Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 31, 2023 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-40671 | |
Entity Registrant Name | NUVALENT, INC. | |
Entity Central Index Key | 0001861560 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 81-5112298 | |
Entity Address, Address Line One | One Broadway | |
Entity Address, Address Line Two | 14th Floor | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02142 | |
City Area Code | 857 | |
Local Phone Number | 357-7000 | |
Title of 12(b) Security | Class A Common Stock, par value $0.0001 per share | |
Trading Symbol | NUVL | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Common Class A [Member] | ||
Document Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 57,194,841 | |
Common Class B [Member] | ||
Document Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 5,435,254 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 88,434 | $ 241,806 |
Marketable securities | 324,824 | 230,357 |
Prepaid expenses and other current assets | 6,515 | 5,828 |
Total current assets | 419,773 | 477,991 |
Other assets | 5,307 | 4,468 |
Total assets | 425,080 | 482,459 |
Current liabilities: | ||
Accounts payable | 9,781 | 7,195 |
Accrued expenses | 19,322 | 12,286 |
Total current liabilities | 29,103 | 19,481 |
Total liabilities | 29,103 | 19,481 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding | 0 | 0 |
Additional paid-in capital | 645,285 | 623,543 |
Accumulated other comprehensive loss | (1,310) | (494) |
Accumulated deficit | (248,004) | (160,077) |
Total stockholders' equity | 395,977 | 462,978 |
Total liabilities and stockholders' equity | 425,080 | 482,459 |
Common Class A [Member] | ||
Stockholders' equity: | ||
Common stock | 5 | 5 |
Common Class B [Member] | ||
Stockholders' equity: | ||
Common stock | $ 1 | $ 1 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Preferred stock, par value | $ / shares | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common Class A [Member] | ||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 140,000,000 | 140,000,000 |
Common stock, shares issued | 51,735,660 | 51,233,701 |
Common stock, shares outstanding | 51,735,660 | 51,233,701 |
Common Class B [Member] | ||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, shares issued | 5,435,254 | 5,435,254 |
Common stock, shares outstanding | 5,435,254 | 5,435,254 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating expenses: | ||||
Research and development | $ 29,611 | $ 14,625 | $ 77,658 | $ 40,876 |
General and administrative | 9,172 | 5,763 | 25,397 | 15,933 |
Total operating expenses | 38,783 | 20,388 | 103,055 | 56,809 |
Loss from operations | (38,783) | (20,388) | (103,055) | (56,809) |
Other income (expense): | ||||
Interest income and other income (expense) | 5,138 | 672 | 15,128 | 1,078 |
Total other income, net | 5,138 | 672 | 15,128 | 1,078 |
Net loss | $ (33,645) | $ (19,716) | $ (87,927) | $ (55,731) |
Net loss per share attributable to common stockholders, basic | $ (0.59) | $ (0.41) | $ (1.55) | $ (1.15) |
Net loss per share attributable to common stockholders, diluted | $ (0.59) | $ (0.41) | $ (1.55) | $ (1.15) |
Weighted average shares of common stock outstanding, basic | 57,091,394 | 48,410,514 | 56,888,839 | 48,338,580 |
Weighted average shares of common stock outstanding, diluted | 57,091,394 | 48,410,514 | 56,888,839 | 48,338,580 |
Comprehensive loss: | ||||
Net loss | $ (33,645) | $ (19,716) | $ (87,927) | $ (55,731) |
Other comprehensive income (loss): | ||||
Unrealized gains (losses) on marketable securities | 227 | 266 | (816) | (638) |
Comprehensive loss | $ (33,418) | $ (19,450) | $ (88,743) | $ (56,369) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common stock [Member] Common Class A [Member] | Common stock [Member] Common Class B [Member] | Additional paid-in capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated deficit [Member] |
Beginning Balance , Shares at Dec. 31, 2021 | 42,862,175 | 5,435,254 | ||||
Beginning Balance at Dec. 31, 2021 | $ 285,037 | $ 4 | $ 1 | $ 363,483 | $ (228) | $ (78,223) |
Issuance of common stock upon exercise of stock options , Shares | 16,572 | |||||
Issuance of common stock upon exercise of stock options | 13 | 13 | ||||
Unrealized gains (losses) on marketable securities | (791) | (791) | ||||
Stock-based compensation expense | 2,205 | 2,205 | ||||
Net loss | (17,549) | (17,549) | ||||
Ending Balance , Shares at Mar. 31, 2022 | 42,878,747 | 5,435,254 | ||||
Ending Balance at Mar. 31, 2022 | 268,915 | $ 4 | $ 1 | 365,701 | (1,019) | (95,772) |
Beginning Balance , Shares at Dec. 31, 2021 | 42,862,175 | 5,435,254 | ||||
Beginning Balance at Dec. 31, 2021 | 285,037 | $ 4 | $ 1 | 363,483 | (228) | (78,223) |
Net loss | (55,731) | |||||
Ending Balance , Shares at Sep. 30, 2022 | 43,057,073 | 5,435,254 | ||||
Ending Balance at Sep. 30, 2022 | 236,583 | $ 4 | $ 1 | 371,398 | (866) | (133,954) |
Beginning Balance , Shares at Dec. 31, 2021 | 42,862,175 | 5,435,254 | ||||
Beginning Balance at Dec. 31, 2021 | 285,037 | $ 4 | $ 1 | 363,483 | (228) | (78,223) |
Net loss | (81,900) | |||||
Ending Balance , Shares at Dec. 31, 2022 | 51,233,701 | 5,435,254 | ||||
Ending Balance at Dec. 31, 2022 | 462,978 | $ 5 | $ 1 | 623,543 | (494) | (160,077) |
Beginning Balance , Shares at Mar. 31, 2022 | 42,878,747 | 5,435,254 | ||||
Beginning Balance at Mar. 31, 2022 | 268,915 | $ 4 | $ 1 | 365,701 | (1,019) | (95,772) |
Issuance of common stock upon exercise of stock options , Shares | 22,839 | |||||
Issuance of common stock upon exercise of stock options | 200 | 200 | ||||
Unrealized gains (losses) on marketable securities | (113) | (113) | ||||
Stock-based compensation expense | 2,449 | 2,449 | ||||
Net loss | (18,466) | (18,466) | ||||
Ending Balance , Shares at Jun. 30, 2022 | 42,901,586 | 5,435,254 | ||||
Ending Balance at Jun. 30, 2022 | 252,985 | $ 4 | $ 1 | 368,350 | (1,132) | (114,238) |
Issuance of common stock upon exercise of stock options , Shares | 155,487 | |||||
Issuance of common stock upon exercise of stock options | 394 | 394 | ||||
Unrealized gains (losses) on marketable securities | 266 | 266 | ||||
Stock-based compensation expense | 2,654 | 2,654 | ||||
Net loss | (19,716) | (19,716) | ||||
Ending Balance , Shares at Sep. 30, 2022 | 43,057,073 | 5,435,254 | ||||
Ending Balance at Sep. 30, 2022 | 236,583 | $ 4 | $ 1 | 371,398 | (866) | (133,954) |
Beginning Balance , Shares at Dec. 31, 2022 | 51,233,701 | 5,435,254 | ||||
Beginning Balance at Dec. 31, 2022 | 462,978 | $ 5 | $ 1 | 623,543 | (494) | (160,077) |
Issuance of common stock upon exercise of stock options , Shares | 82,989 | |||||
Issuance of common stock upon exercise of stock options | 619 | 619 | ||||
Unrealized gains (losses) on marketable securities | 192 | 192 | ||||
Stock-based compensation expense | 5,371 | 5,371 | ||||
Net loss | (25,192) | (25,192) | ||||
Ending Balance , Shares at Mar. 31, 2023 | 51,316,690 | 5,435,254 | ||||
Ending Balance at Mar. 31, 2023 | 443,968 | $ 5 | $ 1 | 629,533 | (302) | (185,269) |
Beginning Balance , Shares at Dec. 31, 2022 | 51,233,701 | 5,435,254 | ||||
Beginning Balance at Dec. 31, 2022 | 462,978 | $ 5 | $ 1 | 623,543 | (494) | (160,077) |
Net loss | (87,927) | |||||
Ending Balance , Shares at Sep. 30, 2023 | 51,735,660 | 5,435,254 | ||||
Ending Balance at Sep. 30, 2023 | 395,977 | $ 5 | $ 1 | 645,285 | (1,310) | (248,004) |
Beginning Balance , Shares at Mar. 31, 2023 | 51,316,690 | 5,435,254 | ||||
Beginning Balance at Mar. 31, 2023 | 443,968 | $ 5 | $ 1 | 629,533 | (302) | (185,269) |
Issuance of common stock upon exercise of stock options , Shares | 202,210 | |||||
Issuance of common stock upon exercise of stock options | 1,469 | 1,469 | ||||
Issuance of common stock under employee stock purchase plan, shares | 6,575 | |||||
Issuance of common stock under employee stock purchase plan | 193 | 193 | ||||
Unrealized gains (losses) on marketable securities | (1,235) | (1,235) | ||||
Stock-based compensation expense | 5,848 | 5,848 | ||||
Net loss | (29,090) | (29,090) | ||||
Ending Balance , Shares at Jun. 30, 2023 | 51,525,475 | 5,435,254 | ||||
Ending Balance at Jun. 30, 2023 | 421,153 | $ 5 | $ 1 | 637,043 | (1,537) | (214,359) |
Issuance of common stock upon exercise of stock options , Shares | 210,185 | |||||
Issuance of common stock upon exercise of stock options | 1,388 | 1,388 | ||||
Unrealized gains (losses) on marketable securities | 227 | 227 | ||||
Stock-based compensation expense | 6,854 | 6,854 | ||||
Net loss | (33,645) | (33,645) | ||||
Ending Balance , Shares at Sep. 30, 2023 | 51,735,660 | 5,435,254 | ||||
Ending Balance at Sep. 30, 2023 | $ 395,977 | $ 5 | $ 1 | $ 645,285 | $ (1,310) | $ (248,004) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (87,927) | $ (55,731) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 18,073 | 7,308 |
Net amortization (accretion) of premiums (discounts) on marketable securities | (8,017) | 460 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 712 | (844) |
Other assets | (839) | (1,117) |
Accounts payable | 2,676 | 1,727 |
Accrued expenses | 5,792 | 1,005 |
Net cash used in operating activities | (69,530) | (47,192) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (292,764) | (50,293) |
Proceeds from sales and maturities of marketable securities | 205,498 | 105,029 |
Net cash provided by (used in) investing activities | (87,266) | 54,736 |
Cash flows from financing activities: | ||
Payments of insurance costs financed by a third-party | (155) | (364) |
Proceeds from issuance of common stock upon option exercise | 3,476 | 607 |
Proceeds from issuance of common stock under employee stock purchase plan | 193 | |
Payments of offering costs | (90) | |
Net cash provided by financing activities | 3,424 | 243 |
Net increase (decrease) in cash and cash equivalents | (153,372) | 7,787 |
Cash and cash equivalents at beginning of period | 241,806 | 68,526 |
Cash and cash equivalents at end of period | 88,434 | 76,313 |
Supplemental disclosure of noncash financing information: | ||
Insurance premium financed by a third-party | $ 1,399 | $ 1,820 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business and Basis of Presentation | 1. Nature of Business and Basis of Presentation Nuvalent, Inc. (the “Company”) is a clinical stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer. The Company was founded in January 2017 as a Delaware corporation. The Company is headquartered in Cambridge, Massachusetts. The Company is subject to risks similar to those of other pre-commercial stage companies in the biopharmaceutical industry, including dependence on key individuals, the need to develop commercially viable products, competition from other companies, many of which are larger and better capitalized, the need to obtain adequate additional financing to fund the development of its product candidates, and the impact of public health emergencies, natural disasters and global geopolitical events on the Company’s business. There can be no assurance that the Company’s research and development will be successful, that adequate protection for the Company’s intellectual property will be obtained and maintained, that any product candidates will receive required regulatory approval or that approved products, if any, will be commercially viable. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from the sale of its products. On October 19, 2023, the Company issued and sold 5,357,143 shares of Class A common stock in a follow-on public offering at a public offering price of $ 56.00 per share, resulting in proceeds of $ 282.0 million after deducting underwriting discounts and commissions but before deducting offering costs (see Note 10). Basis of presentation The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, Nuvalent Securities Corporation. All intercompany balances and transactions have been eliminated in consolidation. The Company has incurred recurring losses since inception, including net losses of $ 87.9 million for the nine months ended September 30, 2023 , and $ 81.9 million for the year ended December 31, 2022. As of September 30, 2023, the Company had an accumulated deficit of $ 248.0 million. The Company expects to continue to generate operating losses for the foreseeable future. The Company believes that its existing cash, cash equivalents and marketable securities, including the proceeds from its follow-on public offering in October 2023, will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the date of issuance of these consolidated financial statements. The Company will need to obtain additional funding through public or private equity offerings, debt financings or strategic alliances. 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 strategic alliances. 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 programs. If the Company is unable to obtain funding, the Company will be required to delay, reduce or eliminate some or all of its research and development programs or the Company may be unable to continue operations. Although management will continue to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations when needed or at all. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The Company is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). The JOBS Act provides that an emerging growth company can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. The Company elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or non-public entities, the Company is required to adopt the new or revised standard at the time non-public entities adopt the new or revised standard. Because the market value of the Company’s Class A common stock held by non-affiliates exceeded $ 700.0 million as of June 30, 2023, the Company has been public for more than one year and it has filed at least one annual report, the Company will cease to be an emerging growth company as of December 31, 2023. As a result, beginning with the Company’s Annual Report on Form 10-K for the year ending December 31, 2023, the Company will be subject to certain requirements that apply to other public companies but did not previously apply to the Company due to its status as an emerging growth company, including the provisions of Section 404 of the Sarbanes-Oxley Act, which require that the Company’s independent registered public accounting firm provides an attestation report on the effectiveness of the Company’s internal control over financial reporting, and the Company will no longer be able to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. Use of estimates The preparation of 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 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 valuation of stock-based awards and the accrual of research and development expenses. 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. Unaudited interim financial information The consolidated balance sheet at December 31, 2022, was derived from audited consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited consolidated financial statements as of September 30, 2023, and for the three and nine months ended September 30, 2023 and 2022, have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the consolidated financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2022, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, on file with the SEC. In the opinion of management, these consolidated financial statements reflect all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of the Company’s financial position as of September 30, 2023, and results of operations for the three and nine months ended September 30, 2023 and 2022, and cash flows for the nine months ended September 30, 2023 and 2022. The Company’s results of operations for the three and nine months ended September 30, 2023, are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023 . 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. The Company’s investments are comprised of commercial paper and corporate bonds of corporations and U.S. treasury and U.S. government agency debt securities. As of September 30, 2023 and December 31, 2022, the Company maintained cash, cash equivalents and marketable securities balances in excess of federally insured limits. However, the Company mitigates credit risk by maintaining a diversified portfolio, placing its cash with high credit quality financial institutions and limiting the amount of investment exposure as to institution, maturity and investment type. The Company is dependent on third-party vendors for the manufacturing of its product candidates. In particular, the Company relies, and expects to continue to rely, on a small number of vendors to manufacture materials and components required for the production of its product candidates. These programs could be adversely affected by a significant interruption in the manufacturing process. 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 4). 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. Marketable securities The Company’s marketable securities (non-equity instruments) are classified as available-for-sale and are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses are based on the specific identification method and are included as a component of other income (expense), net in the consolidated statements of operations and comprehensive loss. The Company classifies its marketable securities with maturities beyond one year as short-term, based on their highly liquid nature and because such marketable securities are available for current operations. Effective January 1, 2023, when the fair value is below the amortized cost of a marketable security, an estimate of expected credit losses is made. The credit-related impairment amount is recognized in the consolidated statements of operations and comprehensive loss. Credit losses are recognized through the use of an allowance for credit losses account in the consolidated balance sheet and subsequent improvements in expected credit losses are recognized as a reversal of an amount in the allowance account. If the Company intends to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis, then the allowance for the credit loss is written-off and the excess of the amortized cost basis of the asset over its fair value is recorded in the consolidated statements of operations and comprehensive loss. There were no credit losses recorded during the three and nine months ended September 30, 2023 . Net income (loss) per share Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) 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 and unvested restricted stock units. For periods in which the Company reported a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their affect is anti-dilutive. The Company has two classes of common stock outstanding: Class A common stock and Class B common stock. The rights of the holders of Class A and Class B common stock are substantially identical, except with respect to voting and conversion. Each share of Class B common stock is convertible into one share of Class A common stock at the option of the holder at any time, subject to the ownership limitations provided for in the Company’s amended and restated certificate of incorporation. The Company allocates undistributed earnings attributable to common stock between the common stock classes on a one-to-one basis when computing net income (loss) per share. As a result, basic and diluted net income (loss) per share of Class A common stock and share of Class B common stock are equivalent. 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 because including them would have had an anti-dilutive effect: As of September 30, 2023 2022 Options to purchase common stock 8,530,387 6,577,891 8,530,387 6,577,891 Recently adopted accounting pronouncements Effective January 1, 2023 , the Company adopted ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments for the year ending December 31, 2023. The new standard adjusts the accounting for assets held at amortized cost basis, including marketable securities accounted for as available for sale, and trade receivables. The standard eliminates the probable initial recognition threshold and requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. The adoption of this standard did no t have a material impact on the Company’s consolidated financial statements and related disclosures. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2023 | |
Marketable Securities [Abstract] | |
Marketable Securities | 3. Marketable Securities Marketable securities by security type consisted of the following (in thousands): September 30, 2023 Amortized Gross Gross Fair Value Commercial paper (due within one year) $ 94,686 $ — $ ( 124 ) $ 94,562 Corporate bonds (due within one year) 70,504 — ( 354 ) 70,150 Government securities (due within one year) 74,856 — ( 257 ) 74,599 U.S. treasury securities (due within one year) 23,821 — ( 34 ) 23,787 Corporate bonds (due after one year through three years) 55,417 — ( 481 ) 54,936 Government securities (due after one year through 4,845 — ( 36 ) 4,809 U.S. treasury securities (due after one year through 2,005 — ( 24 ) 1,981 $ 326,134 $ — $ ( 1,310 ) $ 324,824 December 31, 2022 Amortized Gross Gross Fair Value Commercial paper (due within one year) $ 90,685 $ 1 $ ( 93 ) $ 90,593 Corporate bonds (due within one year) 70,668 1 ( 332 ) 70,337 Government securities (due within one year) 19,267 22 ( 28 ) 19,261 U.S. treasury securities (due within one year) 28,560 — ( 23 ) 28,537 Corporate bonds (due after one year through 5,262 — ( 18 ) 5,244 Government securities (due after one year through 16,409 — ( 24 ) 16,385 $ 230,851 $ 24 $ ( 518 ) $ 230,357 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The following tables present the Company’s fair value hierarchy for its assets, which are measured at fair value on a recurring basis (in thousands): Fair Value Measurements at September 30, 2023: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 55,745 $ — $ — $ 55,745 Marketable securities: Commercial paper — 94,562 — 94,562 Corporate bonds — 125,086 — 125,086 Government securities — 79,408 — 79,408 U.S. treasury securities — 25,768 — 25,768 $ 55,745 $ 324,824 $ — $ 380,569 Fair Value Measurements at December 31, 2022: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 240,803 $ — $ — $ 240,803 Marketable securities: Commercial paper — 90,593 — 90,593 Corporate bonds — 75,581 — 75,581 Government securities — 35,646 — 35,646 U.S. treasury securities — 28,537 — 28,537 $ 240,803 $ 230,357 $ — $ 471,160 Money market funds were valued by the Company based on quoted market prices for identical securities, which represent a Level 1 measurement within the fair value hierarchy. Commercial paper, corporate bonds, government securities and U.S. treasury securities 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. During the three and nine months ended September 30, 2023 and 2022 , there were no transfers in or out of Level 3. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Expenses | 5. Accrued Expenses Accrued expenses consisted of the following (in thousands): September 30, 2023 December 31, 2022 Accrued employee compensation and benefits $ 4,465 $ 4,852 Accrued external research and development expenses 13,036 5,944 Other 1,821 1,490 $ 19,322 $ 12,286 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 6. Stock-Based Compensation 2021 stock option and incentive plan On July 23, 2021, the Company’s board of directors adopted and its stockholders approved the 2021 Stock Option and Incentive Plan (the “2021 Plan”), which became effective on July 28, 2021. The 2021 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock units, unrestricted stock awards, cash-based awards and dividend equivalent rights. The number of shares of Class A common stock reserved for issuance under the 2021 Plan shall be increased on each January 1 by 5.0 % of the number of shares of the Company’s Class A and Class B common stock outstanding on the immediately preceding December 31 or such lesser number of shares determined by the Company’s board of directors or compensation committee of the board of directors. The number of shares of Class A common stock reserved for issuance was increased by 2,833,447 shares effective as of January 1, 2023, in accordance with the provisions of the 2021 Plan described above. The shares of Class A common stock underlying any awards that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of stock, expired or are otherwise terminated (other than by exercise) under the 2021 Plan and the Company’s previously outstanding 2017 Stock Option and Grant Plan will be added back to the shares of Class A common stock available under the 2021 Plan. As of September 30, 2023 , 5,923,195 shares of Class A common stock remained available for future issuance under the 2021 Plan. 2021 employee stock purchase plan On July 23, 2021, the Company’s board of directors adopted and its stockholders approved the 2021 Employee Stock Purchase Plan, which became effective on July 28, 2021. The Company’s board of directors approved the amendment and restatement of the 2021 Employee Stock Purchase Plan in its entirety on June 16, 2022 (as amended and restated, the “ESPP”). The ESPP permits eligible employees to purchase shares of Class A common stock at a discount and consists of consecutive, overlapping 12-month offering periods, each consisting of two six-month purchase periods beginning in December and June. On the first day of each offering period, the Company will grant to each employee who is enrolled in the ESPP an option to purchase up to a whole number of shares of Class A common stock. The purchase price of each of the shares purchased in a given purchase period will be 85 % of the closing price of a share of the Class A common stock on the first day of the offering period or the last day of the purchase period, whichever is lower. The number of shares of Class A common stock that may be issued under the ESPP will automatically increase on each January through January 1, 2031, by the least of (i) 473,064 shares of Class A common stock, (ii) 1 % of the number of shares of the Company’s Class A and Class B common stock outstanding on the immediately preceding December 31 or (iii) such lesser number of shares as determined by the administrator of the ESPP. The initial offering period of the ESPP commenced on December 1, 2022. The number of shares of Class A common stock reserved for issuance was increased by 473,064 shares effective as of January 1, 2023, in accordance with the provisions of the ESPP described above. During the nine months ended September 30, 2023 , 6,575 shares were sold under the ESPP. As of September 30, 2023 , 1,412,617 shares remained available for issuance and sale. Option grants During the nine months ended September 30, 2023 , the Company granted options to its employees and directors with service-based vesting for the purchase of an aggregate of 2,572,030 shares of Class A common stock with a total grant-date fair value of $ 55.8 million. Stock-based compensation The Company recorded stock-based compensation expense related to common stock options and restricted common stock in the following expense categories of its consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development expenses $ 3,016 $ 1,019 $ 8,222 $ 2,985 General and administrative expenses 3,838 1,635 9,851 4,323 $ 6,854 $ 2,654 $ 18,073 $ 7,308 As of September 30, 2023 , total unrecognized compensation cost related to common stock options was $ 68.5 million, which is expected to be recognized over a weighted average period of 2.8 years. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Leases The Company leases office space pursuant to a month-to month lease and as such categorizes all of its lease expense as short-term lease cost. During the three months ended September 30, 2023 and 2022 , the Company recorded short-term lease costs of $ 0.1 million and less than $ 0.1 million, respectively. During the nine months ended September 30, 2023 and 2022 , the Company recorded short-term lease costs of $ 0.2 million and $ 0.1 million, respectively. Revenue share The Company has revenue sharing agreements with Deerfield Healthcare Innovations Fund, L.P. and Deerfield Private Design Fund, IV, L.P. (collectively, “Deerfield”), each an investor in the Company, and the Company’s scientific founder to pay each of Deerfield and the scientific founder a low single digit percentage rate of net sales of certain commercial products. The payment obligation expires on the later of 12 years from the first commercial sale in a country or the expiration of the last-to-expire patent in that country for both Deerfield and the Company’s scientific founder. The Company accounts for the liability with Deerfield at fair value with changes recognized in the consolidated statements of operations and comprehensive loss. The Company accounts for the obligation to the scientific founder as a contingent liability. Given the early-stage nature of the underlying technology and inherent risks associated with obtaining regulatory approval and achieving commercialization, the Company ascribed no value to the revenue sharing agreements with Deerfield at inception and at September 30, 2023 and December 31, 2022 . The Company currently does not have any net sales and as a result has paid no amounts under these agreements no r has the Company accrued any liability as of September 30, 2023 and December 31, 2022 under these agreements. Indemnification agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, contract research organizations, 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. The Company has not incurred any material costs as a result of such indemnifications and is not currently aware of any indemnification claims. |
Defined Contribution Plan
Defined Contribution Plan | 9 Months Ended |
Sep. 30, 2023 | |
Defined Contribution Plan [Abstract] | |
Defined Contribution Plan | 8. Defined Contribution Plan The Company has a 401(k) defined contribution plan (the “401(k) Plan”) for its employees. Eligible employees may make pretax and after-tax contributions to the 401(k) Plan up to statutory limits. The Company has established a match program for employee contributions to the 401(k) Plan up to a maximum of six percent of the employee’s salary. For the three months ended September 30, 2023 and 2022 , the Company recorded expense of $ 0.3 million and $ 0.2 million, respectively, related to these matching contributions. For the nine months ended September 30, 2023 and 2022 , the Company recorded expense of $ 0.8 million and $ 0.5 million, respectively, related to these matching contributions. |
Related Parties
Related Parties | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Parties | 9. Related Parties The Company is obligated to pay low single digit percentage rates of net sales of certain commercial products to Deerfield and its scientific founder. As of September 30, 2023 and December 31, 2022 , no products have been commercialized and no amounts have been paid or become due (see Note 7). In February 2017, the Company entered into a three-year consulting agreement with the scientific founder of the Company who is also a board member and a stockholder. The consulting agreement between the scientific founder and the Company continues at will. During each of the three months ended September 30, 2023 and 2022 , the Company paid the scientific founder $ 0.1 million. During each of the nine months ended September 30, 2023 and 2022 , the Company paid the scientific founder $ 0.2 million. As of September 30, 2023 and December 31, 2022 , the Company had no accounts payable and less than $ 0.1 million in accounts payable, respectively, to the scientific founder. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 10. Subsequent Events On October 19, 2023, the Company issued and sold 5,357,143 shares of Class A common stock in a follow-on public offering at a public offering price of $ 56.00 per share, resulting in proceeds of $ 282.0 million after underwriting discounts and commission but before deducting offering costs. In addition, the underwriters have an option to purchase, within 30 days following the date of the prospectus filed in connection with the public offering, up to an additional 803,571 shares at the public offering price of $ 56.00 per share. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Use of estimates | Use of estimates The preparation of 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 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 valuation of stock-based awards and the accrual of research and development expenses. 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. |
Unaudited interim financial information | Unaudited interim financial information The consolidated balance sheet at December 31, 2022, was derived from audited consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited consolidated financial statements as of September 30, 2023, and for the three and nine months ended September 30, 2023 and 2022, have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the consolidated financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2022, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, on file with the SEC. In the opinion of management, these consolidated financial statements reflect all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of the Company’s financial position as of September 30, 2023, and results of operations for the three and nine months ended September 30, 2023 and 2022, and cash flows for the nine months ended September 30, 2023 and 2022. The Company’s results of operations for the three and nine months ended September 30, 2023, are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023 . |
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. The Company’s investments are comprised of commercial paper and corporate bonds of corporations and U.S. treasury and U.S. government agency debt securities. As of September 30, 2023 and December 31, 2022, the Company maintained cash, cash equivalents and marketable securities balances in excess of federally insured limits. However, the Company mitigates credit risk by maintaining a diversified portfolio, placing its cash with high credit quality financial institutions and limiting the amount of investment exposure as to institution, maturity and investment type. The Company is dependent on third-party vendors for the manufacturing of its product candidates. In particular, the Company relies, and expects to continue to rely, on a small number of vendors to manufacture materials and components required for the production of its product candidates. These programs could be adversely affected by a significant interruption in the manufacturing process. |
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 4). 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. |
Marketable securities | Marketable securities The Company’s marketable securities (non-equity instruments) are classified as available-for-sale and are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses are based on the specific identification method and are included as a component of other income (expense), net in the consolidated statements of operations and comprehensive loss. The Company classifies its marketable securities with maturities beyond one year as short-term, based on their highly liquid nature and because such marketable securities are available for current operations. Effective January 1, 2023, when the fair value is below the amortized cost of a marketable security, an estimate of expected credit losses is made. The credit-related impairment amount is recognized in the consolidated statements of operations and comprehensive loss. Credit losses are recognized through the use of an allowance for credit losses account in the consolidated balance sheet and subsequent improvements in expected credit losses are recognized as a reversal of an amount in the allowance account. If the Company intends to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis, then the allowance for the credit loss is written-off and the excess of the amortized cost basis of the asset over its fair value is recorded in the consolidated statements of operations and comprehensive loss. There were no credit losses recorded during the three and nine months ended September 30, 2023 . |
Net income (loss) per share | Net income (loss) per share Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) 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 and unvested restricted stock units. For periods in which the Company reported a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their affect is anti-dilutive. The Company has two classes of common stock outstanding: Class A common stock and Class B common stock. The rights of the holders of Class A and Class B common stock are substantially identical, except with respect to voting and conversion. Each share of Class B common stock is convertible into one share of Class A common stock at the option of the holder at any time, subject to the ownership limitations provided for in the Company’s amended and restated certificate of incorporation. The Company allocates undistributed earnings attributable to common stock between the common stock classes on a one-to-one basis when computing net income (loss) per share. As a result, basic and diluted net income (loss) per share of Class A common stock and share of Class B common stock are equivalent. 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 because including them would have had an anti-dilutive effect: As of September 30, 2023 2022 Options to purchase common stock 8,530,387 6,577,891 8,530,387 6,577,891 |
Recently adopted accounting pronouncements | Recently adopted accounting pronouncements Effective January 1, 2023 , the Company adopted ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments for the year ending December 31, 2023. The new standard adjusts the accounting for assets held at amortized cost basis, including marketable securities accounted for as available for sale, and trade receivables. The standard eliminates the probable initial recognition threshold and requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. The adoption of this standard did no t have a material impact on the Company’s consolidated financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings 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 because including them would have had an anti-dilutive effect: As of September 30, 2023 2022 Options to purchase common stock 8,530,387 6,577,891 8,530,387 6,577,891 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Marketable Securities [Abstract] | |
Summary of Marketable securities by Security | Marketable securities by security type consisted of the following (in thousands): September 30, 2023 Amortized Gross Gross Fair Value Commercial paper (due within one year) $ 94,686 $ — $ ( 124 ) $ 94,562 Corporate bonds (due within one year) 70,504 — ( 354 ) 70,150 Government securities (due within one year) 74,856 — ( 257 ) 74,599 U.S. treasury securities (due within one year) 23,821 — ( 34 ) 23,787 Corporate bonds (due after one year through three years) 55,417 — ( 481 ) 54,936 Government securities (due after one year through 4,845 — ( 36 ) 4,809 U.S. treasury securities (due after one year through 2,005 — ( 24 ) 1,981 $ 326,134 $ — $ ( 1,310 ) $ 324,824 December 31, 2022 Amortized Gross Gross Fair Value Commercial paper (due within one year) $ 90,685 $ 1 $ ( 93 ) $ 90,593 Corporate bonds (due within one year) 70,668 1 ( 332 ) 70,337 Government securities (due within one year) 19,267 22 ( 28 ) 19,261 U.S. treasury securities (due within one year) 28,560 — ( 23 ) 28,537 Corporate bonds (due after one year through 5,262 — ( 18 ) 5,244 Government securities (due after one year through 16,409 — ( 24 ) 16,385 $ 230,851 $ 24 $ ( 518 ) $ 230,357 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value Assets Measured on Recurring Basis | The following tables present the Company’s fair value hierarchy for its assets, which are measured at fair value on a recurring basis (in thousands): Fair Value Measurements at September 30, 2023: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 55,745 $ — $ — $ 55,745 Marketable securities: Commercial paper — 94,562 — 94,562 Corporate bonds — 125,086 — 125,086 Government securities — 79,408 — 79,408 U.S. treasury securities — 25,768 — 25,768 $ 55,745 $ 324,824 $ — $ 380,569 Fair Value Measurements at December 31, 2022: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 240,803 $ — $ — $ 240,803 Marketable securities: Commercial paper — 90,593 — 90,593 Corporate bonds — 75,581 — 75,581 Government securities — 35,646 — 35,646 U.S. treasury securities — 28,537 — 28,537 $ 240,803 $ 230,357 $ — $ 471,160 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): September 30, 2023 December 31, 2022 Accrued employee compensation and benefits $ 4,465 $ 4,852 Accrued external research and development expenses 13,036 5,944 Other 1,821 1,490 $ 19,322 $ 12,286 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of stock-based compensation expenses | The Company recorded stock-based compensation expense related to common stock options and restricted common stock in the following expense categories of its consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development expenses $ 3,016 $ 1,019 $ 8,222 $ 2,985 General and administrative expenses 3,838 1,635 9,851 4,323 $ 6,854 $ 2,654 $ 18,073 $ 7,308 |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Oct. 19, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Net loss | $ 33,645 | $ 29,090 | $ 25,192 | $ 19,716 | $ 18,466 | $ 17,549 | $ 87,927 | $ 55,731 | $ 81,900 | |
Accumulated deficit | $ 248,004 | $ 248,004 | $ 160,077 | |||||||
Common Class A [Member] | Subsequent Event [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Stock issued during period shares new shares | 5,357,143 | |||||||||
Shares issued price per share | $ 56 | |||||||||
Net proceeds from issuance of common stock in follow-on public offering after underwriting discounts and commission and offering costs | $ 282,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Detail) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 8,530,387 | 6,577,891 |
Options to purchase common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 8,530,387 | 6,577,891 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Marketable securities credit loss | $ 0 | $ 0 | |
Common Class A [Member] | Minimum [Member] | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Market value stock held by non affiliates | $ 700,000,000 | ||
ASU 2016-13 [Member] | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Change in accounting principle, accounting standards update, adopted [true false] | true | true | |
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2023 | Jan. 01, 2023 | |
Change in accounting principle, accounting standards update, immaterial effect [true false] | true | true |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable securities by Security (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 326,134 | $ 230,851 |
Gross Unrealized Gains | 24 | |
Gross Unrealized Losses | (1,310) | (518) |
Fair Value | 324,824 | 230,357 |
Commercial paper [Member] | Due within one year [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 94,686 | 90,685 |
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | (124) | (93) |
Fair Value | 94,562 | 90,593 |
Government Securities [Member] | Due from one to two years [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 4,845 | 16,409 |
Gross Unrealized Losses | (36) | (24) |
Fair Value | 4,809 | 16,385 |
Government Securities [Member] | Due within one year [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 74,856 | 19,267 |
Gross Unrealized Gains | 22 | |
Gross Unrealized Losses | (257) | (28) |
Fair Value | 74,599 | 19,261 |
US Treasury Securities [Member] | Due from one to two years [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 2,005 | |
Gross Unrealized Losses | (24) | |
Fair Value | 1,981 | |
US Treasury Securities [Member] | Due within one year [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 23,821 | 28,560 |
Gross Unrealized Losses | (34) | (23) |
Fair Value | 23,787 | 28,537 |
Corporate bonds [Member] | Due from one to two years [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 5,262 | |
Gross Unrealized Losses | (18) | |
Fair Value | 5,244 | |
Corporate bonds [Member] | Due from one to three years [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 55,417 | |
Gross Unrealized Losses | (481) | |
Fair Value | 54,936 | |
Corporate bonds [Member] | Due within one year [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 70,504 | 70,668 |
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | (354) | (332) |
Fair Value | $ 70,150 | $ 70,337 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value Assets Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 324,824 | $ 230,357 |
Fair Value Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 380,569 | 471,160 |
Fair Value Recurring [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 55,745 | 240,803 |
Fair Value Recurring [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 94,562 | 90,593 |
Fair Value Recurring [Member] | Corporate bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 125,086 | 75,581 |
Fair Value Recurring [Member] | Government securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 79,408 | 35,646 |
Fair Value Recurring [Member] | U.S. treasury securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 25,768 | 28,537 |
Fair Value Recurring [Member] | Fair value, inputs, level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 55,745 | 240,803 |
Fair Value Recurring [Member] | Fair value, inputs, level 1 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 55,745 | 240,803 |
Fair Value Recurring [Member] | Fair value, inputs, level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 324,824 | 230,357 |
Fair Value Recurring [Member] | Fair value, inputs, level 2 [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 94,562 | 90,593 |
Fair Value Recurring [Member] | Fair value, inputs, level 2 [Member] | Corporate bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 125,086 | 75,581 |
Fair Value Recurring [Member] | Fair value, inputs, level 2 [Member] | Government securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 79,408 | 35,646 |
Fair Value Recurring [Member] | Fair value, inputs, level 2 [Member] | U.S. treasury securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 25,768 | $ 28,537 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||||
Fair value transfers in or out of Level 3 | $ 0 | $ 0 | $ 0 | $ 0 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] | ||
Accrued employee compensation and benefits | $ 4,465 | $ 4,852 |
Accrued external research and development expenses | 13,036 | 5,944 |
Other | 1,821 | 1,490 |
Total Accrued expenses | $ 19,322 | $ 12,286 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Millions | 9 Months Ended | ||
Jan. 01, 2023 | Jul. 28, 2021 | Sep. 30, 2023 | |
Unrecognized compensation cost related to common stock options | $ 68.5 | ||
Share based payment weighted average period | 2 years 9 months 18 days | ||
2021 Stock Option and Incentive Plan [Member] | Common Class A [Member] | |||
Shares available for future issuance | 5,923,195 | ||
Number of additional authorized shares reserved | 2,833,447 | ||
2021 Employee Stock Purchase Plan [Member] | |||
Shares available for future issuance | 1,412,617 | ||
Number of additional authorized shares reserved | 473,064 | ||
Number of shares issued | 6,575 | ||
2021 Employee Stock Purchase Plan [Member] | Common Class A [Member] | |||
Percentage of purchase price of each shares purchased | 85% | ||
Service Based [Member] | Employees and Directors [Member] | |||
Service-based vesting options granted | 2,572,030 | ||
Aggregate fair value of restricted stock, vested | $ 55.8 | ||
Maximum [Member] | 2021 Stock Option and Incentive Plan [Member] | Common Class A [Member] | Class A And Class B Common Stock Outstanding [Member] | |||
Share based compensation arrangement by share based payment award annual increase percentage | 5% | ||
Maximum [Member] | 2021 Employee Stock Purchase Plan [Member] | Common Class A [Member] | |||
Share based compensation arrangement by share based payment award annual increase amount | 473,064 | ||
Maximum [Member] | 2021 Employee Stock Purchase Plan [Member] | Common Class A [Member] | Class A And Class B Common Stock Outstanding [Member] | |||
Share based compensation arrangement by share based payment award annual increase percentage | 1% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-Based Compensation Expenses (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation | $ 6,854 | $ 2,654 | $ 18,073 | $ 7,308 |
Research and Development Expenses [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation | 3,016 | 1,019 | 8,222 | 2,985 |
General and Administrative Expenses [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation | $ 3,838 | $ 1,635 | $ 9,851 | $ 4,323 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Accrued liability | $ 0 | $ 0 | $ 0 | ||
Short-term lease cost | $ 100,000 | $ 200,000 | $ 100,000 | ||
Maximum [Member] | |||||
Short-term lease cost | $ 100,000 |
Defined Contribution Plan - Add
Defined Contribution Plan - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Defined contribution plan, employer discretionary contribution amount | $ 0.3 | $ 0.2 | $ 0.8 | $ 0.5 |
Defined contribution plan employer matching contribution percent of match | 6% |
Related Parties - Additional In
Related Parties - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Deerfield And Scientific Founder [Member] | |||||
Related party amounts paid | $ 0 | $ 0 | |||
Consulting Agreement [Member] | |||||
Related party amounts paid | $ 100,000 | $ 100,000 | 200,000 | $ 200,000 | |
Accounts payable, related parties | $ 0 | $ 0 | |||
Consulting Agreement [Member] | Maximum [Member] | |||||
Accounts payable, related parties | $ 100,000 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Event [Member] - Common Class A [Member] $ / shares in Units, $ in Millions | Oct. 19, 2023 USD ($) $ / shares shares |
Subsequent Event [Line Items] | |
Stock issued during period shares new shares | shares | 5,357,143 |
Net proceeds from issuance of common stock in follow-on public offering after underwriting discounts and commission and offering costs | $ | $ 282 |
Shares issued price per share | $ / shares | $ 56 |
Underwriters | |
Subsequent Event [Line Items] | |
Shares issued price per share | $ / shares | $ 56 |
Common stock shares available for sale | shares | 803,571 |
Common stock shares available for sale period | 30 days |