure of the Corporation (including its Board of
Directors or any committee thereof, independent legal counsel, or stockholders) to make a determination concerning the permissibility
of such advancement of Expenses under this Article V shall not be a defense to an action brought by a Director for recovery of
the unpaid amount of an advancement claim and shall not create a presumption that such advancement is not permissible. The burden
of proving that a Director is not entitled to an advancement of expenses shall be on the Corporation.
(c) In
any suit brought by the Corporation to recover an advancement of expenses pursuant to the terms of an undertaking, the Corporation
shall be entitled to recover such expenses upon a final adjudication that the Director has not met any applicable standard for
indemnification set forth in the DGCL.
SECTION 6. Advancement
of Expenses to Officers and Non-Officer Employees Prior to Final Disposition.
(a) The
Corporation may, at the discretion of the Board of Directors of the Corporation, advance any or all Expenses incurred by or on
behalf of any Officer or any Non-Officer Employee in connection with any Proceeding in which such person is involved by reason
of his or her Corporate Status as an Officer or Non-Officer Employee upon the receipt by the Corporation of a statement or statements
from such Officer or Non-Officer Employee requesting such advance or advances from time to time, whether prior to or after final
disposition of such Proceeding. Such statement or statements shall reasonably evidence the Expenses incurred by such Officer or
Non-Officer Employee and shall be preceded or accompanied by an undertaking by or on behalf of such person to repay any Expenses
so advanced if it shall ultimately be determined that such Officer or Non-Officer Employee is not entitled to be indemnified against
such Expenses.
(b) In
any suit brought by the Corporation to recover an advancement of expenses pursuant to the terms of an undertaking, the Corporation
shall be entitled to recover such expenses upon a final adjudication that the Officer or Non-Officer Employee has not met any applicable
standard for indemnification set forth in the DGCL.
SECTION 7. Contractual
Nature of Rights.
(a) The
provisions of this Article V shall be deemed to be a contract between the Corporation and each Director and Officer entitled
to the benefits hereof at any time while this Article V is in effect, in consideration of such person’s past or current
and any future performance of services for the Corporation. Neither amendment, repeal or modification of any provision of this
Article V nor the adoption of any provision of the Certificate of Incorporation inconsistent with this Article V shall
eliminate or reduce any right conferred by this Article V in respect of any act or omission occurring, or any cause of action
or claim that accrues or arises or any state of facts existing, at the time of or before such amendment, repeal, modification or
adoption of an inconsistent provision (even in the case of a proceeding based on such a state of facts that is commenced after
such time), and all rights to indemnification and advancement of Expenses granted herein or arising out of any act or omission
shall vest at the time of the act or omission in question, regardless of when or if any proceeding with respect to such act or
omission is commenced. The rights to indemnification and to advancement of expenses provided by, or granted pursuant to, this Article V
shall continue notwithstanding that the person has ceased to be a director or officer of the Corporation and shall inure to the
benefit of the estate, heirs, executors, administrators, legatees and distributes of such person.
(b) If
a claim for indemnification hereunder by a Director or Officer is not paid in full by the Corporation within sixty (60) days after
receipt by the Corporation of a written claim for indemnification, such Director or Officer may at any time thereafter bring suit
against the Corporation to recover the unpaid amount of the claim, and if successful in whole or in part, such Director or Officer
shall also be entitled to be paid the expenses of prosecuting such claim. The failure of the Corporation (including its Board of
Directors or any committee thereof, independent legal counsel, or stockholders) to make a determination concerning the permissibility
of such indemnification under this Article V shall not be a defense to an action brought by a Director or Officer for recovery
of the unpaid amount of an indemnification claim and shall not create a presumption that such indemnification is not permissible.
The burden of proving that a Director or Officer is not entitled to indemnification shall be on the Corporation.
(c) In
any suit brought by a Director or Officer to enforce a right to indemnification hereunder, it shall be a defense that such Director
or Officer has not met any applicable standard for indemnification set forth in the DGCL.
SECTION 8. Non-Exclusivity of Rights.
The rights to indemnification and to advancement of Expenses set forth in this Article V shall not be exclusive of any other right
which any Director, Officer, or Non-Officer Employee may have or hereafter acquire under any statute, provision of the Certificate
or these By-laws, agreement, vote of stockholders or Disinterested Directors or otherwise.
SECTION 9. Insurance. The Corporation
may maintain insurance, at its expense, to protect itself and any Director, Officer or Non-Officer Employee against any liability
of any character asserted against or incurred by the Corporation or any such Director, Officer or Non-Officer Employee, or arising
out of any such person’s Corporate Status, whether or not the Corporation would have the power to indemnify such person against
such liability under the DGCL or the provisions of this Article V.
SECTION 10. Other Indemnification.
The Corporation’s obligation, if any, to indemnify or provide advancement of Expenses to any person under this Article V
as a result of such person serving, at the request of the Corporation, as a director, partner, trustee, officer, employee or agent
of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise shall be reduced by any amount
such person may collect as indemnification or advancement of Expenses from such other corporation, partnership, joint venture,
trust, employee benefit plan or enterprise (the “Primary Indemnitor”). Any indemnification or advancement of Expenses
under this Article V owed by the Corporation as a result of a person serving, at the request of the Corporation, as a director,
partner, trustee, officer, employee or agent of another corporation, partnership, joint venture, trust, employee benefit plan or
other enterprise shall only be in excess of, and shall be secondary to, the indemnification or advancement of Expenses available
from the applicable Primary Indemnitor(s) and any applicable insurance policies.
ARTICLE VI
Miscellaneous Provisions
SECTION 1. Fiscal Year. The fiscal
year of the Corporation shall be determined by the Board of Directors.
SECTION 2. Seal. The Board of
Directors shall have power to adopt and alter the seal of the Corporation.
SECTION 3. Execution of Instruments.
All deeds, leases, transfers, contracts, bonds, notes and other obligations to be entered into by the Corporation in the ordinary
course of its business without director action may be executed on behalf of the Corporation by the Chairman of the Board, if one
is elected, the President or the Treasurer or any other officer, employee or agent of the Corporation as the Board of Directors
or the executive committee of the Board may authorize.
SECTION 4. Voting of Securities.
Unless the Board of Directors otherwise provides, the Chairman of the Board, if one is elected, the President or the Treasurer
may waive notice of and act on behalf of the Corporation (including with regard to voting and actions by written consent), or appoint
another person or persons to act as proxy or attorney in fact for the Corporation with or without discretionary power and/or power
of substitution, at any meeting of stockholders or shareholders of any other corporation or organization, any of whose securities
are held by the Corporation.
SECTION 5. Resident Agent. The
Board of Directors may appoint a resident agent upon whom legal process may be served in any action or proceeding against the Corporation.
SECTION 6. Corporate Records.
The original or attested copies of the Certificate, By-laws and records of all meetings of the incorporators, stockholders and
the Board of Directors and the stock transfer books, which shall contain the names of all stockholders, their record addresses
and the amount of stock held by each, may be kept outside the State of Delaware and shall be kept at the principal office of the
Corporation, at an office of its counsel, at an office of its transfer agent or at such other place or places as may be designated
from time to time by the Board of Directors.
SECTION 7. Certificate. All references
in these By-laws to the Certificate shall be deemed to refer to the Amended and Restated Certificate of Incorporation of the Corporation,
as amended and/or restated and in effect from time to time.
SECTION 8. Exclusive Jurisdiction.
Unless the Corporation consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware
shall be the sole and exclusive forum for state law claims for (i) any derivative action or proceeding brought on behalf of the
Corporation, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of
the Corporation to the Corporation or the Corporation’s stockholders, (iii) any action asserting a claim arising pursuant
to any provision of the Delaware General Corporation Law or the Certificate or By-laws, (iv) any action to interpret, apply, enforce
or determine the validity of the Certificate or By-laws, or (v) any action asserting a claim against the Corporation governed by
the internal affairs doctrine. The provisions of this Section 8 shall not apply to any claims arising under the Exchange Act or
the Securities Act of 1933, as amended. Any person or entity purchasing or otherwise acquiring any interest in shares of capital
stock of the Corporation shall be deemed to have notice of and consented to the provisions of this Section 8.
SECTION 9. Amendment
of By-laws.
(a) Amendment
by Directors. Except as provided otherwise by law, any section or portion of these By-laws may be amended or repealed by the
Board of Directors by the affirmative vote of a majority of the directors then in office.
(b) Amendment
by Stockholders. Except as otherwise required by these By-laws or by law, these By-laws may be amended or repealed at any Annual
Meeting, or special meeting of stockholders called for such purpose in accordance with these By-Laws, by the affirmative vote of
a majority of the outstanding shares entitled to vote on such amendment or repeal, voting together as a single class. Notwithstanding
the foregoing, stockholder approval shall not be required unless mandated by the Certificate, these By-laws, or other applicable
law.
SECTION 10. Notices. If mailed,
notice to stockholders shall be deemed given when deposited in the mail, postage prepaid, directed to the stockholder at such stockholder’s
address as it appears on the records of the Corporation. Without limiting the manner by which notice otherwise may be given to
stockholders, any notice to stockholders may be given by electronic transmission in the manner provided in Section 232 of the DGCL.
SECTION 11. Waivers. A written
waiver of any notice, signed by a stockholder or director, or waiver by electronic transmission by such person, whether given before
or after the time of the event for which notice is to be given, shall be deemed equivalent to the notice required to be given to
such person. Neither the business to be transacted at, nor the purpose of, any meeting need be specified in such a waiver.
SECTION 12. Mission Statement.
The Corporation is a biotechnology company that was founded with the mission of turning promising science into useful medicines.
The Corporation aspires to re-prioritize stagnated drugs, pursue new combination therapy approaches, and search for promising science
to advance for unserved and underserved patients who are waiting. The Corporation aspires to work closely with its partners, and
the Corporation believes it is strengthened by shared-value partnerships with patient groups and innovators in industry and academia.
Adopted August 29, 2019, subject to and effective upon the effectiveness
of the Corporation’s Registration Statement on Form S-1 for its initial public offering.
Exhibit 4.2
EXECUTION VERSION
AMENDED AND RESTATED
INVESTORS’ RIGHTS AGREEMENT
TABLE OF CONTENTS
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Page |
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1. |
Definitions |
1 |
|
|
|
|
2. |
Registration Rights |
6 |
|
2.1 |
Demand Registration |
6 |
|
2.2 |
Company Registration |
7 |
|
2.3 |
Underwriting Requirements |
8 |
|
2.4 |
Obligations of the Company |
9 |
|
2.5 |
Furnish Information |
11 |
|
2.6 |
Expenses of Registration |
11 |
|
2.7 |
Delay of Registration |
12 |
|
2.8 |
Indemnification |
12 |
|
2.9 |
Reports Under Exchange Act |
14 |
|
2.10 |
Limitations on Subsequent Registration Rights |
15 |
|
2.11 |
“Market Stand-off” Agreement |
15 |
|
2.12 |
Restrictions on Transfer |
16 |
|
2.13 |
Termination of Registration Rights |
17 |
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|
|
|
3. |
Information Rights |
17 |
|
3.1 |
Delivery of Financial Statements |
17 |
|
3.2 |
Inspection |
19 |
|
3.3 |
Termination of Information Rights |
19 |
|
3.4 |
Confidentiality |
20 |
|
|
|
|
4. |
Rights to Future Stock Issuances |
20 |
|
4.1 |
Right of First Offer |
20 |
|
4.2 |
Termination |
22 |
|
4.3 |
Right of First Negotiation |
22 |
|
|
|
|
5. |
Additional Covenants |
22 |
|
5.1 |
Insurance |
22 |
|
5.2 |
Employee Agreements |
22 |
|
5.3 |
Employee Stock |
23 |
|
5.4 |
Matters Requiring Investor Director Approval |
23 |
|
5.5 |
Additional Board Approval Matters: |
24 |
|
5.6 |
Board Matters |
24 |
|
5.7 |
Successor Indemnification |
25 |
|
5.8 |
Expenses of Counsel |
25 |
|
5.9 |
Indemnification Matters |
25 |
|
5.10 |
Right to Conduct Activities |
26 |
|
5.11 |
FCPA Compliance |
27 |
|
5.12 |
Termination of Covenants |
28 |
6. |
Miscellaneous |
28 |
|
6.1 |
Successors and Assigns |
28 |
|
6.2 |
Governing Law |
28 |
|
6.3 |
Counterparts |
29 |
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6.4 |
Titles and Subtitles |
29 |
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6.5 |
Notices |
29 |
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6.6 |
Amendments and Waivers |
30 |
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6.7 |
Severability |
30 |
|
6.8 |
Aggregation of Stock |
30 |
|
6.9 |
Additional Investors |
31 |
|
6.10 |
Entire Agreement |
31 |
|
6.11 |
Dispute Resolution |
31 |
|
6.12 |
Delays or Omissions |
32 |
Schedule A |
- |
Schedule of Investors |
AMENDED AND RESTATED INVESTORS’
RIGHTS AGREEMENT
THIS AMENDED AND RESTATED
INVESTORS’ RIGHTS AGREEMENT (this “Agreement”), is made as of the 30th day of August, 2019, by and among
SpringWorks Therapeutics, Inc., a Delaware corporation (the “Company”), and each of the investors listed on
Schedule A hereto, each of which is referred to in this Agreement as an “Investor”.
RECITALS
WHEREAS, the Company
and certain of the Investors are parties to that certain Investors’ Rights Agreement, dated as of March 29, 2019 (as may
be amended and/or restated from time to time, the “Prior Agreement”);
WHEREAS, pursuant
to Section 6.6 of the Prior Agreement, subject to certain exceptions, any term of the Prior Agreement may be amended with the written
consent of the Company and the holders of a majority of the Series A Preferred Stock and the Series B Preferred Stock then outstanding
voting together as a single class on an as-converted basis, (such holders, the “Requisite Parties”);
WHEREAS, the Company
and the undersigned Investors, representing the Requisite Parties, possess the authority required under the Prior Agreement, and
desire, to amend the Prior Agreement as set forth herein; and
WHEREAS, the Requisite
Parties have executed this Agreement, consenting to the amendment and restatement of the Prior Agreement hereby;
NOW, THEREFORE,
the parties agree as follows:
| 1. | Definitions. For purposes of this Agreement: |
1.1 “Affiliate”
means, with respect to any specified Person, any other Person who, directly or indirectly, controls, is controlled by, or is under
common control with such Person, including without limitation any general partner, managing member, officer or director of such
Person or any venture capital fund now or hereafter existing that is controlled by one or more general partners (or member thereof)
or managing members (or member thereof) of, or shares the same management company (or member thereof) with, such Person. For the
avoidance of doubt, “Affiliate” shall include, with respect to any Person that is a limited liability company, a limited
partnership or a registered investment company, an entity that is a nominee for a limited liability company, limited partnership,
or registered investment company, a fund or entity managed by the same manager or managing member or general partner or management
company, investment adviser or by an entity controlling, controlled by, or under common control with such manager or managing member,
general partner or management company or investment adviser.
1.2 “Bain”
means BCSW LP.
1.3 “Board
of Directors” means the board of directors of the Company.
1.4 “Boxer”
means Boxer Capital, LLC
1.5 “Certificate
of Incorporation” means the Company’s Amended and Restated Certificate of Incorporation, filed with the Secretary
of State of the State of Delaware on the date hereof (as amended and/or restated, from time to time).
1.6 “Citadel”
means Citdael Multi-Strategy Equities Master Fund Ltd.
1.7 “Common
Stock” means shares of the Company’s common stock, par value $0.0001 per share.
1.8 “Competitor”
means a Person engaged, directly or indirectly (including through any partnership, limited liability company, corporation, joint
venture or similar arrangement (whether now existing or formed hereafter)), in a business competitive with that of the Company’s,
but shall not include any financial investment firm or collective investment vehicle (including, without limitation, any private
equity fund, venture capital fund or similar vehicle and any Affiliates thereof) that, together with its Affiliates hold less than
20% of the outstanding equity of a Competitor and does not have a right to designate any members of the board of directors of any
Competitor. Notwithstanding anything to the contrary provided herein, in no event shall Bain, Boxer, Citadel, Fifth Avenue, HBM
Healthcare Investments (Cayman) Ltd., OrbiMed, Pfizer, Perceptive or any of their respective Affiliates be deemed to be a “Competitor”
of the Company.
1.9 “Damages”
means any loss, damage, claim or liability (joint or several) to which a party hereto may become subject under the Securities Act,
the Exchange Act, or other federal or state law, insofar as such loss, damage, claim or liability (or any action in respect thereof)
arises out of or is based upon: (i) any untrue statement or alleged untrue statement of a material fact contained in any registration
statement of the Company, including any preliminary prospectus or final prospectus contained therein or any amendments or supplements
thereto; (ii) an omission or alleged omission to state therein a material fact required to be stated therein, or necessary to make
the statements therein not misleading; or (iii) any violation or alleged violation by the indemnifying party (or any of its agents
or Affiliates) of the Securities Act, the Exchange Act, any state securities law, or any rule or regulation promulgated under the
Securities Act, the Exchange Act, or any state securities law.
1.10 “Debt
Financing” means a type of debt financing transaction undertaken for working capital purposes or to fund capital expenditures,
such as purchasing equipment or materials. A Debt Financing shall not include (i) any offering of the Company’s convertible
debt securities undertaken for any short-term bridge financing preceding a larger equity financing round to which such financing
is automatically convertible into; or (ii) any offering of the Company’s debt securities made in conjunction with the entrance
by the company into a strategic collaboration or license agreement.
1.11 “Derivative
Securities” means any securities or rights convertible into, or exercisable or exchangeable for (in each case, directly
or indirectly), Common Stock, including options and warrants.
1.12 “Exchange
Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
1.13 “Excluded
Registration” means (i) a registration relating to the sale or grant of securities to employees of the Company or a subsidiary
pursuant to a stock option, stock purchase, equity incentive or similar plan; (ii) a registration relating to an SEC Rule 145 transaction;
(iii) a registration on any form that does not include substantially the same information as would be required to be included in
a registration statement covering the sale of the Registrable Securities; or (iv) a registration in which the only Common Stock
being registered is Common Stock issuable upon conversion of debt securities that are also being registered.
1.14 “Fifth
Avenue” shall mean Fifth Avenue Private Equity 15 LLC.
1.15 “FOIA
Party” means a Person that, in the reasonable determination of the Board of Directors, may be subject to, and thereby
required to disclose non-public information furnished by or relating to the Company under, the Freedom of Information Act, 5 U.S.C.
552 (“FOIA”), any state public records access law, any state or other jurisdiction’s laws similar in intent
or effect to FOIA, or any other similar statutory or regulatory requirement.
1.16 “Form
S-1” means such form under the Securities Act as in effect on the date hereof or any successor registration form under
the Securities Act subsequently adopted by the SEC.
1.17 “Form
S-3” means such form under the Securities Act as in effect on the date hereof or any registration form under the Securities
Act subsequently adopted by the SEC that permits incorporation of substantial information by reference to other documents filed
by the Company with the SEC.
1.18 “GAAP”
means generally accepted accounting principles in the United States as in effect from time to time.
1.19 “Holder”
means any holder of Registrable Securities who is a party to this Agreement.
1.20 “Immediate
Family Member” means a child, stepchild, grandchild, parent, stepparent, grandparent, spouse, sibling, mother-in-law,
father-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law, including, adoptive relationships, of a natural person
referred to herein.
1.21 “Initiating
Holders” means, collectively, Holders who properly initiate a registration request under this Agreement.
1.22 “IPO”
means the Company’s first underwritten public offering of its Common Stock under the Securities Act.
1.23 “Junior
Series A Preferred Stock” means the Company’s Junior Series A Preferred Stock par value $0.0001.
1.24 “Key
Employee” means any executive-level employee of the Company (including, division director and vice president-level positions)
as well as any employee of the Company who, either alone or in concert with others, develops, invents, programs, or designs any
Company Intellectual Property (as defined in the Purchase Agreement).
1.25 “LifeArc
Group” means LifeArc, its group undertakings and any investment funds in which LifeArc (or its group undertaking) is
an investor.
1.26 “Major
Investor” means any Investor that, individually or together with such Investor’s Affiliates, holds at least 2,500,000
shares of Preferred Stock (as adjusted for any stock split, stock dividend, combination, or other recapitalization or reclassification
effected after the date hereof).
1.27 “New
Securities” means, collectively, equity securities of the Company, other than Exempted Securities (as defined in the
Company’s Certificate of Incorporation), whether or not currently authorized, as well as rights, options, or warrants to
purchase such equity securities, or securities of any type whatsoever that are, or may become, convertible or exchangeable into
or exercisable for such equity securities.
1.28 “OrbiMed”
means OrbiMed Private Investments VI, LP.
1.29 “Perceptive”
means Perceptive Life Sciences Master Fund, L.P.
1.30 “Person”
means any individual, corporation, partnership, trust, limited liability company, association or other entity.
1.31 “Pfizer”
means Pfizer Inc., Pfizer Ventures (US) LLC and any of their respective Affiliates.
1.32 “Preferred
Stock” means, collectively, shares of the Company’s Junior Series A Preferred Stock, Series A Preferred Stock,
and Series B Preferred Stock.
1.33 “Registrable
Securities” means (i) the Common Stock issuable or issued upon conversion of any shares of Preferred Stock; (ii) any
Common Stock, or any Common Stock issued or issuable (directly or indirectly) upon conversion and/or exercise of any other securities
of the Company, acquired by the Investors after the date hereof; and (iii) any Common Stock issued as (or issuable upon the conversion
or exercise of any warrant, right, or other security that is issued as) a dividend or other distribution with respect to, or in
exchange for or in replacement of, the shares referenced in clauses (i) and (ii) above;; excluding in all cases, however, any Registrable
Securities sold by a Person in a transaction in which the applicable rights under this Agreement are not assigned pursuant to Subsection
6.1, and excluding for purposes of Section 2 any shares for which registration rights have terminated pursuant to Subsection
2.13 of this Agreement.
1.34 “Registrable
Securities then outstanding” means the number of shares determined by adding the number of shares of outstanding Common
Stock that are Registrable Securities and the number of shares of Common Stock issuable (directly or indirectly) pursuant to then
exercisable and/or convertible securities that are Registrable Securities.
1.35 “Required
Preferred Directors” means (a) for as long as the directorship to be filled by the Series B Director remains vacant,
the approval of a majority of the Series A Directors designated by Pfizer, Inc., Bain and OrbiMed, and (b) if the directorship
to be filled by the Series B Director is no longer vacant, the approval of a majority of (i) the Series A Directors and (ii) the
Series B Director, voting together as a group.
1.36 “Restricted
Securities” means the securities of the Company required to be notated with the legend set forth in Subsection 2.12(b)
hereof.
1.37 “Right
of First Refusal and Co-Sale Agreement” means that certain Right of First Refusal and Co-Sale Agreement, dated as of
the date hereof among the Company, the Investors and certain other stockholders of the Company, as the same may be amended or restated
from time to time.
1.38 “SEC”
means the Securities and Exchange Commission.
1.39 “SEC
Rule 144” means Rule 144 promulgated by the SEC under the Securities Act.
1.40 “SEC
Rule 145” means Rule 145 promulgated by the SEC under the Securities Act.
1.41 “Securities
Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
1.42 “Selling
Expenses” means all underwriting discounts, selling commissions, and stock transfer taxes applicable to the sale of Registrable
Securities, and fees and disbursements of counsel for any Holder, except for the fees and disbursements of the Selling Holder Counsel
borne and paid by the Company as provided in Subsection 2.6.
1.43 “Series
A Director” has the meaning ascribed to it in the Voting Agreement.
1.44 “Series
A Preferred Stock” means shares of the Company’s Series A Preferred Stock, par value $0.0001.
1.45 “Series
B Director” has the meaning ascribed to it in the Voting Agreement.
1.46 “Series
B Preferred Stock” means the shares of the Company’s Series B Preferred Stock par value $0.0001.
1.47
“Transaction Agreements” means this Agreement, the Purchase Agreement, the Voting Agreement and the Right of
First Refusal and Co-Sale Agreement.
1.48 “Voting
Agreement” means that certain Voting Agreement, dated as of the date hereof among the Company, the Investors and certain
other stockholders of the Company, as the same may be amended or restated from time to time.
| 2. | Registration Rights. The Company covenants and agrees
as follows: |
(a) Form
S-1 Demand. If at any time after the earlier of (i) three (3) years after the date of this Agreement or (ii) one hundred eighty
(180) days after the effective date of the registration statement for the IPO, the Company receives a request from Holders of more
than twenty percent (20%) of the Registrable Securities then outstanding (the “Required Vote”) that the Company
file a Form S-1 registration statement with respect to their Registrable Securities and if the anticipated aggregate offering price,
net of Selling Expenses, would exceed five million dollars ($5,000,000), then the Company shall (x) within ten (10) days after
the date such request is given, give notice thereof (the “Demand Notice”) to all Holders other than the Initiating
Holders; and (y) as soon as practicable, and in any event within sixty (60) days after the date such request is given by the Initiating
Holders, file a Form S-1 registration statement under the Securities Act covering all Registrable Securities that the Initiating
Holders requested to be registered and any additional Registrable Securities requested to be included in such registration by any
other Holders, as specified by notice given by each such Holder to the Company within twenty (20) days of the date the Demand Notice
is given, and in each case, subject to the limitations of Subsections 2.1(c) and 2.3.
(b) Form
S-3 Demand. If at any time when it is eligible to use a Form S-3 registration statement, the Company receives a request from
Holders of at least twenty percent (20%) of the Registrable Securities then outstanding that the Company file a Form S-3 registration
statement with respect to outstanding Registrable Securities of such Holders having an anticipated aggregate offering price, net
of Selling Expenses, of at least $2 million, then the Company shall (i) within ten (10) days after the date such request is given,
give a Demand Notice to all Holders other than the Initiating Holders; and (ii) as soon as practicable, and in any event within
forty-five (45) days after the date such request is given by the Initiating Holders, file a Form S-3 registration statement under
the Securities Act covering all Registrable Securities requested to be included in such registration by any other Holders, as specified
by notice given by each such Holder to the Company within twenty (20) days of the date the Demand Notice is given, and in each
case, subject to the limitations of Subsections 2.1(c) and 2.3.
(c) Notwithstanding
the foregoing obligations, if the Company furnishes to Holders requesting a registration pursuant to this Subsection 2.1
a certificate signed by the Company’s chief executive officer stating that in the good faith judgment of the Board of Directors
it would be materially detrimental to the Company and its stockholders for such registration statement to either become effective
or remain effective for as long as such registration statement otherwise would be required to remain effective, because such action
would (i) materially interfere with a significant acquisition, corporate reorganization, or other similar transaction involving
the Company; (ii) require premature disclosure of material information that the Company has a bona fide business purpose for preserving
as confidential; or (iii) render the Company unable to comply with requirements under the Securities Act or Exchange Act, then
the Company shall have the right to defer taking action with respect to such filing, and any time periods with respect to filing
or effectiveness thereof shall be tolled correspondingly, for a period of not more than seventy-five (75) days after the request
of the Initiating Holders is given; provided, however, that the Company may not invoke this right more than once
in any twelve (12) month period; and provided further that the Company shall not register any securities for its own account
or that of any other stockholder during such one seventy-five (75) day period other than an Excluded Registration.
(d) The
Company shall not be obligated to effect, or to take any action to effect, any registration pursuant to Subsection 2.1(a)
(i) during the period that is sixty (60) days before the Company’s good faith estimate of the date of filing of, and ending
on a date that is one hundred eighty (180) days after the effective date of, a Company-initiated registration, provided
that the Company is actively employing in good faith commercially reasonable efforts to cause such registration statement to become
effective; (ii) after the Company has effected two registrations pursuant to Subsection 2.1(a); or (iii) if the Initiating
Holders propose to dispose of shares of Registrable Securities that may be immediately registered on Form S-3 pursuant to a request
made pursuant to Subsection 2.1(b). The Company shall not be obligated to effect, or to take any action to effect, any registration
pursuant to Subsection 2.1(b) (i) during the period that is thirty (30) days before the Company’s good faith estimate
of the date of filing of, and ending on a date that is ninety (90) days after the effective date of, a Company-initiated registration,
provided that the Company is actively employing in good faith commercially reasonable efforts to cause such registration
statement to become effective; or (ii) if the Company has effected two registrations pursuant to Subsection 2.1(b) within
the twelve (12) month period immediately preceding the date of such request. A registration shall not be counted as “effected”
for purposes of this Subsection 2.1(d) until such time as the applicable registration statement has been declared effective
by the SEC, unless the Initiating Holders withdraw their request for such registration, elect not to pay the registration expenses
therefor, and forfeit their right to one demand registration statement pursuant to Subsection 2.6, in which case such withdrawn
registration statement shall be counted as “effected” for purposes of this Subsection 2.1(d); provided, that
if such withdrawal is during a period the Company has deferred taking action pursuant to Subsection 2.1(c), then the Initiating
Holders may withdraw their request for registration and such registration will not be counted as “effected” for purposes
of this Subsection 2.1(d).
2.2 Company
Registration. If the Company proposes to register (including, for this purpose, a registration effected by the Company for
stockholders other than the Holders) any of its securities under the Securities Act in connection with the public offering of such
securities solely for cash (other than in an Excluded Registration), the Company shall, at such time, promptly give each Holder
notice of such registration. Upon the request of each Holder given within twenty (20) days after such notice is given by the Company,
the Company shall, subject to the provisions of Subsection 2.3, cause to be registered all of the Registrable Securities
that each such Holder has requested to be included in such registration. The Company shall have the right to terminate or withdraw
any registration initiated by it under this Subsection 2.2 before the effective date of such registration, whether
or not any Holder has elected to include Registrable Securities in such registration. The expenses (other than Selling Expenses)
of such withdrawn registration shall be borne by the Company in accordance with Subsection 2.6.
| 2.3 | Underwriting Requirements. |
(a) If,
pursuant to Subsection 2.1, the Initiating Holders intend to distribute the Registrable Securities covered by their request
by means of an underwriting, they shall so advise the Company as a part of their request made pursuant to Subsection 2.1,
and the Company shall include such information in the Demand Notice. The underwriter(s) will be selected by the Company and shall
be reasonably acceptable to a majority in interest of the Initiating Holders. In such event, the right of any Holder to include
such Holder’s Registrable Securities in such registration shall be conditioned upon such Holder’s participation in
such underwriting and the inclusion of such Holder’s Registrable Securities in the underwriting to the extent provided herein.
All Holders proposing to distribute their securities through such underwriting shall (together with the Company as provided in
Subsection 2.4(e)) enter into an underwriting agreement in customary form with the underwriter(s) selected for such underwriting.
Notwithstanding any other provision of this Subsection 2.3, if the managing underwriter(s) advise(s) the Initiating Holders
in writing that marketing factors require a limitation on the number of shares to be underwritten, then the Initiating Holders
shall so advise all Holders of Registrable Securities that otherwise would be underwritten pursuant hereto, and the number of
Registrable Securities that may be included in the underwriting shall be allocated among such Holders of Registrable Securities,
including the Initiating Holders, in proportion (as nearly as practicable) to the number of Registrable Securities owned by each
Holder or in such other proportion as shall mutually be agreed to by all such selling Holders; provided, however,
that the number of Registrable Securities held by the Holders who hold or will hold, as the case may be, any Common Stock then
issued or issuable upon conversion of Series A Preferred Stock or Series B Preferred Stock to be included in such underwriting
shall not be reduced unless all other securities are first entirely excluded from the underwriting (and in the event of any such
reduction of any Common Stock then issued or issuable upon conversion of Series A Preferred Stock or Series B Preferred Stock
that are included in the offering, such reduction shall be on a pari passu basis with respect to all holders of such Common Stock
then issued or issuable upon conversion of Series A Preferred Stock and Series B Preferred Stock). To facilitate the allocation
of shares in accordance with the above provisions, the Company or the underwriters may round the number of shares allocated to
any Holder to the nearest one hundred (100) shares.
(b) In
connection with any offering involving an underwriting of shares of the Company’s capital stock pursuant to Subsection
2.2, the Company shall not be required to include any of the Holders’ Registrable Securities in such underwriting unless
the Holders accept the terms of the underwriting as agreed upon between the Company and its underwriters, and then only in such
quantity as the underwriters in their sole discretion determine will not jeopardize the success of the offering by the Company.
If the total number of securities, including Registrable Securities, requested by stockholders to be included in such offering
exceeds the number of securities to be sold (other than by the Company) that the underwriters in their reasonable discretion determine
is compatible with the success of the offering, then the Company shall be required to include in the offering only that number
of such securities, including Registrable Securities, which the underwriters and the Company in their sole discretion determine
will not jeopardize the success of the offering. If the underwriters determine that less than all of the Registrable Securities
requested to be registered can be included in such offering, then the Registrable Securities that are included in such offering
shall be allocated among the selling Holders in proportion (as nearly as practicable to) the number of Registrable Securities owned
by each selling Holder or in such other proportions as shall mutually be agreed to by all such selling Holders. To facilitate the
allocation of shares in accordance with the above provisions, the Company or the underwriters may round the number of shares allocated
to any Holder to the nearest one hundred (100) shares. Notwithstanding the foregoing, (i) in no event shall the number of Registrable
Securities included in the offering be reduced unless all other securities (other than securities to be sold by the Company) are
first entirely excluded from the offering, (ii) in no event shall the number of Registrable Securities included in the offering
be reduced below twenty-five percent (25%) of the total number of securities included in such offering unless such offering is
the IPO, in which case the selling Holders may be excluded further if the underwriters make the determination described above and
no other stockholder’s securities are included in such offering and (iii) in no event shall the number of Registrable Securities
held by Holders who hold or will hold Common Stock then issued or issuable upon conversion of any Series A Preferred Stock or Series
B Preferred Stock be reduced unless all other Registrable Securities are first entirely excluded from the offering (and in the
event of any such reduction of any Common Stock then issued or issuable upon conversion of Series A Preferred Stock or Series B
Preferred Stock that are included in the offering, such reduction shall be on a pari passu basis with respect to all holders of
such Common Stock then issued or issuable upon conversion of Series A Preferred Stock and Series B Preferred Stock). For purposes
of the provision in this Subsection 2.3(b) concerning apportionment, for any selling Holder that is a partnership, limited
liability company, or corporation, the partners, members, retired partners, retired members, stockholders, and Affiliates of such
Holder, or the estates and Immediate Family Members of any such partners, retired partners, members, and retired members and any
trusts for the benefit of any of the foregoing Persons, shall be deemed to be a single “selling Holder,” and any pro
rata reduction with respect to such “selling Holder” shall be based upon the aggregate number of Registrable Securities
owned by all Persons included in such “selling Holder,” as defined in this sentence.
(c) For
purposes of Subsection 2.1, a registration shall not be counted as “effected” if, as a result of an exercise
of the underwriter’s cutback provisions in Subsection 2.3(a), fewer than fifty percent (50%) of the Registrable
Securities that Holders have requested to be included in such registration statement are actually included.
2.4 Obligations
of the Company. Whenever required under this Section 2 to effect the registration of any Registrable Securities, the
Company shall, as expeditiously as reasonably possible:
(a) prepare
and file with the SEC a registration statement with respect to such Registrable Securities and use its commercially reasonable
efforts to cause such registration statement to become effective and, upon the request of the Holders of a majority of the Registrable
Securities registered thereunder, keep such registration statement effective for a period of up to one hundred twenty (120) days
or, if earlier, until the distribution contemplated in the registration statement has been completed; provided, however,
that (i) such one hundred twenty (120) day period shall be extended for a period of time equal to the period the Holder refrains,
at the request of an underwriter of Common Stock (or other securities) of the Company, from selling any securities included in
such registration, and (ii) in the case of any registration of Registrable Securities on Form S-3 that are intended to be offered
on a continuous or delayed basis, subject to compliance with applicable SEC rules, such one hundred twenty (120) day period shall
be extended for up to ninety (90) days, if necessary, to keep the registration statement effective until all such Registrable Securities
are sold;
(b) prepare
and file with the SEC such amendments and supplements to such registration statement, and the prospectus used in connection with
such registration statement, as may be necessary to comply with the Securities Act in order to enable the disposition of all securities
covered by such registration statement;
(c) furnish
to the selling Holders such numbers of copies of a prospectus, including a preliminary prospectus, as required by the Securities
Act, and such other documents as the Holders may reasonably request in order to facilitate their disposition of their Registrable
Securities;
(d) use
its commercially reasonable efforts to register and qualify the securities covered by such registration statement under such other
securities or blue-sky laws of such jurisdictions as shall be reasonably requested by the selling Holders; provided that
the Company shall not be required to qualify to do business or to file a general consent to service of process in any such states
or jurisdictions, unless the Company is already subject to service in such jurisdiction and except as may be required by the Securities
Act;
(e) in
the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual
and customary form, with the underwriter(s) of such offering;
(f) use
its commercially reasonable efforts to cause all such Registrable Securities covered by such registration statement to be listed
on a national securities exchange or trading system and each securities exchange and trading system (if any) on which similar securities
issued by the Company are then listed;
(g) provide
a transfer agent and registrar for all Registrable Securities registered pursuant to this Agreement and provide a CUSIP number
for all such Registrable Securities, in each case not later than the effective date of such registration;
(h) promptly
make available for inspection by the selling Holders, any managing underwriter(s) participating in any disposition pursuant to
such registration statement, and any attorney or accountant or other agent retained by any such underwriter or selected by the
selling Holders, all financial and other records, pertinent corporate documents, and properties of the Company, and cause the Company’s
officers, directors, employees, and independent accountants to supply all information reasonably requested by any such seller,
underwriter, attorney, accountant, or agent, in each case, as necessary or advisable to verify the accuracy of the information
in such registration statement and to conduct appropriate due diligence in connection therewith;
(i) notify
each selling Holder, promptly after the Company receives notice thereof, of the time when such registration statement has been
declared effective or a supplement to any prospectus forming a part of such registration statement has been filed; and
(j) after
such registration statement becomes effective, notify each selling Holder of any request by the SEC that the Company amend or supplement
such registration statement or prospectus.
In addition, the Company
shall ensure that, at all times after any registration statement covering a public offering of securities of the Company under
the Securities Act shall have become effective, its insider trading policy shall provide that the Company’s directors may
implement a trading program under Rule 10b5-1 of the Exchange Act.
2.5 Furnish
Information. It shall be a condition precedent to the obligations of the Company to take any action pursuant to this Section
2 with respect to the Registrable Securities of any selling Holder that such Holder shall furnish to the Company such information
regarding itself, the Registrable Securities held by it, and the intended method of disposition of such securities as is reasonably
required to effect the registration of such Holder’s Registrable Securities.
2.6 Expenses
of Registration. All expenses (other than Selling Expenses) incurred in connection with registrations, filings, or qualifications
pursuant to Section 2, including all registration, filing, and qualification fees; printers’ and accounting fees;
fees and disbursements of counsel for the Company; and the reasonable fees and disbursements, not to exceed $75,000 of one counsel
for the selling Holders selected by the Holders of a majority of the Registrable Securities to be registered (“Selling
Holder Counsel”), shall be borne and paid by the Company; provided, however, that the Company shall not be required to
pay for any expenses of any registration proceeding begun pursuant to Subsection 2.1 if the registration request is subsequently
withdrawn at the request of the Holders of a majority of the Registrable Securities to be registered (in which case all selling
Holders shall bear such expenses pro rata based upon the number of Registrable Securities that were to be included in the withdrawn
registration), unless the Holders of a majority of the Registrable Securities agree to forfeit their right to one registration
pursuant to Subsection 2.1(a) or Subsection 2.1(b), as the case may be; provided further that if, at the time of
such withdrawal, the Holders shall have learned of a material adverse change in the condition, business, or prospects of the Company
from that known to the Holders at the time of their request and have withdrawn the request with reasonable promptness after learning
of such information then the Holders shall not be required to pay any of such expenses and shall not forfeit their right to one
registration pursuant to Subsection 2.1(a) or Subsection 2.1(b). All Selling Expenses relating to Registrable Securities
registered pursuant to this Section 2 shall be borne and paid by the Holders pro rata on the basis of the number of Registrable
Securities registered on their behalf.
2.7 Delay
of Registration. No Holder shall have any right to obtain or seek an injunction restraining or otherwise delaying any registration
pursuant to this Agreement as the result of any controversy that might arise with respect to the interpretation or implementation
of this Section 2.7.
2.8 Indemnification.
If any Registrable Securities are included in a registration statement under this Section 2:
(a) To
the extent permitted by law, the Company will indemnify and hold harmless each selling Holder, and the partners, members, officers,
directors, and stockholders of each such Holder; legal counsel and accountants for each such Holder; any underwriter (as defined
in the Securities Act) for each such Holder; and each Person, if any, who controls such Holder or underwriter within the meaning
of the Securities Act or the Exchange Act, against any Damages, and the Company will pay to each such Holder, underwriter, controlling
Person, or other aforementioned Person any legal or other expenses reasonably incurred thereby in connection with investigating
or defending any claim or proceeding from which Damages may result, as such expenses are incurred; provided, however,
that the indemnity agreement contained in this Subsection 2.8(a) shall not apply to amounts paid in settlement of any such
claim or proceeding if such settlement is effected without the consent of the Company, which consent shall not be unreasonably
withheld, nor shall the Company be liable for any Damages to the extent that they arise out of or are based upon actions or omissions
made in reliance upon and in conformity with written information furnished by or on behalf of any such Holder, underwriter, controlling
Person, or other aforementioned Person expressly for use in connection with such registration.
(b) To
the extent permitted by law, each selling Holder, severally and not jointly, will indemnify and hold harmless the Company, and
each of its directors, each of its officers who has signed the registration statement, each Person (if any), who controls the Company
within the meaning of the Securities Act, legal counsel and accountants for the Company, any underwriter (as defined in the Securities
Act), any other Holder selling securities in such registration statement, and any controlling Person of any such underwriter or
other Holder, against any Damages, in each case only to the extent that such Damages arise out of or are based upon actions or
omissions made in reliance upon and in conformity with written information furnished by or on behalf of such selling Holder expressly
for use in connection with such registration; and each such selling Holder will pay to the Company and each other aforementioned
Person any legal or other expenses reasonably incurred thereby in connection with investigating or defending any claim or proceeding
from which Damages may result, as such expenses are incurred; provided, however, that the indemnity agreement contained
in this Subsection 2.8(b) shall not apply to amounts paid in settlement of any such claim or proceeding if such settlement
is effected without the consent of the Holder, which consent shall not be unreasonably withheld; and provided further that
in no event shall the aggregate amounts payable by any Holder by way of indemnity or contribution under Subsections 2.8(b)
and 2.8(d) exceed the proceeds from the offering received by such Holder (net of any Selling Expenses paid by such Holder),
except in the case of fraud or willful misconduct by such Holder.
(c) Promptly
after receipt by an indemnified party under this Subsection 2.8 of notice of the commencement of any action (including any
governmental action) for which a party may be entitled to indemnification hereunder, such indemnified party will, if a claim in
respect thereof is to be made against any indemnifying party under this Subsection 2.8, give the indemnifying party notice
of the commencement thereof. The indemnifying party shall have the right to participate in such action and, to the extent the indemnifying
party so desires, participate jointly with any other indemnifying party to which notice has been given, and to assume the defense
thereof with counsel mutually satisfactory to the parties; provided, however, that an indemnified party (together
with all other indemnified parties that may be represented without conflict by one counsel) shall have the right to retain one
separate counsel, with the fees and expenses to be paid by the indemnifying party, if representation of such indemnified party
by the counsel retained by the indemnifying party would be inappropriate due to actual or potential differing interests between
such indemnified party and any other party represented by such counsel in such action. The failure to give notice to the indemnifying
party within a reasonable time of the commencement of any such action shall relieve such indemnifying party of any liability to
the indemnified party under this Subsection 2.8, only to the extent that such failure materially prejudices the indemnifying
party’s ability to defend such action. The failure to give notice to the indemnifying party will not relieve it of any liability
that it may have to any indemnified party otherwise than under this Subsection 2.8.
(d) To
provide for just and equitable contribution to joint liability under the Securities Act in any case in which either: (i) any party
otherwise entitled to indemnification hereunder makes a claim for indemnification pursuant to this Subsection 2.8 but it
is judicially determined (by the entry of a final judgment or decree by a court of competent jurisdiction and the expiration of
time to appeal or the denial of the last right of appeal) that such indemnification may not be enforced in such case, notwithstanding
the fact that this Subsection 2.8 provides for indemnification in such case, or (ii) contribution under the Securities
Act may be required on the part of any party hereto for which indemnification is provided under this Subsection 2.8, then,
and in each such case, such parties will contribute to the aggregate losses, claims, damages, liabilities, or expenses to which
they may be subject (after contribution from others) in such proportion as is appropriate to reflect the relative fault of each
of the indemnifying party and the indemnified party in connection with the statements, omissions, or other actions that resulted
in such loss, claim, damage, liability, or expense, as well as to reflect any other relevant equitable considerations. The relative
fault of the indemnifying party and of the indemnified party shall be determined by reference to, among other things, whether the
untrue or allegedly untrue statement of a material fact, or the omission or alleged omission of a material fact, relates to information
supplied by the indemnifying party or by the indemnified party and the parties’ relative intent, knowledge, access to information,
and opportunity to correct or prevent such statement or omission; provided, however, that, in any such case (x) no
Holder will be required to contribute any amount in excess of the public offering price of all such Registrable Securities offered
and sold by such Holder pursuant to such registration statement, and (y) no Person guilty of fraudulent misrepresentation (within
the meaning of Section 11(f) of the Securities Act) will be entitled to contribution from any Person who was not guilty of such
fraudulent misrepresentation; and provided further that in no event shall a Holder’s liability pursuant to this Subsection
2.8(d), when combined with the amounts paid or payable by such Holder pursuant to Subsection 2.8(d), exceed the proceeds
from the offering received by such Holder (net of any Selling Expenses paid by such Holder), except in the case of willful misconduct
or fraud by such Holder.
(e) Notwithstanding
the foregoing, to the extent that the provisions on indemnification and contribution contained in the underwriting agreement entered
into in connection with the underwritten public offering are in conflict with the foregoing provisions, the provisions in the underwriting
agreement shall control.
(f) Unless
otherwise superseded by an underwriting agreement entered into in connection with the underwritten public offering, the obligations
of the Company and Holders under this Subsection 2.8 shall survive the completion of any offering of Registrable Securities
in a registration under this Section 2, and otherwise shall survive the termination of this Agreement.
2.9 Reports
Under Exchange Act. With a view to making available to the Holders the benefits of SEC Rule 144 and any other rule or regulation
of the SEC that may at any time permit a Holder to sell securities of the Company to the public without registration or pursuant
to a registration on Form S-3, the Company shall:
(a) make
and keep available adequate current public information, as those terms are understood and defined in SEC Rule 144, at all times
after the effective date of the registration statement filed by the Company for the IPO;
(b) use
commercially reasonable efforts to file with the SEC in a timely manner all reports and other documents required of the Company
under the Securities Act and the Exchange Act (at any time after the Company has become subject to such reporting requirements);
and
(c) furnish
to any Holder, so long as the Holder owns any Registrable Securities, forthwith upon request (i) to the extent accurate, a written
statement by the Company that it has complied with the reporting requirements of SEC Rule 144 (at any time after ninety (90) days
after the effective date of the registration statement filed by the Company for the IPO), the Securities Act, and the Exchange
Act (at any time after the Company has become subject to such reporting requirements), or that it qualifies as a registrant whose
securities may be resold pursuant to Form S-3 (at any time after the Company so qualifies); (ii) a copy of the most recent annual
or quarterly report of the Company and such other reports and documents so filed by the Company; and (iii) such other information
as may be reasonably requested in availing any Holder of any rule or regulation of the SEC that permits the selling of any such
securities without registration (at any time after the Company has become subject to the reporting requirements under the Exchange
Act) or pursuant to Form S-3 (at any time after the Company so qualifies to use such form).
2.10 Limitations
on Subsequent Registration Rights. From and after the date of this Agreement, the Company shall not, without the prior written
consent of the Required Vote , enter into any agreement with any holder or prospective holder of any securities of the Company
that (i) would provide to such holder the right to include securities in any registration on other than a subordinate basis after
all Holders have had the opportunity to include in the registration and offering all shares of Registrable Securities that they
wish to so include; or (ii) allow such holder or prospective holder to initiate a demand for registration of any securities held
by such holder or prospective holder; provided that this limitation shall not apply to any additional Investor who becomes
a party to this Agreement in accordance with Subsection 6.9.
2.11 “Market
Stand-off” Agreement. Each Holder hereby agrees that it will not, without the prior written consent of the managing underwriter,
during the period commencing on the date of the final prospectus relating to the registration by the Company for its own behalf
of shares of its Common Stock in the IPO and ending on the date specified by the Company and the managing underwriter (such period
not to exceed one hundred eighty (180) days plus such additional period up to eighteen (18) additional days as may be requested
by the Company or an underwriter to accommodate regulatory restrictions on (1) the publication or other distribution of research
reports and (2) analyst recommendations and opinions, including, but not limited to, the restrictions contained in FINRA Rule 2711(f)(4)
or NYSE Rule 472(f)(4), or any successor provisions or amendments thereto), (i) lend; offer; pledge; sell; contract to sell; sell
any option or contract to purchase; purchase any option or contract to sell; grant any option, right, or warrant to purchase; or
otherwise transfer or dispose of, directly or indirectly, any shares of Common Stock or any securities convertible into or exercisable
or exchangeable (directly or indirectly) for Common Stock held immediately before the effective date of the registration statement
for such offering, or (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the
economic consequences of ownership of such securities, whether any such transaction described in clause (i) or (ii) above is to
be settled by delivery of Common Stock or other securities, in cash, or otherwise. The foregoing provisions of this Subsection
2.11 shall apply only to the IPO, shall not apply to (1) the sale of any shares to an underwriter pursuant to an underwriting
agreement, (2) the transfer of any securities as a bona fide gift, (3) the transfer of any shares to any trust for the direct or
indirect benefit of the Holder or the immediate family of the Holder, provided that the trustee of the trust agrees to be
bound in writing by the restrictions set forth herein, (4) transfers by will or intestate succession or by operation of law, (5)
distributions to current or former partners, members or stockholders of a Holder, or (6) the transfer to Affiliates of the Holder
(whether or not such transfer is for consideration); provided, that any such “lock-up” restrictions pursuant
to this Subsection 2.11 shall be applicable to the Holders only if all officers and directors are subject to the same restrictions,
such restrictions are the same for all Holders,and all stockholders individually, and together with their Affiliates, owning one
percent (1%) or more of the Company’s outstanding Common Stock (after giving effect to conversion into Common Stock of all
outstanding Preferred Stock) are subject to the same restrictions. The underwriters in connection with such registration are intended
third party beneficiaries of this Subsection 2.12 and shall have the right, power and authority to enforce the provisions
hereof as though they were a party hereto. Each Holder further agrees to execute such agreements as may be reasonably requested
by the underwriters in connection with such registration that are consistent with this Subsection 2.11 or that are necessary
to give further effect thereto. Any discretionary waiver or termination of the restrictions of any or all of such agreements by
the Company or the underwriters shall apply pro rata to all Holders subject to such agreements, based on the number of shares (or
units) subject to such agreement. The foregoing provisions of this Section 2.11 shall not apply to transactions
relating to securities acquired (i) in the IPO or (ii) in open market transactions from and after the IPO.
2.12 Restrictions
on Transfer.
(a) The
Preferred Stock and the Registrable Securities shall not be sold, pledged, or otherwise transferred, and the Company shall not
recognize and shall issue stop-transfer instructions to its transfer agent with respect to any such sale, pledge, or transfer,
except upon the conditions specified in this Agreement, which conditions are intended to ensure compliance with the provisions
of the Securities Act. A transferring Holder will cause any proposed purchaser, pledgee, or transferee of the Preferred Stock and
the Registrable Securities held by such Holder to agree to take and hold such securities subject to the provisions and upon the
conditions specified in this Agreement.
(b) Each
certificate, instrument, or book entry representing (i) the Preferred Stock, (ii) the Registrable Securities, and (iii) any other
securities issued in respect of the securities referenced in clauses (i) and (ii), upon any stock split, stock dividend, recapitalization,
merger, consolidation, or similar event, shall (unless otherwise permitted by the provisions of Subsection 2.12(c)) be notated
with a legend substantially in the following form:
THE SECURITIES REPRESENTED HEREBY
HAVE BEEN ACQUIRED FOR INVESTMENT AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933. SUCH SHARES MAY NOT BE SOLD, PLEDGED,
OR TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR A VALID EXEMPTION FROM THE REGISTRATION AND PROSPECTUS DELIVERY REQUIREMENTS
OF SAID ACT.
THE SECURITIES REPRESENTED HEREBY
MAY BE TRANSFERRED ONLY IN ACCORDANCE WITH THE TERMS OF AN AGREEMENT BETWEEN THE COMPANY AND THE STOCKHOLDER, A COPY OF WHICH IS
ON FILE WITH THE SECRETARY OF THE COMPANY.
The Holders consent to
the Company making a notation in its records and giving instructions to any transfer agent of the Restricted Securities in order
to implement the restrictions on transfer set forth in this Subsection 2.12.
(c) The
holder of such Restricted Securities, by acceptance of ownership thereof, agrees to comply in all respects with the provisions
of this Section 2. Before any proposed sale, pledge, or transfer of any Restricted Securities, unless (i) there is in effect
a registration statement under the Securities Act covering the proposed transaction or (ii) such sale, pledge or transfer of Restricted
Securities is between members of the LifeArc Group, the Holder thereof shall give notice to the Company of such Holder’s
intention to effect such sale, pledge, or transfer, which notice shall describe the manner and circumstances of the proposed sale,
pledge, or transfer in sufficient detail and, if reasonably requested by the Company, shall be accompanied at such Holder’s
expense by either (i) a written opinion of legal counsel who shall, and whose legal opinion shall, be reasonably satisfactory to
the Company, addressed to the Company, to the effect that the proposed transaction may be effected without registration under the
Securities Act; (ii) a “no action” letter from the SEC to the effect that the proposed sale, pledge, or transfer of
such Restricted Securities without registration will not result in a recommendation by the staff of the SEC that action be taken
with respect thereto; or (iii) any other evidence reasonably satisfactory to counsel to the Company to the effect that the proposed
sale, pledge, or transfer of the Restricted Securities may be effected without registration under the Securities Act; whereupon
the Holder of such Restricted Securities shall be entitled to sell, pledge, or transfer such Restricted Securities in accordance
with the terms of the notice given by the Holder to the Company. The Company will not require such a legal opinion or “no
action” letter (1) in any transaction in compliance with SEC Rule 144; (2) in any transaction in which such Holder transfers
or distributes Restricted Securities to an Affiliate of such Holder (whether or not any such transfer or distribution is for consideration);
(3) a transfer by a Holder that is a partnership, limited liability company or corporation to a partner, limited partner, retired
partner, member, retired member or stockholder of a Holder (whether or not any such transfer or distribution is for consideration);
(4) a transfer to a charity; (5) a transfer by gift, will or intestate succession of any Holder to his or her spouse or to the
siblings, lineal descendants or ancestors of such Holder or his or her spouse; or (6) the transfer by a Holder exercising its co-sale
rights under the Right of First Refusal and Co-Sale Agreement; provided that each transferee agrees in writing to be subject
to the terms of this Subsection 2.12. Each certificate, instrument, or book entry representing the Restricted Securities
transferred as above provided shall be notated with, except if such transfer is made pursuant to SEC Rule 144, the appropriate
restrictive legend set forth in Subsection 2.12(b), except that such certificate instrument, or book entry shall not be
notated with such restrictive legend if, in the opinion of counsel for such Holder and the Company, such legend is not required
in order to establish compliance with any provisions of the Securities Act.
2.13 Termination
of Registration Rights. The right of any Holder to request registration or inclusion of Registrable Securities in any registration
pursuant to Subsections 2.1 or 2.2 shall terminate upon the earliest to occur of.
(a) immediately
before the closing of a Deemed Liquidation Event, as such term is defined in the Company’s Certificate of Incorporation;
and
(b) the
fourth anniversary of the IPO.
3.1 Delivery
of Financial Statements. The Company shall deliver to each Major Investor, provided that the Board of Directors has
not reasonably determined that such Major Investor is a Competitor:
(a) as
soon as practicable, but in any event within one hundred and twenty (120) days after the end of each fiscal year of the Company
(i) a balance sheet as of the end of such year, (ii) statements of income and of cash flows for such year, and a comparison between
(x) the actual amounts as of and for such fiscal year and (y) the comparable amounts for the prior year and as included in the
Company’s Budget (as defined in Subsection 3.1(c)) for such year, with an explanation of any material differences
between such amounts and a schedule as to the sources and applications of funds for such year, and (iii) a statement of stockholders’
equity as of the end of such year; beginning on January 1, 2019 all such financial statements shall be audited and certified by
independent public accountants of regionally or nationally recognized standing selected by the Company and prepared in accordance
with GAAP.
(b) as
soon as practicable, but in any event within forty-five (45) days after the end of each of the first three (3) quarters of each
fiscal year of the Company, unaudited statements of income and cash flows for such fiscal quarter, and an unaudited balance sheet
and a statement of stockholders’ equity as of the end of such fiscal quarter; beginning on January 1, 2019 all such statements
shall be prepared in accordance with GAAP (except that such financial statements may (i) be subject to normal year-end audit adjustments;
and (ii) not contain all notes thereto that may be required in accordance with GAAP);
(c) as
soon as practicable, but in any event thirty (30) days before the end of each fiscal year, an operating budget and business plan
for the next fiscal year, which includes a forecast of the Company’s revenues, expenses and cash position on a quarterly
basis for the next fiscal year (collectively, the “Budget”), which, prior to delivery under this Subsection
3.1, shall be submitted for approval by the Board no later than sixty (60) days before the end of each fiscal year. If the
Budget is not so approved, then the immediately prior Budget that was so approved shall remain in effect until a new Budget is
so approved;
(d) as
soon as practicable, but in any event within thirty (30) days of the end of each month, an unaudited income statement and statement
of cash flows for such month, and an unaudited balance sheet and statement of stockholders’ equity as of the end of such
month, all prepared in accordance with GAAP (except that such financial statements may (i) be subject to normal year-end audit
adjustments and (ii) not contain all notes thereto that may be required in accordance with GAAP).
(e) as
soon as practicable, but in any event within forty-five (45) days after the end of each of the first three (3) quarters of each
fiscal year of the Company, a statement showing the number of shares of each class and series of capital stock and securities convertible
into or exercisable for shares of capital stock outstanding at the end of the period, the Common Stock issuable upon conversion
or exercise of any outstanding securities convertible or exercisable for Common Stock and the exchange ratio or exercise price
applicable thereto, and the number of shares of issued stock options and stock options not yet issued but reserved for issuance,
if any, all in sufficient detail as to permit any Major Investor to calculate its percentage equity ownership in the Company, and
certified by the chief financial officer or chief executive officer of the Company as being true, complete and correct;
(f) with
respect to the financial statements called for in Subsection 3.1(a), Subsection 3.1(b), an instrument executed
by the chief financial officer and chief executive officer of the Company certifying that such financial statements fairly present
the financial condition of the Company and its results of operation for the periods specified therein, and were prepared in accordance
with GAAP consistently applied with prior practice for earlier periods (except as otherwise set forth in Subsection 3.1(b);
and
(g) such
other information relating to the financial condition, business, prospects, or corporate affairs of the Company as any Major Investor
may from time to time reasonably request; provided, however, that the Company shall not be obligated under this Subsection
3.1 to provide information (i) that the Company reasonably determines in good faith to be a trade secret or confidential information
(unless covered by an enforceable confidentiality agreement, in a form reasonably acceptable to the Company); or (ii) the disclosure
of which would adversely affect the attorney-client privilege between the Company and its counsel.
If, for any period, the
Company has any subsidiary whose accounts are consolidated with those of the Company, then in respect of such period the financial
statements delivered pursuant to the foregoing sections shall be the consolidated and consolidating financial statements of the
Company and all such consolidated subsidiaries.
Notwithstanding anything
else in this Subsection 3.1 to the contrary, the Company may cease providing the information set forth in this Subsection
3.1 during the period starting with the date sixty (60) days before the Company’s good-faith estimate of the date of
filing of a registration statement if it reasonably concludes it must do so to comply with the SEC rules applicable to such registration
statement and related offering; provided that the Company’s covenants under this Subsection 3.1 shall be reinstated
at such time as the Company is no longer actively employing its commercially reasonable efforts to cause such registration statement
to become effective.
3.2 Inspection.
The Company shall permit each Major Investor (provided that the Board of Directors has not reasonably determined that such
Major Investor is a Competitor of the Company), at such Major Investor’s expense, to visit and inspect the Company’s
properties; examine its books of account and records; and discuss the Company’s affairs, finances, and accounts with its
officers, during normal business hours of the Company as may be reasonably requested by the Major Investor; provided, however,
that the Company shall not be obligated pursuant to this Subsection 3.2 to provide access to any information that it reasonably
and in good faith considers to be a trade secret or confidential information (unless covered by an enforceable confidentiality
agreement, in form reasonably acceptable to the Company, it being understood and agreed it being understood and agreed that such
form will include provisions substantially similar with respect to level of restrictions as contained in Section 3.4, but expanded
to include customary provisions such as injunctive relief) or the disclosure of which would adversely affect the attorney-client
privilege between the Company and its counsel.
3.3 Termination
of Information Rights. The covenants set forth in Subsection 3.1 and Subsection 3.2 shall terminate and
be of no further force or effect (i) immediately before the consummation of the IPO, (ii) when the Company first becomes subject
to the periodic reporting requirements of Section 12(g) or 15(d) of the Exchange Act, or (iii) upon a Deemed Liquidation Event,
as such term is defined in the Company’s Certificate of Incorporation, whichever event occurs first.
3.4 Confidentiality.
Each Investor agrees that such Investor will keep confidential and will not disclose, divulge, or use for any purpose (other than
to monitor its investment in the Company) any confidential information obtained from the Company pursuant to the terms of this
Agreement (including notice of the Company’s intention to file a registration statement), unless such confidential information
(a) is known or becomes known to the public in general (other than as a result of a breach of this Subsection 3.4 by such
Investor), (b) is or has been independently developed or conceived by the Investor without use of the Company’s confidential
information, or (c) is or has been made known or disclosed to the Investor by a third party without a breach of any obligation
of confidentiality such third party may have to the Company; provided, however, that an Investor may disclose confidential
information (i) to its attorneys, accountants, consultants, and other professionals to the extent necessary to obtain their services
in connection with monitoring its investment in the Company; (ii) to any prospective purchaser of any Registrable Securities from
such Investor, if such prospective purchaser agrees to be bound by the provisions of this Subsection 3.4; (iii) to any existing
or prospective Affiliate, partner, member, stockholder, or wholly owned subsidiary of such Investor in the ordinary course of business,
provided that such Investor informs such Person that such information is confidential and directs such Person to maintain
the confidentiality of such information; (iv) to any federal, state regulatory agency or self regulatory body that requests or
demands such information; or (v) as may otherwise be required by law, regulation, rule, court order or subpoena, provided
that the Investor promptly notifies the Company of such disclosure and takes reasonable steps to minimize the extent of any such
required disclosure.
| 4. | Rights to Future Stock Issuances. |
4.1 Right
of First Offer. Subject to the terms and conditions of this Subsection 4.1 and applicable securities laws, if the Company
proposes to offer or sell any New Securities, the Company shall first offer such New Securities to each Major Investor. A Major
Investor shall be entitled to apportion the right of first offer hereby granted to it in such proportions as it deems appropriate,
among (i) itself, (ii) its Affiliates and (iii) its beneficial interest holders, such as limited partners, members
or any other Person having “beneficial ownership,” as such term is defined in Rule 13d-3 promulgated under the Exchange
Act, of such Major Investor (“Investor Beneficial Owners”); provided that each such Affiliate or Investor
Beneficial Owner (x) is not a Competitor or FOIA Party, unless such party’s purchase of New Securities is otherwise
consented to by the Board of Directors, (y) agrees to enter into this Agreement and each of the Voting Agreement and Right
of First Refusal and Co-Sale Agreement of even date herewith among the Company, the Investors and the other parties named therein,
as an “Investor” under each such agreement (provided that any Competitor or FOIA Party shall not be entitled
to any rights as a Major Investor under Subsections 3.1, 3.2 and 4.1 hereof).
(a) The
Company shall give notice (the “Offer Notice”) to each Major Investor, stating (i) its bona fide intention to
offer such New Securities, (ii) the number of such New Securities to be offered, and (iii) the price and terms, if any, upon which
it proposes to offer such New Securities.
(b) By
notification to the Company within twenty (20) days after the Offer Notice is given, each Major Investor may elect to purchase
or otherwise acquire, at the price and on the terms specified in the Offer Notice, up to that portion of such New Securities which
equals the proportion that the Common Stock then held, or issuable (directly or indirectly) upon conversion and/or exercise, as
applicable, of the Preferred Stock and any other Derivative Securities then held, by such Major Investor bears to the total Common
Stock of held by all of the Major Investors (assuming full conversion and/or exercise, as applicable, of all Preferred Stock and
other Derivative Securities held by the Major Investors). At the expiration of such twenty (20) day period, the Company shall promptly
notify each Major Investor that elects to purchase or acquire all the shares available to it (each, a “Fully Exercising
Investor”) of any other Major Investor’s failure to do likewise. During the ten (10) day period commencing after
the Company has given such notice, each Fully Exercising Investor may, by giving notice to the Company, elect to purchase or acquire,
in addition to the number of shares specified above, up to that portion of the New Securities for which Major Investors were entitled
to subscribe but that were not subscribed for by the Major Investors which is equal to the proportion that the Common Stock issued
and held, or issuable (directly or indirectly) upon conversion and/or exercise, as applicable, of Preferred Stock and any other
Derivative Securities then held, by such Fully Exercising Investor bears to the Common Stock issued and held, or issuable (directly
or indirectly) upon conversion and/or exercise, as applicable, of the Preferred Stock and any other Derivative Securities then
held, by all Fully Exercising Investors who wish to purchase such unsubscribed shares. The closing of any sale pursuant to this
Subsection 4.1(b) shall occur within the later of ninety (90) days of the date that the Offer Notice is given and the date
of initial sale of New Securities pursuant to Subsection 4.1(c).
(c) If
all New Securities referred to in the Offer Notice are not elected to be purchased or acquired as provided in Subsection 4.1(b),
the Company may, during the sixty (60) day period following the expiration of the periods provided in Subsection 4.1(b),
offer and sell the remaining unsubscribed portion of such New Securities to any Person or Persons at a price not less than, and
upon terms no more favorable to the offeree than, those specified in the Offer Notice. If the Company does not enter into an agreement
for the sale of the New Securities within such period, or if such agreement is not consummated within thirty (30) days of the execution
thereof, the right provided hereunder shall be deemed to be revived and such New Securities shall not be offered unless first reoffered
to the Major Investors in accordance with this Subsection 4.1.
(d) The
right of first offer in this Subsection 4.1 shall not be applicable to (i) Exempted Securities (as defined in the Company’s
Certificate of Incorporation); and (ii) shares of Common Stock issued in the IPO.
(e) Notwithstanding
any provision hereof to the contrary, in lieu of complying with the provisions of this Subsection 4.1, the Company may elect
to give notice to the Major Investors within thirty (30) days after the issuance of New Securities. Such notice shall describe
the type, price, and terms of the New Securities. Each Major Investor shall have twenty (20) days from the date notice is given
to elect to purchase up to the number of New Securities that would, if purchased by such Major Investor, maintain such Major Investor’s
percentage-ownership position, calculated as set forth in Subsection 4.1(b) before giving effect to the issuance of such
New Securities.
4.2 Termination.
The covenants set forth in Subsections 4.1 and 4.3 shall terminate and be of no further force or effect (i) immediately
before the consummation of the IPO, or (ii) upon a Deemed Liquidation Event, as such term is defined in the Company’s Certificate
of Incorporation, whichever event occurs first.
4.3 Right
of First Negotiation. Perceptive, on behalf of itself and its Affiliates, will have a right of first negotiation (“ROFN”)
with respect to any future Debt Financings by the Company, such that prior to entering into any such Debt Financing with any third
party, the Company shall promptly notify Perceptive in writing that it may pursue such a potential Debt Financing and Perceptive
shall have ten (10) Business Days from the receipt of such notice to provide the Company written notice that it desires to enter
into good faith negotiations with the Company regarding the Debt Financing (the “ROFN Option”). If Perceptive
does not provide written notice that it is exercising its ROFN Option within such period, then the Company shall have no further
obligation with respect to the ROFN Option and shall be free to negotiate and enter into any Debt Financing with any third party.
If Perceptive properly exercises the ROFN Option as described above, then the Parties shall negotiate exclusively, reasonably and
in good faith concerning the terms of the Debt Financing for a period of thirty (30) days. If the parties do not execute
an agreement with respect to the Debt Financing within such 30- day period, then the Company shall be free to negotiate and enter
into any Debt Financing with any third party; provided that if such third party transaction is, when taken as a whole, materially
less favorable to the Company than the terms last offered to the Company by Perspective, then the Company will provide written
notice describing and offering Perceptive such Debt Financing for a period of five (5) Business Days (after Perceptive’s
receipt of such notice) before entering such Debt Financing with a third party. If Perceptive elects to pursue such Debt Financing,
it shall deliver written notice to the Company within such 5 Business Day period, and the parties will proceed to negotiate and
finalize definitive agreements.
5.1 Insurance.
The Company shall use its best efforts to obtain, within ninety (90) days of the date hereof, from financially sound and reputable
insurers Directors and Officers liability insurance covering such risks as are adequate and customary for its size and business,
and in an amount and on terms and conditions satisfactory to the Board of Directors, including the Required Preferred Directors,
and will use its best efforts to cause such insurance policy to be maintained . Notwithstanding any other provision of this Section
5.1 to the contrary, for so long as a Series A Director or a Series B Director is serving on the Board of Directors, the Company
shall not cease to maintain a Directors and Officers liability insurance policy in an amount of at least five million dollars ($5,000,000),
and the Company shall annually, within one hundred twenty (120) days after the end of each fiscal year of the Company, deliver
to the Investors a certification that such a Directors and Officers liability insurance policy remains in effect.
5.2 Employee
Agreements. The Company will cause (i) each person now or hereafter employed by it, or by any subsidiary (or engaged by the
Company or any subsidiary as a consultant/independent contractor) with access to confidential information and/or trade secrets
to enter into a nondisclosure and proprietary rights assignment agreement in the form previously provided to the Investors; and
(ii) each Key Employee to enter into a one (1) year noncompetition and nonsolicitation agreement, substantially in the form approved
by the Board of Directors, including the Required Preferred Directors, in the form attached hereto as Exhibit A. In addition, the
Company shall not amend, modify, terminate, waive, or otherwise alter, in whole or in part, any of the above-referenced agreements
or any restricted stock agreement between the Company and any employee, without the consent of the Board, including the Required
Preferred Directors .
5.3 Employee
Stock. Unless otherwise approved by the Board of Directors, including the Required Preferred Directors, all employees and consultants
of the Company who purchase, receive options to purchase, or receive awards of shares of the Company’s capital stock after
the date hereof shall be required to execute restricted stock or option agreements, as applicable, providing for (i) vesting of
shares over a four (4) year period, with the first twenty-five percent (25%) of such shares vesting following twelve (12) months
of continued employment or service, and the remaining shares vesting in equal monthly installments over the following thirty-six
(36) months, and (ii) a market stand-off provision substantially similar to that in Subsection 2.11. Without the prior approval
by the Board of Directors, including the Required Preferred Directors, the Company shall not amend, modify, terminate, waive or
otherwise alter, in whole or in part, any stock purchase, stock restriction or option agreement with any existing employee or service
provider if such amendment would cause it to be inconsistent with this Subsection 5.3. In addition, unless otherwise approved
by the Board of Directors, including the Required Preferred Directors, the Company shall retain a “right of first refusal”
on employee transfers until the Company’s IPO and shall have the right to repurchase unvested shares at cost upon termination
of employment of a holder of restricted stock.
5.4 Matters
Requiring Investor Director Approval. The Company hereby covenants and agrees that, for so long as there is a Series A Director
or Series B Director, it shall not and the Company shall not cause or permit any subsidiary of the Company to, directly or indirectly,
take the following actions without the approval of the Board of Directors and the Required Preferred Directors:
(a) make,
or permit any subsidiary to make, any loan or advance to, or own any stock or other securities of, any subsidiary or other corporation,
partnership, or other entity unless it is wholly owned by the Company;
(b) make,
or permit any subsidiary to make, any loan or advance to any Person, including, without limitation, any employee or director of
the Company or any subsidiary, except advances and similar expenditures in the ordinary course of business or under the terms of
an employee stock or option plan approved by the Board of Directors , which shall not, in the aggregate, exceed $100,000;
(c) guarantee,
directly or indirectly, or permit any subsidiary to guarantee, directly or indirectly, any indebtedness except for trade accounts
of the Company or any subsidiary arising in the ordinary course of business;
(d) make
any investment inconsistent with any investment policy approved by the Board of Directors;
(e) otherwise
enter into or be a party to any transaction with any director, officer, or employee of the Company or any “associate”
(as defined in Rule 12b-2 promulgated under the Exchange Act) of any such Person, including without limitation any “management
bonus” or similar plan providing payments to employees in connection with a Deemed Liquidation Event, as such term is defined
in the Company’s Certificate of Incorporation, except for transactions contemplated by the Transaction Agreements;
(f) change
the principal business of the Company, enter new lines of business, or exit the current line of business;
(g) sell,
assign, license, pledge, or encumber material technology or intellectual property, other than licenses granted in the ordinary
course of business;
(h) enter
into any corporate strategic relationship involving the payment, contribution, or assignment by the Company or to the Company of
money or assets greater than $250,000; or
(i) enter
into, terminate, or amend any material agreement with any Affiliate.
5.5 Additional
Board Approval Matters. The Company hereby further covenants and agrees that, for so long as there is a Series A Director or
Series B Director, it shall not and the Company shall not cause or permit any subsidiary of the Company to, directly or indirectly,
take the following actions without the approval of no fewer than two thirds of the members of the Board of Directors; provided
that (i) for so long as there are eight total members of the Board of Directors, such vote must include the affirmative vote of
at least one (1) of the directors designated by OrbiMed and Bain and (ii) for so long as there are nine total members of the Board
of Directors, such vote must include the affirmative vote of at least two (2) of the directors designated by OrbiMed, Bain and
Perceptive:
(a) incur
any aggregate indebtedness in excess of $500,000 that is not already included in the Budget approved by the Board of Directors,
other than trade credit incurred in the ordinary course of business;
(b) hire,
terminate, or change the compensation of any executive officers (including, without limitation, the CEO, CBO, CSO, CFO, COO and
CMO), including approving any option grants or stock awards to executive officers;
(c) approve,
on an annual basis, the Company’s Budget or commence any research and/or development program that involves expenditures outside
the Budget; or
(d) amend
or adopt any equity incentive plan.
5.6 Board
Matters. Unless otherwise determined by the vote of a majority of the directors then in office, the Board of Directors shall
meet at least quarterly in accordance with an agreed-upon schedule. The Company shall cause to be established, as soon as practicable
after such request, and will maintain, an audit and compensation committee, each of which shall consist solely of non-management
directors. Each non-employee director shall be entitled in such person’s discretion to be a member of any committee of the
Board of Directors.
5.7 Successor
Indemnification. If the Company or any of its successors or assignees consolidates with or merges into any other Person and
is not the continuing or surviving corporation or entity of such consolidation or merger, then to the extent necessary, proper
provision shall be made so that the successors and assignees of the Company assume the obligations of the Company with respect
to indemnification of members of the Board of Directors as in effect immediately before such transaction, whether such obligations
are contained in the Company’s Bylaws, its Certificate of Incorporation, or elsewhere, as the case may be.
5.8 Expenses
of Counsel. In the event of a transaction which is a Sale of the Company (as defined in the Voting Agreement of even date herewith
among the Investors and the Company), the reasonable fees and disbursements of one counsel for the Major Investors selected by
the Required Majority (“Investor Counsel”) not to exceed $100,000, in their capacities as stockholders, shall
be borne and paid by the Company. At the outset of considering a transaction which, if consummated would constitute a Sale of the
Company, the Company shall use its best efforts to obtain the ability to share with the Investor Counsel (and such counsel's clients)
the confidential information (including, without limitation, the initial and all subsequent drafts of memoranda of understanding,
letters of intent and other transaction documents and related noncompete, employment, consulting and other compensation agreements
and plans) pertaining to and memorializing any of the transactions which, individually or when aggregated with others would constitute
the Sale of the Company. The Company shall use its best efforts to share (and cause the Company's counsel and investment bankers
to share) such materials when distributed to the Company's executives and/or any one or more of the other parties to such transaction(s).
In the event that Investor Counsel deems it appropriate, in its reasonable discretion, to enter into a joint defense agreement
or other arrangement to enhance the ability of the parties to protect their communications and other reviewed materials under the
attorney client privilege, the Company shall, and shall direct its counsel to, execute and deliver to Investor Counsel and its
clients such an agreement in form and substance reasonably acceptable to Investor Counsel. In the event that one or more of the
other party or parties to such transactions require the clients of Investor Counsel to enter into a confidentiality agreement and/or
joint defense agreement in order to receive such information, then the Company shall share whatever information can be shared without
entry into such agreement and shall, at the same time, in good faith work expeditiously to enable Investor Counsel and its clients
to negotiate and enter into the appropriate agreement(s) without undue burden to the clients of Investor Counsel.
5.9 Indemnification
Matters.
(a) The
Company hereby acknowledges that one (1) or more of the directors nominated to serve on the Board of Directors by the Investors
(each a “Fund Director”) may have certain rights to indemnification, advancement of expenses and/or insurance
provided by one or more of the Investors and certain of their affiliates (collectively, the “Fund Indemnitors”).
The Company hereby agrees (a) that it is the indemnitor of first resort (i.e., its obligations to any such Fund Director
are primary and any obligation of the Fund Indemnitors to advance expenses or to provide indemnification for the same expenses
or liabilities incurred by such Fund Director are secondary), (b) that it shall be required to advance the full amount of expenses
incurred by such Fund Director and shall be liable for the full amount of all expenses, judgments, penalties, fines and amounts
paid in settlement by or on behalf of any such Fund Director to the extent legally permitted and as required by the Company’s
Certificate of Incorporation or Bylaws of the Company (or any agreement between the Company and such Fund Director), without regard
to any rights such Fund Director may have against the Fund Indemnitors, and, (c) that it irrevocably waives, relinquishes and releases
the Fund Indemnitors from any and all claims against the Fund Indemnitors for contribution, subrogation or any other recovery of
any kind in respect thereof. The Company further agrees that no advancement or payment by the Fund Indemnitors on behalf
of any such Fund Director with respect to any claim for which such Fund Director has sought indemnification from the Company shall
affect the foregoing and the Fund Indemnitors shall have a right of contribution and/or be subrogated to the extent of such advancement
or payment to all of the rights of recovery of such Fund Director against the Company. The Investor Directors and the Investor
Inemnitors are intended third party beneficiaries of this Subsection 5.9(a) and shall have the right, power and authority
to enforce the provisions of this Subsection 5.9(a) as though they were a party to this Agreement.
(b) The
Company hereby agrees that upon the appointment of the Seires B Director in accordance with the terms of the Voting Agreement,
it will enter into an indemnification agreement with such Series B Director substantially in the form entered into with the other
members of the Board.
5.10 Right
to Conduct Activities.
(a) The
Company agrees and acknowledges that certain of the Investors are professional investment funds or in the business of venture capital
investing and therefore review the business plans and related proprietary information of many enterprises, and invest in numerous
enterprises, including enterprises that may have products or services that compete directly or indirectly with those of the Company.
The Company hereby agrees that, (a) to the fullest extent permitted under applicable law, no Investor shall be liable to the Company
for any claim arising out of, or based upon, (i) the investment by such Investor or any Affiliate of such Investor in any entity
competitive with the Company, or (ii) actions taken by any partner, officer or other representative of such Investor or any Affiliate
of such Investor to assist any such competitive company, whether or not such action was taken as a member of the board of directors
of such competitive company or otherwise, and whether or not such action has a detrimental effect on the Company, and (b) nothing
in this Agreement or any other Transaction Agreement or any agreement between the Company or its Affiliates and any Investor or
its Affiliates shall preclude or in any way restrict the Investors or their Affiliates from investing or participating in any particular
enterprise, whether or not such enterprise has products or services that compete with those of the Company. Further, the Company
and each of the Investors acknowledges and agrees that (A) certain of the Investors (or the Affiliates of such Investors) (each,
a “Strategic Investor”) may presently have, or may engage in the future in, internal development programs, or
may receive information from third parties that relates to, and may develop and commercialize products independently or in cooperation
with such third parties, that are similar to or that are directly or indirectly competitive with, the Company’s development
programs, products or services and (B) any employee of such Strategic Investor serving on the Board is serving in such capacity
at the request, and for the benefit, of the Company. Accordingly, such Strategic Investor’s designation of any individual
to the Board (any individual designated to the Board by any Investor is referred to as a “Board Designee”),
the service of any Board Designee on the Board, or the exercise by a Strategic Investor of any rights under this Agreement or any
other Transaction Agreement or any agreement between the Company or its Affiliates and any Investor or its Affiliates, shall not
in any way preclude or restrict such Strategic Investor from conducting any development program, commercializing any product or
service or otherwise engaging in any enterprise, whether or not such development program, product, service or enterprise, competes
with those of the Company, so long as such activities do not result in a violation of the confidentiality provisions of this Agreement
or any other Transaction Agreement or any agreement between the Company or its Affiliates and any Investor or its Affiliates. Nothing
herein shall be construed to impose on any Investor or any Board Designee any restriction, duty or obligation other than as expressly
set forth herein or therein.
(b) The
Company hereby agrees and acknowledges that HBM Healthcare Investments (Cayman) Ltd., together with its affiliates, is a professional
investment fund, and as such invests in numerous portfolio companies, some of which may be deemed competitive with the Company’s
business (as currently conducted or as currently propose to be conducted). The Company hereby agrees that, to the extent permitted
under applicable law, HBM Healthcare Investments (Cayman) Ltd. shall not be liable to the Company for any claim arising out of,
or based upon, (i) the investment by HBM Healthcare Investments (Cayman) Ltd. in any entity competitive with the Company, or (ii)
actions taken by any partner, officer or other representative of HBM Healthcare Investments (Cayman) Ltd. to assist any such competitive
company, whether or not such action was taken as a member of the board of directors of such competitive company or otherwise, and
whether or not such action has a detrimental effect on the Company; provided, however, that the foregoing shall not relieve (x)
any of the Investors from liability associated with the unauthorized disclosure of the Company’s confidential information
obtained pursuant to this Agreement or through participation on the Board of Directors, or (y) any director or officer of the Company
from any liability associated with his or her fiduciary duties to the Company.
(c) The
Company renounces, to the fullest extent permitted by law, any interest or expectancy of the Company in, or in being offered an
opportunity to participate in, any matter, transaction or interest that is presented to, or acquired, created or developed by,
or which otherwise comes into the possession of a Board Designee of either Bain or OrbiMed or their Affiliates and agrees that
it shall not take any action, or adopt any resolution, inconsistent with the foregoing.
5.11 FCPA
Compliance. The Company shall not, and shall not permit any of its subsidiaries or any of its or their respective directors,
officers, managers, employees, independent contractors, representatives or agents (collectively, “Representatives”)
to, promise, authorize or make any payment to, or otherwise contribute any item of value to, directly or indirectly, any non-U.S.
government official, in each case, in violation of the U.S. Foreign Corrupt Practices Act (“FCPA”) or any other
applicable anti-bribery or anti-corruption law. The Company shall, and shall cause each of its subsidiaries to, cease all of its
or their respective activities, as well as remediate any actions taken by the Company, its subsidiaries or any of its or their
respective Representatives in violation of the FCPA or any other applicable anti-bribery or anti-corruption law. The Company shall,
and shall cause each of its subsidiaries to, maintain systems or internal controls (including, but not limited to, accounting systems,
purchasing systems and billing systems) to ensure compliance with the FCPA or any other applicable anti-bribery or anti-corruption
law.
5.12 Termination
of Covenants. The covenants set forth in this Section 5, except for Subsections 5.7 – 11, shall
terminate and be of no further force or effect (i) immediately before the consummation of the IPO, or (ii) upon a Deemed Liquidation
Event, as such term is defined in the Company’s Certificate of Incorporation, whichever event occurs first.
6.1 Successors
and Assigns. The rights under this Agreement may be assigned in whole or in part (but only with all related obligations) by
a Holder to a transferee of Registrable Securities that (i) is an Affiliate of a Holder or, in the case of LifeArc, an Affiliate
or a member of the LifeArc Group; (ii) is a Holder’s Immediate Family Member or trust for the benefit of an individual Holder
or one or more of such Holder’s Immediate Family Members; or (iii) after such transfer, holds at least 5% shares of Registrable
Securities (subject to appropriate adjustment for stock splits, stock dividends, combinations, and other recapitalizations); provided,
however, that (x) the Company is, within a reasonable time after such transfer, furnished with written notice of the name
and address of such transferee and the Registrable Securities with respect to which such rights are being transferred; and (y)
such transferee agrees in a written instrument delivered to the Company to be bound by and subject to the terms and conditions
of this Agreement, including the provisions of Subsection 2.11. For the purposes of determining the number of shares of
Registrable Securities held by a transferee, the holdings of a transferee (1) that is an Affiliate or stockholder of a Holder;
(2) who is a Holder’s Immediate Family Member; or (3) that is a trust for the benefit of an individual Holder or such Holder’s
Immediate Family Member shall be aggregated together and with those of the transferring Holder; provided further that all
transferees who would not qualify individually for assignment of rights shall, as a condition to the applicable transfer, establish
a single attorney-in-fact for the purpose of exercising any rights, receiving notices, or taking any action under this Agreement.
The terms and conditions of this Agreement inure to the benefit of and are binding upon the respective successors and permitted
assignees of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties
hereto or their respective successors and permitted assignees any rights, remedies, obligations or liabilities under or by reason
of this Agreement, except as expressly provided herein.
6.2 Governing
Law. This Agreement shall be governed by the internal law of the State of Delaware, without regard to conflict of law principles
that would result in the application of any law other than the law of the State of Delaware.
6.3 Counterparts.
This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together
shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf or any
electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) or other transmission method
and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.
6.4 Titles
and Subtitles. The titles and subtitles used in this Agreement are for convenience only and are not to be considered in construing
or interpreting this Agreement.
6.5 Notices.
All notices and other communications given or made pursuant to this Agreement shall be in writing and shall be deemed effectively
given upon the earlier of actual receipt or (i) personal delivery to the party to be notified; (ii) when sent, if sent by electronic
mail or facsimile during the recipient’s normal business hours, and if not sent during normal business hours, then on the
recipient’s next business day; (iii) five (5) days after having been sent by registered or certified mail, return receipt
requested, postage prepaid; or (iv) one (1) business day after the business day of deposit with a nationally recognized overnight
courier, freight prepaid, specifying next-day delivery, with written verification of receipt. All communications shall be sent
to the respective parties at their addresses as set forth on Schedule A hereto, or to the principal office of the Company
and to the attention of the Chief Executive Officer, in the case of the Company, or to such email address, facsimile number, or
address as subsequently modified by written notice given in accordance with this Subsection 6.5. If notice is given to the
Company, a copy shall also be sent to Kingsley Taft, Esq., Goodwin Procter LLP, 100 Northern Avenue, Boston, Massachusetts 02210,
(617) 523-1231 (fax), ktaft@goodwinlaw.com, and if notice is given to Stockholders, a copy shall also be given to Tannenbaum Helpern
Syracuse & Hirschtritt LLP, 900 Third Avenue, 13th Floor, New York, NY 10022, Attn: David R. Lallouz. Notwithstanding
any of the foregoing, with respect to HBM Healthcare Investments (Cayman) Ltd., only a nationally recognized overnight courier
shall be used to effectuate the delivery of any notices pursuant to this Subsection 6.5, and such notice or other communication
for purposes of this Agreement shall not be treated as effective or having been given if some other delivery method is utilized;
and a copy (which shall not constitute notice) shall also be sent to Cooley LLP, 3175 Hanover Street, Palo Alto, CA 94304, Attention:
Mehdi Khodadad, Esq.
6.6 Amendments
and Waivers. Any term of this Agreement may be amended, modified or terminated and the observance of any term of this Agreement
may be waived (either generally or in a particular instance, and either retroactively or prospectively) only with the written consent
of the Company, the holders of at least a majority of the Series A Preferred Stock then outstanding, and the Series B Preferred
Stock then outstanding voting together as a single class on an as-converted basis, provided, however, that this Agreement
may not be amended, modified or termination and the observance of any term hereof may not be waived (either generally or in a particular
instance and either retroactively or prospectively) with respect to any series of Preferred Stock, without the written consent
of the holders of , as applicable, (1) more than 50% of the then outstanding shares of Series B Preferred Stock, with respect to
the Series B Preferred Stock; (2) at least 55% of the then outstanding shares of Series A Preferred Stock, with respect to the
Series A Preferred Stock; and (3) more than 50% of the then outstanding shares of Junior Series A Preferred Stock, with respect
to the Junior Series A Preferred Stock; unless such amendment, modification, termination or waiver applies to all series of Preferred
Stock in the same fashion; provided, further, that the Company may in its sole discretion waive compliance with Subsection
2.12(c) (and the Company’s failure to object promptly in writing after notification of a proposed assignment allegedly
in violation of Subsection 2.12(c) shall be deemed to be a waiver); and provided further that any provision hereof
may be waived by any waiving party on such party’s own behalf, without the consent of any other party; Notwithstanding the
foregoing, (a) this Agreement may not be amended, modified or terminated and the observance of any term hereof may not be waived
with respect to any Investor without the written consent of such Investor, unless such amendment, modification, termination, or
waiver applies to all Investors in the same fashion (it being agreed that a waiver of the provisions of Section 4 with respect
to a particular transaction shall be deemed to apply to all Investors in the same fashion if such waiver does so by its terms,
notwithstanding the fact that certain Investors may nonetheless, by agreement with the Company, purchase securities in such transaction);
(b) Subsections 3.1 and 3.2, Section 4 and any other section of this Agreement applicable to the Major Investors
(including this clause (b) of this Subsection 6.6) may not be amended, modified, terminated or waived without the written
consent of the holders of at least a majority of the Registrable Securities then outstanding and held by the Major Investors. Notwithstanding
the foregoing, Schedule A hereto may be amended by the Company from time to time to add transferees of any Registrable Securities
in compliance with the terms of this Agreement without the consent of the other parties; and Schedule A hereto may also
be amended by the Company after the date of this Agreement without the consent of the other parties to add information regarding
any additional Investor who becomes a party to this Agreement in accordance with Subsection 6.9; and (c) any amendment,
modification, termination or waiver of Subection 1.8 that materially and adversely affects the rights of an Investor named therein
shall require the consent of such Investor . The Company shall give prompt notice of any amendment or termination hereof or waiver
hereunder to any party hereto that did not consent in writing to such amendment, modification, termination, or waiver. Any amendment,
modification, termination, or waiver effected in accordance with this Subsection 6.6 shall be binding on all parties hereto,
regardless of whether any such party has consented thereto. No waivers of or exceptions to any term, condition, or provision of
this Agreement, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of any such
term, condition, or provision.
6.7 Severability.
In case any one or more of the provisions contained in this Agreement is for any reason held to be invalid, illegal or unenforceable
in any respect, such invalidity, illegality, or unenforceability shall not affect any other provision of this Agreement, and such
invalid, illegal, or unenforceable provision shall be reformed and construed so that it will be valid, legal, and enforceable to
the maximum extent permitted by law.
6.8 Aggregation
of Stock. All shares of Registrable Securities held or acquired by Affiliates shall be aggregated together for the purpose
of determining the availability of any rights under this Agreement and such Affiliated persons may apportion such rights as among
themselves in any manner they deem appropriate.
6.9 Additional
Investors. Notwithstanding anything to the contrary contained herein, (i) if the Company issues additional shares of the Company’s
Series B Preferred Stock after the date hereof or (ii) shares held by LifeArc are transferred within the LifeArc Group, any purchaser,
in the case of (i), or transferee, in the case of (ii), of such shares of Series B Preferred Stock may become a party to this Agreement
by executing and delivering an additional counterpart signature page to this Agreement, and thereafter shall be deemed an “Investor”
for all purposes hereunder. No action or consent by the Investors shall be required for such joinder to this Agreement by such
additional Investor, so long as such additional Investor has agreed in writing to be bound by all of the obligations as an “Investor”
hereunder.
6.10 Entire
Agreement. This Agreement (including any Schedules and Exhibits hereto) constitutes the full and entire understanding and agreement
among the parties with respect to the subject matter hereof, and any other written or oral agreement relating to the subject matter
hereof existing between the parties is expressly canceled. Upon the effectiveness of this Agreement, that certain Registration
Rights Ageement, dated as of August 18, 2017, by and among the Company and the parties named thereto, shall be deemed amended and
restated and superseded and replaced in its entirety by this Agreement, and shall be of no further force or effect.
6.11 Dispute
Resolution. The parties (a) hereby irrevocably and unconditionally submit to the jurisdiction of the state courts of Delaware
and to the jurisdiction of the United States District Court for the District of Delaware for the purpose of any suit, action or
other proceeding arising out of or based upon this Agreement, (b) agree not to commence any suit, action or other proceeding arising
out of or based upon this Agreement except in the state courts of Delaware or the United States District Court for the District
of Delaware, and (c) hereby waive, and agree not to assert, by way of motion, as a defense, or otherwise, in any such suit, action
or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is
exempt or immune from attachment or execution, that the suit, action or proceeding is brought in an inconvenient forum, that the
venue of the suit, action or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in
or by such court.
Waiver
of Jury Trial: EACH PARTY HEREBY WAIVES ITS RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING
OUT OF THIS AGREEMENT, THE OTHER TRANSACTION DOCUMENTS, THE SECURITIES OR THE SUBJECT MATTER HEREOF OR THEREOF. THE SCOPE OF THIS
WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT
MATTER OF THIS TRANSACTION, INCLUDING, WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS (INCLUDING NEGLIGENCE), BREACH OF DUTY
CLAIMS, AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS. THIS SECTION HAS BEEN FULLY DISCUSSED BY EACH OF THE PARTIES HERETO AND
THESE PROVISIONS WILL NOT BE SUBJECT TO ANY EXCEPTIONS. EACH PARTY HERETO HEREBY FURTHER WARRANTS AND REPRESENTS THAT SUCH PARTY
HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT SUCH PARTY KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING
CONSULTATION WITH LEGAL COUNSEL.
Each party will bear
its own costs in respect of any disputes arising under this Agreement. The prevailing party shall be entitled to reasonable attorney’s
fees, costs, and necessary disbursements in addition to any other relief to which such party may be entitled. Each of the parties
to this Agreement consents to personal jurisdiction for any equitable action sought in the U.S. District Court for the District
of Delaware or any court of the State of Delaware having subject matter jurisdiction.
6.12 Delays
or Omissions. No delay or omission to exercise any right, power, or remedy accruing to any party under this Agreement, upon
any breach or default of any other party under this Agreement, shall impair any such right, power, or remedy of such nonbreaching
or nondefaulting party, nor shall it be construed to be a waiver of or acquiescence to any such breach or default, or to any similar
breach or default thereafter occurring, nor shall any waiver of any single breach or default be deemed a waiver of any other breach
or default theretofore or thereafter occurring. All remedies, whether under this Agreement or by law or otherwise afforded to any
party, shall be cumulative and not alternative.
[Remainder of Page Intentionally Left
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IN WITNESS WHEREOF, the
parties have executed this Agreement as of the date first written above.
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SPRINGWORKS THERAPEUTICS, INC. |
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By: |
/s/ Saqib Islam |
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Name: |
Saqib Islam |
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Title: |
Chief Executive Officer |
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Investors: |
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PFIZER INC. |
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By: |
/s/ Barbara
Dalton |
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Name: Barbara Dalton |
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Title: Vice President |
Signature
Page to Series B Investors Rights Agreement
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Investors: |
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PFIZER VENTURES (US) LLC |
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By: |
/s/ Barbara
Dalton |
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Name: Barbara Dalton |
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Title: President |
Signature
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Investors: |
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BC SW, LP |
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By: |
Bain Capital Life Sciences Investors, LLC its general partner |
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By: |
/s/ Jeff Schwartz |
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Name: Jeff Schwartz |
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Title: Managing Director |
Signature
Page to Series B Investors Rights Agreement
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Investors: |
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ORBIMED PRIVATE INVESTMENTS VI, LP |
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By: |
OrbiMed Capital GP VI LLC, |
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its General Partner |
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By: |
OrbiMed Advisors LLC, |
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its Managing Member |
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By: |
/s/ Carl Gordon |
|
Name: Carl Gordon |
|
Title: Member |
INVESTORS RIGHTS AGREEMENT
|
LIFEARC |
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By: |
/s/ Peter Keen |
|
|
|
Name: Peter Keen |
|
Title: Director |
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
PERCEPTIVE LIFE SCIENCES MASTER FUND, LTD. |
|
|
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By: |
/s/ Adam Stone |
|
|
|
Name: Adam Stone |
|
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Title: CEO |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
BIOTECHNOLOGY VALUE FUND, LP |
|
|
|
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By: |
/s/ Mark Lampert |
|
Name: Mark Lampert |
|
Title: President BVF Inc., General Partner of BVF Partners L.P., itself GP of Biotechnology Value Fund, L.P. |
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Address: |
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44 Montgomery Street, 40th Floor |
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San Francisco, CA 94104 |
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With a copy to (which shall not constitute notice): |
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Gibson, Dunn & Crutcher LLP |
|
555 Mission Street, Suite 3000 |
|
San Francisco, CA 94105 |
|
Attention: Ryan A. Murr |
|
EIN: |
36-3924731 |
|
|
|
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Contact: |
James Kratky, CCO |
|
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Email: |
kratky@bvflp.com |
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Address for physical delivery of securities: |
|
|
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The Depository Trust Company |
|
570 Washington Boulevard – 5th Floor |
|
Jersey City, NJ 07310 |
|
Attn: BNY Mellon Branch Deposit Department |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
BIOTECHNOLOGY VALUE FUND II, LP |
|
|
|
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By: |
/s/ Mark Lampert |
|
Name: Mark Lampert |
|
Title: President BVF Inc., General Partner of BVF Partners L.P., itself GP of Biotechnology Value Fund II, L.P. |
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Address: |
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44 Montgomery Street, 40th Floor |
|
San Francisco, CA 94104 |
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With a copy to (which shall not constitute notice): |
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|
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Gibson, Dunn & Crutcher LLP |
|
555 Mission Street, Suite 3000 |
|
San Francisco, CA 94105 |
|
Attention: Ryan A. Murr |
|
EIN: |
94-3341571 |
|
|
|
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Contact: |
James Kratky, CCO |
|
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Email: |
kratky@bvflp.com |
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Address for physical delivery of securities: |
|
|
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The Depository Trust Company |
|
570 Washington Boulevard – 5th Floor |
|
Jersey City, NJ 07310 |
|
Attn: BNY Mellon Branch Deposit Department |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
BIOTECHNOLOGY VALUE TRADING FUND OS, L.P. |
|
|
|
|
By: |
/s/ Mark Lampert |
|
Name: Mark Lampert |
|
Title: President BVF Inc., General Partner of BVF Partners L.P., itself sole member of BVF Partners OS Ltd., itself GP of
Biotechnology Trading Fund OS, L.P. |
|
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Address: |
|
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PO Box 309 Ugland House, |
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Grand Cayman, KY1- 1104, |
|
Cayman Islands |
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With a copy to (which shall not constitute notice): |
|
|
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Gibson, Dunn & Crutcher LLP |
|
555 Mission Street, Suite 3000 |
|
San Francisco, CA 94105 |
|
Attention: Ryan A. Murr |
|
EIN: |
98-1263910 |
|
|
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Contact: |
James Kratky, CCO |
|
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Email: |
kratky@bvflp.com |
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Address for physical delivery of securities: |
|
|
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The Depository Trust Company |
|
570 Washington Boulevard – 5th Floor |
|
Jersey City, NJ 07310 |
|
Attn: BNY Mellon Branch Deposit Department |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
MSI BVF SPV, L.L.C. |
|
c/o Magnitude Capital |
|
|
|
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By: |
/s/ Mark Lampert |
|
Name: Mark Lampert |
|
Title: President BVF Inc., itself General Partner of BVF Partners L.P., itself attorney-in-fact for MSI BVF SPV, L.L.C. |
|
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Address: |
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200 Park Avenue, 56th Floor |
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New York, NY 10166 |
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With a copy to (which shall not constitute notice): |
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Gibson, Dunn & Crutcher LLP |
|
555 Mission Street, Suite 3000 |
|
San Francisco, CA 94105 |
|
Attention: Ryan A. Murr |
|
EIN: |
46-5658235 |
|
|
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Contact: |
James Kratky, CCO |
|
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Email: |
kratky@bvflp.com |
|
|
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Address for physical delivery of securities: |
|
|
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BNP Paribas Prime Brokerage, Inc. |
|
787 7th Ave, 8th floor |
|
New York , NY 10019 |
|
Attn: Jose A. Nevarez |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
HBM HEALTHCARE INVESTMENTS (CAYMAN) LTD. |
|
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|
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By: |
/s/ Jean-Marc Lesieur |
|
|
|
Name: Jean-Marc Lesieur |
|
|
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Title: Managing Director |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
BOXER CAPITAL, LLC |
|
|
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By: |
/s/ Aaron Davis |
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|
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Name: Aaron Davis |
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|
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Title: Chief Executive Officer |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
MVA INVESTORS, LLC |
|
|
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By: |
/s/ Aaron Davis |
|
|
|
Name: Aaron Davis |
|
|
|
Title: Chief Executive Officer |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
CITADEL MULTI-STRATEGY EQUITIES MASTER FUND LTD. |
|
|
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By: Citadel Advisors LLC, its portfolio manager |
|
|
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By: |
/s/ Noah Goldberg |
|
|
|
Name: Noah Goldberg |
|
|
|
Title: Authorized Signatory |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
FIFTH AVENUE PRIVATE EQUITY 15 LLC |
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|
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By: |
/s/
Charles D. Bryceland |
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|
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Name: Charles D. Bryceland |
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|
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Title: Authorized Signatory |
Signature
Page to Investor Rights Agreement
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Investors: |
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Summer Beauty Limited |
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By: |
/s/ Jacky Xu |
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Name: |
Jacky Xu |
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|
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Title: |
21/3/2019 |
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
MOUSSERENA, L.P. |
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By: |
/s/ Charles Heilbronn |
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|
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Name: Charles Heilbronn |
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|
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Title: |
President of Serena Limited General Partner of Mousserena,
L.P. |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
SAMSARA BIOCAPITAL, L.P. |
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|
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By: Samsara BioCapital GP, LLC, General Partner |
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By: |
/s/ Srinivas Akkaraju |
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|
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Name: Srinivas Akkaraju, MD, PhD |
|
Title: Managing Member |
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Address: 628 Middlefield Road
Palo Alto, CA 94301 |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
By: |
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|
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On behalf of |
Authorised Signatory
For and on behalf of
The Wellcome Foundation Limited
Corporate Director |
|
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GLAXO GROUP LIMITED |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
ArrowMark Life Science Fund, LP |
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|
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By: its General Partner |
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AMP Life Science GP, LLC |
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|
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By: |
/s/ David Corkins |
|
Name: David Corkins |
|
Title: Managing Member |
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ArrowMark Fundamental Opportunity Fund, L.P. |
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|
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By: its General Partner |
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ArrowMark Partners GP, LLC |
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|
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By: |
/s/ David Corkins |
|
Name: David Corkins |
|
Title: Managing Member |
|
Lookfar Investments, LLC |
|
|
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By: |
/s/ David Corkins |
|
Name: David Corkins |
|
Title: Managing Member |
|
CF Ascent LLC |
|
|
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By: |
/s/ David Corkins |
|
Name: David Corkins |
|
Title: Managing Member |
|
THB Iron Rose LLC |
|
|
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By: its Investment Adviser |
|
ArrowMark Colorado Holdings LLC |
|
|
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By: |
/s/ David Corkins |
|
Name: David Corkins |
|
Title: Managing Member |
|
Iron Horse Investment, LLC |
|
|
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By: its Investment Adviser |
|
ArrowMark Colorado Holdings LLC |
|
|
|
By: |
/s/ David Corkins |
|
Name: David Corkins |
|
Title: Managing Member |
[Signature
Page to Investor Rights Agreement]
IN WITNESS WHEREOF, the parties have executed
this Agreement as of the date first written above.
|
LAURION CAPITAL MASTER FUND LTD |
|
|
|
By: Laurion Capital Management LP |
|
Its: Investment Manager |
|
|
|
By: |
/s/ Jason Riesel |
|
Name: Jason Riesel |
|
Title: General Counsel and CCO |
|
|
|
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By: |
/s/ Masih Mohebbi |
|
Name: Masih Mohebbi |
|
Title: Chief Financial Officer |
|
|
|
Address: |
|
|
|
360 Madison Ave, 20th Floor
New York, NY 10017
Attn: Jason Riesel
E-Mail: compliance@laurioncap.com |
Signature
Page to Investor Rights Agreement
IN WITNESS WHEREOF, the parties have executed
this Investor Rights Agreement as of the date first written above.
|
TODD & KAREN WANEK JTWROS |
|
|
|
/s/ Todd Wanek |
|
Name: Todd Wanek |
|
|
|
/s/ Karen Wanek |
|
Name: Karen Wanek |
[Signature
Page to Investor Rights Agreement]
SCHEDULE A
Investors
Name and Address: |
Pfizer Ventures (US) LLC
c/o Pfizer Inc.
235 East 42nd Street
New York, NY 10017
United States of America
Attention: Barbara Dalton
Email: barbara.dalton@pfizer.com
With a copy to:
Andrew J. Muratore, Esq.
Pfizer Inc.
235 East 42nd Street
New York, NY 10017
United States of America
Email: andrew.j.muratore@pfizer.com
|
BC SW, LP
c/o Bain Capital Life Sciences, LP
200 Clarendon Street
Boston, MA 02116
With a copy to:
WilmerHale
60 State Street
Boston, MA 02109
Attn: Stuart M. Falber, Esq.
stuart.falber@wilmerhale.com
|
OrbiMed Private Investments VI,
LP
c/o OrbiMed Advisors LLC
601 Lexington Avenue, 54th
Floor
New York, NY 10022
Attention: General Counsel
Tel: 212-739-6400
Email: Legal@OrbiMed.com
With a copy to:
WilmerHale
60 State Street
Boston, MA 02109
Attn: Stuart M. Falber, Esq.
stuart.falber@wilmerhale.com
|
Perceptive Life Sciences Master
Fund, Ltd.
51 Astor Place, 10th floor
New York, NY 10003 |
Biotechnology Value Fund, LP
44 Montgomery Street, 40th Floor
San Francisco, CA 94104
With a copy to (which shall not constitute
notice): Gibson, Dunn & Crutcher LLP
555 Mission Street, Suite 3000
San Francisco, CA 94105 Attention:
Ryan A. Murr |
Biotechnology Value Fund II, LP
44 Montgomery Street, 40th Floor
San Francisco, CA 94104
With a copy to (which shall not constitute
notice): Gibson, Dunn & Crutcher LLP
555 Mission Street, Suite 3000
San Francisco, CA 94105 Attention:
Ryan A. Murr |
Biotechnology Value Trading Fund
OS, LP
44 Montgomery Street, 40th Floor
San Francisco, CA 94104
With a copy to (which shall not constitute
notice): Gibson, Dunn & Crutcher LLP
555 Mission Street, Suite 3000
San Francisco, CA 94105 Attention:
Ryan A. Murr |
MSI BVF SPV LLC
44 Montgomery Street, 40th Floor
San Francisco, CA 94104
With a copy to (which shall not constitute
notice): Gibson, Dunn & Crutcher LLP
555 Mission Street, Suite 3000
San Francisco, CA 94105 Attention:
Ryan A. Murr |
HBM Healthcare Investments (Cayman)
Ltd.
Bundesplatz 1
CH-6300 Zug
Switzerland |
Boxer Capital, LLC
11682 El Camino Real, Suite 320
San Diego, CA 92130
United States |
MVA Investors, LLC
11682 El Camino Real, Suite 320
San Diego, CA 92130
United States |
LifeArc
Lynton House, 7-12 Tavistock
Square
London WC1H 9LT |
Citadel Multi-Strategy Equities
Master Fund Ltd.
c/o Citadel Advisors LLC
601 Lexington Avenue
New York, New York
Attn: Noah Goldberg and Harry Greenbaum
CitadelAgreementNotice@citadel.com |
Fifth Avenue Private Equity 15 LLC
630 Fifth Avenue
New York, NY 100111 |
Summer Beauty Limited
4003, 40F, Two Exchange Square,
Central, Hong Kong |
Mousserena, L.P
9 West 57th Street
Suite 4605
New York, NY |
Samsara BioCapital, L.P.
628 Middlefield Road
Palo Alto, CA 94301 |
ArrowMark Life Science Fund, L.P.
100 Fillmore Street,
Suite 325
Denver, Colorado 80206 |
ArrowMark Fundamental Opportunity
Fund, L.P.
100 Fillmore Street,
Suite 325
Denver, Colorado 80206 |
Lookfar Investments, LLC
100 Fillmore Street,
Suite 325
Denver, Colorado 80206 |
CF Ascent LLC
100 Fillmore Street,
Suite 325
Denver, Colorado 80206 |
THB Iron Rose, LLC
100 Fillmore Street,
Suite 325
Denver, Colorado 80206 |
Iron Horse Investments, LLC
100 Fillmore Street,
Suite 325
Denver, Colorado 80206 |
Glaxo Group Limited
980 Great West Road
Brentford, TW8 9GS
United Kingdom |
Laurion Capital Master Fund Ltd.
360 Madison Ave, 20th Floor
New York, NY 10017
Attention: Jason Riesel
E-mail: compliance@laurioncap.com |
Todd & Karen Wanek JWROS
100 North Tampa Street
Suite 400
Tampa, FL 33602 |
Exhibit 5.1
|
|
Goodwin
Procter llp
100
Northern Avenue
Boston, MA 02210
goodwinlaw.com
+1
617 570 1000 |
|
|
|
|
September
3, 2019 |
SpringWorks
Therapeutics, Inc.
100
Washington Blvd.
Stamford,
CT 06902
Re: Securities
Registered under Registration Statement on Form S-1
Ladies
and Gentlemen:
We
have acted as counsel to you in connection with your filing of a Registration Statement on Form S-1 (File No. 333-233351) (as
amended or supplemented, the “Registration Statement”) pursuant to the Securities Act of 1933, as amended (the “Securities
Act”), relating to the registration of the offering by SpringWorks Therapeutics, Inc., a Delaware corporation (the “Company”)
of up to 8,455,882 shares (the “Shares”) of the Company’s Common Stock, $0.0001 par value per share, including
Shares purchasable by the underwriters upon their exercise of an over-allotment option granted to the underwriters by the Company.
The Shares are being sold to the several underwriters named in, and pursuant to, an underwriting agreement among the Company and
such underwriters (the “Underwriting Agreement”).
We
have reviewed such documents and made such examination of law as we have deemed appropriate to give the opinions set forth below.
We have relied, without independent verification, on certificates of public officials and, as to matters of fact material to the
opinions set forth below, on certificates of officers of the Company.
The
opinion set forth below is limited to the Delaware General Corporation Law.
Based
on the foregoing, we are of the opinion that the Shares have been duly authorized and, upon issuance and delivery against payment
therefor in accordance with the terms of the Underwriting Agreement, the Shares will be validly issued, fully paid and non-assessable.
We
hereby consent to the inclusion of this opinion as Exhibit 5.1 to the Registration Statement and to the references to our firm
under the caption “Legal Matters” in the Registration Statement. In giving our consent, we do not admit that we are
in the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations thereunder.
|
Very
truly yours, |
|
|
|
/s/
Goodwin Procter LLP |
|
|
|
GOODWIN
PROCTER LLP |
Exhibit 10.2
SPRINGWORKS THERAPEUTICS, INC.
2019 STOCK OPTION AND EQUITY INCENTIVE
PLAN
| SECTION 1. | GENERAL PURPOSE OF THE PLAN; DEFINITIONS |
The name of the plan is the SpringWorks
Therapeutics, Inc. 2019 Stock Option and Equity Incentive Plan (the “Plan”). The purpose of the Plan is to encourage
and enable the officers, employees, Non-Employee Directors and Consultants of SpringWorks Therapeutics, Inc. (the “Company”)
and its Affiliates upon whose judgment, initiative and efforts the Company largely depends for the successful conduct of its business
to acquire a proprietary interest in the Company. It is anticipated that providing such persons with a direct stake in the Company’s
welfare will assure a closer identification of their interests with those of the Company and its stockholders, thereby stimulating
their efforts on the Company’s behalf and strengthening their desire to remain with the Company.
The following terms shall be defined as
set forth below:
“Act” means the Securities
Act of 1933, as amended, and the rules and regulations thereunder.
“Administrator” means
either the Board or the compensation committee of the Board or a similar committee performing the functions of the compensation
committee and which is comprised of not less than two Non-Employee Directors who are independent.
“Affiliate” means, at
the time of determination, any “parent” or “subsidiary” of the Company as such terms are defined in Rule
405 of the Act. The Board will have the authority to determine the time or times at which “parent” or “subsidiary”
status is determined within the foregoing definition.
“Award” or “Awards,”
except where referring to a particular category of grant under the Plan, shall include Incentive Stock Options, Non-Qualified Stock
Options, Stock Appreciation Rights, Restricted Stock Units, Restricted Stock Awards, Unrestricted Stock Awards, Cash-Based Awards,
and Dividend Equivalent Rights.
“Award Certificate” means
a written or electronic document setting forth the terms and provisions applicable to an Award granted under the Plan. Each Award
Certificate is subject to the terms and conditions of the Plan.
“Board” means the Board
of Directors of the Company.
“Cash-Based Award” means
an Award entitling the recipient to receive a cash-denominated payment.
“Code” means the Internal
Revenue Code of 1986, as amended, and any successor Code, and related rules, regulations and interpretations.
“Consultant” means a
consultant or adviser who provides bona fide services to the Company or an Affiliate as an independent contractor and who
qualifies as a consultant or advisor under Instruction A.1.(a)(1) of Form S-8 under the Act.
“Dividend Equivalent Right”
means an Award entitling the grantee to receive credits based on cash dividends that would have been paid on the shares of Stock
specified in the Dividend Equivalent Right (or other award to which it relates) if such shares had been issued to and held by the
grantee.
“Effective Date” means
the date on which the Plan becomes effective as set forth in Section 19.
“Exchange Act” means
the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder.
“Fair Market Value” of
the Stock on any given date means the fair market value of the Stock determined in good faith by the Administrator; provided, however,
that if the Stock is listed on the National Association of Securities Dealers Automated Quotation System (“Nasdaq”),
Nasdaq Global Market, The New York Stock Exchange or another national securities exchange or traded on any established market,
the determination shall be made by reference to market quotations. If there are no market quotations for such date, the determination
shall be made by reference to the last date preceding such date for which there are market quotations; provided further, however,
that if the date for which Fair Market Value is determined is the Registration Date, the Fair Market Value shall be the “Price
to the Public” (or equivalent) set forth on the cover page for the final prospectus relating to the Company’s initial
public offering.
“Incentive Stock Option”
means any Stock Option designated and qualified as an “incentive stock option” as defined in Section 422 of the
Code.
“Non-Employee Director”
means a member of the Board who is not also an employee of the Company or any Subsidiary.
“Non-Qualified Stock Option”
means any Stock Option that is not an Incentive Stock Option.
“Option” or “Stock
Option” means any option to purchase shares of Stock granted pursuant to Section 5.
“Registration Date” means
the date upon which the registration statement on Form S-1 that is filed by the Company with respect to its initial public offering
is declared effective by the Securities and Exchange Commission.
“Restricted Shares” means
the shares of Stock underlying a Restricted Stock Award that remain subject to a risk of forfeiture or the Company’s right
of repurchase.
“Restricted Stock Award”
means an Award of Restricted Shares subject to such restrictions and conditions as the Administrator may determine at the time
of grant.
“Restricted Stock Units”
means an Award of stock units subject to such restrictions and conditions as the Administrator may determine at the time of grant.
“Sale Event” means (i)
the sale of all or substantially all of the assets of the Company on a consolidated basis to an unrelated person or entity, (ii)
a merger, reorganization or consolidation pursuant to which the holders of the Company’s outstanding voting power and outstanding
stock immediately prior to such transaction do not own a majority of the outstanding voting power and outstanding stock or other
equity interests of the resulting or successor entity (or its ultimate parent, if applicable) immediately upon completion of such
transaction, (iii) the sale of all of the Stock of the Company to an unrelated person, entity or group thereof acting in concert,
or (iv) any other transaction in which the owners of the Company’s outstanding voting power immediately prior to such transaction
do not own at least a majority of the outstanding voting power of the Company or any successor entity immediately upon completion
of the transaction other than as a result of the acquisition of securities directly from the Company.
“Sale Price” means the
value as determined by the Administrator of the consideration payable, or otherwise to be received by stockholders, per share of
Stock pursuant to a Sale Event.
“Section 409A” means
Section 409A of the Code and the regulations and other guidance promulgated thereunder.
“Service Relationship” means
any relationship as an employee, director or Consultant of the Company or any Affiliate (e.g., a Service Relationship shall be
deemed to continue without interruption in the event an individual’s status changes from full-time employee to part-time
employee or Consultant).
“Stock” means the Common
Stock, par value $0.0001 per share, of the Company, subject to adjustments pursuant to Section 3.
“Stock Appreciation Right”
means an Award entitling the recipient to receive shares of Stock (or cash, to the extent explicitly provided for in the applicable
Award Certificate) having a value equal to the excess of the Fair Market Value of the Stock on the date of exercise over the exercise
price of the Stock Appreciation Right multiplied by the number of shares of Stock with respect to which the Stock Appreciation
Right shall have been exercised.
“Subsidiary” means any
corporation or other entity (other than the Company) in which the Company has at least a 50 percent interest, either directly or
indirectly.
“Ten Percent Owner” means
an employee who owns or is deemed to own (by reason of the attribution rules of Section 424(d) of the Code) more than 10 percent
of the combined voting power of all classes of stock of the Company or any parent or subsidiary corporation.
“Unrestricted Stock Award”
means an Award of shares of Stock free of any restrictions.
| SECTION 2. | ADMINISTRATION OF PLAN; ADMINISTRATOR AUTHORITY TO SELECT
GRANTEES AND DETERMINE AWARDS |
(a) Administration
of Plan. The Plan shall be administered by the Administrator.
(b) Powers
of Administrator. The Administrator shall have the power and authority to grant Awards consistent with the terms of the Plan,
including the power and authority:
(i) to
select the individuals to whom Awards may from time to time be granted;
(ii) to
determine the time or times of grant, and the extent, if any, of Incentive Stock Options, Non-Qualified Stock Options, Stock Appreciation
Rights, Restricted Stock Awards, Restricted Stock Units, Unrestricted Stock Awards, Cash-Based Awards, and Dividend Equivalent
Rights, or any combination of the foregoing, granted to any one or more grantees;
(iii) to
determine the number of shares of Stock to be covered by any Award;
(iv) to
determine and modify from time to time the terms and conditions, including restrictions, not inconsistent with the terms of the
Plan, of any Award, which terms and conditions may differ among individual Awards and grantees, and to approve the forms of Award
Certificates;
(v) to
accelerate at any time the exercisability or vesting of all or any portion of any Award;
(vi) subject
to the provisions of Section 5(c), to extend at any time the period in which Stock Options may be exercised; and
(vii) at
any time to adopt, alter and repeal such rules, guidelines and practices for administration of the Plan and for its own acts and
proceedings as it shall deem advisable; to interpret the terms and provisions of the Plan and any Award (including related written
instruments); to make all determinations it deems advisable for the administration of the Plan; to decide all disputes arising
in connection with the Plan; and to otherwise supervise the administration of the Plan.
All decisions and interpretations of the
Administrator shall be binding on all persons, including the Company and Plan grantees.
(c) Delegation
of Authority to Grant Awards. Subject to applicable law, the Administrator, in its discretion, may delegate to a committee
consisting of one or more officers of the Company including the Chief Executive Officer of the Company all or part of the Administrator’s
authority and duties with respect to the granting of Awards to individuals who are (i) not subject to the reporting and other provisions
of Section 16 of the Exchange Act and (ii) not members of the delegated committee. Any such delegation by the Administrator
shall include a limitation as to the amount of Stock underlying Awards that may be granted during the period of the delegation
and shall contain guidelines as to the determination of the exercise price and the vesting criteria. The Administrator may revoke
or amend the terms of a delegation at any time but such action shall not invalidate any prior actions of the Administrator’s
delegate or delegates that were consistent with the terms of the Plan.
(d) Award
Certificate. Awards under the Plan shall be evidenced by Award Certificates that set forth the terms, conditions and limitations
for each Award which may include, without limitation, the term of an Award and the provisions applicable in the event employment
or service terminates.
(e) Indemnification.
Neither the Board nor the Administrator, nor any member of either or any delegate thereof, shall be liable for any act, omission,
interpretation, construction or determination made in good faith in connection with the Plan, and the members of the Board and
the Administrator (and any delegate thereof) shall be entitled in all cases to indemnification and reimbursement by the Company
in respect of any claim, loss, damage or expense (including, without limitation, reasonable attorneys’ fees) arising or resulting
therefrom to the fullest extent permitted by law and/or under the Company’s articles or bylaws or any directors’ and
officers’ liability insurance coverage which may be in effect from time to time and/or any indemnification agreement between
such individual and the Company.
(f) Foreign
Award Recipients. Notwithstanding any provision of the Plan to the contrary, in order to comply with the laws in other countries
in which the Company and its Subsidiaries operate or have employees or other individuals eligible for Awards, the Administrator,
in its sole discretion, shall have the power and authority to: (i) determine which Subsidiaries shall be covered by the Plan; (ii)
determine which individuals outside the United States are eligible to participate in the Plan; (iii) modify the terms and conditions
of any Award granted to individuals outside the United States to comply with applicable foreign laws; (iv) establish subplans and
modify exercise procedures and other terms and procedures, to the extent the Administrator determines such actions to be necessary
or advisable (and such subplans and/or modifications shall be attached to this Plan as appendices); provided, however, that no
such subplans and/or modifications shall increase the share limitations contained in Section 3(a) hereof; and (v) take any action,
before or after an Award is made, that the Administrator determines to be necessary or advisable to obtain approval or comply with
any local governmental regulatory exemptions or approvals. Notwithstanding the foregoing, the Administrator may not take any actions
hereunder, and no Awards shall be granted, that would violate the Exchange Act or any other applicable United States securities
law, the Code, or any other applicable United States governing statute or law.
| SECTION 3. | STOCK ISSUABLE UNDER THE PLAN; MERGERS; SUBSTITUTION |
(a) Stock
Issuable. The maximum number of shares of Stock reserved and available for issuance under the Plan shall be 3,537,225 shares
(the “Initial Limit”), which number includes 783,034 shares remaining available for issuance under the Company’s
2019 Stock Option and Incentive Plan as of the Effective Date and not subject to outstanding awards, subject to adjustment as provided
in Section 3(c), plus on January 1, 2020 and each January 1 thereafter, the number of shares of Stock reserved and available
for issuance under the Plan shall be cumulatively increased by (i) five (5%) percent of the number of shares of Stock issued and
outstanding on the immediately preceding December 31 or (ii) such lesser number of shares as determined by the Administrator (the
“Annual Increase”). Subject to such overall limitation, the maximum aggregate number of shares of Stock that may be
issued in the form of Incentive Stock Options shall not exceed the Initial Limit cumulatively increased on January 1, 2020 and
on each January 1 thereafter by the lesser of the Annual Increase for such year or 3,537,225 shares of Stock, subject in all cases
to adjustment as provided in Section 3(c). For purposes of this limitation, the shares of Stock underlying any awards under the
Plan and under the Company’s 2019 Stock Incentive Plan that are forfeited, canceled, held back upon exercise of an Option
or settlement of an Award to cover the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied
without the issuance of Stock or otherwise terminated (other than by exercise) shall be added back to the shares of Stock available
for issuance under the Plan and, to the extent permitted under Section 422 of the Code and the regulations promulgated thereunder,
the shares of Stock that may be issued as Incentive Stock Options. In the event the Company repurchases shares of Stock on the
open market, such shares shall not be added to the shares of Stock available for issuance under the Plan. Subject to such overall
limitations, shares of Stock may be issued up to such maximum number pursuant to any type or types of Award. The shares available
for issuance under the Plan may be authorized but unissued shares of Stock or shares of Stock reacquired by the Company.
(b) Maximum
Awards to Non-Employee Directors. Notwithstanding anything to the contrary in this Plan, the value of all Awards awarded under
this Plan and all other cash compensation paid by the Company to any Non-Employee Director in any calendar year shall not exceed
$500,000, provided, however that such amount shall be $1,000,000 for the calendar year in which the applicable Non-Employee director
is initially elected or appointed to the Board. For the purpose of this limitation, the value of any Award shall be its grant date
fair value, as determined in accordance with ASC 718 or successor provision but excluding the impact of estimated forfeitures related
to service-based vesting provisions.
(c) Changes
in Stock. Subject to Section 3(d) hereof, if, as a result of any reorganization, recapitalization, reclassification, stock
dividend, stock split, reverse stock split or other similar change in the Company’s capital stock, the outstanding shares
of Stock are increased or decreased or are exchanged for a different number or kind of shares or other securities of the Company,
or additional shares or new or different shares or other securities of the Company or other non-cash assets are distributed with
respect to such shares of Stock or other securities, or, if, as a result of any merger or consolidation, sale of all or substantially
all of the assets of the Company, the outstanding shares of Stock are converted into or exchanged for securities of the Company
or any successor entity (or a parent or subsidiary thereof), the Administrator shall make an appropriate or proportionate adjustment
in (i) the maximum number of shares reserved for issuance under the Plan, including the maximum number of shares that may be issued
in the form of Incentive Stock Options, (ii) the number and kind of shares or other securities subject to any then outstanding
Awards under the Plan, (iii) the repurchase price, if any, per share subject to each outstanding Restricted Stock Award, and (iv) the
exercise price for each share subject to any then outstanding Stock Options and Stock Appreciation Rights under the Plan, without
changing the aggregate exercise price (i.e., the exercise price multiplied by the number of shares subject to Stock Options and
Stock Appreciation Rights) as to which such Stock Options and Stock Appreciation Rights remain exercisable. The Administrator shall
also make equitable or proportionate adjustments in the number of shares subject to outstanding Awards and the exercise price and
the terms of outstanding Awards to take into consideration cash dividends paid other than in the ordinary course or any other extraordinary
corporate event. The adjustment by the Administrator shall be final, binding and conclusive. No fractional shares of Stock shall
be issued under the Plan resulting from any such adjustment, but the Administrator in its discretion may make a cash payment in
lieu of fractional shares.
(d) Mergers
and Other Transactions. In the case of and subject to the consummation of a Sale Event, the parties thereto may cause the assumption
or continuation of Awards theretofore granted by the successor entity, or the substitution of such Awards with new Awards of the
successor entity or parent thereof, with appropriate adjustment as to the number and kind of shares and, if appropriate, the per
share exercise prices, as such parties shall agree. To the extent the parties to such Sale Event do not provide for the assumption,
continuation or substitution of Awards, upon the effective time of the Sale Event, the Plan and all outstanding Awards granted
hereunder shall terminate. In such case, except as may be otherwise provided in the relevant Award Certificate, all Options and
Stock Appreciation Rights with time-based vesting conditions or restrictions that are not vested and/or exercisable immediately
prior to the effective time of the Sale Event shall become fully vested and exercisable as of the effective time of the Sale Event,
all other Awards with time-based vesting, conditions or restrictions shall become fully vested and nonforfeitable as of the effective
time of the Sale Event, and all Awards with conditions and restrictions relating to the attainment of performance goals may become
vested and nonforfeitable in connection with a Sale Event in the Administrator’s discretion or to the extent specified in
the relevant Award Certificate. In the event of such termination, (i) the Company shall have the option (in its sole discretion)
to make or provide for a payment, in cash or in kind, to the grantees holding Options and Stock Appreciation Rights, in exchange
for the cancellation thereof, in an amount equal to the difference between (A) the Sale Price multiplied by the number of shares
of Stock subject to outstanding Options and Stock Appreciation Rights (to the extent then exercisable at prices not in excess of
the Sale Price) and (B) the aggregate exercise price of all such outstanding Options and Stock Appreciation Rights (provided that,
in the case of an Option or Stock Appreciation Right with an exercise price equal to or less than the Sale Price, such Option or
Stock Appreciation Right shall be cancelled for no consideration); or (ii) each grantee shall be permitted, within a specified
period of time prior to the consummation of the Sale Event as determined by the Administrator, to exercise all outstanding Options
and Stock Appreciation Rights (to the extent then exercisable) held by such grantee. The Company shall also have the option (in
its sole discretion) to make or provide for a payment, in cash or in kind, to the grantees holding other Awards in an amount equal
to the Sale Price multiplied by the number of vested shares of Stock under such Awards.
Grantees under the Plan will be such employees,
Non-Employee Directors and Consultants of the Company and its Affiliates as are selected from time to time by the Administrator
in its sole discretion; provided that Awards may not be granted to employees, Directors or Consultants who are providing services
only to any “parent” of the Company, as such term is defined in Rule 405 of the Act, unless (i) the stock underlying
the Awards is treated as “service recipient stock” under Section 409A or (ii) the Company, in consultation with its
legal counsel, has determined that such Awards are exempt from or otherwise comply with Section 409A.
(a) Award
of Stock Options. The Administrator may grant Stock Options under the Plan. Any Stock Option granted under the Plan shall be
in such form as the Administrator may from time to time approve.
Stock Options granted under the Plan may
be either Incentive Stock Options or Non-Qualified Stock Options. Incentive Stock Options may be granted only to employees of the
Company or any Subsidiary that is a “subsidiary corporation” within the meaning of Section 424(f) of the Code.
To the extent that any Option does not qualify as an Incentive Stock Option, it shall be deemed a Non-Qualified Stock Option.
Stock Options granted pursuant to this Section 5
shall be subject to the following terms and conditions and shall contain such additional terms and conditions, not inconsistent
with the terms of the Plan, as the Administrator shall deem desirable. If the Administrator so determines, Stock Options may be
granted in lieu of cash compensation at the optionee’s election, subject to such terms and conditions as the Administrator
may establish.
(b) Exercise
Price. The exercise price per share for the Stock covered by a Stock Option granted pursuant to this Section 5 shall be
determined by the Administrator at the time of grant but shall not be less than 100 percent of the Fair Market Value on the date
of grant. In the case of an Incentive Stock Option that is granted to a Ten Percent Owner, the exercise price of such Incentive
Stock Option shall be not less than 110 percent of the Fair Market Value on the grant date. Notwithstanding the foregoing, Stock
Options may be granted with an exercise price per share that is less than 100 percent of the Fair Market Value on the date of grant
(i) pursuant to a transaction described in, and in a manner consistent with, Section 424(a) of the Code, (ii) to individuals who
are not subject to U.S. income tax on the date of grant, or (iii) the Stock Option is otherwise compliant with Section 409A.
(c) Option
Term. The term of each Stock Option shall be fixed by the Administrator, but no Stock Option shall be exercisable more than
ten years after the date the Stock Option is granted. In the case of an Incentive Stock Option that is granted to a Ten Percent
Owner, the term of such Stock Option shall be no more than five years from the date of grant.
(d) Exercisability;
Rights of a Stockholder. Stock Options shall become exercisable at such time or times, whether or not in installments, as shall
be determined by the Administrator at or after the grant date. The Administrator may at any time accelerate the exercisability
of all or any portion of any Stock Option. An optionee shall have the rights of a stockholder only as to shares acquired upon the
exercise of a Stock Option and not as to unexercised Stock Options.
(e) Method
of Exercise. Stock Options may be exercised in whole or in part, by giving written or electronic notice of exercise to the
Company, specifying the number of shares to be purchased. Payment of the purchase price may be made by one or more of the following
methods except to the extent otherwise provided in the Option Award Certificate:
(i) In
cash, by certified or bank check or other instrument acceptable to the Administrator;
(ii) Through
the delivery (or attestation to the ownership following such procedures as the Company may prescribe) of shares of Stock that are
not then subject to restrictions under any Company plan. Such surrendered shares shall be valued at Fair Market Value on the exercise
date;
(iii) By
the optionee delivering to the Company a properly executed exercise notice together with irrevocable instructions to a broker to
promptly deliver to the Company cash or a check payable and acceptable to the Company for the purchase price; provided that in
the event the optionee chooses to pay the purchase price as so provided, the optionee and the broker shall comply with such procedures
and enter into such agreements of indemnity and other agreements as the Company shall prescribe as a condition of such payment
procedure; or
(iv) With
respect to Stock Options that are not Incentive Stock Options, by a “net exercise” arrangement pursuant to which the
Company will reduce the number of shares of Stock issuable upon exercise by the largest whole number of shares with a Fair Market
Value that does not exceed the aggregate exercise price.
Payment instruments will be received subject to collection.
The transfer to the optionee on the records of the Company or of the transfer agent of the shares of Stock to be purchased pursuant
to the exercise of a Stock Option will be contingent upon receipt from the optionee (or a purchaser acting in his stead in accordance
with the provisions of the Stock Option) by the Company of the full purchase price for such shares and the fulfillment of any other
requirements contained in the Option Award Certificate or applicable provisions of laws (including the satisfaction of any withholding
taxes that the Company is obligated to withhold with respect to the optionee). In the event an optionee chooses to pay the purchase
price by previously-owned shares of Stock through the attestation method, the number of shares of Stock transferred to the optionee
upon the exercise of the Stock Option shall be net of the number of attested shares. In the event that the Company establishes,
for itself or using the services of a third party, an automated system for the exercise of Stock Options, such as a system using
an internet website or interactive voice response, then the paperless exercise of Stock Options may be permitted through the use
of such an automated system.
(f) Annual
Limit on Incentive Stock Options. To the extent required for “incentive stock option” treatment under Section 422
of the Code, the aggregate Fair Market Value (determined as of the time of grant) of the shares of Stock with respect to which
Incentive Stock Options granted under this Plan and any other plan of the Company or its parent and subsidiary corporations become
exercisable for the first time by an optionee during any calendar year shall not exceed $100,000. To the extent that any Stock
Option exceeds this limit, it shall constitute a Non-Qualified Stock Option.
| SECTION 6. | STOCK APPRECIATION RIGHTS |
(a) Award
of Stock Appreciation Rights. The Administrator may grant Stock Appreciation Rights under the Plan. A Stock Appreciation Right
is an Award entitling the recipient to receive shares of Stock (or cash, to the extent explicitly provided for in the applicable
Award Certificate) having a value equal to the excess of the Fair Market Value of a share of Stock on the date of exercise over
the exercise price of the Stock Appreciation Right multiplied by the number of shares of Stock with respect to which the Stock
Appreciation Right shall have been exercised.
(b) Exercise
Price of Stock Appreciation Rights. The exercise price of a Stock Appreciation Right shall not be less than 100 percent of
the Fair Market Value of the Stock on the date of grant.
(c) Grant
and Exercise of Stock Appreciation Rights. Stock Appreciation Rights may be granted by the Administrator independently of any
Stock Option granted pursuant to Section 5 of the Plan.
(d) Terms
and Conditions of Stock Appreciation Rights. Stock Appreciation Rights shall be subject to such terms and conditions as shall
be determined on the date of grant by the Administrator. The term of a Stock Appreciation Right may not exceed ten years. The terms
and conditions of each such Award shall be determined by the Administrator, and such terms and conditions may differ among individual
Awards and grantees.
| SECTION 7. | RESTRICTED STOCK AWARDS |
(a) Nature
of Restricted Stock Awards. The Administrator may grant Restricted Stock Awards under the Plan. A Restricted Stock Award is
any Award of Restricted Shares subject to such restrictions and conditions as the Administrator may determine at the time of grant.
Conditions may be based on continuing employment (or other Service Relationship) and/or achievement of pre-established performance
goals and objectives.
(b) Rights
as a Stockholder. Upon the grant of the Restricted Stock Award and payment of any applicable purchase price, a grantee shall
have the rights of a stockholder with respect to the voting of the Restricted Shares and receipt of dividends; provided that if
the lapse of restrictions with respect to the Restricted Stock Award is tied to the attainment of performance goals, any dividends
paid by the Company during the performance period shall accrue and shall not be paid to the grantee until and to the extent the
performance goals are met with respect to the Restricted Stock Award. Unless the Administrator shall otherwise determine, (i) uncertificated
Restricted Shares shall be accompanied by a notation on the records of the Company or the transfer agent to the effect that they
are subject to forfeiture until such Restricted Shares are vested as provided in Section 7(d) below, and (ii) certificated Restricted
Shares shall remain in the possession of the Company until such Restricted Shares are vested as provided in Section 7(d) below,
and the grantee shall be required, as a condition of the grant, to deliver to the Company such instruments of transfer as the Administrator
may prescribe.
(c) Restrictions.
Restricted Shares may not be sold, assigned, transferred, pledged or otherwise encumbered or disposed of except as specifically
provided herein or in the Restricted Stock Award Certificate. Except as may otherwise be provided by the Administrator either in
the Award Certificate or, subject to Section 16 below, in writing after the Award is issued, if a grantee’s employment (or
other Service Relationship) with the Company and its Subsidiaries terminates for any reason, any Restricted Shares that have not
vested at the time of termination shall automatically and without any requirement of notice to such grantee from or other action
by or on behalf of, the Company be deemed to have been reacquired by the Company at its original purchase price (if any) from such
grantee or such grantee’s legal representative simultaneously with such termination of employment (or other Service Relationship),
and thereafter shall cease to represent any ownership of the Company by the grantee or rights of the grantee as a stockholder.
Following such deemed reacquisition of Restricted Shares that are represented by physical certificates, a grantee shall surrender
such certificates to the Company upon request without consideration.
(d) Vesting
of Restricted Shares. The Administrator at the time of grant shall specify the date or dates and/or the attainment of pre-established
performance goals, objectives and other conditions on which the non-transferability of the Restricted Shares and the Company’s
right of repurchase or forfeiture shall lapse. Subsequent to such date or dates and/or the attainment of such pre-established performance
goals, objectives and other conditions, the shares on which all restrictions have lapsed shall no longer be Restricted Shares and
shall be deemed “vested.”
| SECTION 8. | RESTRICTED STOCK UNITS |
(a) Nature
of Restricted Stock Units. The Administrator may grant Restricted Stock Units under the Plan. A Restricted Stock Unit is an
Award of stock units that may be settled in shares of Stock (or cash, to the extent explicitly provided for in the Award Certificate)
upon the satisfaction of such restrictions and conditions at the time of grant. Conditions may be based on continuing employment
(or other Service Relationship) and/or achievement of pre-established performance goals and objectives. The terms and conditions
of each such Award shall be determined by the Administrator, and such terms and conditions may differ among individual Awards and
grantees. Except in the case of Restricted Stock Units with a deferred settlement date that complies with Section 409A, at the
end of the vesting period, the Restricted Stock Units, to the extent vested, shall be settled in the form of shares of Stock. Restricted
Stock Units with deferred settlement dates are subject to Section 409A and shall contain such additional terms and conditions as
the Administrator shall determine in its sole discretion in order to comply with the requirements of Section 409A.
(b) Election
to Receive Restricted Stock Units in Lieu of Compensation. The Administrator may, in its sole discretion, permit a grantee
to elect to receive a portion of future cash compensation otherwise due to such grantee in the form of an award of Restricted Stock
Units. Any such election shall be made in writing and shall be delivered to the Company no later than the date specified by the
Administrator and in accordance with Section 409A and such other rules and procedures established by the Administrator. Any such
future cash compensation that the grantee elects to defer shall be converted to a fixed number of Restricted Stock Units based
on the Fair Market Value of Stock on the date the compensation would otherwise have been paid to the grantee if such payment had
not been deferred as provided herein. The Administrator shall have the sole right to determine whether and under what circumstances
to permit such elections and to impose such limitations and other terms and conditions thereon as the Administrator deems appropriate.
Any Restricted Stock Units that are elected to be received in lieu of cash compensation shall be fully vested, unless otherwise
provided in the Award Certificate.
(c) Rights
as a Stockholder. A grantee shall have the rights as a stockholder only as to shares of Stock acquired by the grantee upon
settlement of Restricted Stock Units; provided, however, that the grantee may be credited with Dividend Equivalent Rights with
respect to the stock units underlying his Restricted Stock Units, subject to the provisions of Section 11 and such terms and conditions
as the Administrator may determine.
(d) Termination.
Except as may otherwise be provided by the Administrator either in the Award Certificate or, subject to Section 16 below,
in writing after the Award is issued, a grantee’s right in all Restricted Stock Units that have not vested shall automatically
terminate upon the grantee’s termination of employment (or cessation of Service Relationship) with the Company and its Subsidiaries
for any reason.
| SECTION 9. | UNRESTRICTED STOCK AWARDS |
Grant or Sale of Unrestricted Stock.
The Administrator may grant (or sell at par value or such higher purchase price determined by the Administrator) an Unrestricted
Stock Award under the Plan. An Unrestricted Stock Award is an Award pursuant to which the grantee may receive shares of Stock free
of any restrictions under the Plan. Unrestricted Stock Awards may be granted in respect of past services or other valid consideration,
or in lieu of cash compensation due to such grantee.
| SECTION 10. | CASH-BASED AWARDS |
Grant of Cash-Based Awards. The Administrator
may grant Cash-Based Awards under the Plan. A Cash-Based Award is an Award that entitles the grantee to a payment in cash upon
the attainment of specified performance goals. The Administrator shall determine the maximum duration of the Cash-Based Award,
the amount of cash to which the Cash-Based Award pertains, the conditions upon which the Cash-Based Award shall become vested or
payable, and such other provisions as the Administrator shall determine. Each Cash-Based Award shall specify a cash-denominated
payment amount, formula or payment ranges as determined by the Administrator. Payment, if any, with respect to a Cash-Based Award
shall be made in accordance with the terms of the Award and may be made in cash.
| SECTION 11. | DIVIDEND EQUIVALENT RIGHTS |
(a) Dividend
Equivalent Rights. The Administrator may grant Dividend Equivalent Rights under the Plan. A Dividend Equivalent Right is an
Award entitling the grantee to receive credits based on cash dividends that would have been paid on the shares of Stock specified
in the Dividend Equivalent Right (or other Award to which it relates) if such shares had been issued to the grantee. A Dividend
Equivalent Right may be granted hereunder to any grantee as a component of an award of Restricted Stock Units or as a freestanding
award. The terms and conditions of Dividend Equivalent Rights shall be specified in the Award Certificate. Dividend equivalents
credited to the holder of a Dividend Equivalent Right may be paid currently or may be deemed to be reinvested in additional shares
of Stock, which may thereafter accrue additional equivalents. Any such reinvestment shall be at Fair Market Value on the date of
reinvestment or such other price as may then apply under a dividend reinvestment plan sponsored by the Company, if any. Dividend
Equivalent Rights may be settled in cash or shares of Stock or a combination thereof, in a single installment or installments.
A Dividend Equivalent Right granted as a component of an Award of Restricted Stock Units shall provide that such Dividend Equivalent
Right shall be settled only upon settlement or payment of, or lapse of restrictions on, such other Award, and that such Dividend
Equivalent Right shall expire or be forfeited or annulled under the same conditions as such other Award.
(b) Termination.
Except as may otherwise be provided by the Administrator either in the Award Certificate or, subject to Section 16 below,
in writing after the Award is issued, a grantee’s rights in all Dividend Equivalent Rights shall automatically terminate
upon the grantee’s termination of employment (or cessation of Service Relationship) with the Company and its Subsidiaries
for any reason.
| SECTION 12. | Transferability of Awards |
(a) Transferability.
Except as provided in Section 12(b) below, during a grantee’s lifetime, his or her Awards shall be exercisable only
by the grantee, or by the grantee’s legal representative or guardian in the event of the grantee’s incapacity. No Awards
shall be sold, assigned, transferred or otherwise encumbered or disposed of by a grantee other than by will or by the laws of descent
and distribution or pursuant to a domestic relations order. No Awards shall be subject, in whole or in part, to attachment, execution,
or levy of any kind, and any purported transfer in violation hereof shall be null and void.
(b) Administrator
Action. Notwithstanding Section 12(a), the Administrator, in its discretion, may provide either in the Award Certificate
regarding a given Award or by subsequent written approval that the grantee (who is an employee or director) may transfer his or
her Non-Qualified Stock Options to his or her immediate family members, to trusts for the benefit of such family members, or to
partnerships in which such family members are the only partners, provided that the transferee agrees in writing with the Company
to be bound by all of the terms and conditions of this Plan and the applicable Award. In no event may an Award be transferred by
a grantee for value.
(c) Family
Member. For purposes of Section 12(b), “family member” shall mean a grantee’s child, stepchild, grandchild,
parent, stepparent, grandparent, spouse, former spouse, sibling, niece, nephew, mother-in-law, father-in-law, son-in-law, daughter-in-law,
brother-in-law, or sister-in-law, including adoptive relationships, any person sharing the grantee’s household (other than
a tenant of the grantee), a trust in which these persons (or the grantee) have more than 50 percent of the beneficial interest,
a foundation in which these persons (or the grantee) control the management of assets, and any other entity in which these persons
(or the grantee) own more than 50 percent of the voting interests.
(d) Designation
of Beneficiary. To the extent permitted by the Company, each grantee to whom an Award has been made under the Plan may designate
a beneficiary or beneficiaries to exercise any Award or receive any payment under any Award payable on or after the grantee’s
death. Any such designation shall be on a form provided for that purpose by the Administrator and shall not be effective until
received by the Administrator. If no beneficiary has been designated by a deceased grantee, or if the designated beneficiaries
have predeceased the grantee, the beneficiary shall be the grantee’s estate.
| SECTION 13. | TAX WITHHOLDING |
(a) Payment
by Grantee. Each grantee shall, no later than the date as of which the value of an Award or of any Stock or other amounts received
thereunder first becomes includable in the gross income of the grantee for income tax purposes, pay to the Company, or make arrangements
satisfactory to the Administrator regarding payment of, any Federal, state, or local taxes of any kind required by law to be withheld
by the Company with respect to such income. The Company and its Subsidiaries shall, to the extent permitted by law, have the right
to deduct any such taxes from any payment of any kind otherwise due to the grantee. The Company’s obligation to deliver evidence
of book entry (or stock certificates) to any grantee is subject to and conditioned on tax withholding obligations being satisfied
by the grantee.
(b) Payment
in Stock. The Administrator may require the Company’s tax withholding obligation to be satisfied, in whole or in part,
by the Company withholding from shares of Stock to be issued pursuant to any Award a number of shares with an aggregate Fair Market
Value (as of the date the withholding is effected) that would satisfy the withholding amount due; provided, however, that the amount
withheld does not exceed the maximum statutory tax rate or such lesser amount as is necessary to avoid liability accounting treatment.
For purposes of share withholding, the Fair Market Value of withheld shares shall be determined in the same manner as the value
of Stock includible in income of the Participants. The Administrator may also require the Company’s tax withholding obligation
to be satisfied, in whole or in part, by an arrangement whereby a certain number of shares of Stock issued pursuant to any Award
are immediately sold and proceeds from such sale are remitted to the Company in an amount that would satisfy the withholding amount
due.
| SECTION 14. | Section 409A awards |
Awards are intended to be exempt from Section
409A to the greatest extent possible and to otherwise comply with Section 409A. The Plan and all Awards shall be interpreted in
accordance with such intent. To the extent that any Award is determined to constitute “nonqualified deferred compensation”
within the meaning of Section 409A (a “409A Award”), the Award shall be subject to such additional rules and requirements
as specified by the Administrator from time to time in order to comply with Section 409A. In this regard, if any amount under a
409A Award is payable upon a “separation from service” (within the meaning of Section 409A) to a grantee who is then
considered a “specified employee” (within the meaning of Section 409A), then no such payment shall be made prior to
the date that is the earlier of (i) six months and one day after the grantee’s separation from service, or (ii) the grantee’s
death, but only to the extent such delay is necessary to prevent such payment from being subject to interest, penalties and/or
additional tax imposed pursuant to Section 409A. Further, the settlement of any 409A Award may not be accelerated except to the
extent permitted by Section 409A.
| SECTION 15. | TERMINATION OF SERVICE RELATIONSHIP, TRANSFER, LEAVE
OF ABSENCE, ETC. |
(a) Termination
of Service Relationship. If the grantee’s Service Relationship is with an Affiliate and such Affiliate ceases to be an
Affiliate, the grantee shall be deemed to have terminated his or her Service Relationship for purposes of the Plan.
(b) For
purposes of the Plan, the following events shall not be deemed a termination of a Service Relationship:
(i) a
transfer to the employment of the Company from an Affiliate or from the Company to an Affiliate, or from one Affiliate to another;
or
(ii) an
approved leave of absence for military service or sickness, or for any other purpose approved by the Company, if the employee’s
right to re-employment is guaranteed either by a statute or by contract or under the policy pursuant to which the leave of absence
was granted or if the Administrator otherwise so provides in writing.
| SECTION 16. | AMENDMENTS AND TERMINATION |
The Board may, at any time, amend or discontinue
the Plan and the Administrator may, at any time, amend or cancel any outstanding Award for the purpose of satisfying changes in
law or for any other lawful purpose, but no such action shall materially and adversely affect rights under any outstanding Award
without the holder’s consent. The Administrator is specifically authorized to exercise its discretion to reduce the exercise
price of outstanding Stock Options or Stock Appreciation Rights or effect the repricing of such Awards through cancellation and
re-grants. To the extent required under the rules of any securities exchange or market system on which the Stock is listed, to
the extent determined by the Administrator to be required by the Code to ensure that Incentive Stock Options granted under the
Plan are qualified under Section 422 of the Code, Plan amendments shall be subject to approval by Company stockholders. Nothing
in this Section 16 shall limit the Administrator’s authority to take any action permitted pursuant to Section 3(c)
or 3(d).
| SECTION 17. | STATUS OF PLAN |
With respect to the portion of any Award
that has not been exercised and any payments in cash, Stock or other consideration not received by a grantee, a grantee shall have
no rights greater than those of a general creditor of the Company unless the Administrator shall otherwise expressly determine
in connection with any Award or Awards. In its sole discretion, the Administrator may authorize the creation of trusts or other
arrangements to meet the Company’s obligations to deliver Stock or make payments with respect to Awards hereunder, provided
that the existence of such trusts or other arrangements is consistent with the foregoing sentence.
| SECTION 18. | GENERAL PROVISIONS |
(a) No
Distribution. The Administrator may require each person acquiring Stock pursuant to an Award to represent to and agree with
the Company in writing that such person is acquiring the shares without a view to distribution thereof.
(b) Issuance
of Stock. To the extent certificated, stock certificates to grantees under this Plan shall be deemed delivered for all purposes
when the Company or a stock transfer agent of the Company shall have mailed such certificates in the United States mail, addressed
to the grantee, at the grantee’s last known address on file with the Company. Uncertificated Stock shall be deemed delivered
for all purposes when the Company or a Stock transfer agent of the Company shall have given to the grantee by electronic mail (with
proof of receipt) or by United States mail, addressed to the grantee, at the grantee’s last known address on file with the
Company, notice of issuance and recorded the issuance in its records (which may include electronic “book entry” records).
Notwithstanding anything herein to the contrary, the Company shall not be required to issue or deliver any evidence of book entry
or certificates evidencing shares of Stock pursuant to the exercise or settlement of any Award, unless and until the Administrator
has determined, with advice of counsel (to the extent the Administrator deems such advice necessary or advisable), that the issuance
and delivery is in compliance with all applicable laws, regulations of governmental authorities and, if applicable, the requirements
of any exchange on which the shares of Stock are listed, quoted or traded. Any Stock issued pursuant to the Plan shall be subject
to any stop-transfer orders and other restrictions as the Administrator deems necessary or advisable to comply with federal, state
or foreign jurisdiction, securities or other laws, rules and quotation system on which the Stock is listed, quoted or traded. The
Administrator may place legends on any Stock certificate or notations on any book entry to reference restrictions applicable to
the Stock. In addition to the terms and conditions provided herein, the Administrator may require that an individual make such
reasonable covenants, agreements, and representations as the Administrator, in its discretion, deems necessary or advisable in
order to comply with any such laws, regulations, or requirements. The Administrator shall have the right to require any individual
to comply with any timing or other restrictions with respect to the settlement or exercise of any Award, including a window-period
limitation, as may be imposed in the discretion of the Administrator.
(c) Stockholder
Rights. Until Stock is deemed delivered in accordance with Section 18(b), no right to vote or receive dividends or any other
rights of a stockholder will exist with respect to shares of Stock to be issued in connection with an Award, notwithstanding the
exercise of a Stock Option or any other action by the grantee with respect to an Award.
(d) Other
Compensation Arrangements; No Employment Rights. Nothing contained in this Plan shall prevent the Board from adopting other
or additional compensation arrangements, including trusts, and such arrangements may be either generally applicable or applicable
only in specific cases. The adoption of this Plan and the grant of Awards do not confer upon any employee any right to continued
employment with the Company or any Subsidiary.
(e) Trading
Policy Restrictions. Option exercises and other Awards under the Plan shall be subject to the Company’s insider trading
policies and procedures, as in effect from time to time.
(f) Clawback
Policy. Awards under the Plan shall be subject to the Company’s clawback policy, as in effect from time to time.
| SECTION 19. | EFFECTIVE DATE OF PLAN |
This Plan shall become effective upon the
date immediately preceding the Registration Date subject to prior stockholder approval in accordance with applicable state law,
the Company’s bylaws and articles of incorporation, and applicable stock exchange rules. No grants of Stock Options and other
Awards may be made hereunder after the tenth anniversary of the Effective Date and no grants of Incentive Stock Options may be
made hereunder after the tenth anniversary of the date the Plan is approved by the Board.
This Plan and all Awards and actions taken
thereunder shall be governed by, and construed in accordance with the General Corporation Law of the State of Delaware as to matters
within the scope thereof, and as to all other matters shall be governed by and construed in accordance with the internal laws of
the Commonwealth of Massachusetts, applied without regard to conflict of law principles.
DATE APPROVED BY BOARD OF DIRECTORS: August 30, 2019
DATE APPROVED BY STOCKHOLDERS: August 30, 2019
INCENTIVE STOCK OPTION AGREEMENT
UNDER THE SPRINGWORKS THERAPEUTICS, INC.
2019 STOCK OPTION AND EQUITY INCENTIVE PLAN
Name of Optionee: |
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Grant Date: |
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Pursuant to the SpringWorks Therapeutics,
Inc. 2019 Stock Option and Equity Incentive Plan as amended through the date hereof (the “Plan”), SpringWorks Therapeutics,
Inc. (the “Company”) hereby grants to the Optionee named above an option (the “Stock Option”) to purchase
on or prior to the Expiration Date specified above all or part of the number of shares of Common Stock, par value $0.0001 per share
(the “Stock”), of the Company specified above at the Option Exercise Price per Share specified above subject to the
terms and conditions set forth herein and in the Plan.
1. Exercisability
Schedule. No portion of this Stock Option may be exercised until such portion shall have become exercisable. Except as set
forth below, and subject to the discretion of the Administrator (as defined in Section 2 of the Plan) to accelerate the exercisability
schedule hereunder, this Stock Option shall be exercisable with respect to the following number of Option Shares on the dates indicated
so long as the Optionee remains an employee1 of the
Company or a Subsidiary on such dates:
Incremental Number of
Option Shares Exercisable* |
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Exercisability Date |
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* Max. of $100,000 per yr.
1
Company to confirm that vesting should be tied to continued employment rather than continued service relationship in any capacity
(i.e., if the optionee’s employment ends but the optionee continues to provide services as a consultant, vesting will cease
on the date the employment relationship ends). Note that, if an option is exercised after three months following the date employment
ends, the option will cease to qualify as an ISO.
Once exercisable, this Stock Option shall
continue to be exercisable at any time or times prior to the close of business on the Expiration Date, subject to the provisions
hereof and of the Plan.
2. Manner
of Exercise.
(a) The
Optionee may exercise this Stock Option only in the following manner: from time to time on or prior to the Expiration Date of this
Stock Option, the Optionee may give written notice to the Administrator of his or her election to purchase some or all of the Option
Shares purchasable at the time of such notice. This notice shall specify the number of Option Shares to be purchased.
Payment of the purchase price for the Option
Shares may be made by one or more of the following methods: (i) in cash, by certified or bank check or other instrument acceptable
to the Administrator; (ii) through the delivery (or attestation to the ownership) of shares of Stock that have been purchased
by the Optionee on the open market or that are beneficially owned by the Optionee and are not then subject to any restrictions
under any Company plan and that otherwise satisfy any holding periods as may be required by the Administrator; or (iii) by
the Optionee delivering to the Company a properly executed exercise notice together with irrevocable instructions to a broker to
promptly deliver to the Company cash or a check payable and acceptable to the Company to pay the option purchase price, provided
that in the event the Optionee chooses to pay the option purchase price as so provided, the Optionee and the broker shall comply
with such procedures and enter into such agreements of indemnity and other agreements as the Administrator shall prescribe as a
condition of such payment procedure; or (iv) a combination of (i), (ii) and (iii) above. Payment instruments will be received
subject to collection.
The transfer to the Optionee on the records
of the Company or of the transfer agent of the Option Shares will be contingent upon (i) the Company’s receipt from the Optionee
of the full purchase price for the Option Shares, as set forth above, (ii) the fulfillment of any other requirements contained
herein or in the Plan or in any other agreement or provision of laws, and (iii) the receipt by the Company of any agreement, statement
or other evidence that the Company may require to satisfy itself that the issuance of Stock to be purchased pursuant to the exercise
of Stock Options under the Plan and any subsequent resale of the shares of Stock will be in compliance with applicable laws and
regulations. In the event the Optionee chooses to pay the purchase price by previously-owned shares of Stock through the attestation
method, the number of shares of Stock transferred to the Optionee upon the exercise of the Stock Option shall be net of the Shares
attested to.
(b) The
shares of Stock purchased upon exercise of this Stock Option shall be transferred to the Optionee on the records of the Company
or of the transfer agent upon compliance to the satisfaction of the Administrator with all requirements under applicable laws or
regulations in connection with such transfer and with the requirements hereof and of the Plan. The determination of the Administrator
as to such compliance shall be final and binding on the Optionee. The Optionee shall not be deemed to be the holder of, or to have
any of the rights of a holder with respect to, any shares of Stock subject to this Stock Option unless and until this Stock Option
shall have been exercised pursuant to the terms hereof, the Company or the transfer agent shall have transferred the shares to
the Optionee, and the Optionee’s name shall have been entered as the stockholder of record on the books of the Company. Thereupon,
the Optionee shall have full voting, dividend and other ownership rights with respect to such shares of Stock.
(c) The
minimum number of shares with respect to which this Stock Option may be exercised at any one time shall be 100 shares, unless the
number of shares with respect to which this Stock Option is being exercised is the total number of shares subject to exercise under
this Stock Option at the time.
(d) Notwithstanding
any other provision hereof or of the Plan, no portion of this Stock Option shall be exercisable after the Expiration Date hereof.
3. Termination
of Employment. If the Optionee’s employment by the Company or a Subsidiary (as defined in the Plan) is terminated, the
period within which to exercise the Stock Option may be subject to earlier termination as set forth below.
(a) Termination
Due to Death. If the Optionee’s employment terminates by reason of the Optionee’s death, any portion of this Stock
Option outstanding on such date, to the extent exercisable on the date of death, may thereafter be exercised by the Optionee’s
legal representative or legatee for a period of 12 months from the date of death or until the Expiration Date, if earlier. Any
portion of this Stock Option that is not exercisable on the date of death shall terminate immediately and be of no further force
or effect.
(b) Termination
Due to Disability. If the Optionee’s employment terminates by reason of the Optionee’s disability (as determined
by the Administrator), any portion of this Stock Option outstanding on such date, to the extent exercisable on the date of such
termination of employment, may thereafter be exercised by the Optionee for a period of 12 months from the date of disability or
until the Expiration Date, if earlier. Any portion of this Stock Option that is not exercisable on the date of disability shall
terminate immediately and be of no further force or effect.
(c) Termination
for Cause. If the Optionee’s employment terminates for Cause, any portion of this Stock Option outstanding on such date
shall terminate immediately and be of no further force and effect. For purposes hereof, “Cause” shall mean, unless
otherwise provided in an employment agreement between the Company and the Optionee, a determination by the Administrator that the
Optionee shall be dismissed as a result of (i) any material breach by the Optionee of any agreement between the Optionee and the
Company; (ii) the conviction of, indictment for or plea of nolo contendere by the Optionee to a felony or a crime involving moral
turpitude; or (iii) any material misconduct or willful and deliberate non-performance (other than by reason of disability) by the
Optionee of the Optionee’s duties to the Company.
(d) Other
Termination. If the Optionee’s employment terminates for any reason other than the Optionee’s death, the Optionee’s
disability, or Cause, and unless otherwise determined by the Administrator, any portion of this Stock Option outstanding on such
date may be exercised, to the extent exercisable on the date of termination, for a period of three months from the date of termination
or until the Expiration Date, if earlier. Any portion of this Stock Option that is not exercisable on the date of termination shall
terminate immediately and be of no further force or effect.
The Administrator’s determination
of the reason for termination of the Optionee’s employment shall be conclusive and binding on the Optionee and his or her
representatives or legatees.
4. Incorporation
of Plan. Notwithstanding anything herein to the contrary, this Stock Option shall be subject to and governed by all the terms
and conditions of the Plan, including the powers of the Administrator set forth in Section 2(b) of the Plan. Capitalized terms
in this Agreement shall have the meaning specified in the Plan, unless a different meaning is specified herein.
5. Transferability.
This Agreement is personal to the Optionee, is non-assignable and is not transferable in any manner, by operation of law or otherwise,
other than by will or the laws of descent and distribution. This Stock Option is exercisable, during the Optionee’s lifetime,
only by the Optionee, and thereafter, only by the Optionee’s legal representative or legatee.
6. Status
of the Stock Option. This Stock Option is intended to qualify as an “incentive stock option” under Section 422
of the Internal Revenue Code of 1986, as amended (the “Code”), but the Company does not represent or warrant that this
Stock Option qualifies as such. The Optionee should consult with his or her own tax advisors regarding the tax effects of this
Stock Option and the requirements necessary to obtain favorable income tax treatment under Section 422 of the Code, including,
but not limited to, holding period requirements. To the extent any portion of this Stock Option does not so qualify as an “incentive
stock option,” such portion shall be deemed to be a non-qualified stock option. If the Optionee intends to dispose or does
dispose (whether by sale, gift, transfer or otherwise) of any Option Shares within the one-year period beginning on the date after
the transfer of such shares to him or her, or within the two-year period beginning on the day after the grant of this Stock Option,
he or she will so notify the Company within 30 days after such disposition.
7. Tax
Withholding. The Optionee shall, not later than the date as of which the exercise of this Stock Option becomes a taxable event
for Federal income tax purposes, pay to the Company or make arrangements satisfactory to the Administrator for payment of any Federal,
state, and local taxes required by law to be withheld on account of such taxable event. The Company shall have the authority to
cause the required tax withholding obligation to be satisfied, in whole or in part, by withholding from shares of Stock to be issued
to the Optionee a number of shares of Stock with an aggregate Fair Market Value that would satisfy the withholding amount due.
8. No
Obligation to Continue Employment. Neither the Company nor any Subsidiary is obligated by or as a result of the Plan or this
Agreement to continue the Optionee in employment and neither the Plan nor this Agreement shall interfere in any way with the right
of the Company or any Subsidiary to terminate the employment of the Optionee at any time.
9. Integration.
This Agreement constitutes the entire agreement between the parties with respect to this Stock Option and supersedes all prior
agreements and discussions between the parties concerning such subject matter.
10. Data
Privacy Consent. In order to administer the Plan and this Agreement and to implement or structure future equity grants, the
Company, its subsidiaries and affiliates and certain agents thereof (together, the “Relevant Companies”) may process
any and all personal or professional data, including but not limited to Social Security or other identification number, home address
and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or
this Agreement (the “Relevant Information”). By entering into this Agreement, the Optionee (i) authorizes the Company
to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy rights the
Optionee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such
information in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant
Companies consider appropriate. The Optionee shall have access to, and the right to change, the Relevant Information. Relevant
Information will only be used in accordance with applicable law.
11. Notices.
Notices hereunder shall be mailed or delivered to the Company at its principal place of business and shall be mailed or delivered
to the Optionee at the address on file with the Company or, in either case, at such other address as one party may subsequently
furnish to the other party in writing.
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SPRINGWORKS THERAPEUTICS, INC. |
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By: |
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Title: |
The foregoing Agreement is hereby accepted and the terms and
conditions thereof hereby agreed to by the undersigned. Electronic acceptance of this Agreement pursuant to the Company’s
instructions to the Optionee (including through an online acceptance process) is acceptable.
Dated: |
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Optionee’s Signature |
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Optionee’s name and address: |
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RESTRICTED
STOCK AWARD AGREEMENT
UNDER THE SPRINGWORKS THERAPEUTICS, inc.
2019 STOCK OPTION AND EQUITY INCENTIVE PLAN
Name of Grantee: |
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No. of Shares: |
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Grant Date: |
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Pursuant to the SpringWorks Therapeutics,
Inc. 2019 Stock Option and Equity Incentive Plan (the “Plan”) as amended through the date hereof, SpringWorks Therapeutics,
Inc. (the “Company”) hereby grants a Restricted Stock Award (an “Award”) to the Grantee named above. Upon
acceptance of this Award, the Grantee shall receive the number of shares of Common Stock, par value $0.0001 per share (the “Stock”)
of the Company specified above, subject to the restrictions and conditions set forth herein and in the Plan. The Company acknowledges
the receipt from the Grantee of consideration with respect to the par value of the Stock in the form of cash, past or future services
rendered to the Company by the Grantee or such other form of consideration as is acceptable to the Administrator.
1. Award.
The shares of Restricted Stock awarded hereunder shall be issued and held by the Company’s transfer agent in book entry form,
and the Grantee’s name shall be entered as the stockholder of record on the books of the Company. Thereupon, the Grantee
shall have all the rights of a stockholder with respect to such shares, including voting and dividend rights, subject, however,
to the restrictions and conditions specified in Paragraph 2 below. The Grantee shall (i) sign and deliver to the Company a
copy of this Award Agreement and (ii) deliver to the Company a stock power endorsed in blank.
2. Restrictions
and Conditions.
(a) Any
book entries for the shares of Restricted Stock granted herein shall bear an appropriate legend, as determined by the Administrator
in its sole discretion, to the effect that such shares are subject to restrictions as set forth herein and in the Plan.
(b) Shares
of Restricted Stock granted herein may not be sold, assigned, transferred, pledged or otherwise encumbered or disposed of by the
Grantee prior to vesting.
(c) If
the Grantee’s employment1 with the Company and its Subsidiaries is voluntarily or involuntarily terminated for
any reason (including death) prior to vesting of shares of Restricted Stock granted herein, all shares of Restricted Stock shall
immediately and automatically be forfeited and returned to the Company.
3. Vesting
of Restricted Stock. The restrictions and conditions in Paragraph 2 of this Agreement shall lapse on the Vesting Date
or Dates specified in the following schedule so long as the Grantee remains an employee1
of the Company or a Subsidiary on such Dates. If a series of Vesting Dates is specified, then the restrictions and conditions in
Paragraph 2 shall lapse only with respect to the number of shares of Restricted Stock specified as vested on such date.
Incremental Number
of Shares Vested |
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Subsequent to such Vesting Date or Dates,
the shares of Stock on which all restrictions and conditions have lapsed shall no longer be deemed Restricted Stock. The Administrator
may at any time accelerate the vesting schedule specified in this Paragraph 3.
4. Dividends.
Dividends on shares of Restricted Stock shall be paid currently to the Grantee.
5. Incorporation
of Plan. Notwithstanding anything herein to the contrary, this Award shall be subject to and governed by all the terms and
conditions of the Plan, including the powers of the Administrator set forth in Section 2(b) of the Plan. Capitalized terms in this
Agreement shall have the meaning specified in the Plan, unless a different meaning is specified herein.
6. Transferability.
This Agreement is personal to the Grantee, is non-assignable and is not transferable in any manner, by operation of law or otherwise,
other than by will or the laws of descent and distribution.
7. Tax
Withholding. The Grantee shall, not later than the date as of which the receipt of this Award becomes a taxable event for Federal
income tax purposes, pay to the Company or make arrangements satisfactory to the Administrator for payment of any Federal, state,
and local taxes required by law to be withheld on account of such taxable event. Except in the case where an election is made pursuant
to Paragraph 8 below, the Company shall have the authority to cause the required tax withholding obligation to be satisfied, in
whole or in part, by withholding from shares of Stock to be issued or released by the transfer agent a number of shares of Stock
with an aggregate Fair Market Value that would satisfy the withholding amount due.
8. Election
Under Section 83(b). The Grantee and the Company hereby agree that the Grantee may, within 30 days following the Grant Date
of this Award, file with the Internal Revenue Service and the Company an election under Section 83(b) of the Internal Revenue Code.
In the event the Grantee makes such an election, he or she agrees to provide a copy of the election to the Company. The Grantee
acknowledges that he or she is responsible for obtaining the advice of his or her tax advisors with regard to the Section 83(b)
election and that he or she is relying solely on such advisors and not on any statements or representations of the Company or any
of its agents with regard to such election.
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Company to confirm that vesting should be tied to continued employment rather than continued service relationship in any capacity
(i.e., if the grantee’s employment ends but the grantee continues to provide services as a consultant, vesting will cease
on the date the employment relationship ends)..
9. No
Obligation to Continue Employment. Neither the Company nor any Subsidiary is obligated by or as a result of the Plan or this
Agreement to continue the Grantee in employment and neither the Plan nor this Agreement shall interfere in any way with the right
of the Company or any Subsidiary to terminate the employment of the Grantee at any time.
10. Integration.
This Agreement constitutes the entire agreement between the parties with respect to this Award and supersedes all prior agreements
and discussions between the parties concerning such subject matter.
11. Data
Privacy Consent. In order to administer the Plan and this Agreement and to implement or structure future equity grants, the
Company, its subsidiaries and affiliates and certain agents thereof (together, the “Relevant Companies”) may process
any and all personal or professional data, including but not limited to Social Security or other identification number, home address
and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or
this Agreement (the “Relevant Information”). By entering into this Agreement, the Grantee (i) authorizes the Company
to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy rights the
Grantee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such information
in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant Companies
consider appropriate. The Grantee shall have access to, and the right to change, the Relevant Information. Relevant Information
will only be used in accordance with applicable law.
12. Notices.
Notices hereunder shall be mailed or delivered to the Company at its principal place of business and shall be mailed or delivered
to the Grantee at the address on file with the Company or, in either case, at such other address as one party may subsequently
furnish to the other party in writing.
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SPRINGWORKS THERAPEUTICS, INC. |
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By: |
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Title: |
The foregoing Agreement is hereby accepted and the terms and
conditions thereof hereby agreed to by the undersigned. Electronic acceptance of this Agreement pursuant to the Company’s
instructions to the Grantee (including through an online acceptance process) is acceptable.
Dated: |
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Grantee’s Signature |
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Grantee’s name and address: |
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NON-QUALIFIED
STOCK OPTION AGREEMENT
FOR COMPANY EMPLOYEES
UNDER the SPRINGWORKS THERAPEUTICS, inc.
2019 STOCK OPTION AND EQUITY INCENTIVE PLAN
Name of Optionee: |
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Option Exercise Price per Share: |
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Grant Date: |
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Expiration Date: |
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Pursuant to the SpringWorks Therapeutics,
Inc. 2019 Stock Option and Equity Incentive Plan as amended through the date hereof (the “Plan”), SpringWorks Therapeutics,
Inc. (the “Company”) hereby grants to the Optionee named above an option (the “Stock Option”) to purchase
on or prior to the Expiration Date specified above all or part of the number of shares of Common Stock, par value $0.0001 per share
(the “Stock”) of the Company specified above at the Option Exercise Price per Share specified above subject to the
terms and conditions set forth herein and in the Plan. This Stock Option is not intended to be an “incentive stock option”
under Section 422 of the Internal Revenue Code of 1986, as amended.
1. Exercisability
Schedule. No portion of this Stock Option may be exercised until such portion shall have become exercisable. Except as set
forth below, and subject to the discretion of the Administrator (as defined in Section 2 of the Plan) to accelerate the exercisability
schedule hereunder, this Stock Option shall be exercisable with respect to the following number of Option Shares on the dates indicated
so long as Optionee remains an employee1 of the Company
or a Subsidiary on such dates:
Incremental Number of
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_____________ (___%) |
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Company to confirm that vesting should be tied to continued employment rather than continued service relationship in any capacity
(i.e., if the optionee’s employment ends but the optionee continues to provide services as a consultant, vesting will cease
on the date the employment relationship ends).
Once exercisable, this Stock Option shall
continue to be exercisable at any time or times prior to the close of business on the Expiration Date, subject to the provisions
hereof and of the Plan.
2. Manner
of Exercise.
(a) The
Optionee may exercise this Stock Option only in the following manner: from time to time on or prior to the Expiration Date of this
Stock Option, the Optionee may give written notice to the Administrator of his or her election to purchase some or all of the Option
Shares purchasable at the time of such notice. This notice shall specify the number of Option Shares to be purchased.
Payment of the purchase price for the Option
Shares may be made by one or more of the following methods: (i) in cash, by certified or bank check or other instrument acceptable
to the Administrator; (ii) through the delivery (or attestation to the ownership) of shares of Stock that have been purchased
by the Optionee on the open market or that are beneficially owned by the Optionee and are not then subject to any restrictions
under any Company plan and that otherwise satisfy any holding periods as may be required by the Administrator; (iii) by the
Optionee delivering to the Company a properly executed exercise notice together with irrevocable instructions to a broker to promptly
deliver to the Company cash or a check payable and acceptable to the Company to pay the option purchase price, provided that in
the event the Optionee chooses to pay the option purchase price as so provided, the Optionee and the broker shall comply with such
procedures and enter into such agreements of indemnity and other agreements as the Administrator shall prescribe as a condition
of such payment procedure; (iv) by a “net exercise” arrangement pursuant to which the Company will reduce the
number of shares of Stock issuable upon exercise by the largest whole number of shares with a Fair Market Value that does not exceed
the aggregate exercise price; or (v) a combination of (i), (ii), (iii) and (iv) above. Payment instruments will be received
subject to collection.
The transfer to the Optionee on the records
of the Company or of the transfer agent of the Option Shares will be contingent upon (i) the Company’s receipt from the Optionee
of the full purchase price for the Option Shares, as set forth above, (ii) the fulfillment of any other requirements contained
herein or in the Plan or in any other agreement or provision of laws, and (iii) the receipt by the Company of any agreement, statement
or other evidence that the Company may require to satisfy itself that the issuance of Stock to be purchased pursuant to the exercise
of Stock Options under the Plan and any subsequent resale of the shares of Stock will be in compliance with applicable laws and
regulations. In the event the Optionee chooses to pay the purchase price by previously-owned shares of Stock through the attestation
method, the number of shares of Stock transferred to the Optionee upon the exercise of the Stock Option shall be net of the Shares
attested to.
(b) The
shares of Stock purchased upon exercise of this Stock Option shall be transferred to the Optionee on the records of the Company
or of the transfer agent upon compliance to the satisfaction of the Administrator with all requirements under applicable laws or
regulations in connection with such transfer and with the requirements hereof and of the Plan. The determination of the Administrator
as to such compliance shall be final and binding on the Optionee. The Optionee shall not be deemed to be the holder of, or to have
any of the rights of a holder with respect to, any shares of Stock subject to this Stock Option unless and until this Stock Option
shall have been exercised pursuant to the terms hereof, the Company or the transfer agent shall have transferred the shares to
the Optionee, and the Optionee’s name shall have been entered as the stockholder of record on the books of the Company. Thereupon,
the Optionee shall have full voting, dividend and other ownership rights with respect to such shares of Stock.
(c) The
minimum number of shares with respect to which this Stock Option may be exercised at any one time shall be 100 shares, unless the
number of shares with respect to which this Stock Option is being exercised is the total number of shares subject to exercise under
this Stock Option at the time.
(d) Notwithstanding
any other provision hereof or of the Plan, no portion of this Stock Option shall be exercisable after the Expiration Date hereof.
3. Termination
of Employment. If the Optionee’s employment the Company or a Subsidiary (as defined in the Plan) is terminated, the period
within which to exercise the Stock Option may be subject to earlier termination as set forth below.
(a) Termination
Due to Death. If the Optionee’s employment terminates by reason of the Optionee’s death, any portion of this Stock
Option outstanding on such date, to the extent exercisable on the date of death, may thereafter be exercised by the Optionee’s
legal representative or legatee for a period of 12 months from the date of death or until the Expiration Date, if earlier. Any
portion of this Stock Option that is not exercisable on the date of death shall terminate immediately and be of no further force
or effect.
(b) Termination
Due to Disability. If the Optionee’s employment terminates by reason of the Optionee’s disability (as determined
by the Administrator), any portion of this Stock Option outstanding on such date, to the extent exercisable on the date of such
termination of employment, may thereafter be exercised by the Optionee for a period of 12 months from the date of disability or
until the Expiration Date, if earlier. Any portion of this Stock Option that is not exercisable on the date of disability shall
terminate immediately and be of no further force or effect.
(c) Termination
for Cause. If the Optionee’s employment terminates for Cause, any portion of this Stock Option outstanding on such date
shall terminate immediately and be of no further force and effect. For purposes hereof, “Cause” shall mean, unless
otherwise provided in an employment agreement between the Company and the Optionee, a determination by the Administrator that the
Optionee shall be dismissed as a result of (i) any material breach by the Optionee of any agreement between the Optionee and the
Company; (ii) the conviction of, indictment for or plea of nolo contendere by the Optionee to a felony or a crime involving moral
turpitude; or (iii) any material misconduct or willful and deliberate non-performance (other than by reason of disability) by the
Optionee of the Optionee’s duties to the Company.
(d) Other
Termination. If the Optionee’s employment terminates for any reason other than the Optionee’s death, the Optionee’s
disability or Cause, and unless otherwise determined by the Administrator, any portion of this Stock Option outstanding on such
date may be exercised, to the extent exercisable on the date of termination, for a period of three months from the date of termination
or until the Expiration Date, if earlier. Any portion of this Stock Option that is not exercisable on the date of termination shall
terminate immediately and be of no further force or effect.
The Administrator’s determination
of the reason for termination of the Optionee’s employment shall be conclusive and binding on the Optionee and his or her
representatives or legatees.
4. Incorporation
of Plan. Notwithstanding anything herein to the contrary, this Stock Option shall be subject to and governed by all the terms
and conditions of the Plan, including the powers of the Administrator set forth in Section 2(b) of the Plan. Capitalized terms
in this Agreement shall have the meaning specified in the Plan, unless a different meaning is specified herein.
5. Transferability.
This Agreement is personal to the Optionee, is non-assignable and is not transferable in any manner, by operation of law or otherwise,
other than by will or the laws of descent and distribution. This Stock Option is exercisable, during the Optionee’s lifetime,
only by the Optionee, and thereafter, only by the Optionee’s legal representative or legatee.
6. Tax
Withholding. The Optionee shall, not later than the date as of which the exercise of this Stock Option becomes a taxable event
for Federal income tax purposes, pay to the Company or make arrangements satisfactory to the Administrator for payment of any Federal,
state, and local taxes required by law to be withheld on account of such taxable event. The Company shall have the authority to
cause the required tax withholding obligation to be satisfied, in whole or in part, by withholding from shares of Stock to be issued
to the Optionee a number of shares of Stock with an aggregate Fair Market Value that would satisfy the withholding amount due.
7. No
Obligation to Continue Employment. Neither the Company nor any Subsidiary is obligated by or as a result of the Plan or this
Agreement to continue the Optionee in employment and neither the Plan nor this Agreement shall interfere in any way with the right
of the Company or any Subsidiary to terminate the employment of the Optionee at any time.
8. Integration.
This Agreement constitutes the entire agreement between the parties with respect to this Stock Option and supersedes all prior
agreements and discussions between the parties concerning such subject matter.
9. Data
Privacy Consent. In order to administer the Plan and this Agreement and to implement or structure future equity grants, the
Company, its subsidiaries and affiliates and certain agents thereof (together, the “Relevant Companies”) may process
any and all personal or professional data, including but not limited to Social Security or other identification number, home address
and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or
this Agreement (the “Relevant Information”). By entering into this Agreement, the Optionee (i) authorizes the Company
to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy rights the
Optionee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such
information in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant
Companies consider appropriate. The Optionee shall have access to, and the right to change, the Relevant Information. Relevant
Information will only be used in accordance with applicable law.
10. Notices.
Notices hereunder shall be mailed or delivered to the Company at its principal place of business and shall be mailed or delivered
to the Optionee at the address on file with the Company or, in either case, at such other address as one party may subsequently
furnish to the other party in writing.
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SPRINGWORKS THERAPEUTICS, INC. |
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Title: |
The foregoing Agreement is hereby accepted and the terms and
conditions thereof hereby agreed to by the undersigned. Electronic acceptance of this Agreement pursuant to the Company’s
instructions to the Optionee (including through an online acceptance process) is acceptable.
Dated: |
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Optionee’s Signature |
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Optionee’s name and address: |
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NON-QUALIFIED
STOCK OPTION AGREEMENT
FOR NON-EMPLOYEE DIRECTORS
UNDER THE SPRINGWORKS THERAPEUTICS, INC.
2019 STOCK OPTION AND EQUTY INCENTIVE PLAN
Name of Optionee: |
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No. of Option Shares: |
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Option Exercise Price per Share: |
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Grant Date: |
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Expiration Date: |
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Pursuant to the SpringWorks Therapeutics,
Inc. 2019 Stock Option and Equity Incentive Plan as amended through the date hereof (the “Plan”), SpringWorks Therapeutics,
Inc. (the “Company”) hereby grants to the Optionee named above, who is a Director of the Company but is not an employee
of the Company, an option (the “Stock Option”) to purchase on or prior to the Expiration Date specified above all or
part of the number of shares of Common Stock, par value $0.0001 per share (the “Stock”), of the Company specified above
at the Option Exercise Price per Share specified above subject to the terms and conditions set forth herein and in the Plan. This
Stock Option is not intended to be an “incentive stock option” under Section 422 of the Internal Revenue Code of 1986,
as amended.
1. Exercisability
Schedule. No portion of this Stock Option may be exercised until such portion shall have become exercisable. Except as set
forth below, and subject to the discretion of the Administrator (as defined in Section 2 of the Plan) to accelerate the exercisability
schedule hereunder, this Stock Option shall be exercisable with respect to the following number of Option Shares on the dates indicated
so long as the Optionee remains in service as a member of the Board on such dates1:
1
Company to confirm that vesting should be tied to continued Board service rather than continued service relationship in any capacity
(i.e., if the director ceases to serve on the Board but the continues to provide services as an employee or a consultant, vesting
will cease on the date the optionee ceases to serve as a director).
Incremental Number of
Option Shares Exercisable |
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Exercisability Date |
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_____________ (___%) |
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_____________ (___%) |
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_____________ (___%) |
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_____________ (___%) |
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_____________ (___%) |
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Once exercisable, this Stock Option shall
continue to be exercisable at any time or times prior to the close of business on the Expiration Date, subject to the provisions
hereof and of the Plan. Notwithstanding the foregoing, 100% of the Option Shares shall immediately become exercisable upon (i)
termination of the Optionee’s service as a Director by reason of the Optionee’s death or disability and (ii) a Sale
Event, provided that the Grantee continues to provide services as a Director through the date of such Sale Event.
2. Manner
of Exercise.
(a) The
Optionee may exercise this Stock Option only in the following manner: from time to time on or prior to the Expiration Date of this
Stock Option, the Optionee may give written notice to the Administrator of his or her election to purchase some or all of the Option
Shares purchasable at the time of such notice. This notice shall specify the number of Option Shares to be purchased.
Payment of the purchase price for the Option
Shares may be made by one or more of the following methods: (i) in cash, by certified or bank check or other instrument acceptable
to the Administrator; (ii) through the delivery (or attestation to the ownership) of shares of Stock that have been purchased
by the Optionee on the open market or that are beneficially owned by the Optionee and are not then subject to any restrictions
under any Company plan and that otherwise satisfy any holding periods as may be required by the Administrator; (iii) by the
Optionee delivering to the Company a properly executed exercise notice together with irrevocable instructions to a broker to promptly
deliver to the Company cash or a check payable and acceptable to the Company to pay the option purchase price, provided that in
the event the Optionee chooses to pay the option purchase price as so provided, the Optionee and the broker shall comply with such
procedures and enter into such agreements of indemnity and other agreements as the Administrator shall prescribe as a condition
of such payment procedure; (iv) by a “net exercise” arrangement pursuant to which the Company will reduce the
number of shares of Stock issuable upon exercise by the largest whole number of shares with a Fair Market Value that does not exceed
the aggregate exercise price; or (v) a combination of (i), (ii), (iii) and (iv) above. Payment instruments will be received
subject to collection.
The transfer to the Optionee on the records
of the Company or of the transfer agent of the Option Shares will be contingent upon (i) the Company’s receipt from the Optionee
of the full purchase price for the Option Shares, as set forth above, (ii) the fulfillment of any other requirements contained
herein or in the Plan or in any other agreement or provision of laws, and (iii) the receipt by the Company of any agreement, statement
or other evidence that the Company may require to satisfy itself that the issuance of Stock to be purchased pursuant to the exercise
of Stock Options under the Plan and any subsequent resale of the shares of Stock will be in compliance with applicable laws and
regulations. In the event the Optionee chooses to pay the purchase price by previously-owned shares of Stock through the attestation
method, the number of shares of Stock transferred to the Optionee upon the exercise of the Stock Option shall be net of the Shares
attested to.
(b) The
shares of Stock purchased upon exercise of this Stock Option shall be transferred to the Optionee on the records of the Company
or of the transfer agent upon compliance to the satisfaction of the Administrator with all requirements under applicable laws or
regulations in connection with such transfer and with the requirements hereof and of the Plan. The determination of the Administrator
as to such compliance shall be final and binding on the Optionee. The Optionee shall not be deemed to be the holder of, or to have
any of the rights of a holder with respect to, any shares of Stock subject to this Stock Option unless and until this Stock Option
shall have been exercised pursuant to the terms hereof, the Company or the transfer agent shall have transferred the shares to
the Optionee, and the Optionee’s name shall have been entered as the stockholder of record on the books of the Company. Thereupon,
the Optionee shall have full voting, dividend and other ownership rights with respect to such shares of Stock.
(c) The
minimum number of shares with respect to which this Stock Option may be exercised at any one time shall be 100 shares, unless the
number of shares with respect to which this Stock Option is being exercised is the total number of shares subject to exercise under
this Stock Option at the time.
(d) Notwithstanding
any other provision hereof or of the Plan, no portion of this Stock Option shall be exercisable after the Expiration Date hereof.
3. Termination
as Director. If the Optionee ceases to be a Director of the Company, the period within which to exercise the Stock Option may
be subject to earlier termination as set forth below.
(a) Termination
Due to Death. If the Optionee’s service as a Director terminates by reason of the Optionee’s death, any portion
of this Stock Option outstanding on such date, to the extent exercisable on the date of death, may thereafter be exercised by the
Optionee’s legal representative or legatee for a period of 12 months from the date of death or until the Expiration Date,
if earlier. Any portion of this Stock Option that is not exercisable on the date of death shall terminate immediately and be of
no further force or effect.
(b) Other
Termination. If the Optionee ceases to be a Director for any reason other than the Optionee’s death, any portion of this
Stock Option outstanding on such date may be exercised, to the extent exercisable on the date the Optionee ceased to be a Director,
for a period of 12 months from the date the Optionee ceased to be a Director or until the Expiration Date, if earlier. Any portion
of this Stock Option that is not exercisable on the date the Optionee ceases to be a Director shall terminate immediately and be
of no further force or effect.
4. Incorporation
of Plan. Notwithstanding anything herein to the contrary, this Stock Option shall be subject to and governed by all the terms
and conditions of the Plan, including the powers of the Administrator set forth in Section 2(b) of the Plan. Capitalized terms
in this Agreement shall have the meaning specified in the Plan, unless a different meaning is specified herein.
5. Transferability.
This Agreement is personal to the Optionee, is non-assignable and is not transferable in any manner, by operation of law or otherwise,
other than by will or the laws of descent and distribution. This Stock Option is exercisable, during the Optionee’s lifetime,
only by the Optionee, and thereafter, only by the Optionee’s legal representative or legatee.
6. No
Obligation to Continue as a Director. Neither the Plan nor this Stock Option confers upon the Optionee any rights with respect
to continuance as a Director.
7. Integration.
This Agreement constitutes the entire agreement between the parties with respect to this Stock Option and supersedes all prior
agreements and discussions between the parties concerning such subject matter.
8. Data
Privacy Consent. In order to administer the Plan and this Agreement and to implement or structure future equity grants, the
Company, its subsidiaries and affiliates and certain agents thereof (together, the “Relevant Companies”) may process
any and all personal or professional data, including but not limited to Social Security or other identification number, home address
and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or
this Agreement (the “Relevant Information”). By entering into this Agreement, the Optionee (i) authorizes the Company
to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy rights the
Optionee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such
information in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant
Companies consider appropriate. The Optionee shall have access to, and the right to change, the Relevant Information. Relevant
Information will only be used in accordance with applicable law.
9. Notices.
Notices hereunder shall be mailed or delivered to the Company at its principal place of business and shall be mailed or delivered
to the Optionee at the address on file with the Company or, in either case, at such other address as one party may subsequently
furnish to the other party in writing.
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SPRINGWORKS THERAPEUTICS, INC. |
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By: |
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Title: |
The foregoing Agreement is hereby accepted and the terms and
conditions thereof hereby agreed to by the undersigned. Electronic acceptance of this Agreement pursuant to the Company’s
instructions to the Optionee (including through an online acceptance process) is acceptable.
Dated: |
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Optionee’s Signature |
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Optionee’s name and address: |
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RESTRICTED
STOCK UNIT AWARD AGREEMENT
FOR COMPANY EMPLOYEES
UNDER the SPRINGWORKS THERAPEUTICS, inc.
2019 STOCK OPTION AND EQUITY INCENTIVE PLAN
Name of Grantee: |
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No. of Restricted Stock Units: |
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Grant Date: |
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Pursuant to the SpringWorks Therapeutics,
Inc. 2019 Stock Option and Equity Incentive Plan as amended through the date hereof (the “Plan”), SpringWorks Therapeutics,
Inc. (the “Company”) hereby grants an award of the number of Restricted Stock Units listed above (an “Award”)
to the Grantee named above. Each Restricted Stock Unit shall relate to one share of Common Stock, par value $0.0001 per share (the
“Stock”) of the Company.
1. Restrictions
on Transfer of Award. This Award may not be sold, transferred, pledged, assigned or otherwise encumbered or disposed of by
the Grantee, and any shares of Stock issuable with respect to the Award may not be sold, transferred, pledged, assigned or otherwise
encumbered or disposed of until (i) the Restricted Stock Units have vested as provided in Paragraph 2 of this Agreement and (ii)
shares of Stock have been issued to the Grantee in accordance with the terms of the Plan and this Agreement.
2. Vesting
of Restricted Stock Units. The restrictions and conditions of Paragraph 1 of this Agreement shall lapse on the Vesting
Date or Dates specified in the following schedule so long as the Grantee remains an employee1
of the Company or a Subsidiary on such Dates. If a series of Vesting Dates is specified, then the restrictions and conditions in
Paragraph 1 shall lapse only with respect to the number of Restricted Stock Units specified as vested on such date.
Incremental Number of
Restricted Stock Units Vested |
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Vesting Date |
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_____________ (___%) |
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_____________ (___%) |
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_______________ |
_____________ (___%) |
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_____________ (___%) |
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The Administrator may at any time accelerate
the vesting schedule specified in this Paragraph 2.
1
Company to confirm that vesting should be tied to continued employment rather than continued service relationship in any capacity
(i.e., if the grantee’s employment ends but the grantee continues to provide services as a consultant, vesting will cease
on the date the employment relationship ends).
3. Termination
of Employment. If the Grantee’s employment with the Company and its Subsidiaries terminates for any reason (including
death or disability) prior to the satisfaction of the vesting conditions set forth in Paragraph 2 above, any Restricted Stock Units
that have not vested as of such date shall automatically and without notice terminate and be forfeited, and neither the Grantee
nor any of his or her successors, heirs, assigns, or personal representatives will thereafter have any further rights or interests
in such unvested Restricted Stock Units.
4. Issuance
of Shares of Stock. As soon as practicable following each Vesting Date (but in no event later than two and one-half months
after the end of the year in which the Vesting Date occurs), the Company shall issue to the Grantee the number of shares of Stock
equal to the aggregate number of Restricted Stock Units that have vested pursuant to Paragraph 2 of this Agreement on such date
and the Grantee shall thereafter have all the rights of a stockholder of the Company with respect to such shares.
5. Incorporation
of Plan. Notwithstanding anything herein to the contrary, this Agreement shall be subject to and governed by all the terms
and conditions of the Plan, including the powers of the Administrator set forth in Section 2(b) of the Plan. Capitalized terms
in this Agreement shall have the meaning specified in the Plan, unless a different meaning is specified herein.
6. Tax
Withholding. The Grantee shall, not later than the date as of which the receipt of this Award becomes a taxable event for Federal
income tax purposes, pay to the Company or make arrangements satisfactory to the Administrator for payment of any Federal, state,
and local taxes required by law to be withheld on account of such taxable event. The Company shall have the authority to cause
the required tax withholding obligation to be satisfied, in whole or in part, by withholding from shares of Stock to be issued
to the Grantee a number of shares of Stock with an aggregate Fair Market Value that would satisfy the withholding amount due.
7. Section
409A of the Code. This Agreement shall be interpreted in such a manner that all provisions relating to the settlement of the
Award are exempt from the requirements of Section 409A of the Code as “short-term deferrals” as described in Section
409A of the Code.
8. No
Obligation to Continue Employment. Neither the Company nor any Subsidiary is obligated by or as a result of the Plan or this
Agreement to continue the Grantee in employment and neither the Plan nor this Agreement shall interfere in any way with the right
of the Company or any Subsidiary to terminate the employment of the Grantee at any time.
9. Integration.
This Agreement constitutes the entire agreement between the parties with respect to this Award and supersedes all prior agreements
and discussions between the parties concerning such subject matter.
10. Data
Privacy Consent. In order to administer the Plan and this Agreement and to implement or structure future equity grants, the
Company, its subsidiaries and affiliates and certain agents thereof (together, the “Relevant Companies”) may process
any and all personal or professional data, including but not limited to Social Security or other identification number, home address
and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or
this Agreement (the “Relevant Information”). By entering into this Agreement, the Grantee (i) authorizes the Company
to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy rights the
Grantee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such information
in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant Companies
consider appropriate. The Grantee shall have access to, and the right to change, the Relevant Information. Relevant Information
will only be used in accordance with applicable law.
11. Notices.
Notices hereunder shall be mailed or delivered to the Company at its principal place of business and shall be mailed or delivered
to the Grantee at the address on file with the Company or, in either case, at such other address as one party may subsequently
furnish to the other party in writing.
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SPRINGWORKS THERAPEUTICS, INC. |
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By: |
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Title: |
The foregoing Agreement is hereby accepted and the terms and
conditions thereof hereby agreed to by the undersigned. Electronic acceptance of this Agreement pursuant to the Company’s
instructions to the Grantee (including through an online acceptance process) is acceptable.
Dated: |
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Grantee’s Signature |
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Grantee’s name and address: |
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RESTRICTED
STOCK UNIT AWARD AGREEMENT
FOR NON-EMPLOYEE DIRECTORS
UNDER the SPRINGWORKS Therapeutics, inc.
2019 STOCK OPTION AND INCENTIVE PLAN
Name of Grantee: |
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No. of Restricted Stock Units: |
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Grant Date: |
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Pursuant to the SpringWorks Therapeutics,
Inc. 2019 Stock Option and Equity Incentive Plan as amended through the date hereof (the “Plan”), SpringWorks Therapeutics
Inc. (the “Company”) hereby grants an award of the number of Restricted Stock Units listed above (an “Award”)
to the Grantee named above. Each Restricted Stock Unit shall relate to one share of Common Stock, par value $0.0001 per share (the
“Stock”) of the Company.
1. Restrictions
on Transfer of Award. This Award may not be sold, transferred, pledged, assigned or otherwise encumbered or disposed of by
the Grantee, and any shares of Stock issuable with respect to the Award may not be sold, transferred, pledged, assigned or otherwise
encumbered or disposed of until (i) the Restricted Stock Units have vested as provided in Paragraph 2 of this Agreement and (ii)
shares of Stock have been issued to the Grantee in accordance with the terms of the Plan and this Agreement.
2. Vesting
of Restricted Stock Units. The restrictions and conditions of Paragraph 1 of this Agreement shall lapse on the Vesting
Date or Dates specified in the following schedule so long as the Grantee remains in service as a member of the Board on such Dates.1
If a series of Vesting Dates is specified, then the restrictions and conditions in Paragraph 1 shall lapse only with respect
to the number of Restricted Stock Units specified as vested on such date.
Incremental Number of
Restricted Stock Units Vested |
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Vesting Date |
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_____________ (___%) |
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_____________ (___%) |
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_____________ (___%) |
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_____________ (___%) |
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Company to confirm that vesting should be tied to continued Board service rather than continued service relationship in any capacity
(i.e., if the director ceases to serve on the Board but the continues to provide services as an employee or a consultant, vesting
will cease on the date the grantee ceases to serve as a director).
Notwithstanding the foregoing, 100% of the
Option Shares shall immediately become exercisable upon (i) termination of the Grantee’s service as a Director by reason
of the Grantee’s death or disability and (ii) a Sale Event, provided that the Grantee continues to provide services as a
Director through the date of such Sale Event. The Administrator may at any time accelerate the vesting schedule specified in this
Paragraph 2.
3. Termination
of Service. If the Grantee’s service as a Director terminates for any reason (other than death or disability) prior to
the satisfaction of the vesting conditions set forth in Paragraph 2 above, any Restricted Stock Units that have not vested as of
such date shall automatically and without notice terminate and be forfeited, and neither the Grantee nor any of his or her successors,
heirs, assigns, or personal representatives will thereafter have any further rights or interests in such unvested Restricted Stock
Units.
4. Issuance
of Shares of Stock. As soon as practicable following each Vesting Date (but in no event later than two and one-half months
after the end of the year in which the Vesting Date occurs), the Company shall issue to the Grantee the number of shares of Stock
equal to the aggregate number of Restricted Stock Units that have vested pursuant to Paragraph 2 of this Agreement on such date
and the Grantee shall thereafter have all the rights of a stockholder of the Company with respect to such shares.
5. Incorporation
of Plan. Notwithstanding anything herein to the contrary, this Agreement shall be subject to and governed by all the terms
and conditions of the Plan, including the powers of the Administrator set forth in Section 2(b) of the Plan. Capitalized terms
in this Agreement shall have the meaning specified in the Plan, unless a different meaning is specified herein.
6. Section
409A of the Code. This Agreement shall be interpreted in such a manner that all provisions relating to the settlement of the
Award are exempt from the requirements of Section 409A of the Code as “short-term deferrals” as described in Section
409A of the Code.
7. No
Obligation to Continue as a Director. Neither the Plan nor this Award confers upon the Grantee any rights with respect to continuance
as a Director.
8. Integration.
This Agreement constitutes the entire agreement between the parties with respect to this Award and supersedes all prior agreements
and discussions between the parties concerning such subject matter.
9. Data
Privacy Consent. In order to administer the Plan and this Agreement and to implement or structure future equity grants, the
Company, its subsidiaries and affiliates and certain agents thereof (together, the “Relevant Companies”) may process
any and all personal or professional data, including but not limited to Social Security or other identification number, home address
and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or
this Agreement (the “Relevant Information”). By entering into this Agreement, the Grantee (i) authorizes the Company
to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy rights the
Grantee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such information
in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant Companies
consider appropriate. The Grantee shall have access to, and the right to change, the Relevant Information. Relevant Information
will only be used in accordance with applicable law.
10. Notices.
Notices hereunder shall be mailed or delivered to the Company at its principal place of business and shall be mailed or delivered
to the Grantee at the address on file with the Company or, in either case, at such other address as one party may subsequently
furnish to the other party in writing.
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The foregoing Agreement is hereby accepted and the terms and
conditions thereof hereby agreed to by the undersigned. Electronic acceptance of this Agreement pursuant to the Company’s
instructions to the Grantee (including through an online acceptance process) is acceptable.
Dated: |
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Grantee’s Signature |
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Grantee’s name and address: |
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Exhibit 10.3
SPRINGWORKS THERAPEUTICS,
INC.
2019 EMPLOYEE STOCK PURCHASE
PLAN
The purpose of the SpringWorks Therapeutics,
Inc. 2019 Employee Stock Purchase Plan (“the Plan”) is to provide eligible employees of SpringWorks Therapeutics, Inc.
(the “Company”) and each Designated Subsidiary (as defined in Section 11) with opportunities to purchase shares of
the Company’s common stock, par value $0.0001 per share (the “Common Stock”). An aggregate of 442,153 shares
of Common Stock in the aggregate have been approved and reserved for this purpose, plus on January 1, 2020, and each January 1
thereafter through January 1, 2029, the number of shares of Common Stock reserved and available for issuance under the Plan shall
be cumulatively increased by the least of (i) one percent (1%) percent of the number of shares of Common Stock issued and outstanding
on the immediately preceding December 31st, (ii) 663,229 shares of Common Stock or (iii) such number of shares of Common Stock
as determined by the Administrator. The Plan is intended to constitute an “employee stock purchase plan” within the
meaning of Section 423(b) of the Internal Revenue Code of 1986, as amended (the “Code”), and shall be interpreted in
accordance with that intent.
1. Administration.
The Plan will be administered by the person or persons (the “Administrator”) appointed by the Company’s Board
of Directors (the “Board”) for such purpose. The Administrator has authority at any time to: (i) adopt, alter and repeal
such rules, guidelines and practices for the administration of the Plan and for its own acts and proceedings as it shall deem advisable;
(ii) interpret the terms and provisions of the Plan; (iii) make all determinations it deems advisable for the administration of
the Plan; (iv) decide all disputes arising in connection with the Plan; and (v) otherwise supervise the administration of the Plan.
All interpretations and decisions of the Administrator shall be binding on all persons, including the Company and the Participants.
No member of the Board or individual exercising administrative authority with respect to the Plan shall be liable for any action
or determination made in good faith with respect to the Plan or any option granted hereunder.
2. Offerings.
The Company may make one or more offerings to eligible employees to purchase Common Stock under the Plan (“Offerings”).
Unless otherwise determined by the Administrator, an Offering will begin on the first business day occurring on or after each May
1 and November 1 and will end on the last business day occurring on or before the following October 31 and April 1 respectively.
The Administrator may, in its discretion, designate a different period for any Offering, provided that no Offering shall exceed
one year in duration or overlap any other Offering.
3. Eligibility.
All individuals classified as employees on the payroll records of the Company and each Designated Subsidiary are eligible to participate
in any one or more of the Offerings under the Plan, provided that as of the first day of the applicable Offering (the “Offering
Date”) they are customarily employed by the Company or a Designated Subsidiary for more than 20 hours a week and have completed
at least three (3) months of employment. Notwithstanding any other provision herein, individuals who are not contemporaneously
classified as employees of the Company or a Designated Subsidiary for purposes of the Company’s or applicable Designated
Subsidiary’s payroll system are not considered to be eligible employees of the Company or any Designated Subsidiary and shall
not be eligible to participate in the Plan. In the event any such individuals are reclassified as employees of the Company or a
Designated Subsidiary for any purpose, including, without limitation, common law or statutory employees, by any action of any third
party, including, without limitation, any government agency, or as a result of any private lawsuit, action or administrative proceeding,
such individuals shall, notwithstanding such reclassification, remain ineligible for participation. Notwithstanding the foregoing,
the exclusive means for individuals who are not contemporaneously classified as employees of the Company or a Designated Subsidiary
on the Company’s or Designated Subsidiary’s payroll system to become eligible to participate in this Plan is through
an amendment to this Plan, duly executed by the Company, which specifically renders such individuals eligible to participate herein.
4. Participation.
(a) Participants.
An eligible employee who is not a Participant in any prior Offering may participate in a subsequent Offering by submitting an enrollment
form to his or her appropriate payroll location at least 15 business days before the Offering Date (or by such other deadline as
shall be established by the Administrator for the Offering).
(b) Enrollment.
The enrollment form will (a) state a whole percentage to be deducted from an eligible employee’s Compensation (as defined
in Section 11) per pay period, (b) authorize the purchase of Common Stock in each Offering in accordance with the terms
of the Plan and (c) specify the exact name or names in which shares of Common Stock purchased for such individual are to be
issued pursuant to Section 10. An employee who does not enroll in accordance with these procedures will be deemed to have
waived the right to participate. Unless a Participant files a new enrollment form or withdraws from the Plan, such Participant’s
deductions and purchases will continue at the same percentage of Compensation for future Offerings, provided he or she remains
eligible.
(c) Notwithstanding
the foregoing, participation in the Plan will neither be permitted nor be denied contrary to the requirements of the Code.
5. Employee
Contributions. Each eligible employee may authorize payroll deductions at a minimum of one (1) percent up to a maximum
of fifteen (15) percent of such employee’s Compensation for each pay period. The Company will maintain book accounts
showing the amount of payroll deductions made by each Participant for each Offering. No interest will accrue or be paid on payroll
deductions.
6. Deduction
Changes. Except as may be determined by the Administrator in advance of an Offering, a Participant may not increase or decrease
his or her payroll deduction during any Offering, but may increase or decrease his or her payroll deduction with respect to the
next Offering (subject to the limitations of Section 5) by filing a new enrollment form at least fifteen (15) business days
before the next Offering Date (or by such other deadline as shall be established by the Administrator for the Offering). The Administrator
may, in advance of any Offering, establish rules permitting a Participant to increase, decrease or terminate his or her payroll
deduction during an Offering.
7. Withdrawal.
A Participant may withdraw from participation in the Plan by delivering a written notice of withdrawal to his or her appropriate
payroll location. The Participant’s withdrawal will be effective as of the next business day. Following a Participant’s
withdrawal, the Company will promptly refund such individual’s entire account balance under the Plan to him or her (after
payment for any Common Stock purchased before the effective date of withdrawal). Partial withdrawals are not permitted. Such an
employee may not begin participation again during the remainder of the Offering, but may enroll in a subsequent Offering in accordance
with Section 4.
8. Grant
of Options. On each Offering Date, the Company will grant to each eligible employee who is then a Participant in the Plan an
option (“Option”) to purchase on the last day of such Offering (the “Exercise Date”), at the Option Price
hereinafter provided for, the lowest of (a) a number of shares of Common Stock determined by dividing such Participant’s
accumulated payroll deductions on such Exercise Date by the Option Price (as defined herein), (b) the number of shares determined
by dividing $25,000 by the Fair Market Value of the Common Stock on the Offering Date for such Offering; or (c) such other lesser
maximum number of shares as shall have been established by the Administrator in advance of the Offering; provided, however, that
such Option shall be subject to the limitations set forth below. Each Participant’s Option shall be exercisable only to the
extent of such Participant’s accumulated payroll deductions on the Exercise Date. The purchase price for each share purchased
under each Option (the “Option Price”) will be 85 percent of the Fair Market Value of the Common Stock on the Offering
Date or the Exercise Date, whichever is less.
Notwithstanding the foregoing, no Participant
may be granted an option hereunder if such Participant, immediately after the option was granted, would be treated as owning stock
possessing five (5) percent or more of the total combined voting power or value of all classes of stock of the Company or
any Parent or Subsidiary (as defined in Section 11). For purposes of the preceding sentence, the attribution rules of Section 424(d)
of the Code shall apply in determining the stock ownership of a Participant, and all stock which the Participant has a contractual
right to purchase shall be treated as stock owned by the Participant. In addition, no Participant may be granted an Option which
permits his or her rights to purchase stock under the Plan, and any other employee stock purchase plan of the Company and its Parents
and Subsidiaries, to accrue at a rate which exceeds $25,000 of the fair market value of such stock (determined on the option grant
date or dates) for each calendar year in which the Option is outstanding at any time. The purpose of the limitation in the preceding
sentence is to comply with Section 423(b)(8) of the Code and shall be applied taking Options into account in the order in
which they were granted.
9. Exercise
of Option and Purchase of Shares. Each employee who continues to be a Participant in the Plan on the Exercise Date shall be
deemed to have exercised his or her Option on such date and shall acquire from the Company such number of whole shares of Common
Stock reserved for the purpose of the Plan as his or her accumulated payroll deductions on such date will purchase at the Option
Price, subject to any other limitations contained in the Plan. Any amount remaining in a Participant’s account at the end
of an Offering solely by reason of the inability to purchase a fractional share will be carried forward to the next Offering; any
other balance remaining in a Participant’s account at the end of an Offering will be refunded to the Participant promptly.
10. Issuance
of Certificates. Certificates or book-entries at the Company’s transfer agent representing shares of Common Stock purchased
under the Plan may be issued only in the name of the employee, in the name of the employee and another person of legal age as joint
tenants with rights of survivorship, or in the name of a broker authorized by the employee to be his, her or their, nominee for
such purpose.
11. Definitions.
The term “Compensation” means
the regular or basic rate of compensation.
The term “Designated Subsidiary”
means any present or future Subsidiary (as defined below) that has been designated by the Board to participate in the Plan. The
Board may so designate any Subsidiary, or revoke any such designation, at any time and from time to time, either before or after
the Plan is approved by the stockholders. The current list of Designated Subsidiaries is attached hereto as Appendix A.
The term “Fair Market Value of the
Common Stock” on any given date means the fair market value of the Common Stock determined in good faith by the Administrator;
provided, however, that if the Common Stock is admitted to quotation on the National Association of Securities Dealers Automated
Quotation System (“NASDAQ”), the NASDAQ Global Market, The New York Stock Exchange or another national securities exchange,
the determination shall be made by reference to the closing price on such date. If there is no closing price for such date, the
determination shall be made by reference to the last date preceding such date for which there is a closing price.
The term “Parent” means a “parent
corporation” with respect to the Company, as defined in Section 424(e) of the Code.
The term “Participant” means
an individual who is eligible as determined in Section 3 and who has complied with the provisions of Section 4.
The term “Subsidiary” means
a “subsidiary corporation” with respect to the Company, as defined in Section 424(f) of the Code.
12. Rights
on Termination of Employment. If a Participant’s employment terminates for any reason before the Exercise Date for any
Offering, no payroll deduction will be taken from any pay due and owing to the Participant and the balance in the Participant’s
account will be paid to such Participant or, in the case of such Participant’s death, to his or her designated beneficiary
as if such Participant had withdrawn from the Plan under Section 7. An employee will be deemed to have terminated employment,
for this purpose, if the corporation that employs him or her, having been a Designated Subsidiary, ceases to be a Subsidiary, or
if the employee is transferred to any corporation other than the Company or a Designated Subsidiary. An employee will not be deemed
to have terminated employment for this purpose, if the employee is on an approved leave of absence for military service or sickness
or for any other purpose approved by the Company, if the employee’s right to reemployment is guaranteed either by a statute
or by contract or under the policy pursuant to which the leave of absence was granted or if the Administrator otherwise provides
in writing.
13. Special
Rules. Notwithstanding anything herein to the contrary, the Administrator may adopt special rules applicable to the employees
of a particular Designated Subsidiary, whenever the Administrator determines that such rules are necessary or appropriate for the
implementation of the Plan in a jurisdiction where such Designated Subsidiary has employees; provided that such rules are consistent
with the requirements of Section 423(b) of the Code. Any special rules established pursuant to this Section 13 shall,
to the extent possible, result in the employees subject to such rules having substantially the same rights as other Participants
in the Plan.
14. Optionees
Not Stockholders. Neither the granting of an Option to a Participant nor the deductions from his or her pay shall constitute
such Participant a holder of the shares of Common Stock covered by an Option under the Plan until such shares have been purchased
by and issued to him or her.
15. Rights
Not Transferable. Rights under the Plan are not transferable by a Participant other than by will or the laws of descent and
distribution, and are exercisable during the Participant’s lifetime only by the Participant.
16. Application
of Funds. All funds received or held by the Company under the Plan may be combined with other corporate funds and may be used
for any corporate purpose.
17. Adjustment
in Case of Changes Affecting Common Stock. In the event of a subdivision of outstanding shares of Common Stock, the payment
of a dividend in Common Stock or any other change affecting the Common Stock, the number of shares approved for the Plan and the
share limitation set forth in Section 8 shall be equitably or proportionately adjusted to give proper effect to such event.
18. Amendment
of the Plan. The Board may at any time and from time to time amend the Plan in any respect, except that without the approval
within 12 months of such Board action by the stockholders, no amendment shall be made increasing the number of shares approved
for the Plan or making any other change that would require stockholder approval in order for the Plan, as amended, to qualify as
an “employee stock purchase plan” under Section 423(b) of the Code.
19. Insufficient
Shares. If the total number of shares of Common Stock that would otherwise be purchased on any Exercise Date plus the number
of shares purchased under previous Offerings under the Plan exceeds the maximum number of shares issuable under the Plan, the shares
then available shall be apportioned among Participants in proportion to the amount of payroll deductions accumulated on behalf
of each Participant that would otherwise be used to purchase Common Stock on such Exercise Date.
20. Termination
of the Plan. The Plan may be terminated at any time by the Board. Upon termination of the Plan, all amounts in the accounts
of Participants shall be promptly refunded.
21. Governmental
Regulations. The Company’s obligation to sell and deliver Common Stock under the Plan is subject to obtaining all governmental
approvals required in connection with the authorization, issuance, or sale of such stock.
22. Governing
Law. This Plan and all Options and actions taken thereunder shall be governed by, and construed in accordance with the General
Corporation Law of the State of Delaware as to matters within the scope thereof, and as to all other matters shall be governed
by and construed in accordance with the internal laws of the Commonwealth of Massachusetts, applied without regard to conflict
of law principles.
23. Issuance
of Shares. Shares may be issued upon exercise of an Option from authorized but unissued Common Stock, from shares held in the
treasury of the Company, or from any other proper source.
24. Tax
Withholding. Participation in the Plan is subject to any minimum required tax withholding on income of the Participant in connection
with the Plan. Each Participant agrees, by entering the Plan, that the Company and its Subsidiaries shall have the right to deduct
any such taxes from any payment of any kind otherwise due to the Participant, including shares issuable under the Plan.
25. Notification
Upon Sale of Shares. Each Participant agrees, by entering the Plan, to give the Company prompt notice of any disposition of
shares purchased under the Plan where such disposition occurs within two years after the date of grant of the Option pursuant to
which such shares were purchased or within one year after the date such shares were purchased.
26. Effective
Date. This Plan shall become effective upon the date immediately preceding the date upon which the registration statement on
Form S-1 that is filed by the Company with respect to its initial public offering is declared effective by the Securities and Exchange
Commission following stockholder approval in accordance with applicable state law, the Company’s bylaws and articles of incorporation,
each as amended, and applicable stock exchange rules.
APPENDIX A
Designated Subsidiaries
None
Exhibit 10.14
EXECUTION VERSION
August 16, 2019
Daniel S. Lynch
Re: | | Employment Agreement Termination Letter |
Dear Mr. Lynch:
Reference is hereby
made to that certain Employment Agreement (the “Agreement”) dated as of February 1, 2018, by and between SpringWorks
Therapeutics Operating Company, Inc. (together with its predecessors, subsidiaries, and affiliates, including its parent entity,
the “Company”), and you.
The Company and you
agree that the Agreement is terminated effective as of the time (the “Effective Time”) immediately prior to
the Company’s first public filing with the Securities and Exchange Commission in connection the initial public offering of
the Company’s common stock under the Securities Act of 1933, as amended (a “Company IPO”). As of the date
hereof, you agree that you will no longer serve as the Executive Chair of the Board of Directors of the Company, but instead will
continue to serve as a director and Chair of the Board of Directors of the Company (and your signature below will serve as your
resignation as an employee and Executive Chair effective as of the Effective Time).
The Company and you
also agree that upon termination of the Agreement, the following will apply:
| (i) | all of the rights and obligations that have accrued to the parties pursuant to the Agreement as
of the date hereof shall not be affected by this letter agreement; |
| (ii) | notwithstanding Section 18 of the Agreement, all future rights and obligations of the parties
under the Agreement are terminated in their entirety; |
| (iii) | notwithstanding anything contained in the Agreement or in any other equity award agreement granted
to you by the Company, upon a Sale of the Company (as defined below), the vesting schedule of all equity awards held by you shall
be accelerated in full and all unvested equity (restricted stock and stock options) shall be immediately exercisable with respect
to the full number of shares of common stock represented thereby. A “Sale of the Company” means, regardless of form
thereof, consummation of (a) the sale of all or substantially all of the assets of the Company on a consolidated basis to an unrelated
person or entity, (b) a merger, reorganization or consolidation in which the outstanding capital stock of the Company are converted
into or exchanged for securities of the successor entity and the holders of the Company’s outstanding voting power immediately
prior to such transaction do not own, in substantially the same proportions, a majority of the outstanding voting power of the
successor entity immediately upon completion of such transaction, (c) the sale of all or a majority of the capital stock of the
Company to an unrelated person or entity or (d) any other transaction in which the owners of the Company’s outstanding voting
power immediately prior to such transaction do not own, in substantially the same proportions, a majority of the outstanding voting
power of the successor entity immediately upon completion of the transaction, provided that in no event will any capital raising
transaction (including the Company’s planned initial public offering of its common stock) be treated as a “Sale of
the Company” hereunder. |
| (iv) | in the event that you no longer serve as a director on the
Company’s Board of Directors (other than due to your removal for Cause (as defined below) or your voluntary resignation),
or the Board of Directors of the Company (or a committee thereof) fails to nominate you for election as a director at a meeting
of the stockholders of the Company at or prior to the expiration of your then current term, the portion of your existing
equity awards that would have otherwise vested during the Applicable Period (as defined below) following the date on which you
cease to serve on the Company’s Board of Directors if not for your termination or failure to be nominated for reelection,
shall immediately accelerate and vest in full. |
| a. | For purposes of this letter agreement, “Cause” shall mean: (i) your conviction of,
or pleading nolo contendere to, any felony, or a misdemeanor involving moral turpitude, deceit, dishonesty or fraud, or any similar
criminal conduct by you that would reasonably be expected to result in material injury or reputational harm to the Company if you
were retained in your position; (ii) your intentional misconduct or willful or gross neglect of your material duties, which such
intentional misconduct or willful or gross neglect you fail to cure within thirty (30) days following the receipt of notice from
the Chief Executive Officer of the Company or the Board of Directors (the “Cure Period”); (iii) your chronic or habitual
use or consumption of illegal drugs or alcoholic beverages on the Company’s premises or such that it materially interferes
with your performance of your duties as Chair of the Company’s Board of Directors which has continued following written notice
thereof from the Company’s Chief Executive Officer or Board of Directors and after the Cure Period; (iv) material breach
by you of any of the provisions contained in the Confidentiality, Assignment of Inventions and Restrictive Covenant Agreement by
and between the Company and you, dated as of June 29, 2018, which is not cured by you during the Cure Period; (v) a material violation
or failure to comply by you with the Company’s written policies, which is not cured during the Cure Period; or (vi) failure
to cooperate with a bona fide internal investigation or an investigation by regulatory or law enforcement authorities, after being
instructed by the Board of Directors to cooperate, or the willful destruction or failure to preserve documents or other materials
known to be relevant to such investigation or the inducement of others to fail to cooperate or to produce documents or other materials
in connection with such investigation. |
| b. | For purposes of this letter agreement, “Applicable Period” shall mean a period of twelve
(12) successive months plus two (2) additional successive months for each full year of service to the Company (including, without
limitation, your service as a director and Chair of the Board of Directors of the Company), measured from February 1, 2018, up
to a maximum aggregate period of eighteen (18) successive months. |
The above paragraph
will apply only to equity awards granted to you by the Company as of the date hereof but will not apply to any future equity awards
granted to you by the Company, which will be governed solely by the terms of the specific equity award agreements.
In the event that
the Company IPO has not been consummated prior to September 30, 2019 or, if earlier, upon the Company abandoning plans to consummate
the Company IPO prior to September 30, 2019, then, promptly following such event, the Company and you shall each work in good faith
to enter into an employment agreement having terms and conditions substantively equivalent to those of the Agreement prior to the
effectiveness of this letter agreement.
This letter agreement
constitutes the entire agreement between the parties and supersedes all prior agreements and understandings, whether written or
oral, relating to the subject matter of this letter agreement, including without limitation, the Agreement.
If you are agreement
with the foregoing, please sign and return this letter agreement to the Company. Thank you very much for your continued service
to and support of the Company, and please do not hesitate to contact me with any questions.
[signature
page follows]
Sincerely,
SPRINGWORKS THERAPEUTICS OPERATING
COMPANY, INC.
By: /s/ Saqib Islam______________________________
Name: Saqib Islam
Title: Chief Executive Officer
AGREED TO AND ACCEPTED BY:
By: /s/ Daniel S.
Lynch______________________________
Name: Daniel S. Lynch
Exhibit 23.1
Consent of Independent Registered
Public Accounting Firm
We consent to the reference to our firm under the
caption "Experts" and to the use of our report dated June 7, 2019, except for the section entitled “Reverse Stock
Split” in Note 16, as to which the date is September 3, 2019, in Amendment No. 1 to the Registration Statement (Form S-1
No 333-233351) and related Prospectus of SpringWorks Therapeutics, Inc. (formerly SpringWorks Therapeutics, LLC) for the registration
of its common stock.
/s/ Ernst & Young LLP
New York, New York
September 3, 2019