Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 22, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | COGENT BIOSCIENCES, INC. | ||
Entity Central Index Key | 0001622229 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 103,913,396 | ||
Entity Public Float | $ 968.2 | ||
Entity Shell Company | false | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity File Number | 001-38443 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 46-5308248 | ||
Entity Address, Address Line One | 275 Wyman Street | ||
Entity Address, Address Line Two | 3rd Floor | ||
Entity Address, City or Town | Waltham | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02451 | ||
City Area Code | (617) | ||
Local Phone Number | 945-5576 | ||
Title of 12(b) Security | Common Stock, $0.001 Par Value | ||
Trading Symbol | COGT | ||
Security Exchange Name | NASDAQ | ||
ICFR Auditor Attestation Flag | true | ||
Document Financial Statement Error Correction [Flag] | false | ||
Auditor Name | PricewaterhouseCoopers LLP | ||
Auditor Location | Boston, Massachusetts | ||
Auditor Firm ID | 238 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 53,229 | $ 139,886 |
Short-term marketable securities | 212,481 | 119,390 |
Prepaid expenses and other current assets | 5,061 | 4,435 |
Restricted cash | 0 | 1,255 |
Total current assets | 270,771 | 264,966 |
Long-term marketable securities | 7,460 | 0 |
Operating lease, right-of-use assets | 21,998 | 23,316 |
Property and equipment, net | 8,344 | 7,783 |
Other assets | 4,864 | 4,745 |
Total assets | 313,437 | 300,810 |
Current liabilities: | ||
Accounts payable | 10,655 | 5,842 |
Accrued expenses and other current liabilities | 26,127 | 17,884 |
CVR liability (Note 3) | 0 | 1,700 |
Operating lease liabilities | 1,386 | 1,423 |
Total current liabilities | 38,168 | 26,849 |
Operating lease liabilities, net of current portion | 17,467 | 18,226 |
Total liabilities | 55,635 | 45,075 |
Commitments and contingencies (Note 9) | ||
Stockholders’ equity: | ||
Preferred stock, value | ||
Common stock, $0.001 par value; 150,000,000 shares authorized; 86,124,249 shares and 69,893,434 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 86 | 70 |
Additional paid-in capital | 801,059 | 601,153 |
Accumulated other comprehensive income (loss) | 246 | (104) |
Accumulated deficit | (603,624) | (411,214) |
Total stockholders’ equity | 257,802 | 255,735 |
Total liabilities and stockholders’ equity | 313,437 | 300,810 |
Series A Convertible Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock, value | $ 60,035 | $ 65,830 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Preferred stock, par value | $ 0.001 | |
Preferred stock, shares authorized | 10,000,000 | |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, Par value | $ 0.001 | $ 0.001 |
Common stock, Shares authorized | 150,000,000 | 150,000,000 |
Common stock, Shares issued | 86,124,249 | 69,893,434 |
Common stock, Shares outstanding | 86,124,249 | 69,893,434 |
Series A Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 1,000,000 | 1,000,000 |
Preferred stock, shares issued | 74,465 | 81,050 |
Preferred stock, shares outstanding | 74,465 | 81,050 |
Undesignated Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 9,000,000 | 9,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | |||
Research and development | $ 173,755 | $ 121,627 | $ 55,913 |
General and administrative | 34,375 | 26,212 | 19,638 |
Total operating expenses | 208,130 | 147,839 | 75,551 |
Loss from operations | (208,130) | (147,839) | (75,551) |
Other income: | |||
Interest income | 13,077 | 3,989 | 467 |
Other income, net | 943 | 2,249 | 2,468 |
Change in fair value of CVR liability | 1,700 | 1,360 | 343 |
Total other income, net | 15,720 | 7,598 | 3,278 |
Net loss | $ (192,410) | $ (140,241) | $ (72,273) |
Net loss per share attributable to common stockholders, basic | $ (2.42) | $ (2.39) | $ (1.87) |
Net loss per share attributable to common stockholders, diluted | $ (2.42) | $ (2.39) | $ (1.87) |
Weighted average common shares outstanding, basic | 79,657,942 | 58,739,713 | 38,730,813 |
Weighted average common shares outstanding, diluted | 79,657,942 | 58,739,713 | 38,730,813 |
Comprehensive loss: | |||
Net loss | $ (192,410) | $ (140,241) | $ (72,273) |
Other comprehensive loss | |||
Net unrealized gains (losses) on marketable securities | 350 | (104) | 0 |
Total other comprehensive loss | 350 | (104) | 0 |
Comprehensive loss | $ (192,060) | $ (140,345) | $ (72,273) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Underwritten Public Offering [Member] | ATM [Member] | Preferred Stock [Member] | Preferred Stock [Member] Series A Non-Voting Convertible Preferred Stock [Member] | Common Stock [Member] | Common Stock [Member] Underwritten Public Offering [Member] | Common Stock [Member] ATM [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] Underwritten Public Offering [Member] | Additional Paid-in Capital [Member] ATM [Member] | Accumulated Other Comprehensive (Income) Loss [Member] | Accumulated Deficit [Member] |
Beginning Balances at Dec. 31, 2020 | $ 234,667 | $ 110,881 | $ 32 | $ 322,454 | $ (198,700) | ||||||||
Beginning Balances, Shares at Dec. 31, 2020 | 132,244 | 32,347,905 | |||||||||||
Conversion of preferred stock into common stock | $ (25,481) | $ 8 | 25,473 | ||||||||||
Conversion of preferred stock into common stock, Shares | (28,955) | 7,238,750 | |||||||||||
Issuance of common stock for services | 260 | 260 | |||||||||||
Issuance of common stock for services, Shares | 31,683 | ||||||||||||
Issuance of common stock upon exercise of stock options | 24 | 24 | |||||||||||
Issuance of common stock upon exercise of stock options, Shares | 15,758 | ||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | 31 | 31 | |||||||||||
Issuance of common stock under Employee Stock Purchase Plan, shares | 4,497 | ||||||||||||
Issuance of common stock, net of issuance costs | $ 38,006 | $ 4 | $ 38,002 | ||||||||||
Issuance of common stock, net of issuance costs, Shares | 3,954,900 | ||||||||||||
Issuance of common stock to settle CVR liability | 2,043 | 2,043 | |||||||||||
Issuance of common stock to settle CVR liability, Shares | 212,429 | ||||||||||||
Stock-based compensation expense | 11,426 | 11,426 | |||||||||||
Net loss | (72,273) | (72,273) | |||||||||||
Ending Balances at Dec. 31, 2021 | 214,184 | $ 85,400 | $ 44 | 399,713 | (270,973) | ||||||||
Ending Balances, Shares at Dec. 31, 2021 | 103,289 | 43,805,922 | |||||||||||
Conversion of preferred stock into common stock | $ (19,570) | $ 6 | 19,564 | ||||||||||
Conversion of preferred stock into common stock, Shares | (22,239) | 5,559,750 | |||||||||||
Issuance of common stock upon exercise of stock options | 1,238 | 1,238 | |||||||||||
Issuance of common stock upon exercise of stock options, Shares | 154,822 | ||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | 351 | 351 | |||||||||||
Issuance of common stock under Employee Stock Purchase Plan, shares | 49,000 | ||||||||||||
Issuance of common stock, net of issuance costs | $ 161,915 | $ 18 | $ 161,897 | ||||||||||
Issuance of common stock, net of issuance costs, Shares | 17,899,698 | ||||||||||||
Pre-funded warrant exercise | 24 | $ 2 | 22 | ||||||||||
Pre-funded warrant exercise, shares | 2,424,242 | ||||||||||||
Unrealized gains (losses) on marketable securities | (104) | $ (104) | |||||||||||
Stock-based compensation expense | 18,368 | 18,368 | |||||||||||
Net loss | (140,241) | (140,241) | |||||||||||
Ending Balances at Dec. 31, 2022 | 255,735 | $ 65,830 | $ 70 | 601,153 | (104) | (411,214) | |||||||
Ending Balances, Shares at Dec. 31, 2022 | 81,050 | 69,893,434 | |||||||||||
Conversion of preferred stock into common stock | $ (5,795) | $ 2 | 5,793 | ||||||||||
Conversion of preferred stock into common stock, Shares | (6,585) | 1,646,250 | |||||||||||
Issuance of common stock upon exercise of stock options | 965 | 965 | |||||||||||
Issuance of common stock upon exercise of stock options, Shares | 123,687 | ||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | 752 | 752 | |||||||||||
Issuance of common stock under Employee Stock Purchase Plan, shares | 85,878 | ||||||||||||
Issuance of common stock, net of issuance costs | $ 161,789 | $ 14 | $ 161,775 | ||||||||||
Issuance of common stock, net of issuance costs, Shares | 14,375,000 | ||||||||||||
Unrealized gains (losses) on marketable securities | 350 | 350 | |||||||||||
Stock-based compensation expense | 30,621 | 30,621 | |||||||||||
Net loss | (192,410) | (192,410) | |||||||||||
Ending Balances at Dec. 31, 2023 | $ 257,802 | $ 60,035 | $ 86 | $ 801,059 | $ 246 | $ (603,624) | |||||||
Ending Balances, Shares at Dec. 31, 2023 | 74,465 | 86,124,249 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Underwritten Public Offering [Member] | ||
Issuance cost | $ 10.7 | $ 10.8 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | |||
Net loss | $ (192,410) | $ (140,241) | $ (72,273) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization expense | 2,270 | 842 | 147 |
Stock-based compensation expense | 30,621 | 18,368 | 11,686 |
Amortization of right-of-use operating lease assets | 1,318 | 5,036 | 1,844 |
Change in fair value of CVR liability | (1,700) | (1,360) | (343) |
Net amortization (accretion) of premiums (discounts) on marketable securities | (5,173) | (1,638) | 0 |
Loss on disposal of property and equipment | 8 | 0 | 0 |
Right-of-use asset impairment | 0 | (396) | 0 |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | (626) | (1,486) | (227) |
Other assets | (119) | (1,018) | (3,727) |
Accounts payable | 4,813 | 2,359 | 2,751 |
Accrued expenses and other current liabilities | 8,170 | 9,586 | 3,431 |
Operating lease liability | (796) | (8,690) | (2,052) |
Net cash used in operating activities | (153,624) | (118,638) | (58,763) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (2,796) | (6,863) | (1,719) |
Purchases of marketable securities | (348,803) | (177,855) | 0 |
Maturities and sales of marketable securities | 253,775 | 60,000 | 0 |
Net cash used in investing activities | (97,824) | (124,718) | (1,719) |
Cash flows from financing activities: | |||
Proceeds from issuance of shares of common stock, net of offering costs of $10.7 million | 161,819 | 0 | 0 |
Proceeds from issuance of shares of common stock and pre-funded warrants, net of offering costs of $10.8 million | 0 | 161,945 | 0 |
Proceeds from issuance of common stock under ATM, net of issuance costs of $1.2 million | 0 | 0 | 38,006 |
Proceeds from issuance of common stock upon stock option exercises | 965 | 1,238 | 24 |
Proceeds from pre-funded warrant exercises | 0 | 24 | 0 |
Proceeds from issuance of stock from employee stock purchase plan | 752 | 351 | 31 |
Payments to CVR Holders | 0 | 0 | (85) |
Net cash provided by financing activities | 163,536 | 163,558 | 37,976 |
Net decrease in cash, cash equivalents and restricted cash | (87,912) | (79,798) | (22,506) |
Cash, cash equivalents and restricted cash at beginning of period | 141,141 | 220,939 | 243,445 |
Cash, cash equivalents and restricted cash at end of period | 53,229 | 141,141 | 220,939 |
Supplemental disclosure of cash flow information: | |||
Right-of-use assets obtained in exchange for new operating lease liabilities | 0 | 25,184 | 0 |
Supplemental disclosure of noncash investing and financing information: | |||
Conversion of Series A non-voting convertible preferred stock into common stock | 5,795 | 19,570 | 25,481 |
Offering costs included in accounts payable and accrued expenses | 30 | 30 | 0 |
Property & equipment included in accounts payable and accrued expenses | 43 | 58 | 0 |
Issuance of common shares in partial settlement of CVR liability | $ 0 | $ 0 | $ 2,043 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
ATM [Member] | |||
Offering/Issuance costs | $ 1.2 | ||
Common Stock Underwritten Public Offering [Member] | |||
Offering/Issuance costs | $ 10.7 | $ 10.8 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pay vs Performance Disclosure | |||
Net Income (Loss) | $ (192,410) | $ (140,241) | $ (72,273) |
Insider Trading Arrangements
Insider Trading Arrangements | 12 Months Ended |
Dec. 31, 2023 | |
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 the Business and Basi
Nature of the Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business and Basis of Presentation | 1. Nature of the Business and Basis of Presentation Cogent Biosciences, Inc. (“Cogent” or the “Company”) is a biotechnology company focused on developing precision therapies for genetically defined diseases. Cogent’s approach is to design rational precision therapies that treat the underlying cause of disease and improve the lives of patients. Cogent’s most advanced program is bezuclastinib, also known as CGT9486, a highly selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. In the vast majority of cases, KIT D816V is responsible for driving Systemic Mastocytosis (“SM”), a serious and rare disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (“GIST”), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib is a highly selective and potent KIT inhibitor with the potential to provide a new treatment option for these patient populations. In addition to bezuclastinib, the Company's research team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting mutations in FGFR2, ErbB2 and PI3Kα (genes/pathways). The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales. The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has incurred recurring losses since inception, including a net loss of $ 192.4 million for the year ended December 31, 2023. As of December 31, 2023, the Company had an accumulated deficit of $ 603.6 million. The Company expects to continue to generate operating losses in the foreseeable future. As of the issuance date of the consolidated financial statements, the Company expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months from issuance of the consolidated financial statements. The Company expects that it will continue to incur significant expenses in connection with its ongoing business activities. The Company will need to seek additional funding through equity offerings, debt financings, collaborations, licensing arrangements or other marketing and distribution arrangements, partnerships, joint ventures, combinations or divestitures of one or more of its assets or businesses. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into collaborative arrangements or divest its assets. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. Arrangements with collaborators or others may require the Company to relinquish rights to certain of its technologies or product candidates. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate its research and development programs or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Mono, Inc. and Kiq Bio LLC. All intercompany accounts and transactions have been eliminated. Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual of research and development expenses, the valuation of the CVR liability and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates, as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions. Concentrations of Credit Risk and of Significant Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company maintains most of its cash and cash equivalents at two accredited financial institutions. The Company has not experienced any losses on such accounts and does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Such deposits have and will continue to exceed federally insured limits. The Company is dependent on third-party vendors for its product candidates. In particular, the Company relies, and expects to continue to rely, on a small number of vendors to manufacture supplies and process its product candidates for its development programs. These programs could be adversely affected by a significant interruption in the manufacturing process. Cash Equivalents The Company considers all highly liquid investments with original maturities of generally three months or less at the date of purchase to be cash equivalents. Restricted Cash Restricted cash consists of security deposits in separate restricted bank accounts as required under the terms of the Company’s lease agreement for its former corporate headquarters in Cambridge, Massachusetts, which expired in April 2023 . Marketable Securities The Company’s marketable securities, consisting of debt securities, are classified as available-for-sale. Available-for-sale marketable debt securities are carried at fair value with the unrealized gains and losses included in other comprehensive income (loss) as a component of stockholders’ equity until realized. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other income (expense). The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. If the decline in fair value is due to credit-related factors, a loss is recognized in net income, and if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss). Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Estimated Useful Life Laboratory equipment 5 years Computer equipment and software 3 years Furniture and fixtures 5 years Leasehold improvements Shorter of life of lease or 10 years Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated in accordance with the above guidelines once placed into service. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred. Impairment of Long-Lived Assets Long-lived assets consist of property and equipment and operating lease right-of-use assets. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in loss from operations when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. 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 must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy described above (see Note 3). The carrying values of the Company’s accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities. Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is the development and commercialization of precision therapies for genetically defined diseases. All of the Company’s tangible assets are held in the United States. Leases The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the assets’ economic benefits. The Company determines the initial classification and measurement of its operating right-of-use assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The Company’s policy is to not record leases with an original term of twelve months or less on its consolidated balance sheets. The Company’s only existing leases are for office and laboratory space. The right-of-use asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Lease payments included in the measurement of the lease liability consist of the following: the fixed noncancelable lease payments, payments for optional renewal periods where it is reasonably certain the renewal period will be exercised, and payments for early termination options unless it is reasonably certain the lease will not be terminated early. Leases may contain rent escalation clauses and variable lease payments that require additional rental payments in later years of the term, including payments based on an index or inflation rate. Payments based on the change in an index or inflation rate, or payments based on a change in the Company’s portion of the operating expenses, including real estate taxes and insurance, are not included in the initial lease liability and are recorded as a period expense when incurred. The operating leases may include an option to renew the lease term for various renewal periods and/or to terminate the leases early. These options to exercise the renewal or early termination clauses in the Company’s operating leases were not reasonably certain of exercise as of the date of adoption and these have not been included in the determination of the initial lease liability or operating lease expense. Rent expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the consolidated statements of operations and comprehensive loss. For finance leases, any interest expense is recognized using the effective interest method and is included within interest expense. The Company has no financing leases. Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries, stock-based compensation and benefits, facilities costs and laboratory supplies, depreciation, manufacturing expenses and external costs of outside vendors engaged to conduct preclinical development activities and clinical trials as well as the cost of licensing technology. The Company has entered into various research and development contracts with companies both inside and outside of the United States. These agreements are generally cancelable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing external research and development costs. When billing terms under these contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of outstanding liabilities to those third parties as of the end of the reporting period. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or trials, including the phase or completion of events, communication from the contract research organizations or other companies of any actual costs incurred during the period that have not yet been invoiced, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. Upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed. Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. Stock-Based Compensation The Company measures stock options and other stock-based awards granted to employees, non-employees and directors based on their fair value on the date of the grant and recognizes compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award. The Company applies the straight-line method of expense recognition to all awards with only service-based vesting conditions and applies the graded-vesting method to all awards with performance-based vesting conditions or to awards with both service-based and performance-based vesting conditions. The Company estimates the fair value of stock-based awards to employees and non-employees using the Black-Scholes option-pricing model, which requires the input of highly subjective assumptions, including (a) the expected volatility of its stock, (b) the expected term of the award, (c) the risk-free interest rate, and (d) expected dividends. Due to the lack of a sufficient history of public trading of the Company’s common stock and a lack of sufficient company-specific historical and implied volatility data, the Company has based the estimate of expected volatility on the historical volatility of a group of companies in the pharmaceutical and biotechnology industries in a similar stage of development and that are publicly traded. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. The Company estimates the expected life of employee stock options using the "simplified" method, whereby, the expected life equals the average of the vesting term and the original contractual term of the option. The risk-free interest rates for periods within the expected life of the option are based on the U.S. Treasury yield curve in effect during the period the options were granted. The expected dividend yield of zero is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The Company accounts for forfeitures as they occur. The Company measures the fair value of stock-based awards with market-based vesting conditions on the date of grant using a Monte Carlo simulation mode l. For performance-based stock options, the Company begins to recognize expense when it determines that the achievement of such performance conditions is deemed probable. This determination requires significant judgment by management. At the date achievement becomes probable, the Company records a cumulative expense catch-up, with remaining expense amortized over the remaining service period. For awards with market conditions, the stock-based compensation expense will be recognized over the derived service period regardless of whether the award achieves the market condition and will only be adjusted to the extent the service condition is not met . Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. For the years ended December 31, 2023 and 2022 , the Company’s only element of other comprehensive loss was unrealized gains (losses) on marketable securities. Net Income (Loss) per Share Basic net income (loss) per common share attributable to common stockholders is computed by dividing the net income (loss) attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share attributable to common stockholders is computed by dividing net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock options. Accordingly, in periods in which the Company reported a net loss, dilutive common shares were not assumed to have been issued as their affect was anti-dilutive, and as a result, diluted net loss per common share was the same as basic net loss per common share. Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU 2020-06 Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) related to the measurement and disclosure requirements for convertible instruments and contracts in an entity’s own equity. The pronouncement simplifies and adds disclosure requirements for the accounting and measurement of convertible instruments and the settlement assessment for contracts in an entity’s own equity. The Company adopted ASU 2020-06 on January 1, 2022 . The adoption of this guidance did no t have a material impact on the Company’s consolidated financial statements. Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07 Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures related to reportable segment disclosure requirements. The pronouncement improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses, and requires disclosure of incremental segment information on an annual and interim basis. The pronouncement is effective for annual periods beginning after December 15, 2023. The Company is evaluating the impact of the ASU on its financial statements. In December 2023, the FASB issued ASU 2023-09 Income Taxes (Topic 740): Improvements to Income Tax Disclosures related to income tax disclosure requirements. The pronouncement enhances the transparency and decision usefulness of income tax disclosures. The pronouncement is effective for annual periods beginning after December 15, 2024. The Company is evaluating the impact of the ASU on its financial statements. |
Marketable Securities and Fair
Marketable Securities and Fair Value of Financial Assets and Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Marketable Securities and Fair Value of Financial Assets and Liabilities | 3. Marketable Securities and Fair Value of Financial Assets and Liabilities The following table summarizes the Company’s marketable securities (in thousands) : December 31, 2023 Amortized Gross Gross Fair U.S. Treasury bills and notes (due within one year) $ 212,274 $ 213 $ ( 6 ) $ 212,481 U.S. Treasury bills and notes (due after one through five year) $ 7,421 $ 39 $ — $ 7,460 $ 219,695 $ 252 $ ( 6 ) $ 219,941 December 31, 2022 Amortized Gross Gross Fair U.S. Treasury bills and notes (due within one year) $ 119,494 $ — $ ( 104 ) $ 119,390 $ 119,494 $ — $ ( 104 ) $ 119,390 As of December 31, 2023, the Company held 9 securities that were in an unrealized loss position. The aggregate fair value of securities held by the Company in an unrealized loss position for less than twelve months as of December 31, 2023 was $ 34.7 million and there were no securities held by the Company in an unrealized loss position for more than twelve months. As of December 31, 2022, the Company held seven securities that were in an unrealized loss position. The aggregate fair value of securities held by the Company in an unrealized loss position for less than twelve months as of December 31, 2022 was $ 99.5 million and there were no securities held by the Company in an unrealized loss position for more than twelve months. The Company has the intent and ability to hold such securities until recovery. As a result, the Company did no t record any charges for impairments for its marketable debt securities for the years ended December 31, 2023, 2022 or 2021. The following tables present the Company’s fair value hierarchy for its financial assets and liabilities, which are measured at fair value on a recurring basis (in thousands) : Fair Value Measurements at December 31, 2023 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 46,184 $ — $ — $ 46,184 Marketable securities: U.S. Treasury bills and notes $ — $ 219,941 $ — $ 219,941 Total Assets $ 46,184 $ 219,941 $ — $ 266,125 Fair Value Measurements at December 31, 2022 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 108,829 $ — $ — $ 108,829 Marketable securities: U.S. Treasury bills and notes $ — $ 119,390 $ — $ 119,390 Total Assets $ 108,829 $ 119,390 $ — $ 228,219 Liabilities: CVR Liability $ — $ — $ 1,700 $ 1,700 Total Liabilities $ — $ — $ 1,700 $ 1,700 Money market funds were valued using quoted prices in active markets, which represent a Level 1 measurement in the fair value hierarchy. U.S. Treasury bills and notes were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy. On July 6, 2020, the Company issued a non-transferrable contingent value right (“CVR”), which was distributed to stockholders of record as of the close of business on July 6, 2020, and prior to the issuance of any shares to acquire Kiq Bio LLC (“Kiq”) (the “Kiq Acquisition”) or sold to the Private Investment in Public Equity (“PIPE”) investors. In November 2020, the Company issued 707,938 shares of common stock in partial settlement of the CVR liability. In February 2021, the Company issued an additional 212,429 shares of common stock and paid $ 0.1 million in partial settlement of the CVR liability. In the fourth quarter of 2022, the Company updated the probability weighted discounted cash flow assumptions to reflect the then current probability of receiving the milestone payments from Sotio prior to the expiration of the CVR and the Company recorded a decrease in the CVR liability of $ 1.4 million as a component of other income (expense). The Company recorded an additional decrease in fair value of the liability of $ 1.7 million in the first quarter of 2023, reducing the liability to zero as the probability of additional CVR payments occurring prior to the expiration of CVR term was remote. The CVRs expired on August 6, 2023 and no further payments will be made to CVR holders. The following table sets forth a summary of the changes in the fair value of the Company’s CVR liability (in thousands) : Balance at December 31, 2020 $ 5,531 Change in fair value ( 343 ) CVR settlement ( 2,128 ) Balance at December 31, 2021 3,060 Change in fair value ( 1,360 ) Balance at December 31, 2022 1,700 Change in fair val ue ( 1,700 ) Balance at December 31, 2023 $ — During the years ended December 31, 2023, 2022, and 2021 , there were no transfers between Level 1, Level 2 and Level 3. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 4. Property and Equipment, Net Property and equipment, net consisted of the following (in thousands) : December 31, 2023 2022 Laboratory equipment $ 7,635 $ 5,507 Computer equipment and software 745 546 Furniture and fixtures 1,164 873 Leasehold improvements 2,438 1,776 Construction-in-progress 27 482 Total property and equipment 12,009 9,184 Accumulated depreciation and amortization ( 3,665 ) ( 1,401 ) Property and equipment, net $ 8,344 $ 7,783 Depreciation and amortization expense was $ 2.3 million, $ 0.8 million and $ 0.1 million for the years ended December 31, 2023, 2022 and 2021 , respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 5. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands) : December 31, 2023 2022 Accrued employee compensation and benefits $ 9,874 $ 6,063 Accrued external research and development expense 10,252 5,898 Accrued external manufacturing costs 3,302 3,741 Accrued professional and consulting services 2,258 1,778 Other 441 404 $ 26,127 $ 17,884 |
Preferred Stock, Series A Non-V
Preferred Stock, Series A Non-Voting Convertible Preferred Stock and Common Stock | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Preferred Stock, Series A Non-Voting Convertible Preferred Stock and Common Stock | 6. Preferred Stock, Series A Non-Voting Convertible Preferred Stock and Common Stock The Company’s authorized capital stock consists of 150,000,000 shares of common stock, par value $ 0.001 per share, and 10,000,000 shares of preferred stock, par value $ 0.001 per share, 1,000,000 of which are designated as Series A Preferred Stock and 9,000,000 of which shares of preferred stock are undesignated. Series A Non-Voting Convertible Preferred Stock On July 6, 2020, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series A Non-Voting Convertible Preferred Stock (“Series A Preferred Stock”) with the Secretary of State of the State of Delaware (the “Certificate of Designation”) in connection with the Kiq Acquisition and the PIPE. The Certificate of Designation provides for the issuance of shares of Series A Preferred Stock, par value $ 0.001 per share. Holders of Series A Preferred Stock are entitled to receive dividends on shares of Series A Preferred Stock equal, on an as-if-converted-to-common-stock basis, and in the same form as dividends actually paid on shares of the common stock. Except as otherwise required by law, the Series A Preferred Stock does not have voting rights. However, as long as any shares of Series A Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series A Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock, (b) alter or amend the Certificate of Designation, (c) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series A Preferred Stock, (d) increase the number of authorized shares of Series A Preferred Stock, (e) prior to the stockholder approval of the Conversion Proposal or at any time while at least 40 % of the originally issued Series A Preferred Stock remains issued and outstanding, consummate a Fundamental Transaction (as defined in the Certificate of Designation) or (f) enter into any agreement with respect to any of the foregoing. The Series A Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company. Each share of Series A Preferred Stock is convertible at any time at the option of the holder thereof, into 250 shares of common stock, subject to certain limitations, including that a holder of Series A Preferred Stock is prohibited from converting shares of Series A Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 4.9 % and 19.9 %) of the total number of shares of common stock issued and outstanding immediately after giving effect to such conversion. Cumulatively, through December 31, 2023, 88,860 shares of Series A Preferred Stock, or 54.4 % of the issued Series A Preferred Stock, have been converted into 22,215,000 shares of common stock. The 74,465 shares of Series A Preferred Stock outstanding as of December 31, 2023 are convertible into 18,616,250 shares of common stock. No other classes of preferred stock have been designated and no other preferred shares have been issued or are outstanding as of December 31, 2023 or 2022. Common Stock Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are not entitled to receive dividends, unless declared by the board of directors. In the event of the Company’s liquidation, dissolution or winding up, holders of the Company’s common stock will be entitled to share ratably in all assets remaining after payment of all debts and other liabilities and any liquidation preference of any outstanding preferred stock. The shares to be issued by us in this offering will be, when issued and paid for, validly issued, fully paid and non-assessable. On February 8, 2021, the Company filed a shelf registration statement on Form S-3 with the SEC. The shelf registration statement allows the Company to sell from time-to-time up to $ 200.0 million of common stock, preferred stock, debt securities, warrants or units comprised of any combination of these securities, for its own account in one or more offerings. The terms of any offering under the shelf registration statement will be established at the time of such offering and will be described in a prospectus supplement filed with the SEC prior to the completion of any such offering. Additionally, on February 8, 2021, pursuant to the Form S-3, the Company entered into a Sales Agreement (the “SVB Sales Agreement”) with SVB Leerink LLC (“SVB Leerink”), pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $ 75.0 million through SVB Leerink as the sales agent. Cumulatively, the Company sold 3,954,900 shares of common stock under the SVB Sales Agreement with offering prices ranging between $ 9.25 and $ 10.30 per share for net proceeds of approximately $ 38.0 million. The Company terminated the existing SVB Sales Agreement, effective as of May 5, 2022. The Company did no t incur any termination penalties as a result of the termination of the SVB Sales Agreement. On May 6, 2022, pursuant to the Form S-3, the Company entered into a Sales Agreement (the “Guggenheim Sales Agreement”) with Guggenheim Securities, LLC (“Guggenheim Securities”), pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $ 75.0 million through Guggenheim Securities, as the sales agent. As of December 31, 2023 , no shares have been sold under the Guggenheim Sales Agreement. On June 13, 2022, the Company completed an underwritten public offering of 17,899,698 shares of its common stock at a public offering price of $ 8.25 per share (including the exercise in full by the underwriters of their 30 -day option to purchase up to 2,730,000 additional shares of common stock) and, in lieu of common stock to certain investors, pre-funded warrants to purchase 3,030,302 shares of its common stock at a purchase price of $ 8.24 per underlying share. The net proceeds from the offering were approximately $ 161.9 million, after deducting the underwriting discounts and commissions of $ 10.4 million and offering expenses of $ 0.4 million. Each pre-funded warrant entitles the holder to purchase shares of common stock at an exercise price of $ 0.01 per share and is exercisable at any time beginning on the date of issuance. These warrants were recorded as a component of stockholders’ equity within additional paid-in capital. Per the terms of the warrant agreement, a holder of the outstanding warrant is not entitled to exercise any portion of the pre-funded warrant if, upon giving effect to such exercise, would cause the aggregate number of shares of common stock beneficially owned by such holder (together with its affiliates and any other person whose beneficial ownership of common stock would be aggregated with the holder) to exceed 9.99 % of the total number of then issued and outstanding shares of common stock, as such percentage ownership is determined in accordance with the terms of the pre-funded warrant and subject to such holder’s rights under the pre-funded warrant to increase or decrease such percentage to any other percentage not in excess of 19.99 % upon at least 61 days’ prior notice from such holder. As of December 31, 2023 , 2,424,242 pre-funded warrants have been exercised and 606,060 pre-funded warrants remain outstanding. On February 10, 2023, the Company filed a Form S-3ASR with the SEC (“2023 Shelf Registration”) for the issuance of common stock, preferred stock, warrants, rights, debt securities and units, which became effective immediately upon filing. At the time any of the securities covered by the 2023 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering. In June 2023, the Company completed an underwritten public offering of 14,375,000 shares of its common stock at a public offering price of $ 12.00 per share (including the exercise in full by the underwriters of their 30 -day option to purchase up to 1,875,000 additional shares of common stock). The net proceeds from the offering were approximately $ 161.8 million, after deducting the underwriting discounts and commissions of $ 10.3 million and offering expenses of $ 0.4 million. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 7. Stock-Based Compensation 2018 Stock Option and Incentive Plan The Company’s 2018 Stock Option and Incentive Plan, (the “2018 Plan”), which became effective on March 27, 2018, provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards, cash-based awards and dividend equivalent rights. The number of shares initially reserved for issuance under the 2018 Plan was 700,180 . Additionally, the shares of common stock that remained available for issuance under the previously outstanding 2015 Stock Incentive Plan (the “2015 Plan”) became available under the 2018 Plan. The number of shares reserved for the 2018 Plan automatically increases on each January 1 by 4 % of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or a lesser number of shares determined by the Company’s board of directors. At the Company’s 2021 annual stockholder meeting, the Company’s stockholders approved the amendment and restatement of the 2018 Stock Plan to increase the number of shares of common stock issuable under the 2018 Plan by 6,000,000 shares. On June 7, 2023, at the Company’s 2023 annual stockholder meeting, the Company’s stockholders approved the amendment and restatement of the 2018 Plan to increase the number of shares of common stock issuable under the 2018 Plan by an additional 6,000,000 shares (the “2023 Pool Increase”). The shares of common stock underlying any awards that are forfeited, canceled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, repurchased or are otherwise terminated by the Company under the 2018 Plan or the 2015 Plan will be added back to the shares of common stock available for issuance under the 2018 Plan. As of December 31, 2023 , 4,187,660 shares of common stock remain available for issuance under the 2018 Plan. The number of authorized shares reserved for issuance under the 2018 Plan was increased by 3,444,970 shares effective as of January 1, 2024. Inducement Plan On October 22, 2020, the board of directors adopted the Cogent Biosciences, Inc. 2020 Inducement Plan (the “Inducement Plan”). The board of directors also adopted a form of non-qualified stock option agreement for use with the Inducement Plan. A total of 3,750,000 shares of common stock have been reserved for issuance under the Inducement Plan, subject to adjustment for stock dividends, stock splits, or other changes in the Company's common stock or capital structure. On November 5, 2020, the Company filed a Registration Statement on Form S-8 related to the 3,750,000 shares of its common stock reserved for issuance under the Inducement Plan. As of December 31, 2023 , 677,995 shares of common stock remain available for issuance under the Inducement Plan. 2018 Employee Stock Purchase Plan The Company’s 2018 Employee Stock Purchase Plan (the “ESPP”) became effective on March 28, 2018, at which time a total of 78,500 shares of common stock were reserved for issuance. In addition, the number of shares of common stock that may be issued under the ESPP automatically increases on each January 1 through January 1, 2027, by the least of (i) 125,000 shares of common stock, (ii) 1 % of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or (iii) such lesser number of shares as determined by the ESPP administrator. As of December 31, 2023 , 443,390 shares remain available for issuance under the ESPP. In January 2024, 71,150 shares were issued to employees under the ESPP. The number of authorized shares reserved for issuance under the ESPP was increased by 125,000 shares effective as of January 1, 2024. Performance-based restricted stock units In February 2023, the Board approved grants in aggregate of up to 2,500,000 performance-based restricted stock units (“PSUs”) under the 2018 Plan, which grants were subject to forfeiture in the event that the Company’s stockholders did not approve the 2023 Pool Increase. On June 7, 2023, stockholders approved the 2023 Pool Increase and a grant date was established for accounting purposes for these PSUs in accordance with ASC 718 Compensation- Stock Compensation. An award holder can generally receive between 0 % and 200 % of the target award based on achievement of specified stock price hurdles and/or research and development milestones over a three-year performance period ending in February 2026. Any PSUs earned will vest, if at all, in a single tranche in February 2026 subject to a condition of continuing employment through the end of the performance period. As of December 31, 2023, none of the research or development performance targets are probable of achievement. The fair value of the market-based awards was estimated on the date of grant for accounting purposes using a Monte Carlo simulation model. The fair value of the performance-based awards was based on the closing share price of the Company’s common stock on the accounting grant date. Stock Options The following table presents, on a weighted average basis, the assumptions used in the Black-Scholes option-pricing model to determine the fair value of stock options granted to employees and directors: Year Ended December 31, 2023 2022 2021 Risk-free interest rate 3.9 % 2.2 % 1.3 % Expected volatility 76.7 % 72.4 % 75.3 % Expected dividend yield — — — Expected life (in years) 6.01 6.22 6.21 The following table summarizes the activity of our 2018 Stock Option and Incentive Plan and the Inducement Plan, excluding performance-based stock options: Number Weighted Weighted Aggregate (in years) (in thousands) Outstanding as of December 31, 2022 12,831,771 $ 9.19 Granted 3,296,179 13.18 Exercised ( 123,687 ) 7.80 Forfeited ( 501,517 ) 10.91 Outstanding as of December 31, 2023 15,502,746 $ 9.99 7.80 $ 1,343 Vested and expected to vest as of December 31, 2023 15,502,746 $ 9.99 7.80 $ 1,343 Options exercisable as of December 31, 2023 8,444,596 $ 9.49 7.41 $ 1,249 The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had strike prices lower than the fair value of the Company’s common stock. The aggregate intrinsic value of options exercised during the years ended December 31, 2023, 2022 and 2021 was $ 0.6 million, $ 1.0 million and $ 0.1 million, respectively. The weighted average grant-date fair value of awards granted during the years ended December 31, 2023, 2022 and 2021 was $ 9.12 per share, $ 5.52 per share and $ 5.93 per share, respectively. Performance-based restricted stock units The following table summarizes the activity of our performance-based restricted stock units: Number Weighted Unvested as of December 31, 2022 — $ — Granted 2,500,000 7.93 Vested — — Forfeited — — Unvested as of December 31, 2023 2,500,000 $ 7.93 Employee Stock Purchase Plan The Company estimates the fair value of shares to be issued under the 2018 Employee Stock Purchase Plan using the Black-Scholes option-pricing model on the date of grant, or first day of the offering period. The following table summarizes information pertaining to stock purchase rights granted under the employee stock purchase plan, during the years indicated: Year Ended December 31, 2023 2022 2021 Risk-free interest rate 4.0 % 1.3 % 0.1 % Expected volatility 75.7 % 64.1 % 66.9 % Expected dividend yield — — — Expected life (in years) 0.50 0.50 0.50 Stock-Based Compensation The following table summarizes stock-based compensation expense during the years ended December 31, 2023, 2022, 2021 in thousands: Year Ended December 31, 2023 2022 2021 Stock-based compensation expense by type of award: Time-based stock options $ 26,012 $ 18,144 $ 11,361 Performance-based restricted stock units $ 4,196 — — Employee stock purchase plan 413 224 65 Non-employee stock options — — 260 Total $ 30,621 $ 18,368 $ 11,686 The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations and comprehensive loss (in thousands) : Year Ended December 31, 2023 2022 2021 Research and development expenses $ 14,595 $ 8,510 $ 4,392 General and administrative expenses 16,026 9,858 7,294 Total $ 30,621 $ 18,368 $ 11,686 As of December 31, 2023 , total unrecognized compensation cost related to the unvested stock-based options was $ 47.9 million, which is expected to be recognized over a weighted average period of 2.13 years. As of December 31, 2023 , the total minimum amount of unrecognized compensation cost related to the stock price hurdles for the unvested PSUs was $ 15.6 million based on the maximum achievement of 200 % of the target award, which is expected to be recognized ratably over a weighted average period of 2.12 years. If any research or development milestones become probable of achievement, the Company will recognize incremental stock compensation expense of up to $ 2.4 million through a cumulative catch up adjustment in the period of change in probability. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. Income Taxes During the years ended December 31, 2023, 2022 and 2021 , the Company recorded no current or deferred income tax benefits due to its full valuation allowance. Also, the Company had no foreign operations. A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended December 31, 2023 2022 2021 Federal statutory income tax rate ( 21.0 )% ( 21.0 )% ( 21.0 )% State taxes, net of federal benefit ( 4.8 ) ( 4.4 ) ( 2.9 ) Federal and state tax credits ( 7.9 ) ( 6.1 ) ( 4.0 ) Rate change ( 2.3 ) - - Nondeductible stock compensation 1.8 1.1 1.4 Other items ( 0.9 ) ( 0.2 ) 0.4 Change in valuation allowance 35.1 30.6 26.1 Effective income tax rate 0.0 % 0.0 % 0.0 % The Company's net deferred tax assets as of December 31, 2023 and 2022 consisted of the following (in thousands) : December 31, 2023 2022 Deferred tax assets (liabilities): Net operating loss carryforwards $ 47,953 $ 36,161 Tax credits 28,759 12,202 Accrued expenses 2,371 1,676 Capitalized research and development expense 66,318 33,155 Operating lease right-of-use assets ( 6,011 ) ( 5,922 ) Operating lease liabilities 6,687 4,991 Contingent consideration 929 864 Stock compensation 8,880 4,758 Other 1,184 1,659 Total deferred tax assets 157,070 89,544 Valuation allowance ( 157,070 ) ( 89,544 ) Net deferred tax assets $ — $ — As of December 31, 2023 , the Company had U.S. federal and state net operating loss carryforwards of $ 195.7 million and $ 110.6 million, respectively, which may be available to offset future taxable income and begin to expire in 2035 . Of the federal net operating loss carryforwards at December 31, 2023 , $ 192.4 million is available to be carried forward indefinitely but can only offset 80 % of taxable income per year. As of December 31, 2023 , the Company had U.S. federal and state research and development tax credit carryforwards of $ 14.0 million and $ 3.1 million, respectively, which may be available to offset future income tax liabilities and begin to expire in 2040 and 2035 , respectively. The Company also had federal orphan drug tax credits of $ 12.4 million which may be available to offset future income tax liabilities and begin to expire in 2041 . On December 22, 2017, the Tax Cuts and Jobs Act (the "TCJA") was signed into law. Under the TCJA provisions, effective with tax years beginning on or after January 1, 2022, taxpayers can no longer immediately expense research and development expenditures. Taxpayers are now required to capitalize and amortize these costs over 5 years for research conducted within the United States or 15 years for research conducted abroad. Utilization of the U.S. federal and state net operating loss carryforwards and tax credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period. As a result of the shares issued in July 2020 related to the acquisition of Kiq and the sale of Series A convertible preferred stock, the Company experienced a change in ownership, as defined by Section 382. As a result of the ownership change, utilization of the federal and state net operating loss carryforwards and research and development tax credit carryforwards is subject to annual limitation under Section 382. Under Section 382, the annual limitation is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. As of December 31, 2023, approximately $ 69.7 million and $ 4.0 million of federal and state net operating losses, respectively, as well as $ 3.5 million of future amortization for federal purposes were subject to the July 2020 limitation of $ 0.3 million per year. A second ownership change occurred in December 2020 as a result of the underwritten public offering of common stock which resulted in a limitation of tax attributes generated from July 2020 to December 2020. The December 2020 ownership change is not expected to have a material impact to the Company’s net operating loss carryforwards or research and development tax credit carryforwards as these net operating losses and tax credit carryforwards may be utilized, subject to annual limitation, assuming sufficient taxable income is generated before expiration. The Company has not performed a Section 382 analysis since December 2020. The Company has not performed a research and development tax credit study. Any change to the Company’s credits as a result of a study would be offset by a change in the valuation allowance. The Company has evaluated the positive and negative evidence bearing upon its ability to realize its net deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception and its lack of commercialization of any products or generation of any revenue from product sales since inception and has concluded that it is more likely than not that the Company will not realize the benefits of its net deferred tax assets. Accordingly, a full valuation allowance has been established against the deferred tax assets as of December 31, 2023, 2022, and 2021. Management reevaluates the positive and negative evidence at each reporting period. The changes in the valuation allowance during the years ended December 31, 2023 and 2022 primarily related to net operating loss carryforwards and capitalized research and development expenses and the change in the valuation allowance during the year ended December 31, 2021 primarily related to the operating loss carryforwards. Changes were as follows (in thousands): Year Ended December 31, 2023 2022 2021 Valuation allowance as of beginning of year $ 89,544 $ 46,687 $ 27,799 Decreases recorded to income tax provision — — — Increases recorded to income tax provision 67,526 42,857 18,888 Valuation allowance as of end of year $ 157,070 $ 89,544 $ 46,687 As of December 31, 2023, 2022, and 2021 , the Company had no t recorded any amounts for unrecognized tax benefits. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. The statute of limitations for assessment by the Internal Revenue Service remains open for all years since 2020, with certain states open since 2019. 'The Company's tax attributes related to years prior to 2020 can still be adjusted under audit. No federal or state tax audits are currently in process. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Operating Leases Corporate Headquarters- Waltham, MA On March 19, 2022, the Company and Cimpress USA Incorporated (the “Cimpress”) entered into a sublease agreement (the “Waltham Sublease”) pursuant to which the Company subleases approximately 17,749 square feet of office space in Waltham, Massachusetts, which serves as the Company’s corporate headquarters. The Waltham Sublease became effective on May 5, 2022. The Waltham Sublease has a term of four years and four months , commencing June 1, 2022 and expiring September 30, 2026 . The Company will pay Cimpress base rent at an initial rate of $ 42.50 per square foot per year. Rent is payable in equal monthly installments and subject to $ 1.00 per square foot annual increases over the term. Additionally, the Company is responsible for reimbursing Cimpress for the Company’s share of the building’s property taxes and operating expenses. In connection with the Waltham Sublease, the Company provided a cash security deposit to the landlord in an amount of $ 0.4 million which is recorded in Other Assets in the consolidated balance sheet as of December 31, 2023. The lease commencement date occurred in May 2022, following landlord consent, as the Company gained access to the space under the terms of the lease. The Company recorded a right-of-use asset and lease liability for this lease of $ 2.9 million at the lease commencement date. Research Facility- Boulder, CO On July 6, 2021, the Company entered into a lease agreement (the “Original Lease”) pursuant to which the Company leases approximately 38,075 square feet (the “Initial Premises”) in Boulder, Colorado, which includes office and laboratory space. Subsequently, on March 29, 2022, the Company entered into the First Amendment to the lease agreement (the “First Amendment” and together with the Original Lease, the “Boulder Lease”) pursuant to which the Company leases approximately 6,582 square feet of additional office space on the second floor (the “Expansion Premises”). The Boulder Lease has an initial term of 12 years with the option to extend for three successive five-year terms. Boulder Lease payments began in June 2023 after an initial free rent period. Rent is payable in equal monthly installments and subject to annual increases over the term. Additionally, the Company is responsible for reimbursing the landlord for its share of the building’s property taxes and operating expenses. The Boulder Lease is an operating lease. In connection with the Boulder Lease, the Company provided a cash security deposit to the landlord in an amount of $ 0.7 million which is recorded in Other Assets in the consolidated balance sheet as of December 31, 2023. The Company recorded the initial right-of-use assets and lease liabilities for the lease of $ 22.3 million as of the lease commencement dates. Former Corporate Headquarters- Cambridge, MA The Company leased office and laboratory space in Cambridge, Massachusetts under a non-cancelable operating lease (the “Cambridge Lease”) that expired in April 2023 . The elements of the lease expense, net of sublease income, were as follows (in thousands) : Year Ended Year Ended Year Ended Lease cost Operating lease cost $ 3,796 $ 4,052 $ 2,424 Variable lease cost (1) 687 991 825 Sublease income ( 950 ) ( 2,621 ) ( 2,468 ) Total lease cost $ 3,533 $ 2,422 $ 781 Other information Cash paid for amounts included in the measurement of $ 3,537 $ 8,413 $ 3,250 Weighted average remaining lease term 10.58 10.84 1.33 Weighted average discount rate 8.00 % 8.04 % 9.50 % (1) The variable lease costs for the year ended December 31, 2023 include common area maintenance and other operating charges. Future minimum lease payments under the Company’s operating leases as of December 31, 2023 are as follows (in thousands) : Year Ending December 31, 2024 $ 2,780 2025 2,841 2026 2,697 2027 2,132 2028 2,179 Thereafter 15,384 Total future minimum lease payments 28,013 Less: imputed interest 9,160 Total operating lease liability $ 18,853 Included in the consolidated balance sheet: Current operating lease liability $ 1,386 Operating lease liability, net of current portion 17,467 Total operating lease liability $ 18,853 Under the terms of the Cambridge Lease, the Company issued a $ 1.3 million letter of credit to the landlord as collateral for the leased facility. The underlying cash collateralizing this letter of credit was classified as current restricted cash in the accompanying consolidated balance sheets as of December 31, 2022. The deposit was refunded at the expiration of the lease in 2023. License Agreements Plexxikon License Agreement In July 2020, the Company obtained an exclusive, sublicensable, worldwide license (the “License Agreement”) to certain patents and other intellectual property rights to research, develop and commercialize bezuclastinib. Under the terms of the License Agreement, the Company is required to pay Plexxikon Inc. (“Plexxikon”) aggregate payments of up to $ 7.5 million upon the satisfaction of certain clinical milestones and up to $ 25.0 million upon the satisfaction of certain regulatory milestones. During the second quarter of 2022, as a result of the progression of the PEAK study, the first clinical milestone was achieved, resulting in payment of $ 2.5 million to Plexxikon in June 2022. As of December 31, 2023 , no other milestone payments have been made or are considered probable of occurring. The Company is also required to pay Plexxikon tiered royalties ranging from a low-single digit percentage to a high-single digit percentage on annual net sales of products. These royalty obligations last on a product-by-product basis and country-by-country basis until the latest of (i) the date on which there is no valid claim of a licensed Plexxikon patent covering a subject product in such country or (ii) the 10th anniversary of the date of the first commercial sale of the product in such country. In addition, if the Company sublicenses the rights under the License Agreement, the Company is required to pay a certain percentage of the sublicense revenue to Plexxikon ranging from mid-double digit percentages to mid-single digit percentages, depending on whether the sublicense is entered into prior to or after certain clinical trial events. The license agreement will expire on a country-by-country and licensed product-by-licensed product basis until the later of the last to expire of the patents covering such licensed products or services or the 10-year anniversary of the date of first commercial sale of the licensed product in such country. The Company may terminate the license agreement within 30 days after written notice in the event of a material breach. The Company may also terminate the agreement upon written notice in the event of the Company’s bankruptcy, liquidation or insolvency. In addition, the Company has the right to terminate this agreement in its entirety at will upon 90 days’ advance written notice to Plexxikon. Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements that will have a material effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2023 or 2022. Legal Proceedings The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10. Net Loss per Share Basic and diluted net loss per common share was calculated as follows ( in thousands, except share and per share amounts ): Year Ended December 31, 2023 2022 2021 Numerator: Net loss $ ( 192,410 ) $ ( 140,241 ) $ ( 72,273 ) Net loss attributable to common stockholders $ ( 192,410 ) $ ( 140,241 ) $ ( 72,273 ) Denominator: Weighted average common shares outstanding, 79,657,942 58,739,713 38,730,813 Net loss per common share, basic and diluted $ ( 2.42 ) $ ( 2.39 ) $ ( 1.87 ) The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be anti-dilutive and would result in a reduction to net loss per share. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated above because including them would have had an anti-dilutive effect: December 31, 2023 2022 2021 Stock options to purchase common stock 15,502,746 12,831,771 8,793,626 Performance-based restricted stock units subject to vesting 2,500,000 — — Series A Preferred Stock 18,616,250 20,262,500 25,822,250 36,618,996 33,094,271 34,615,876 In accordance with ASC Topic 260, Earnings Per Share, the outstanding pre-funded warrants are included in the computation of basic and diluted net loss per share because the exercise price is negligible ($ 0.01 per share) and they are fully vested and exercisable at any time after the original issuance date. |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Retirement Plan | 11. Retirement Plan The Company has a defined-contribution plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The 401(k) Plan allows for discretionary matching contributions of 100 % of the first 4 % of elective contributions, which vest immediately. Contributions under the plan were approximately $ 1.2 million, $ 0.8 million and $ 0.4 million for the years ended December 31, 2023, 2022 and 2021, respectively. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 12. Subsequent Events On February 13, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) for a private placement (the “Private Placement”) with certain institutional and accredited investors (each, a “Purchaser” and collectively, the “Purchasers”). The closing of the Private Placement occurred on February 16, 2024. Pursuant to the Purchase Agreement, the Purchasers purchased (i) an aggregate of 17,717,997 shares of the Company’s common stock, par value $ 0.001 per share, at a price per share of $ 7.50 , and (ii) 12,280 shares of the Company’s Series B Non-Voting Convertible Preferred Stock, par value $ 0.001 per share (the “Series B Preferred Shares”), at a price per share of $ 7,500.00 , for an gross proceeds of $ 225 million, after deducting placement fees and offering expenses. Each Series B Preferred Share is convertible into 1,000 shares of common stock. Pursuant to the Purchase Agreement, the Company has agreed to submit to its stockholders the approval of an increase in the authorized shares of common stock at its 2024 annual meeting of stockholders (the “Requisite Stockholder Approval”). On February 14, 2024, the Company filed a Certificate of Designations of Preferences, Rights and Limitations of the Series B Non-Voting Convertible Preferred Stock with the Secretary of State of the State of Delaware (the “Certificate of Designation”) in connection with the Private Placement. The Certificate of Designation provides for the issuance of up to 12,280 shares of the Company’s Series B Preferred Stock. Following the Requisite Stockholder Approval, each share of Series B Preferred Stock will automatically convert into 1,000 shares of common stock, subject to certain limitations, including that a holder of Series B Preferred Stock is prohibited from converting shares of Series B Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 0 % and 19.9 %) of the total number of shares of common stock issued and outstanding immediately after giving effect to such conversion. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Mono, Inc. and Kiq Bio LLC. All intercompany accounts and transactions have been eliminated. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual of research and development expenses, the valuation of the CVR liability and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates, as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions. |
Concentrations of Credit Risk and of Significant Suppliers | Concentrations of Credit Risk and of Significant Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company maintains most of its cash and cash equivalents at two accredited financial institutions. The Company has not experienced any losses on such accounts and does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Such deposits have and will continue to exceed federally insured limits. The Company is dependent on third-party vendors for its product candidates. In particular, the Company relies, and expects to continue to rely, on a small number of vendors to manufacture supplies and process its product candidates for its development programs. These programs could be adversely affected by a significant interruption in the manufacturing process. |
Cash Equivalents | Cash Equivalents The Company considers all highly liquid investments with original maturities of generally three months or less at the date of purchase to be cash equivalents. |
Restricted Cash | Restricted Cash Restricted cash consists of security deposits in separate restricted bank accounts as required under the terms of the Company’s lease agreement for its former corporate headquarters in Cambridge, Massachusetts, which expired in April 2023 . |
Marketable Securities | Marketable Securities The Company’s marketable securities, consisting of debt securities, are classified as available-for-sale. Available-for-sale marketable debt securities are carried at fair value with the unrealized gains and losses included in other comprehensive income (loss) as a component of stockholders’ equity until realized. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other income (expense). The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. If the decline in fair value is due to credit-related factors, a loss is recognized in net income, and if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss). |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Estimated Useful Life Laboratory equipment 5 years Computer equipment and software 3 years Furniture and fixtures 5 years Leasehold improvements Shorter of life of lease or 10 years Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated in accordance with the above guidelines once placed into service. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets consist of property and equipment and operating lease right-of-use assets. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in loss from operations when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value. |
Fair Value Measurements | Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. 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 must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy described above (see Note 3). The carrying values of the Company’s accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities. |
Segment Information | Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is the development and commercialization of precision therapies for genetically defined diseases. All of the Company’s tangible assets are held in the United States. |
Leases | Leases The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the assets’ economic benefits. The Company determines the initial classification and measurement of its operating right-of-use assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The Company’s policy is to not record leases with an original term of twelve months or less on its consolidated balance sheets. The Company’s only existing leases are for office and laboratory space. The right-of-use asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Lease payments included in the measurement of the lease liability consist of the following: the fixed noncancelable lease payments, payments for optional renewal periods where it is reasonably certain the renewal period will be exercised, and payments for early termination options unless it is reasonably certain the lease will not be terminated early. Leases may contain rent escalation clauses and variable lease payments that require additional rental payments in later years of the term, including payments based on an index or inflation rate. Payments based on the change in an index or inflation rate, or payments based on a change in the Company’s portion of the operating expenses, including real estate taxes and insurance, are not included in the initial lease liability and are recorded as a period expense when incurred. The operating leases may include an option to renew the lease term for various renewal periods and/or to terminate the leases early. These options to exercise the renewal or early termination clauses in the Company’s operating leases were not reasonably certain of exercise as of the date of adoption and these have not been included in the determination of the initial lease liability or operating lease expense. Rent expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the consolidated statements of operations and comprehensive loss. For finance leases, any interest expense is recognized using the effective interest method and is included within interest expense. The Company has no financing leases. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries, stock-based compensation and benefits, facilities costs and laboratory supplies, depreciation, manufacturing expenses and external costs of outside vendors engaged to conduct preclinical development activities and clinical trials as well as the cost of licensing technology. The Company has entered into various research and development contracts with companies both inside and outside of the United States. These agreements are generally cancelable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing external research and development costs. When billing terms under these contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of outstanding liabilities to those third parties as of the end of the reporting period. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or trials, including the phase or completion of events, communication from the contract research organizations or other companies of any actual costs incurred during the period that have not yet been invoiced, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. Upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed. |
Patent Costs | Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. |
Stock-Based Compensation | Stock-Based Compensation The Company measures stock options and other stock-based awards granted to employees, non-employees and directors based on their fair value on the date of the grant and recognizes compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award. The Company applies the straight-line method of expense recognition to all awards with only service-based vesting conditions and applies the graded-vesting method to all awards with performance-based vesting conditions or to awards with both service-based and performance-based vesting conditions. The Company estimates the fair value of stock-based awards to employees and non-employees using the Black-Scholes option-pricing model, which requires the input of highly subjective assumptions, including (a) the expected volatility of its stock, (b) the expected term of the award, (c) the risk-free interest rate, and (d) expected dividends. Due to the lack of a sufficient history of public trading of the Company’s common stock and a lack of sufficient company-specific historical and implied volatility data, the Company has based the estimate of expected volatility on the historical volatility of a group of companies in the pharmaceutical and biotechnology industries in a similar stage of development and that are publicly traded. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. The Company estimates the expected life of employee stock options using the "simplified" method, whereby, the expected life equals the average of the vesting term and the original contractual term of the option. The risk-free interest rates for periods within the expected life of the option are based on the U.S. Treasury yield curve in effect during the period the options were granted. The expected dividend yield of zero is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The Company accounts for forfeitures as they occur. The Company measures the fair value of stock-based awards with market-based vesting conditions on the date of grant using a Monte Carlo simulation mode l. For performance-based stock options, the Company begins to recognize expense when it determines that the achievement of such performance conditions is deemed probable. This determination requires significant judgment by management. At the date achievement becomes probable, the Company records a cumulative expense catch-up, with remaining expense amortized over the remaining service period. For awards with market conditions, the stock-based compensation expense will be recognized over the derived service period regardless of whether the award achieves the market condition and will only be adjusted to the extent the service condition is not met . |
Comprehensive Loss | Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. For the years ended December 31, 2023 and 2022 , the Company’s only element of other comprehensive loss was unrealized gains (losses) on marketable securities. |
Net Income (Loss) per Share | Net Income (Loss) per Share Basic net income (loss) per common share attributable to common stockholders is computed by dividing the net income (loss) attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share attributable to common stockholders is computed by dividing net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock options. Accordingly, in periods in which the Company reported a net loss, dilutive common shares were not assumed to have been issued as their affect was anti-dilutive, and as a result, diluted net loss per common share was the same as basic net loss per common share. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. |
Recently Adopted and Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU 2020-06 Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) related to the measurement and disclosure requirements for convertible instruments and contracts in an entity’s own equity. The pronouncement simplifies and adds disclosure requirements for the accounting and measurement of convertible instruments and the settlement assessment for contracts in an entity’s own equity. The Company adopted ASU 2020-06 on January 1, 2022 . The adoption of this guidance did no t have a material impact on the Company’s consolidated financial statements. Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07 Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures related to reportable segment disclosure requirements. The pronouncement improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses, and requires disclosure of incremental segment information on an annual and interim basis. The pronouncement is effective for annual periods beginning after December 15, 2023. The Company is evaluating the impact of the ASU on its financial statements. In December 2023, the FASB issued ASU 2023-09 Income Taxes (Topic 740): Improvements to Income Tax Disclosures related to income tax disclosure requirements. The pronouncement enhances the transparency and decision usefulness of income tax disclosures. The pronouncement is effective for annual periods beginning after December 15, 2024. The Company is evaluating the impact of the ASU on its financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Life | Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Estimated Useful Life Laboratory equipment 5 years Computer equipment and software 3 years Furniture and fixtures 5 years Leasehold improvements Shorter of life of lease or 10 years |
Marketable Securities and Fai_2
Marketable Securities and Fair Value of Financial Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Marketable Securities | The following table summarizes the Company’s marketable securities (in thousands) : December 31, 2023 Amortized Gross Gross Fair U.S. Treasury bills and notes (due within one year) $ 212,274 $ 213 $ ( 6 ) $ 212,481 U.S. Treasury bills and notes (due after one through five year) $ 7,421 $ 39 $ — $ 7,460 $ 219,695 $ 252 $ ( 6 ) $ 219,941 December 31, 2022 Amortized Gross Gross Fair U.S. Treasury bills and notes (due within one year) $ 119,494 $ — $ ( 104 ) $ 119,390 $ 119,494 $ — $ ( 104 ) $ 119,390 |
Schedule of Financial Assets and Liabilities at Fair Value on Recurring Basis | The following tables present the Company’s fair value hierarchy for its financial assets and liabilities, which are measured at fair value on a recurring basis (in thousands) : Fair Value Measurements at December 31, 2023 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 46,184 $ — $ — $ 46,184 Marketable securities: U.S. Treasury bills and notes $ — $ 219,941 $ — $ 219,941 Total Assets $ 46,184 $ 219,941 $ — $ 266,125 Fair Value Measurements at December 31, 2022 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 108,829 $ — $ — $ 108,829 Marketable securities: U.S. Treasury bills and notes $ — $ 119,390 $ — $ 119,390 Total Assets $ 108,829 $ 119,390 $ — $ 228,219 Liabilities: CVR Liability $ — $ — $ 1,700 $ 1,700 Total Liabilities $ — $ — $ 1,700 $ 1,700 |
Summary of Changes in the Fair Value of Company's CVR Liability | The following table sets forth a summary of the changes in the fair value of the Company’s CVR liability (in thousands) : Balance at December 31, 2020 $ 5,531 Change in fair value ( 343 ) CVR settlement ( 2,128 ) Balance at December 31, 2021 3,060 Change in fair value ( 1,360 ) Balance at December 31, 2022 1,700 Change in fair val ue ( 1,700 ) Balance at December 31, 2023 $ — |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following (in thousands) : December 31, 2023 2022 Laboratory equipment $ 7,635 $ 5,507 Computer equipment and software 745 546 Furniture and fixtures 1,164 873 Leasehold improvements 2,438 1,776 Construction-in-progress 27 482 Total property and equipment 12,009 9,184 Accumulated depreciation and amortization ( 3,665 ) ( 1,401 ) Property and equipment, net $ 8,344 $ 7,783 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands) : December 31, 2023 2022 Accrued employee compensation and benefits $ 9,874 $ 6,063 Accrued external research and development expense 10,252 5,898 Accrued external manufacturing costs 3,302 3,741 Accrued professional and consulting services 2,258 1,778 Other 441 404 $ 26,127 $ 17,884 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Fair Value Option Granted | The following table presents, on a weighted average basis, the assumptions used in the Black-Scholes option-pricing model to determine the fair value of stock options granted to employees and directors: Year Ended December 31, 2023 2022 2021 Risk-free interest rate 3.9 % 2.2 % 1.3 % Expected volatility 76.7 % 72.4 % 75.3 % Expected dividend yield — — — Expected life (in years) 6.01 6.22 6.21 |
Schedule of Common Stock Option Activity | The following table summarizes the activity of our 2018 Stock Option and Incentive Plan and the Inducement Plan, excluding performance-based stock options: Number Weighted Weighted Aggregate (in years) (in thousands) Outstanding as of December 31, 2022 12,831,771 $ 9.19 Granted 3,296,179 13.18 Exercised ( 123,687 ) 7.80 Forfeited ( 501,517 ) 10.91 Outstanding as of December 31, 2023 15,502,746 $ 9.99 7.80 $ 1,343 Vested and expected to vest as of December 31, 2023 15,502,746 $ 9.99 7.80 $ 1,343 Options exercisable as of December 31, 2023 8,444,596 $ 9.49 7.41 $ 1,249 |
Schedule of Performance-Based Restricted Stock Units | The following table summarizes the activity of our performance-based restricted stock units: Number Weighted Unvested as of December 31, 2022 — $ — Granted 2,500,000 7.93 Vested — — Forfeited — — Unvested as of December 31, 2023 2,500,000 $ 7.93 |
Summary of Information Pertaining to Stock Purchase Rights Granted under Employee Stock Purchase Plan | The following table summarizes information pertaining to stock purchase rights granted under the employee stock purchase plan, during the years indicated: Year Ended December 31, 2023 2022 2021 Risk-free interest rate 4.0 % 1.3 % 0.1 % Expected volatility 75.7 % 64.1 % 66.9 % Expected dividend yield — — — Expected life (in years) 0.50 0.50 0.50 |
Schedule of Stock-based Compensation Expense by Type of Award | The following table summarizes stock-based compensation expense during the years ended December 31, 2023, 2022, 2021 in thousands: Year Ended December 31, 2023 2022 2021 Stock-based compensation expense by type of award: Time-based stock options $ 26,012 $ 18,144 $ 11,361 Performance-based restricted stock units $ 4,196 — — Employee stock purchase plan 413 224 65 Non-employee stock options — — 260 Total $ 30,621 $ 18,368 $ 11,686 |
Schedule of Stock Based Compensation Expense | The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations and comprehensive loss (in thousands) : Year Ended December 31, 2023 2022 2021 Research and development expenses $ 14,595 $ 8,510 $ 4,392 General and administrative expenses 16,026 9,858 7,294 Total $ 30,621 $ 18,368 $ 11,686 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended December 31, 2023 2022 2021 Federal statutory income tax rate ( 21.0 )% ( 21.0 )% ( 21.0 )% State taxes, net of federal benefit ( 4.8 ) ( 4.4 ) ( 2.9 ) Federal and state tax credits ( 7.9 ) ( 6.1 ) ( 4.0 ) Rate change ( 2.3 ) - - Nondeductible stock compensation 1.8 1.1 1.4 Other items ( 0.9 ) ( 0.2 ) 0.4 Change in valuation allowance 35.1 30.6 26.1 Effective income tax rate 0.0 % 0.0 % 0.0 % |
Schedule of Deferred Tax Assets | The Company's net deferred tax assets as of December 31, 2023 and 2022 consisted of the following (in thousands) : December 31, 2023 2022 Deferred tax assets (liabilities): Net operating loss carryforwards $ 47,953 $ 36,161 Tax credits 28,759 12,202 Accrued expenses 2,371 1,676 Capitalized research and development expense 66,318 33,155 Operating lease right-of-use assets ( 6,011 ) ( 5,922 ) Operating lease liabilities 6,687 4,991 Contingent consideration 929 864 Stock compensation 8,880 4,758 Other 1,184 1,659 Total deferred tax assets 157,070 89,544 Valuation allowance ( 157,070 ) ( 89,544 ) Net deferred tax assets $ — $ — |
Changes in Valuation Allowance for Deferred Tax Assets | The changes in the valuation allowance during the years ended December 31, 2023 and 2022 primarily related to net operating loss carryforwards and capitalized research and development expenses and the change in the valuation allowance during the year ended December 31, 2021 primarily related to the operating loss carryforwards. Changes were as follows (in thousands): Year Ended December 31, 2023 2022 2021 Valuation allowance as of beginning of year $ 89,544 $ 46,687 $ 27,799 Decreases recorded to income tax provision — — — Increases recorded to income tax provision 67,526 42,857 18,888 Valuation allowance as of end of year $ 157,070 $ 89,544 $ 46,687 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Elements of Lease Expense Net of Sublease Income | The elements of the lease expense, net of sublease income, were as follows (in thousands) : Year Ended Year Ended Year Ended Lease cost Operating lease cost $ 3,796 $ 4,052 $ 2,424 Variable lease cost (1) 687 991 825 Sublease income ( 950 ) ( 2,621 ) ( 2,468 ) Total lease cost $ 3,533 $ 2,422 $ 781 Other information Cash paid for amounts included in the measurement of $ 3,537 $ 8,413 $ 3,250 Weighted average remaining lease term 10.58 10.84 1.33 Weighted average discount rate 8.00 % 8.04 % 9.50 % (1) The variable lease costs for the year ended December 31, 2023 include common area maintenance and other operating charges. |
Summary of Future Minimum Payments under Operating Lease | Year Ending December 31, 2024 $ 2,780 2025 2,841 2026 2,697 2027 2,132 2028 2,179 Thereafter 15,384 Total future minimum lease payments 28,013 Less: imputed interest 9,160 Total operating lease liability $ 18,853 Included in the consolidated balance sheet: Current operating lease liability $ 1,386 Operating lease liability, net of current portion 17,467 Total operating lease liability $ 18,853 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share Basic and Diluted | Basic and diluted net loss per common share was calculated as follows ( in thousands, except share and per share amounts ): Year Ended December 31, 2023 2022 2021 Numerator: Net loss $ ( 192,410 ) $ ( 140,241 ) $ ( 72,273 ) Net loss attributable to common stockholders $ ( 192,410 ) $ ( 140,241 ) $ ( 72,273 ) Denominator: Weighted average common shares outstanding, 79,657,942 58,739,713 38,730,813 Net loss per common share, basic and diluted $ ( 2.42 ) $ ( 2.39 ) $ ( 1.87 ) |
Summary of Potential Dilutive Securities | The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be anti-dilutive and would result in a reduction to net loss per share. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated above because including them would have had an anti-dilutive effect: December 31, 2023 2022 2021 Stock options to purchase common stock 15,502,746 12,831,771 8,793,626 Performance-based restricted stock units subject to vesting 2,500,000 — — Series A Preferred Stock 18,616,250 20,262,500 25,822,250 36,618,996 33,094,271 34,615,876 |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Net loss | $ (192,410) | $ (140,241) | $ (72,273) |
Accumulated deficit | $ (603,624) | $ (411,214) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Estimated Useful Life (Detail) | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | |
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] | us-gaap:UsefulLifeTermOfLeaseMember |
Laboratory Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Computer Equipment and Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 3 years |
Furniture and Fixtures [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 10 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2023 Segment | |
Significant Accounting Policies [Line Items] | |
Lease expiration month and year | 2023-04 |
Number of operating segment | 1 |
Expected dividend yield | 0% |
Accounting Standards Update 2020-06 [Member] | |
Significant Accounting Policies [Line Items] | |
Change in accounting principle, accounting standards update, adopted [true false] | true |
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2022 |
Change in accounting principle, accounting standards update, immaterial effect [true false] | true |
Marketable Securities and Fai_3
Marketable Securities and Fair Value of Financial Assets and Liabilities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Amortized Cost | $ 219,695 | $ 119,494 |
Marketable Securities, Gross Unrealized Gains | 252 | |
Marketable Securities, Gross Unrealized Losses | (6) | (104) |
Marketable Securities, Fair Value | 219,941 | 119,390 |
U.S. Treasury Bills and Notes (Due within One Year) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Amortized Cost | 212,274 | 119,494 |
Marketable Securities, Gross Unrealized Gains | 213 | |
Marketable Securities, Gross Unrealized Losses | (6) | (104) |
Marketable Securities, Fair Value | 212,481 | $ 119,390 |
U.S. Treasury Bills and Notes (Due After One Through Five Years) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Amortized Cost | 7,421 | |
Marketable Securities, Gross Unrealized Gains | 39 | |
Marketable Securities, Fair Value | $ 7,460 |
Marketable Securities and Fai_4
Marketable Securities and Fair Value of Financial Assets and Liabilities - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Aug. 06, 2023 | Feb. 28, 2021 USD ($) shares | Nov. 30, 2020 shares | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) Security | Dec. 31, 2022 USD ($) Security | Dec. 31, 2021 USD ($) | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |||||||
Number of held securities in an unrealized loss position | Security | 9 | 7 | |||||
Unrealized loss possition less than 12 months | $ 34,700,000 | $ 99,500,000 | |||||
Unrealized loss position more than 12 months | 0 | 0 | |||||
Marketable debt securities, charges for credit-related impairments | 0 | 0 | $ 0 | ||||
Fair value asset, transfers between Level 1, Level 2 and Level 3, amount | 0 | 0 | 0 | ||||
CVR expired date | Aug. 06, 2023 | ||||||
CVR Liability [Member] | |||||||
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |||||||
Issuance of common stock | shares | 212,429 | 707,938 | |||||
Partial settlement | $ 100,000 | 2,128,000 | |||||
Change in fair value | $ 1,700,000 | $ 1,700,000 | $ 1,360,000 | $ 343,000 | |||
Payments of probable reduction | $ 0 |
Marketable Securities and Fai_5
Marketable Securities and Fair Value of Financial Assets and Liabilities - Schedule of Financial Assets and Liabilities at Fair Value on Recurring Basis (Detail) - Recurring Basis [Member] - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Assets: | ||
Total Assets | $ 266,125 | $ 228,219 |
Liabilities: | ||
CVR Liability | 1,700 | |
Total Liabilities | 1,700 | |
Level 1 [Member] | ||
Assets: | ||
Total Assets | 46,184 | 108,829 |
Level 2 [Member] | ||
Assets: | ||
Total Assets | 219,941 | 119,390 |
Level 3 [Member] | ||
Liabilities: | ||
CVR Liability | 1,700 | |
Total Liabilities | 1,700 | |
Money Market Funds [Member] | ||
Assets: | ||
Cash equivalents | 46,184 | 108,829 |
Money Market Funds [Member] | Level 1 [Member] | ||
Assets: | ||
Cash equivalents | 46,184 | 108,829 |
U.S. Treasury Bills and Notes [Member] | ||
Assets: | ||
Marketable Securities | 219,941 | 119,390 |
U.S. Treasury Bills and Notes [Member] | Level 2 [Member] | ||
Assets: | ||
Marketable Securities | $ 219,941 | $ 119,390 |
Marketable Securities and Fai_6
Marketable Securities and Fair Value of Financial Assets and Liabilities - Summary of Changes in the Fair Value of Company's CVR Liability (Detail) - CVR Liability [Member] - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Feb. 28, 2021 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |||||
Beginning balance | $ 1,700 | $ 1,700 | $ 3,060 | $ 5,531 | |
Decrease in fair value | $ (1,700) | $ (1,700) | $ (1,360) | $ (343) | |
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Change In Fair Value Of Contingent Value Right Liability | Change In Fair Value Of Contingent Value Right Liability | Change In Fair Value Of Contingent Value Right Liability | ||
CVR settlement | $ (100) | $ (2,128) | |||
Ending balance | $ 0 | $ 1,700 | $ 3,060 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 12,009 | $ 9,184 |
Accumulated depreciation and amortization | (3,665) | (1,401) |
Property and equipment, net | 8,344 | 7,783 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 7,635 | 5,507 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 745 | 546 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,164 | 873 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,438 | 1,776 |
Construction-in-Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 27 | $ 482 |
Property Plant Equipment Net -
Property Plant Equipment Net - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Property Plant And Equipments [Abstract] | |||
Depreciation and amortization expense | $ 2,270 | $ 842 | $ 147 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued employee compensation and benefits | $ 9,874 | $ 6,063 |
Accrued external research and development expense | 10,252 | 5,898 |
Accrued external manufacturing costs | 3,302 | 3,741 |
Accrued professional and consulting services | 2,258 | 1,778 |
Other | 441 | 404 |
Total | $ 26,127 | $ 17,884 |
Preferred Stock, Series A Non_2
Preferred Stock, Series A Non-Voting Convertible Preferred Stock and Common Stock - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | 42 Months Ended | |||||
Jun. 13, 2022 | Feb. 08, 2021 | Jun. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2023 | May 06, 2022 | |
Class Of Stock [Line Items] | ||||||||
Common stock, Shares authorized | 150,000,000 | 150,000,000 | 150,000,000 | |||||
Common stock, Par value | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Preferred stock, par value | $ 0.001 | $ 0.001 | ||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||||||
Preferred stock, shares outstanding | 0 | 0 | 0 | |||||
Preferred stock, shares issued | 0 | 0 | 0 | |||||
Proceeds from issuance of common stock to LPC | $ 161,819,000 | $ 0 | $ 0 | |||||
Pre-funded warrants, purchase price per share | $ 0.01 | $ 0.01 | ||||||
Underwritten Public Offering [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Beneficial ownership limitation percentage for conversion of common stock issued and outstanding | 9.99% | |||||||
Shares of common stock issued and sold | 17,899,698 | 14,375,000 | ||||||
Exercise of stock options additional shares of common stock | 2,730,000 | 1,875,000 | ||||||
Stock offering price, per share | $ 8.25 | $ 12 | ||||||
Proceeds from issuance of common stock to LPC | $ 161,900,000 | $ 161,800,000 | ||||||
Underwriting discounts and commissions expenses | 10,400,000 | 10,300,000 | ||||||
Offering expenses | $ 400,000 | $ 400,000 | ||||||
Pre-funded warrants, shares | 3,030,302 | |||||||
Pre-funded warrants exercised | 2,424,242 | 2,424,242 | ||||||
Pre-funded warrants remain outstanding | 606,060 | 606,060 | ||||||
Underwriters exercise period option | 30 days | 30 days | ||||||
Guggenheim Securities, LLC [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Shares of common stock issued and sold | 0 | |||||||
SVB Leerink LLC [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Agreement termination penalties | $ 0 | |||||||
Shares of common stock issued and sold | 3,954,900 | |||||||
Proceeds from issuance of common stock to LPC | $ 38,000,000 | |||||||
Minimum [Member] | SVB Leerink LLC [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Stock offering price, per share | $ 9.25 | |||||||
Maximum [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Proceeds from issuance of equity and debt financing | $ 200,000,000 | |||||||
Maximum [Member] | Underwritten Public Offering [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Beneficial ownership limitation percentage for conversion of common stock issued and outstanding | 19.99% | |||||||
Maximum [Member] | Guggenheim Securities, LLC [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Stock offering cost | $ 75,000,000 | |||||||
Maximum [Member] | SVB Leerink LLC [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Stock offering cost | $ 75,000,000 | |||||||
Stock offering price, per share | $ 10.3 | |||||||
Common Stock [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Conversion of preferred stock into common stock, Shares | 1,646,250 | 5,559,750 | 7,238,750 | 22,215,000 | ||||
Common stock voting right | Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. | |||||||
Exercise of stock options additional shares of common stock | 123,687 | 154,822 | 15,758 | |||||
Pre-funded warrants, purchase price per share | $ 0.01 | |||||||
Common Stock [Member] | Underwritten Public Offering [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Pre-funded warrants, purchase price per share | $ 8.24 | |||||||
Series A Preferred Stock [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | ||||||
Minimum percentage of originally issued shares remain issued and outstanding | 40% | 40% | ||||||
Convertible preferred stock, common stock issuable upon conversion | 250 | 250 | ||||||
Percentage of preferred stock issued | 54.40% | 54.40% | ||||||
Cumulative amount of shares conversion | 88,860 | |||||||
Series A Preferred Stock [Member] | Minimum [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Beneficial ownership limitation percentage for conversion of common stock issued and outstanding | 4.90% | 4.90% | ||||||
Series A Preferred Stock [Member] | Maximum [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Beneficial ownership limitation percentage for conversion of common stock issued and outstanding | 19.90% | 19.90% | ||||||
Series A Convertible Preferred Stock [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Preferred stock, shares authorized | 1,000,000 | 1,000,000 | 1,000,000 | |||||
Preferred stock, shares outstanding | 74,465 | 81,050 | 74,465 | |||||
Common stock issued upon conversion of preferred stock | 18,616,250 | 18,616,250 | ||||||
Preferred stock, shares issued | 74,465 | 81,050 | 74,465 | |||||
Undesignated Preferred Stock [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Preferred stock, shares authorized | 9,000,000 | 9,000,000 | 9,000,000 | |||||
Preferred stock, shares outstanding | 0 | 0 | 0 | |||||
Preferred stock, shares issued | 0 | 0 | 0 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |||||||||
Jan. 01, 2024 | Jun. 07, 2023 | Mar. 28, 2018 | Mar. 27, 2018 | Feb. 28, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Jan. 31, 2024 | Nov. 05, 2020 | Oct. 22, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Common stock shares issued | 86,124,249 | 69,893,434 | |||||||||
Aggregate intrinsic value of options exercised | $ 0.6 | $ 1 | $ 0.1 | ||||||||
Weighted average grant date fair value | $ 9.12 | $ 5.52 | $ 5.93 | ||||||||
Unrecognized compensation expenses, recognition period | 2 years 1 month 13 days | ||||||||||
Maximum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Incremental stock compensation expense | $ 2.4 | ||||||||||
2020 Inducement Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares available for issuance | 677,995 | ||||||||||
Shares reserved for future issuance | 3,750,000 | 3,750,000 | |||||||||
Employee Stock Option | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Unrecognized compensation cost | $ 47.9 | ||||||||||
Unrecognized compensation expenses, recognition period | 2 years 1 month 17 days | ||||||||||
Unvested PSUs [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Unrecognized compensation cost | $ 15.6 | ||||||||||
Percentage of Share Based Compensation Nonvested Awards Stock Maximum Achievement | 200% | ||||||||||
2018 Stock Option and Incentive Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of increases in authorized shares | 700,180 | ||||||||||
Percentage applied to the outstanding shares as annual increase in the number of shares authorized for issuance | 4% | ||||||||||
Increased in authorized shares reserved for issuance | 6,000,000 | 6,000,000 | |||||||||
Shares available for issuance | 4,187,660 | ||||||||||
Expiration period | 3 years | ||||||||||
2018 Stock Option and Incentive Plan [Member] | Minimum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Percentage of vesting of award | 0% | ||||||||||
2018 Stock Option and Incentive Plan [Member] | Maximum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of shares grants | 2,500,000 | ||||||||||
Percentage of vesting of award | 200% | ||||||||||
2018 Stock Option and Incentive Plan [Member] | Subsequent Event [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Increased in authorized shares reserved for issuance | 3,444,970 | ||||||||||
2018 Employee Stock Purchase Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares available for issuance | 443,390 | ||||||||||
Shares reserved for future issuance | 78,500 | ||||||||||
2018 Employee Stock Purchase Plan [Member] | Maximum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of increases in authorized shares | 125,000 | ||||||||||
Percentage of shares of common stock available for issuance | 1% | ||||||||||
2018 Employee Stock Purchase Plan [Member] | Subsequent Event [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Increased in authorized shares reserved for issuance | 125,000 | ||||||||||
2018 Employee Stock Purchase Plan [Member] | Employees [Member] | Subsequent Event [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Common stock shares issued | 71,150 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Fair Value Option Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Stock Options/Shares Outstanding, Weighted-Average Exercise Price, and Additional Disclosures [Abstract] | |||
Risk-free interest rate | 3.90% | 2.20% | 1.30% |
Expected volatility | 76.70% | 72.40% | 75.30% |
Expected dividend yield | 0% | ||
Expected life (in years) | 6 years 3 days | 6 years 2 months 19 days | 6 years 2 months 15 days |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Common Stock Option Activity (Detail) - 2018 Stock Option and Incentive Plan and Inducement Plan [Member] $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Options Outstanding, Beginning balance | shares | 12,831,771 |
Number of Options, Granted | shares | 3,296,179 |
Number of Options, Exercised | shares | (123,687) |
Number of Options, Forfeited | shares | (501,517) |
Number of Options Outstanding, Ending balance | shares | 15,502,746 |
Number of Options, Vested and expected to vest | shares | 15,502,746 |
Number of Options, Exercisable | shares | 8,444,596 |
Weighted Average Exercise Price, Outstanding, Beginning balance | $ / shares | $ 9.19 |
Weighted Average Exercise Price, Granted | $ / shares | 13.18 |
Weighted Average Exercise Price, Exercised | $ / shares | 7.8 |
Weighted Average Exercise Price, Forfeited | $ / shares | 10.91 |
Weighted Average Exercise Price, Outstanding, Ending balance | $ / shares | 9.99 |
Weighted Average Exercise Price, Vested and expected to vest | $ / shares | 9.99 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 9.49 |
Weighted Average Contractual Term, Outstanding, Ending balance | 7 years 9 months 18 days |
Weighted Average Contractual Term, Vested and expected to vest | 7 years 9 months 18 days |
Weighted Average Contractual Term, Exercisable | 7 years 4 months 28 days |
Aggregate Intrinsic Value, Outstanding | $ | $ 1,343 |
Aggregate Intrinsic Value, Vested and expected to vest | $ | 1,343 |
Aggregate Intrinsic Value, Exercisable | $ | $ 1,249 |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of Performance-Based Restricted Stock Units (Details) - Performance-Based Restricted Stock Units [Member] | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Shares, Granted | shares | 2,500,000 |
Number of Shares, Unvested, Ending balance | shares | 2,500,000 |
Weighted Average Grant Date Fair Value per Share, Granted | $ / shares | $ 7.93 |
Weighted Average Grant Date Fair Value per Share, Ending Balance | $ / shares | $ 7.93 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Information Pertaining to Stock Purchase Rights Granted under Employee Stock Purchase Plan (Detail) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 3.90% | 2.20% | 1.30% |
Expected volatility | 76.70% | 72.40% | 75.30% |
Expected dividend yield | 0% | ||
Expected life (in years) | 6 years 3 days | 6 years 2 months 19 days | 6 years 2 months 15 days |
2018 Employee Stock Purchase Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 4% | 1.30% | 0.10% |
Expected volatility | 75.70% | 64.10% | 66.90% |
Expected life (in years) | 6 months | 6 months | 6 months |
Stock-Based Compensation - Sc_4
Stock-Based Compensation - Schedule of Stock-based Compensation Expense by Type of Award (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-Based Payment Arrangement, Expense | $ 30,621 | $ 18,368 | $ 11,686 |
Employee Stock [Member] | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-Based Payment Arrangement, Expense | 413 | 224 | 65 |
Time Based Stock Options [Member] | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-Based Payment Arrangement, Expense | 26,012 | $ 18,144 | 11,361 |
Performance-Based Restricted Stock Units [Member] | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-Based Payment Arrangement, Expense | $ 4,196 | ||
Non-employee Stock Options [Member] | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-Based Payment Arrangement, Expense | $ 260 |
Stock-Based Compensation - Sc_5
Stock-Based Compensation - Schedule of Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 30,621 | $ 18,368 | $ 11,686 |
Research and Development Expenses [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 14,595 | 8,510 | 4,392 |
General and Administrative Expenses [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 16,026 | $ 9,858 | $ 7,294 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Line Items] | |||
Current income tax benefits | $ 0 | $ 0 | $ 0 |
Tax cuts and jobs act of 2017 period for research and development expenses capitalization domestic | 5 years | ||
Tax cuts and jobs act of 2017 period for research and development expenses capitalization foreign | 15 years | ||
Deferred income tax benefits | $ 0 | 0 | 0 |
Operating losses carried forward, expiration date | 2035 | ||
Operating loss carryforwards, federal | $ 192,400,000 | ||
Percentage of net operating loss carry forward deductible from current year taxable income | 80% | ||
Federal orphan drug tax credits | $ 12,400,000 | ||
Federal orphan drug credit carry forwards expiration year | 2041 | ||
Annual limitation amount per year under section 382 | $ 300,000 | ||
Unrecognized tax benefits | 0 | $ 0 | $ 0 |
U.S. federal [Member] | |||
Income Tax Disclosure [Line Items] | |||
Net operating losses carryforwards | 195,700,000 | ||
Research and development tax credits carryforwards | $ 14,000,000 | ||
Tax credit carryforwards, expiration year | 2040 | ||
Net operating losses subject to limitation under section 382 | $ 69,700,000 | ||
Future amortization (NOL equivalents) subject to limitation under section 382 | 3,500,000 | ||
State [Member] | |||
Income Tax Disclosure [Line Items] | |||
Net operating losses carryforwards | 110,600,000 | ||
Research and development tax credits carryforwards | $ 3,100,000 | ||
Tax credit carryforwards, expiration year | 2035 | ||
Net operating losses subject to limitation under section 382 | $ 4,000,000 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Detail) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | |||
Federal statutory income tax rate | (21.00%) | (21.00%) | (21.00%) |
State taxes, net of federal benefit | (4.80%) | (4.40%) | (2.90%) |
Federal and state tax credits | (7.90%) | (6.10%) | (4.00%) |
Rate change | (2.30%) | ||
Nondeductible stock compensation | 1.80% | 1.10% | 1.40% |
Other items | (0.90%) | (0.20%) | 0.40% |
Change in valuation allowance | 35.10% | 30.60% | 26.10% |
Effective income tax rate | 0% | 0% | 0% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets (liabilities): | ||
Net operating loss carryforwards | $ 47,953 | $ 36,161 |
Tax credits | 28,759 | 12,202 |
Accrued expenses | 2,371 | 1,676 |
Capitalized research and development expense | 66,318 | 33,155 |
Operating lease right-of-use assets | (6,011) | (5,922) |
Operating lease liabilities | 6,687 | 4,991 |
Contingent consideration | 929 | 864 |
Stock compensation | 8,880 | 4,758 |
Other | 1,184 | 1,659 |
Total deferred tax assets | 157,070 | 89,544 |
Valuation allowance | (157,070) | (89,544) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Changes in Valua
Income Taxes - Changes in Valuation Allowance for Deferred Tax Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Valuation allowance as of beginning of year | $ 89,544 | $ 46,687 | $ 27,799 |
Increases recorded to income tax provision | 67,526 | 42,857 | 18,888 |
Valuation allowance as of end of year | $ 157,070 | $ 89,544 | $ 46,687 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | |||||||
May 05, 2022 $ / ft² | Mar. 19, 2022 ft² | Jul. 06, 2021 ft² | Jul. 30, 2020 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Jun. 30, 2022 USD ($) | May 31, 2022 USD ($) | Mar. 29, 2022 ft² | |
Commitments And Contingencies Disclosure [Line Items] | |||||||||
Lease expiration month and year | 2023-04 | ||||||||
Operating lease, initial right-of-use asset | $ 21,998,000 | $ 23,316,000 | |||||||
Operating lease liabilities | 18,853,000 | ||||||||
Plexxikon License Agreement [Member] | |||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||
Clinical milestone achieved, triggering payment | $ 2,500,000 | ||||||||
Other milestone payments | $ 0 | ||||||||
License agreement expiration terms | The license agreement will expire on a country-by-country and licensed product-by-licensed product basis until the later of the last to expire of the patents covering such licensed products or services or the 10-year anniversary of the date of first commercial sale of the licensed product in such country. The Company may terminate the license agreement within 30 days after written notice in the event of a material breach. The Company may also terminate the agreement upon written notice in the event of the Company’s bankruptcy, liquidation or insolvency. In addition, the Company has the right to terminate this agreement in its entirety at will upon 90 days’ advance written notice to Plexxikon. | ||||||||
Waltham Sublease [Member] | |||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||
Operating lease liabilities | $ 2,900,000 | ||||||||
Security deposit amount | $ 400,000 | ||||||||
Square feet of office space | ft² | 17,749 | ||||||||
Sublease term of contract | 4 years 4 months | ||||||||
Initial base rent per square foot per year | $ / ft² | 42.5 | ||||||||
Sublease commencement date | Jun. 01, 2022 | ||||||||
Rent annual increase per square foot | $ / ft² | 1 | ||||||||
Sublease expiration date | Sep. 30, 2026 | ||||||||
Maximum [Member] | Plexxikon License Agreement [Member] | |||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||
Aggregate payments received upon satisfaction of clinical milestones | $ 7,500,000 | ||||||||
Aggregate payments received | $ 25,000,000 | ||||||||
Office and Laboratory Space [Member] | The Boulder Lease [Member] | |||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||
Lessee, operating lease, existence of option to extend | true | ||||||||
Operating Lease payments description | Boulder Lease payments began in June 2023 after an initial free rent period. | ||||||||
Operating lease, initial right-of-use asset | 22,300,000 | ||||||||
Operating lease liabilities | 22,300,000 | ||||||||
Area of lease agreement | ft² | 38,075 | ||||||||
Lease description | The Boulder Lease has an initial term of 12 years with the option to extend for three successive five-year terms. | ||||||||
Lease, term of contract | 12 years | ||||||||
Security deposit amount | $ 700,000 | ||||||||
Office and Laboratory Space [Member] | First Amendment [Member] | The Boulder Lease [Member] | |||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||
Area of lease agreement | ft² | 6,582 | ||||||||
Current restricted cash [Member] | Letter of Credit [Member] | Collateral [Member] | |||||||||
Commitments And Contingencies Disclosure [Line Items] | |||||||||
Security deposit amount | $ 1,300,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Elements of Lease Expense Net of Sublease Income (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | ||
Lease cost | ||||
Operating lease cost | $ 3,796 | $ 4,052 | $ 2,424 | |
Variable lease cost (1) | [1] | 687 | 991 | 825 |
Sublease income | (950) | (2,621) | (2,468) | |
Total lease cost | 3,533 | 2,422 | 781 | |
Other information | ||||
Cash paid for amounts included in the measurement of lease liabilities | $ 3,537 | $ 8,413 | $ 3,250 | |
Weighted average remaining lease term | 10 years 6 months 29 days | 10 years 10 months 2 days | 1 year 3 months 29 days | |
Weighted average discount rate | 8% | 8.04% | 9.50% | |
[1] The variable lease costs for the year ended December 31, 2023 include common area maintenance and other operating charges. |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Future Minimum Payments under Operating Lease (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
2024 | $ 2,780 | |
2025 | 2,841 | |
2026 | 2,697 | |
2027 | 2,132 | |
2028 | 2,179 | |
Thereafter | 15,384 | |
Total future minimum lease payments | 28,013 | |
Less: imputed interest | 9,160 | |
Operating lease liabilities | 18,853 | |
Operating lease liability | 1,386 | $ 1,423 |
Operating lease liability, net of current portion | 17,467 | $ 18,226 |
Total operating lease liability | $ 18,853 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Earnings Per Share Basic and Diluted (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |||
Net loss | $ (192,410) | $ (140,241) | $ (72,273) |
Net loss attributable to common stockholders | $ (192,410) | $ (140,241) | $ (72,273) |
Weighted average common shares outstanding, basic | 79,657,942 | 58,739,713 | 38,730,813 |
Weighted average common shares outstanding, diluted | 79,657,942 | 58,739,713 | 38,730,813 |
Net loss per common share, basic | $ (2.42) | $ (2.39) | $ (1.87) |
Net loss per common share, diluted | $ (2.42) | $ (2.39) | $ (1.87) |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Potential Dilutive Securities (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential dilutive securities excluded from computation of diluted net loss per common share | 36,618,996 | 33,094,271 | 34,615,876 |
Stock Options to Purchase Common Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential dilutive securities excluded from computation of diluted net loss per common share | 15,502,746 | 12,831,771 | 8,793,626 |
Performance-Based Restricted Stock Units Subject to Vesting [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential dilutive securities excluded from computation of diluted net loss per common share | 2,500,000 | ||
Series A Preferred Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential dilutive securities excluded from computation of diluted net loss per common share | 18,616,250 | 20,262,500 | 25,822,250 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Details) | Dec. 31, 2023 $ / shares |
Earnings Per Share [Abstract] | |
Pre-funded warrants, exercise price | $ 0.01 |
Retirement Plan - Additional In
Retirement Plan - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Defined Contribution Plan Disclosure [Line Items] | |||
Defined contribution plan, employer matching contribution percentage of match | 100% | ||
Defined contribution plan, matching amount | $ 1.2 | $ 0.8 | $ 0.4 |
Maximum [Member] | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Defined contribution plan, employer matching contribution percent | 4% |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Feb. 16, 2024 | Feb. 14, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Subsequent Event [Line Items] | ||||
Common stock, Par value | $ 0.001 | $ 0.001 | ||
Preferred stock, par value | $ 0.001 | |||
Series B Non Voting Convertible Preferred Stock [Member] | Minimum [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Converstion of shares percentage | 0% | |||
Series B Non Voting Convertible Preferred Stock [Member] | Maximum [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Converstion of shares percentage | 19.90% | |||
Purchase Agreement [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Sale of securities, value | $ 225 | |||
Number of shares convertible | 1,000 | |||
Purchase Agreement [Member] | Common Stock [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Stock issued (in shares) | 17,717,997 | |||
Common stock, Par value | $ 0.001 | |||
Stock offering price, per share | $ 7.5 | |||
Purchase Agreement [Member] | Series B Non Voting Convertible Preferred Stock [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Stock issued (in shares) | 12,280 | |||
Preferred stock, par value | $ 0.001 | |||
Stock offering price, per share | $ 7,500 | |||
Number of shares convertible | 1,000 | |||
Maximum number of shares issuable under certificate of designation | 12,280 |