UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 1.01. | Entry into a Material Definitive Agreement. |
On October 22, 2021, SpringWorks Therapeutics, Inc. (the “Company” or “SpringWorks”) entered into Amendment No. 1 to that certain Clinical Trial Collaboration and Supply Agreement, dated as of June 25, 2019, between GlaxoSmithKline LLC (“GSK”) and SpringWorks Therapeutics, Inc. (the “Amendment”, and such agreement, as amended, the “Agreement”) to enable cohort expansion and additional sub-studies of nirogacestat, the Company’s investigational gamma secretase inhibitor, in combination with BLENREP (belantamab mafodotin-blmf), GSK’s antibody-drug conjugate targeting B-cell maturation agent (BCMA), in patients with relapsed or refractory multiple myeloma.
The Amendment follows encouraging preliminary data observed with the first combination dose level that evaluated (0.95 mg/kg Q3W BLENREP plus nirogacestat) in the exploration Phase 1 portion of the nirogacestat DREAMM-5 sub-study. This dose level has advanced to a randomized Phase 2 cohort expansion and is now enrolling additional patients to further explore its safety and efficacy profile compared to a 2.5 mg/kg Q3W BLENREP monotherapy control arm, which is the same as the FDA approved monotherapy dose and schedule of BLENREP. In parallel, additional dose levels and schedules of BLENREP plus nirogacestat continue to be evaluated in the Phase 1 portion of the study.
Pursuant to the Amendment, the parties plan to investigate new dosing regimens involving the combination of nirogacestat and BLENREP, in combination with standard-of-care multiple myeloma therapies, for relapsed and refractory multiple myeloma in additional sub-studies under the on-going Phase 1/2 DREAMM-5 platform study. Specifically, the two new sub-studies are designed to explore BLENREP plus nirogacestat in combination with lenalidomide plus dexamethasone and with pomalidomide plus dexamethasone, respectively. Data from these sub-studies may enable future clinical trials in earlier lines of multiple myeloma.
Pursuant to the terms of the Agreement, GSK is sponsoring and conducting the Phase 1/2 study to evaluate the safety, tolerability and preliminary efficacy of the combinations and is assuming all development costs associated with the study other than expenses related to the manufacturing of nirogacestat and certain expenses related to intellectual property rights. SpringWorks and GSK have formed a joint development committee to help manage and oversee the clinical study.
The foregoing description of the Amendment is not complete and is qualified in its entirety by reference to the full text of the Amendment, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 8.01 | Other Events. |
The Company issued a press release announcing entry into the Amendment on October 27, 2021. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description | |
| 1.1† | Amendment No. 1 dated October 22, 2021, to the Clinical Trial Collaboration and Supply Agreement, dated as of June 25, 2019, between GlaxoSmithKline LLC and SpringWorks Therapeutics, Inc. | |
| 99.1 | Press Release issued by SpringWorks Therapeutics, Inc. on October 27, 2021 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
† Portions of this exhibit (indicated by asterisks) have been omitted in accordance with Item 601(b)(10) of Regulation S-K.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: October 27, 2021 | SpringWorks Therapeutics, Inc. | |
| By: | /s/ Francis I. Perier, Jr. | |
| Francis I. Perier, Jr. | ||
| Chief Financial Officer | ||
Exhibit 1.1
CERTAIN INFORMATION IDENTIFIED BY BRACKETED ASTERISKS ([* * *]) HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
FIRST (1st) AMENDMENT TO
CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT
This Amendment No. 1 to that certain Clinical Trial Collaboration and Supply Agreement (the “Agreement”), dated as of June 25, 2019, between GlaxoSmithKline LLC (“GSK”) and SpringWorks Therapeutics, Inc. (“SpringWorks”) is dated as of October 22, 2021 (the “Amendment Effective Date”).
WHEREAS, the Parties have been collaborating under the Agreement on a clinical trial being sponsored by GSK of the Combination Therapy for relapsed and refractory multiple myeloma (the “Ongoing Study”), with SpringWorks supplying the SpringWorks Compound for use in connection with the Ongoing Study and otherwise participating in study-related governance as therein provided; and
WHEREAS, the Parties now desire to amend the Agreement in accordance with Section 27.1 to supplement their research of the Combination Therapy to (i) add additional dosing regimens in the Ongoing Study, and (ii) collaborate on additional clinical trials of the Combination Therapy in combination with other pharmaceutical agents for relapsed and refractory multiple myeloma.
NOW, THEREFORE, in consideration of the mutual agreements and covenants set forth herein and other good and valuable consideration, the receipt and sufficiency of which the Parties hereby acknowledge, the Parties, intending to be legally bound hereby, agree as follows:
| 1) | Capitalized terms used, but not otherwise defined herein, shall have the respective meanings ascribed to such terms in the Agreement. |
| 2) | Section 1.81 of the Agreement is hereby deleted in its entirety and replaced with the following: |
| “1.81 | “Sub-Study(ies)” means, as applicable, (a) the Ongoing Study to be performed under this Agreement and pursuant to the applicable Sub-Study Protocol, or (b) such other clinical trials investigating the Combination Therapy in combination with other pharmaceutical agent(s) (the “Additional Studies”), as described in the applicable Sub-Study Protocol, for relapsed and refractory multiple myeloma to be performed under this Agreement and pursuant to the applicable Sub-Study Protocol, in each case as the context requires.” |
| 3) | Section 1.84 of the Agreement is hereby deleted in its entirety and replaced with the following: |
| “1.84 | “Sub-Study Protocol” means the written documentation agreed between the Parties which describes the relevant Sub-Study and sets forth specific activities to be performed as part of such Sub-Study conduct, a summary of which will be attached hereto as Appendix A in accordance with Section 2.4.” |
| 4) | For the avoidance of doubt, the Parties agree that the terms and conditions of the Agreement that applied to the Ongoing Study prior to the Amendment Effective Date will apply mutatis mutandis to the Sub-Studies as of the Amendment Effective Date, including inter alia that the Sub-Studies will be sponsored by GSK under the Platform Study, SpringWorks will supply the SpringWorks Compound for use in connection with the Sub-Studies and the Parties will participate in study-related governance as contemplated by the Agreement, as amended hereby. |
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| 5) | The first three sentences of Section 2.4 are deleted and replaced in their entirety as follows: |
“Summaries of the study designs for the amended Ongoing Study and the Additional Studies have been agreed by the Parties as of the Amendment Effective Date and are attached as Appendix A-1. GSK will use such summaries to develop each Sub-Study Protocol in coordination with SpringWorks. After the applicable Sub-Study Protocol has been mutually agreed by the Parties, it shall be deemed a part of this Agreement as Appendix A.”
| 6) | The first sentence of Section 5.1 is deleted and replaced in its entirety as follows: |
“At any time during the Term and for a period of 90 days thereafter, either Party shall have the option to propose new agreement(s) for the purpose of performing one or more additional studies of the Combination Therapy, whether in combination with additional therapeutic agents or not, for the treatment of relapsed and refractory multiple myeloma, including phase II and phase III studies (including registration studies) (collectively, the Follow On Studies”).”
| 7) | A new Section 5.4 is hereby added as follows: |
“During the Term, the Parties will consider in good faith requests by investigators to conduct investigator-sponsored studies or supported collaborative studies of the Combination Therapy (alone or in combination with additional pharmaceutical agents) for the treatment of multiple myeloma. Each Party shall inform the other of any such requests and the Parties will discuss such requests through the JDC. Neither Party shall be obligated to approve or support any such request which does not satisfy its standard policies and procedures for such support; provided that such Party will inform the JDC of the reason for such study’s non-compliance with its standard policies and procedures. In the event both Parties agree to support any such study, each Party shall use reasonable efforts to supply reasonable quantities of its Compound to the extent reasonably available for such study (e.g., each Party continues to manufacture its Compound subject to any generally applicable shortage of its Compound and subject to other internal and Third Party commitments of each Party with respect to the use and supply of its Compound). Such supply will be pursuant to a separate agreement between the applicable Party(ies) and the investigator and/or the investigator’s institution, as appropriate.”
| 8) | Section 6.4 of the Agreement is hereby deleted and replaced in its entirety as follows: |
“As required by Applicable Law or a Regulatory Authority and otherwise upon GSK’s reasonable request, SpringWorks shall reasonably cooperate with GSK in good faith in support of GSK’s submissions to or interactions with Regulatory Authorities related to the Combination Therapy or the Sub-Study(ies), including by participating in any discussions with any such Regulatory Authority regarding matters related to the Combination Therapy or the Sub-Study(ies). Without limiting the foregoing, GSK shall use reasonable efforts, consistent with Applicable Law and to the extent reasonably practicable, to facilitate the participation of, and permit the attendance of, appropriate representatives of SpringWorks (at SpringWorks’ sole cost) at substantive meetings with Regulatory Authorities, solely to the extent such meetings relate to the Sub-Study(ies), the SpringWorks Compound or the Combination Therapy. GSK shall use reasonable efforts to provide advance notice to SpringWorks of such meetings and will provide reasonable cooperation to SpringWorks as SpringWorks may request in connection with the preparation for such meetings.”
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| 9) | The first sentence of Section 8.1 is hereby deleted in its entirety and replaced with the following: |
“The Parties shall form a joint development committee (the “Joint Development Committee” or “JDC”), made up of three (3) representatives of each of SpringWorks and GSK unless otherwise agreed (but in any event, the JDC shall be made up of an equal number of representatives from each Party), which shall have responsibility for discussing the strategy for development of the Combination Therapy and coordinating all regulatory and other activities under, and pursuant to, this Agreement.”
| 10) | Section 24.1 of the Agreement is hereby deleted in its entirety and replaced with the following: |
| “24.1 | The term of this Agreement shall commence on the Effective Date and shall continue in full force and effect until Sub-Study Completion, delivery of all Licensed Clinical Data and the Final Sub-Study Report, and the completion of any analyses contemplated by the Sub-Study Protocol or otherwise agreed by the Parties to be conducted under this Agreement, unless earlier terminated by either Party pursuant to this Article 24 (the “Term”). For the avoidance of doubt, this Agreement shall not expire until the foregoing events occur for all applicable Sub-Studies covered by this Agreement.” |
| 11) | Section 31.1 of the Agreement is hereby amended to revise the SpringWorks addresses as follows: |
“SpringWorks Therapeutics, Inc.
100 Washington Blvd. 5th Floor
Stamford, CT 06902
Attention: Chief Operating Officer
With copies to:
SpringWorks Therapeutics, Inc.
100 Washington Blvd. 5th Floor
Stamford, CT 06902
Attention: General Counsel”
| 12) | The Parties will cooperate to adjust Schedule 1 of the Agreement in a manner consistent with the current objectives of such schedule as reasonably required to take into account the Ongoing Study and the Additional Studies. |
| 13) | Appendix B to the Agreement (Supply of Compound) is hereby deleted in its entirety and replaced with Appendix B (Supply of Compound) attached hereto. |
| 14) | The Parties will appropriately amend each of the Related Agreements if and to the extent required to fulfill the purpose of this Amendment No. 1. |
| 15) | This Amendment, together with the Agreement, constitutes the final, complete and exclusive statement of the agreement between the Parties pertaining to its subject matter and supersedes any and all prior and contemporaneous understandings or agreements of the parties with respect thereto. To the extent any provision of this amendment conflicts with any provision of the Agreement as in effect prior to the Amendment Effective Date, the provisions of this Amendment shall govern. Except as amended hereby, the Agreement remains unmodified and in full force and effect in accordance with its terms. |
| 16) | This Amendment shall be governed and construed in accordance with the substantive laws of the State of New York, without giving effect to its choice of law principles. |
| 17) | This Amendment may be executed in counterparts, each of which shall constitute an original, but all of which when taken together shall constitute a single instrument. Delivery of an executed counterpart of a signature page to this Amendment by telecopier or other electronic means (e.g., via PDF or DocuSign) shall be effective delivery of a manually executed counterpart of this Amendment. |
[signature page follows]
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IN WITNESS WHEREOF, the Parties, acting through their duly authorized representatives, have executed this Amendment as of the Amendment Effective Date.
| GLAXOSMITHKLINE LLC | SPRINGWORKS THERAPEUTICS, INC. | |||
| By: | /s/ Ira Gupta | By: | /s/ Saqib Islam | |
| Name: | Ira Gupta | Name: | Saqib Islam | |
| Title: | VP & MDL (BLENREP) – Oncology R&D | Title: | CEO | |
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Appendix A-1
SUMMARIES OF STUDY DESIGNS FOR ONGOING STUDY AND ADDITIONAL STUDIES
[***]
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[***]
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[***]
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Appendix B
SUPPLY OF COMPOUND
Schedule of Deliveries for SpringWorks Compound
| Delivery Date | Quantity of 50mg Uncoated Tablet Bottles*† | Quantity of 100mg Coated Tablet Bottles*† |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| Total | [***] | [***] |
|
Delivery Date† |
Quantity of 50mg Uncoated Tablet Bottles*† | Quantity of 100mg Coated Tablet Bottles*† |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
*[***]
†Delivery Dates for, and Quantities of, SpringWorks Compound are estimates only. Delivery Dates and Quantities may change based on requirements for Sub-Studies and as agreed by the Parties in accordance with this Agreement.
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Exhibit 99.1
SpringWorks Therapeutics Announces the Initiation of an Expanded Phase 2 Cohort and Addition of New Sub-Studies to Existing Clinical Collaboration with GlaxoSmithKline Evaluating Nirogacestat in Combination with BLENREP in Patients with Relapsed or Refractory Multiple Myeloma
-- Based on Encouraging Preliminary Data Observed with the First Dose Exploration Cohort (0.95 mg/kg BLENREP Q3W + Nirogacestat) a Randomized Phase 2 Cohort Expansion to Compare Against 2.5 mg/kg Q3W BLENREP Monotherapy Has Been Initiated --
-- Two New Sub-Studies of BLENREP + Nirogacestat Combined with Standard-of-Care Therapies Now Planned --
STAMFORD, Conn., – October 27, 2021 – SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced an update from its ongoing clinical collaboration with GlaxoSmithKline (GSK) evaluating nirogacestat, SpringWorks’ investigational gamma secretase inhibitor, in combination with BLENREP (belantamab mafodotin-blmf), GSK’s antibody-drug conjugate targeting B-cell maturation agent (BCMA), in patients with relapsed or refractory multiple myeloma. The nirogacestat and BLENREP combination is being evaluated as a sub-study of GSK’s ongoing DREAMM-5 platform trial.
The first combination dose level that evaluated 0.95 mg/kg Q3W BLENREP plus nirogacestat has been expanded based on encouraging preliminary data observed in the dose exploration Phase 1 portion of the nirogacestat DREAMM-5 sub-study. The expanded Phase 2 cohort is further exploring the safety and efficacy profile compared to a 2.5 mg/kg Q3W BLENREP monotherapy control arm, which is the same as the FDA approved monotherapy dose and schedule of BLENREP. In parallel, additional dose levels and schedules of BLENREP plus nirogacestat continue to be evaluated in the Phase 1 portion of the study.
In addition, two new sub-studies will evaluate the BLENREP plus nirogacestat combination with standard-of-care multiple myeloma therapies in the DREAMM-5 trial. These two new sub-studies will explore BLENREP plus nirogacestat in combination with pomalidomide and dexamethasone and in combination with lenalidomide plus dexamethasone. Data from these sub-studies may enable future clinical trials in earlier lines of multiple myeloma.
“We continue to remain intensely focused on advancing nirogacestat as a potential best-in-class cornerstone of BCMA combination therapy for patients with multiple myeloma and are pleased with the progress that has been made with our collaborator GSK,” said Saqib Islam, Chief Executive Officer of SpringWorks. “We believe in the emerging role of nirogacestat as a BCMA potentiator and we look forward to working with GSK to advance the expanded program.”
Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of multiple myeloma cells. In preclinical models, nirogacestat has been shown to increase the cell surface density of BCMA and reduce levels of soluble BCMA, thereby enhancing the activity of BCMA-targeted therapies.1 To date, SpringWorks has entered into clinical collaborations with six industry partners, including GSK, to evaluate nirogacestat in combination with BCMA therapies across modalities.
The platform study is being advanced pursuant to a non-exclusive global clinical trial collaboration agreement that SpringWorks and GSK entered into in June 2019 and that was amended in October 2021 to enable additional sub-studies to be conducted. Under the terms of the agreement, GSK is sponsoring and conducting the platform study to evaluate the safety, tolerability and preliminary efficacy of the combination and is assuming all development costs associated with the study other than expenses related to the manufacturing of nirogacestat and certain expenses related to intellectual property rights. SpringWorks and GSK have formed a joint development committee to help manage and oversee the clinical study.
About Nirogacestat
Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.
In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or 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 for BCMA-directed therapies. Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is evaluating nirogacestat as a BCMA potentiator and has six collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies, two bispecific antibodies and a monoclonal antibody. SpringWorks has also formed research collaborations with Fred Hutchinson Cancer Research Center and Dana-Farber Cancer Institute to further characterize the ability of nirogacestat to modulate BCMA and potentiate BCMA therapies using a variety of preclinical multiple myeloma models.
Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma. The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.
About SpringWorks Therapeutics
SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology portfolio of small molecule product candidates and is advancing 16 development programs, including two potentially registrational clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to expand its portfolio and create more solutions for patients with cancer. For more information, please visit www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations, and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our development plans, our preclinical and clinical results, and other future conditions. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “would,” “should” and “could,” and similar expressions or words, identify forward-looking statements. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks relating to: (i) the success and timing of our product development activities, including the initiation and completion of SpringWorks’ clinical trials, (ii) the fact that interim data from a clinical study may not be predictive of the final results of such study or the results of other ongoing or future studies, (iii) the success and timing of our collaboration partners’ ongoing and planned clinical trials, (iv) our ability to obtain and maintain regulatory approval of any of our product candidates, (v) our plans to research, discover and develop additional product candidates, (vi) our ability to enter into collaborations for the development of new product candidates, (vii) our ability to establish manufacturing capabilities, and our and our collaboration partners’ abilities to manufacture our product candidates and scale production, (viii) our ability to meet any specific milestones set forth herein, and (ix) uncertainties and assumptions regarding the impact of the COVID-19 pandemic on SpringWorks’ business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines.
Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements.
For further information regarding the risks, uncertainties and other factors that may cause differences between SpringWorks’ expectations and actual results, you should review the “Risk Factors” in Item 1A of Part I of SpringWorks’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, as well as discussions of potential risks, uncertainties and other important factors in SpringWorks’ subsequent filings.
SpringWorks Media/Investor Contact:
Kim Diamond
Vice President, Communications and Investor Relations
203-561-1646
kdiamond@springworkstx.com
References
1Eastman S, Shelton C, Gupta I, Krueger J, Blackwell C, Bojczuk P. Synergistic Activity of Belantamab Mafodotin (anti-BCMA immuno-conjugate) with PF-03084014 (gamma-secretase inhibitor) in BCMA-Expressing Cancer Cell Lines. Blood. 2019;134(supplement_1):4401. doi:10.1182/blood-2019-123705.