What changed in this filing

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Item 1. Financial Statements

2025-11-06 compared with 2025-08-14 · 216 added, 156 removed, 524 unchanged (42% of the section changed)

3 unchanged sentences

(In thousands, except share and per share amounts)

September 30,

Current assets:

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10,000,000 shares

authorized and no shares issued and outstanding at June 30, 2025

authorized and no shares issued and outstanding at September 30, 2025

and December 31, 2024

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1,000,000,000 shares authorized,

120,142,811 shares issued and outstanding at June 30, 2025;

214,409,450 shares issued and outstanding at September 30, 2025;

119,835,162 shares issued and outstanding at December 31, 2024

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Total liabilities, preferred stock and stockholders’ equity

(1) Includes related-party amounts of $ 490 and $ 1,274 as of June 30, 2025 and December 31, 2024 , respectively (see Note 15).

(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.

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(In thousands, except share and per share amounts)

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Product revenue, net

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Other comprehensive income (loss)

Unrealized (loss) gain, net of tax

Unrealized (loss), net of tax

Comprehensive loss

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Weighted-average common shares outstanding, basic and diluted

(1) Includes related-party amounts o f $ 472 and $ 924 for the three and six months ended June 30, 2025 , respectively, and no related-party amounts for the three and six months ended June 30, 2024 (see Note 15) .

(2) Includes related-party amounts of $ 1,140 and $ 2,268 for the three and six months ended June 30, 2025 , respectively, and $ 1,131 and $ 2,266 for the three and six months ended June 30, 2024, respectively (see Note 15).

(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.

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Balances at June 30, 2025

Stock-based compensation expense

Issuance of common stock upon

restricted stock units vesting

Common stock issued in connection with

at-the-market offering, net

Pre-funded warrants issued in connection

with public offering, net

Common stock issued in connection with

public offering, net

Issuance of common stock under the

employee stock purchase plan

Unrealized loss, net of tax

Balances at September 30, 2025

Treasury Stock

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Balances at June 30, 2024

Stock-based compensation expense

Exercise of stock options

Issuance of common stock under the

employee stock purchase plan

Unrealized loss, net of tax

Balances at September 30, 2024

The accompanying notes are an integral part of these condensed consolidated financial statements.

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(In thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Cash flows from operating activities:

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Accrued expenses

Deferred revenue

Operating lease liabilities

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Proceeds from issuance of common stock under the employee stock purchase plan

Proceeds from issuance of common stock, net of issuance costs

Payments for offering costs

Proceeds from at-the-market offering, net of commissions

Proceeds from underwritten public offering, net of underwriting discounts and commissions

Payments for at-the-market offering costs

Payments for underwritten public offering costs

Net cash provided by financing activities

Net decrease in cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Cash and cash equivalents at beginning of period

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Deferred offering costs in accrued expenses

Deferred offering costs in accounts payable

The accompanying notes are an integral part of these condensed consolidated financial statements.

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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 administration and subcutaneous administration, which are designed to be more system- and patient-friendly than intravenous administration.

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 a recent Type C meeting, the FDA advised that a single, Phase 2/3 randomized, double-blind, placebo-controlled trial evaluating mAb efficacy from a relatively modest number 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.

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.

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The Company was incorporated in the State of Delaware in June 2020.

The Company operates as a hybrid company.

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.

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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 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.

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).

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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.

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”) and net proceeds received from shares of common stock sold under the Sales Agreement (as defined below).

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.

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 $ 30.9 million for the six months ended June 30, 2025.

As of June 30, 2025, the Company had an accumulated deficit of $ 932.9 million.

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 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.

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.

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Unaudited Interim Financial Information

The accompanying condensed consolidated balance sheet as of June 30, 2025, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025 and 2024, the condensed consolidated statements of cash flows for the six months ended June 30, 2025 and 2024 and the condensed consolidated statements of stockholders’ equity for the three and six months ended June 30, 2025 and 2024 are unaudited.

The accompanying unaudited condensed consolidated financial statements as of June 30, 2025 and for the three and six months ended June 30, 2025 and 2024 have been prepared by the Company pursuant to the rules and regulations of the U.S.

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.

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.

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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 June 30, 2025 and December 31, 2024, the condensed consolidated results of operations for the three and six months ended June 30, 2025 and 2024, the condensed consolidated cash flows for the six months ended June 30, 2025 and 2024, and changes in stockholders’ equity for the three and six months ended June 30, 2025 and 2024 have been made.

The Company’s condensed consolidated results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2025 .

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 .

Summary of Significant Accounting Policies

As of June 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.

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

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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 and other market-specific or relevant factors it believes to be reasonable under the circumstances.

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.

1 unchanged sentence

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

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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 December 15, 2024.

The guidance is effective for the Company for the annual period beginning after

December 15, 2024.

All entities should apply the guidance prospectively but have the option to apply it retrospectively.

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Fair Value Measurements at

June 30, 2025:

September 30, 2025:

Cash equivalents:

Money market funds

Treasury securities

Fair Value Measurements at

2 unchanged sentences

Money market funds

The money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy.

There were no changes to the valuation methods during the three and six months ended June 30, 2025 or 2024.

Treasury securities

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.

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 six months ended June 30, 2025 or 2024 .

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 .

The following table presents non-current inventories (in thousands):

September 30,

Work in process

Finished goods

As of June 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.

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.

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Prepaid expenses and other current assets consisted of the following (in thousands):

September 30,

Prepaid external research, development and manufacturing costs

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Accrued expenses consisted of the following (in thousands):

September 30,

Accrued external research, development and manufacturing costs

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Otherwise, the Company is solely responsible for the development, manufacture and commercialization of the CoV Antibodies and associated Products at its own cost and expense.

The Company is solely responsible for preparing and submitting all investigational new drug applications, new drug applications, biologics license applications and other regulatory filings for the CoV Antibodies and Products in the Field, and for obtaining and maintaining all marketing approvals for Products in the Field, at its sole expense.

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

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 six months ended June 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 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 June 30, 2025;

however, milestone payments do not accrue for certain in vitro diagnostic devices consisting of or containing CoV Antibodies.

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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 June 30, 2025.

During the three and six months ended June 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.

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 June 30, 2025.

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.

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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 six months ended June 30, 2025, the Company expensed $ 0.4 million and $ 0.9 million , respectively, of royalties, while reserving all rights under the Adimab Assignment Agreement and the applicable law.

During the three and six months ended June 30, 2024 , the Company did no t expense any royalties.

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.

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Effective January 2024, the Company became obligated to pay Adimab a quarterly fee of $ 0.6 million.

During both the three months ended June 30, 2025 and 2024, the Company recognized $ 0.6 million of research and development expense related to the quarterly fee.

During both the six months ended June 30, 2025 and 2024 , the Company recognized $ 1.2 million of research and development expense related to the quarterly fee.

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;

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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 six months ended June 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 six months ended June 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.

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.

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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 June 30, 2025.

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.

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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 June 30, 2025, no royalty payments have been paid to or have been earned by Adimab under the Adimab Collaboration Agreement.

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 Agreement at any time upon advance written notice to Adimab.

The Company may terminate the Adimab Collaboration

Agreement at any time upon advance written notice to Adimab.

In addition, subject to certain conditions, either party may terminate the Adimab Collaboration Agreement in the event of a material breach by the other party that is not cured within specified periods.

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The first annual fee became due in September 2023 and was paid in October 2023.

During both the three months ended June 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 six months ended June 30, 2025 and 2024 , the Company recognized $ 1.0 million of research and development expense related to the annual fee under the Adimab Platform Transfer Agreement.

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.

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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 June 30, 2025.

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.

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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 June 30, 2025, no royalty payments have been paid to or have been earned by Adimab under the Adimab Platform Transfer Agreement.

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.

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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 June 30, 2025 , no royalties had become due to WuXi Biologics.

Through September 30, 2025 , no royalties had become due to WuXi Biologics.

The Cell Line License Agreement remains in effect until it is terminated.

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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 six months ended June 30, 2025 and 2024 .

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 .

Population Health Partners, L.P.

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The PHP Work Order was effective for six months from the PHP Effective Date and terminated in accordance with its terms in May 2023.

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.

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 six months ended June 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.

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”).

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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.

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):

For the Three Months

Ended June 30,

Ended September 30,

For the Three Months

Ended June 30,

For the Six Months

Ended June 30,

For The Six Months

Ended June 30,

Ended September 30,

For the Nine Months

Ended September 30,

For The Nine Months

Ended September 30,

Operating lease cost

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Operating cash flows related to operating leases

Future minimum lease payments under the noncancelable leases as of June 30, 2025 was as follows (in thousands):

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 six months ended June 30, 2025)

2025 (excluding the nine months ended September 30, 2025)

Total lease payments

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Present value of operating lease liability

As of June 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 2.5 years.

As of June 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 0.5 years.

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.

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The Commercial Manufacturing Agreement outlines the terms and conditions under which WuXi Biologics manufactures drug substance and drug product for commercial use.

Through June 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 June 30, 2025 , the total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics was $ 25.9 million, which was included in accounts payable and accrued expenses.

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 June 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 June 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.

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.

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Either party may terminate the agreement upon the breach or default by the other party, other than a non-payment breach, that is not timely cured after notice thereof.

Both parties are also entitled to terminate the Commercial Manufacturing Agreement if the

other party becomes insolvent or is the subject of a petition in bankruptcy or of any other related proceeding or event.

Either party may terminate either the Commercial Manufacturing Agreement in its entirety, or an individual order, (i) to the extent the other party suffers a force majeure event that is continuing for a predefined period of time and (ii) if the other party fails to make a payment when due under the arrangement and such non-payment is not timely cured after notice thereof.

Both parties are also entitled to terminate the Commercial Manufacturing Agreement if the other party becomes insolvent or is the subject of a petition in bankruptcy or of any other related proceeding or event.

Either party may terminate either the Commercial Manufacturing Agreement in its entirety, or an individual order, (i) to the extent the other party suffers

a force majeure event that is continuing for a predefined period of time and (ii) if the other party fails to make a payment when due under the arrangement and such non-payment is not timely cured after notice thereof.

Until regulatory approval and future economic benefit is probable, the Company will continue to expense costs related to batches manufactured under the Commercial Manufacturing Agreement.

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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 June 30, 2025 and December 31, 2024.

The termination fees were not probable of payment as of September 30, 2025 and December 31, 2024.

Legal Proceedings

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Legal fees and other costs associated with such proceedings are expensed as incurred.

As of June 30, 2025, the Company was not a party to any material legal proceedings.

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 (“CDMOs”), business partners and other parties with respect to certain matters, including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties.

In 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.

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The proceeds of the Term Facility may be used for working capital and general business purposes.

As of June 30, 2025, the Company had not satisfied the net product revenue milestone required to be eligible to access proceeds from the Term Facility as of the earliest draw down date, August 15, 2025.

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 %.

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Shares Reserved for Future Issuance

As of June 30, 2025 , the Company had reserved 37,342,175 shares of common stock for the exercise of outstanding stock options and the issuance of awards available for grant under the Company’s 2020 Equity Incentive Plan, 2021 Equity Incentive Plan and 2021 Employee Stock Purchase Plan (see Note 11).

Shelf Registration Statement

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.

As of June 30, 2025 , $ 325 million of the Company’s securities remained available for offer and sale under this shelf registration statement.

In December 2023, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cant or Fitzgerald & Co., as sales agent (“Cantor”), 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.

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

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.

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.

As of June 30, 2025 , $ 34.5 million remained available for sale under the Sales Agreement.

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.

Stock-Based Compensation

2020 Equity Incentive Plan

The Company’s 2020 Equity Incentive Plan (the “2020 Plan”) provides for the Company to grant incentive stock options, non-qualified stock options, restricted stock awards, restricted stock units and other stock-based awards to employees, members of the board of directors and consultants.

The 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.

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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 June 30, 2025 , there were 808,615 shares authorized to be issued upon the exercise of outstanding stock option grants and no shares reserved for future issuance under the 2020 Plan.

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, restricted stock units and other stock-based awards.

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;

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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 June 30, 2025 , there were an aggregate of 36,681,059 shares authorized to be issued under the 2020 Plan and the 2021 Plan, which included 808,615 and 22,106,919 shares authorized to be issued upon the exercise of outstanding stock option and restricted stock unit grants from the 2020 Plan and 2021 Plan, respectively, and 0 and 13,765,525 shares reserved for future issuance under the 2020 Plan and 2021 Plan, respectively.

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

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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 June 30,

Six Months Ended

Three Months Ended September 30,

Nine Months Ended

September 30,

Nine Months Ended

September 30,

Expected term (in years)

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Outstanding at December 31, 2024

Outstanding at June 30, 2025

Vested and expected to vest at June 30, 2025

Options exercisable at June 30, 2025

The weighted-average grant date fair value of stock options granted during the three and six months ended June 30, 2025 was $ 0.43 and $ 0.90 , respectively, per share.

The weighted-average grant date fair value of stock options granted during the three and six months ended June 30, 2024 was $ 1.48 and $ 2.21 , 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 June 30, 2025 and 2024.

The total intrinsic value of stock options exercised was less than $ 0.1 million for both the three and six months ended June 30, 2025 .

The total intrinsic value of stock options exercised was $ 0.2 million for both the three and six months ended June 30, 2024.

Outstanding at September 30, 2025

Vested and expected to vest at September 30, 2025

Options exercisable at September 30, 2025

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 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 2025, the Company’s board of directors approved restricted stock unit (“RSU” ) grants to the Company’s executive officers under the 2021 Plan.

An aggregate of 1,700,000 RSUs were issued at a grant date fair value of $ 1.61 per share.

The RSUs will vest over an eighteen-month period, with one-third of the RSUs vesting every six months following the grant date of February 15, 2025, subject to continuous service as of each vesting date.

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:

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Outstanding at December 31, 2024

Outstanding at June 30, 2025

Outstanding at September 30, 2025

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 June 30,

Six Months Ended

Three Months Ended September 30,

Nine Months Ended

September 30,

Nine Months Ended

September 30,

Research and development

Selling, general and administrative

As of June 30, 2025 , total unrecognized stock-based compensation expense related to unvested stock options was $ 14.8 million, which is expected to be recognized over a weighted-average period of 2 .3 years.

As of June 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 1.13 years.

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

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A total of 1,342,773 shares of common stock were initially reserved for issuance under the 2021 ESPP.

There were 681,657 shares issued under the 2021 ESPP as of June 30, 2025 .

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.

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The first offering under the 2021 ESPP was June 6, 2022.

As of June 30, 2025 , 661,116 shares remained available for issuance under the 2021 ESPP.

During the three and six months ended June 30, 2025 and 2024 , the Company recognized less than $ 0.1 million in related stock-based compensation expense.

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

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The aggregate grant date fair value of the PHP Warrant was $ 17.4 million, which was recognized as warrant expense on the grant date in November 2022.

There were no warrants issued during the three and six months ended June 30, 2025 and 2024.

As of June 30, 2025 , 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 7.38 years.

For the three and six months ended June 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.

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.

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.

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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 the potential effects on the Company's financial position, results of operations, and cash flows.

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.

Defined Contribution Plan

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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 six months ended June 30, 2025, the Company contributed $ 0.2 million and $ 0.4 million, respectively, to the 401(k) Plan.

For the three and six months ended June 30, 2024 , the Company contributed $ 0.1 million and $ 0.3 million, respectively, to the 401(k) Plan.

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.

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 June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Net loss attributable to common stockholders

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Net loss per share attributable to common stockholders, basic and diluted

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 six months ended June 30, 2025.

There were no shares of unvested restricted common stock for the three and six months ended June 30, 2024.

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.

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.

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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 Six Months

Ended June 30,

For the Six Months

Ended June 30,

For the Nine Months

Ended September 30,

For the Nine Months

Ended September 30,

Stock options to purchase common stock

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Related-Party Transactions

As of June 30, 2025 and December 31, 2024, an aggregate of $ 0.5 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 June 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.

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).

During the three and six months ended June 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 six months ended June 30, 2025, the Company expensed $ 0.4 million and $ 0.9 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 six months ended June 30, 2024 , the Company did no t recognize any costs of product revenue with respect to royalties under the Adimab Assignment Agreement.

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, 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 June 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 six months ended June 30, 2025 and

2024 , the Company recognized $ 1.2 million of research and development expense related to the quarterly fee under the Adimab Collaboration Agreement.

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.

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 June 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.

Adimab DNA Sequencing Services Agreement

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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 six months ended June 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.

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.

Segment Reporting

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The following table presents information about reported segment revenues, and significant segment expenses as provided to the CODM.

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Product revenue, net

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(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 $ 405 and $ 2,163 for the three months ended June 30, 2025 and 2024 , respectively and interest income of $ 1,033 and $ 4,762 for the six months ended June 30, 2025 and 2024 , respectively.

(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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements