Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Jul. 25, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | SNDX | |
Entity Registrant Name | Syndax Pharmaceuticals, Inc. | |
Entity Central Index Key | 0001395937 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-37708 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 32-0162505 | |
Entity Address, Address Line One | 35 Gatehouse Drive | |
Entity Address, Address Line Two | Building D | |
Entity Address, Address Line Three | Floor 3 | |
Entity Address, City or Town | Waltham | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02451 | |
City Area Code | 781 | |
Local Phone Number | 419-1400 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Common Stock, Shares Outstanding | 85,096,358 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 105,396 | $ 295,394 |
Short-term investments | 319,701 | 275,304 |
Short-term deposits | 7,170 | 6,885 |
Other receivable | 9,582 | 0 |
Prepaid expenses and other current assets | 4,207 | 3,293 |
Total current assets | 446,056 | 580,876 |
Long-term investments | 29,516 | 29,829 |
Property and equipment, net | 2 | 8 |
Right-of-use asset, net | 1,000 | 1,487 |
Restricted cash | 217 | 217 |
Other assets | 156 | 463 |
Total assets | 476,947 | 612,880 |
Current liabilities: | ||
Accounts payable | 11,568 | 9,961 |
Collaboration payable, net | 3,102 | 7,232 |
Accrued expenses and other current liabilities | 26,809 | 39,856 |
Current portion of right-of-use liability | 981 | 1,035 |
Current portion of capital lease | 12 | 12 |
Total current liabilities | 42,472 | 58,096 |
Long-term liabilities: | ||
Right-of-use liability, less current portion | 133 | 578 |
Capital lease, less current portion | 4 | 10 |
Total long-term liabilities | 137 | 588 |
Total liabilities | 42,609 | 58,684 |
Commitments and contingencies (Note 12) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; 0 shares outstanding at June 30, 2024 and December 31, 2023 | 0 | 0 |
Common stock, $0.0001 par value, 200,000,000 shares authorized; 85,028,629 and 84,826,632 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 9 | 8 |
Additional paid-in capital | 1,478,009 | 1,456,370 |
Accumulated other comprehensive (loss) gain | (817) | 218 |
Accumulated deficit | (1,042,863) | (902,400) |
Total stockholders’ equity | 434,338 | 554,196 |
Total liabilities and stockholders’ equity | $ 476,947 | $ 612,880 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 85,028,629 | 84,826,632 |
Common stock, shares outstanding | 85,028,629 | 84,826,632 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Revenue: | ||||
Milestone and license revenue | $ 3,500 | $ 0 | $ 3,500 | $ 0 |
Total revenues | 3,500 | 0 | 3,500 | 0 |
Operating expenses: | ||||
Research and development | 48,655 | 34,764 | 105,147 | 68,819 |
Selling, general and administrative | 29,061 | 14,914 | 52,083 | 26,875 |
Total operating expenses | 77,716 | 49,678 | 157,230 | 95,694 |
Loss from operations | (74,216) | (49,678) | (153,730) | (95,694) |
Other income (expense), net: | ||||
Interest expense | (45) | (35) | (100) | (75) |
Interest income | 6,284 | 5,191 | 13,540 | 10,268 |
Other expense | (86) | (93) | (173) | (240) |
Total other income, net | 6,153 | 5,063 | 13,267 | 9,953 |
Net loss | (68,063) | (44,615) | (140,463) | (85,741) |
Other comprehensive loss: | ||||
Unrealized (loss) gain on short-term investments | (61) | (238) | (817) | 232 |
Comprehensive loss | (68,124) | (44,853) | (141,280) | (85,509) |
Net loss attributable to common stockholders | $ (68,063) | $ (44,615) | $ (140,463) | $ (85,741) |
Net loss per share attributable to common stockholders—basic | $ (0.8) | $ (0.64) | $ (1.65) | $ (1.23) |
Net loss per share attributable to common stockholders—diluted | $ (0.8) | $ (0.64) | $ (1.65) | $ (1.23) |
Weighted-average number of common shares used to compute net loss per share attributable to common stockholders —basic | 85,274,829 | 69,638,427 | 85,244,015 | 69,539,209 |
Weighted-average number of common shares used to compute net loss per share attributable to common stockholders—diluted | 85,274,829 | 69,638,427 | 85,244,015 | 69,539,209 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (140,463) | $ (85,741) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 6 | 6 |
Accretion of investments | (7,470) | (7,685) |
Non-cash operating lease expense | 486 | 259 |
Stock-based compensation | 18,795 | 14,303 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (890) | 459 |
Collaboration (payable) receivable, net | (4,129) | 3,967 |
Other receivable | (9,582) | 0 |
Accounts payable | 1,607 | 6,629 |
Accrued expenses and other liabilities | (13,553) | (6,796) |
Net cash used in operating activities | (155,193) | (74,599) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of short and long-term investments | (167,385) | (142,593) |
Proceeds from sales and maturities of short-term investments | 129,736 | 236,415 |
Net cash (used in) provided by investing activities | (37,649) | 93,822 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from Employee Stock Purchase Plan | 546 | 374 |
Proceeds from stock option exercises | 2,298 | 3,424 |
Net cash provided by financing activities | 2,844 | 3,798 |
NET (DECREASE) INCREASE CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (189,998) | 23,021 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH—beginning of period | 295,611 | 74,471 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH —end of period | $ 105,613 | $ 97,492 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ (68,063) | $ (72,400) | $ (44,615) | $ (41,126) | $ (140,463) | $ (85,741) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | 1. Nature of Business Syndax Pharmaceuticals, Inc., is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. We were incorporated in Delaware in 2005. We have operations in New York, New York and Waltham, Massachusetts and we operate in one segment. References in these notes to condensed consolidated financial statements to “Syndax,” “the Company,” “we,” “us” or “our” refer to Syndax Pharmaceuticals, Inc. and its wholly owned subsidiaries. |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The Company has prepared the accompanying condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP. Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. The interim unaudited condensed financial statements have been prepared on the same basis as the annual audited financial statements and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of June 30, 2024, and the results of operations and comprehensive loss for the three and six months ended June 30, 2024 and 2023, and cash flows for the six months ended June 30, 2024 and 2023. The results for the three and six months ended June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024, any other interim periods, or any future year or period. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2023, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K as filed with the Securities and Exchange Commission, or the SEC, on February 27, 2024. In 2011, the Company established a wholly owned subsidiary in the United Kingdom, which the Company dissolved in June 2024. In 2014, the Company established a wholly owned U.S. subsidiary, and in 2021, the Company established a wholly owned subsidiary in the Netherlands. To date, there have been no material activities for these entities. All intercompany balances and transactions have been eliminated in consolidation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies The Company’s significant accounting policies, which are disclosed in the audited consolidated financial statements for the year ended December 31, 2023, and the notes thereto are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on February 27, 2024 . Since the date of filing, there have been no material changes to the Company’s significant accounting policies except as noted below. Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of costs and expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to the Company’s condensed consolidated financial statements. Significant Risks and Uncertainties We are subject to challenges and risks specific to our business and our ability to execute on our strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of our late-stage product candidate; delays or problems in the supply of our products, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; the challenges of protecting and enhancing our intellectual property rights; and complying with applicable regulatory requirements. Recently Issued and Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other accounting standard setting bodies that we adopt as of the specified effective date. Unless otherwise discussed below, we do not believe that the adoption of recently issued standards have or may have a material impact on our consolidated statements or disclosures. Segment Reporting In December 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. The guidance in this update is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024. The Company is currently in the process of evaluating the effects of this pronouncement on our related disclosures. |
Significant Collaborative Resea
Significant Collaborative Research and License Agreements | 6 Months Ended |
Jun. 30, 2024 | |
Research and Development [Abstract] | |
Significant Collaborative Research and License Agreements | 4. Significant Collaborative Research and License Agreements Incyte Collaboration In September 2021, the Company entered into the Incyte License and Collaboration Agreement, or the Incyte License, with Incyte covering the worldwide development and commercialization of axatilimab. Also in September 2021, the Company entered into a share purchase agreement with Incyte, or the Incyte Share Purchase Agreement. These agreements are collectively referred to as the Incyte Agreements. Under the terms of the Incyte Agreements, Incyte received exclusive commercialization rights outside of the United States, subject to certain royalty payment obligations set forth below. In the United States, Incyte and the Company will co-commercialize axatilimab, with the Company having the right to co-promote axatilimab with Incyte, subject to the Company’s exercise of its co-promotion option. Incyte will be responsible for leading all aspects of the commercialization of axatilimab in the United States. The Company and Incyte will share equally the profits and losses from co-commercialization efforts in the United States. The Company and Incyte have agreed to co-develop axatilimab and to share development costs associated with global and U.S. – specific clinical trials, with Incyte responsible for 55 % of such costs and the Company responsible for 45 % of such costs. Each company will be responsible for funding any of its own independent development activities. Incyte is responsible for 100 % of future development costs for trials that are specific to ex-U.S. countries. All development costs related to the collaboration will be subject to a joint development plan. Under the terms of the Incyte Agreements, in December 2021, Incyte paid the Company a non-refundable cash payment of $ 117.0 million and the Company issued 1,421,523 shares of common stock with an aggregate purchase price of $ 35.0 million, or $ 24.62 per share. Additionally, under the terms of the Incyte Agreements, the Company is eligible to receive up to $ 220.0 million in future contingent development and regulatory milestones and up to $ 230.0 million in commercialization milestones as well as tiered royalties ranging in the mid-teens percentage on net sales of the licensed product comprising axatilimab in Europe and Japan and low double digit percentage in the rest of the world outside of the United States. The Company’s right to receive royalties in any particular country will expire upon the last to occur of (a) the expiration of licensed patent rights covering the licensed product in that particular country, (b) a specified period of time after the first post - marketing authorization sale of a licensed product in that country, and (c) the expiration of any regulatory exclusivity for that licensed product in that country. As of June 30, 2024, the Company has recorded approximately $ 2.0 million as a collaboration receivable due from Incyte related to the Company’s development and pre-commercialization costs under the Incyte Agreements and has recorded approximately $ 5.1 million as a collaboration payable due to Incyte for development and pre-commercialization costs incurred by Incyte as of June 30, 2024. Both expense and cost offset are recorded as part of research and development expense and general and administrative expense. Vitae Pharmaceuticals, Inc. In October 2017, the Company entered into a license agreement, or the Vitae License Agreement, with Vitae Pharmaceuticals, LLC, or Vitae, a subsidiary of AbbVie, Inc., under which the Company was granted an exclusive, sublicensable, worldwide license to a portfolio of preclinical, orally available, small molecule inhibitors of the Menin–KMT2A binding interaction, or the Menin Assets. Subject to the achievement of certain milestone events, the Company may be required to pay Allergan up to $ 99.0 million in one-time development and regulatory milestone payments over the term of the Vitae License Agreement. In the event that the Company or any of its affiliates or sublicensees commercializes the Menin Assets, the Company will also be obligated to pay Vitae low single to low double-digit royalties on sales, subject to reduction in certain circumstances, as well as up to an aggregate of $ 70.0 million in potential one-time, sales-based milestone payments based on achievement of certain annual sales thresholds. The Company is solely responsible for the development and commercialization of the Menin Assets. Each party may terminate the Vitae License Agreement for the other party’s uncured material breach or insolvency, and the Company may terminate the Vitae License Agreement at any time upon advance written notice to Vitae. Vitae may terminate the Vitae License Agreement if the Company or any of its affiliates or sublicensees institutes a legal challenge to the validity, enforceability, or patentability of the licensed patent rights. Unless terminated earlier in accordance with its terms, the Vitae License Agreement will continue on a country-by-country and product-by-product basis until the later of: (i) the expiration of all of the licensed patent rights in such country; (ii) the expiration of all regulatory exclusivity applicable to the product in such country; and (iii) 10 years from the date of the first commercial sale of the product in such country. As of the date of the Vitae License Agreement, the asset acquired had no alternative future use nor had it reached a stage of technological feasibility. As the processes or activities that were acquired along with the license do not constitute a “business,” the transaction has been accounted for as an asset acquisition. Since the effective date of the Vitae License Agreement, the Company achieved certain development and regulatory milestones, resulting in $ 18.0 m illion in expense, which includes $ 8.0 million paid in the three months ended June 30, 2024. UCB Biopharma Sprl In 2016, the Company entered into a license agreement, or the UCB License Agreement, as amended from time to time, with UCB Biopharma Sprl, or UCB, under which UCB granted to the Company a worldwide, sublicensable, exclusive license to UCB6352, which the Company refers to as axatilimab, an anti-CSF-1R monoclonal antibody. Subject to the achievement of certain milestone events, the Company may be required to pay UCB up to $ 119.5 million in one-time development and regulatory milestone payments over the term of the UCB License Agreement. In the event that the Company or any of its affiliates or sublicensees commercializes axatilimab, the Company will also be obligated to pay UCB low double-digit royalties on sales, subject to reduction in certain circumstances, as well as up to an aggregate of $ 250.0 million in potential one-time, sales-based milestone payments based on achievement of certain annual sales thresholds. Under certain circumstances, the Company may be required to share a percentage of non-royalty income from sublicensees, subject to certain deductions, with UCB. The Company is solely responsible for the development and commercialization of axatilimab, except that UCB was responsible for performing a limited set of transitional chemistry, manufacturing and control tasks related to axatilimab. Each party may terminate the UCB License Agreement for the other party’s uncured material breach or insolvency, and the Company may terminate the UCB License Agreement at any time upon advance written notice to UCB. UCB may terminate the UCB License Agreement if the Company or any of its affiliates or sublicensees institutes a legal challenge to the validity, enforceability, or patentability of the licensed patent rights. Unless terminated earlier in accordance with its terms, the UCB License Agreement will continue on a country-by-country and product-by-product basis until the later of: (i) the expiration of all of the licensed patent rights in such country; (ii) the expiration of all regulatory exclusivity applicable to the product in such country; and (iii) 10 years from the date of the first commercial sale of the product in such country. As of the date of the UCB License Agreement, the asset acquired had no alternative future use nor had it reached a stage of technological feasibility. As the processes or activities that were acquired along with the license do not constitute a “business,” the transaction has been accounted for as an asset acquisition. As a result, in 2016, the upfront payment of $ 5.0 million was recorded as research and development expense in the consolidated statements of operations. Additionally, in connection with its most recent amendment of the UCB License Agreement, in the second quarter of 2022 the Company paid UCB $ 5.8 million, which was recognized as a milestone expense. Since the effective date of the license agreement, the Company achieved certain development and regulatory milestones and has recorded $ 16.0 million as research and development expense, which includes $ 10.0 million paid in the three months ended March 31, 2024. Bayer Pharma AG (formerly known as Bayer Schering Pharma AG) In March 2007, the Company entered into a license agreement with Bayer Schering Pharma AG, or Bayer, for a worldwide, exclusive license to develop and commercialize entinostat and any other products containing the same active ingredient. The Company will pay Bayer royalties on a sliding scale based on net sales, if any, and make future milestone payments to Bayer of up to $ 150.0 million in the event that certain specified development and regulatory goals and sales levels are achieved. Eddingpharm Investment Company Limited In August 2016, the Company entered into a license agreement with Eddingpharm Investment Company, or Eddingpharm, to develop and commercialize entinostat. Eddingpharm will pay the Company royalties on a sliding scale based on net sales, if any, and make future milestone payments up to $ 10.0 million in the event that certain specified development and regulatory goals are achieved. In April 2024, certain milestones were achieved and the Company recognized $ 3.5 million of milestone and license revenue in the three months ended June 30, 2024. |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss per Share Attributable to Common Stockholders | 5. Net Loss per Share Attributable to Common Stockholders Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Because the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods. The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company: Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 (In thousands, except share and per (In thousands, except share and per Numerator—basic and diluted: Net loss $ ( 68,063 ) $ ( 44,615 ) $ ( 140,463 ) $ ( 85,741 ) Net loss attributable to common $ ( 68,063 ) $ ( 44,615 ) $ ( 140,463 ) $ ( 85,741 ) Net loss per share attributable to common $ ( 0.80 ) $ ( 0.64 ) $ ( 1.65 ) $ ( 1.23 ) Denominator—basic and diluted: Weighted-average number of common shares 85,274,829 69,638,427 85,244,015 69,539,209 The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares): June 30, 2024 2023 Options to purchase common stock 12,226,274 10,429,475 Employee Stock Purchase Plan 29,426 15,331 Non-vested restricted stock units (RSUs) 1,486,146 526,736 For additional information related to the Company’ s common stock see Note 10. |
Other Receivables
Other Receivables | 6 Months Ended |
Jun. 30, 2024 | |
Other Receivables, Net, Current [Abstract] | |
Other Receivables | 6. Other Receivables Contemporaneous with the Company’s New Drug Application, or NDA, submission to the U.S. Food and Drug Administration for revumenib, it was required to pay a $ 6.1 million refundable fee under the Prescription Drug User Fee Act, or PDUFA. The $ 6.1 million payment was made in January 2024. In April 2024, entinostat received marketing approval in China. As of June 30, 2024, the Company has recorded a $ 3.5 million milestone receivable related to achieved milestones under the license agreement with Eddingpharm. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 7. Fair Value Measurements The carrying amounts of cash and cash equivalents, restricted cash, accounts payable, and accrued expenses approximated their estimated fair values due to the short-term nature of these financial instruments. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value are performed in a manner to maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, which are the following: Level 1— Quoted prices (unadjusted) in active markets that are accessible at the market date for identical unrestricted assets or liabilities. Level 2— Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs for which all significant inputs are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3— Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The table below presents information about the Company’s assets and liabilities that are regularly measured and carried at fair value and indicate the level within the fair value hierarchy of valuation techniques the Company utilized to determine such fair values (in thousands): Fair Value Measurements Using Quoted Prices Significant (unadjusted) Other Significant Total in Active Observable Unobservable Carrying Markets Inputs Inputs Value (Level 1) (Level 2) (Level 3) (In thousands) June 30, 2024 Assets: Cash and cash equivalents $ 105,396 $ 105,396 $ — $ — Short-term investments 319,701 — 319,701 — Long-term investments 29,516 — 29,516 — Total assets $ 454,613 $ 105,396 $ 349,217 $ — December 31, 2023 Assets: Cash and cash equivalents $ 295,394 $ 295,394 $ — $ — Short-term investments 275,304 — 275,304 — Long-term investments 29,829 — 29,829 — Total assets $ 600,527 $ 295,394 $ 305,133 $ — There have been no material impairments of our assets measured and carried at fair value during the period ended June 30, 2024 and 2023. In addition, there have been no changes in valuation techniques during the periods ended June 30, 2024 and 2023. The fair value of Level 1 instruments classified as cash equivalents are valued using quoted market prices in active markets. The fair value of Level 2 instruments classified as cash equivalents and short and long-term investments are determined based on quoted prices in active markets, which are either directly or indirectly observable as of the reporting date with fair value being determined using models or other valuation methodologies. The Company’s short and long-term investments are classified as available-for-sale securities. As of June 30, 2024 , the remaining contractual maturities of the available-for-sale securities were 1 to 16 months, and the balance in the Company’s accumulated other comprehensive loss was comprised solely of activity related to the Company’s available-for-sale securities. There were no realized gains or losses recognized on the sale or maturity of available-for-sale securities, during the three and six months ended June 30, 2024 and 2023. As a result, the Company did not reclassify any amounts out of accumulated other comprehensive loss for the same periods. The Company has a limited number of available-for-sale securities that are not in significant loss positions as of June 30, 2024, which the Company does not intend to sell, and it has concluded it will not be required to sell before recovery of the amortized cost for the investment at maturity. The following table summarizes the available-for-sale securities: Amortized Unrealized Unrealized Cost Gains Losses Fair Value (In thousands) June 30, 2024 Commercial paper $ 125,696 $ — $ ( 73 ) $ 125,623 Corporate bonds 40,037 — ( 68 ) 39,969 US Treasury 177,303 — ( 669 ) 176,634 Federal bonds 6,998 — ( 7 ) 6,991 $ 350,034 $ — $ ( 817 ) $ 349,217 December 31, 2023 Commercial paper $ 160,657 $ 149 $ — $ 160,806 Corporate bonds 47,150 62 — 47,212 US Treasury 68,111 46 — 68,157 Federal bonds 28,998 — ( 40 ) 28,958 $ 304,916 $ 257 $ ( 40 ) $ 305,133 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Jun. 30, 2024 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | 8. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): June 30, 2024 December 31, 2023 Prepaid insurance $ 1,555 $ 807 Interest receivable on investments 1,300 1,227 Prepaid subscription 633 769 Prepaid state and local taxes 493 264 Prepaid rent 164 163 Other 62 63 Total prepaid expenses and other current assets $ 4,207 $ 3,293 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 9. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2024 December 31, 2023 Accrued clinical study and trial costs $ 17,516 $ 16,346 Accrued compensation and related costs 7,779 11,172 Accrued professional fees 1,294 1,450 Accrued milestone costs — 10,000 Other 220 888 Total accrued expenses and other current liabilities $ 26,809 $ 39,856 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 10. Stock-Based Compensation In January 2024, the number of shares of common stock available for issuance under the Company’s 2015 Omnibus Incentive Plan, or the 2015 Plan, was increased by 3,393,065 shares of common stock due to the automatic annual provision to increase shares of common stock available under the 2015 Plan. Additionally in December 2023, the Company’s board of directors approved an increase of 1,100,000 shares of common stock available for issuance under the Company’s 2023 Inducement Plan, or Inducement Plan. As of June 30, 2024, there were 3,798,637 shares of common stock available for issuance under the 2015 Plan and 323,150 shares of common stock available for issuance under the Inducement Plan. The Company recognized stock-based compensation expense related to the issuance of stock option awards and restricted stock units to employees and non-employees and related to the Company’s 2015 Employee Stock Purchase Plan, or ESPP, in the condensed consolidated statements of comprehensive loss as follows: Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Research and development $ 4,318 $ 3,698 $ 8,461 $ 6,476 Selling, general and administrative 5,578 4,367 10,334 7,827 Total $ 9,896 $ 8,065 $ 18,795 $ 14,303 Compensation expense by type of award in the three and six months ended June 30, 2024 and 2023 was as follows: Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Stock options $ 7,801 $ 7,019 $ 14,985 $ 12,411 RSUs 1,999 978 3,616 1,760 ESPP 96 68 194 132 Total $ 9,896 $ 8,065 $ 18,795 $ 14,303 As of June 30, 2024, there were $ 101.3 million of unrecognized compensation costs related to employee and non-employee unvested stock options and RSUs granted under the 2023 Inducement Plan, 2015 Plan and the Company’s 2007 Stock Plan, which are expected to be recognized over a weighted-average remaining service period of 2.8 years. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Stockholders' Equity | 11. Stockholders’ Equity The following table presents the changes in stockholders’ equity for the three and six months ended June 30, 2024: (In thousands, except share data) Common Stock Additional Accumulated Accumulated Total Shares Amount Balance as of December 31, 2023 84,826,632 $ 8 $ 1,456,370 $ 218 $ ( 902,400 ) $ 554,196 Stock purchase under ESPP 35,463 — — — — — Stock-based compensation expense — — 8,899 — — 8,899 Unrealized loss on investments — — — ( 974 ) — ( 974 ) Vesting of RSUs 3,750 — — — — — Employee withholdings ESPP — — 309 — — 309 Proceeds from exercise of stock options 113,841 — 1,859 — — 1,859 Net loss — — — — ( 72,400 ) ( 72,400 ) Balance as of March 31, 2024 84,979,686 $ 8 $ 1,467,437 $ ( 756 ) $ ( 974,800 ) $ 491,889 Stock-based compensation expense — — 9,896 — — 9,896 Unrealized loss on investments — — — ( 61 ) — ( 61 ) Vesting of RSUs 1,603 — — — — — Employee withholdings ESPP — — 237 — — 237 Proceeds from exercise of stock options 47,340 — 439 — — 439 Par value adjustment — 1 — — — 1 Net loss — — — — ( 68,063 ) ( 68,063 ) Balance as of June 30, 2024 85,028,629 $ 9 $ 1,478,009 $ ( 817 ) $ ( 1,042,863 ) $ 434,338 The following table presents the changes in stockholders’ equity for the three and six months ended June 30, 2023: (In thousands, except share data) Common Stock Additional Accumulated Accumulated Total Shares Amount Balance as of December 31, 2022 68,111,385 $ 7 $ 1,161,288 $ ( 806 ) $ ( 693,040 ) $ 467,449 Stock purchase under ESPP 16,537 — — — — — Stock-based compensation expense — — 6,238 — — 6,238 Unrealized gain on short-term investments — — — 470 — 470 Vesting of RSUs 5,000 — — — — — Employee withholdings ESPP — — 196 — — 196 Prefunded warrants, exercise 85,998 — — — — — Proceeds from exercise of stock options 276,506 — 2,278 — — 2,278 Net loss — — — — ( 41,126 ) ( 41,126 ) Balance as of March 31, 2023 68,495,426 $ 7 $ 1,170,000 $ ( 336 ) $ ( 734,166 ) $ 435,505 Stock-based compensation expense — — 8,065 — — 8,065 Unrealized loss on short-term investments — — — ( 238 ) — ( 238 ) Vesting of RSUs 1,602 — — — — — Employee withholdings ESPP — — 179 — — 179 Prefunded warrants, exercise 771,133 — ( 1 ) — — ( 1 ) Proceeds from exercise of stock options 163,037 — 1,146 — — 1,146 Net loss — — — — ( 44,615 ) ( 44,615 ) Balance as of June 30, 2023 69,431,198 $ 7 $ 1,179,389 $ ( 574 ) $ ( 778,781 ) $ 400,041 At-the Market Program In May 2023, the Company entered into a sales agreement with Cowen and Company, or TD Cowen, under which the Company could, from time to time, issue and sell shares of its common stock having aggregate sales proceeds of up to $ 200.0 million, in a series of one or more ATM equity offerings, or the 2023 ATM Program. TD Cowen is not required to sell any specific share amounts but acts as the Company’s sales agent, using commercially reasonable efforts consistent with its normal trading and sales practices. Pursuant to the sales agreement, shares will be sold pursuant to the previous shelf registration statement on Form S-3ASR (Registration No. 333-277424), which became automatically effective upon the filing on February 27,2024. The Company’s common stock will be sold at prevailing market prices at the time of the sale, and as a result, prices may vary. For the period ended June 30, 2024, the Company sold no shares of common stock under the 2023 ATM Program. Pre-Funded Warrants In December 2021, the Company sold pre-funded warrants to purchase 1,142,856 shares of common stock. As of June 30, 2024 , 285,714 pre-funded warrants were considered issued and outstanding. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies From time to time, the Company may be subject to various claims and proceedings in the ordinary course of business. If the potential loss from any claim, asserted or unasserted, or proceeding is considered probable and the amount is reasonably estimable, the Company will accrue a liability for the estimated loss. There were no contingent liabilities recorded as of June 30, 2024 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | The Company’s significant accounting policies, which are disclosed in the audited consolidated financial statements for the year ended December 31, 2023, and the notes thereto are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on February 27, 2024 . Since the date of filing, there have been no material changes to the Company’s significant accounting policies except as noted below. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of costs and expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to the Company’s condensed consolidated financial statements. |
Significant Risks and Uncertainties | Significant Risks and Uncertainties We are subject to challenges and risks specific to our business and our ability to execute on our strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of our late-stage product candidate; delays or problems in the supply of our products, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; the challenges of protecting and enhancing our intellectual property rights; and complying with applicable regulatory requirements. |
Recently Issued and Adopted Accounting Pronouncements | Recently Issued and Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other accounting standard setting bodies that we adopt as of the specified effective date. Unless otherwise discussed below, we do not believe that the adoption of recently issued standards have or may have a material impact on our consolidated statements or disclosures. Segment Reporting In December 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. The guidance in this update is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024. The Company is currently in the process of evaluating the effects of this pronouncement on our related disclosures. |
Net Loss per Share Attributab_2
Net Loss per Share Attributable to Common Stockholders (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss per Share Attributable to Common Stockholders | The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company: Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 (In thousands, except share and per (In thousands, except share and per Numerator—basic and diluted: Net loss $ ( 68,063 ) $ ( 44,615 ) $ ( 140,463 ) $ ( 85,741 ) Net loss attributable to common $ ( 68,063 ) $ ( 44,615 ) $ ( 140,463 ) $ ( 85,741 ) Net loss per share attributable to common $ ( 0.80 ) $ ( 0.64 ) $ ( 1.65 ) $ ( 1.23 ) Denominator—basic and diluted: Weighted-average number of common shares 85,274,829 69,638,427 85,244,015 69,539,209 |
Potential Dilutive Securities Excluded from Computation of Diluted Net Loss per Common Share | The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares): June 30, 2024 2023 Options to purchase common stock 12,226,274 10,429,475 Employee Stock Purchase Plan 29,426 15,331 Non-vested restricted stock units (RSUs) 1,486,146 526,736 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Values of Financial Assets and Liabilities Measured at Fair Value | The table below presents information about the Company’s assets and liabilities that are regularly measured and carried at fair value and indicate the level within the fair value hierarchy of valuation techniques the Company utilized to determine such fair values (in thousands): Fair Value Measurements Using Quoted Prices Significant (unadjusted) Other Significant Total in Active Observable Unobservable Carrying Markets Inputs Inputs Value (Level 1) (Level 2) (Level 3) (In thousands) June 30, 2024 Assets: Cash and cash equivalents $ 105,396 $ 105,396 $ — $ — Short-term investments 319,701 — 319,701 — Long-term investments 29,516 — 29,516 — Total assets $ 454,613 $ 105,396 $ 349,217 $ — December 31, 2023 Assets: Cash and cash equivalents $ 295,394 $ 295,394 $ — $ — Short-term investments 275,304 — 275,304 — Long-term investments 29,829 — 29,829 — Total assets $ 600,527 $ 295,394 $ 305,133 $ — |
Summary of Available-for-Sale Securities | The following table summarizes the available-for-sale securities: Amortized Unrealized Unrealized Cost Gains Losses Fair Value (In thousands) June 30, 2024 Commercial paper $ 125,696 $ — $ ( 73 ) $ 125,623 Corporate bonds 40,037 — ( 68 ) 39,969 US Treasury 177,303 — ( 669 ) 176,634 Federal bonds 6,998 — ( 7 ) 6,991 $ 350,034 $ — $ ( 817 ) $ 349,217 December 31, 2023 Commercial paper $ 160,657 $ 149 $ — $ 160,806 Corporate bonds 47,150 62 — 47,212 US Treasury 68,111 46 — 68,157 Federal bonds 28,998 — ( 40 ) 28,958 $ 304,916 $ 257 $ ( 40 ) $ 305,133 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): June 30, 2024 December 31, 2023 Prepaid insurance $ 1,555 $ 807 Interest receivable on investments 1,300 1,227 Prepaid subscription 633 769 Prepaid state and local taxes 493 264 Prepaid rent 164 163 Other 62 63 Total prepaid expenses and other current assets $ 4,207 $ 3,293 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2024 December 31, 2023 Accrued clinical study and trial costs $ 17,516 $ 16,346 Accrued compensation and related costs 7,779 11,172 Accrued professional fees 1,294 1,450 Accrued milestone costs — 10,000 Other 220 888 Total accrued expenses and other current liabilities $ 26,809 $ 39,856 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Share Based Compensation Expense Related to Issuance of Stock Option Awards to Employees and Non Employees Related to Employee Stock Purchase Plan | The Company recognized stock-based compensation expense related to the issuance of stock option awards and restricted stock units to employees and non-employees and related to the Company’s 2015 Employee Stock Purchase Plan, or ESPP, in the condensed consolidated statements of comprehensive loss as follows: Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Research and development $ 4,318 $ 3,698 $ 8,461 $ 6,476 Selling, general and administrative 5,578 4,367 10,334 7,827 Total $ 9,896 $ 8,065 $ 18,795 $ 14,303 |
Summary in Compensation Expense by Type of Award | Compensation expense by type of award in the three and six months ended June 30, 2024 and 2023 was as follows: Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Stock options $ 7,801 $ 7,019 $ 14,985 $ 12,411 RSUs 1,999 978 3,616 1,760 ESPP 96 68 194 132 Total $ 9,896 $ 8,065 $ 18,795 $ 14,303 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Summary of Changes in Stockholders' Equity | The following table presents the changes in stockholders’ equity for the three and six months ended June 30, 2024: (In thousands, except share data) Common Stock Additional Accumulated Accumulated Total Shares Amount Balance as of December 31, 2023 84,826,632 $ 8 $ 1,456,370 $ 218 $ ( 902,400 ) $ 554,196 Stock purchase under ESPP 35,463 — — — — — Stock-based compensation expense — — 8,899 — — 8,899 Unrealized loss on investments — — — ( 974 ) — ( 974 ) Vesting of RSUs 3,750 — — — — — Employee withholdings ESPP — — 309 — — 309 Proceeds from exercise of stock options 113,841 — 1,859 — — 1,859 Net loss — — — — ( 72,400 ) ( 72,400 ) Balance as of March 31, 2024 84,979,686 $ 8 $ 1,467,437 $ ( 756 ) $ ( 974,800 ) $ 491,889 Stock-based compensation expense — — 9,896 — — 9,896 Unrealized loss on investments — — — ( 61 ) — ( 61 ) Vesting of RSUs 1,603 — — — — — Employee withholdings ESPP — — 237 — — 237 Proceeds from exercise of stock options 47,340 — 439 — — 439 Par value adjustment — 1 — — — 1 Net loss — — — — ( 68,063 ) ( 68,063 ) Balance as of June 30, 2024 85,028,629 $ 9 $ 1,478,009 $ ( 817 ) $ ( 1,042,863 ) $ 434,338 The following table presents the changes in stockholders’ equity for the three and six months ended June 30, 2023: (In thousands, except share data) Common Stock Additional Accumulated Accumulated Total Shares Amount Balance as of December 31, 2022 68,111,385 $ 7 $ 1,161,288 $ ( 806 ) $ ( 693,040 ) $ 467,449 Stock purchase under ESPP 16,537 — — — — — Stock-based compensation expense — — 6,238 — — 6,238 Unrealized gain on short-term investments — — — 470 — 470 Vesting of RSUs 5,000 — — — — — Employee withholdings ESPP — — 196 — — 196 Prefunded warrants, exercise 85,998 — — — — — Proceeds from exercise of stock options 276,506 — 2,278 — — 2,278 Net loss — — — — ( 41,126 ) ( 41,126 ) Balance as of March 31, 2023 68,495,426 $ 7 $ 1,170,000 $ ( 336 ) $ ( 734,166 ) $ 435,505 Stock-based compensation expense — — 8,065 — — 8,065 Unrealized loss on short-term investments — — — ( 238 ) — ( 238 ) Vesting of RSUs 1,602 — — — — — Employee withholdings ESPP — — 179 — — 179 Prefunded warrants, exercise 771,133 — ( 1 ) — — ( 1 ) Proceeds from exercise of stock options 163,037 — 1,146 — — 1,146 Net loss — — — — ( 44,615 ) ( 44,615 ) Balance as of June 30, 2023 69,431,198 $ 7 $ 1,179,389 $ ( 574 ) $ ( 778,781 ) $ 400,041 |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2024 Segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of operating segments | 1 |
State of incorporation | DE |
Significant Collaborative Res_2
Significant Collaborative Research and License Agreements - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2021 | Sep. 30, 2021 | Oct. 31, 2017 | Aug. 31, 2016 | Jul. 31, 2016 | Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2016 | Mar. 31, 2007 | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||||
Research and Development Expense | $ 48,655 | $ 34,764 | $ 105,147 | $ 68,819 | |||||||||
Milestone and license revenue | 3,500 | $ 0 | 3,500 | $ 0 | |||||||||
Incyte Agreement [Member] | |||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||||
Common stock shares purchased | 1,421,523 | ||||||||||||
Purchase price per share | $ 24.62 | ||||||||||||
Proceeds from issuance of common stock | $ 35,000 | ||||||||||||
Collaboration receivable | 2,000 | 2,000 | |||||||||||
Collaboration expense due to counterparty | 5,100 | 5,100 | |||||||||||
Incyte Agreement [Member] | Maximum [Member] | |||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||||
Potential milestone payments to be made | $ 220,000 | ||||||||||||
Commercialization milestones and tiered royalties | $ 230,000 | ||||||||||||
Incyte Agreement [Member] | Non-Refundable Cash Payments [Member] | |||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||||
Upfront milestone payable | $ 117,000 | ||||||||||||
Allergan License Agreement [Member] | Vitae Pharmaceuticals Inc [Member] | |||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||||
Potential milestone payments to be made | $ 99,000 | ||||||||||||
Aggregate Potential Milestone Payable | $ 70,000 | ||||||||||||
Milestone Expenses Paid | 8,000 | 8,000 | |||||||||||
Development and regulaotry milestones Expenses | $ 18,000 | 18,000 | |||||||||||
License Agreements Expiration Period | 10 years | ||||||||||||
Ucb License Agreement [Member] | U C B Biopharma [Member] | |||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||||
Research and Development Expense | $ 10,000 | $ 16,000 | $ 5,000 | ||||||||||
Potential milestone payments to be made | $ 119,500 | ||||||||||||
Aggregate Potential Milestone Payable | $ 250,000 | ||||||||||||
License Agreements Expiration Period | 10 years | ||||||||||||
Milestone Payment Due | $ 5,800 | ||||||||||||
License Agreement [Member] | Bayer Pharma Ag [Member] | Maximum [Member] | |||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||||
Aggregate payment obligation | $ 150,000 | ||||||||||||
License Agreement [Member] | Eddingpharm Investment [Member] | |||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||||
Milestone and license revenue | $ 3,500 | ||||||||||||
License Agreement [Member] | Eddingpharm Investment [Member] | Maximum [Member] | |||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||||
Milestone Payment Due | $ 10,000 | ||||||||||||
Global and U.S. [Member] | Incyte Agreement [Member] | |||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||||
Development costs associated with clinical trials | 45% | ||||||||||||
Global and U.S. [Member] | Incyte Agreement [Member] | Incyte Corporation [Member] | |||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||||
Development costs associated with clinical trials | 55% | ||||||||||||
Ex-U.S. Countries [Member] | Incyte Agreement [Member] | |||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||||
Development costs associated with clinical trials | 100% |
Net Loss per Share Attributab_3
Net Loss per Share Attributable to Common Stockholders - Computation of Basic and Diluted Net Loss per Share Attributable to Common Stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Numerator—basic and diluted: | ||||||
Net Income (Loss) | $ (68,063) | $ (72,400) | $ (44,615) | $ (41,126) | $ (140,463) | $ (85,741) |
Net loss attributable to common stockholders - basic | (68,063) | (44,615) | (140,463) | (85,741) | ||
Net loss attributable to common stockholders - diluted | $ (68,063) | $ (44,615) | $ (140,463) | $ (85,741) | ||
Net loss per share attributable to common stockholders—basic | $ (0.8) | $ (0.64) | $ (1.65) | $ (1.23) | ||
Net loss per share attributable to common stockholders— diluted | $ (0.8) | $ (0.64) | $ (1.65) | $ (1.23) | ||
Denominator—basic and diluted: | ||||||
Weighted-average number of common shares used to compute net loss per share attributable to common stockholders—basic | 85,274,829 | 69,638,427 | 85,244,015 | 69,539,209 | ||
Weighted-average number of common shares used to compute net loss per share attributable to common stockholders—diluted | 85,274,829 | 69,638,427 | 85,244,015 | 69,539,209 |
Net Loss per Share Attributab_4
Net Loss per Share Attributable to Common Stockholders - Potential Dilutive Securities Excluded from Computation of Diluted Net Loss per Common Share (Detail) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Employee Stock Option | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per common share | 12,226,274 | 10,429,475 |
Employee Stock Purchase Plan [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per common share | 29,426 | 15,331 |
Non-Vested Restricted Stock Units (RSUs) [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per common share | 1,486,146 | 526,736 |
Significant Agreements - Additi
Significant Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||
Oct. 31, 2017 | Jul. 31, 2016 | Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2016 | Mar. 31, 2007 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Research and development expense | $ 48,655 | $ 34,764 | $ 105,147 | $ 68,819 | ||||||
Allergan License Agreement Member | Vitae Pharmaceuticals Inc [Member] | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Potential milestone payments to be made | $ 99,000 | |||||||||
Aggregate potential milestone payable | $ 70,000 | |||||||||
License expiration year | 10 years | |||||||||
Milestone Expenses Paid | 8,000 | 8,000 | ||||||||
Development and regulaotry milestones Expenses | $ 18,000 | $ 18,000 | ||||||||
UCB License Agreement [Member] | UCB Biopharma [Member] | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Potential milestone payments to be made | $ 119,500 | |||||||||
Aggregate potential milestone payable | $ 250,000 | |||||||||
License expiration year | 10 years | |||||||||
Research and development expense | $ 10,000 | $ 16,000 | $ 5,000 | |||||||
Milestone payment payable | $ 5,800 | |||||||||
License Agreement [Member] | Bayer Pharma AG [Member] | Maximum [Member] | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Aggregate payment obligation | $ 150,000 |
Other Receivables (Additional I
Other Receivables (Additional Information) (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Other Receivables, Net, Current [Abstract] | |
Refundable fee payble | $ 6.1 |
Payment for fully-refundable fee | 6.1 |
Receivables Related to Achieved Milestones | $ 3.5 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Values of Financial Assets and Liabilities Measured at Fair Value (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 319,701 | $ 275,304 |
Long-term investments | 29,516 | 29,829 |
Carrying Value [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 105,396 | 295,394 |
Short-term investments | 319,701 | 275,304 |
Long-term investments | 29,516 | 29,829 |
Total assets | 454,613 | 600,527 |
Quoted Prices (Unadjusted) in Active Markets Level 1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 105,396 | 295,394 |
Total assets | 105,396 | 295,394 |
Significant Other Observable Inputs Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | 319,701 | 275,304 |
Long-term investments | 29,516 | 29,829 |
Total assets | $ 349,217 | $ 305,133 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Fair Value Measurements [Line Items] | ||||
Realized gains or losses recognized on the sale or maturity of available-for-sale securities | $ 0 | $ 0 | $ 0 | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 350,034 | $ 304,916 |
Unrealized Gains | 257 | |
Unrealized Losses | (817) | (40) |
Fair Value | 349,217 | 305,133 |
Commercial Paper [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 125,696 | 160,657 |
Unrealized Gains | 149 | |
Unrealized Losses | (73) | |
Fair Value | 125,623 | 160,806 |
Corporate Bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 40,037 | 47,150 |
Unrealized Gains | 62 | |
Unrealized Losses | (68) | |
Fair Value | 39,969 | 47,212 |
U.S. Treasury [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 177,303 | 68,111 |
Unrealized Gains | 46 | |
Unrealized Losses | (669) | |
Fair Value | 176,634 | 68,157 |
Federal Bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 6,998 | 28,998 |
Unrealized Losses | (7) | (40) |
Fair Value | $ 6,991 | $ 28,958 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid insurance | $ 1,555 | $ 807 |
Interest receivable on investments | 1,300 | 1,227 |
Prepaid subscriptions | 633 | 769 |
Prepaid state and local taxes | 493 | 264 |
Prepaid rent | 164 | 163 |
Other | 62 | 63 |
Total prepaid expenses and other current assets | $ 4,207 | $ 3,293 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accrued clinical study and trial costs | $ 17,516 | $ 16,346 |
Accrued compensation and related costs | 7,779 | 11,172 |
Accrued professional fees | 1,294 | 1,450 |
Accrued milestone costs | 0 | 10,000 |
Other | 220 | 888 |
Total accrued expenses and other current liabilities | $ 26,809 | $ 39,856 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jan. 01, 2024 | Dec. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share based compensation expense, total | $ 9,896 | $ 8,065 | $ 18,795 | $ 14,303 | ||
Proceeds from stock option exercises | 2,298 | 3,424 | ||||
Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share based compensation expense, total | $ 1,999 | $ 978 | $ 3,616 | $ 1,760 | ||
2015 Plan [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for issuance | 3,798,637 | 3,798,637 | 3,393,065 | |||
2015 and 2007 [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation expense related to stock option and RSUs | $ 101,300 | $ 101,300 | ||||
Weighted average period to recognize compensation expense | 2 years 9 months 18 days | |||||
2023 Inducement Plan [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for issuance | 323,150 | 323,150 | ||||
Common stock reserved for issuance | 1,100,000 |
Stock-Based Compensation - Shar
Stock-Based Compensation - Share Based Compensation Expense Related to Issuance of Stock Option Awards to Employees and Non Employees Related to Employee Stock Purchase Plan (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation expense, total | $ 9,896 | $ 8,065 | $ 18,795 | $ 14,303 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation expense, total | 4,318 | 3,698 | 8,461 | 6,476 |
Selling, General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation expense, total | $ 5,578 | $ 4,367 | $ 10,334 | $ 7,827 |
Stock-Based Compensation - Comp
Stock-Based Compensation - Compensation Expense by Type of Award (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation expense, total | $ 9,896 | $ 8,065 | $ 18,795 | $ 14,303 |
Stock options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation expense, total | 7,801 | 7,019 | 14,985 | 12,411 |
Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation expense, total | 1,999 | 978 | 3,616 | 1,760 |
Employee Stock Purchase Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation expense, total | $ 96 | $ 68 | $ 194 | $ 132 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Changes in Stockholders' Equity (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Class of Stock [Line Items] | ||||||
Beginning balance | $ 491,889 | $ 554,196 | $ 435,505 | $ 467,449 | $ 554,196 | $ 467,449 |
Stock-based compensation expense | 9,896 | 8,899 | 8,065 | 6,238 | ||
Unrealized loss on investments | (61) | (974) | $ (238) | 470 | (817) | 232 |
Prefunded warrants, exercise, shares | (1) | |||||
Employee withholdings ESPP | 237 | 309 | $ 179 | 196 | ||
Proceeds from exercise of stock options | 439 | 1,859 | 1,146 | 2,278 | ||
Par value adjustment | 1 | |||||
Net Income (Loss) | (68,063) | (72,400) | (44,615) | (41,126) | (140,463) | (85,741) |
Ending balance | 434,338 | 491,889 | 400,041 | 435,505 | 434,338 | 400,041 |
Common Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Beginning balance | $ 8 | $ 8 | $ 7 | $ 7 | $ 8 | $ 7 |
Beginning balance, shares | 84,979,686 | 84,826,632 | 68,495,426 | 68,111,385 | 84,826,632 | 68,111,385 |
Stock purchase under ESPP, shares | 35,463 | 16,537 | ||||
Vesting of RSUs, shares | 1,603 | 3,750 | 1,602 | 5,000 | ||
Prefunded warrants, exercise, shares | 771,133 | 85,998 | ||||
Proceeds from exercise of stock options, shares | 47,340 | 113,841 | 163,037 | 276,506 | ||
Par value adjustment | $ 1 | |||||
Ending balance | $ 9 | $ 8 | $ 7 | $ 7 | $ 9 | $ 7 |
Ending balance, shares | 85,028,629 | 84,979,686 | 69,431,198 | 68,495,426 | 85,028,629 | 69,431,198 |
Additional Paid-In Capital [Member] | ||||||
Class of Stock [Line Items] | ||||||
Beginning balance | $ 1,467,437 | $ 1,456,370 | $ 1,170,000 | $ 1,161,288 | $ 1,456,370 | $ 1,161,288 |
Stock-based compensation expense | 9,896 | 8,899 | $ 8,065 | 6,238 | ||
Prefunded warrants, exercise, shares | (1) | |||||
Employee withholdings ESPP | 237 | 309 | $ 179 | 196 | ||
Proceeds from exercise of stock options | 439 | 1,859 | 1,146 | 2,278 | ||
Ending balance | 1,478,009 | 1,467,437 | 1,179,389 | 1,170,000 | 1,478,009 | 1,179,389 |
Accumulated Other Comprehensive(Loss) / Income [Member] | ||||||
Class of Stock [Line Items] | ||||||
Beginning balance | (756) | 218 | (336) | (806) | 218 | (806) |
Unrealized loss on investments | (61) | (974) | (238) | 470 | ||
Ending balance | (817) | (756) | (574) | (336) | (817) | (574) |
Accumulated Deficit [Member] | ||||||
Class of Stock [Line Items] | ||||||
Beginning balance | (974,800) | (902,400) | (734,166) | (693,040) | (902,400) | (693,040) |
Net Income (Loss) | (68,063) | (72,400) | (44,615) | (41,126) | ||
Ending balance | $ (1,042,863) | $ (974,800) | $ (778,781) | $ (734,166) | $ (1,042,863) | $ (778,781) |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | ||
May 31, 2023 | Jun. 30, 2024 | Dec. 31, 2021 | |
Pre Funded Warrants [Member] | |||
Class Of Stock [Line Items] | |||
Warrants issued (in shares) | 1,142,856 | ||
Number of pre funded warrants exercised for common stock | 285,714 | ||
Cowen and Company LLC [Member] | At The Market Equity Offering Sales Agreement [Member] | |||
Class Of Stock [Line Items] | |||
Proceeds from issuance of common stock | $ 200 |
Commitments and Contingencies (
Commitments and Contingencies (Additional Information) (Details) $ in Thousands | Jun. 30, 2024 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Contingent liabilities | $ 0 |