Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2021 | Apr. 30, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 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 $0.0001 per share | |
Trading Symbol(s) | SWTX | |
Name of each exchange on which registered | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 49,061,125 | |
Entity Central Index Key | 0001773427 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 95,426 | $ 147,089 |
Marketable securities | 381,985 | 361,395 |
Prepaid expenses and other current assets | 4,103 | 4,914 |
Total current assets | 481,514 | 513,398 |
Long-term marketable securities | 63,631 | 53,336 |
Property and equipment, net | 1,024 | 1,075 |
Operating lease right-of-use assets | 1,697 | 1,944 |
Equity investment | 3,610 | 3,871 |
Restricted cash | 565 | 565 |
Other assets | 2,547 | 2,002 |
Total assets | 554,588 | 576,191 |
Current liabilities: | ||
Accounts payable | 2,229 | 1,350 |
Accrued expenses | 15,256 | 14,885 |
Operating lease liabilities, current | 1,244 | 1,375 |
Total current liabilities | 18,729 | 17,610 |
Operating lease liabilities, long-term | 1,031 | 1,359 |
Other long-term liabilities | 131 | 164 |
Total liabilities | 19,891 | 19,133 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding at March 31, 2021 and December 31, 2020. | 0 | 0 |
Common stock, $0.0001 par value, 150,000,000 shares authorized, 49,024,152 and 48,819,591 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively. | 5 | 5 |
Additional paid-in capital | 683,029 | 675,615 |
Accumulated other comprehensive income | 53 | 41 |
Accumulated deficit | (148,390) | (118,603) |
Total stockholders’ equity | 534,697 | 557,058 |
Total liabilities and stockholders’ equity | $ 554,588 | $ 576,191 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 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) | 49,024,152 | 48,819,591 |
Common stock, shares outstanding (shares) | 49,024,152 | 48,819,591 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating expenses: | ||
Research and development | $ 17,375 | $ 9,727 |
General and administrative | 12,381 | 6,403 |
Total operating expenses | 29,756 | 16,130 |
Loss from operations | (29,756) | (16,130) |
Interest and other income: | ||
Other income | 3 | 0 |
Interest income, net | 227 | 936 |
Total interest and other income | 230 | 936 |
Equity investment loss | (261) | (100) |
Net loss | $ (29,787) | $ (15,294) |
Net loss per share, basic and diluted (usd per share) | $ (0.62) | $ (0.37) |
Weighted average common shares outstanding, basic and diluted (shares) | 48,229,539 | 41,789,120 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (29,787) | $ (15,294) |
Changes in other comprehensive income: | ||
Unrealized gain on marketable securities, net | 12 | 0 |
Total changes in other comprehensive income | 12 | 0 |
Comprehensive loss | $ (29,775) | $ (15,294) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders’ Equity - 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 | |||||
Beginning balance (in shares) | 43,003,733 | ||||
Stock-based compensation expense | 1,350 | 1,350 | |||
Forfeitures of restricted stock awards | 0 | ||||
Forfeiture of restricted stock awards (in shares) | (5,228) | ||||
Exercise of stock options | 6 | 6 | |||
Exercise of stock options (in shares) | 2,884 | ||||
Other comprehensive income, net of tax | 0 | ||||
Net loss | (15,294) | (15,294) | |||
Ending balance at Mar. 31, 2020 | 308,134 | $ 4 | 396,453 | 0 | (88,323) |
Ending balance (in shares) at Mar. 31, 2020 | 43,003,733 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Beginning balance (in shares) | 43,003,733 | ||||
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 | |||||
Beginning balance (in shares) | 49,024,152 | ||||
Stock-based compensation expense | 7,055 | 7,055 | |||
Issuance of restricted stock award (in shares) | 145,535 | ||||
Exercise of stock options | 359 | 359 | |||
Exercise of stock options (in shares) | 59,026 | ||||
Other comprehensive income, net of tax | 12 | 12 | |||
Net loss | (29,787) | (29,787) | |||
Ending balance at Mar. 31, 2021 | $ 534,697 | $ 5 | $ 683,029 | $ 53 | $ (148,390) |
Ending balance (in shares) at Mar. 31, 2021 | 49,024,152 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Beginning balance (in shares) | 49,024,152 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating activities | ||
Net loss | $ (29,787) | $ (15,294) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 110 | 70 |
Non-cash operating lease expense | 257 | 263 |
Stock compensation expense | 7,055 | 1,350 |
Equity investment loss | 261 | 100 |
Changes in operating assets and liabilities | ||
Prepaid expenses and other current assets | 697 | 1,142 |
Other assets | (545) | (281) |
Accounts payable | 879 | (1,037) |
Accrued expenses | 357 | (2,358) |
Lease liability | (355) | (353) |
Other long-term liabilities | (33) | 0 |
Net cash used in operating activities | (21,104) | (16,398) |
Investing activities | ||
Capital expenditures | (45) | (160) |
Purchases of marketable securities | (86,373) | 0 |
Proceeds from sale and maturity of debt securities | 55,500 | 0 |
Net cash used in investing activities | (30,918) | (160) |
Financing activities | ||
Proceeds from stock option exercises | 359 | 6 |
Net cash provided by financing activities | 359 | 6 |
Net increase (decrease) in cash and cash equivalents | (51,663) | (16,552) |
Cash and cash equivalents including Restricted cash, beginning of period | 147,654 | 328,192 |
Cash and cash equivalents including Restricted cash, end of period | $ 95,991 | $ 311,640 |
Nature of Operations
Nature of Operations | 3 Months Ended |
Mar. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations | Nature of Operations SpringWorks Therapeutics, Inc., or the Company, was formed in Delaware on August 18, 2017. 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 $148.4 million and $118.6 million, and working capital of $462.8 million and $495.8 million, as of March 31, 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 $541.0 million and $561.8 million as of March 31, 2021 and December 31, 2020, respectively. Based on the Company's cash, cash equivalents and marketable securities as of March 31, 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 Company did not observe significant impacts on its business or results of operations for the periods presented due to the global emergence of COVID-19. While the extent to which COVID-19 impacts the Company’s future results will depend on future developments, the pandemic and associated impacts could result in a material impact to the Company’s future financial condition, results of operations and cash flows. |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 2. 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. 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 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
Marketable Securities | 3 Months Ended |
Mar. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities The following table summarizes the Company’s available-for-sale marketable securities as of March 31, 2021 and December 31, 2020: As of March 31, 2021 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Marketable securities: Short-term investments: U.S. Government securities $ 170,392 $ 61 $ — $ 170,453 Corporate debt securities 79,464 4 (25) 79,443 Commercial paper 132,089 — — 132,089 Long-term investments: U.S. Government securities 53,219 18 — 53,237 Corporate debt securities 10,399 — (5) 10,394 Total $ 445,563 $ 83 $ (30) $ 445,616 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 March 31, 2021, the Company did not hold any investments with maturity dates greater than five years. As of, and for the three months ended March 31, 2021, the Company did not have any allowance for credit losses or impairments of its marketable securities. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 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 March 31, 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 March 31, 2021 Fair Value Hierarchy (in thousands) Total Level 1 Level 2 Level 3 Cash equivalents: Money market funds $ 73,022 $ 73,022 $ — $ — Short-term investments: U.S. Government securities 170,453 170,453 — — Corporate debt securities 79,443 — 79,443 — Commercial paper 132,089 — 132,089 — Long-term investments: U.S. Government securities 53,237 53,237 — — Corporate debt securities 10,394 — 10,394 — Total $ 518,638 $ 296,712 $ 221,926 $ — 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 March 31, 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. |
Investment and Variable Interes
Investment and Variable Interest Entity | 3 Months Ended |
Mar. 31, 2021 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Investment and Variable Interest Entity | Investment and Variable Interest Entity 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 March 31, 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 $0.1 million for the three months ended March 31, 2021 and March 31, 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 $3.6 million as of March 31, 2021, representing the maximum exposure to loss as a result of the Company’s involvement with MapKure. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consists of the following: March 31, December 31, (in thousands) 2021 2020 Accrued professional fees $ 889 $ 827 Accrued compensation and benefits 1,920 5,834 Accrued research and development 11,789 7,922 Accrued other 658 302 Total accrued expenses $ 15,256 $ 14,885 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 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 amount of such obligations are unknown or uncertain. Leases Maturities of the Company’s operating lease liabilities in accordance with ASC 842 as of March 31, 2021 are as follows: (in thousands) Operating Leases 2021 $ 916 2022 1,297 2023 135 2024 and thereafter — Total lease payments 2,348 Less: imputed interest (73) Present value of lease liabilities $ 2,275 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 March 31, 2021, there was no litigation or contingency with at least a reasonable possibility of a material loss. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 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 March 31, 2021, there were 5,306,612 shares available for issuance in connection with future awards under the 2019 Equity Incentive Plan. Stock-Based Awards During the three months ended March 31, 2021, the Company granted 1,245,580 stock option awards and 145,535 restricted stock awards to its officers, employees and directors under the 2019 Equity Incentive Plan. During the three months ended March 31, 2021, 146,162 restricted stock awards previously issued to employees of the Company vested, and 59,026 stock options were exercised. As of March 31, 2021, there were 1,694,896 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 March 31, 2021, 84,527 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 general and administrative expense, and research and development expense, for the three months ended March 31, 2021 was $4.8 million and $2.3 million, respectively, and $1.0 million and $0.4 million, respectively, for the three months ended March 31, 2020. As of March 31, 2021, the unrecognized compensation expense related to unvested stock options and restricted stock awards was $86.2 million and $10.0 million, which is expected to be recognized over a weighted-average remaining period of approximately 2.92 and 1.19 years, respectively. As of March 31, 2021, the Company had 5,692,100 stock options outstanding and 686,241 unvested restricted stock awards. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 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 March 31, 2021 and 2020, because to do so would be anti-dilutive: As of March 31, 2021 2020 Common stock options issued and outstanding 5,692,100 4,349,449 Restricted stock subject to future vesting 686,241 1,136,760 Total potentially dilutive securities 6,378,341 5,486,209 |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 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. 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 EstimatesThe 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 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 Issued Accounting Pronouncements (not yet adopted) | 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 (Tables)
Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2021 and December 31, 2020: As of March 31, 2021 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Marketable securities: Short-term investments: U.S. Government securities $ 170,392 $ 61 $ — $ 170,453 Corporate debt securities 79,464 4 (25) 79,443 Commercial paper 132,089 — — 132,089 Long-term investments: U.S. Government securities 53,219 18 — 53,237 Corporate debt securities 10,399 — (5) 10,394 Total $ 445,563 $ 83 $ (30) $ 445,616 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
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of financial assets subject to fair value measurements | As of March 31, 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 March 31, 2021 Fair Value Hierarchy (in thousands) Total Level 1 Level 2 Level 3 Cash equivalents: Money market funds $ 73,022 $ 73,022 $ — $ — Short-term investments: U.S. Government securities 170,453 170,453 — — Corporate debt securities 79,443 — 79,443 — Commercial paper 132,089 — 132,089 — Long-term investments: U.S. Government securities 53,237 53,237 — — Corporate debt securities 10,394 — 10,394 — Total $ 518,638 $ 296,712 $ 221,926 $ — 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)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | Accrued expenses consists of the following: March 31, December 31, (in thousands) 2021 2020 Accrued professional fees $ 889 $ 827 Accrued compensation and benefits 1,920 5,834 Accrued research and development 11,789 7,922 Accrued other 658 302 Total accrued expenses $ 15,256 $ 14,885 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum lease obligations | Maturities of the Company’s operating lease liabilities in accordance with ASC 842 as of March 31, 2021 are as follows: (in thousands) Operating Leases 2021 $ 916 2022 1,297 2023 135 2024 and thereafter — Total lease payments 2,348 Less: imputed interest (73) Present value of lease liabilities $ 2,275 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2021 and 2020, because to do so would be anti-dilutive: As of March 31, 2021 2020 Common stock options issued and outstanding 5,692,100 4,349,449 Restricted stock subject to future vesting 686,241 1,136,760 Total potentially dilutive securities 6,378,341 5,486,209 |
Nature of Operations (Details)
Nature of Operations (Details) $ in Thousands | Mar. 31, 2021USD ($)trial | Dec. 31, 2020USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of clinical trials (trials) | trial | 2 | |
Accumulated deficit | $ (148,390) | $ (118,603) |
Working capital | 462,800 | 495,800 |
Cash, cash equivalents and marketable securities | $ 541,000 | $ 561,800 |
Basis of Presentation (Details)
Basis of Presentation (Details) | 3 Months Ended |
Mar. 31, 2021segment | |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Marketable securities: | ||
Amortized Cost | $ 445,563 | $ 414,690 |
Gross Unrealized Gains | 83 | 52 |
Gross Unrealized Losses | (30) | (11) |
Estimated Fair Value | 445,616 | 414,731 |
U.S. Government securities | Short-term investments: | ||
Marketable securities: | ||
Amortized Cost | 170,392 | 157,079 |
Gross Unrealized Gains | 61 | 24 |
Gross Unrealized Losses | 0 | (1) |
Estimated Fair Value | 170,453 | 157,102 |
U.S. Government securities | Long-term investments: | ||
Marketable securities: | ||
Amortized Cost | 53,219 | 53,310 |
Gross Unrealized Gains | 18 | 26 |
Estimated Fair Value | 53,237 | 53,336 |
Corporate debt securities | Short-term investments: | ||
Marketable securities: | ||
Amortized Cost | 79,464 | 74,773 |
Gross Unrealized Gains | 4 | 2 |
Gross Unrealized Losses | (25) | (10) |
Estimated Fair Value | 79,443 | 74,765 |
Corporate debt securities | Long-term investments: | ||
Marketable securities: | ||
Amortized Cost | 10,399 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (5) | |
Estimated Fair Value | 10,394 | |
Commercial paper | Short-term investments: | ||
Marketable securities: | ||
Amortized Cost | 132,089 | 129,528 |
Estimated Fair Value | $ 132,089 | $ 129,528 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Fair Value Measurements | ||
Total financial assets | $ 518,638 | $ 522,454 |
U.S. Government securities | ||
Fair Value Measurements | ||
Short-term investments | 170,453 | 157,102 |
Long term investments | 53,237 | 53,336 |
Corporate debt securities | ||
Fair Value Measurements | ||
Short-term investments | 79,443 | 74,765 |
Long term investments | 10,394 | |
Commercial paper | ||
Fair Value Measurements | ||
Short-term investments | 132,089 | 129,528 |
Money market funds | ||
Fair Value Measurements | ||
Cash equivalents | 73,022 | 107,723 |
Level 1 | ||
Fair Value Measurements | ||
Total financial assets | 296,712 | 318,161 |
Level 1 | U.S. Government securities | ||
Fair Value Measurements | ||
Short-term investments | 170,453 | 157,102 |
Long term investments | 53,237 | 53,336 |
Level 1 | Corporate debt securities | ||
Fair Value Measurements | ||
Short-term investments | 0 | 0 |
Long term investments | 0 | |
Level 1 | Commercial paper | ||
Fair Value Measurements | ||
Short-term investments | 0 | 0 |
Level 1 | Money market funds | ||
Fair Value Measurements | ||
Cash equivalents | 73,022 | 107,723 |
Level 2 | ||
Fair Value Measurements | ||
Total financial assets | 221,926 | 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 | 79,443 | 74,765 |
Long term investments | 10,394 | |
Level 2 | Commercial paper | ||
Fair Value Measurements | ||
Short-term investments | 132,089 | 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 |
Long term investments | 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 |
Investment and Variable Inter_2
Investment and Variable Interest Entity (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Schedule of Equity Method Investments | |||
Equity investment loss | $ 261 | $ 100 | |
Investment in Mapkure | 3,610 | $ 3,871 | |
MapKure | |||
Schedule of Equity Method Investments | |||
Equity investment loss | 300 | $ 100 | |
Investment in Mapkure | $ 3,600 | ||
MapKure | Series A Preferred units | |||
Schedule of Equity Method Investments | |||
Ownership interest (in percent) | 38.90% |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued professional fees | $ 889 | $ 827 |
Accrued compensation and benefits | 1,920 | 5,834 |
Accrued research and development | 11,789 | 7,922 |
Accrued other | 658 | 302 |
Total accrued expenses | $ 15,256 | $ 14,885 |
Commitments and Contingencies -
Commitments and Contingencies - Maturities of operating lease liabilities (Details) $ in Thousands | Mar. 31, 2021USD ($) |
Operating Leases | |
2021 | $ 916 |
2022 | 1,297 |
2023 | 135 |
2024 and thereafter | 0 |
Total lease payments | 2,348 |
Less: imputed interest | (73) |
Present value of lease liabilities | $ 2,275 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Operating Leases | |
Litigation or contingency expense | $ 0 |
Stock-Based Compensation - 2019
Stock-Based Compensation - 2019 Equity Incentive Plan (Details) - USD ($) $ in Millions | Jan. 01, 2021 | Jun. 30, 2019 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2019 |
General and administrative | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Stock compensation expense | $ 4.8 | $ 1 | |||
Research and development | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Stock compensation expense | $ 2.3 | $ 0.4 | |||
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) | 5,306,612 | ||||
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) | 59,026 | ||||
Stock options vested and exercisable (in shares) | 1,694,896 | ||||
Unrecognized compensation expense related to unvested stock options | $ 86.2 | ||||
Unrecognized compensation expense expected to be recognized over a weighted-average remaining period (in years) | 2 years 11 months 1 day | ||||
Stock options outstanding (in shares) | 5,692,100 | ||||
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 | $ 10 | ||||
Unrecognized compensation expense expected to be recognized over a weighted-average remaining period (in years) | 1 year 2 months 8 days | ||||
Unvested restricted stock award outstanding (in shares) | 686,241 | ||||
2019 Equity Incentive Plan | Restricted stock | Employees | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Restricted stock awards vested (in shares) | 146,162 | ||||
2019 Equity Incentive Plan | Executive officers and employees | Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Granted (in shares) | 1,245,580 | ||||
2019 Equity Incentive Plan | Executive officers and employees | Restricted stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Restricted stock awards vested (in shares) | 145,535 | ||||
CEO Performance Award | Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Stock options vested and exercisable (in shares) | 84,527 | ||||
CEO Performance Award | CEO | Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Granted (in shares) | 176,411 |
Net Loss per Share (Details)
Net Loss per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Total potentially dilutive securities (in shares) | 6,378,341 | 5,486,209 |
Common | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Total potentially dilutive securities (in shares) | 5,692,100 | 4,349,449 |
Restricted stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Total potentially dilutive securities (in shares) | 686,241 | 1,136,760 |