0001773427-21-000025 | 10-Q | XBRL Viewer | Springworks Therapeutics INC

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2021	Oct. 29, 2021
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2021
Document Transition Report	false
Entity File Number	001-39044
Entity Registrant Name	SPRINGWORKS THERAPEUTICS, INC.
Entity Incorporation, State	DE
Entity Tax Identification Number	83-4066827
Entity Address, Street	100 Washington Blvd
Entity Address, City	Stamford
Entity Address, State	CT
Entity Address, Zip Code	06902
City Area Code	203
Local Phone Number	883-9490
Title of each class	Common Stock, par value $0.0001 per share
Trading Symbol(s)	SWTX
Name of each exchange on which registered	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		49,249,215
Entity Central Index Key	0001773427
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q3

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Current assets:
Cash and cash equivalents	$ 93,852	$ 147,089
Marketable securities	334,060	361,395
Prepaid expenses and other current assets	5,101	4,914
Total current assets	433,013	513,398
Long-term marketable securities	52,731	53,336
Property and equipment, net	2,089	1,075
Operating lease right-of-use assets	1,242	1,944
Equity investment	3,184	3,871
Restricted cash	565	565
Other assets	2,451	2,002
Total assets	495,275	576,191
Current liabilities:
Accounts payable	2,498	1,350
Accrued expenses	24,344	14,885
Operating lease liabilities, current	1,257	1,375
Total current liabilities	28,099	17,610
Operating lease liabilities, long-term	367	1,359
Other long-term liabilities	131	164
Total liabilities	28,597	19,133
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding at September 30, 2021 and December 31, 2020	0	0
Common stock, $0.0001 par value, 150,000,000 shares authorized, 49,208,425 and 48,819,591 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively.	5	5
Additional paid-in capital	703,090	675,615
Accumulated other comprehensive income	24	41
Accumulated deficit	(236,441)	(118,603)
Total stockholders’ equity	466,678	557,058
Total liabilities and stockholders’ equity	$ 495,275	$ 576,191

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2021	Dec. 31, 2020
Statement of Financial Position [Abstract]
Preferred stock, par value (usd per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized (shares)	10,000,000	10,000,000
Preferred stock, shares issued (shares)	0	0
Preferred stock, shares outstanding (shares)	0	0
Common stock, par value (usd per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized (shares)	150,000,000	150,000,000
Common stock, shares issued (shares)	49,208,425	48,819,591
Common stock, shares outstanding (shares)	49,208,425	48,819,591

Condensed Consolidated Statements of Operations (unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Operating expenses:
Research and development	$ 22,866	$ 13,923	$ 72,332	$ 36,597
General and administrative	18,029	7,669	45,340	20,946
Total operating expenses	40,895	21,592	117,672	57,543
Loss from operations	(40,895)	(21,592)	(117,672)	(57,543)
Interest and other income:
Other income (loss)	(58)	0	(96)	0
Interest income, net	179	63	617	1,156
Total interest and other income	121	63	521	1,156
Equity investment loss	(267)	(130)	(687)	(459)
Net loss	$ (41,041)	$ (21,659)	$ (117,838)	$ (56,846)
Net loss per share, basic (usd per share)	$ (0.84)	$ (0.51)	$ (2.43)	$ (1.35)
Net loss per share, diluted (usd per share)	$ (0.84)	$ (0.51)	$ (2.43)	$ (1.35)
Weighted average number of shares outstanding, basic (in shares)	48,595,420	42,148,837	48,417,300	41,961,691
Weighted average number of shares outstanding, diluted (in shares)	48,595,420	42,148,837	48,417,300	41,961,691

Condensed Consolidated Statements of Comprehensive Loss (unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Statement of Comprehensive Income [Abstract]
Net loss	$ (41,041)	$ (21,659)	$ (117,838)	$ (56,846)
Changes in other comprehensive income:
Unrealized gain (loss) on marketable securities, net	(1)	69	(17)	25
Total changes in other comprehensive income	(1)	69	(17)	25
Comprehensive loss	$ (41,042)	$ (21,590)	$ (117,855)	$ (56,821)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Condensed Consolidated Statements of Stockholders’ Equity (unaudited) - USD ($) $ in Thousands	Total	Common	Additional Paid-In Capital	Accumulated Other Comprehensive Income	Accumulated Deficit
Increase (Decrease) in Stockholders' Equity
Beginning balance (in shares)		43,006,077
Beginning balance at Dec. 31, 2019	$ 322,072	$ 4	$ 395,097	$ 0	$ (73,029)
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense	6,992		6,992
Forfeiture of restricted stock awards (in shares)		(10,990)
Exercise of stock options	512		512
Exercise of stock options (in shares)		133,717
Other comprehensive income, net of tax	25			25
Net loss	(56,846)				(56,846)
Ending balance at Sep. 30, 2020	272,755	$ 4	402,601	25	(129,875)
Ending balance (in shares) at Sep. 30, 2020		43,128,804
Increase (Decrease) in Stockholders' Equity
Beginning balance (in shares)		43,016,501
Beginning balance at Jun. 30, 2020	290,874	$ 4	399,130	(44)	(108,216)
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense	3,043		3,043
Forfeiture of restricted stock awards (in shares)		(5,762)
Exercise of stock options	428		428
Exercise of stock options (in shares)		118,065
Other comprehensive income, net of tax	69			69
Net loss	(21,659)				(21,659)
Ending balance at Sep. 30, 2020	272,755	$ 4	402,601	25	(129,875)
Ending balance (in shares) at Sep. 30, 2020		43,128,804
Increase (Decrease) in Stockholders' Equity
Beginning balance (in shares)		43,128,804
Beginning balance (in shares)		48,819,591
Beginning balance at Dec. 31, 2020	557,058	$ 5	675,615	41	(118,603)
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense	26,562		26,562
Forfeiture of restricted stock awards (in shares)		(7,142)
Issuance of restricted stock award (in shares)		264,551
Exercise of stock options	913		913
Exercise of stock options (in shares)		131,425
Other comprehensive income, net of tax	(17)			(17)
Net loss	(117,838)				(117,838)
Ending balance at Sep. 30, 2021	466,678	$ 5	703,090	24	(236,441)
Ending balance (in shares) at Sep. 30, 2021		49,208,425
Increase (Decrease) in Stockholders' Equity
Beginning balance (in shares)		49,103,066
Beginning balance at Jun. 30, 2021	496,583	$ 5	691,953	25	(195,400)
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense	10,712		10,712
Forfeiture of restricted stock awards (in shares)		(950)
Issuance of restricted stock award (in shares)		53,260
Exercise of stock options	425		425
Exercise of stock options (in shares)		53,049
Other comprehensive income, net of tax	(1)			(1)
Net loss	(41,041)				(41,041)
Ending balance at Sep. 30, 2021	$ 466,678	$ 5	$ 703,090	$ 24	$ (236,441)
Ending balance (in shares) at Sep. 30, 2021		49,208,425
Increase (Decrease) in Stockholders' Equity
Beginning balance (in shares)		49,208,425

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Operating activities
Net loss	$ (117,838)	$ (56,846)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense	344	239
Non-cash operating lease expense	745	789
Stock compensation expense	26,562	6,992
Equity investment loss	687	459
Changes in operating assets and liabilities
Prepaid expenses and other current assets	(301)	1,626
Other assets	(449)	(281)
Accounts payable	1,148	(1,590)
Accrued expenses	8,613	2,319
Lease liability	(1,039)	(1,060)
Other long-term liabilities	(33)	96
Net cash used in operating activities	(81,561)	(47,257)
Investing activities
Capital expenditures	(512)	(588)
Equity Investments	0	(3,500)
Purchases of marketable securities	(218,863)	(191,963)
Proceeds from sale and maturity of debt securities	246,786	0
Net cash provided by (used in) investing activities	27,411	(196,051)
Financing activities
Proceeds from stock option exercises	913	512
Net cash provided by financing activities	913	512
Net decrease in cash and cash equivalents	(53,237)	(242,796)
Cash and cash equivalents including Restricted cash, beginning of period	147,654	328,192
Cash and cash equivalents including Restricted cash, end of period	$ 94,417	$ 85,396

Nature of Operations	9 Months Ended
Nature of Operations	Sep. 30, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Nature of Operations	Nature of Operations SpringWorks Therapeutics, Inc., together with its wholly-owned subsidiaries, collectively, the Company, is 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. The Company has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. Two of the programs are late-stage clinical product candidates: nirogacestat and mirdametinib. The Company has incurred losses and negative operating cash flows since inception and had an accumulated deficit of $236.4 million and $118.6 million, and working capital of $404.9 million and $495.8 million, as of September 30, 2021 and December 31, 2020, 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, consultants and vendors. The Company had cash, cash equivalents and marketable securities of $480.6 million and $561.8 million as of September 30, 2021 and December 31, 2020, respectively. Based on the Company's cash, cash equivalents and marketable securities as of September 30, 2021, management estimates that its current liquidity will enable it to meet operating expenses through at least twelve months after the date that these financial statements are issued. COVID-19 Pandemic On March 11, 2020, the World Health Organization designated the outbreak of the disease associated with the novel strain of coronavirus known as COVID-19 as a global pandemic. Governments and businesses around the world have taken unprecedented actions to mitigate the spread of COVID-19, including, but not limited to, shelter-in-place orders, quarantines, significant restrictions on travel, as well as restrictions that prohibit many employees from going to work. Uncertainty with respect to the economic impacts of the pandemic has introduced significant volatility in the financial markets. The global pandemic caused by COVID-19 (including the impact of emerging variant strains of the COVID-19 virus) did not have significant impacts on the Company's financial condition, results of operations or cash flows for the periods presented. While the extent to which the ongoing COVID-19 pandemic impacts the Company’s future results will depend on future developments, the pandemic and associated impacts, including the duration, spread and intensity of the pandemic (including any resurgences), the impact of emerging variant strains of the COVID-19 virus and the rollout of COVID-19 vaccines, all of which remain uncertain and difficult to predict, could result in a material impact to the Company’s future financial condition, results of operations and cash flows.

Basis of Presentation	9 Months Ended
Basis of Presentation	Sep. 30, 2021
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The Company’s unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP, for interim financial information and Article 10 of Regulation S-X of the Securities and Exchange Commission, or SEC, and should be read in conjunction with the Company's consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on February 25, 2021. The condensed consolidated financial statements presented in this Quarterly Report on Form 10-Q are unaudited; however, in the opinion of management, such financial statements reflect all adjustments, consisting solely of normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. 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 condensed consolidated financial statements include, but are not limited to, research and development expenses and the valuation of stock-based compensation awards. Management bases its estimates on historical experience, known trends and other market-specific or relevant factors that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. On an ongoing basis, management evaluates its estimates, and adjusts those estimates and assumptions when facts or circumstances change. Changes in estimates are recorded in the period in which they become known. Research and Development Expenses In accordance with ASC 730, “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 U.S. Food and Drug Administration, are charged to research and development expense as incurred. These expenses consist of expenses incurred in performing development activities, including salaries and benefits, stock-based compensation expense, preclinical expenses, clinical trial and related clinical manufacturing expenses, contract services and other outside expenses. Expenses incurred for certain research and development activities, including expenses associated with particular activities performed by contract research organizations, investigative sites in connection with clinical trials and contract manufacturing organizations, are recognized based on an evaluation of the progress or completion of specific tasks using either time-based measures or data such as information provided to the Company by its vendors on actual activities completed or costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of expense recognition. Expenses for research and development activities incurred that have yet to be invoiced by the vendors that perform the related activities are reflected in the consolidated financial statements as accrued research and development expenses. Advance payments for goods or services to be received in the future for research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. 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. Recently Adopted Accounting Pronouncements In 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740), which simplifies the accounting for income taxes. ASU 2019-12 became effective for the Company on January 1, 2021. The adoption of ASU 2019-12 did not have a significant impact on the Company’s consolidated financial statements.

Marketable Securities

9 Months Ended

Sep. 30, 2021

Investments, Debt and Equity Securities [Abstract]

Marketable Securities

The following table summarizes the Company’s available-for-sale marketable securities as of September 30, 2021 and December 31, 2020:


	As of September 30, 2021
(in thousands)	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Estimated Fair Value
Marketable securities:
Short-term investments:
U.S. Government securities	$	131,302	$	40	$	—	$	131,342
Corporate debt securities	91,315		9		(16)		91,308
Commercial paper	111,410		—		—		111,410
Long-term investments:
U.S. Government securities	52,740		3		(12)		52,731

Total	$	386,767	$	52	$	(28)	$	386,791


	As of December 31, 2020
(in thousands)	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Estimated Fair Value
Marketable securities:
Short-term investments:
U.S. Government securities	$	157,079	$	24	$	(1)	$	157,102
Corporate debt securities	74,773		2		(10)		74,765
Commercial paper	129,528		—		—		129,528
Long-term investments:
U.S. Government securities	53,310		26		—		53,336
Total	$	414,690	$	52	$	(11)	$	414,731

The Company’s marketable securities are available-for-sale securities and consist of high-quality, highly liquid debt securities including corporate debt securities, U.S. government securities and commercial paper.

The Company’s available-for-sale securities classified as short-term marketable securities in the condensed consolidated balance sheets mature within one year or less of the balance sheet date. Marketable securities that mature greater than one year from the balance sheet date are classified as long-term. As of September 30, 2021, the Company did not hold any investments with maturity dates greater than five years.

As of, and for the three and nine months ended September 30, 2021, the Company did not have any allowance for credit losses or impairments of its marketable securities.

Fair Value Measurements

9 Months Ended

Sep. 30, 2021

Fair Value Disclosures [Abstract]

Fair Value Measurements

The fair value of the Company’s financial assets measured on a recurring basis are classified based upon a fair value hierarchy consisting of the following three levels:

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).

The fair value hierarchy is based on inputs to valuation techniques used to measure fair value that are either observable or unobservable. Observable inputs reflect assumptions market participants would use in pricing an asset or liability based on market data obtained from independent sources while unobservable inputs reflect a reporting entity's pricing based upon their own market assumptions.

As of September 30, 2021 and December 31, 2020, the Company's financial assets and liabilities recognized at fair value on a recurring basis consisted of the following:


	As of September 30, 2021
			Fair Value Hierarchy
(in thousands)	Total		Level 1		Level 2		Level 3

Cash equivalents:
Money market funds	$	54,099	$	54,099	$	—	$	—
Short-term investments:
U.S. Government securities	131,342		131,342		—		—
Corporate debt securities	91,308		—		91,308		—
Commercial paper	111,410		—		111,410		—
Long-term investments:
U.S. Government securities	52,731		52,731		—		—

Total	$	440,890	$	238,172	$	202,718	$	—


	As of December 31, 2020
			Fair Value Hierarchy
(in thousands)	Total		Level 1		Level 2		Level 3

Cash equivalents:
Money market funds	$	107,723	$	107,723	$	—	$	—
Short-term investments:
U.S. Government securities	157,102		157,102		—		—
Corporate debt securities	74,765		—		74,765		—
Commercial paper	129,528		—		129,528		—
Long-term investments:
U.S. Government securities	53,336		53,336		—		—
Total	$	522,454	$	318,161	$	204,293	$	—

As of September 30, 2021 and December 31, 2020, the Company’s financial assets measured at fair value on a recurring basis using a market approach included cash equivalents, which consist of money market funds, and marketable securities, which consist of high-quality, highly liquid available-for-sale debt securities including corporate debt securities, U.S. government securities and commercial paper.

The Company’s money market funds are readily convertible into cash and the net asset value of each fund on the last day of the quarter is used to determine fair value. The U.S. Government securities are classified as Level 1 and valued utilizing quoted market prices. The Company’s corporate debt securities and commercial paper are classified as Level 2 and valued utilizing various market and industry inputs.

The Company considers all highly liquid instruments that have maturities of three months or less when acquired to be cash equivalents. The carrying amounts reflected in the Company’s condensed consolidated balance sheets for cash equivalents, accounts payable, and accrued expenses approximate fair value due to their short-term maturities.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

License Agreements and Investments	9 Months Ended
License Agreements and Investments	Sep. 30, 2021
Equity Method Investments and Joint Ventures [Abstract]
License Agreements and Investments	License Agreements and Investments TEAD Inhibitor License In May 2021, the Company announced an exclusive worldwide license agreement with Katholieke Universiteit Leuven, or KU Leuven, and the Flanders Institute for Biotechnology, or VIB, pursuant to which the Company in-licensed a portfolio of novel small molecule inhibitors of the TEA Domain, or TEAD, family of transcription factors, designed for the potential treatment of biomarker-defined solid tumors driven by aberrant Hippo pathway signaling. Under the terms of the agreement, the Company made an upfront payment of $11 million to KU Leuven and VIB, which was recorded as research and development expense in the condensed consolidated statement of operations. Pursuant to the terms of the agreement, KU Leuven and VIB are also eligible to receive up to $285 million in development, regulatory and commercial milestones and tiered single-digit percentage royalties based on any future net sales of products developed based on the in-licensed technology. MapKure In June 2019, the Company announced the formation of MapKure, an entity jointly owned by the Company and BeiGene Ltd., or BeiGene. BeiGene licensed to MapKure exclusive rights to BGB-3245, an oral, small molecule selective inhibitor of specific BRAF driver mutations and genetic fusions. MapKure is advancing BGB-3245 through 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. As of September 30, 2021, the Company’s ownership interest in MapKure was 38.9%. 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 also contributes to clinical development and other operational activities for BGB-3245 through a service agreement with MapKure. The Company determined that MapKure is a variable interest entity. The Company is not the primary beneficiary, as 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 the equity method of accounting. In accordance with ASC 323-10-35-6, the Company records MapKure’s earnings or losses based on a one quarter lag. The Company recognized an equity loss of $0.3 million and $0.7 million for the three and nine months ended September 30, 2021, respectively and $0.1 million and $0.5 million for the three and nine months ended September 30, 2020, respectively. The Company’s ownership interest in MapKure is included in “Equity method investments” in the condensed consolidated balance sheets. The balance of the Company’s investment was $3.2 million as of September 30, 2021, representing the maximum exposure to loss as a result of the Company’s involvement with MapKure.

Accrued Expenses

9 Months Ended

Sep. 30, 2021

Payables and Accruals [Abstract]

Accrued Expenses

Accrued expenses consists of the following:


	September 30,		December 31,
(in thousands)	2021		2020
Accrued professional fees	$	1,393	$	827
Accrued compensation and benefits	5,975		5,834
Accrued research and development	13,746		7,922
Accrued other	3,230		302
Total accrued expenses	$	24,344	$	14,885

Commitments and Contingencies

9 Months Ended

Sep. 30, 2021

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

The Company enters into contracts in the normal course of business 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 the Company believes that non-cancelable obligations under these agreements are not material.

Additionally, the Company has excluded milestone or royalty payments or other contractual payment obligations as the timing and amounts of such obligations are unknown or uncertain.

Leases

Future lease payments under non-cancelable leases with terms of greater than one year as of September 30, 2021 are as follows:


(in thousands)	Operating Leases
2021	$	231
2022	1,297
2023	135
2024 and thereafter	—
Total lease payments	1,663
Less: imputed interest	(39)
Present value of lease liabilities	$	1,624

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 September 30, 2021, there was no litigation or contingency with at least a reasonable possibility of a material loss.

Stock-Based Compensation

9 Months Ended

Sep. 30, 2021

Share-based Payment Arrangement [Abstract]

Stock-Based Compensation

2019 Equity Incentive Plan

The 2019 Equity Incentive Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards and dividend equivalent rights to the Company’s officers, employees, directors and other key persons (including consultants). The number of shares reserved for issuance under the 2019 Equity Incentive Plan is cumulatively increased each January 1 by 5% of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or such lesser number of shares determined by the Company’s compensation committee. Effective January 1, 2021, the number of shares reserved for issuance under the 2019 Equity Incentive Plan was increased by 2,440,980 shares.

The terms of stock options and restricted stock awards, including vesting requirements, are determined by the Board of Directors or its delegates, subject to the provisions of the 2019 Equity Incentive Plan. Stock option awards granted by the Company generally vest over four years and restricted stock awards granted by the Company generally vest over three years.

As of September 30, 2021, there were 4,390,020 shares available for issuance in connection with future awards under the 2019 Equity Incentive Plan.

Stock-Based Awards

During the nine months ended September 30, 2021, the Company granted 2,107,668 stock option awards and 264,551 restricted stock awards to its officers, employees and directors under the 2019 Equity Incentive Plan.

During the nine months ended September 30, 2021, 421,651 restricted stock awards previously issued to employees of the Company vested, and 131,425 stock options were exercised.

As of September 30, 2021, there were 2,409,721 stock options vested and exercisable. In June 2019, the Company’s CEO received an award of 176,411 stock options, or the 2019 CEO Performance Award. During the quarter ended September 30, 2021, 106,577 options of the CEO Performance Award became exercisable upon the satisfaction of the market condition applicable to this award.

Stock-based compensation expense included in the condensed consolidated statements of operations for each of the periods presented is as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2021		2020		2021		2020
Research and development	$	4,285	$	986	$	9,613	$	2,180
General and administrative	6,427		2,057		16,949		4,812
Total stock-based compensation expense	$	10,712	$	3,043	$	26,562	$	6,992

As of September 30, 2021, the unrecognized compensation expense related to unvested stock options and restricted stock awards was $112.3 million and $16.4 million, respectively, which is expected to be recognized over a weighted-average remaining period of approximately 2.72 and 1.51 years, respectively.

As of September 30, 2021, the Company had 6,424,419 stock options outstanding and 522,626 unvested restricted stock awards.

Net Loss per Share

9 Months Ended

Sep. 30, 2021

Earnings Per Share [Abstract]

Net Loss per Share

Since the Company had a net loss in each of the periods presented, basic and diluted net loss per share are the same. The table below provides potentially dilutive securities not included in the computation of the diluted net loss per share for the periods ended September 30, 2021 and 2020, because to do so would be anti-dilutive:


	As of September 30,
	2021	2020
Common stock options issued and outstanding	6,424,419	4,556,742
Restricted stock subject to future vesting	522,626	836,606
Total potentially dilutive securities	6,947,045	5,393,348

Basis of Presentation (Policies)	9 Months Ended
Basis of Presentation (Policies)	Sep. 30, 2021
Accounting Policies [Abstract]
Basis of Presentation	Basis of PresentationThe Company’s unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP, for interim financial information and Article 10 of Regulation S-X of the Securities and Exchange Commission, or SEC, and should be read in conjunction with the Company's consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on February 25, 2021. The condensed consolidated financial statements presented in this Quarterly Report on Form 10-Q are unaudited; however, in the opinion of management, such financial statements reflect all adjustments, consisting solely of normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented.
Use of Estimates	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 condensed consolidated financial statements include, but are not limited to, research and development expenses and the valuation of stock-based compensation awards. Management bases its estimates on historical experience, known trends and other market-specific or relevant factors that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. On an ongoing basis, management evaluates its estimates, and adjusts those estimates and assumptions when facts or circumstances change. Changes in estimates are recorded in the period in which they become known.
Research and Development Expenses	Research and Development Expenses In accordance with ASC 730, “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 U.S. Food and Drug Administration, are charged to research and development expense as incurred. These expenses consist of expenses incurred in performing development activities, including salaries and benefits, stock-based compensation expense, preclinical expenses, clinical trial and related clinical manufacturing expenses, contract services and other outside expenses. Expenses incurred for certain research and development activities, including expenses associated with particular activities performed by contract research organizations, investigative sites in connection with clinical trials and contract manufacturing organizations, are recognized based on an evaluation of the progress or completion of specific tasks using either time-based measures or data such as information provided to the Company by its vendors on actual activities completed or costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of expense recognition. Expenses for research and development activities incurred that have yet to be invoiced by the vendors that perform the related activities are reflected in the consolidated financial statements as accrued research and development expenses. Advance payments for goods or services to be received in the future for research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed.
Segment Information	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.
Recently Adopted Accounting Pronouncements	Recently Adopted Accounting Pronouncements In 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740), which simplifies the accounting for income taxes. ASU 2019-12 became effective for the Company on January 1, 2021. The adoption of ASU 2019-12 did not have a significant impact on the Company’s consolidated financial statements.

- Definition

Disclosure of accounting policy for segment reporting.

+ References + Details

Marketable Securities (Tables)

9 Months Ended

Sep. 30, 2021

Investments, Debt and Equity Securities [Abstract]

Summary of available-for-sale marketable securities

The following table summarizes the Company’s available-for-sale marketable securities as of September 30, 2021 and December 31, 2020:


	As of September 30, 2021
(in thousands)	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Estimated Fair Value
Marketable securities:
Short-term investments:
U.S. Government securities	$	131,302	$	40	$	—	$	131,342
Corporate debt securities	91,315		9		(16)		91,308
Commercial paper	111,410		—		—		111,410
Long-term investments:
U.S. Government securities	52,740		3		(12)		52,731

Total	$	386,767	$	52	$	(28)	$	386,791


	As of December 31, 2020
(in thousands)	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Estimated Fair Value
Marketable securities:
Short-term investments:
U.S. Government securities	$	157,079	$	24	$	(1)	$	157,102
Corporate debt securities	74,773		2		(10)		74,765
Commercial paper	129,528		—		—		129,528
Long-term investments:
U.S. Government securities	53,310		26		—		53,336
Total	$	414,690	$	52	$	(11)	$	414,731

Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2021

Fair Value Disclosures [Abstract]

Schedule of financial assets subject to fair value measurements

As of September 30, 2021 and December 31, 2020, the Company's financial assets and liabilities recognized at fair value on a recurring basis consisted of the following:


	As of September 30, 2021
			Fair Value Hierarchy
(in thousands)	Total		Level 1		Level 2		Level 3

Cash equivalents:
Money market funds	$	54,099	$	54,099	$	—	$	—
Short-term investments:
U.S. Government securities	131,342		131,342		—		—
Corporate debt securities	91,308		—		91,308		—
Commercial paper	111,410		—		111,410		—
Long-term investments:
U.S. Government securities	52,731		52,731		—		—

Total	$	440,890	$	238,172	$	202,718	$	—


	As of December 31, 2020
			Fair Value Hierarchy
(in thousands)	Total		Level 1		Level 2		Level 3

Cash equivalents:
Money market funds	$	107,723	$	107,723	$	—	$	—
Short-term investments:
U.S. Government securities	157,102		157,102		—		—
Corporate debt securities	74,765		—		74,765		—
Commercial paper	129,528		—		129,528		—
Long-term investments:
U.S. Government securities	53,336		53,336		—		—
Total	$	522,454	$	318,161	$	204,293	$	—

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2021

Payables and Accruals [Abstract]

Schedule of accrued expenses

Accrued expenses consists of the following:


	September 30,		December 31,
(in thousands)	2021		2020
Accrued professional fees	$	1,393	$	827
Accrued compensation and benefits	5,975		5,834
Accrued research and development	13,746		7,922
Accrued other	3,230		302
Total accrued expenses	$	24,344	$	14,885

Commitments and Contingencies (Tables)

9 Months Ended

Sep. 30, 2021

Commitments and Contingencies Disclosure [Abstract]

Schedule of future minimum lease obligations

Future lease payments under non-cancelable leases with terms of greater than one year as of September 30, 2021 are as follows:


(in thousands)	Operating Leases
2021	$	231
2022	1,297
2023	135
2024 and thereafter	—
Total lease payments	1,663
Less: imputed interest	(39)
Present value of lease liabilities	$	1,624

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2021

Share-based Payment Arrangement [Abstract]

Schedule of stock-based compensation expense

Stock-based compensation expense included in the condensed consolidated statements of operations for each of the periods presented is as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2021		2020		2021		2020
Research and development	$	4,285	$	986	$	9,613	$	2,180
General and administrative	6,427		2,057		16,949		4,812
Total stock-based compensation expense	$	10,712	$	3,043	$	26,562	$	6,992

Net Loss per Share (Tables)

9 Months Ended

Sep. 30, 2021

Earnings Per Share [Abstract]

Schedule of potential common shares not included in the calculation of the diluted net loss per share

The table below provides potentially dilutive securities not included in the computation of the diluted net loss per share for the periods ended September 30, 2021 and 2020, because to do so would be anti-dilutive:


	As of September 30,
	2021	2020
Common stock options issued and outstanding	6,424,419	4,556,742
Restricted stock subject to future vesting	522,626	836,606
Total potentially dilutive securities	6,947,045	5,393,348

Nature of Operations (Details) $ in Thousands	Sep. 30, 2021 USD ($) trial	Dec. 31, 2020 USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Number of clinical trials (trials) \| trial	2
Accumulated deficit	$ (236,441)	$ (118,603)
Working capital	404,900	495,800
Cash, cash equivalents and marketable securities	$ 480,600	$ 561,800

Basis of Presentation (Details)	9 Months Ended
Basis of Presentation (Details)	Sep. 30, 2021 segment
Accounting Policies [Abstract]
Number of operating segments	1

Marketable Securities (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Marketable securities:
Amortized Cost	$ 386,767	$ 414,690
Gross Unrealized Gains	52	52
Gross Unrealized Losses	(28)	(11)
Estimated Fair Value	386,791	414,731
U.S. Government securities \| Short-term investments:
Marketable securities:
Amortized Cost	131,302	157,079
Gross Unrealized Gains	40	24
Gross Unrealized Losses		(1)
Estimated Fair Value	131,342	157,102
U.S. Government securities \| Long-term investments:
Marketable securities:
Amortized Cost	52,740	53,310
Gross Unrealized Gains	3	26
Gross Unrealized Losses	(12)
Estimated Fair Value	52,731	53,336
Corporate debt securities \| Short-term investments:
Marketable securities:
Amortized Cost	91,315	74,773
Gross Unrealized Gains	9	2
Gross Unrealized Losses	(16)	(10)
Estimated Fair Value	91,308	74,765
Commercial paper \| Short-term investments:
Marketable securities:
Amortized Cost	111,410	129,528
Estimated Fair Value	$ 111,410	$ 129,528

Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands	Jun. 30, 2021	Dec. 31, 2020
Fair Value Measurements
Total financial assets	$ 440,890	$ 522,454
U.S. Government securities
Fair Value Measurements
Short-term investments	131,342	157,102
Long term investments	52,731	53,336
Corporate debt securities
Fair Value Measurements
Short-term investments	91,308	74,765
Commercial paper
Fair Value Measurements
Short-term investments	111,410	129,528
Money market funds
Fair Value Measurements
Cash equivalents	54,099	107,723
Level 1
Fair Value Measurements
Total financial assets	238,172	318,161
Level 1 \| U.S. Government securities
Fair Value Measurements
Short-term investments	131,342	157,102
Long term investments	52,731	53,336
Level 1 \| Corporate debt securities
Fair Value Measurements
Short-term investments	0	0
Level 1 \| Commercial paper
Fair Value Measurements
Short-term investments	0	0
Level 1 \| Money market funds
Fair Value Measurements
Cash equivalents	54,099	107,723
Level 2
Fair Value Measurements
Total financial assets	202,718	204,293
Level 2 \| U.S. Government securities
Fair Value Measurements
Short-term investments	0	0
Long term investments	0	0
Level 2 \| Corporate debt securities
Fair Value Measurements
Short-term investments	91,308	74,765
Level 2 \| Commercial paper
Fair Value Measurements
Short-term investments	111,410	129,528
Level 2 \| Money market funds
Fair Value Measurements
Cash equivalents	0	0
Level 3
Fair Value Measurements
Total financial assets	0	0
Level 3 \| U.S. Government securities
Fair Value Measurements
Short-term investments	0	0
Long term investments	0	0
Level 3 \| Corporate debt securities
Fair Value Measurements
Short-term investments	0	0
Level 3 \| Commercial paper
Fair Value Measurements
Short-term investments	0	0
Level 3 \| Money market funds
Fair Value Measurements
Cash equivalents	$ 0	$ 0

License Agreements and Investments (Details) - USD ($) $ in Thousands	1 Months Ended	3 Months Ended		9 Months Ended
	May 31, 2021	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
Schedule of Equity Method Investments
Equity investment loss		$ 267	$ 130	$ 687	$ 459
Investment in Mapkure		3,184		3,184		$ 3,871
MapKure
Schedule of Equity Method Investments
Equity investment loss		300	$ 100	700	$ 500
Investment in Mapkure		$ 3,200		$ 3,200
MapKure \| Series A Preferred units
Schedule of Equity Method Investments
Ownership interest (in percent)		38.90%		38.90%
Asset Purchase and Exclusive License Agreement \| KU
Schedule of Equity Method Investments
Upfront payment	$ 11,000
Potential future payments	$ 285,000

Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Payables and Accruals [Abstract]
Accrued professional fees	$ 1,393	$ 827
Accrued compensation and benefits	5,975	5,834
Accrued research and development	13,746	7,922
Accrued other	3,230	302
Total accrued expenses	$ 24,344	$ 14,885

Commitments and Contingencies - Maturities of operating lease liabilities (Details) $ in Thousands	Sep. 30, 2021 USD ($)
Operating Leases
2021	$ 231
2022	1,297
2023	135
2024 and thereafter	0
Total lease payments	1,663
Less: imputed interest	(39)
Present value of lease liabilities	$ 1,624

Commitments and Contingencies (Details)	9 Months Ended
Commitments and Contingencies (Details)	Sep. 30, 2021 USD ($)
Operating Leases
Litigation or contingency expense	$ 0

Stock-Based Compensation (Details) - USD ($) $ in Millions		1 Months Ended	9 Months Ended	12 Months Ended
Stock-Based Compensation (Details) - USD ($) $ in Millions	Jan. 01, 2021	Jun. 30, 2019	Sep. 30, 2021	Dec. 31, 2019
2019 Equity Incentive Plan
Share-based Compensation Arrangement by Share-based Payment Award
Percentage of annual increase in the shares				5.00%
Number of additional shares reserved for issuance (in shares)	2,440,980
Shares available for future issuance (in shares)			4,390,020
2019 Equity Incentive Plan \| Stock options
Share-based Compensation Arrangement by Share-based Payment Award
Vesting period (in years)			4 years
Exercise of stock options (in shares)			131,425
Stock options vested and exercisable (in shares)			2,409,721
Unrecognized compensation expense related to unvested stock options			$ 112.3
Unrecognized compensation expense expected to be recognized over a weighted-average remaining period (in years)			2 years 8 months 19 days
Stock options outstanding (in shares)			6,424,419
2019 Equity Incentive Plan \| Restricted stock
Share-based Compensation Arrangement by Share-based Payment Award
Vesting period (in years)			3 years
Unrecognized compensation expense related to restricted stock awards			$ 16.4
Unrecognized compensation expense expected to be recognized over a weighted-average remaining period (in years)			1 year 6 months 3 days
Unvested restricted stock award outstanding (in shares)			522,626
2019 Equity Incentive Plan \| Restricted stock \| Employees
Share-based Compensation Arrangement by Share-based Payment Award
Restricted stock awards vested (in shares)			421,651
2019 Equity Incentive Plan \| Executive officers and employees \| Stock options
Share-based Compensation Arrangement by Share-based Payment Award
Granted (in shares)			2,107,668
2019 Equity Incentive Plan \| Executive officers and employees \| Restricted stock
Share-based Compensation Arrangement by Share-based Payment Award
Granted, other than options (shares)			264,551
CEO Performance Award \| Stock options
Share-based Compensation Arrangement by Share-based Payment Award
Stock options vested and exercisable (in shares)			106,577
CEO Performance Award \| CEO \| Stock options
Share-based Compensation Arrangement by Share-based Payment Award
Granted (in shares)		176,411

Stock-Based Compensation - Total stock-based compensation expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Share-based Compensation Arrangement by Share-based Payment Award
Total stock-based compensation expense	$ 10,712	$ 3,043	$ 26,562	$ 6,992
Research and development
Share-based Compensation Arrangement by Share-based Payment Award
Total stock-based compensation expense	4,285	986	9,613	2,180
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award
Total stock-based compensation expense	$ 6,427	$ 2,057	$ 16,949	$ 4,812

Net Loss per Share (Details) - shares	9 Months Ended
Net Loss per Share (Details) - shares	Sep. 30, 2021	Sep. 30, 2020
Antidilutive Securities Excluded from Computation of Earnings Per Share
Total potentially dilutive securities (in shares)	6,947,045	5,393,348
Common
Antidilutive Securities Excluded from Computation of Earnings Per Share
Total potentially dilutive securities (in shares)	6,424,419	4,556,742
Restricted stock
Antidilutive Securities Excluded from Computation of Earnings Per Share
Total potentially dilutive securities (in shares)	522,626	836,606