Invivyd, Inc. 10-Q

Item 1 . Financial Statements. INVIVYD , INC. Conden sed Consolidated Balance Sheets (UNaudited) (In thousands, except share and per share amounts) September 30, 2025 December 31, 2024 Assets Current assets: Cash and cash equivalents $ 84,967 $ 69,349 Accounts receivable, net 9,852 10,906 Prepaid expenses and other current assets 14,950 20,426 Total current assets 109,769 100,681 Inventory 25,395 25,907 Property and equipment, net 1,260 1,508 Operating lease right-of-use assets 2,728 1,385 Other non-current assets 6 34 Total assets $ 139,158 $ 129,515 Liabilities, Preferred Stock and Stockholders’ Equity Current liabilities: Accounts payable $ 18,104 $ 10,448 Accrued expenses (1) 25,277 50,197 Operating lease liabilities 1,083 1,304 Other current liability 32 27 Total current liabilities 44,496 61,976 Operating lease liabilities, non-current 1,594 — Total liabilities 46,090 61,976 Commitments and contingencies (Note 9) Stockholders’ equity: Preferred stock (undesignated), $ 0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding at September 30, 2025 and December 31, 2024 — — Common stock, $ 0.0001 par value; 1,000,000,000 shares authorized, 214,409,450 shares issued and outstanding at September 30, 2025; 119,835,162 shares issued and outstanding at December 31, 2024 22 12 Additional paid-in capital 1,036,500 969,526 Accumulated other comprehensive loss ( 41 ) ( 5 ) Accumulated deficit ( 943,413 ) ( 901,994 ) Total stockholders’ equity 93,068 67,539 Total liabilities, preferred stock and stockholders’ equity $ 139,158 $ 129,515 (1) Includes related-party amounts of $ 716 and $ 1,274 as of September 30, 2025 and December 31, 2024 , respectively (see Note 15). The accompanying notes are an integral part of these condensed consolidated financial statements. 1 INVIVYD , INC. Condensed Consolidated Statem ents of Operations and Comprehensive Loss (UNaudited) (In thousands, except share and per share amounts) Three Months Ended September 30, Three Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Revenue: Product revenue, net $ 13,129 $ 9,300 $ 36,219 $ 11,564 Total revenue 13,129 9,300 36,219 11,564 Operating costs and expenses: Cost of product revenue (1) 1,088 806 2,607 894 Research and development (2) 8,046 57,850 28,260 119,344 Selling, general and administrative 15,018 12,955 48,357 48,973 Total operating costs and expenses 24,152 71,611 79,224 169,211 Loss from operations ( 11,023 ) ( 62,311 ) ( 43,005 ) ( 157,647 ) Other income: Other income, net 553 1,572 1,586 6,165 Total other income, net 553 1,572 1,586 6,165 Net loss ( 10,470 ) ( 60,739 ) ( 41,419 ) ( 151,482 ) Other comprehensive income (loss) Unrealized (loss), net of tax ( 2 ) ( 6 ) ( 36 ) ( 5 ) Comprehensive loss $ ( 10,472 ) $ ( 60,745 ) $ ( 41,455 ) $ ( 151,487 ) Net loss per share attributable to common stockholders, basic and diluted $ ( 0.06 ) $ ( 0.51 ) $ ( 0.30 ) $ ( 1.28 ) Weighted-average common shares outstanding, basic and diluted 170,169,865 119,495,284 136,874,025 118,163,599 (1) Includes related-party amounts o f $ 525 and $ 1,449 for the three and nine months ended September 30, 2025 , respectively, and related-party amounts of $ 463 for both the three and nine months ended September 30, 2024 (see Note 15) . (2) Includes related-party amounts of $ 1,158 and $ 3,426 for the three and nine months ended September 30, 2025 , respectively, and $ 1,133 and $ 3,399 for the three and nine months ended September 30, 2024, respectively (see Note 15). The accompanying notes are an integral part of these condensed consolidated financial statements. 2 INVIVYD , INC. CONDENSED CONSO LIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (UNAUDITED) (In thousands, except share amounts) Common Stock Treasury Stock Additional Paid-in Accumulated Other Comprehensive Accumulated Total Stockholders’ Shares Amount Shares Amount Capital Income (Loss) Deficit Equity Balances at December 31, 2024 119,835,162 $ 12 — $ — $ 969,526 $ ( 5 ) $ ( 901,994 ) 67,539 Stock-based compensation expense — — — — 2,826 — — 2,826 Exercise of stock options 36,111 — — — 37 — — 37 Issuance of common stock under the employee stock purchase plan 90,172 — — — 44 — — 44 Unrealized loss, net of tax — — — — — ( 8 ) — ( 8 ) Net loss — — — — — — ( 16,289 ) ( 16,289 ) Balances at March 31, 2025 119,961,445 $ 12 — $ — $ 972,433 $ ( 13 ) $ ( 918,283 ) $ 54,149 Stock-based compensation expense — — — — 3,180 — — 3,180 Exercise of stock options 87,000 — — — 68 — — 68 Issuance of common stock under the employee stock purchase plan 94,366 — — — 78 — — 78 Unrealized loss, net of tax — — — — — ( 26 ) — ( 26 ) Net loss — — — — — — ( 14,660 ) ( 14,660 ) Balances at June 30, 2025 120,142,811 $ 12 — $ — $ 975,759 $ ( 39 ) $ ( 932,943 ) $ 42,789 Stock-based compensation expense — — — — 3,073 — — 3,073 Issuance of common stock upon restricted stock units vesting 561,000 — — — — — — — Common stock issued in connection with at-the-market offering, net 4,400,000 1 — — 4,092 — — 4,093 Pre-funded warrants issued in connection with public offering, net — — — — 11,096 — — 11,096 Common stock issued in connection with public offering, net 89,234,480 9 — — 42,424 — — 42,433 Issuance of common stock under the employee stock purchase plan 71,159 — — — 56 — — 56 Unrealized loss, net of tax — — — — — ( 2 ) — ( 2 ) Net loss — — — — — — ( 10,470 ) ( 10,470 ) Balances at September 30, 2025 214,409,450 22 — $ — $ 1,036,500 $ ( 41 ) $ ( 943,413 ) $ 93,068 3 Common Stock Treasury Stock Additional Paid-in Accumulated Other Comprehensive Accumulated Total Stockholders’ Shares Amount Shares Amount Capital Income (Loss) Deficit Equity Balances at December 31, 2023 110,160,684 $ 11 — $ — $ 909,539 $ ( 13 ) $ ( 732,069 ) $ 177,468 Stock-based compensation expense — — — — 5,379 — — 5,379 Issuance of common stock, net of issuance costs 9,000,000 1 — — 39,056 — — 39,057 Issuance of common stock under the employee stock purchase plan 60,546 — — — 89 — — 89 Unrealized gain on available-for-sale securities, net of tax — — — — — 1 — 1 Net loss — — — — — — ( 43,496 ) ( 43,496 ) Balances at March 31, 2024 119,221,230 $ 12 — $ — $ 954,063 $ ( 12 ) $ ( 775,565 ) $ 178,498 Stock-based compensation expense — — — — 9,128 — — 9,128 Exercise of stock options 172,223 — — — 188 — — 188 Issuance of common stock under the employee stock purchase plan 49,182 — — — 75 — — 75 Net loss — — — — — — ( 47,247 ) ( 47,247 ) Balances at June 30, 2024 119,442,635 $ 12 — $ — $ 963,454 $ ( 12 ) $ ( 822,812 ) $ 140,642 Stock-based compensation expense — — — — 3,140 — — 3,140 Exercise of stock options 124,078 — — — 97 — — 97 Issuance of common stock under the employee stock purchase plan 37,322 — — — 27 — — 27 Unrealized loss, net of tax — — — — — $ ( 6 ) — $ ( 6 ) Net loss — — — — — — ( 60,739 ) ( 60,739 ) Balances at September 30, 2024 119,604,035 $ 12 — $ — $ 966,718 $ ( 18 ) $ ( 883,551 ) $ 83,161 The accompanying notes are an integral part of these condensed consolidated financial statements. 4 INVIVYD , INC. Condensed Consolidated Statements of Cash Flows (UNAUDITED) (In thousands) Nine Months Ended September 30, Nine Months Ended September 30, 2025 2024 Cash flows from operating activities: Net loss $ ( 41,419 ) $ ( 151,482 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 9,079 16,731 Amortization of operating lease right-of-use assets 1,066 1,215 Depreciation and amortization expense 606 382 Other non-cash adjustments 296 — Changes in operating assets and liabilities: Accounts receivable 731 ( 8,154 ) Inventory ( 21 ) ( 23,391 ) Prepaid expenses and other current assets 5,359 15,311 Other non-current assets 28 ( 7,277 ) Accounts payable 7,457 9,714 Accrued expenses ( 24,831 ) 16,032 Operating lease liabilities ( 1,036 ) ( 1,247 ) Other current liabilities 5 ( 15 ) Other non-current liabilities — ( 700 ) Net cash used in operating activities ( 42,680 ) ( 132,881 ) Cash flows from investing activities: Purchases of property and equipment ( 155 ) ( 145 ) Net cash used in investing activities ( 155 ) ( 145 ) Cash flows from financing activities: Proceeds from exercises of stock options 105 285 Proceeds from issuance of common stock under the employee stock purchase plan 178 191 Proceeds from at-the-market offering, net of commissions 4,484 39,285 Proceeds from underwritten public offering, net of underwriting discounts and commissions 54,048 — Payments for at-the-market offering costs ( 145 ) ( 507 ) Payments for underwritten public offering costs ( 217 ) — Net cash provided by financing activities 58,453 39,254 Net increase (decrease) in cash and cash equivalents 15,618 ( 93,772 ) Cash and cash equivalents at beginning of period 69,349 200,641 Cash and cash equivalents at end of period $ 84,967 $ 106,869 Supplemental disclosure of cash flow information Deferred offering costs in accrued expenses $ 170 $ 35 Deferred offering costs in accounts payable $ 270 $ 40 The accompanying notes are an integral part of these condensed consolidated financial statements. 5 INVIVYD, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 1. Nature of the Business and Basis of Presentation Invivyd, Inc. (the “Company”) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. PEMGARDA® (pemivibart) is the Company’s first monoclonal antibody (“mAb”) to receive regulatory authorization and was designed to keep pace with SARS-CoV-2 viral evolution. On March 22, 2024, the Company received emergency use authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) for PEMGARDA injection, for intravenous use, a half-life extended investigational mAb, for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. In January 2024, the Company nominated VYD2311, a next generation mAb candidate for COVID-19, as a drug candidate, and in September 2024, the Company announced dosing of the first participants in a Phase 1/2 clinical trial of VYD2311. VYD2311 is a mAb with high in vitro neutralization potency shown against prominent SARS-CoV-2 variants tested to date. The Phase 1/2 randomized, blinded, placebo-controlled clinical trial evaluated escalating dosing as well as safety, tolerability, pharmacokinetics and immunogenicity of VYD2311 in healthy trial participants. The Phase 1/2 clinical trial was conducted in Australia and evaluated multiple dose levels of VYD2311 through various routes of administration, including exploration of intramuscular ( “ IM”) administration and subcutaneous administration, which are designed to be more system- and patient-friendly than intravenous administration. In June 2025, the Company announced positive full Phase 1/2 clinical data for VYD2311 for both safety and pharmacokinetics. In August 2025, the Company announced alignment with advice from the FDA on a compact and, therefore, rapid pathway to potential Biologics License Application ( “ BLA”) approval for VYD2311 for the prevention of COVID-19. As part of Type C meeting feedback, the FDA advised that a single, randomized, placebo-controlled trial evaluating mAb efficacy in prevention of RT-PCR-confirmed symptomatic COVID-19 disease events could support a BLA submission for VYD2311 for the prevention of COVID-19 in a broad population of Americans (12 years of age and older, weighing at least 40kg), including immunocompromised people, subject to agreement on safety database size and pending full protocol review. In October 2025, the Company announced that the FDA cleared the Company’s Investigational New Drug (“IND”) application for VYD2311 and provided feedback to advance the Company’s REVOLUTION clinical program, Invivyd’s development program for VYD2311. The REVOLUTION clinical program will include two clinical trials, DECLARATION and LIBERTY. The DECLARATION clinical trial is the Company’s BLA-enabling, Phase 3 randomized, triple-blind, placebo-controlled pivotal clinical trial to evaluate the efficacy and safety of VYD2311 for the prevention of symptomatic COVID at three months, with either a single dose or monthly doses of VYD2311, each administered via IM injection, compared to placebo. The LIBERTY clinical trial is designed as a Phase 3, randomized, pooled-vaccine, double-blind clinical trial to evaluate head-to-head safety and tolerability and co-administration interaction of VYD2311 with approved mRNA-based COVID vaccines in adults, subject to final alignment with the FDA. The DECLARATION and LIBERTY clinical trials are expected to begin around year-end 2025, with top-line data anticipated mid-2026. Additional studies in the REVOLUTION clinical program may be contemplated for conduct post-approval of VYD2311, if a BLA is granted by the FDA, to further elaborate the profile of antibody prevention of COVID. Like pemivibart, VYD2311 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. In July 2025, the Company announced that it had formed the SPEAR (Spike Protein Elimination and Recovery) Study Group with leading investigators to structure and guide anticipated clinical trials evaluating the effects of broadly neutralizing anti-SARS-CoV-2 spike protein mAb therapy in people suffering from Long COVID or Post-Vaccination Syndrome (“PVS”). The SPEAR Study Group intends to launch multi-center translational clinical research on Long COVID and PVS using next-generation antibodies like the Company’s investigational mAb candidate VYD2311. 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 New Haven, Connecticut, and remotely. The Company leases dedicated laboratory and office space in Newton, Massachusetts for research and development purposes. In 2022, the Company expanded its research team 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 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, risks associated with market acceptance and commercialization of products, competition from other 6 products, protection of proprietary intellectual property, compliance with government regulations, 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. To date, the Company has received regulatory authorization for only one product candidate, PEMGARDA, which has not been approved, but has been authorized for emergency use by the FDA under an EUA, for pre-exposure prophylaxis of COVID-19 in certain adults and adolescent individuals (12 years of age and older weighing at least 40 kg). Beyond pemivibart and VYD2311, all of the Company’s other product candidates, other than adintrevimab, are currently in research development. The Company has initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including potential targets such as respiratory syncytial virus and measles. The Company’s additional product candidates will require significant additional research and development efforts, including extensive clinical testing, and regulatory authorization or approval prior to potential commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and compliance-reporting capabilities. It is uncertain when, if ever, the Company will generate substantial revenue from product sales to be able to fund its operating expenses and capital requirements. Substantial Doubt about Ability to Continue as a Going Concern 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, proceeds from the Company’s initial public offering (“IPO”), net proceeds received from shares of common stock sold under the Sales Agreement (as defined below) and net proceeds received from shares of common stock and pre-funded warrants sold under the Underwriting Agreement (as defined below). After receiving EUA in March 2024, the Company has also funded its operations from sales of PEMGARDA. The Company has incurred recurring losses and negative cash flows from operations since its inception, including a net loss of $ 41.4 million for the nine months ended September 30, 2025. As of September 30, 2025, the Company had an accumulated deficit of $ 943.4 million. The Company may continue to generate operating losses for the foreseeable future. Based on current operating plans and excluding any contribution from future revenues or future external financing, the Company will not have sufficient cash and cash equivalents to fund its operating expenses and capital requirements beyond one year from the issuance of these condensed consolidated financial statements, and therefore, the Company has concluded that there is substantial doubt about its ability to continue as a going concern. The Company will require additional funding through a combination of contribution from revenues, equity offerings, government or private-party grants, debt financings or other capital sources, such as collaborations with other companies, strategic alliances or licensing arrangements to finance its future operations. 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 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. The accompanying condensed consolidated financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities or any other adjustments that might be necessary should the Company be unable to continue as a going concern. Basis of Presentation The accompanying 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. Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of September 30, 2025, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025 and 2024, the condensed consolidated statements of cash flows for the nine months ended September 30, 2025 and 2024 and the condensed consolidated statements of stockholders’ equity for the three and nine months ended September 30, 2025 and 2024 are unaudited. 7 The accompanying unaudited condensed consolidated financial statements as of September 30, 2025 and for the three and nine months ended September 30, 2025 and 2024 have been prepared by the Company pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial statements. The accompanying condensed consolidated balance sheet as of December 31, 2024 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, 2024, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 20, 2025 (the “2024 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, 2025 and December 31, 2024, the condensed consolidated results of operations for the three and nine months ended September 30, 2025 and 2024, the condensed consolidated cash flows for the nine months ended September 30, 2025 and 2024, and changes in stockholders’ equity for the three and nine months ended September 30, 2025 and 2024 have been made. The Company’s condensed consolidated results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2025 . 2. Summary of Significant Accounting Policies As of September 30, 2025, the Company’s significant accounting policies and estimates, which are detailed in the Company’s 2024 Form 10-K, have not materially changed. 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 revenues and 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, stock-based compensation expense, revenue, including discounts and allowances, and inventory obsolescence. The Company bases its estimates on historical experience, known trends, expected future internal sales forecasts 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. If actual market conditions are less favorable than those projected by management or in the event of an adverse FDA action, inventory write-downs may be required. Pre-funded Warrants The Company accounts for pre-funded warrants as equity-classified based on an assessment of the warrant’s specific terms and applicable authoritative guidance included in Distinguishing Liabilities from Equity (“ASC 480”) and Derivatives and Hedging (“ASC 815”). The assessment considers whether the pre-funded warrants are freestanding financial instruments pursuant to ASC 480, whether the pre-funded warrants meet the definition of a liability pursuant to ASC 480, and whether the pre-funded warrants meet all of the requirements for equity classification under ASC 815. The Company’s pre-funded warrants meet all of the criteria for equity classification and are recorded as a component of additional paid-in capital at the time of issuance, and are not remeasured. Recently Issued Accounting Pronouncements The Company is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and may 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. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). ASU 2023-09 modifies the rules on income tax disclosures to enhance the transparency and decision-usefulness of income tax disclosures, particularly in the rate reconciliation table and disclosures about income taxes paid. The amendments are intended to address investors’ requests for income tax disclosures that provide more information to help them better understand an entity’s exposure to potential changes in tax laws and the ensuing risks and opportunities and to assess income tax information that affects cash flow forecasts and capital allocation decisions. The guidance also eliminates certain existing disclosure requirements related to uncertain tax positions and unrecognized deferred tax liabilities. The guidance is effective for the Company for the annual period beginning after 8 December 15, 2024. All entities should apply the guidance prospectively but have the option to apply it retrospectively. The Company is currently evaluating the potential impacts of ASU 2023-09 on its consolidated financial statement disclosures. In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”). The new standard requires additional disclosure of the nature of expenses included in the income statement as well as disclosures about specific types of expenses included in the expense captions presented in the income statement. ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. The Company is currently evaluating the potential impact of ASU 2024-03 on its consolidated financial statement disclosures. 3. 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 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 September 30, 2025: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 52,547 $ — $ — $ 52,547 U.S. Treasury securities $ 7,467 $ 22,371 $ — $ 29,838 $ 60,014 $ 22,371 $ — $ 82,385 Fair Value Measurements at December 31, 2024: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 68,345 $ — $ — $ 68,345 U.S. Treasury securities $ — $ — $ — $ — $ 68,345 $ — $ — $ 68,345 The money market funds and U.S. Treasury securities traded in active markets were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. U.S. Treasury securities that were not the most recently issued securities were valued using observable inputs, such as quoted prices for similar securities, which represent a Level 2 measurement within the fair value hierarchy. There were no changes to the valuation methods during the three and nine months ended September 30, 2025. 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, 2025 . 9 4. Inventory The following table presents non-current inventories (in thousands): September 30, 2025 December 31, 2024 Work in process $ 20,769 $ 20,769 Finished goods 4,626 5,138 $ 25,395 $ 25,907 As of September 30, 2025 , $ 0.4 million of finished goods inventory was classified as a current asset and included within prepaid and other current assets in the condensed consolidated balance sheet. Please refer to Note 5 for additional information. 5. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): September 30, 2025 December 31, 2024 Prepaid external research, development and manufacturing costs $ 12,333 $ 15,264 Prepaid insurance 140 1,173 Other 1,766 3,726 Interest receivable 282 263 Finished goods inventory, current 429 — $ 14,950 $ 20,426 6. Accrued Expenses Accrued expenses consisted of the following (in thousands): September 30, 2025 December 31, 2024 Accrued external research, development and manufacturing costs $ 17,366 $ 41,680 Accrued professional and consultant fees 1,972 2,199 Accrued employee compensation 3,407 3,916 Accrued inventory 414 518 Other 2,118 1,884 $ 25,277 $ 50,197 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 IND applications, new drug applications, biologics license applications and other regulatory filings for the CoV Antibodies and Products in the Field, and for 10 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, 2025 and 2024 , 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. 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 paid through September 30, 2025; 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 pemivibart, 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 pemivibart, which obligated the Company to make a $ 3.2 million milestone payment to Adimab, which was paid in October 2023. 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, 2025. During the three and nine months ended September 30, 2025 and 2024, the Company did no t recognize any in-process research and development (“IPR&D”) expense with respect to contingent consideration payable under the Adimab Assignment Agreement. Except for milestone payments of $ 11.1 million incurred through December 31, 2023, no other milestone payments have been paid to or have been earned by Adimab through September 30, 2025. 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 (the “Royalty Term”). During the three and nine months ended September 30, 2025, the Company expensed $ 0.5 million and $ 1.4 million , respectively, of royalties, while reserving all rights under the Adimab Assignment Agreement and the applicable law. During both the three and nine months ended September 30, 2024, the Company expensed $ 0.5 million of royalties , while reserving all rights under the Adimab Assignment Agreement and the applicable law. 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. 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. 11 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 could 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 agreed to pay Adimab a quarterly fee of $ 1.3 million, which could be cancelled at the Company’s option at any time. For so long as the Company was paying such quarterly fee (or earlier if (i) the Company experienced a change of control after the third anniversary of the Adimab Collaboration Agreement or (ii) Adimab owned less than a specified percentage of the Company’s equity), Adimab and its affiliates agreed not to assist or direct certain third parties to discover or optimize antibodies intended to bind to coronaviruses or influenza viruses. Under the Adimab Collaboration Agreement, the Company could also elect to decrease the scope of Adimab’s exclusivity obligations and obtain a corresponding decrease in the quarterly fee. In December 2023, the Company elected to decrease the scope of Adimab’s exclusivity obligations to cover only coronaviruses and obtained a corresponding decrease in the quarterly fee. Effective January 2024, the Company became obligated to pay Adimab a quarterly fee of $ 0.6 million. During both the three months ended September 30, 2025 and 2024 , the Company recognized $ 0.6 million of research and development expense related to the quarterly fee. During both the nine months ended September 30, 2025 and 2024 , the Company recognized $ 1.8 million 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, 2025 and 2024, 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 Collaboration Agreement. During the three and nine months ended September 30, 2025 and 2024, the Company did no t recognize any IPR&D expense related to drug delivery fees, optimization completion fees or option exercise fees. Please refer to No te 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, 2025. 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, 2025, no royalty payments have been paid to or have been earned by 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 12 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 (the “Adimab Platform Transfer Agreement 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 has been 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 Adimab Platform Transfer Agreement Effective Date, which allows 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 months ended September 30, 2025 and 2024 , the Company recognized $ 0.5 million of research and development expense related to the annual fee under the Adimab Platform Transfer Agreement. During both the nine months ended September 30, 2025 and 2024 , the Company recognized $ 1.5 million of research and development expense related to the annual fee under the Adimab Platform Transfer Agreement. 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, 2025. 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, 2025, no royalty payments have been paid to or have been earned by 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. 13 WuXi Biologics Cell Line License Agreement In December 2020, as amended in February 2023 and March 2024, 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. 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, 2025 , 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. The Company did no t recognize any IPR&D expense under the Cell Line License Agreement during the three and nine months ended September 30, 2025 and 2024 . 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 for an initial term of one year. The PHP MSA renewed for subsequent periods, until terminated in accordance with its terms. The PHP MSA was terminated effective in July 2024. 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 contained 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, 2025 and 2024 , the Company did no t pay any cash compensation to PHP and therefore did not recognize any research and development expense related thereto. 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 was equal to the Nasdaq official closing price 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; 14 • 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 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, which registration rights PHP exercised in January 2024. Upon the consummation of a fundamental transaction 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 fundamental transaction 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 fundamental transaction 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. Tamsin Berry, a member of the Company’s board of directors, is a Limited Partner of PHP. 9. Commitments and Contingencies Operating Lease Commitments In September 2021, the Company entered into a five-year facilities lease agreement for approximately 9,600 square feet of office space in Waltham, Massachusetts, which provided for monthly rental payments, including base rent charges of $ 0.4 million per year, subject to periodic rent increases, and the Company’s proportionate share of operating expenses. The Company exercised its option to terminate and this lease agreement expired in accordance with its terms on May 31, 2025. 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”), which was amended in September 2022. Pursuant to the amended Newton, MA Lease, the Company entered into a two-year noncancelable agreement for new dedicated laboratory and office space in Newton, Massachusetts, on the same campus as, and in lieu of, the space leased under the original lease. The Company took occupancy of the new dedicated laboratory and office space in December 2022. The amended Newton, MA Lease provided for monthly rental payments, including base rent charges of $ 1.3 million per year. In August 2024 and May 2025, the Newton, MA Lease was further amended to extend the lease through December 2027, with an option to further extend the lease for an additional twenty-four months or continue the lease on a month-to-month basis after completion of the term ending in December 2027. The components of operating lease expense were as follows (in thousands): 15 For the Three Months Ended September 30, For the Three Months Ended September 30, For the Nine Months Ended September 30, For The Nine Months Ended September 30, 2025 2024 2025 2024 Lease cost: Operating lease cost $ 323 $ 440 $ 1,144 $ 1,301 Variable lease cost — 4 6 11 Total lease cost $ 323 $ 444 $ 1,150 $ 1,312 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows related to operating leases $ 330 $ 435 $ 1,115 $ 1,304 Future minimum lease payments under the noncancelable leases as of September 30, 2025 was as follows (in thousands): Year Ending December 31, Operating Lease 2025 (excluding the nine months ended September 30, 2025) $ 220 2026 $ 1,320 2027 $ 1,320 Total lease payments 2,860 Present value adjustment ( 183 ) Present value of operating lease liability $ 2,677 As of September 30, 2025 , 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 2.3 years. As of September 30, 2024 , 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 1.1 years. The total operating liabilities are presented on the Company’s condensed consolidated balance sheet based on maturity dates. $ 1.1 million is classified under “ operating lease liabilities, current” for the portion due within twelve months, and $ 1.6 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). Manufacturing Agreements 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. Through September 30, 2025, the Company committed to noncancelable purchase obligations related to commercial drug substance and drug product manufacturing under the Commercial Manufacturing Agreement. As of September 30, 2025 , the total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics was $ 25.6 million, which was included in accounts payable and accrued expenses. The remaining balance is expected to be paid in 2025. Through September 30, 2025, the Company committed to noncancelable purchase obligations related to the procurement of materials to be used in future drug substance and drug product manufacturing under the Commercial Manufacturing Agreement. As of September 30, 2025 , the total remaining contractually binding purchase obligations due to WuXi Biologics was $ 3.5 million, which was included in accounts payable and accrued expenses. The remaining balance is expected to be paid in 2025. 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 16 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, 2025 and December 31, 2024. 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. As of September 30, 2025, the Company was not a party to any material legal proceedings. Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to its vendors, lessors, contract research organizations, contract development and manufacturing organizations, business partners and other parties with respect to certain matters, including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that 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 executive 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. Loan Agreement On April 18, 2025, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company, as lender (the “Lender”). The Loan Agreement provides for a senior secured term loan facility in an aggregate principal amount of up to $ 30 million (the “Term Facility”) consisting of (a) Term A Loans in an aggregate principal amount of up to $ 10 million, which shall be available to be drawn from and after August 15, 2025 through December 31, 2026 upon compliance with certain financial covenants and conditions, (b) Term B Loans in an aggregate principal amount of up to $ 10 million, which shall be available to be drawn during the period commencing on the date of the achievement of certain net product revenue milestones and ending on June 30, 2027, and (c) Term C Loans in an aggregate principal amount of up to $ 10 million, which shall be available to be drawn during the period commencing on the date of the achievement of certain net product revenue milestones and ending on June 30, 2027. The proceeds of the Term Facility may be used for working capital and general business purposes. As of September 30, 2025, the Company had not satisfied the net product revenue milestone required to be eligible to access proceeds from the Term Facility. The loans under the Term Facility are due and payable on March 1, 2029 and bear interest that is payable monthly, commencing with the month in which any loans are funded under the Term Facility, in arrears at a per annum rate, subject to increase during an Event of Default (as defined in the Loan Agreement), equal to the greater of (x) the Wall Street Journal prime rate minus 0.25 %, subject to a 9.00 % cap, and (y) 6.00 %. Commencing on April 1, 2027, which date may be extended to April 1, 2028 upon the achievement of certain net product revenue milestones (the “Interest-Only Period Extension”), the Company is required to repay the principal of the Term Facility in 24 consecutive equal monthly installments or, in the case of the Interest-Only Period Extension, 12 consecutive equal monthly installments. At maturity, or if earlier prepaid, the Company will also be required to pay a final payment fee equal to 4.50 % of the aggregate principal amount of the loans advanced under the Term Facility. The Loan Agreement provides for an unused term loan commitment fee equal to 1.00 % of the Term Facility upon the earliest to occur of (a) July 1, 2027, (b) the occurrence of an Event of Default under the Loan Agreement and (c) the termination of the Loan Agreement; provided, that such fee will be waived by the Lender in the event that the Company has requested and the Lender has funded any loans under the Term Facility prior to such date. 10. Common Stock Shares Reserved for Future Issuance 17 As of September 30, 2025 , the Company had reserved 36,387,016 shares of common stock for the exercise of outstanding stock options , the vesting of outstanding restricted stock units (“RSUs”) 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 Statements In September 2022, the Company filed a shelf registration statement on Form S-3 with the SEC 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 (the “2022 Shelf Registration Statement”). As of September 30, 2025 , $ 267.5 million of the Company’s securities remained available for offer and sale under the 2022 Shelf Registration Statement. In October 2025, the Company filed a new shelf registration statement on Form S-3 with the SEC and an accompanying base prospectus for the offer and sale of up to $ 350 million of the Company’s securities (the “2025 Shelf Registration Statement”). As of the date of this Quarterly Report on Form 10-Q, the 2025 Shelf Registration Statement has not yet been declared effective by the SEC. However, the Company is permitted to continue to offer and sell, subject to applicable SEC requirements, unsold securities remaining on the 2022 Shelf Registration Statement until the 2025 Shelf Registration Statement has been declared effective (or April 3, 2026, if sooner). August 2025 Underwritten Public Offering In August 2025, the Company completed an underwritten public offering pursuant to an underwriting agreement (the “Underwriting Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), as representative of the underwriters named therein, pursuant to which it issued and sold an aggregate of 89,234,480 shares of its common stock at a price of $ 0.52 per share, and pre-funded warrants to purchase up to an aggregate of 21,342,442 shares of common stock at a price of $ 0.5199 per pre-funded warrant (the “August 2025 Underwritten Public Offering”) . The price of $ 0.5199 per pre-funded warrant represented the $ 0.52 per share purchase price for the common stock less the exercise price of $ 0.0001 per pre-funded warrant. The pre-funded warrants are exercisable at any time after their original issuance and will not expire. The Company received total net proceeds of approximately $ 53.5 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company. As of September 30, 2025, there were no exercises of pre-funded warrants. ATM Facility In December 2023, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor and filed with the SEC a prospectus supplement (the “2023 ATM Prospectus Supplement” ) to the 2022 Shelf Registration Statement, pursuant to which the Company may, at its option, offer and sell shares of its common stock, with a sales value of up to $ 75.0 million, from time to time, through Cantor, acting as sales agent, in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act of 1933, as amended. Cantor is entitled to a commission of 3 % of the gross proceeds from any sales of such shares. In February 2024, the Company sold 9,000,000 shares of its common stock under the Sales Agreement at an average price of $ 4.50 per share for $ 39.3 million in net proceeds after deducting issuance costs. In August 2025, the Company sold 4,400,000 shares of its common stock under the Sales Agreement at an average price of $ 1.05 per share for $ 4.5 million in proceeds net of commissions. As of September 30, 2025, $ 29.9 million remained available for sale under the 2023 ATM Prospectus Supplement. In October 2025, the Company sold 18,655,402 shares of its common stock under the Sales Agreement at an average price of $ 1.60 per share for $ 28.9 million in proceeds net of commissions. In October 2025, in connection with the filing of the 2025 Shelf Registration Statement, the Company filed with the SEC a new prospectus supplement, pursuant to which the Company may, at its option, after the 2025 Registration Statement is declared effective by the SEC, offer and sell shares of its common stock, with a sales value of up to $ 75.0 million, from time to time, through Cantor, acting as sales agent, in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act of 1933, as amended. Cantor is entitled to a commission of 3 % of the gross proceeds from any sales of such shares. 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, RSUs 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. 18 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, 2025 , there were 485,615 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, RSUs and other stock-based awards. The number of shares initially reserved for issuance under the 2021 Plan was equal to 35,075,122 , which was the sum of 11,413,572 new shares; plus the number of shares (not to exceed 23,661,550 shares) , which represented (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 December 2024, the 2021 Plan was amended by Amendment No. 1 to the 2021 Plan, which decreased the aggregate number of shares of the Company’s common stock reserved for issuance under the 2021 Plan by 8,000,000 shares. In addition, the number of shares of the Company’s common stock reserved for issuance under the 2021 Plan wil l automatically increase on the first day of each calendar year pursuant to the evergreen provision thereof , 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 pursuant to the evergreen provision thereof . On January 1, 2024, 3,304,820 shares of common stock were added to the shares authorized for issuance under the 2021 Plan, pursuant to the evergreen provision thereof, as determined by the Company’s board of directors. The number of shares to be issued under the 2021 Plan did not increase pursuant to the evergreen provision thereof on January 1, 2023 nor January 1, 2025, 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, 2025 , there were an aggregate of 35,797,059 shares authorized to be issued under the 2020 Plan and the 2021 Plan, which included 485,615 and 22,370,287 shares authorized to be issued upon the exercise of outstanding stock option and vesting of RSU grants from the 2020 Plan and 2021 Plan, respectively, and 0 and 12,941,157 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. 19 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 September 30, Three Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Expected term (in years) 5.9 6.1 5.8 5.9 Expected volatility 61.7 % 61.8 % 61.1 % 62.5 % Risk-free interest rate 3.8 % 4.1 % 4.3 % 4.1 % Expected dividend yield — % — % — % — % Stock Option Activity The following table summarizes the Company’s stock option activity since December 31, 2024: Number of Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value (in years) (in thousands) Outstanding at December 31, 2024 14,987,559 $ 4.51 7.5 $ — Granted 11,191,844 $ 1.46 Exercised ( 123,111 ) $ 0.85 Forfeited ( 4,739,390 ) $ 4.14 Outstanding at September 30, 2025 21,316,902 $ 3.01 8.3 $ 823 Vested and expected to vest at September 30, 2025 21,316,902 $ 3.01 8.3 $ 823 Options exercisable at September 30, 2025 8,838,857 $ 4.75 7.3 $ 59 The weighted-average grant date fair value of stock options granted during the three and nine months ended September 30, 2025 was $ 0.58 and $ 0.86 , respectively, per share. The weighted-average grant date fair value of stock options granted during the three and nine months ended September 30, 2024 was $ 0.74 and $ 2.06 , 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, 2025 and 2024. The total intrinsic value of stock options exercised was $ 0 and less than $ 0.1 million for the three and nine months ended September 30, 2025 , respectively. The total intrinsic value of stock options exercised was $ 0.1 million and $ 0.3 million for the three and nine months ended September 30, 2024, respectively. Restricted Stock Unit Activity In February and September 2025, the Company’ s board of directors approved RSU grants to the Company’s executive officers and employees under the 2021 Plan. In February 2025, an aggregate of 1,700,000 RSUs were issued at a grant date fair value of $ 1.61 per share. In September 2025, an aggregate of 400,000 RSUs were issued at a grant date fair value of $ 1.15 per share. All RSU grants are scheduled to vest over an eighteen-month period, with one-third of the RSUs vesting every six months following the relevant grant date, subject to continuous service as of each vesting date. The following table summarizes the Company’s RSU activity since December 31, 2024: Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2024 — $ — Granted 2,100,000 $ 1.52 Vested ( 561,000 ) $ 1.61 Forfeited — $ — Outstanding at September 30, 2025 1,539,000 $ 1.49 20 Stock-Based Compensation Expense The Company recorded stock-based compensation expense (service-based stock options, RSUs, and the Company ’s employee stock purchase plan) in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended September 30, Three Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Research and development $ 822 $ 932 $ 2,440 $ 3,497 Selling, general and administrative 2,251 1,934 6,639 13,234 $ 3,073 $ 2,866 $ 9,079 $ 16,731 As of September 30, 2025 , total unrecognized stock-based compensation expense related to unvested stock options was $ 12.7 million, which is expected to be recognized over a weighted-average period of 2 .3 years. As of September 30, 2025 , the total unrecognized stock-based compensation expense related to unvested RSUs was $ 2.1 million, which is expected to be recognized over a weighted-average period of 1.02 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 752,816 shares issued under the 2021 ESPP as of September 30, 2025 . 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, pursuant to the evergreen provision thereof, 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 pursuant to the evergreen provision thereof on January 1, 2023, January 1, 2024, nor January 1, 2025, as determined by the Company’s board of directors. The first offering under the 2021 ESPP was June 6, 2022. As of September 30, 2025 , 589,957 shares remained available for issuance under the 2021 ESPP. During both the three months ended September 30, 2025 and 2024 , the Company recognized less than $ 0.1 million in related stock-based compensation expense. During the nine months ended September 30, 2025 and 2024 , the Company recognized less than $ 0.2 million and less than $ 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. Other than the pre-funded warrants issued in the August 2025 Underwritten Public Offering, there were no warrants issued during the three and nine months ended September 30, 2025 and 2024. As of September 30, 2025 , other than the pre-funded warrants issued in the August 2025 Underwritten Public Offering, there were 6,824,712 warrants outstanding and not yet vested at a weighted-average exercise price of $ 3.48 , with a weighted-average remaining contractual term of 7.13 years. 12. Income Taxes For the three and nine months ended September 30, 2025 and 2024 , 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. In July 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted. The OBBBA makes permanent key elements of the Tax Cuts and Jobs Act of 2017, including bonus depreciation, domestic research cost expensing and the business interest expense limitation, among other tax changes. The Company is currently evaluating the impact of the legislation and determined the OBBBA did not have a material im pact on its effective tax rate for the three and nine months ended September 30, 2025. 21 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, as amended, 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, 2025, the Company contributed $ 0.2 million and $ 0.6 million, respectively, to the 401(k) Plan. For the three and nine months ended September 30, 2024 , the Company contributed $ 0.2 million and $ 0.5 million, respectively, to the 401(k) Plan. 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 September 30, Three Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Numerator: Net loss attributable to common stockholders $ ( 10,470 ) $ ( 60,739 ) $ ( 41,419 ) $ ( 151,482 ) Denominator: Weighted-average common shares outstanding, basic and diluted 170,169,865 119,495,284 136,874,025 118,163,599 Net loss per share attributable to common stockholders, basic and diluted $ ( 0.06 ) $ ( 0.51 ) $ ( 0.30 ) $ ( 1.28 ) The 21,342,442 shares of common stock issuable upon exercise of pre-funded warrants described in Note 10 are included as outstanding common stock in the calculation of net loss per common share. 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 the three and nine months ended September 30, 2025. There were no shares of unvested restricted common stock for the three and nine months ended September 30, 2024. 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 Ended September 30, For the Nine Months Ended September 30, 2025 2024 Stock options to purchase common stock 21,316,902 21,875,754 Restricted stock units 1,539,000 — Warrants to purchase common stock 6,824,712 6,824,712 29,680,614 28,700,466 15. Related-Party Transactions As of September 30, 2025 and December 31, 2024, an aggregate of $ 0.7 million and $ 1.3 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 and was included in accrued expenses. As of September 30, 2025 and December 31, 2024 , 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). 22 During the three and nine months ended September 30, 2025 and 2024, 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, 2025 and 2024 , 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, 2025, the Company expensed $ 0.5 million and $ 1.4 million, respectively, of royalties as costs of product revenue, while reserving all rights under the Adimab Assignment Agreement and the applicable law. During both the three and nine months ended September 30, 2024 , the Company expensed $ 0.5 million of royalties as costs of product revenue with respect to royalties 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 months ended September 30, 2025 and 2024 , the Company recognized $ 0.6 million of research and development expense related to the quarterly fee under the Adimab Collaboration Agreement. During both the nine months ended September 30, 2025 and 2024 , the Company recognized $ 1.8 million of research and development expense related to the quarterly fee under the Adimab Collaboration Agreement. During the three and nine months ended September 30, 2025 and 2024 , 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 Collaboration Agreement. 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), including an annual fee of single digit millions on each of the first four anniversaries of the Adimab Platform Transfer Agreement Effective Date. During both the three months ended September 30, 2025 and 2024 , the Company recognized $ 0.5 million of research and development expense related to the annual fee under the Adimab Platform Transfer Agreement. During both the nine months ended September 30, 2025 and 2024 , the Company recognized $ 1.5 million of research and development expense related to the annual fee under the Adimab Platform Transfer Agreement. Adimab DNA Sequencing Services Agreement In May 2023, as amended in January 2024 and January 2025, 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, 2025 and 2024, 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. 16. Segment Reporting The Company operates as a single reportable and operating segment dedicated to the research and development, commercialization, and sale of mAbs in the U.S to deliver protection from serious viral infectious diseases. The determination of a single reportable segment is consistent with the consolidated financial information regularly reviewed by the Chief Operating Decision Maker (the “CODM”) in assessing performance and deciding how to allocate resources on a consolidated basis. The CODM assesses performance and allocates resources based on the Company’s net loss reported on the consolidated statements of operations and comprehensive loss. The CODM’s area of focus is period over period fluxes and budget-to-actual variances when assessing performance and deciding how to allocate resources. The following table presents information about reported segment revenues, and significant segment expenses as provided to the CODM. 23 Three Months Ended September 30, Three Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Revenue: Product revenue, net $ 13,129 $ 9,300 $ 36,219 $ 11,564 Total revenue 13,129 9,300 36,219 11,564 Operating costs and expenses: Cost of product revenue 1,088 806 2,607 894 Direct, external research and development expenses by program: Pemivibart 333 4,637 2,629 27,936 VYD2311 265 45,045 2,778 64,175 Adintrevimab 41 128 368 475 Total direct, external research and development expenses by program 639 49,810 5,775 92,586 Unallocated research and development expenses (1) 6,585 7,108 20,046 23,261 Other segment items (2) 12,767 11,021 41,717 35,739 Stock-based compensation 3,073 2,866 9,079 16,731 Total operating costs and expenses 24,152 71,611 79,224 169,211 Loss from operations ( 11,023 ) ( 62,311 ) ( 43,005 ) ( 157,647 ) Other income: Other income, net (3) 553 1,572 1,586 6,165 Total other income, net 553 1,572 1,586 6,165 Net loss $ ( 10,470 ) $ ( 60,739 ) $ ( 41,419 ) $ ( 151,482 ) (1) Includes personnel related expenses (excluding research and development stock-based compensation) and external discovery-related and other costs. (2) Includes commercial, general and administrative personnel related costs (excluding stock-based compensation), professional and consulting fees and other costs. (3) Includes interest income of $ 554 and $ 1,563 for the three months ended September 30, 2025 and 2024 , respectively and interest income of $ 1,587 and $ 6,325 for the nine months ended September 30, 2025 and 2024 , respectively. 24