Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 02, 2023 | |
Cover [Abstract] | ||
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 | |
Entity Registrant Name | INVIVYD, INC. | |
Entity Central Index Key | 0001832038 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-40703 | |
Entity Tax Identification Number | 85-1403134 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 1601 Trapelo Road | |
Entity Address, Address Line Two | Suite 178 | |
Entity Address, City or Town | Waltham | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02451 | |
City Area Code | 781 | |
Local Phone Number | 819-0080 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | IVVD | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 110,114,960 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 181,822 | $ 92,076 |
Marketable securities | 83,063 | 279,915 |
Prepaid expenses and other current assets | 5,218 | 4,926 |
Total current assets | 270,103 | 376,917 |
Property and equipment, net | 2,002 | 2,282 |
Operating lease right-of-use asset | 2,625 | 3,777 |
Other non-current assets | 187 | 191 |
Total assets | 274,917 | 383,167 |
Current liabilities: | ||
Accounts payable | 9,168 | 1,517 |
Accrued expenses | 15,958 | 21,911 |
Operating lease liability, current | 1,638 | 1,559 |
Other current liabilities | 27 | 44 |
Total current liabilities | 26,791 | 25,031 |
Operating lease liability, non-current | 927 | 2,165 |
Other non-current liability | 700 | 0 |
Early-exercise liability | 0 | 1 |
Total liabilities | 28,418 | 27,197 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity (deficit): | ||
Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding at September 30, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 109,846,329 shares issued and outstanding at September 30, 2023; 109,044,046 shares issued and outstanding at December 31, 2022 | 11 | 11 |
Additional paid-in capital | 904,905 | 889,657 |
Accumulated other comprehensive loss | (2) | (272) |
Accumulated deficit | (658,415) | (533,426) |
Total stockholders' equity | 246,499 | 355,970 |
Total liabilities, preferred stock and stockholders' equity | $ 274,917 | $ 383,167 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (PARENTHETICAL) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Preferred stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 1,000,000,000 | 1,000,000,000 |
Common stock, shares issued (in shares) | 109,846,329 | 109,044,046 |
Common stock, shares outstanding (in shares) | 109,846,329 | 109,044,046 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) - 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 | [1] | $ 25,574 | $ 30,131 | $ 96,393 | $ 159,295 |
Acquired in-process research and development | [2] | 4,600 | 4,000 | 5,575 | 4,000 |
Selling, general and administrative | 12,886 | 13,200 | 34,038 | 36,524 | |
Total operating expenses | 43,060 | 47,331 | 136,006 | 199,819 | |
Loss from operations | (43,060) | (47,331) | (136,006) | (199,819) | |
Other income (expense): | |||||
Other income | 3,620 | 2,244 | 11,017 | 3,076 | |
Total other income | 3,620 | 2,244 | 11,017 | 3,076 | |
Net loss | (39,440) | (45,087) | (124,989) | (196,743) | |
Other comprehensive income (loss) | |||||
Unrealized gain on available-for-sale securities, net of tax | 20 | 46 | 270 | 54 | |
Comprehensive loss | $ (39,420) | $ (45,041) | $ (124,719) | $ (196,689) | |
Earnings Per Share, Basic | $ (0.36) | $ (0.42) | $ (1.14) | $ (1.82) | |
Earnings Per Share, Diluted | $ (0.36) | $ (0.42) | $ (1.14) | $ (1.82) | |
Weighted Average Number of Shares Outstanding, Basic | 109,754,812 | 108,420,674 | 109,333,684 | 108,154,397 | |
Weighted Average Number of Shares Outstanding, Diluted | 109,754,812 | 108,420,674 | 109,333,684 | 108,154,397 | |
[1] Includes related-party amounts of $ 1,448 and $ 6,666 for the three and nine months ended September 30, 2023 , respectively, and $ 1,742 and $ 6,027 for the three and nine months ended September 30, 2022 , respectively Includes related-party amounts of $ 4,600 and $ 4,975 for the three and nine months ended September 30, 2023 , respectively, and $ 4,000 for both the three and nine months ended September 30, 2022 (see Note 15). |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (PARENTHETICAL) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Research and Development Arrangement [Member] | ||||
Related party expenses | $ 1,448 | $ 1,742 | $ 6,666 | $ 6,027 |
In Process Research and Development [Member] | ||||
Related party expenses | $ 4,600 | $ 4,000 | $ 4,975 | $ 4,000 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (UNAUDITED) - USD ($) $ in Thousands | Total | Common Stock [Member] | Treasury Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] |
Treasury Stock, Common, Shares | 468,751 | |||||
Balances at Dec. 31, 2021 | $ 558,019 | $ 11 | $ 850,125 | $ (8) | $ (292,109) | |
Balances, shares at Dec. 31, 2021 | 110,782,909 | |||||
Treasury stock at Dec. 31, 2021 | $ 0 | |||||
Vesting of restricted common stock from early-exercised options | 1 | 1 | ||||
Exercise of stock options, shares | 50,353 | |||||
Exercise of stock options | 47 | 47 | ||||
Repurchase of unvested restricted common stock, shares | (1,158,089) | (1,158,089) | ||||
Stock-based compensation expense | 1,983 | 1,983 | ||||
Retirement of treasury shares, shares | (1,626,840) | |||||
Unrealized gain on available-for-sale securities, net of tax | 8 | 8 | ||||
Net loss | (100,666) | (100,666) | ||||
Balances at Mar. 31, 2022 | 459,392 | $ 11 | 852,156 | 0 | (392,775) | |
Balances, shares at Mar. 31, 2022 | 109,675,173 | |||||
Treasury stock at Mar. 31, 2022 | $ 0 | |||||
Balances at Dec. 31, 2021 | 558,019 | $ 11 | 850,125 | (8) | (292,109) | |
Balances, shares at Dec. 31, 2021 | 110,782,909 | |||||
Treasury stock at Dec. 31, 2021 | 0 | |||||
Unrealized gain on available-for-sale securities, net of tax | 54 | |||||
Net loss | (196,743) | |||||
Balances at Sep. 30, 2022 | 377,443 | $ 11 | 866,238 | 46 | (488,852) | |
Balances, shares at Sep. 30, 2022 | 108,957,401 | |||||
Treasury stock at Sep. 30, 2022 | $ 0 | |||||
Treasury Stock, Common, Shares | 0 | |||||
Balances at Mar. 31, 2022 | 459,392 | $ 11 | 852,156 | 0 | (392,775) | |
Balances, shares at Mar. 31, 2022 | 109,675,173 | |||||
Treasury stock at Mar. 31, 2022 | $ 0 | |||||
Exercise of stock options, shares | 98,000 | |||||
Exercise of stock options | 76 | 76 | ||||
Repurchase of unvested restricted common stock, shares | (992,648) | (992,648) | ||||
Stock-based compensation expense | 6,361 | 6,361 | ||||
Net loss | (50,990) | (50,990) | ||||
Balances at Jun. 30, 2022 | 414,839 | $ 11 | 858,593 | 0 | (443,765) | |
Balances, shares at Jun. 30, 2022 | 108,780,525 | |||||
Treasury stock at Jun. 30, 2022 | $ 0 | |||||
Treasury Stock, Common, Shares | 992,648 | |||||
Exercise of stock options, shares | 125,000 | |||||
Exercise of stock options | 97 | 97 | ||||
Stock-based compensation expense | 7,399 | 7,399 | ||||
Issuance of common stock under the employee stock purchase plan, shares | 51,876 | |||||
Issuance of common stock under the employee stock purchase plan | 149 | 149 | ||||
Retirement of treasury shares, shares | (992,648) | |||||
Unrealized gain on available-for-sale securities, net of tax | 46 | 46 | ||||
Net loss | (45,087) | (45,087) | ||||
Balances at Sep. 30, 2022 | 377,443 | $ 11 | 866,238 | 46 | (488,852) | |
Balances, shares at Sep. 30, 2022 | 108,957,401 | |||||
Treasury stock at Sep. 30, 2022 | $ 0 | |||||
Treasury Stock, Common, Shares | 0 | |||||
Treasury Stock, Common, Shares | 0 | |||||
Balances at Dec. 31, 2022 | 355,970 | $ 11 | 889,657 | (272) | (533,426) | |
Balances, shares at Dec. 31, 2022 | 109,044,046 | |||||
Treasury stock at Dec. 31, 2022 | $ 0 | |||||
Vesting of restricted common stock from early-exercised options | 1 | 1 | ||||
Exercise of stock options, shares | 423,203 | |||||
Exercise of stock options | 459 | 459 | ||||
Repurchase of unvested restricted common stock, shares | (206,802) | (206,802) | ||||
Stock-based compensation expense | 5,400 | 5,400 | ||||
Issuance of common stock under the employee stock purchase plan, shares | 55,779 | |||||
Issuance of common stock under the employee stock purchase plan | 83 | 83 | ||||
Retirement of treasury shares, shares | (206,802) | |||||
Unrealized gain on available-for-sale securities, net of tax | 157 | 157 | ||||
Net loss | (35,321) | (35,321) | ||||
Balances at Mar. 31, 2023 | 326,749 | $ 11 | 895,600 | (115) | (568,747) | |
Balances, shares at Mar. 31, 2023 | 109,316,226 | |||||
Treasury stock at Mar. 31, 2023 | $ 0 | |||||
Balances at Dec. 31, 2022 | 355,970 | $ 11 | 889,657 | (272) | (533,426) | |
Balances, shares at Dec. 31, 2022 | 109,044,046 | |||||
Treasury stock at Dec. 31, 2022 | 0 | |||||
Unrealized gain on available-for-sale securities, net of tax | 270 | |||||
Net loss | (124,989) | |||||
Balances at Sep. 30, 2023 | 246,499 | $ 11 | 904,905 | (2) | (658,415) | |
Balances, shares at Sep. 30, 2023 | 109,846,329 | |||||
Treasury stock at Sep. 30, 2023 | $ 0 | |||||
Treasury Stock, Common, Shares | 0 | |||||
Balances at Mar. 31, 2023 | 326,749 | $ 11 | 895,600 | (115) | (568,747) | |
Balances, shares at Mar. 31, 2023 | 109,316,226 | |||||
Treasury stock at Mar. 31, 2023 | $ 0 | |||||
Vesting of restricted common stock from early-exercised options | 1 | 1 | ||||
Exercise of stock options, shares | 255,440 | |||||
Exercise of stock options | 215 | 215 | ||||
Repurchase of unvested restricted common stock, shares | (46,600) | (46,600) | ||||
Stock-based compensation expense | 4,677 | 4,677 | ||||
Issuance of common stock under the employee stock purchase plan, shares | 45,267 | |||||
Issuance of common stock under the employee stock purchase plan | 56 | 56 | ||||
Retirement of treasury shares, shares | (46,600) | |||||
Unrealized gain on available-for-sale securities, net of tax | 93 | 93 | ||||
Net loss | (50,228) | (50,228) | ||||
Balances at Jun. 30, 2023 | 281,563 | $ 11 | 900,549 | (22) | (618,975) | |
Balances, shares at Jun. 30, 2023 | 109,570,333 | |||||
Treasury stock at Jun. 30, 2023 | $ 0 | |||||
Treasury Stock, Common, Shares | 0 | |||||
Exercise of stock options, shares | 230,291 | |||||
Exercise of stock options | 35 | 35 | ||||
Stock-based compensation expense | 4,264 | 4,264 | ||||
Issuance of common stock under the employee stock purchase plan, shares | 45,705 | |||||
Issuance of common stock under the employee stock purchase plan | 57 | 57 | ||||
Unrealized gain on available-for-sale securities, net of tax | 20 | 20 | ||||
Net loss | (39,440) | (39,440) | ||||
Balances at Sep. 30, 2023 | $ 246,499 | $ 11 | $ 904,905 | $ (2) | $ (658,415) | |
Balances, shares at Sep. 30, 2023 | 109,846,329 | |||||
Treasury stock at Sep. 30, 2023 | $ 0 | |||||
Treasury Stock, Common, Shares | 0 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (124,989) | $ (196,743) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 14,341 | 15,743 |
Net amortization of premiums and accretion of discounts on marketable securities | (6,256) | 92 |
Amortization of operating lease right-of-use assets | 1,152 | 242 |
Depreciation expense | 360 | 14 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (292) | 22,366 |
Other non-current assets | 4 | 3,061 |
Accounts payable | 7,685 | 10,371 |
Accrued expenses | (5,452) | (27,554) |
Operating lease liabilities | (1,159) | 222 |
Other current liabilities | (18) | (53) |
Other non-current liabilities | 700 | (6) |
Net cash used in operating activities | (113,924) | (172,583) |
Cash flows from investing activities: | ||
Purchase of marketable securities | (91,202) | (140,360) |
Maturities of marketable securities | 294,583 | 49,000 |
Purchases of property and equipment | (615) | (494) |
Net cash provided by (used in) investing activities | 202,766 | (91,854) |
Cash flows from financing activities: | ||
Proceeds from exercises of stock options | 709 | 220 |
Proceeds from issuance of common stock under the employee stock purchase plan | 196 | 149 |
Payments for repurchases of unvested restricted common stock | (1) | (4) |
Net cash provided by financing activities | 904 | 365 |
Net increase (decrease) in cash and cash equivalents | 89,746 | (264,072) |
Cash and cash equivalents at beginning of period | 92,076 | 542,224 |
Cash and cash equivalents at end of period | 181,822 | 278,152 |
Supplemental disclosure of cash flow information | ||
Operating lease right-of-use asset recognized upon adoption of ASC 842 | 0 | 1,728 |
Purchases of property and equipment in accounts payable and accrued expenses | $ 0 | $ 867 |
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 the Business and Basis of Presentation | 1. Nature of the Business and Basis of Presentation Invivyd, Inc., together with its consolidated subsidiaries (the “Company”), is a biopharmaceutical company on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2. The Company’s proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. Leveraging its INVYMAB platform approach, the Company is generating a robust pipeline of product candidates which could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications. In June and July 2023, the Company announced positive initial data from an ongoing Phase 1 clinical trial of VYD222, a monoclonal antibody (“mAb”) candidate in development for the prevention of symptomatic COVID-19 in vulnerable populations, such as immunocompromised people. In May 2023, the Company completed the dosing of all participants in the Phase 1 clinical trial. Initial Phase 1 data announced in June and July 2023 showed that a single administration of VYD222 was generally well-tolerated at all three dose levels tested with no serious adverse events having been reported. In June 2023, the Company also announced that it had reached general alignment with the U.S. Food and Drug Administration (the “FDA”) on a pathway to potential emergency use authorization (“EUA”) for VYD222 and anticipated follow-on mAb candidates designed to prevent symptomatic COVID-19. The Company plans to leverage this pathway in the U.S., which includes the use of serum neutralizing titers as a correlate of protection (surrogate of clinical efficacy) in an immunobridging approach to a pivotal clinical trial of VYD222. In September 2023, the Company announced dosing of the first participant in a Phase 3 pivotal clinical trial of VYD222, referred to as the CANOPY clinical trial, which is designed to evaluate protection against symptomatic COVID-19 after receiving VYD222. The safety, tolerability, pharmacokinetic profile, and immunogenicity of VYD222 will also be evaluated. The CANOPY clinical trial is designed to rapidly generate the clinical data needed to enable a potential EUA submission for VYD222. In November 2023, the Company announced the completion of enrollment in the CANOPY clinical trial, with approximately 750 participants enrolled in two cohorts (A and B) across multiple trial sites in the U.S. In Cohort A, the Company enrolled approximately 300 participants who are significantly immunocompromised. The primary efficacy endpoint for Cohort A will be serum neutralizing titers against relevant SARS-CoV-2 variants at Day 28, which will be calculated based on the pharmacokinetic concentration of VYD222 from the immunocompromised participants and the IC 50 value for VYD222 against relevant SARS-CoV-2 variants. In Cohort B, the Company enrolled approximately 450 participants at risk of exposure to SARS-CoV-2. The primary endpoint for Cohort B will be safety and tolerability. The Company expects to have initial primary endpoint data from the CANOPY clinical trial by late 2023 or early in the first quarter of 2024. Given the urgent unmet medical need, the Company aims to submit an application for an EUA for VYD222 to the FDA as soon as practicable. The Company is actively preparing for the potential commercial launch of VYD222 in the U.S. in 2024, if authorized. VYD222 is the Company’s second mAb candidate to enter clinical testing. VYD222 was designed for broad activity and has demonstrated in vitro neutralizing activity against various pre-Omicron and Omicron variants, such as XBB.1.5, XBB.1.16, and XBB.1.5.10, an Omicron variant that has the same spike glycoprotein sequence as EG.5. VYD222 was engineered from adintrevimab, the Company’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for both the prevention and treatment of COVID-19. Beyond VYD222, the Company plans to leverage its INVYMAB platform approach to produce additional mAb candidates optimized to stay ahead of the evolving SARS-CoV-2 virus. The Company has multiple anti-SARS-CoV-2 mAb candidates in the discovery/preclinical stage. In addition, the Company continues to engage with regulatory agencies with the goal of streamlining the development of novel antibodies to protect immunocompromised and other high-risk populations against the evolving SARS-CoV-2 virus. The Company is also developing its commercialization approach to determine how best to bring its product candidates, if authorized or approved, to these populations. The Company was incorporated in the State of Delaware in June 2020. The Company operates as a hybrid company with employees working at its corporate headquarters in Waltham, Massachusetts and remotely. In June 2022, and subsequently amended in September 2022, the Company entered into a lease for dedicated laboratory and office space in Newton, Massachusetts for research and development purposes. In 2022, the Company expanded its research team in order to enable internal discovery and development of its mAb candidates, while continuing to leverage the Company’s existing partnership with Adimab, LLC (“Adimab”). The Company is focused on antibody discovery and use of Adimab’s platform technology while building its own internal capabilities. In addition, the Company performs research and development activities internally and engages third parties, including Adimab, to perform ongoing research and development and other services on its behalf. The Company is subject to a number of risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, completing clinical trials, the ability to raise additional capital to fund operations, obtaining regulatory authorization or approval for product candidates, market acceptance of products, competition from substitute products, protection of proprietary intellectual property, compliance with government regulations, the impact of COVID-19, dependence on key personnel, the ability to attract and retain qualified employees, and reliance on third-party organizations for the discovery, manufacturing, clinical and commercial success of its product candidates. The Company has not generated any revenue since inception. The Company’s product candidates require significant additional research and development efforts, including extensive clinical testing and regulatory authorization or approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and compliance-reporting capabilities. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales, including government supply contracts. The accompanying condensed 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 primarily funded its operations with proceeds from sales of convertible preferred stock and proceeds from the Company’s initial public offering (“IPO”). The Company has incurred losses and negative cash flows from operations since its inception, including a net loss of $ 125.0 million for the nine months ended September 30, 2023. As of September 30, 2023, the Company had an accumulated deficit of $ 658.4 million. The Company expects to continue to generate operating losses for the foreseeable future. The Company expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of these interim condensed consolidated financial statements. The Company expects to seek additional funding through a combination of equity offerings, government or private-party funding or grants, debt financings, collaborations with other companies, strategic alliances and licensing arrangements. 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 collaborations or other arrangements. The terms of any financing may adversely affect the holdings or rights of the Company’s stockholders. If the Company is unable to obtain sufficient capital, the Company will be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion, or future commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues 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, if at all. Impact of COVID-19 on the Company's Operations COVID-19 continues to present public health and economic challenges around the world. The full impact of the COVID-19 pandemic remains uncertain, and such impact may directly or indirectly affect the potential commercial prospects of VYD222 and other product candidates for the prevention and treatment of COVID-19. The evolution of the disease and the continued emergence of variants of concern (“VoCs”), and the availability, administration and acceptance of vaccines, mAbs, antiviral agents, and other therapeutic modalities may affect the design and enrollment of the Company’s clinical trials, the potential regulatory authorization or approval of the Company’s product candidates, the availability of funding and partnership opportunities, and the commercialization of the Company’s product candidates, if authorized or approved. In addition, the Company’s business and operations may be more broadly adversely affected by the COVID-19 pandemic. It is not possible to determine the scale and rate of economic recovery from the COVID-19 pandemic, supply chain disruptions, and labor availability and costs, or the impact of other indirect factors that may be attributable to the pandemic. The ultimate extent to which COVID-19 directly or indirectly impacts the Company’s business, financial condition, operations, and product development timelines and plans remains uncertain and will depend on future developments, including the duration and spread of outbreaks and the continued emergence of VoCs, actions taken to prevent or treat COVID-19, and its economic impact on local, regional, national and international markets. To date, the Company has experienced some delays and disruptions in its development activities as a result of the COVID-19 pandemic. Some of the Company’s clinical research organizations (“CROs”), contract development and manufacturing organizations (“CDMOs”) and other service providers have also been impacted. The Company will continue to monitor developments as it addresses uncertainties relating to the COVID-19 pandemic. Additionally, if the financial markets and/or the overall economy are impacted for an extended period as a result of the COVID-19 pandemic or otherwise, the Company’s results and operations may be materially adversely affected and may affect the Company’s ability to raise capital. Basis of Presentation The Company’s condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying condensed consolidated financial statements include the accounts of Invivyd, Inc. and its wholly owned subsidiaries, Invivyd Security Corporation, Invivyd Switzerland GmbH, and Invivyd Netherlands B.V. All intercompany accounts and transactions have been eliminated in consolidation. The Company views its operations and manages its business in one operating segment, which is the business of discovering, developing and commercializing differentiated products for the prevention and treatment of infectious diseases. |
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 As of September 30, 2023, the Company’s significant accounting policies and estimates, which are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the U.S. Securities and Exchange Commission (“SEC”) on March 23, 2023 (the “2022 Form 10-K”) have not changed, except as discussed below. On January 1, 2023, the Company adopted Accounting Standards Update No. 2016-13 ( “ASU 2016-13”) , Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments . ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets. In April 2019, the FASB issued clarification to ASU 2016-13 within ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, or ASU 2016-13. The guidance is effective for fiscal years beginning after December 15, 2022. The adoption of the standard was immaterial to the accompanying condensed consolidated financial statements and related disclosures. Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of September 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, the condensed consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022 and the condensed consolidated statements of stockholders’ equity (deficit) for the three and nine months ended September 30, 2023 and 2022 are unaudited. The accompanying unaudited condensed 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 SEC for interim financial statements. The accompanying condensed consolidated balance sheet as of December 31, 2022 was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited annual consolidated financial statements, and the notes thereto, as of and for the year ended December 31, 2022, which are included in the Company’s 2022 Form 10-K. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s condensed consolidated financial position as of September 30, 2023 and December 31, 2022, the condensed consolidated results of operations for the three and nine months ended September 30, 2023 and 2022, the condensed consolidated cash flows for the nine months ended September 30, 2023 and 2022 and changes in stockholders’ equity (deficit) for the nine months ended September 30, 2023 and 2022 have been made. The Company’s condensed consolidated 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 . Use of Estimates The preparation of the Company’s condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, research and development expenses and related prepaid or accrued costs and stock-based compensation expense. The Company bases its estimates on historical experience, known trends and other market-specific or relevant factors 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. Changes in estimates are recorded in the period in which they become known. Actual results may differ materially from those estimates or assumptions. The Company is monitoring the potential impact of the COVID-19 pandemic on its business and condensed consolidated financial statements. The Company is not aware of any specific event or circumstance that would require any update to its estimates or judgments reflected in these condensed consolidated financial statements or a revision of the carrying value of its assets or liabilities as of the issuance date of these condensed consolidated financial statements. These estimates may change as new events occur and additional information is obtained. Recently Issued and Adopted Accounting Pronouncements The Company is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and will remain an emerging growth company until the last day of the fiscal year following the fifth anniversary of the completion of its IPO. However, if certain events occur prior to the end of such five-year period, including if it becomes a “large accelerated filer,” its annual gross revenues exceeds $ 1.235 billion or it issues more than $ 1.0 billion of non-convertible debt in the previous three-year period, it will cease to be an emerging growth company prior to the end of such five-year period. For so long as the Company remains an emerging growth company, it is permitted and intends to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. For example, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of these accounting standards until they would otherwise apply to private companies. There have been no new accounting pronouncements or changes to accounting pronouncements that could be expected to materially impact the Company’s unaudited condensed consolidated financial statements during the nine months ended September 30, 2023 , as compared to the recent accounting pronouncements described in Note 2 of the Company’s condensed consolidated financial statements included in its 2022 Form 10-K. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2023 | |
Marketable Securities [Abstract] | |
Marketable Securities | 3. Marketable Securities Marketable securities held by the Company are classified as available-for-sale debt securities pursuant to ASC 320, Investments – Debt and Equity Securities , and carried at fair value in the accompanying condensed consolidated balance sheet on a settlement date basis. The following tables summarize the gross unrealized gains, unrealized losses and credit losses of the Company’s marketable securities as of September 30, 2023 and December 31, 2022 (in thousands): September 30, 2023 Amortized Cost Unrealized Gains Unrealized Losses Credit Losses Fair Value U.S. Treasury securities $ 12,988 $ — $ ( 1 ) $ — $ 12,987 Federal agency securities 70,077 8 ( 9 ) — 70,076 Total financial assets $ 83,065 $ 8 $ ( 10 ) $ — $ 83,063 December 31, 2022 Amortized Cost Unrealized Gains Unrealized Losses Credit Losses Fair Value U.S. Treasury securities $ 107,973 $ 13 $ ( 115 ) $ — $ 107,871 Federal agency securities 172,214 39 ( 209 ) — 172,044 Total financial assets $ 280,187 $ 52 $ ( 324 ) $ — $ 279,915 The Company did not record any charges for credit-related impairments for its available-for-sale securities during the three and nine months ended September 30, 2023 . No available-for-sale marketable securities held as of September 30, 2023 or December 31, 2022 had remaining maturities greater than twelve months. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements Fair Value Measurements Certain assets of the Company are carried at fair value under U.S. GAAP. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability 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. 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. The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis (in thousands): Fair Value Measurements at Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 181,411 $ — $ — $ 181,411 Marketable securities: U.S. Treasury securities 12,987 — — 12,987 Federal agency securities — 70,076 — 70,076 $ 194,398 $ 70,076 $ — $ 264,474 Fair Value Measurements at Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 91,050 $ — $ — $ 91,050 Marketable securities: U.S. Treasury securities 107,871 — — 107,871 Federal agency securities — 172,044 — 172,044 $ 198,921 $ 172,044 $ — $ 370,965 The money market funds and U.S. Treasury securities were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. The Company’s cash equivalents and marketable securities also consisted of federal agency securities, which were valued based on Level 2 inputs. In determining the fair value of its federal agency securities, the Company relied on quoted prices for similar securities in active markets or other inputs that are observable or can be corroborated by observable market data. Since federal agency securities typically do not trade as U.S. government agency securities and no exchange exists to price such investments, they are recognized as Level 2 assets. There were no changes to the valuation methods during the three and nine months ended September 30, 2023 or 2022. The Company evaluates transfers between levels at the end of each reporting period. There were no transfers into or out of Level 1, Level 2 or Level 3 fair value measurements during the three and nine months ended September 30, 2023 or 2022. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid Expenses and Other Current Assets | 5. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, Prepaid external research, development and manufacturing costs $ 3,265 $ 843 Prepaid insurance 214 2,392 Prepaid compensation and other 1,026 1,314 Interest receivable 713 377 $ 5,218 $ 4,926 |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Liabilities [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses consisted of the following (in thousands): September 30, December 31, Accrued external research, development and manufacturing costs $ 10,278 $ 13,955 Accrued professional and consultant fees 1,606 1,153 Accrued employee compensation 3,862 5,985 Other 212 818 $ 15,958 $ 21,911 |
License and Collaboration Agree
License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 2023 | |
License Agreements [Abstract] | |
License and Collaboration Agreements | 7. License and Collaboration Agreements Adimab Assignment Agreement In July 2020, the Company entered into an Assignment and License Agreement with Adimab (the “Adimab Assignment Agreement”). Under the terms of the agreement, Adimab assigned to the Company all rights, title and interest in and to certain of its coronavirus-specific antibodies (each, a “CoV Antibody” and together, the “CoV Antibodies”), including modified or derivative forms thereof, and related intellectual property. In addition, Adimab granted to the Company a non-exclusive, worldwide, royalty-bearing, sublicensable license to certain of its platform patents and technology for the development, manufacture and commercialization of the CoV Antibodies and pharmaceutical products containing or comprising one or more CoV Antibodies (each, a “Product”) for all indications and uses, with the exception of certain diagnostic uses and use as a research reagent (the “Field”). The Company is entitled to sublicense the assigned rights and licensed intellectual property solely with respect to any CoV Antibody or Product, subject to specified conditions of the agreement. The Company is obligated to use commercially reasonable efforts to achieve specified development and regulatory milestones for Products in certain major markets and to commercialize a product in any country in which the Company obtains marketing approval. Pursuant to the terms of the Adimab Assignment Agreement, the parties will establish one or more work plans that set forth the activities to be performed under the agreement (each, a “Work Plan”), and each party is responsible for performing the obligations to which it is assigned under such Work Plans. Upon execution of the Adimab Assignment Agreement, the Company and Adimab agreed on an initial Work Plan that outlined the services that will be performed commencing at inception of the arrangement. The Company is obligated to pay Adimab quarterly for its services performed under each Work Plan at a specified full-time equivalent rate. Otherwise, the Company is solely responsible for the development, manufacture and commercialization of the CoV Antibodies and associated Products at its own cost and expense. The Company is solely responsible for preparing and submitting all investigational new drug applications, new drug applications, biologics license applications and other regulatory filings for the CoV Antibodies and Products in the Field, and for obtaining and maintaining all marketing approvals for Products in the Field, at its sole expense. Additionally, the Company has the sole right to prosecute, maintain, enforce and defend patents covering the CoV Antibodies and Products, all at its own expense. Amounts paid with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement are recognized as research and development expense as such amounts are incurred. During the three and nine months ended September 30, 2023 , the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement. During the three and nine months ended September 30, 2022 , the Company recognized $ 0.1 million and $ 0.6 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement. Please refer to Note 15 for additional information. The Company is obligated to pay Adimab up to $ 16.5 million upon the achievement of specified development and regulatory milestones for the first Product under the agreement that achieves such specified milestones and up to $ 8.1 million upon the achievement of specified development and regulatory milestones for the second Product under the agreement that achieves such specified milestones. The maximum aggregate amount of milestone payments payable under the agreement for any and all Products is $ 24.6 million , of which a total of $ 11.1 million has been achieved and $ 7.9 million had been paid as of September 30, 2023; however, milestone payments do not accrue for certain in vitro diagnostic devices consisting of or containing CoV Antibodies. In March 2023, the Company achieved the first specified milestone for the second product candidate under the Adimab Assignment Agreement upon dosing of the first subject in a Phase 1 clinical trial evaluating VYD222, which obligated the Company to make a $ 0.4 million milestone payment to Adimab, which was paid in May 2023. In September 2023, the Company achieved specified milestones for the second product candidate under the Adimab Assignment Agreement upon dosing of the first subject in a pivotal clinical trial evaluating VYD222, which obligated the Company to make a $ 3.2 million milestone payment to Adimab, which was paid in October 2023. During the three and nine months ended September 30, 2023 , the Company recognized $ 3.2 million and $ 3.6 million, respectively, of in-process research and development (“IPR&D”) expense with respect to contingent consideration payable under the Adimab Assignment Agreement. During the three and nine months ended September 30, 2022, the Company did not recognize any IPR&D expense in connection with contingent consideration payable under the Adimab Assignment Agreement. The next potential milestone under the Adimab Assignment Agreement is a low single-digit million-dollar regulatory milestone, which was not considered probable under U.S. GAAP and therefore, no expense was recognized as of September 30, 2023. The Company is obligated to pay Adimab royalties of a mid-single-digit percentage based on net sales of any Products, beginning upon the first commercial sale of a Product in accordance with the Adimab Assignment Agreement . The royalty rate is subject to reductions specified under the agreement. Royalties are due on a Product-by-Product and country-by-country basis beginning upon the first commercial sale of each Product and ending on the later of (i) 12 years after the first commercial sale of such Product in such country and (ii) the expiration of the last valid claim of a patent covering such Product in such country (“Royalty Term”). In addition, the Company is obligated to pay Adimab royalties of a specified percentage in the range of 45 % to 55 % of any compulsory sublicense consideration received by the Company in lieu of certain royalty payments. Except for milestone payments of $ 7.5 million incurred through December 31, 2022, and milestone payments of $ 3.6 million incurred during the nine months ended September 3 0, 2023 , no other milestone, royalty or other contingent payments had become due to Adimab through September 30, 2023. Unless earlier terminated, the Adimab Assignment Agreement remains in effect until the expiration of the last-to-expire Royalty Term for any and all Products. The Company may terminate the agreement at any time for any or no reason upon advance written notice to Adimab, or in the event of a material breach by Adimab that is not cured with specific periods. Adimab may only terminate the agreement for an uncured material breach by the Company for its due diligence obligation or a payment obligation. Upon any termination of the agreement prior to its expiration, all licenses and rights granted pursuant to the arrangement will automatically terminate and revert to the granting party and all other rights and obligations of the parties will terminate. The Company concluded that the Adimab Assignment Agreement represented an asset acquisition of IPR&D assets with no alternative future use. The arrangement did not qualify as a business combination because substantially all of the fair value of the assets acquired was concentrated in a single asset. Adimab Collaboration Agreement In May 2021, the Company entered into a Collaboration Agreement with Adimab, as amended in November 2022 and September 2023 (the “Adimab Collaboration Agreement”), for the discovery and optimization of proprietary antibodies as potential therapeutic product candidates. Under the Adimab Collaboration Agreement, the Company and Adimab will collaborate on research programs for a specified number of targets selected by the Company within a specified time period. Under the Adimab Collaboration Agreement, Adimab granted the Company a worldwide, non-exclusive license to certain of its platform patents and technology and antibody patents to perform the Company’s responsibilities during the ongoing research period and for a specified evaluation period thereafter (the “Evaluation Term”). In addition, the Company granted Adimab a license to certain of the Company’s patents and intellectual property solely to perform Adimab’s responsibilities under the research plans. Under the Adimab Collaboration Agreement, the Company has an exclusive option, on a program-by-program basis, to obtain licenses and assignments to commercialize selected products containing or comprising antibodies directed against the applicable target, which option may be exercised upon the payment of a specified option fee for each program. Upon exercise of an option by the Company, Adimab will assign to the Company all right, title and interest in the antibodies of the optioned research program and will grant the Company a worldwide, royalty-free, fully paid-up, non-exclusive, sublicensable license under the Adimab platform technology for the development, manufacture and commercialization of the antibodies for which the Company has exercised its options and products containing or comprising those antibodies. The Company is obligated to use commercially reasonable efforts to develop, seek marketing approval for, and commercialize one product that contains an antibody discovered in each optioned research program. The Company is obligated to pay Adimab a quarterly fee of $ 1.3 million, which may be cancelled at the Company’s option at any time. For so long as the Company is paying such quarterly fee (or earlier if (i) the Company experiences a change of control after the third anniversary of the Adimab Collaboration Agreement or (ii) Adimab owns less than a specified percentage of the Company’s equity), Adimab and its affiliates will not assist or direct certain third parties to discover or optimize antibodies that are intended to bind to coronaviruses or influenza viruses. The Company may also elect to decrease the scope of Adimab’s exclusivity obligations and obtain a corresponding decrease in the quarterly fee. During the three and nine months ended September 30, 2023 , the Company recognized $ 1.3 million and $3 .9 million, respectively, of research and development expense related to the quarterly fee. During the three and nine months ended September 30, 2022 , the Company recognized $ 1.3 million and $ 3.9 million, respectively, of research and development expense related to the quarterly fee. For each agreed upon research program that is commenced, the Company is obligated to pay Adimab quarterly for its services performed during a given research program at a specified full-time equivalent rate; a discovery delivery fee of $ 0.2 million; and an optimization completion fee of $ 0.2 million. For each option exercised by the Company to commercialize a specific research program, the Company is obligated to pay Adimab an exercise fee of $ 1.0 million. Amounts paid with respect to services performed by Adimab on the Company’s behalf in each of the research programs under the Adimab Collaboration Agreement are recognized as research and development expense as such amounts are incurred and services are rendered. During the three and nine months ended September 30, 2023 , the Company recognized $ 0.1 million and $ 0.5 million, respectively, of research and development expense with respect to services performed by Adimab on the Company ’s behalf under the Adimab Collaboration Agreement. During the three and nine months ended September 30, 2022 , the Company recognized $ 0.3 million and $ 1.3 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement. During both the three and nine months ended September 30, 2023, the Company recognized $ 1.0 million, $ 0.2 million, and $ 0.2 million of IPR&D expense related to an option exercise fee, a drug delivery fee and an optimization completion fee, respectively. During both the three and nine months ended September 30, 2022, the Company recognized $ 1.0 million of IPR&D expense related to an option exercise fee. During the three and nine months ended September 30, 2022, the Company recognized $ 0 and $ 0.2 million, respectively, of research and development expense related to a drug delivery fee. Please refer to Note 15 for additional information. The Company is obligated to pay Adimab up to $ 18.0 million upon the achievement of specified development and regulatory milestones for each product under the Adimab Collaboration Agreement that achieves such milestones. The next potential milestone under the Adimab Collaboration Agreement is a low single-digit million-dollar clinical milestone, which was not considered probable under U.S. GAAP and therefore, no expense was recognized as of September 30, 2023. The Company is also obligated to pay Adimab royalties of a mid-single-digit percentage based on net sales of any product under the Adimab Collaboration Agreement, subject to reductions for third-party licenses. The royalty term will expire for each product on a country-by-country basis upon the later of (i) 12 years after the first commercial sale of such product in such country and (ii) the expiration of the last valid claim of any patent claiming composition of matter or method of making or using any antibody identified or optimized under the Adimab Collaboration Agreement in such country. In addition, the Company is obligated to pay Adimab for Adimab’s performance of certain validation work with respect to certain antigens acquired from a third party. In consideration for this work, the Company is obligated to pay Adimab royalties of a low single-digit percentage based on net sales of products that contain such antigens for the same royalty term as antibody-based products, but the Company is not obligated to make any milestone payments for such antigen products. Through September 30, 2023, the Company had not paid any royalties to Adimab under the Adimab Collaboration Agreement. The Adimab Collaboration Agreement will expire (i) if the Company does not exercise any option, upon the conclusion of the last Evaluation Term for the research programs, or (ii) if the Company exercises an option, on the expiration of the last royalty term for a product in a particular country, unless the agreement is earlier terminated. The Company may terminate the Adimab Collaboration Agreement at any time upon advance written notice to Adimab. In addition, subject to certain conditions, either party may terminate the Adimab Collaboration Agreement in the event of a material breach by the other party that is not cured within specified periods. The Company concluded that the Adimab Collaboration Agreement represented an asset acquisition of IPR&D with no alternative future use. Therefore, payments made by the Company to Adimab for milestones achieved will be recognized as IPR&D expense in the related period in which the services are performed or the related milestone is considered probable of achievement. Amounts paid with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement are recognized as research and development expense as such amounts are incurred and services are rendered. Please refer to Note 15 for additional information. Adimab Platform Transfer Agreement In September 2022 (“Effective Date”), the Company entered into a Platform Transfer Agreement with Adimab (the “Adimab Platform Transfer Agreement”) under which the Company was granted the right under certain intellectual property of Adimab to practice certain elements of Adimab’s platform technology, including B-cell cloning using Adimab’s proprietary yeast cell lines and other antibody optimization libraries, trade secrets, protocols and software of Adimab, to discover, engineer and optimize antibodies. The Company does not have access to Adimab’s proprietary discovery libraries. The Company was also granted the right under certain intellectual property of Adimab to research, develop, make, sell and exploit such antibodies and products containing such antibodies. The Adimab platform will be transferred to the Company in accordance with the terms of the Adimab Platform Transfer Agreement. In September 2022, the Company recognized $ 3.0 million as IPR&D expense in connection with the upfront consideration payable for the rights assigned pursuant to the Adimab Platform Transfer Agreement. The Company is obligated to pay Adimab an annual fee of single digit millions on each of the first four anniversaries of the Effective Date, which will allow the Company to receive material improvements to the platform technology, including materially improved antibody optimization libraries, updates that provide new functionality to the platform, and software upgrades, from Adimab through June 2027. The first annual fee became due in September 2023 and was paid in October 2023. During both the three and nine months ended September 30, 2023, the Company recognized a portion of the first annual fee as research and development expense. Beginning in July 2027 and ending in June 2042, unless terminated earlier, the Company has the option to receive additional material improvements to the platform technology from Adimab, subject to a commercially reasonable fee to be negotiated by the parties. The Company is obligated to pay Adimab up to $ 9.5 million upon the achievement of specified development and regulatory milestones for each product under the Adimab Platform Transfer Agreement that achieves such milestones. The next potential milestone under the Adimab Platform Transfer Agreement is a mid-six-digit dollar preclinical milestone, which was not considered probable under U.S. GAAP and therefore, no expense was recognized as of September 30, 2023. In addition, the Company is obligated to pay Adimab royalties of a low single-digit percentage based on net sales of products containing an antibody discovered, engineered or optimized using Adimab’s platform technology, subject to reductions specified under the Adimab Platform Transfer Agreement. Royalties are due on a product-by-product and country-by-country basis. The royalty term will expire for each product on a country-by-country basis upon the later of (i) 12 years after the first commercial sale of such product in such country and (ii) the expiration of the last valid claim of a program antibody patent for covering the program antibody contained in such product in such country. Through September 30, 2023, the Company had not paid any royalties to Adimab under the Adimab Platform Transfer Agreement. The Company may terminate the Adimab Platform Transfer Agreement at any time upon advance written notice to Adimab. In addition, subject to certain conditions, either party may terminate the Adimab Platform Transfer Agreement in the event of a material breach by the other party that is not cured within specified periods or in connection with the other party’s insolvency. The Company concluded that the Adimab Platform Transfer Agreement represented an asset acquisition of IPR&D with no alternative future use. Therefore, payments made by the Company to Adimab for milestones achieved will be recognized as IPR&D expense in the related period in which the services are performed or the related milestone is considered probable of achievement. Amounts paid with respect to the annual material improvement fees are recognized as research and development expense as such amounts are incurred. Please refer to Note 15 for additional information. WuXi Biologics Cell Line License Agreement In December 2020, as amended in February 2023, the Company entered into a Cell Line License Agreement with WuXi Biologics (Hong Kong) Limited (“WuXi Biologics”) (the “Cell Line License Agreement”), under which WuXi Biologics granted to the Company a non-exclusive, non-transferable, worldwide, royalty-bearing, sublicensable license to certain of its intellectual property, including certain patent rights associated with a proprietary cell line developed by WuXi Biologics for the exploitation of certain recombinant antibodies developed using such proprietary cell line (each, a “Licensed Product”). Each Licensed Product generated under the arrangement will be produced from a transformed or transfected version of the proprietary cell line derived by WuXi Biologics (each of such transformed or transfected cell lines, a “Licensed Cell Line”). In December 2020, the Company recognized an upfront fee of $ 0.2 million upon completion of cell bank generation for the first Licensed Cell Line created under the Cell Line License Agreement. In February 2023 and June 2023, the Company recognized license fees of $ 0.4 million and $ 0.2 million, respectively, upon completion of cell bank generation for the additional Licensed Cell Lines created under the Cell Line License Agreement. The Company is also obligated to pay royalties in the range of less than 1.0 % to WuXi Biologics based on net sales of any Licensed Products manufactured by the Company or a third party on its behalf. However, if the Company uses WuXi Biologics to manufacture all of its commercial supplies for Licensed Products, no royalties would be owed by the Company to WuXi Biologics for net sales of Licensed Products. The Company has an option to buy out its royalty obligations on a Licensed Cell Line-by-Licensed Cell Line basis by making a one-time payment in the low eight-figures to WuXi Biologics. Royalties are due on a Licensed Product-by-Licensed Product basis commencing on the date of the first commercial sale of the applicable product and continuing for so long as the Company commercializes Licensed Products or, if earlier, until the Company exercises its option to buy out the royalty obligations. Through September 30, 2023 , no royalties had become due to WuXi Biologics. The Cell Line License Agreement remains in effect until it is terminated. The Company may terminate the Cell Line License Agreement at any time with notice to WuXi Biologics. WuXi Biologics may terminate the Cell Line License Agreement in the event the Company fails to make a payment when due under the Cell Line License Agreement and such non-payment is not cured within a specified period after notice. Either party may terminate the Cell Line License Agreement in the event of a material breach by the other party that is not cured within a specified period after notice. Upon termination of the Cell Line License Agreement, the license conveyed by WuXi Biologics to the Company will continue in full force and effect with respect to all Licensed Products manufactured using the Licensed Cell Line already generated under the Cell Line License Agreement, provided that the Company continues to pay its royalty obligations, if any. The Company concluded that the Cell Line License Agreement represented an asset acquisition of IPR&D with no alternative future use. The Cell Line License Agreement did not qualify as a business combination because substantially all of the fair value of the assets acquired was concentrated in a single asset. Therefore, the $ 0 and $ 0.6 million of license fees were recognized as IPR&D expense during the three and nine months ended September 30, 2023, respectively. Research Collaboration and License Agreement with The Scripps Research Institute In August 2021, the Company entered into a Research Collaboration and License Agreement (the “Research Agreement”) with The Scripps Research Institute (“TSRI”). Under the terms of the Research Agreement, TSRI performed research activities to identify vaccine candidates for the prevention, diagnosis or treatment of influenza or beta coronaviruses. In August 2021, the Company paid TSRI $ 1.5 million in funding, which was credited against research funding payable by the Company under the Research Agreement. In April 2022, the Company provided written notice to TSRI to terminate the Research Agreement. Following early termination in the second quarter of 2022, all licenses were terminated and reverted to TSRI. Amounts incurred for services performed by TSRI under the Research Agreement were expensed to research and development expense as the services were rendered. During the three and nine months ended September 30, 2023 , the Company did no t recognize any research and development expense with respect to services performed under the Research Agreement as it was terminated during 2022. During the three and nine months ended September 30, 2022 , the Company recognized $ 0 and $ 1.7 million, respectively, of research and development expense with respect to services performed under the Research Agreement. |
Population Health Partners, L.P
Population Health Partners, L.P | 9 Months Ended |
Sep. 30, 2023 | |
Other Commitments [Abstract] | |
Population Health Partners, L.P | 8. Population Health Partners, L.P In November 2022 (the “PHP Effective Date”), the Company entered into a Master Services Agreement with Population Health Partners, L.P. (“PHP”), pursuant to which PHP agreed to provide services and create deliverables for the Company as agreed between the Company and PHP and set forth in one or more work orders under such agreement (the “PHP MSA”). The term of the PHP MSA commenced on the PHP Effective Date and will continue for a period of one year, unless terminated earlier in accordance with its terms. On the PHP Effective Date, the Company and PHP entered into the first work order under the PHP MSA (the “PHP Work Order”), pursuant to which PHP agreed to advise and counsel the Company regarding clinical development and regulatory matters with respect to the Company’s product candidates. The PHP Work Order was effective for six months from the PHP Effective Date and terminated in accordance with its terms in May 2023. The PHP MSA contains customary confidentiality provisions and representations and warranties of the parties, as well as mutual non-solicitation of certain employees during the term of the PHP MSA and for a period of one year thereafter. As compensation for the services and deliverables under the PHP Work Order, the Company paid PHP a cash fee of $ 0.5 million per month during the term of the PHP Work Order for an aggregate fee of $ 3.0 million (the “Aggregate Fee”). During the three and nine months ended September 30, 2023, the Company recognized $ 0 and $ 2.3 million, respectively, of research and development expense related to the cash compensation paid to PHP. Please refer to Note 15 for additional information. In addition to the cash compensation, on the PHP Effective Date, the Company issued a warrant to purchase shares of the Company’s common stock to PHP (the “PHP Warrant”). The exercise price of the PHP Warrant is $ 3.48 per share of the Company’s common stock, which is equal to the Nasdaq official closing price (as defined in the PHP Warrant) of a share of the Company’s common stock on the trading day immediately prior to the PHP Effective Date. The PHP Warrant is exercisable for up to an aggregate of 6,824,712 shares of the Company’s common stock, and vests in three separate tranches as follows: 3,591,954 shares of the Company’s common stock underlying the PHP Warrant vests if the Company’s Market Capitalization (as defined below) equals or exceeds $758,517,511 by November 15, 2028; 1,795,977 shares of the Company’s common stock underlying the PHP Warrant vests if the Company’s Market Capitalization equals or exceeds $1,137,776,266 by November 15, 2029; and 1,436,781 shares of the Company’s common stock underlying the PHP Warrant vests if the Company’s Market Capitalization equals or exceeds $1,517,035,022 by November 15, 2030. For purposes of the PHP Warrant, the term “Market Capitalization” means, with respect to a particular trading day, the total value of the outstanding shares of the Company’s common stock on such date, calculated by multiplying the Company’s volume weighted average price for the ten (10) trading days immediately preceding such date by the Company’s total number of outstanding shares of the Company’s common stock as reflected in (i) the Company’s most recent periodic or annual report filed with the SEC (e.g., Annual Report on Form 10-K or Quarterly Report on Form 10-Q), as the case may be, (ii) a more recent public announcement by the Company or (iii) a more recent written notice by the Company or the Company’s transfer agent setting forth the number of shares of the Company's common stock outstanding. The PHP Warrant is exercisable for ten years from the PHP Effective Date with respect to the vested portion(s) of the PHP Warrant. The PHP Warrant may be exercised by cash exercise or, at the election of PHP, by means of “cashless exercise” pursuant to a formula set forth in the PHP Warrant. The Company has also granted PHP certain “piggyback” registration rights requiring the Company to register any shares of the Company’s common stock underlying the PHP Warrant for resale with the SEC, subject to the Company’s existing obligations under that certain Second Amended and Restated Investors’ Rights Agreement, dated April 16, 2021, by and among the Company and the investors party thereto. Upon the consummation of a change of control of the Company (as defined in the PHP Warrant) on or prior to November 15, 2028, all of the shares underlying the PHP Warrant would become immediately vested and exercisable; upon the consummation of a change of control of the Company after November 15, 2028 but on or prior to November 15, 2029, the shares underlying the second and third tranches of the PHP Warrant would become immediately vested and exercisable; and upon the consummation of a change of control of the Company after November 15, 2029 but on or prior to November 15, 2030, the shares underlying the third tranche of the PHP Warrant would become immediately vested and exercisable. Refer to Note 11 for additional information on the PHP Warrant. Clive Meanwell, M.D. and Tamsin Berry, members of the Company’s board of directors, are Managing Partner and Partner of PHP, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Operating Lease Commitments In September 2021, the Company entered into a five-year noncancelable facilities lease agreement for approximately 9,600 square feet of office space in Waltham, Massachusetts. The monthly rental payments under the lease, which include base rent charges of $ 0.4 million per year, are subject to periodic rent increases through September 2026. In addition to base rent, monthly rental payments include the Company’s proportionate share of operating expenses. The lease terms provide for one five-year extension term with base rent calculated on the then-market rate. In June 2022, the Company entered into a two-year noncancelable agreement for dedicated laboratory and office space in Newton, Massachusetts (the “Newton, MA Lease”). The monthly rental payments under the agreement include base rent charges of $ 0.7 million per year. The agreement terms provide for a month-to-month extension after completion of the initial two-year term with base rent calculated on the then-market rate with three months’ prior notice. In September 2022, the Company amended the Newton, MA Lease. Pursuant to the amendment, the Company entered into a separate two-year noncancelable agreement for new dedicated laboratory and office space on the same campus as the Newton, MA Lease. The Company took occupancy of the new dedicated laboratory and office space in December 2022. The monthly rental payments under the amended agreement include base rent charges of $ 1.3 million per year. The agreement terms provide for a month-to-month extension, after completion of the initial two-year term extending through November 2024, with base rent calculated on the then-market rate with three months ’ prior notice. The components of operating lease expense were as follows (in thousands): For the Three Months For the Three Months For the Nine Months For The Nine Months 2023 2022 2023 2022 Lease cost: Operating lease cost $ 430 $ 275 $ 1,290 $ 541 Variable lease cost 11 8 34 24 Total lease cost $ 441 $ 283 $ 1,324 $ 565 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows related to operating leases $ 432 $ 275 $ 1,296 $ 551 Future minimum lease payments under the noncancelable leases as of September 30, 2023 was as follows (in thousands): Year Ending December 31, Operating Lease 2023 (excluding the nine months ended September 30, 2023) 435 2024 1,521 2025 430 2026 328 Total lease payments 2,714 Present value adjustment ( 149 ) Present value of operating lease liability $ 2,565 As of September 30, 2023 , the Company’s operating leases were measured using a weighted-average incremental borrowing rate of 6.0 % over a weighted-average remaining lease term of 2.0 years. As of September 30, 2022 , the Company’s operating lease was measured using a weighted-average incremental borrowing rate of 6.0 % over a weighted average remaining lease term of 4.0 years. The total operating liabilities are presented on the Company’s condensed consolidated balance sheet based on maturity dates. $ 1.6 million of the total operating liabilities are classified under “ operating lease liabilities, current” for the portion due within twelve months, and $ 0.9 million is classified under “operating lease liabilities, non-current”. License Agreements The Company has entered into license agreements with Adimab and WuXi Biologics (see Note 7). Other Agreements In November 2022, the Company entered into the PHP MSA (see Note 8). Concurrently with the PHP MSA, the Company entered into the PHP Work Order, pursuant to which PHP agreed to advise and counsel the Company regarding clinical development and regulatory matters with respect to its product candidates. The PHP Work Order was effective for six months from November 2022 and terminated in accordance with its terms in May 2023. As compensation for the services and deliverables under the PHP Work Order, the Company paid PHP a cash fee of $ 0.5 million per month during the term of the PHP Work Order for an Aggregate Fee of $ 3.0 million. Clinical and Manufacturing Agreements In July 2020, the Company entered into a Clinical Master Services Agreement with WuXi Biologics (the “Clinical Master Services Agreement”). The Clinical Master Services Agreement outlines the terms and conditions under which WuXi Biologics coordinates biologics development and clinical manufacturing services for the Company. In December 2020, the Company entered into a Commercial Manufacturing Services Agreement with WuXi Biologics, which was amended and restated in August 2021 and further amended and restated in September 2023 (as amended and restated, the “Commercial Manufacturing Agreement”). The Commercial Manufacturing Agreement outlines the terms and conditions under which WuXi Biologics manufactures drug substance and drug product for commercial use. The Company committed to minimum noncancelable purchase obligations related to batches of adintrevimab drug substance and certain services with respect to the product requirements for 2022 and 2023 and batches of drug product and certain services with respect to the product requirements for 2022, the payments for which have extended into 2023. In April 2022, the total volume of contractually binding drug substance and drug product batches to be manufactured under the Commercial Manufacturing Agreement was reduced to $ 51.6 million, a decrease of $ 107.8 million from the previous commitment of minimum non-cancelable purchase obligations of $ 159.4 million. In addition, WuXi Biologics agreed to provide the Company with a credit in the low eight-figures to offset future services rendered by WuXi Biologics. In July 2022, the Company provided notice to WuXi Biologics to cancel the contractually binding adintrevimab drug product batches. In November 2022, WuXi Biologics reassigned the remaining contractually binding adintrevimab drug substance batches under the Commercial Manufacturing Agreement to contractually binding NVD200 drug substance batches under its Clinical Master Services Agreement. In March 2023, WuXi Biologics reassigned the remaining contractually binding NVD200 drug substance batches to VYD222 drug substance batches. In March 2023, the remaining amount of the low eight-figure credit was applied to WuXi Biologics services as a reduction of research and development expenses and a reduction of accounts payable. As of September 30, 2023, there were no remaining costs of contractually binding VYD222 drug substance batches to be manufactured under the Clinical Master Services Agreement. As of September 2023, $ 0.1 million related to the contractually binding VYD222 drug substance batches was included in accounts payable and accrued expenses, which is expected to be paid in the fourth quarter of 2023. In June 2023, the Company committed to a noncancelable purchase obligation related to the procurement of resin for future use in VYD222 drug substance batches under the Commercial Manufacturing Agreement. As of September 30, 2023, the total costs of contractually binding resin to be incurred by the Company was $ 10.4 million. During the three months ended September 30, 2023, the Company committed to noncancelable purchase obligations related to the procurement of materials to be used in VYD222 drug substance and drug product batches under the Commercial Manufacturing Agreement. As of September 30, 2023, the total costs of contractually binding materials to be incurred by the Company was $ 5.7 million. In September 2023, the Company committed to a noncancelable purchase obligation related to commercial VYD222 drug substance batches under the Commercial Manufacturing Agreement. As of September 30, 2023, the total costs of contractually binding commercial VYD222 drug substance batches to be incurred by the Company was $ 34.8 million. Unless earlier terminated, the Commercial Manufacturing Agreement remains in effect for an initial period of five years from the date of the last amendment and restatement of the agreement and thereafter automatically renews for further successive periods of five years each. Either party may terminate the agreement upon the breach or default by the other party, other than a non-payment breach, that is not timely cured after notice thereof. Both parties are also entitled to terminate the Commercial Manufacturing Agreement if the other party becomes insolvent or is the subject of a petition in bankruptcy or of any other related proceeding or event. Either party may terminate either the Commercial Manufacturing Agreement in its entirety, or an individual order, (i) to the extent the other party suffers a force majeure event that is continuing for a predefined period of time and (ii) if the other party fails to make a payment when due under the arrangement and such non-payment is not timely cured after notice thereof. Until regulatory approval and future economic benefit is probable, the Company will continue to expense costs related to batches manufactured under the Commercial Manufacturing Agreement. Other Contracts The Company enters into agreements with third parties in the ordinary course of business for various products and services, including those related to research, preclinical and clinical operations, manufacturing and support, supply chain, and distribution. These contracts do not contain any material minimum purchase commitments. Certain of these agreements provide for termination rights subject to the payment of termination fees and/or wind-down costs. Under such agreements, the Company is contractually obligated to make certain payments to vendors upon early termination, primarily to reimburse them for their unrecoverable outlays incurred prior to cancellation as well as any amounts owed by the Company prior to early termination. The actual amounts the Company could pay in the future to the vendors under such agreements may differ from the purchase order amounts due to cancellation provisions. The termination fees were not probable of payment as of September 30, 2023 and December 31, 2022. Legal Proceedings From time to time, the Company may become involved in legal proceedings or other litigation relating to claims arising in the ordinary course of business. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and estimated exposure amount. Legal fees and other costs associated with such proceedings are expensed as incurred. On January 31, 2023, a securities class action lawsuit captioned Brill v. Invivyd, Inc., et. al., Case No. 1:23-CV-10254-LTS, was filed against the Company and certain of its former officers in the U.S. District Court for the District of Massachusetts. The complaint alleges violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder on the basis of purportedly materially false and misleading statements and omissions concerning ADG20’s effectiveness against the Omicron variant of COVID-19. The complaint seeks, among other things, unspecified damages, attorneys’ fees, expert fees, and other costs. The court appointed lead plaintiffs for the action on June 28, 2023. On August 23, 2023, the lead plaintiffs filed an amended complaint that makes allegations similar to those in the original complaint and asserts the same claims against the same defendants as the original complaint. On October 19, 2023, the parties filed a joint stipulation to advise the court that the lead plaintiffs intend to seek leave to file a second amended complaint; by November 17, 2023, the parties will file a stipulation regarding the filing of the proposed second amended complaint and a briefing schedule for defendants’ response thereto. The Company believes that is has strong defenses, and it intends to vigorously defend against this action. The lawsuit is in early stages, and, at this time, no assessment can be made as to the likely outcome or whether the outcome will be material to the Company. Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to its vendors, lessors, CROs, CDMOs, 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 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 that 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. |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Common Stock | 10. Common Stock Shares Reserved for Future Issuance As of September 30, 2023 , the Company had reserved 43,362,371 shares of common stock for the exercise of outstanding stock options and the issuance of awards available for grant under the Company’s 2020 Equity Incentive Plan, 2021 Equity Incentive Plan and 2021 Employee Stock Purchase Plan (see Note 11). Shelf Registration Statement On September 28, 2022, the Company filed a shelf registration statement on Form S-3 with the SEC (File No. 333-267643) and an accompanying base prospectus, which was declared effective by the SEC on October 5, 2022, for the offer and sale of up to $ 400 million of the Company’s securities. As of September 30, 2023, $ 400 million of the Company’s securities remained available for offer and sale under this shelf registration statement. Treasury Stock In February and June 2022, the Company repurchased 1,158,089 and 992,648 shares of unvested restricted common stock, respectively, at the original purchase price upon a termination of service during the vesting period. The shares of common stock repurchased were recorded as treasury stock in the accompanying condensed consolidated balance sheets and condensed consolidated statements of stockholders’ equity (deficit) as such shares were not retired. The fair value of the repurchased common stock was insignificant. In March and September 2022, the Company retired an aggregate of 1,626,840 and 992,648 shares of common stock, respectively, held in treasury. Upon retirement, the shares were redesignated as authorized but unissued shares of the Company’s common stock. In March 2023, the Company repurchased, and subsequently retired, 206,802 shares of unvested restricted common stock at the original purchase price upon a termination of service of an employee during the vesting period. Upon retirement, the shares were redesignated as authorized but unissued shares of the Company’s common stock. In May 2023, the Company repurchased 46,600 shares of unvested restricted common stock at the original purchase price upon a termination of service of an employee during the vesting period. The shares of common stock repurchased were recorded as treasury stock. The fair value of the repurchased common stock was insignificant. In June 2023, the Company retired the 46,600 shares of treasury stock. Upon retirement, the shares were redesignated as authorized but unissued shares of the Company’s common stock. In October 2023, the Company repurchased 31,766 shares of unvested restricted common stock at the original purchase price upon a termination of service of an employee during the vesting period. The shares of common stock repurchased were recorded as treasury stock. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share Based Compensation | 11. Stock-Based Compensation 2020 Equity Incentive Plan The Company’s 2020 Equity Incentive Plan (the “2020 Plan”) provides for the Company to grant incentive stock options, non-qualified stock options, restricted stock awards, restricted stock units and other stock-based awards to employees, members of the board of directors and consultants. The 2020 Plan is administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors. The board of directors may also delegate to one or more officers of the Company the power to grant awards to employees and certain officers of the Company. The exercise prices, vesting and other restrictions are determined at the discretion of the board of directors, or its committee or any such officer if so delegated. The exercise price for stock options granted may not be less than the fair market value of the Company’s common stock on the date of grant, as determined by the board of directors, or at least 110 % of the fair market value of the Company’s common stock on the date of grant in the case of an incentive stock option granted to an employee who owns stock representing more than 10 % of the voting power of all classes of stock as determined by the board of directors as of the date of grant. Prior to the IPO, the Company’s board of directors determined the fair value of the Company’s common stock, taking into consideration its most recently available valuation of common stock performed by third parties as well as additional factors which may have changed since the date of the most recent contemporaneous valuation through the date of grant. Stock options granted under the 2020 Plan expire after ten years and typically vest over a four-year period with the first 25 % vesting upon the first anniversary of a specified vesting commencement date and the remainder vesting in 36 equal monthly installments over the succeeding three years , contingent on the recipient’s continued employment or service. Certain awards of stock options permit the holders to exercise the option in whole or in part prior to the full vesting of the option in exchange for unvested shares of restricted common stock with respect to any unvested portion of the option so exercised. As of September 30, 2023, there were 6,273,185 shares authorized to be issued upon the exercise of outstanding stock option grants and no shares reserved for future issuance under the 2020 Plan. 2021 Equity Incentive Plan In July 2021, the Company’s board of directors adopted, and its stockholders approved, the 2021 Equity Incentive Plan (the “2021 Plan”), which became effective immediately prior to and contingent upon the execution of the underwriting agreement related to the Company’s IPO. The 2021 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based awards. The number of shares reserved for issuance under the 2021 Plan was equal to 35,075,122 , which is the sum of 11,413,572 new shares; plus the number of shares (not to exceed 23,661,550 shares), which represents (i) the number of shares that remained available for issuance under the 2020 Plan, at the time the 2021 Plan became effective, and (ii) any shares subject to outstanding stock options or other stock awards that were granted under the 2020 Plan that are forfeited, terminate, expire or are otherwise not issued. In addition, the number of shares of the Company’s common stock reserved for issuance under the 2021 Plan will automatically increase on the first day of each calendar year, beginning on January 1, 2022 and continuing through January 1, 2031, in an amount equal to 5 % of the shares of common stock outstanding on the last day of the calendar month before the date of each automatic increase, or a lesser number of shares determined by the board of directors. On January 1, 2022, 5,539,145 shares of common stock were automatically added to the shares authorized for issuance under the 2021 Plan. The number of shares to be issued under the 2021 Plan did not increase on January 1, 2023 as determined by the Company ’s board of directors. The shares of 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, repurchased or are otherwise terminated by the Company under the 2021 Plan will be added back to the shares of common stock available for issuance under the 2021 Plan. As of September 30, 2023 , there was an aggregate of 42,279,870 shares authorized to be issued under the 2020 Plan and the 2021 Plan, which includes 6,273,185 and 15,773,163 shares authorized to be issued upon the exercise of outstanding stock option grants from the 2020 Plan and 2021 Plan, respectively, and 0 and 20,233,522 shares reserved for future issuance under the 2020 Plan and 2021 Plan, respectively. Stock Option Valuation The fair value of stock option grants is estimated using the Black-Scholes option-pricing model. Prior to its IPO in August 2021, the Company had been a private company. Due to the proximity to the IPO, the Company continues to lack sufficient company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield 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 following table presents, on a weighted-average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant date fair value of stock options granted: Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended 2023 2022 2023 2022 Expected term (in years) 6.1 6.0 5.9 6.0 Expected volatility 64.3 % 75.5 % 68.0 % 73.3 % Risk-free interest rate 4.2 % 2.8 % 3.7 % 2.2 % Expected dividend yield — % — % — % — % Stock Option Activity The following table summarizes the Company’s stock option activity since December 31, 2022: Number of Weighted- Weighted- Aggregate (in years) (in thousands) Outstanding at December 31, 2022 23,239,391 $ 7.01 7.9 $ 1,594 Granted 5,969,889 $ 1.82 Exercised ( 908,934 ) $ 0.78 Forfeited ( 6,253,998 ) $ 7.81 Outstanding at September 30, 2023 22,046,348 $ 5.63 7.6 $ 1,979 Vested and expected to vest at September 30, 2023 22,046,348 $ 5.63 7.6 $ 1,979 Options exercisable at September 30, 2023 7,624,553 $ 7.64 6.5 $ 654 The weighted-average grant date fair value of stock options granted during the three and nine months ended September 30, 2023 was $ 1.06 and $ 1.15 , respectively, per share. The weighted-average grant date fair value of stock options granted during the three and nine months ended September 30, 2022 was $ 2.28 and $ 3.50 , respectively, per share. The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair market value of the common stock for the options that had exercise prices lower than the estimated fair value of the Company's common stock at September 30, 2023 and 2022. The total intrinsic value of stock options exercised was $ 0.1 million and $ 0.5 million for the three and nine months ended September 30, 2023 , respectively. The total intrinsic value of stock options exercised was $ 0.4 million and $ 1.0 million for the three and nine months ended September 30, 2022, respectively. Early Exercise of Stock Options into Restricted Stock The Company’s restricted stock activity during the nine months ended September 30, 2023 was solely due to shares of restricted common stock issued pursuant to the permitted early exercise of stock options as permitted under the 2020 Plan prior to amendments to the 2020 Plan. The 2021 Plan does not permit early exercise of stock options. Shares of common stock issued upon exercise of unvested stock options are restricted and continue to vest in accordance with the original vesting schedule applicable to the associated stock option award. The Company has the right to repurchase any unvested shares of restricted common stock, at the original purchase price, upon any voluntary or involuntary termination of the service relationship during the vesting period. A summary of the Company’s unvested common stock from option early exercises that is subject to repurchase by the Company is as follows: Number Unvested restricted stock at December 31, 2022 360,333 Issued — Vested ( 75,165 ) Repurchased ( 253,402 ) Unvested restricted stock at September 30, 2023 31,766 Proceeds from the early exercise of stock options are recorded as an early-exercise liability on the condensed consolidated balance sheets. The liability for unvested common stock subject to repurchase is then reclassified to common stock and additional paid-in capital as the Company’s repurchase right lapses. Shares issued pursuant to the early exercise of stock options are not considered to be outstanding for accounting purposes until the shares vest. As of both September 30, 2023 and December 31, 2022 , the liability related to the payments for unvested shares from early-exercised options was less than $ 0.1 million. Stock-Based Compensation Expense The Company recorded stock-based compensation expense (service-based stock options and employee stock purchase plan) in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 1,235 $ 3,419 $ 5,116 $ 9,954 Selling, general and administrative 3,029 3,980 9,225 5,789 $ 4,264 $ 7,399 $ 14,341 $ 15,743 As of September 30, 2023 , total unrecognized stock-based compensation expense related to unvested stock-based awards was $ 37.3 million, which is expected to be recognized over a weighted-average period of 2.5 years. 2021 Employee Stock Purchase Plan In July 2021, the Company’s board of directors adopted, and its stockholders approved, the 2021 Employee Stock Purchase Plan (the ‘‘2021 ESPP’’), which became effective immediately prior to and contingent upon the execution of the underwriting agreement related to the Company’s IPO. A total of 1,342,773 shares of common stock were initially reserved for issuance under the 2021 ESPP. There were 260,272 shares issued under the 2021 ESPP as of September 30, 2023 . The number of shares of common stock that may be issued under the 2021 ESPP will automatically increase on the first day of each calendar year, beginning on January 1, 2022 and continuing through January 1, 2031, by an amount equal to the lesser of (i) 1 % of the shares of common stock outstanding on the last day of the calendar month before the date of each automatic increase, (ii) 2,685,546 shares and (iii) an amount determined by the Company’s board of directors. The number of shares to be issued under the 2021 ESPP did not increase on January 1, 2023 as determined by the Company’s b oard of directors. The first offering under the 2021 ESPP was June 6, 2022. As of September 30, 2023 , 1,082,501 shares remained available for issuance under the 2021 ESPP. During the three and nine months ended September 30, 2023, the Company recognized less than $ 0.1 million and $ 0.1 million, respectively, in related stock-based compensation expense. Warrant Expense In November 2022, the Company entered into the PHP MSA, the PHP Work Order and a warrant agreement with respect to the PHP Warrant. To compensate for the services and deliverables provided by PHP, the Company issued 6,824,712 equity-classified warrants to PHP. Each warrant shall give the right to acquire common stock of the Company at a purchase price of $ 3.48 per share. Per the agreement, the PHP Warrant is exercisable upon either the achievement of corresponding market capitalization targets or a consummation of a fundamental transaction (as defined in the PHP Warrant); as such, there are no other requirements, including any continuous service requirements, in order for PHP to be entitled to the PHP Warrant, if and when any portion of it vests. The aggregate grant date fair value of the PHP Warrant was $ 17.4 million, which was recognized as warrant expense on the grant date in November 2022. There were no warrants issued during the three and nine months ended September 30, 2023. As of September 30, 2023 , there were 6,824,712 warrants outstanding at a weighted average exercise price of $ 3.48 , with a weighted-average remaining contractual term of 9.13 years. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 12. Income Taxes For the three and nine months ended September 30, 2023 and 2022, the Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period, due to its uncertainty of realizing a benefit from those items. Substantially all of the Company’s operating losses since inception have been generated in the U.S. |
Defined Contribution Plan
Defined Contribution Plan | 9 Months Ended |
Sep. 30, 2023 | |
Retirement Benefits [Abstract] | |
Defined Contribution Plan | 13. Defined Contribution Plan The Company maintains a 401(k) Plan (the “401(k) Plan”) for the benefit of eligible employees. The 401(k) Plan is a defined contribution plan under Section 401(k) of the Internal Revenue Code of 1986 that 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. Pursuant to the terms of the 401(k) Plan, the Company is required to make non-elective contributions of 3 % of eligible participants’ compensation. For the three and nine months ended September 30, 2023 , the Company contributed $ 0.3 million and $ 0.6 million, respectively, to the 401(k) Plan. For the three and nine months ended September 30, 2022 , the Company contributed $ 0.2 million and $ 0.6 million, respectively, to the 401(k) Plan. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 14. Net Loss per Share Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts): Three Months Ended Three Months Ended Nine Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net loss attributable to common stockholders $ ( 39,440 ) $ ( 45,087 ) $ ( 124,989 ) $ ( 196,743 ) Denominator: Weighted-average common shares outstanding, basic and diluted 109,754,812 108,420,674 109,333,684 108,154,397 Net loss per share attributable to common stockholders, basic and diluted $ ( 0.36 ) $ ( 0.42 ) $ ( 1.14 ) $ ( 1.82 ) Shares of unvested restricted common stock are not considered outstanding for accounting purposes until vested and were excluded from the calculations of basic net loss per share attributable to common stockholders for all periods presented. The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. 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: For the Nine Months 2023 2022 Stock options to purchase common stock 22,046,348 21,404,313 Unvested restricted common stock 31,766 420,389 Warrants to purchase common stock 6,824,712 — 28,902,826 21,824,702 |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 15. Related Party Transactions As of September 30, 2023 and December 31, 2022 , an aggregate of $ 5.8 million and $ 0.3 million, respectively, was due to Adimab under the Adimab Assignment Agreement, the Adimab Collaboration Agreement, the Adimab Platform Transfer Agreement and the Adimab DNA Sequencing Services Agreement (as defined below) by the Company. As of September 30, 2023 and December 31, 2022 , no amounts were due to the Company from Adimab under the Adimab Assignment Agreement, the Adimab Collaboration Agreement, the Adimab Platform Transfer Agreement or the Adimab DNA Sequencing Services Agreement. Adimab Assignment Agreement Under the Adimab Assignment Agreement, Adimab, a principal stockholder of the Company, is entitled to receive milestone and royalty payments upon specified conditions and receives payments from the Company for providing ongoing services under the agreement (see Note 7). During the three and nine months ended September 30, 2023, the Company recognized $ 3.2 million and $ 3.6 million, respectively, as IPR&D expense with respect to a milestone payable under the Adimab Assignment Agreement. During the three and nine months ended September 30, 2023 , the Company did no t recognize any IPR&D expense with respect to contingent consideration payable under the Adimab Assignment Agreement. During the three and nine months ended September 30, 2023 , the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company ’ s behalf under the Adimab Assignment Agreement. During the three and nine months ended September 30, 2022, the Company recognized $ 0.1 million and $ 0.6 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement. Adimab Collaboration Agreement Under the Adimab Collaboration Agreement, the Company is obligated to pay Adimab for certain fees, milestones and royalty payments (see Note 7). During both the three and nine months ended September 30, 2023 and 2022, the Company recognized $ 1.3 million and $ 3.9 million, respectively, of research and development expense related to the quarterly fee. During the three and nine months ended September 30, 2023 , the Company recognized $ 0.1 million and $ 0.5 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement. During the three and nine months ended September 30, 2022, the Company recognized $ 0.3 million and $ 1.3 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement. During both the three and nine months ended September 30, 2023 and 2022, the Company recognized $ 1.0 million of IPR&D expense related to an option exercise fee. During both the three and nine months ended September 30, 2023, the Company recognized $ 0.2 million of IPR&D expense related to a drug delivery fee. During the three and nine months ended September 30, 2022, the Company recognized $ 0 and $ 0.2 million, respectively, of research and development expense related to a drug delivery fee. During both the three and nine months ended September 30, 2023, the Company recognized $ 0.2 million of IPR&D expense related to an optimization completion fee. The Company did no t recognize any IPR&D expense related to an optimization completion fee during the three and nine months September 30, 2022. Adimab Platform Transfer Agreement Under the Adimab Platform Transfer Agreement, the Company is obligated to pay Adimab for certain fees, milestones and royalty payments (see Note 7). During both the three and nine months ended September 30, 2023 , the Company recognized a portion of the first annual fee as research and development expense. During both the three and nine months ended September 30, 2022, the Company recognized $ 3.0 million of IPR&D expense in connection with the upfront consideration payable for the rights assigned pursuant to the Adimab Platform Transfer Agreement. Adimab DNA Sequencing Services Agreement On May 9, 2023, the Company entered into a Services Agreement with Adimab for Adimab to perform DNA sequencing on yeast samples provided by the Company, and the delivery of the resulting data and information to the Company (the “Adimab DNA Sequencing Services Agreement”). In exchange for the services performed, the Company will pay Adimab a fee for each yeast-derived DNA template sample present in the well within the sequencer plate. During the three and nine months ended September 30, 2023, the Company recognized less than $ 0.1 million of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab DNA Sequencing Services Agreement. Mithril Group In March 2022, a group of stockholders, including, among others, Adimab; Mithril II LP; M28 Capital Management LP; Polaris Venture Partners V, L.P.; and Population Health Equity Partners III, L.P., which are collectively referred to as the Mithril Group, submitted a notice of intent to nominate three directors to the Company’s board of directors at the 2022 annual meeting of stockholders. In April 2022, the Mithril Group filed definitive proxy materials with the SEC seeking election of three directors to the Company’s board of directors and adoption of a non-binding resolution for director declassification. Subsequently, during the year ended December 31, 2022, Mithril II LP requested that the Company reimburse it for costs associated with legal expenses, corporate governance matters and stockholder proposals incurred as a result of the aforementioned matters in connection with the Company’s 2022 annual meeting of stockholders. The Company made such reimbursement payment to Mithril II LP in the amount of $ 1.4 million, which the Company recognized as a selling, general and administrative expense. As of September 30, 2023 , no amounts were due to any member of the Mithril Group by the Company, and no amounts were due from any member of the Mithril Group to the Company. Population Health Partners, L.P. Under the PHP MSA and PHP Work Order, the Company was obligated to pay cash compensation for services and deliverables (see Note 8). Clive Meanwell, M.D. and Tamsin Berry, members of the Company’s board of directors, are Managing Partner and Partner of PHP, respectively. During the three and nine months ended September 30, 2023 , the Company recognized $ 0 and $ 2.3 million, respectively, of research and development expense with respect to services performed by PHP in connection with the PHP Work Order, which terminated in accordance with its terms in May 2023. The agreements with PHP were not effective during the three and nine months ended September 30, 2022. As of September 30, 2023 , no amounts were due to PHP by the Company, and no amounts were due from PHP to the Company. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of September 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, the condensed consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022 and the condensed consolidated statements of stockholders’ equity (deficit) for the three and nine months ended September 30, 2023 and 2022 are unaudited. The accompanying unaudited condensed 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 SEC for interim financial statements. The accompanying condensed consolidated balance sheet as of December 31, 2022 was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited annual consolidated financial statements, and the notes thereto, as of and for the year ended December 31, 2022, which are included in the Company’s 2022 Form 10-K. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s condensed consolidated financial position as of September 30, 2023 and December 31, 2022, the condensed consolidated results of operations for the three and nine months ended September 30, 2023 and 2022, the condensed consolidated cash flows for the nine months ended September 30, 2023 and 2022 and changes in stockholders’ equity (deficit) for the nine months ended September 30, 2023 and 2022 have been made. The Company’s condensed consolidated 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 . |
Use of Estimates | Use of Estimates The preparation of the Company’s condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, research and development expenses and related prepaid or accrued costs and stock-based compensation expense. The Company bases its estimates on historical experience, known trends and other market-specific or relevant factors 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. Changes in estimates are recorded in the period in which they become known. Actual results may differ materially from those estimates or assumptions. The Company is monitoring the potential impact of the COVID-19 pandemic on its business and condensed consolidated financial statements. The Company is not aware of any specific event or circumstance that would require any update to its estimates or judgments reflected in these condensed consolidated financial statements or a revision of the carrying value of its assets or liabilities as of the issuance date of these condensed consolidated financial statements. These estimates may change as new events occur and additional information is obtained. |
Recently Issued and Adopted Accounting Pronouncements | Recently Issued and Adopted Accounting Pronouncements The Company is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and will remain an emerging growth company until the last day of the fiscal year following the fifth anniversary of the completion of its IPO. However, if certain events occur prior to the end of such five-year period, including if it becomes a “large accelerated filer,” its annual gross revenues exceeds $ 1.235 billion or it issues more than $ 1.0 billion of non-convertible debt in the previous three-year period, it will cease to be an emerging growth company prior to the end of such five-year period. For so long as the Company remains an emerging growth company, it is permitted and intends to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. For example, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of these accounting standards until they would otherwise apply to private companies. There have been no new accounting pronouncements or changes to accounting pronouncements that could be expected to materially impact the Company’s unaudited condensed consolidated financial statements during the nine months ended September 30, 2023 , as compared to the recent accounting pronouncements described in Note 2 of the Company’s condensed consolidated financial statements included in its 2022 Form 10-K. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Marketable Securities [Abstract] | |
Summary of Marketable Securities | The following tables summarize the gross unrealized gains, unrealized losses and credit losses of the Company’s marketable securities as of September 30, 2023 and December 31, 2022 (in thousands): September 30, 2023 Amortized Cost Unrealized Gains Unrealized Losses Credit Losses Fair Value U.S. Treasury securities $ 12,988 $ — $ ( 1 ) $ — $ 12,987 Federal agency securities 70,077 8 ( 9 ) — 70,076 Total financial assets $ 83,065 $ 8 $ ( 10 ) $ — $ 83,063 December 31, 2022 Amortized Cost Unrealized Gains Unrealized Losses Credit Losses Fair Value U.S. Treasury securities $ 107,973 $ 13 $ ( 115 ) $ — $ 107,871 Federal agency securities 172,214 39 ( 209 ) — 172,044 Total financial assets $ 280,187 $ 52 $ ( 324 ) $ — $ 279,915 The Company did not record any charges for credit-related impairments for its available-for-sale securities during the three and nine months ended September 30, 2023 . |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis | The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis (in thousands): Fair Value Measurements at Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 181,411 $ — $ — $ 181,411 Marketable securities: U.S. Treasury securities 12,987 — — 12,987 Federal agency securities — 70,076 — 70,076 $ 194,398 $ 70,076 $ — $ 264,474 Fair Value Measurements at Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 91,050 $ — $ — $ 91,050 Marketable securities: U.S. Treasury securities 107,871 — — 107,871 Federal agency securities — 172,044 — 172,044 $ 198,921 $ 172,044 $ — $ 370,965 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Summary of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, Prepaid external research, development and manufacturing costs $ 3,265 $ 843 Prepaid insurance 214 2,392 Prepaid compensation and other 1,026 1,314 Interest receivable 713 377 $ 5,218 $ 4,926 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Liabilities [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): September 30, December 31, Accrued external research, development and manufacturing costs $ 10,278 $ 13,955 Accrued professional and consultant fees 1,606 1,153 Accrued employee compensation 3,862 5,985 Other 212 818 $ 15,958 $ 21,911 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Components of Operating Lease Expense | The components of operating lease expense were as follows (in thousands): For the Three Months For the Three Months For the Nine Months For The Nine Months 2023 2022 2023 2022 Lease cost: Operating lease cost $ 430 $ 275 $ 1,290 $ 541 Variable lease cost 11 8 34 24 Total lease cost $ 441 $ 283 $ 1,324 $ 565 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows related to operating leases $ 432 $ 275 $ 1,296 $ 551 |
Schedule of Future Minimum Payments Under Non-cancellable Purchase Obligations | Future minimum lease payments under the noncancelable leases as of September 30, 2023 was as follows (in thousands): Year Ending December 31, Operating Lease 2023 (excluding the nine months ended September 30, 2023) 435 2024 1,521 2025 430 2026 328 Total lease payments 2,714 Present value adjustment ( 149 ) Present value of operating lease liability $ 2,565 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Weighted Average Fair Values and Valuation Assumptions | The following table presents, on a weighted-average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant date fair value of stock options granted: Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended 2023 2022 2023 2022 Expected term (in years) 6.1 6.0 5.9 6.0 Expected volatility 64.3 % 75.5 % 68.0 % 73.3 % Risk-free interest rate 4.2 % 2.8 % 3.7 % 2.2 % Expected dividend yield — % — % — % — % |
Summary of Stock Option Activity | The following table summarizes the Company’s stock option activity since December 31, 2022: Number of Weighted- Weighted- Aggregate (in years) (in thousands) Outstanding at December 31, 2022 23,239,391 $ 7.01 7.9 $ 1,594 Granted 5,969,889 $ 1.82 Exercised ( 908,934 ) $ 0.78 Forfeited ( 6,253,998 ) $ 7.81 Outstanding at September 30, 2023 22,046,348 $ 5.63 7.6 $ 1,979 Vested and expected to vest at September 30, 2023 22,046,348 $ 5.63 7.6 $ 1,979 Options exercisable at September 30, 2023 7,624,553 $ 7.64 6.5 $ 654 |
Schedule of Unvested Common Stock Options | A summary of the Company’s unvested common stock from option early exercises that is subject to repurchase by the Company is as follows: Number Unvested restricted stock at December 31, 2022 360,333 Issued — Vested ( 75,165 ) Repurchased ( 253,402 ) Unvested restricted stock at September 30, 2023 31,766 |
Summary of Share Based Compensation Expense Recognized | The Company recorded stock-based compensation expense (service-based stock options and employee stock purchase plan) in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 1,235 $ 3,419 $ 5,116 $ 9,954 Selling, general and administrative 3,029 3,980 9,225 5,789 $ 4,264 $ 7,399 $ 14,341 $ 15,743 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts): Three Months Ended Three Months Ended Nine Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net loss attributable to common stockholders $ ( 39,440 ) $ ( 45,087 ) $ ( 124,989 ) $ ( 196,743 ) Denominator: Weighted-average common shares outstanding, basic and diluted 109,754,812 108,420,674 109,333,684 108,154,397 Net loss per share attributable to common stockholders, basic and diluted $ ( 0.36 ) $ ( 0.42 ) $ ( 1.14 ) $ ( 1.82 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | For the Nine Months 2023 2022 Stock options to purchase common stock 22,046,348 21,404,313 Unvested restricted common stock 31,766 420,389 Warrants to purchase common stock 6,824,712 — 28,902,826 21,824,702 |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
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 | |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||||
Net loss | $ (39,440) | $ (50,228) | $ (35,321) | $ (45,087) | $ (50,990) | $ (100,666) | $ (124,989) | $ (196,743) | |
Accumulated deficit | $ (658,415) | $ (658,415) | $ (533,426) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Accounting Policies [Abstract] | |
Annual gross revenue | $ 1,235 |
Convertible debt | $ 1,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Summary of the impact of the adoption (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Operating lease right-of-use asset | $ 2,625 | $ 3,777 |
Operating lease liability, current | 1,638 | 1,559 |
Operating lease liability, non-current | $ 927 | $ 2,165 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Amortized Cost | $ 83,065 | $ 280,187 |
Unrealized Gains | 8 | 52 |
Unrealized Losses | (10) | (324) |
Fair Value | 83,063 | 279,915 |
U.S. Treasury Securities [Member] | ||
Amortized Cost | 12,988 | 107,973 |
Unrealized Gains | 0 | 13 |
Unrealized Losses | (1) | (115) |
Fair Value | 12,987 | 107,871 |
Federal Agency Securities [Member] | ||
Amortized Cost | 70,077 | 172,214 |
Unrealized Gains | 8 | 39 |
Unrealized Losses | (9) | (209) |
Fair Value | $ 70,076 | $ 172,044 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Marketable Securities [Abstract] | ||
Available for sale marketable securities | $ 0 | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Assets: | ||
Assets, fair value disclosure | $ 264,474 | $ 370,965 |
U.S. Treasury Securities [Member] | ||
Assets: | ||
Assets, fair value disclosure | 12,987 | 107,871 |
Federal Agency Securities [Member] | ||
Assets: | ||
Assets, fair value disclosure | 70,076 | 172,044 |
Cash Equivalents [Member] | Money Market Fund [Member] | ||
Assets: | ||
Assets, fair value disclosure | 181,411 | 91,050 |
Level 1 [Member] | ||
Assets: | ||
Assets, fair value disclosure | 194,398 | 198,921 |
Level 1 [Member] | U.S. Treasury Securities [Member] | ||
Assets: | ||
Assets, fair value disclosure | 12,987 | 107,871 |
Level 1 [Member] | Federal Agency Securities [Member] | ||
Assets: | ||
Assets, fair value disclosure | 0 | 0 |
Level 1 [Member] | Cash Equivalents [Member] | Money Market Fund [Member] | ||
Assets: | ||
Assets, fair value disclosure | 181,411 | 91,050 |
Level 2 [Member] | ||
Assets: | ||
Assets, fair value disclosure | 70,076 | 172,044 |
Level 2 [Member] | U.S. Treasury Securities [Member] | ||
Assets: | ||
Assets, fair value disclosure | 0 | 0 |
Level 2 [Member] | Federal Agency Securities [Member] | ||
Assets: | ||
Assets, fair value disclosure | 70,076 | 172,044 |
Level 2 [Member] | Cash Equivalents [Member] | Money Market Fund [Member] | ||
Assets: | ||
Assets, fair value disclosure | 0 | 0 |
Level 3 [Member] | ||
Assets: | ||
Assets, fair value disclosure | 0 | 0 |
Level 3 [Member] | U.S. Treasury Securities [Member] | ||
Assets: | ||
Assets, fair value disclosure | 0 | 0 |
Level 3 [Member] | Federal Agency Securities [Member] | ||
Assets: | ||
Assets, fair value disclosure | 0 | 0 |
Level 3 [Member] | Cash Equivalents [Member] | Money Market Fund [Member] | ||
Assets: | ||
Assets, fair value disclosure | $ 0 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Sep. 30, 2022 |
Fair Value Disclosures [Abstract] | ||
Transfers between level 3 | $ 0 | $ 0 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Summary of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid external research, development and manufacturing costs | $ 3,265 | $ 843 |
Prepaid insurance | 214 | 2,392 |
Prepaid compensation and other | 1,026 | 1,314 |
Interest receivable | 713 | 377 |
Prepaid expenses and other current assets | $ 5,218 | $ 4,926 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Liabilities [Abstract] | ||
Accrued external research, development and manufacturing costs | $ 10,278 | $ 13,955 |
Accrued professional and consultant fees | 1,606 | 1,153 |
Accrued employee compensation | 3,862 | 5,985 |
Other | 212 | 818 |
Accrued expenses | $ 15,958 | $ 21,911 |
License and Collaboration Agr_2
License and Collaboration Agreements - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2022 | Jun. 30, 2023 | Mar. 31, 2023 | Feb. 28, 2023 | Aug. 31, 2021 | Jul. 31, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2020 | |
Preferred stock, shares issued (in shares) | 0 | 0 | 0 | |||||||||
Acquired IPR&D expense | $ 3 | $ 0.2 | ||||||||||
Quarterly fee | 1.3 | |||||||||||
Delivery fee | 0.2 | |||||||||||
Completion fee | 0.2 | |||||||||||
Exercise fee | $ 1 | |||||||||||
Accrued Upfront Fee | $ 0.2 | |||||||||||
License fees received | $ 0.2 | $ 0.4 | ||||||||||
Royalty Based on Net Sales of Licensed Products, Percentage | 1% | |||||||||||
Royalty expense | $ 0 | |||||||||||
Research and Development [Member] | ||||||||||||
Quarterly fee | $ 1.3 | $ 1.3 | 0.9 | $ 3.9 | ||||||||
Research Development And Regulatory Milestone | ||||||||||||
Potential milestone payment | 18 | |||||||||||
Adimab Assignment Agreement [Member] | ||||||||||||
Milestone payment | 3.6 | $ 7.5 | ||||||||||
Advance payment | $ 7.9 | |||||||||||
Adimab Assignment Agreement [Member] | Maximum [Member] | ||||||||||||
Potential milestone payment | $ 24.6 | |||||||||||
Royalty percentage of sublicense consideration | 55% | |||||||||||
Adimab Assignment Agreement [Member] | Minimum [Member] | ||||||||||||
Royalty percentage of sublicense consideration | 45% | |||||||||||
Adimab Assignment Agreement [Member] | Research and Development [Member] | ||||||||||||
Recognized expense | 0 | 0.1 | $ 0 | 0.6 | ||||||||
Adimab Assignment Agreement [Member] | Acquired In Process Research And Development Expense [Member] | ||||||||||||
Milestone payment | $ 0.4 | 3.2 | 3.6 | |||||||||
Adimab Assignment Agreement [Member] | First Product [Member] | ||||||||||||
Potential milestone payment | 16.5 | |||||||||||
Adimab Assignment Agreement [Member] | Second Product [Member] | ||||||||||||
Potential milestone payment | $ 8.1 | |||||||||||
Adimab Assignment Agreement [Member] | Research Development And Regulatory Milestone | ||||||||||||
Milestone payment | 11.1 | |||||||||||
Adimab Collaboration Agreement [Member] | ||||||||||||
Expenses | 0.1 | 0.3 | 0.5 | 1.3 | ||||||||
Adimab Collaboration Agreement [Member] | Research and Development [Member] | ||||||||||||
Quarterly fee | 1.3 | 1.3 | 3.9 | 3.9 | ||||||||
Delivery fee | 0 | 0.2 | ||||||||||
Adimab Collaboration Agreement [Member] | Acquired In Process Research And Development Expense [Member] | ||||||||||||
Delivery fee | 1 | 1 | 0.2 | 1 | ||||||||
Adimab Platform Transfer Agreement [Member] | Research Development And Regulatory Milestone | ||||||||||||
Potential milestone payment | 9.5 | |||||||||||
Cell Line License Agreement [Member] | ||||||||||||
Acquired IPR&D expense | 0 | 0.6 | ||||||||||
TSRI | ||||||||||||
Research and development expenses | $ 0 | $ 0 | $ 0 | $ 1.7 | ||||||||
Amount Paid As Pre Paid Funding For Research Plan | $ 1.5 |
Population Health Partners, L_2
Population Health Partners, L.P (Additional Information) (Details) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2023 USD ($) $ / shares shares | |
Other Commitments [Line Items] | ||
Warrant exercise price | $ / shares | $ 3.48 | $ 3.48 |
Exercisable common stock | shares | 6,824,712 | 6,824,712 |
Population Health Partners [Member] | ||
Other Commitments [Line Items] | ||
Cash fee payment per month | $ 0.5 | $ 0.5 |
Aggregate fee | 3 | 3 |
Research and developmet expenses | $ 0 | $ 2.3 |
PHP Warrant [Member] | November 15, 2028 [Member] | ||
Other Commitments [Line Items] | ||
Common stock, conversion basis | 3,591,954 shares of the Company’s common stock underlying the PHP Warrant vests if the Company’s Market Capitalization (as defined below) equals or exceeds $758,517,511 by November 15, 2028; | |
PHP Warrant [Member] | November 15, 2029 [Member] | ||
Other Commitments [Line Items] | ||
Common stock, conversion basis | 1,795,977 shares of the Company’s common stock underlying the PHP Warrant vests if the Company’s Market Capitalization equals or exceeds $1,137,776,266 by November 15, 2029; and | |
PHP Warrant [Member] | November 15, 2030 [Member] | ||
Other Commitments [Line Items] | ||
Common stock, conversion basis | 1,436,781 shares of the Company’s common stock underlying the PHP Warrant vests if the Company’s Market Capitalization equals or exceeds $1,517,035,022 by November 15, 2030. |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Thousands | 9 Months Ended | ||||||||
Sep. 30, 2022 USD ($) | Sep. 14, 2021 USD ($) ft² | Sep. 30, 2023 USD ($) | Sep. 30, 2022 | Jul. 31, 2023 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Nov. 30, 2022 USD ($) | Apr. 30, 2022 USD ($) | |
Long-Term Purchase Commitment [Line Items] | |||||||||
Lease term | 5 years | ||||||||
Lease space | ft² | 9,600 | ||||||||
Monthly rental payments | $ 1,300 | $ 400 | $ 700 | ||||||
Operating lease liability, non-current | $ 927 | $ 2,165 | |||||||
Borrowing rate | 6% | 6% | |||||||
Future minimum payments under non-cancelable purchase obligations | $ 107,800 | ||||||||
Weighted-average remaining lease term | 4 years | 2 years | 4 years | ||||||
Operating lease liability, current | $ 1,638 | 1,559 | |||||||
Fees to be paid in cash | $ 3,000 | ||||||||
Purchase Obligation | 2,714 | 159,400 | |||||||
Total cost incurred | |||||||||
PHP | |||||||||
Long-Term Purchase Commitment [Line Items] | |||||||||
Fees to be paid in cash | $ 500 | ||||||||
VYD222 Drug Substance | |||||||||
Long-Term Purchase Commitment [Line Items] | |||||||||
Future minimum payments under non-cancelable purchase obligations | 100 | ||||||||
A&R Commercial Manufacturing Agreement | |||||||||
Long-Term Purchase Commitment [Line Items] | |||||||||
Future minimum payments under non-cancelable purchase obligations | $ 51,600 | ||||||||
Purchase Obligation | $ 34,800 | $ 10,400 | |||||||
A&R Commercial Manufacturing Agreement | VYD222 Drug Substance | |||||||||
Long-Term Purchase Commitment [Line Items] | |||||||||
Total cost incurred | $ 5,700 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Components of Operating Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Lease cost | ||||
Operating lease cost | $ 430 | $ 275 | $ 1,290 | $ 541 |
Variable lease cost | 11 | 8 | 34 | 24 |
Total lease cost | 441 | 283 | 1,324 | 565 |
Cash paid for amounts included in the measurement of lease liabilities: | ||||
Operating cash flows related to operating leases | $ 432 | $ 275 | $ 1,296 | $ 551 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Future Minimum Payments Under Non-cancellable Purchase Obligations (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Apr. 30, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
2023 (excluding the nine months ended September 30, 2023) | $ 435 | |
2024 | 1,521 | |
2025 | 430 | |
2026 | 328 | |
Total lease payments | 2,714 | $ 159,400 |
Present value adjustment | (149) | |
Present value of operating lease liability | $ 2,565 |
Convertible Preferred Stock - A
Convertible Preferred Stock - Additional Information (Details) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares issued (in shares) | 109,846,329 | 109,044,046 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Common Stock - Additional Infor
Common Stock - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | ||||||||||
May 31, 2023 | Sep. 28, 2022 | Jun. 30, 2022 | Feb. 28, 2022 | Oct. 31, 2023 | Mar. 31, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Mar. 31, 2022 | |
Security for sale offering | $ 400 | ||||||||||
Common stock, shares issued (in shares) | 109,846,329 | 109,044,046 | |||||||||
Convertible Preferred Stock, Shares Reserved for Future Issuance | 43,362,371 | ||||||||||
Shelf Registration Statement [Member] | |||||||||||
Securities, available for offer and sale | $ 400 | ||||||||||
Treasury Stock [Member] | |||||||||||
Common shares repurchased | 46,600 | 992,648 | 1,158,089 | 31,766 | 206,802 | ||||||
Common stock, shares issued (in shares) | 46,600 | 1,626,840 | |||||||||
Common stock shares held | 992,648 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Jan. 01, 2022 shares | Nov. 30, 2022 USD ($) $ / shares shares | Jul. 31, 2021 shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) $ / shares | Sep. 30, 2023 USD ($) Installment $ / shares shares | Sep. 30, 2022 USD ($) $ / shares | Dec. 31, 2022 USD ($) | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of shares of common stock authorized for issuance | 2,685,546 | |||||||
Percentage of number of shares of common stock outstanding | 1% | |||||||
Intrinsic value of stock options exercised | $ | $ 100 | $ 400 | $ 500 | $ 1,000 | ||||
Fair value of common stock Per Share | $ / shares | $ 1.06 | $ 2.28 | $ 1.15 | $ 3.5 | ||||
Liability for unvested shares | $ | $ 37,300 | $ 37,300 | ||||||
Unrecognized stock based compensation expense, Weighted average recognition period | 2 years 6 months | |||||||
Stock based compensation expense | $ | $ 4,264 | $ 7,399 | $ 14,341 | $ 15,743 | ||||
Granted | 5,969,889 | |||||||
Class of Warrant or Right, Outstanding | 6,824,712 | 6,824,712 | ||||||
Weighted average exercise price of Warrant Per Share | $ / shares | $ 3.48 | $ 3.48 | ||||||
Maximum [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Liability for unvested shares | $ | $ 100 | $ 100 | $ 100 | |||||
2020 Equity Incentive Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of shares of common stock authorized for issuance | 6,273,185 | 6,273,185 | ||||||
Shares available for future issuance | 0 | 0 | ||||||
Award vesting period | 4 years | |||||||
Percentage of options vesting | 25% | |||||||
Number of quarterly installments for vesting | Installment | 36 | |||||||
Share-based payment award, expiration period | 10 years | |||||||
Number of quarterly installments for vesting succeeding period | 3 years | |||||||
2020 Equity Incentive Plan | Minimum [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Grant exercise price, percentage of estimated fair value of common stock on date of grant (not less than) | 110% | |||||||
Combined voting power on all classes of stock threshold | 10% | |||||||
2021 Equity Incentive Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of shares of common stock authorized for issuance | 35,075,122 | 42,279,870 | 42,279,870 | |||||
Shares available for future issuance | 20,233,522 | 20,233,522 | ||||||
Issuance of common stock, shares | 5,539,145 | 11,413,572 | ||||||
Percentage of number of shares of common stock outstanding | 5% | |||||||
2021 Equity Incentive Plan | Maximum [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares available for future issuance | 23,661,550 | |||||||
Two Thousand And Twenty Two Employee Stock Purchase Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of shares of common stock authorized for issuance | 1,082,501 | 1,082,501 | ||||||
Two Thousand And Twenty One Employee Stock Purchase Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of shares of common stock authorized for issuance | 1,342,773 | 260,272 | 260,272 | |||||
Two Thousand And Twenty One Employee Stock Purchase Plan | Maximum [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock based compensation expense | $ | $ 100 | $ 100 | ||||||
Two Thousand And Twenty Employee Stock Purchase Plan Member | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares available for future issuance | 0 | 0 | ||||||
PHP Warrants Outstanding [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Issuance of common stock, shares | 6,824,712 | 0 | 0 | |||||
Repurchased common stock, per share | $ / shares | $ 3.48 | |||||||
Warrant expense | $ | $ 17,400 | |||||||
Class of Warrant or Right, Outstanding | 6,824,712 | 6,824,712 | ||||||
Weighted average exercise price of Warrant Per Share | $ / shares | $ 3.48 | $ 3.48 | ||||||
Weighted-average remaining contractual term (Years) | 9 years 1 month 17 days | |||||||
Share-Based Payment Arrangement, Option [Member] | 2021 Equity Incentive Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of shares of common stock authorized for issuance | 15,773,163 | 15,773,163 | ||||||
Share-Based Payment Arrangement, Option [Member] | Two Thousand And Twenty Employee Stock Purchase Plan Member | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of shares of common stock authorized for issuance | 6,273,185 | 6,273,185 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Weighted Average Fair Values and Valuation Assumptions (Details) - Share-Based Payment Arrangement, Option [Member] | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 1 month 6 days | 6 years | 5 years 10 months 24 days | 6 years |
Expected volatility | 64.30% | 75.50% | 68% | 73.30% |
Risk-free interest rate | 4.20% | 2.80% | 3.70% | 2.20% |
Expected dividend yield | 0% | 0% | 0% | 0% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Outstanding at December 31, 2022 | 23,239,391 | |
Granted | 5,969,889 | |
Exercised | (908,934) | |
Forfeited | (6,253,998) | |
Outstanding at September 30, 2023 | 22,046,348 | 23,239,391 |
Vested and expected to vest at September 30, 2023 | 22,046,348 | |
Options exercisable at September 30, 2023 | 7,624,553 | |
Weighted-Average Exercise Price, Beginning Balance at December 31, 2022 (Per Share) | $ 7.01 | |
Weighted-Average Exercise Price, Granted | 1.82 | |
Weighted-Average Exercise Price, Exercised | 0.78 | |
Weighted-Average Exercise Price,Forfeited | 7.81 | |
Weighted-Average Exercise Price, Ending Balance at June 30, 2023 (Per Share) | 5.63 | $ 7.01 |
Weighted-Average Exercise Price,Vested and expected to vest at June 30, 2023 | 5.63 | |
Weighted-Average Exercise Price,Options exercisable at June 30, 2023 | $ 7.64 | |
Weighted Average Remaining Contractual Term (In Years) | 7 years 7 months 6 days | 7 years 10 months 24 days |
Weighted Average Remaining Contractual Term, Vested and Expected to vest at June 30, 2023 | 7 years 7 months 6 days | |
Weighted Average Remaining Contractual Term, Exercisable at June 30, 2023 | 6 years 6 months | |
Aggregate Intrinsic Value, Outstanding at December 31, 2022 | $ 1,594 | |
Aggregate Intrinsic Value, Outstanding at June 30, 2023 | 1,979 | $ 1,594 |
Aggregate Intrinsic Value, Vested and Expected to vest at June 30, 2023 | 1,979 | |
Aggregate Intrinsic Value, Exercisable at June 30, 2023 | $ 654 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Unvested Common Stock From Option Early Exercises (Details) | 9 Months Ended |
Sep. 30, 2023 shares | |
Share-Based Payment Arrangement [Abstract] | |
Beginning Balance at December 31, 2022 | 360,333 |
Issued | 0 |
Vested | (75,165) |
Repurchased | (253,402) |
Ending Balance at September 30, 2023 | 31,766 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Share Based Compensation Expense Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock based compensation expense | $ 4,264 | $ 7,399 | $ 14,341 | $ 15,743 |
Research and Development [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock based compensation expense | 1,235 | 3,419 | 5,116 | 9,954 |
Selling, General and Administrative [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock based compensation expense | $ 3,029 | $ 3,980 | $ 9,225 | $ 5,789 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Income tax expense (benefit) | $ 0 | $ 0 | $ 0 | $ 0 |
Defined Contribution Plan - Add
Defined Contribution Plan - Additional Information (Details) - 401(k) Plan - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Defined Contribution Plan Disclosure [Line Items] | ||||
Percentage of eligible participants of non-elective contributions | 3% | |||
Defined contribution amount | $ 0.3 | $ 0.2 | $ 0.6 | $ 0.6 |
Net Loss Per Share - Basic and
Net Loss Per Share - Basic and Diluted Net Loss Per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Numerator | ||||||||
Net loss attributable to common stockholder | $ (39,440) | $ (50,228) | $ (35,321) | $ (45,087) | $ (50,990) | $ (100,666) | $ (124,989) | $ (196,743) |
Denominator | ||||||||
Weighted-average common shares outstanding, basic and diluted | 109,754,812 | 108,420,674 | 109,333,684 | 108,154,397 | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ (0.36) | $ (0.42) | $ (1.14) | $ (1.82) |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share LineItems | ||
Antidilutive securities excluded from computation of earnings per share, amount | 28,902,826 | 21,824,702 |
Convertible Preferred Stock Member | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share LineItems | ||
Antidilutive securities excluded from computation of earnings per share, amount | 6,824,712 | 0 |
Employee Stock Option [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share LineItems | ||
Antidilutive securities excluded from computation of earnings per share, amount | 22,046,348 | 21,404,313 |
Restricted Stock [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share LineItems | ||
Antidilutive securities excluded from computation of earnings per share, amount | 31,766 | 420,389 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | |||||
Quarterly fee | $ 1.3 | ||||
IPR&D Expense [Member] | |||||
Related Party Transaction [Line Items] | |||||
Option Exercise Fee | $ 1 | $ 1 | 1 | $ 1 | |
Drug Delivery Fee | 0.2 | 0.2 | |||
Optimization Completion Fee | 0.2 | 0 | 0.2 | 0 | |
Research and Development Expense [Member] | |||||
Related Party Transaction [Line Items] | |||||
Quarterly fee | 1.3 | 1.3 | 0.9 | 3.9 | |
Drug Delivery Fee | 0 | 0.2 | |||
Adimab Assignment Agreement [Member] | IPR&D Expense [Member] | |||||
Related Party Transaction [Line Items] | |||||
Revenue From Related Party | 0 | 0 | |||
Related Party Transaction Expenses From Transaction With Related Party | 3.2 | 3.6 | |||
Adimab Assignment Agreement [Member] | Research and Development Expense [Member] | |||||
Related Party Transaction [Line Items] | |||||
Related Party Transaction Expenses From Transaction With Related Party | 0 | 0.1 | 0 | 0.6 | |
Adimab [Member] | |||||
Related Party Transaction [Line Items] | |||||
Due To Related Parties | 5.8 | 5.8 | $ 0.3 | ||
Due from Related Party | 0 | 0 | 0 | ||
Adimab Collaboration Agreement [Member] | Research and Development Expense [Member] | |||||
Related Party Transaction [Line Items] | |||||
Related Party Transaction Expenses From Transaction With Related Party | 0.1 | 0.3 | 0.5 | 1.3 | |
Quarterly fee | 1.3 | 1.3 | 3.9 | 3.9 | |
Mithril Group [Member] | |||||
Related Party Transaction [Line Items] | |||||
Due from Related Party | 0 | 0 | |||
Mithril Group [Member] | Research and Development Expense [Member] | |||||
Related Party Transaction [Line Items] | |||||
Related Party Transaction Expenses From Transaction With Related Party | $ 1.4 | ||||
Adimab Platform Transfer Agreement [Member] | IPR&D Expense [Member] | |||||
Related Party Transaction [Line Items] | |||||
Related Party Transaction Expenses From Transaction With Related Party | $ 3 | $ 3 | |||
PHP Member | |||||
Related Party Transaction [Line Items] | |||||
Due from Related Party | 0 | 0 | |||
PHP Member | Research and Development Expense [Member] | |||||
Related Party Transaction [Line Items] | |||||
Related Party Transaction Expenses From Transaction With Related Party | 0 | 2.3 | |||
Maximum [Member] | Adimab Assignment Agreement [Member] | Research and Development Expense [Member] | |||||
Related Party Transaction [Line Items] | |||||
Related Party Transaction Expenses From Transaction With Related Party | $ 0.1 | $ 0.1 |