0001193125-26-222779.txt : 20260514 0001193125-26-222779.hdr.sgml : 20260514 20260514071846 ACCESSION NUMBER: 0001193125-26-222779 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 74 CONFORMED PERIOD OF REPORT: 20260331 FILED AS OF DATE: 20260514 DATE AS OF CHANGE: 20260514 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Invivyd, Inc. CENTRAL INDEX KEY: 0001832038 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences EIN: 851403134 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-40703 FILM NUMBER: 26975821 BUSINESS ADDRESS: STREET 1: 209 CHURCH STREET CITY: NEW HAVEN STATE: CT ZIP: 06510 BUSINESS PHONE: (781) 819-0080 MAIL ADDRESS: STREET 1: 209 CHURCH STREET CITY: NEW HAVEN STATE: CT ZIP: 06510 FORMER COMPANY: FORMER CONFORMED NAME: Adagio Therapeutics, Inc. DATE OF NAME CHANGE: 20201112 10-Q 1 ivvd-20260331.htm 10-Q 10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

☒

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2026

OR

☐

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________________ to ___________________

Commission File Number: 001-40703

 

INVIVYD, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

85-1403134

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

209 Church Street
New Haven, CT

06510

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (781) 819-0080

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

 

IVVD

 

The Nasdaq Global Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

☐

 

Accelerated filer

☐

 

 

 

 

Non-accelerated filer

☒

 

Smaller reporting company

☒

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of April 30, 2026, the registrant had 294,607,452 shares of common stock, $0.0001 par value per share, outstanding.

 

 


Table of Contents

Page

PART I.

FINANCIAL INFORMATION

1

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

Condensed Consolidated Statements of Stockholders’ Equity

3

Condensed Consolidated Statements of Cash Flows

4

Notes to Unaudited Condensed Consolidated Financial Statements

5

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

23

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

37

Item 4.

Controls and Procedures

37

PART II.

OTHER INFORMATION

38

Item 1.

Legal Proceedings

38

Item 1A.

Risk Factors

38

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

38

Item 5.

Other Information

38

Item 6.

Exhibits

39

Signatures

41

 

i


PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

INVIVYD, INC.

Condensed Consolidated Balance Sheets

(UNaudited)

(In thousands, except share and per share amounts)

 

 

March 31,
2026

 

 

December 31,
2025

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

184,153

 

 

$

226,689

 

Accounts receivable, net(1)

 

 

11,648

 

 

 

13,919

 

Prepaid expenses and other current assets

 

 

9,114

 

 

 

6,859

 

Total current assets

 

 

204,915

 

 

 

247,467

 

Inventory

 

 

25,452

 

 

 

25,499

 

Property and equipment, net

 

 

1,693

 

 

 

1,365

 

Operating lease right-of-use assets

 

 

8,526

 

 

 

2,442

 

Other non-current assets

 

 

1,156

 

 

 

110

 

Total assets

 

$

241,742

 

 

$

276,883

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable(2)

 

$

2,022

 

 

$

13,744

 

Accrued expenses (3)

 

 

27,988

 

 

 

19,053

 

Operating lease liabilities, current

 

 

1,592

 

 

 

1,314

 

Other current liability

 

 

56

 

 

 

52

 

Total current liabilities

 

 

31,658

 

 

 

34,163

 

Operating lease liabilities, non-current

 

 

7,034

 

 

 

1,180

 

Total liabilities

 

 

38,692

 

 

 

35,343

 

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 March 31, 2026
           and December 31, 2025

 

 

—

 

 

 

—

 

        Common stock, $0.0001 par value; 1,000,000,000 shares authorized,
           
282,803,863 shares issued and outstanding at March 31, 2026;
           
281,987,033 shares issued and outstanding at December 31, 2025

 

 

28

 

 

 

28

 

Additional paid-in capital

 

 

1,198,942

 

 

 

1,196,036

 

Accumulated other comprehensive loss

 

 

(37

)

 

 

(41

)

Accumulated deficit

 

 

(995,883

)

 

 

(954,483

)

Total stockholders’ equity

 

 

203,050

 

 

 

241,540

 

Total liabilities and stockholders’ equity

 

$

241,742

 

 

$

276,883

 

 

(1)
Includes an allowance for doubtful accounts of $274 and $323 as of March 31, 2026 and December 31, 2025, respectively.
(2)
Includes related-party amounts of $625 and $0 as of March 31, 2026 and December 31, 2025, respectively (see Note 15).
(3)
Includes related-party amounts of $551 and $703 as of March 31, 2026 and December 31, 2025, respectively (see Note 15).

 

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

1


INVIVYD, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(UNaudited)

(In thousands, except share and per share amounts)

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

2026

 

 

2025

 

Revenue:

 

 

 

 

 

 

Product revenue, net

 

$

13,744

 

 

$

11,304

 

Total revenue

 

 

13,744

 

 

 

11,304

 

Operating costs and expenses:

 

 

 

 

 

 

Cost of product revenue(1)

 

 

1,032

 

 

 

834

 

Research and development(2)

 

 

30,731

 

 

 

10,641

 

Selling, general and administrative

 

 

25,117

 

 

 

16,751

 

Total operating costs and expenses

 

 

56,880

 

 

 

28,226

 

Loss from operations

 

 

(43,136

)

 

 

(16,922

)

Other income:

 

 

 

 

 

 

Other income, net

 

 

1,736

 

 

 

633

 

Total other income, net

 

 

1,736

 

 

 

633

 

Net loss

 

 

(41,400

)

 

 

(16,289

)

Other comprehensive income (loss)

 

 

 

 

 

 

Unrealized gain (loss), net of tax

 

 

4

 

 

 

(8

)

Comprehensive loss

 

$

(41,396

)

 

$

(16,297

)

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

 

$

(0.13

)

 

$

(0.14

)

Weighted-average common shares outstanding, basic and diluted

 

 

309,670,101

 

 

 

119,883,479

 

 

(1)
Includes related-party amounts of $550 and $452 for the three months ended March 31, 2026 and 2025, respectively (see Note 15).
(2)
Includes related-party amounts of $1,127 and $1,128 for the three months ended March 31, 2026 and 2025, respectively (see Note 15).

 

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

2


 

INVIVYD, INC.

CONDENSED CONSOLIDATED 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, 2025

 

 

281,987,033

 

 

$

28

 

 

 

—

 

 

$

—

 

 

$

1,196,036

 

 

$

(41

)

 

$

(954,483

)

 

 

241,540

 

Stock-based compensation expense

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

2,697

 

 

 

 

 

 

 

 

 

2,697

 

Exercise of stock options

 

 

60,028

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

74

 

 

 

—

 

 

 

—

 

 

 

74

 

Issuance of common stock upon restricted stock units vesting

 

 

660,999

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of common stock under the employee stock purchase plan

 

 

95,803

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

135

 

 

 

—

 

 

 

—

 

 

 

135

 

Unrealized gain, net of tax

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

4

 

 

 

—

 

 

 

4

 

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(41,400

)

 

 

(41,400

)

Balances at March 31, 2026

 

 

282,803,863

 

 

$

28

 

 

 

—

 

 

$

—

 

 

$

1,198,942

 

 

$

(37

)

 

$

(995,883

)

 

$

203,050

 

 

 

 

 

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

 

 

 

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

3


 

INVIVYD, INC.

Condensed Consolidated Statements of Cash Flows

(UNAUDITED)

(In thousands)

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

2026

 

 

2025

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(41,400

)

 

$

(16,289

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

2,697

 

 

 

2,826

 

Amortization of operating lease right-of-use assets

 

 

345

 

 

 

432

 

Depreciation and amortization expense

 

 

168

 

 

 

306

 

Other non-cash adjustments

 

 

54

 

 

 

—

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

2,221

 

 

 

2,345

 

Inventory

 

 

47

 

 

 

(58

)

Prepaid expenses and other current assets

 

 

(2,123

)

 

 

1,348

 

Other non-current assets

 

 

(1,046

)

 

 

10

 

Accounts payable

 

 

(11,566

)

 

 

(1,637

)

Accrued expenses

 

 

9,184

 

 

 

(10,009

)

Operating lease liabilities

 

 

(297

)

 

 

(410

)

Other current liabilities

 

 

4

 

 

 

7

 

Net cash used in operating activities

 

 

(41,712

)

 

 

(21,129

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(726

)

 

 

(144

)

Net cash used in investing activities

 

 

(726

)

 

 

(144

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from exercises of stock options

 

 

74

 

 

 

37

 

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

 

 

135

 

 

 

44

 

Payments for at-the-market offering costs

 

 

(76

)

 

 

(71

)

Payments for underwritten public offering costs

 

 

(231

)

 

 

—

 

Net cash (used in) provided by financing activities

 

 

(98

)

 

 

10

 

Effect of exchange rate changes on cash and cash equivalents

 

 

—

 

 

 

(8

)

Net decrease in cash and cash equivalents

 

 

(42,536

)

 

 

(21,271

)

Cash and cash equivalents at beginning of period

 

 

226,689

 

 

 

69,349

 

Cash and cash equivalents at end of period

 

$

184,153

 

 

$

48,078

 

Supplemental disclosure of cash flow information

 

 

 

 

 

 

Deferred offering costs in accrued expenses

 

$

133

 

 

$

—

 

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

4


 

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 focused on the discovery, development and commercialization of monoclonal antibody (“mAb”) therapies for the prevention and treatment of serious viral infectious diseases, beginning with SARS-CoV-2, the virus that causes COVID-19, and expanding into other high-need indications, such as respiratory syncytial virus (“RSV”) and measles.

 

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.

 

In January 2024, the Company nominated VYD2311, a next generation mAb candidate for COVID-19, as a drug candidate. VYD2311 is a mAb with high in vitro neutralization potency shown against prominent SARS-CoV-2 variants tested to date. 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 includes three clinical trials, DECLARATION, LIBERTY, and DRUMMER. In December 2025, the Company initiated DECLARATION, which is a Phase 3 randomized, triple-blind, placebo-controlled clinical trial to evaluate VYD2311 safety and efficacy in prevention of symptomatic, RT-PCR-confirmed COVID-19 at three months, with either a single dose or monthly doses of VYD2311, each administered via intramuscular injection, compared to placebo. DECLARATION is designed to support potential Biologics License Application (“BLA”) submission, with top-line data anticipated in the third quarter of 2026. In February 2026, the Company announced alignment with the FDA on LIBERTY, which is designed as a Phase 3, randomized, double-blind clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of (1) VYD2311, (2) an mRNA COVID vaccine, and (3) co-administered VYD2311 with an mRNA COVID vaccine. Additionally, the Company has agreed with the FDA on an initial Pediatric Study Plan for an efficient safety and immunobridging clinical trial to support potential BLA for VYD2311 in children aged 0-11 years. This DRUMMER pediatric clinical trial will be actioned only if the pivotal DECLARATION clinical trial is successful. The FDA has granted “Fast Track” designation for VYD2311 for the prevention of COVID-19 in individuals with underlying risk factors for progression to severe disease. Fast Track designation is a process designed to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need, including eligibility for priority review and rolling review of BLA submissions, if specified criteria are met.

In addition to the Company’s COVID-19 programs, in November 2025, the Company announced the selection of VBY329, a potential best-in-class mAb candidate being developed for the prevention of RSV infections in neonates, infants and children. The Company expects to advance VBY329 toward IND readiness in the second half of 2026. Also, in April 2026, the Company announced the discovery and advancement of VMS063, a novel, highly potent, half-life-extended, high resistance barrier measles mAb candidate. The Company has begun IND-enablement and regulatory outreach to support rapid VMS063 development, with the goal of expedited development with target IND readiness in late 2026. Through the Company’s proprietary technology platform, the Company continues to investigate additional mAbs for protection and treatment of other important infectious diseases.

 

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.

 

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.

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

5


 

(“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 Agreements (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 three months ended March 31, 2026. As of March 31, 2026, the Company had an accumulated deficit of $995.9 million. The Company may continue to generate operating losses for the foreseeable future.

Based on current operating plans and excluding 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 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 March 31, 2026, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2026 and 2025, the condensed consolidated statements of cash flows for the three months ended March 31, 2026 and 2025 and the condensed consolidated statements of stockholders’ equity for the three months ended March 31, 2026 and 2025 are unaudited.

The accompanying unaudited condensed consolidated financial statements as of March 31, 2026 and for the three months ended March 31, 2026 and 2025 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, 2025 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, 2025, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 5, 2026 (the “2025 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 March 31, 2026 and December 31, 2025, the condensed consolidated results of operations for the three months ended March 31, 2026 and 2025, the condensed consolidated cash flows for the three months ended March 31, 2026 and 2025, and changes in stockholders’ equity for the three months ended March 31, 2026 and 2025 have been made. The Company’s condensed consolidated results of operations for the three months ended March 31, 2026 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2026.

6


 

2. Summary of Significant Accounting Policies

As of March 31, 2026, the Company’s significant accounting policies and estimates, which are detailed in the Company’s 2025 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.

Concentrations of Credit Risk

Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents and accounts receivable. As of March 31, 2026, the Company invested its excess cash in money market funds that are subject to minimal credit and market risks. The Company maintains its existing cash and cash equivalents at two accredited financial institutions. From time to time, these deposits may exceed federally insured limits. The Company has not experienced any losses historically in these accounts. Accordingly, the Company does not believe it is exposed to unusual credit risk related to its existing cash and cash equivalents beyond the normal credit risk associated with commercial banking relationships.

There have been no material changes in customer concentration of accounts receivable from those detailed in the Company’s 2025 Form 10-K. As of March 31, 2026, the Company recorded an allowance for doubtful accounts of $0.3 million related to one direct customer.

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 will remain an emerging growth company until December 31, 2026. 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 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.

 

7


 

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
March 31, 2026:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

181,561

 

 

$

—

 

 

$

—

 

 

$

181,561

 

 

$

181,561

 

 

$

—

 

 

$

—

 

 

$

181,561

 

 

 

Fair Value Measurements at
December 31, 2025:

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

224,172

 

 

$

—

 

 

$

—

 

 

$

224,172

 

 

$

224,172

 

 

$

—

 

 

$

—

 

 

$

224,172

 

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 months ended March 31, 2026.

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 months ended March 31, 2026.

4. Inventory

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

 

 

March 31,
2026

 

 

December 31,
2025

 

Work in process

 

$

20,769

 

 

$

20,769

 

Finished goods

 

 

4,683

 

 

 

4,730

 

 

$

25,452

 

 

$

25,499

 

 

As of March 31, 2026, $0.3 million of finished goods inventory was classified as a current asset and included within prepaid expenses 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):

 

 

March 31,
2026

 

 

December 31,
2025

 

Prepaid external research, development and manufacturing costs

 

$

2,614

 

 

$

3,442

 

Prepaid corporate communication costs

 

 

2,450

 

 

 

—

 

Prepaid insurance

 

 

660

 

 

 

1,024

 

Interest receivable

 

 

561

 

 

 

676

 

Finished goods inventory, current

 

 

262

 

 

 

263

 

Other

 

 

2,567

 

 

 

1,454

 

 

$

9,114

 

 

$

6,859

 

 

8


 

6. Accrued Expenses

Accrued expenses consisted of the following (in thousands):

 

 

March 31,
2026

 

 

December 31,
2025

 

Accrued external research, development and manufacturing costs

 

$

18,492

 

 

$

6,616

 

Accrued professional and consultant fees

 

 

4,498

 

 

 

2,778

 

Accrued employee compensation

 

 

1,793

 

 

 

5,749

 

Other

 

 

3,205

 

 

 

3,910

 

 

$

27,988

 

 

$

19,053

 

 

7. License and Collaboration Agreements

Adimab Assignment Agreement

In July 2020, the Company entered into an Assignment and License Agreement (the “Adimab Assignment Agreement”) with Adimab, LLC (“Adimab”). 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 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 both the three months ended March 31, 2026 and 2025, the Company did not 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 March 31, 2026; however, milestone payments do not accrue for certain in vitro diagnostic devices consisting of or containing CoV Antibodies.

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 March 31, 2026.

During both the three months ended March 31, 2026 and 2025, the Company did not 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 March 31, 2026.

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

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the three months ended March 31, 2026 and 2025, the Company expensed $0.6 million and $0.5 million of royalties, respectively, 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.

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 March 31, 2026 and 2025, the Company recognized $0.6 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 both the three months ended March 31, 2026 and 2025, the Company did not recognize any research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement. During both the three months ended March 31, 2026 and 2025, the Company did not recognize any IPR&D expense related to drug delivery fees, optimization completion fees or option exercise fees. Please refer to Note 15 for additional information.

The Company is obligated to pay Adimab up to $18.0 million upon the achievement of specified development and regulatory milestones for each product under the Adimab Collaboration Agreement that achieves such milestones. The next potential milestone under the Adimab Collaboration Agreement is a low single-digit million-dollar clinical milestone, which was not considered probable under U.S. GAAP and therefore, no expense was recognized as of March 31, 2026. 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

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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 March 31, 2026, 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. 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 March 31, 2026 and 2025, the Company recognized $0.5 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 March 31, 2026.

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 March 31, 2026, 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.

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The Company concluded that the Adimab Platform Transfer Agreement represented an asset acquisition of IPR&D with no alternative future use. Therefore, payments made by the Company to Adimab for milestones achieved will be recognized as IPR&D expense in the related period in which the services are performed or the related milestone is considered probable of achievement. Amounts paid with respect to the annual material improvement fees are recognized as research and development expense as such amounts are incurred. Please refer to Note 15 for additional information.

WuXi Biologics Cell Line License Agreement

In December 2020, as amended in February 2023, March 2024 and March 2026, 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 with respect to certain Licensed Products by making a one-time payment in the low eight-figures to WuXi Biologics and with respect to certain other Licensed Products by making a one-time payment in the middle-seven 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. The royalty obligation shall be waived to the extent the royalty obligation is derived or arising from a Licensed Product sold in the U.S. if the Company’s ability to have such Licensed Product manufactured by WuXi Biologics becomes materially restricted due to certain government actions, with such waiver continuing for so long as such government action continues. Through March 31, 2026, 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 not recognize any IPR&D expense under the Cell Line License Agreement during the three months ended March 31, 2026 and 2025.

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 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 both the three months ended March 31, 2026 and 2025, the Company did not pay any cash compensation to PHP and therefore did not recognize any research and development expense related thereto.

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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;

 

 

 

 

 

•

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. As of March 31, 2026, no portion of the PHP Warrant had vested.

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 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.

In February 2026, the Company further amended the Newton, MA Lease to add additional dedicated laboratory space, which commenced on March 1, 2026. The amendment provides for incremental annual base rent of $0.3 million for the remainder of the lease term, through December 2027.

In May 2025, the Company entered into a short-term lease agreement for approximately 13,600 square feet of office space in New Haven, Connecticut, with an original term of 12 months. The Company has elected the short-term lease recognition exemption under ASC Topic 842 – Leases and therefore has not recognized a right-of-use asset or lease liability on the balance sheet. For the three months ended March 31, 2026, base rent charges of less than $0.1 million were incurred. There were no related expenses incurred for the three months ended March 31, 2025.

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In January 2026, the Company entered into an agreement to lease approximately 33,000 square feet of office space in New Haven, Connecticut (the “New Haven Lease”). The New Haven Lease commenced in March 2026 and has an initial term of one hundred twenty-nine months. The Company’s obligation for the payment of rent for the premises begins six months after the lease commencement date and total future minimum lease payments are expected to be $10.9 million. The lease includes a tenant improvement allowance of approximately $1.0 million.

Under the terms of the New Haven Lease, the Company made a security deposit of $1.0 million in the form of a letter of credit, which will be reduced by 50% in September 2027, following the first twelve months of rent payments.

The components of operating lease expense were as follows (in thousands):

 

 

For the Three Months
Ended March 31,

 

 

For the Three Months
Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Lease cost:

 

 

 

 

 

 

 

Operating lease cost

 

$

423

 

 

$

447

 

 

Variable lease cost

 

 

—

 

 

 

5

 

 

Total lease cost

 

$

423

 

 

$

452

 

 

 

 

 

 

 

 

 

 

Cash paid for amounts included in the measurement of lease liabilities:

 

 

 

 

 

 

 

Operating cash flows related to operating leases

 

$

376

 

 

$

425

 

 

 

 

Future minimum lease payments under the noncancelable leases as of March 31, 2026 was as follows (in thousands):

Year Ending December 31,

Operating Lease

 

2026 (excluding the three months ended March 31, 2026)

$

1,516

 

2027

$

2,549

 

2028

$

917

 

2029

$

1,026

 

2030

$

1,051

 

Thereafter

$

6,594

 

Total lease payments

 

13,653

 

Less: tenant improvement allowance reimbursements yet to be received

 

(956

)

Present value adjustment

 

(4,071

)

Present value of operating lease liability

$

8,626

 

As of March 31, 2026, the Company’s operating leases were measured using a weighted-average incremental borrowing rate of 7.7% over a weighted-average remaining lease term of 7.9 years.

As of March 31, 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 0.6 years.

The total operating liabilities are presented on the Company’s condensed consolidated balance sheet based on maturity dates. As of March 31, 2026, $1.6 million is classified under “operating lease liabilities, current” for the portion due within twelve months, and $7.0 million is classified under “operating lease liabilities, non-current”.

License Agreements

The Company has entered into license agreements with Adimab and WuXi Biologics (see Note 7).

Other 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 March 31, 2026 and December 31, 2025.

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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 March 31, 2026, 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 March 31, 2026, the Company had not satisfied certain financial covenants and conditions, including the net product revenue milestone required to be eligible to access proceeds from the Term Facility. Accordingly, as of March 31, 2026, no amounts have been drawn down under the Loan Agreement.

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 will be 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

As of March 31, 2026, the Company had reserved 60,089,902 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, 2021 Employee Stock Purchase Plan and 2026 Inducement 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”). The 2022 Shelf Registration Statement expired upon the effectiveness of the 2025 Shelf Registration Statement (as defined below).

In October 2025, the Company filed a new shelf registration statement on Form S-3 with the SEC and an accompanying base prospectus, which was declared effective by the SEC on December 23, 2025, for the offer and sale of up to $350 million of the Company’s securities (the “2025 Shelf Registration Statement”). As of March 31, 2026, excluding the $75 million allocated to the 2025

15


 

ATM Prospectus Supplement (as defined below), $275 million of the Company’s securities remained available for offer and sale under the 2025 Shelf Registration Statement.

August 2025 Underwritten Public Offering

In August 2025, the Company completed an underwritten public offering pursuant to an underwriting agreement (the “August 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 March 31, 2026, there were no exercises of pre-funded warrants that were issued in connection with the August 2025 Underwritten Public Offering.

November 2025 Underwritten Public Offering

In November 2025, the Company completed an underwritten public offering pursuant to an underwriting agreement (the “November Underwriting Agreement” and together with the August Underwriting Agreement, the “Underwriting Agreements”) with Cantor, as representative of the underwriters named therein, pursuant to which it issued and sold an aggregate of 44,000,000 shares of its common stock at a price of $2.50 per share, and pre-funded warrants to purchase up to an aggregate of 6,000,000 shares of common stock at a price of $2.4999 per pre-funded warrant (the “November 2025 Underwritten Public Offering”, and, together with the August 2025 Underwritten Public Offering, the “2025 Underwritten Public Offerings”). The price of $2.4999 per pre-funded warrant represented the $2.50 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 $117.2 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company. As of March 31, 2026, there were no exercises of pre-funded warrants that were issued in connection with the November 2025 Underwritten Public Offering.

In December 2025, and in connection with the November 2025 Underwritten Public Offering, Cantor exercised the option pursuant to the November Underwriting Agreement to purchase 4,675,000 additional shares of common stock at the public offering price of $2.50, less underwriting discounts and commissions. In connection with such exercise, the Company received total net proceeds of approximately $10.9 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company.

ATM Facility

In December 2023, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”) with Cantor, as sales agent, and filed with the SEC a prospectus supplement (the “2023 ATM Prospectus Supplement”) to the 2022 Shelf Registration Statement, pursuant to which the Company could, 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 (the “Securities Act”). Cantor was entitled to a commission of 3% of the gross proceeds from any sales of such shares. In 2024, the Company sold 9,000,000 shares of its common stock under the Sales Agreement and the 2023 ATM Prospectus Supplement, at an average price of $4.50 per share for $39.3 million in proceeds net of commissions. In 2025, the Company sold 23,055,402 shares of its common stock under the Sales Agreement and the 2023 ATM Prospectus Supplement at an average price of $1.49 per share for $33.4 million in proceeds net of commissions. Upon the effectiveness of the 2025 Shelf Registration Statement, all offers and sales under the 2023 ATM Prospectus Supplement were deemed terminated.

In October 2025, in connection with the filing of the 2025 Shelf Registration Statement, the Company filed with the SEC a new prospectus supplement (the “2025 ATM Prospectus Supplement”), 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. Cantor is entitled to a commission of 3% of the gross proceeds from any sales of such shares. The 2025 Shelf Registration Statement was declared effective by the SEC on December 23, 2025, and $75.0 million remained available for sale under the 2025 ATM Prospectus Supplement as of March 31, 2026.

In April 2026, the Company sold 11,803,589 shares of its common stock under the Sales Agreement at an average price of $1.70 per share for $19.4 million in proceeds net of commissions.

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

16


 

employees and certain officers of the Company. The exercise prices, vesting and other restrictions are determined at the discretion of the board of directors, or its committee or any such officer if so delegated.

The exercise price for stock options granted may not be less than the fair market value of the Company’s common stock on the date of grant, as determined by the board of directors, or at least 110% of the fair market value of the Company’s common stock on the date of grant in the case of an incentive stock option granted to an employee who owns stock representing more than 10% of the voting power of all classes of stock as determined by the board of directors as of the date of grant. Prior to the IPO, the Company’s board of directors determined the fair value of the Company’s common stock, taking into consideration its most recently available valuation of common stock performed by third parties as well as additional factors which may have changed since the date of the most recent contemporaneous valuation through the date of grant. Stock options granted under the 2020 Plan expire after ten years and typically vest over a four-year period with the first 25% vesting upon the first anniversary of a specified vesting commencement date and the remainder vesting in 36 equal monthly installments over the succeeding three years, contingent on the recipient’s continued employment or service. Certain awards of stock options permit the holders to exercise the option in whole or in part prior to the full vesting of the option in exchange for unvested shares of restricted common stock with respect to any unvested portion of the option so exercised.

As of March 31, 2026, there were 467,615 shares authorized to be issued upon the exercise of outstanding stock options 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 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, 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. On January 1, 2026, 14,099,351 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 March 31, 2026, there were an aggregate of 28,946,439 shares authorized to be issued upon the exercise of outstanding stock options and vesting of RSU grants and 19,574,167 shares reserved for future issuance under the 2021 Plan.

2026 Inducement Plan

In January 2026, the Company’s board of directors adopted the 2026 Inducement Plan (the “2026 Inducement Plan”). Under the 2026 Inducement Plan, the Company is authorized to issue up to 8,000,000 shares pursuant to inducement grants. The only persons eligible to receive grants under the 2026 Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq Listing Rule 5635(c)(4) and the related guidance under Nasdaq IM 5635-1, including individuals who were not previously an employee or director of the Company (or individuals following a bona fide period of non-employment), in each case as an inducement material to such individual’s agreement to enter into employment with the Company. The 2026 Inducement Plan provides for the discretionary grant of nonstatutory stock options, stock appreciation rights, restricted stock awards, RSUs, performance awards, and certain other awards.

As of March 31, 2026, there were an aggregate of 192,000 shares authorized to be issued upon the exercise of outstanding stock options and 7,808,000 shares reserved for future issuance under the 2026 Inducement Plan.

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

17


 

historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.

The following table presents, on a weighted-average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant date fair value of stock options granted:

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Expected term (in years)

 

 

5.8

 

 

 

5.8

 

 

Expected volatility

 

 

69.3

%

 

 

60.9

%

 

Risk-free interest rate

 

 

3.9

%

 

 

4.4

%

 

Expected dividend yield

 

 

—

%

 

 

—

%

 

Stock Option Activity

The following table summarizes the Company’s stock option activity since December 31, 2025:

 

 

Number of
Shares

 

 

Weighted-
Average
Exercise
Price

 

 

Weighted-
Average
Remaining
Contractual
Term

 

 

Aggregate
Intrinsic
Value

 

 

 

 

 

 

 

 

 

(in years)

 

 

(in thousands)

 

Outstanding at December 31, 2025

 

 

21,351,941

 

 

$

2.96

 

 

 

8.1

 

 

$

15,525

 

Granted

 

 

8,138,250

 

 

$

1.86

 

 

 

 

 

 

 

Exercised

 

 

(60,028

)

 

$

1.23

 

 

 

 

 

 

 

Forfeited

 

 

(602,110

)

 

$

2.20

 

 

 

 

 

 

 

Outstanding at March 31, 2026

 

 

28,828,053

 

 

$

2.67

 

 

 

8.4

 

 

$

1,381

 

Vested and expected to vest at March 31, 2026

 

 

28,828,053

 

 

$

2.67

 

 

 

8.4

 

 

$

1,381

 

Options exercisable at March 31, 2026

 

 

11,529,229

 

 

$

4.08

 

 

 

7.0

 

 

$

392

 

The weighted-average grant date fair value of stock options granted during the three months ended March 31, 2026 and 2025 was $1.19 and $0.93, 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 March 31, 2026 and 2025.

The total intrinsic value of stock options exercised was less than $0.1 million for both the three months ended March 31, 2026 and 2025.

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 certain of its 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, 2025:

 

 

Number
of Shares

 

 

Weighted Average Grant Date Fair Value

 

 

 

 

 

 

 

 

Unvested at December 31, 2025

 

 

1,539,000

 

 

$

1.49

 

Granted

 

 

—

 

 

$

—

 

Vested

 

 

(660,999

)

 

$

1.54

 

Forfeited

 

 

(100,000

)

 

$

1.15

 

Unvested at March 31, 2026

 

 

778,001

 

 

$

1.49

 

 

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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 March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Research and development

 

$

733

 

 

$

831

 

 

Selling, general and administrative

 

 

1,964

 

 

 

1,995

 

 

 

$

2,697

 

 

$

2,826

 

 

As of March 31, 2026, total unrecognized stock-based compensation expense related to unvested stock options was $17.9 million, which is expected to be recognized over a weighted-average period of 2.4 years.

As of March 31, 2026, the total unrecognized stock-based compensation expense related to unvested RSUs was $0.9 million, which is expected to be recognized over a weighted-average period of 0.5 years.

2021 Employee Stock Purchase Plan

In July 2021, the Company’s board of directors adopted, and its stockholders approved, the 2021 Employee Stock Purchase Plan (the “2021 ESPP”), which became effective immediately prior to and contingent upon the execution of the underwriting agreement related to the Company’s IPO. A total of 1,342,773 shares of common stock were initially reserved for issuance under the 2021 ESPP. 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. On January 1, 2026, the number of shares authorized for issuance under the 2021 ESPP increased by 2,685,546 shares of common stock, pursuant to the evergreen provision thereof. The first offering under the 2021 ESPP was June 6, 2022. As of March 31, 2026, 3,101,681 shares remained available for issuance under the 2021 ESPP. There were 926,638 shares issued under the 2021 ESPP as of March 31, 2026. During both the three months ended March 31, 2026 and 2025, the Company recognized less than $0.1 million in related stock-based compensation expense.

Warrant Expense

In November 2022, the Company entered into the PHP MSA, the PHP Work Order and a warrant agreement with respect to the PHP Warrant. To compensate for the services and deliverables provided by PHP, the Company issued 6,824,712 equity-classified warrants to PHP. Each warrant shall give the right to acquire common stock of the Company at a purchase price of $3.48 per share. Per the agreement, the PHP Warrant is exercisable upon either the achievement of corresponding market capitalization targets or a consummation of a fundamental transaction (as defined in the PHP Warrant); as such, there are no other requirements, including any continuous service requirements, in order for PHP to be entitled to the PHP Warrant, if and when any portion of it vests.

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

There were no warrants issued during the three months ended March 31, 2026 and 2025.

As of March 31, 2026, other than the pre-funded warrants issued in the 2025 Underwritten Public Offerings, 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 6.63 years.

12. Income Taxes

For both the three months ended March 31, 2026 and 2025, 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.

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’

19


 

compensation. For the three months ended March 31, 2026 and 2025, the Company contributed $0.3 million and $0.2 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 March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Numerator:

 

 

 

 

 

 

 

Net loss attributable to common stockholders

 

$

(41,400

)

 

$

(16,289

)

 

Denominator:

 

 

 

 

 

 

 

Weighted-average common shares outstanding, basic and diluted

 

 

309,670,101

 

 

 

119,883,479

 

 

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

 

$

(0.13

)

 

$

(0.14

)

 

 

The 27,342,442 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.

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 Three Months
Ended March 31,

 

 

For the Three Months
Ended March 31,

 

 

 

2026

 

 

2025

 

Stock options to purchase common stock

 

 

28,828,053

 

 

 

23,014,702

 

Restricted stock units

 

 

778,001

 

 

 

1,700,000

 

Warrants to purchase common stock

 

 

6,824,712

 

 

 

6,824,712

 

 

 

 

36,430,766

 

 

 

31,539,414

 

 

15. Related-Party Transactions

As of March 31, 2026 and December 31, 2025, an aggregate of $1.2 million and $0.7 million, respectively, was due to Adimab, a beneficial owner of more than 5% of the Company’s common stock, 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 accounts payable and accrued expenses. As of March 31, 2026 and December 31, 2025, no amounts were due to the Company from Adimab under the Adimab Assignment Agreement, the Adimab Collaboration Agreement, the Adimab Platform Transfer Agreement, the Adimab DNA Sequencing Services Agreement or the Adimab LCMS Services Agreement (as defined below).

Adimab Assignment Agreement

Under the Adimab Assignment Agreement, Adimab 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 both the three months ended March 31, 2026 and 2025, the Company did not recognize any IPR&D expense with respect to contingent consideration payable under the Adimab Assignment Agreement.

During both the three months ended March 31, 2026 and 2025, the Company did not 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 months ended March 31, 2026 and 2025, the Company expensed $0.6 million and $0.5 million, respectively, of royalties as costs of product revenue, while reserving all rights under the Adimab Assignment Agreement and the applicable law.

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 March 31, 2026 and 2025, the Company recognized $0.6 million of research and development expense related to the quarterly fee under the Adimab Collaboration Agreement.

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During both the three months ended March 31, 2026 and 2025, the Company did not recognize any research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.

During both the three months ended March 31, 2026 and 2025, the Company did not recognize any IPR&D expense related to drug delivery fees, optimization completion fees or option exercise fees.

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 March 31, 2026 and 2025, 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

In May 2023, as amended in January 2024, January 2025 and January 2026, 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 both the three months ended March 31, 2026 and 2025, 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.

Adimab LCMS Services Agreement

In November 2023, as amended in December 2025, the Company entered into a Services Agreement with Adimab for Adimab to provide molecular weight determination services and deliver to the Company the resulting data and information (the “Adimab LCMS Services Agreement”). In exchange for the services performed, the Company will pay Adimab a fee for each sample tested.

During both the three months ended March 31, 2026 and 2025, the Company did not recognize any research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab LCMS 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 Company’s reportable segment derives its revenue from sales of its product, PEMGARDA. No asset information has been provided for the reportable segment as the CODM does not regularly review asset information by reportable segment.

The following table presents information about reported segment revenues, and significant segment expenses as provided to the CODM (in thousands). Certain prior period segment expense amounts have been recast to reflect the current year presentation.

 

21


 

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Revenue:

 

 

 

 

 

 

 

Product revenue, net

 

$

13,744

 

 

$

11,304

 

 

Total revenue

 

 

13,744

 

 

 

11,304

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

Cost of product revenue

 

 

1,032

 

 

 

834

 

 

Direct, external research and development expenses by program:

 

 

 

 

 

 

 

Pemivibart(1)

 

 

188

 

 

 

1,391

 

 

VYD2311(2)

 

 

22,803

 

 

 

1,502

 

 

VBY329(3)

 

 

164

 

 

 

42

 

 

VMS063(4)

 

 

129

 

 

 

—

 

 

Early-stage programs

 

 

29

 

 

 

85

 

 

Total direct, external research and development expenses by program

 

 

23,313

 

 

 

3,020

 

 

Personnel expense (research and development)

 

 

3,167

 

 

 

3,180

 

 

Stock-based compensation (research and development)

 

 

733

 

 

 

831

 

 

Other research and development expense

 

 

3,518

 

 

 

3,610

 

 

Total research and development expense

 

 

30,731

 

 

 

10,641

 

 

Selling, general and administrative

 

 

 

 

 

 

 

Sales and marketing costs

 

 

5,218

 

 

 

2,960

 

 

Personnel expense (selling, general and administrative)

 

 

7,688

 

 

 

5,490

 

 

Stock-based compensation (selling, general and administrative)

 

 

1,964

 

 

 

1,995

 

 

Other selling, general and administrative expense

 

 

10,247

 

 

 

6,306

 

 

Total selling, general and administrative expense

 

 

25,117

 

 

 

16,751

 

 

Total operating costs and expenses

 

 

56,880

 

 

 

28,226

 

 

Loss from operations

 

 

(43,136

)

 

 

(16,922

)

 

Other income:

 

 

 

 

 

 

 

Other income, net(5)

 

 

1,736

 

 

 

633

 

 

Total other income, net

 

 

1,736

 

 

 

633

 

 

Net loss

 

$

(41,400

)

 

$

(16,289

)

 

(1)
In March 2023, the Company announced the nomination of VYD222 (pemivibart) as a novel mAb therapeutic option for COVID-19.
(2)
In March 2024, the Company announced the nomination of VYD2311 as a novel mAb therapeutic option for COVID-19.
(3)
In November 2025, the Company announced the nomination of VBY329 as an RSV mAb candidate for preclinical development.
(4)
In April 2026, the Company announced the nomination of VMS063 as a measles mAb candidate for preclinical development.
(5)
Includes interest income of $1,743 and $628 for the three months ended March 31, 2026 and 2025, respectively.

 

22


 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 5, 2026 (the “2025 Form 10-K”). Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “we,” “us,” and “our” refer to Invivyd, Inc. together with its consolidated subsidiaries.

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include, but are not limited to, statements regarding our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, and are not guarantees of future performance. The words “may,” “anticipate,” “believe,” “could,” “expect,” “intends,” “might,” “plan,” “possible,” “potential,” “aim,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These statements speak only as of the date of this Quarterly Report on Form 10-Q and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements include, without limitation, statements about the following:

•
our plans related to the commercialization of PEMGARDA® (pemivibart), which received emergency use authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) in March 2024, including our expectations about the potential market opportunity;
•
our expectations related to VYD2311, our next generation monoclonal antibody (“mAb”) candidate for COVID-19, the REVOLUTION clinical program for VYD2311 and the potential of VYD2311 to offer the ability to deliver clinically meaningful titer levels through more healthcare system- and patient-friendly means;
•
the anticipated timing, design, progress and results of preclinical studies and clinical trials of our product candidates, including statements regarding initiation or completion of studies or trials and related preparatory work, the period during which results of any studies or trials will become available, and potential regulatory submissions;
•
our devotion to delivering protection from serious viral infectious diseases, and our commitment to developing a robust pipeline of product candidates that could be used in prevention or treatment of serious viral infectious diseases, starting with COVID-19 and expanding into other high-need indications, such as respiratory syncytial virus (“RSV”) and measles;
•
our expectations regarding the regulatory pathway for our product candidates, including the anticipated timing of any submission of filings for regulatory authorization or approval of, and our ability to obtain and maintain regulatory authorizations or approvals for, our product candidates;
•
our plans regarding SARS-CoV-2 variant monitoring of antiviral activity as part of our ongoing industrial virology effort;
•
our expectations regarding the size of the patient populations, market acceptance and opportunity for and clinical utility of our product candidates, if authorized or approved for commercial use;
•
our expectation of continued reliance on third parties for clinical trials and the manufacture and testing of our product candidates, as well as to perform ongoing research and development and other services on our behalf;
•
our manufacturing capabilities and strategy, and our expectations regarding supply and demand of our product candidates;
•
our ability to successfully commercialize our product candidates, if authorized or approved, including our distribution capabilities and strategy;
•
our ability to identify and develop new product candidates that exert continuous pharmaceutical activity in the face of viral evolution;
•
our expectations regarding the SPEAR (Spike Protein Elimination and Recovery) Study Group, including its anticipated focus, goals and plans;

23


 

•
our estimates of our expenses, ongoing losses, future potential revenue, capital requirements and our need for or ability to obtain additional funding;
•
our expectations regarding our ability to continue as a going concern; and
•
our competitive position and the development of and projections relating to our competitors or our industry.

The foregoing list of forward-looking statements is not exhaustive. You should refer to the “Risk Factors” sections of the 2025 Form 10-K and this Quarterly Report on Form 10-Q for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Other sections of this Quarterly Report on Form 10-Q may include additional factors that could harm our business and financial performance. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report on Form 10-Q will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. You should, however, review the factors and risks and other information we describe in the reports we file from time to time with the SEC.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

Overview

Invivyd, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of monoclonal antibody (“mAb”) therapies for the prevention and treatment of serious viral infectious diseases. We are devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2, the virus that causes COVID-19. PEMGARDA® (pemivibart) is our first mAb to receive regulatory authorization and was designed to exert continuous pharmaceutical activity in the face of viral evolution.

Globally, COVID-19 has caused millions of deaths and lasting health problems in many survivors and remains a significant global health concern, particularly for immunocompromised individuals. COVID-19 persists and continues to impact patients, notably those who are immunocompromised, and combating this disease will require for years to come a variety of prevention and treatment options with demonstrated efficacy and safety. By leveraging our capabilities, which we have developed through our experience with adintrevimab and pemivibart and over five years in the COVID-19 space, we aim to develop mAbs that could be used in prevention or treatment of serious viral infectious diseases, starting with COVID-19 and expanding into other high-need indications, such as respiratory syncytial virus (“RSV”) and measles.

On March 22, 2024, we received emergency use authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) for PEMGARDA injection, for intravenous (“IV”) 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.

The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies. 

In January 2024, we nominated VYD2311, a next generation mAb candidate for COVID-19, as a drug candidate. VYD2311 is a mAb with high in vitro neutralization potency shown against prominent SARS-CoV-2 variants tested to date. In September 2024, we announced dosing of the first participants in a Phase 1/2 clinical trial of VYD2311. 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 healthcare system- and patient-friendly than IV administration. In June 2025, we announced positive full Phase 1/2 clinical data for VYD2311 for both safety and

24


 

pharmacokinetics. Like pemivibart, VYD2311 was engineered from adintrevimab, our 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 August 2025, we 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, we announced that the FDA cleared our Investigational New Drug (“IND”) application for VYD2311 and provided feedback to advance our REVOLUTION clinical program, which is our development program for VYD2311. The REVOLUTION clinical program includes three clinical trials, DECLARATION, LIBERTY and DRUMMER.

In December 2025, we initiated DECLARATION, which is a Phase 3 randomized, triple-blind, placebo-controlled clinical trial to evaluate VYD2311 safety and efficacy in prevention of symptomatic, RT-PCR-confirmed COVID-19 at three months, with either a single dose or monthly doses of VYD2311, each administered via IM injection, compared to placebo. In April 2026, we announced that we conducted a prospectively designed, conservative, algorithmic sample size re-estimation pooled, blinded analysis for the DECLARATION clinical trial aimed at ensuring adequate COVID-19 clinical events and associated statistical power given the variability of COVID-19 attack rates. As of the sample-size re-estimation analysis, conducted when the first 1,500 (of 1,818 total) subjects reached Day 45, clinical events accrued to date could support statistical powering for the high end of anticipated VYD2311 efficacy levels with approximately half of the base DECLARATION clinical trial still to go. The sample size re-estimation was designed conservatively with the aim of accomplishing strong statistical power to accommodate a range of potential VYD2311 efficacy results and COVID events in the trial, and upsizing was triggered. The DECLARATION upsizing includes approximately 500 additional subjects, in addition to 1,818 total randomized subjects in the initial trial population. DECLARATION is designed to support potential BLA submission. Depending on recruitment rates following the trial upsizing, top-line data from DECLARATION are expected in the third quarter of 2026.

In February 2026, we announced alignment with the FDA on LIBERTY, which is designed as a Phase 3, randomized, double-blind clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of (1) VYD2311, (2) an mRNA COVID vaccine, and (3) co-administered VYD2311 with an mRNA COVID vaccine.

Additionally, we have agreed with the FDA on an initial Pediatric Study Plan for an efficient safety and immunobridging clinical trial to support potential BLA for VYD2311 in children aged 0-11 years. This DRUMMER pediatric clinical trial will be actioned only if the pivotal DECLARATION clinical trial is successful.

The FDA has granted “Fast Track” designation for VYD2311 for the prevention of COVID-19 in individuals with underlying risk factors for progression to severe disease. Fast Track designation is a process designed to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need, including eligibility for priority review and rolling review of BLA submissions, if specified criteria are met.

In July 2025, we announced that we 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 our investigational mAb candidate VYD2311. In January 2026, we and the SPEAR Study Group announced plans to initiate a Phase 2 clinical trial evaluating VYD2311 in individuals with Long COVID or COVID vaccine injury. The Phase 2 clinical trial is expected to be initiated mid-2026.

We engage in active SARS-CoV-2 variant monitoring of antiviral activity as part of our ongoing industrial virology effort, which leverages a consistent, high-quality, independent, third-party pseudoviral system that routinely tests authentic Invivyd-produced molecules and is supported by structure-based analytics. In September 2024, we announced continued neutralizing activity of PEMGARDA against SARS-CoV-2 variants KP.3.1.1 and LB.1 and attractive neutralization potency of VYD2311, our next generation mAb candidate for COVID-19, against the same contemporary viruses, and we also provided an update to ongoing structural analysis showing no meaningful mutational change in the pemivibart binding site since the Omicron shift late in 2021. In January 2025, March 2025 and August 2025, we announced continued neutralizing activity of PEMGARDA and VYD2311 against dominant SARS-CoV-2 variants XEC, LP.8.1 and XFG, respectively. In May 2026, we announced that in vitro neutralization data showed continued neutralizing activity of PEMGARDA and VYD2311 against emerging SARS-CoV-2 variant BA.3.2.2 (“Cicada”).

In addition to our COVID-19 programs, in November 2025, we announced the selection of VBY329, a potential best-in-class mAb candidate being developed for the prevention of RSV infections in neonates, infants and children. We expect to advance VBY329 toward IND readiness in the second half of 2026. Also, in April 2026, we announced the discovery and

25


 

advancement of VMS063, a novel, highly potent, half-life-extended, high resistance barrier measles mAb candidate. We have begun IND-enablement and regulatory outreach to support rapid VMS063 development, with the goal of expedited development with target IND readiness in late 2026. Through our proprietary technology platform, we continue to investigate additional mAbs for protection and treatment of other important infectious diseases.

We are also committed to advancing national education and awareness about antibodies and their role in immune health. In April 2026, we launched Antibodies for Any Body, a national education campaign designed to elevate public understanding of antibodies, one of the most important parts of the immune system, and their role in protecting against disease. The campaign was launched in collaboration with renowned ski champion Lindsey Vonn, whose career has been defined by training with intention, overcoming challenges, and taking control of her health and wellness.

We rely on partnerships, external consultants and contract research organizations (“CROs”) to conduct discovery, nonclinical, preclinical, clinical and commercial activities. Additionally, we rely on contract testing laboratories and contract development and manufacturing organizations (“CDMOs”) to execute our chemistry, manufacturing and controls development, testing and clinical and commercial manufacturing activities. In 2022, we secured dedicated laboratory space and expanded our research team in order to enable internal discovery and development of our mAb candidates, while continuing to leverage our existing partnership with Adimab, LLC (“Adimab”), including Adimab’s platform technology. In addition, we expect to continue to rely on third parties for clinical trials and the manufacture and testing of our product candidates, as well as to perform ongoing research and development and other services on our behalf.

Since our inception and through March 31, 2026, we have financed our operations primarily through the sale and issuance of preferred and common stock, including net proceeds of $464.7 million from sales of our preferred stock, net proceeds of $327.5 million from sales of our common stock from our initial public offering (“IPO”), net proceeds of $72.7 million from sales of our common stock under the Sales Agreement (as defined below) and net proceeds of $181.6 million from sales of our common stock and pre-funded warrants under the Underwriting Agreements (as defined below). We have also funded our operations from sales of PEMGARDA. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and commercialization of one or more of our product candidates, as they become authorized or approved.

Since our inception, we have incurred significant losses, including a net loss of $41.4 million for the three months ended March 31, 2026. As of March 31, 2026, we had an accumulated deficit of $995.9 million. We may continue to incur significant expenses and recognize losses in the foreseeable future as we expand and progress our research and development activities, manufacturing activities and commercialization efforts. In addition, our losses from operations may fluctuate significantly from period to period depending on the timing of our clinical trials and our expenditures on other research and development activities, manufacturing activities, and commercialization efforts. Our expenses could increase substantially in connection with our ongoing activities, as we:

•
continue to commercialize PEMGARDA;
•
advance the development of VYD2311 and prepare for its potential commercial launch, if approved, as well as advance development of our other product candidates, such as VBY329 and VMS063;
•
initiate and conduct clinical trials of our product candidates, including advancement of our REVOLUTION clinical program;
•
develop product candidates in any new indications or patient populations;
•
advance our preclinical and discovery programs, such as RSV and measles, including development and screening of additional antibodies, as well as engage in ongoing SARS-CoV-2 variant monitoring and testing;
•
seek regulatory authorization or approval for any product candidates that successfully complete clinical trials;
•
pursue coverage and reimbursement for our product candidates, if authorized or approved;
•
acquire or in-license other product candidates, intellectual property and/or technologies;
•
further develop and validate our commercial-scale current Good Manufacturing Practices (“cGMP”) manufacturing process and manufacture material under cGMP at our contracted manufacturing facilities for clinical trials and commercial sales;
•
maintain, expand, enforce, defend and protect our intellectual property portfolio;
•
comply with regulatory requirements established by the applicable regulatory authorities;
•
maintain and expand a sales, marketing and distribution infrastructure to commercialize any product candidates for which we may obtain regulatory authorization or approval;

26


 

•
hire and retain personnel, including research, clinical, development, manufacturing, quality control, quality assurance, regulatory, scientific, commercial and other personnel; and
•
incur additional legal, accounting and other expenses in operating as a public company.

As a result, we 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 support our continuing operations and pursue our growth strategy. We may be unable to secure additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we are unable to secure additional funding when needed, we could be forced to curtail our planned operations and the pursuit of our growth strategy.

Because of the numerous risks and uncertainties associated with pharmaceutical product development and emergence of SARS-CoV-2 variants, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. We may never obtain regulatory authorization or approval for any of our product candidates other than PEMGARDA. Even with product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

Based on current operating plans and excluding future external financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance date of the condensed consolidated financial statements in this Quarterly Report on Form 10-Q, and therefore, we have concluded that there is substantial doubt about our ability to continue as a going concern. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See the section entitled “Liquidity and Capital Resources” for more information.

Components of Our Results of Operations

Product Revenue, Net

In March 2024, we received EUA from the FDA for PEMGARDA. Product revenue, net consists of product revenue earned on the sales of PEMGARDA in the U.S. Product revenues are recognized net of variable consideration, including discounts and allowances, trade discounts and distributor fees, chargebacks, product returns and other incentives such as co-pay assistance programs.

Cost of Product Revenue

Cost of product revenue includes PEMGARDA manufacturing costs, labor and overhead costs, and stability study costs. PEMGARDA manufacturing costs include manufacturing materials, third-party manufacturing costs, packaging costs, shipping costs, and royalties.

Research and Development Expenses

The nature of our business and primary focus of our activities generates a significant amount of research and development costs. Research and development expenses represent costs incurred by us for:

•
the nonclinical and preclinical development of our product candidates, including our discovery efforts;
•
the procurement of our product candidates from a third-party manufacturer; and
•
the global clinical development of our product candidates.

Such costs consist of:

•
personnel-related expenses, including salaries, bonuses, benefits, third-party fees and other compensation-related costs, including stock-based compensation expense, for employees engaged in research and development functions;
•
expenses incurred under agreements with third parties, such as collaborators, consultants, contractors and CROs, that conduct the discovery, nonclinical and preclinical studies and clinical trials of our product candidates and research programs;
•
costs of procuring manufactured product candidates for use in nonclinical studies, preclinical studies, clinical trials and for commercial supply, prior to receiving authorization or approval, from a third-party CDMO;
•
costs of outside consultants and advisors, including their fees and stock-based compensation;
•
laboratory-related expenses, which include equipment, laboratory supplies, rent expense, depreciation expense, and other operating costs;

27


 

•
payments made under third-party licensing agreements; and
•
other expenses incurred as a result of research and development activities.

We expense research and development costs as incurred. Non-refundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the services rendered.

Our primary focus since inception has been the development of antibodies against COVID-19. We have also initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including the selection of a preclinical mAb candidate for the prevention of RSV, the selection of a preclinical mAb candidate for the prevention of measles and the advancement of early discovery programs targeting other potential targets. Our research and development costs consist primarily of external costs, such as fees paid to CDMOs, CROs and consultants in connection with our nonclinical studies, preclinical studies, clinical trials and product candidate manufacturing. To date, external research and development costs for any individual product candidate have been tracked commencing upon product candidate nomination. We do not allocate employee-related costs, costs associated with our discovery efforts and other internal or indirect costs to specific research and development programs or product candidates because these resources are used and these costs are deployed across multiple programs under development and, as such, are not separately classified.

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher and more variable development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Our research and development expenses will increase as we continue advancing VYD2311 through clinical development, particularly as we advance the REVOLUTION clinical program, pursue EUA or regulatory approval of our product candidates, and continue to discover and develop additional product candidates.

At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of any of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales or licensing of our product candidates. This is due to the numerous risks and uncertainties associated with drug development, including the uncertainty of:

 

•
the timing and progress of preclinical and clinical development activities;
•
the number and scope of preclinical and clinical programs we decide to pursue;
•
filing acceptable IND applications with the FDA or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates;
•
sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials, manufacture the product candidates and complete associated regulatory activities;
•
our ability to establish and maintain agreements with third-party manufacturers for clinical supply for our clinical trials and successfully develop, obtain regulatory authorization or approval for our product candidates;
•
successful enrollment and timely completion of clinical trials, including our ability to generate positive data from any such clinical trials;
•
the costs associated with the development of any additional development programs and product candidates we identify in-house or obtain through collaborations, licenses or acquisitions;
•
the prevalence, nature and severity of adverse events experienced with any product candidates;
•
the terms and timing of any collaboration, license or other arrangement, including the terms and timing of any milestone payments thereunder;
•
our ability to obtain and maintain patent, trademark and trade secret protection and regulatory exclusivity for our product candidates, if and when approved, and otherwise protecting our rights in our intellectual property portfolio;
•
our ability to maintain compliance with regulatory requirements, including current Good Clinical Practices, current Good Laboratory Practices and cGMPs, and to comply effectively with other rules, regulations and procedures applicable to the development and sale of pharmaceutical products;
•
timely receipt of regulatory authorizations or approvals from applicable regulatory authorities;

28


 

•
potential significant and changing government regulation, regulatory guidance and requirements and evolving treatment guidelines; and
•
the impact of any business interruptions to our operations or those of third parties with which we work, including as a result of any public health crisis.

A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others.

In emergency situations, such as a pandemic, and with a declaration of a public health emergency by the U.S. Secretary of the Department of Health and Human Services (“HHS”), the FDA has the authority to issue an EUA. While the COVID-19 public health emergency declared by HHS under the Public Health Service Act expired on May 11, 2023, this does not impact the FDA’s ability to authorize COVID-19 drugs and biological products for emergency use pursuant to the relevant declaration under Section 564 of the FDCA. On March 22, 2024, we received EUA from the FDA for PEMGARDA. There can be no assurance that the public health emergency in the U.S. declared under the FDCA will continue to be in place for an extended period of time, that any of our other product candidates will be granted an EUA by the FDA, if we apply for such an authorization, or that we would be able to maintain an EUA, such as the EUA received for PEMGARDA, for an extended period of time. The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564 of the FDCA, unless the declaration is terminated or authorization revoked sooner.

Acquired In-Process Research and Development Expenses

Acquired in-process research and development (“IPR&D”) expenses consist primarily of costs of contingent milestone payments incurred to acquire rights to Adimab’s antibodies relating to COVID-19 and SARS and related intellectual property and a license to certain of Adimab’s platform patents and technology (the “IPR&D assets”) for use in the research and development of our product candidates. We expensed the cost of the IPR&D assets because they had no alternative future use as of the acquisition date. We will recognize additional IPR&D expenses in the future if and when it is deemed probable that we will make contingent milestone payments to Adimab under the terms of the agreement by which we acquired the IPR&D assets.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist primarily of salaries, bonuses, benefits, third-party fees and other compensation-related costs, including stock-based compensation, for our personnel and external contractors involved in our executive, finance, legal, business development and other administrative functions, as well as our commercial function. Selling, general and administrative expenses also include costs incurred for outside services associated with such functions, including legal fees relating to patent and corporate matters; professional fees for accounting, auditing, tax and administrative consulting services; insurance costs; market research costs; and other selling, general and administrative expenses. These costs relate to the operation of the business, unrelated to the research and development function, or any individual program.

Our selling, general and administrative expenses will increase in the future as our business expands and we increase our headcount to support the expected growth in our research and development activities and the commercialization of any authorized or approved product candidates, such as PEMGARDA. We also anticipate increased expenses associated with operating as a public company, including increased costs of accounting, audit, legal, regulatory and tax-related services, director and officer insurance premiums, and investor and public relations costs. We also expect to incur additional intellectual property-related expenses as we file additional patent applications to protect innovations arising from our research and development activities.

Through March 31, 2026, we have operated as a hybrid company with employees working at our corporate headquarters and remotely. We have not incurred material operating expenses for the rent, maintenance and insurance of facilities, or for the depreciation of fixed assets.

Other Income, Net

Other income, net consists of interest income earned from our cash and cash equivalents. We expect our interest income to vary each reporting period depending on our average bank deposits, money market funds and investment balances during the period and market interest rates.

Income Taxes

Since our inception, we have not recorded any income tax expense or realized benefits for the net losses we have incurred or for the research and development tax credits generated in each period as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credit carryforwards will not be realized.

29


 

We continue to monitor the manner in which countries will enact legislation to implement the Pillar Two framework proposed by the Organisation for Economic Co-operation and Development, which proposes a 15% global corporate minimum tax. As of March 31, 2026, various countries have enacted aspects of Pillar Two while committing to enact additional aspects in future years. While we do not expect these rules to have a material impact on our effective tax rate, we continue to monitor these initiatives on a global basis.

Results of Operations

Comparison of the three months ended March 31, 2026 and 2025

The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

 

(in thousands)

 

2026

 

 

2025

 

 

Change

 

Revenue:

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

13,744

 

 

$

11,304

 

 

$

2,440

 

Total revenue

 

 

13,744

 

 

 

11,304

 

 

 

2,440

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of product revenue

 

$

1,032

 

 

$

834

 

 

$

198

 

Research and development

 

 

30,731

 

 

 

10,641

 

 

 

20,090

 

Selling, general and administrative

 

 

25,117

 

 

 

16,751

 

 

 

8,366

 

Total operating costs and expenses

 

 

56,880

 

 

 

28,226

 

 

 

28,654

 

Loss from operations

 

 

(43,136

)

 

 

(16,922

)

 

 

(26,214

)

Other income:

 

 

 

 

 

 

 

 

 

Other income, net

 

 

1,736

 

 

 

633

 

 

 

1,103

 

Total other income, net

 

 

1,736

 

 

 

633

 

 

 

1,103

 

Net loss

 

$

(41,400

)

 

$

(16,289

)

 

$

(25,111

)

The following discussion presents the components of our expenses for the periods presented:

Product Revenue, Net

Product revenue, net was $13.7 million and $11.3 million for the three months ended March 31, 2026 and 2025, respectively. The $2.4 million increase is the result of increased product sales of PEMGARDA due to an increase in product demand.

Cost of Product Revenue

Cost of product revenue was $1.0 million and $0.8 million for the three months ended March 31, 2026 and 2025, respectively. The $0.2 million increase is the result of increased PEMGARDA sales and certain period costs.

We began capitalizing our inventory costs in March 2024, in connection with EUA from the FDA and based upon our expectation that these costs would be recoverable through commercialization of PEMGARDA. Prior to the capitalization of our inventory costs, such costs were recorded as research and development expenses in the period incurred. Had our pre-EUA manufacturing costs been capitalized, our reported margins would approach 80%.

Research and Development Expenses

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

 

(in thousands)

 

2026

 

 

2025

 

 

Change

 

Direct, external research and development expenses by program:

 

 

 

 

 

 

 

 

 

Pemivibart(1)

 

$

188

 

 

$

1,391

 

 

$

(1,203

)

VYD2311(2)

 

 

22,803

 

 

 

1,502

 

 

 

21,301

 

VBY329(3)

 

 

164

 

 

 

42

 

 

 

122

 

VMS063(4)

 

 

129

 

 

 

—

 

 

 

129

 

Early-stage programs

 

 

29

 

 

 

85

 

 

 

(56

)

Unallocated research and development expenses:

 

 

 

 

 

 

 

 

 

Personnel related costs (including stock-based compensation)

 

 

3,900

 

 

 

4,011

 

 

 

(111

)

External discovery-related and other costs

 

 

3,518

 

 

 

3,610

 

 

 

(92

)

Total research and development expenses

 

$

30,731

 

 

$

10,641

 

 

$

20,090

 

(1) In March 2023, we announced the nomination of VYD222 (pemivibart) as a novel mAb therapeutic option for COVID-19.

30


 

(2) In March 2024, we announced the nomination of VYD2311 as a novel mAb therapeutic option for COVID-19.

(3)In November 2025, we announced the nomination of VBY329 as an RSV mAb candidate for preclinical development.

(4)In April 2026, we announced the nomination of VMS063 as a measles mAb candidate for clinical development.

Research and development expenses were $30.7 million for the three months ended March 31, 2026, compared to $10.6 million for the three months ended March 31, 2025. The $20.1 million increase in research and development expenses was primarily due to the following:

•
Decrease in direct costs related to our pemivibart program resulted from a decrease of $0.6 million in contract research costs for our Phase 3 CANOPY clinical trial, $0.5 million in nonclinical expenses and $0.1 million in contract costs for commercial manufacturing;
•
Increase in direct costs related to our VYD2311 program resulted from an increase of $21.5 million in contract research costs for our Phase 3 DECLARATION clinical trial and $0.4 million in external discovery-related and other costs, partially offset by a decrease of $0.3 million in contract costs for commercial manufacturing and $0.3 million in nonclinical expenses;
•
Increase in direct costs related to our VBY329 program resulted from the nomination of VBY329 as an RSV mAb candidate in the fourth quarter of 2025, with costs resulting from nonclinical expenses;
•
Increase in direct costs for our VMS063 program resulted from the nomination of VMS063 as a measles mAb candidate in the second quarter of 2026, with costs resulting from external discovery-related and other costs;
•
Decrease in direct costs related to our early-stage programs resulted from a decrease of external discovery-related and other costs;
•
Decrease in personnel related costs resulted from a decrease of headcount-related costs; and
•
Decrease in external discovery-related and other costs resulted from a decrease of $0.3 million in contract manufacturing costs and $0.1 million in nonclinical costs, partially offset by an increase of $0.2 million in clinical trial expenses and $0.1 million in other external costs.

Selling, General and Administrative Expenses

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

 

(in thousands)

 

2026

 

 

2025

 

 

Change

 

Personnel related costs (including stock-based compensation)

 

$

9,652

 

 

$

7,485

 

 

$

2,167

 

Professional and consultant fees

 

 

12,931

 

 

 

7,910

 

 

 

5,021

 

Other

 

 

2,534

 

 

 

1,356

 

 

 

1,178

 

Total selling, general and administrative expenses

 

$

25,117

 

 

$

16,751

 

 

$

8,366

 

Selling, general and administrative expenses were $25.1 million for the three months ended March 31, 2026, compared to $16.8 million for the three months ended March 31, 2025. The $8.3 million increase in selling, general and administrative expenses was primarily due to the following:

•
Increase in personnel related costs resulted from an increase in headcount-related costs;
•
Increase in professional and consultant fees resulted from an increase of $3.4 million in professional service fees and $1.7 million related to sales and marketing costs, partially offset by a decrease of $0.1 million in insurance costs; and
•
Increase in other costs primarily resulted from an increase of $0.7 million in employee related travel expense, $0.3 million in conference related costs and $0.2 million in technology related costs.

Other Income, net

Other income, net was $1.7 million and $0.6 million for the three months ended March 31, 2026 and 2025, respectively, consisting primarily of interest earned on our invested cash balances. The $1.1 million increase in other income, net was primarily due to an increase in cash invested.

Liquidity and Capital Resources

Sources of Liquidity

Through March 31, 2026, we have incurred significant operating losses and negative cash flows from operations. Although we received an EUA from the FDA for PEMGARDA in March 2024, we may continue to incur significant expenses and potential

31


 

operating losses for the foreseeable future as we continue to commercialize PEMGARDA and advance the development of VYD2311, VBY329, VMS063 and our other product candidates. As of March 31, 2026, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock, $327.5 million from sales of our common stock from our IPO in August 2021, $72.7 million from sales of our common stock under the Sales Agreement (as defined below), and $181.6 million from sales of our common stock and pre-funded warrants under the Underwriting Agreements (as defined below). After receiving EUA in March 2024, we have also funded our operations from sales of PEMGARDA.

As of March 31, 2026, we had cash and cash equivalents of $184.2 million. In April 2026, we sold 11,803,589 shares of our common stock under the Sales Agreement at an average price of $1.70 per share for $19.4 million in proceeds net of commissions.

Shelf Registration Statements

In September 2022, we 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 our securities (the “2022 Shelf Registration Statement”). The 2022 Shelf Registration Statement expired upon the effectiveness of the 2025 Shelf Registration Statement (as defined below).

In October 2025, we filed a new shelf registration statement on Form S-3 with the SEC and an accompanying base prospectus, which was declared effective by the SEC on December 23, 2025, for the offer and sale of up to $350 million of our securities (the “2025 Shelf Registration Statement”). As of March 31, 2026, excluding the $75 million allocated to the 2025 ATM Prospectus Supplement (as defined below), $275 million of our securities remained available for offer and sale under the 2025 Shelf Registration Statement.

Sales Agreement

In December 2023, we entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”) and filed with the SEC a prospectus supplement to the 2022 Shelf Registration Statement (the “2023 ATM Prospectus Supplement”), pursuant to which we could, at our option, offer and sell shares of our 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 (the “Securities Act”). Cantor was entitled to a commission of 3% of the gross proceeds from any sales of such shares. In 2024, we sold 9,000,000 shares of our common stock under the Sales Agreement and 2023 ATM Prospectus Supplement at an average price of $4.50 per share for $39.3 million in proceeds net of commissions. In 2025, we sold 23,055,402 shares of our common stock under the Sales Agreement and 2023 ATM Prospectus Supplement at an average price of $1.49 per share for $33.4 million in proceeds net of commissions. Upon the effectiveness of the 2025 Shelf Registration Statement, all offers and sales under the 2023 ATM Prospectus Supplement were deemed terminated.

In October 2025, in connection with the filing of the 2025 Shelf Registration Statement, we filed with the SEC a new prospectus supplement (the “2025 ATM Prospectus Supplement”), pursuant to which we may, at our option, offer and sell shares of our 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. Cantor is entitled to a commission of 3% of the gross proceeds from any sales of such shares. The 2025 Shelf Registration Statement was declared effective by the SEC on December 23, 2025. As of March 31, 2026, $75.0 million remained available for sale under the 2025 ATM Prospectus Supplement.

Underwriting Agreements

In August 2025, we completed an underwritten public offering pursuant to an underwriting agreement (the “August Underwriting Agreement”) with Cantor, as representative of the underwriters named therein, pursuant to which we issued and sold an aggregate of 89,234,480 shares of our 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 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. We received total net proceeds of approximately $53.5 million, after deducting underwriting discounts and commissions and offering expenses.

In November 2025, we completed an underwritten public offering pursuant to an underwriting agreement (the “November Underwriting Agreement” and together with the August Underwriting Agreement, the “Underwriting Agreements”) with Cantor, as representative of the underwriters named therein, pursuant to which we issued and sold an aggregate of 44,000,000 shares of our common stock at a price of $2.50 per share, and pre-funded warrants to purchase up to an aggregate of 6,000,000 shares of common stock at a price of $2.4999 per pre-funded warrant (the “November 2025 Underwritten Public Offering”). The price of $2.4999 per pre-funded warrant represented the $2.50 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

32


 

expire. We received total net proceeds of approximately $117.2 million, after deducting underwriting discounts and commissions and offering expenses.

In December 2025, and in connection with the November 2025 Underwritten Public Offering, Cantor exercised the option pursuant to the November Underwriting Agreement to purchase 4,675,000 additional shares of common stock at the public offering price of $2.50, less underwriting discounts and commissions. In connection with such exercise, we received total net proceeds of approximately $10.9 million, after deducting underwriting discounts and commissions and offering expenses payable by us.

Loan Agreement

On April 18, 2025, we 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 March 31, 2026, we had not satisfied certain financial covenants and conditions, including the net product revenue milestone required to be eligible to access proceeds from the Term Facility. Accordingly, as of March 31, 2026, no amounts have been drawn down under the Loan Agreement.

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”), we will be 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, we 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 we have requested and the Lender has funded any loans under the Term Facility prior to such date.

Cash Flows

The following table summarizes our sources and uses of cash for each of the periods presented:

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

(in thousands)

 

2026

 

 

2025

 

Net cash used in operating activities

 

$

(41,712

)

 

$

(21,129

)

Net cash used in investing activities

 

 

(726

)

 

 

(144

)

Net cash (used in) provided by financing activities

 

 

(98

)

 

 

10

 

Effect of exchange rate changes on cash and cash equivalents

 

 

—

 

 

 

(8

)

Net decrease in cash and cash equivalents

 

$

(42,536

)

 

$

(21,271

)

Operating Activities

During the three months ended March 31, 2026, operating activities used $41.7 million of cash, primarily due to our net loss of $41.4 million and changes in our operating assets and liabilities of $3.6 million, partially offset by non-cash charges of $3.3 million. The changes in our operating assets and liabilities primarily consisted of a $11.6 million decrease in accounts payable, a $2.1 million increase in prepaid expenses and other current assets, a $1.0 million increase in other non-current assets, and a $0.3 million decrease in operating lease liabilities, partially offset by a $9.2 million increase in accrued expenses and a $2.2 million decrease in accounts receivable. The change in accounts payable and accrued expenses was primarily due to the timing of vendor invoicing and payments.

During the three months ended March 31, 2025, operating activities used $21.1 million of cash, primarily due to our net loss of $16.3 million, and changes in our operating assets and liabilities of $8.4 million, partially offset by non-cash charges of $3.6 million. The changes in our operating assets and liabilities primarily consisted of a $10.0 million decrease in accrued expenses, a $1.6 million decrease in accounts payable, and a $0.4 million decrease in operating lease liabilities, partially offset

33


 

by a $2.3 million decrease in accounts receivable and a $1.3 million decrease in prepaid expenses and other current assets. The decrease in accrued expenses was primarily due to the timing of vendor invoicing and payments.

Investing Activities

Net cash used in investing activities during the three months ended March 31, 2026 consisted of $0.7 million in purchases of property and equipment.

Net cash used in investing activities during the three months ended March 31, 2025 consisted of $0.1 million in purchases of property and equipment.

Financing Activities

Net cash used in financing activities during the three months ended March 31, 2026 consisted of $0.2 million in payments for offering costs related to the Underwriting Agreement and $0.1 million in payments for offering costs related to the Sales Agreement, partially offset by $0.1 million from the issuance of common stock under our employee stock purchase plan, and $0.1 million from exercises of stock options.

Net cash provided by financing activities during the three months ended March 31, 2025 consisted of $0.1 million from the exercises of stock options and the issuance of common stock under our employee stock purchase plan, offset by $0.1 million in payments for offering costs related to the Sales Agreement.

Funding Requirements

Our expenses are expected to increase in connection with our ongoing activities, particularly as we advance the REVOLUTION clinical program, our nonclinical and preclinical studies, and the clinical trials of our other product candidates, our ongoing and planned commercialization efforts, and any associated manufacturing activities in connection with our clinical development and commercialization activities. Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including:

•
the revenue received from sales of PEMGARDA and any other product candidates for which we receive future regulatory authorization or approval;
•
the scope, progress, results and costs of discovery, nonclinical studies, preclinical development, laboratory testing and clinical trials for our product candidates and associated development programs, including our REVOLUTION clinical program;
•
the extent to which we develop, in-license or acquire other product candidates, intellectual property and/or technologies;
•
the scope, progress, results and costs of manufacturing and validation activities associated with our current product candidates with the development and manufacturing of our future product candidates as we advance them through preclinical and clinical development;
•
the number and development requirements of product candidates that we may pursue;
•
the costs, timing and outcome of regulatory review of our product candidates;
•
our headcount growth and associated costs as we expand our research and development capabilities and build and maintain a commercial infrastructure for product candidates for which we obtain regulatory authorization or approval;
•
the timing and costs of securing sufficient manufacturing capacity for clinical and commercial supply of our product candidates, or the raw material components thereof;
•
the costs and timing of commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive regulatory authorization or approval;
•
the costs necessary to obtain regulatory authorizations or approvals, and the costs of post-marketing studies that could be required by regulatory authorities in jurisdictions where authorization or approval is obtained;
•
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
•
the continuation of our existing licensing and collaboration arrangements and entry into new collaborations and licensing arrangements, if at all;
•
the costs we incur in maintaining business operations;

34


 

•
the need to implement additional internal systems and infrastructure;
•
the effect of competing technological, product and market developments;
•
the costs of operating as a public company; and
•
the impact of any business interruptions to our operations or to those of our third-party contractors resulting from any public health crisis.

Substantial Doubt about Ability to Continue as a Going Concern

In accordance with Accounting Standards Update 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), we are required to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern from the issuance date of our condensed consolidated financial statements. Based on current operating plans and excluding future external financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance of these condensed consolidated financial statements, and therefore, we have concluded that there is substantial doubt about our ability to continue as a going concern. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

We expect to finance our operations 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 support our continuing operations and pursue our growth strategy. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders’ ownership interest will be diluted, and the terms of such securities may include liquidation or other preferences and anti-dilution protections that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. Such restrictions could adversely impact our ability to conduct our operations and execute our business plan. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to secure additional funds through contribution from revenues, equity or debt financings or through other sources, when needed, we may be required to delay, limit, reduce or terminate our product development programs or any commercialization efforts or grant rights to develop and market product candidates to third parties that we would otherwise prefer to develop and market ourselves.

Contractual Obligations and Commitments

We lease certain office and laboratory space classified as operating leases. See Note 9 of our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for further detail on our lease obligations and the timing of expected future payments.

In addition, we enter 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, we are 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 us prior to early termination. The actual amounts we 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 March 31, 2026.

Critical Accounting Policies and Significant Judgments and Estimates

Our financial statements are prepared in accordance with generally accepted accounting principles in the U.S. The preparation of our financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and related disclosures. Our critical accounting policies and estimates are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in the 2025 Form 10-K. If actual results or events differ materially from the estimates, judgments and assumptions used by us in applying these policies, our reported financial condition and results of operations could be materially affected. There have been no significant changes to our critical accounting policies and estimates from those described in the 2025 Form 10-K.

35


 

Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations and cash flows is disclosed in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

Emerging Growth Company Status

We are an “emerging growth company,” as defined in the JOBS Act, and will remain an emerging growth company until December 31, 2026. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:

•
an exemption from compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting;
•
reduced disclosure obligations regarding executive compensation;
•
exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved; and
•
an exemption from compliance with the requirements of the Public Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s report on the financial statements.

In addition, 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.

36


 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Financial Officer (our principal executive officer and principal financial officer), evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2026. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as amended, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Based on the evaluation of our disclosure controls and procedures as of March 31, 2026, our Chief Financial Officer concluded that our disclosure controls and procedures as of such date were effective at the reasonable assurance level.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

37


 

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

From time to time, we may become involved in legal proceedings or other litigation relating to claims arising in the ordinary course of business. We accrue 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 March 31, 2026, we were not a party to any material legal proceedings.

Item 1A. Risk Factors.

Information regarding risks and uncertainties related to our business appears in Part I, Item 1A. “Risk Factors” of the 2025 Form 10-K. As of the date of this Quarterly Report on Form 10-Q, there have been no material changes from the risk factors set forth in the 2025 Form 10-K.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

Recent Sales of Unregistered Securities; Use of Proceeds

We did not issue any unregistered equity securities during the three months ended March 31, 2026.

Purchases of Equity Securities by the Issuer

We did not purchase any of our equity securities during the three months ended March 31, 2026.

Item 5. Other Information.

Director and Officer Trading Arrangements

During the three months ended March 31, 2026, none of our directors or officers adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.

 

 

38


 

Item 6. Exhibits.

Exhibit

Number

Description

3.1

 

Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K (File No. 001-40703), filed with the Securities and Exchange Commission on August 10, 2021).

3.2

 

Certificate of Amendment to the Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K (File No. 001-40703), filed with the Securities and Exchange Commission on September 13, 2022).

3.3

 

Certificate of Amendment to the Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K (File No. 001-40703), filed with the Securities and Exchange Commission on May 25, 2023).

3.4

 

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 of the Company’s Current Report on Form 8-K (File No. 001-40703), filed with the Securities and Exchange Commission on September 13, 2022).

3.5

 

Amendment No. 1 to the Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 of the Company’s Current Report on Form 8-K (File No. 001-40703), filed with the Securities and Exchange Commission on May 25, 2023).

3.6

 

Delaware Certificate of Change of Registered Agent (incorporated by reference to Exhibit 3.3 of the Company's Registration Statement on Form S-3 (File No. 333-267643), filed with the Securities and Exchange Commission on September 28, 2022).

10.1+

 

First Amendment to the Employment Agreement of Jill Andersen, by and between the Registrant and Jill Andersen, dated January 31, 2026 (incorporated by reference to Exhibit 10.7 of the Company’s Annual Report on Form 10-K (File No. 001-40703), filed with the Securities and Exchange Commission on March 5, 2026).

10.2+

 

First Amendment to the Employment Agreement of Robert Allen, by and between the Registrant and Robert Allen, dated January 31, 2026 (incorporated by reference to Exhibit 10.9 of the Company’s Annual Report on Form 10-K (File No. 001-40703), filed with the Securities and Exchange Commission on March 5, 2026).

10.3+

 

First Amendment to the Employment Agreement of William Duke, Jr., by and between the Registrant and William Duke, Jr., dated January 31, 2026 (incorporated by reference to Exhibit 10.11 of the Company’s Annual Report on Form 10-K (File No. 001-40703), filed with the Securities and Exchange Commission on March 5, 2026).

10.4+

 

Second Amendment to the Employment Agreement of Julie Green, by and between the Registrant and Julie Green, dated January 31, 2026 (incorporated by reference to Exhibit 10.14 of the Company’s Annual Report on Form 10-K (File No. 001-40703), filed with the Securities and Exchange Commission on March 5, 2026).

10.5+

 

First Amendment to the Employment Agreement of Timothy Lee, by and between the Registrant and Timothy Lee, dated January 31, 2026 (incorporated by reference to Exhibit 10.16 of the Company’s Annual Report on Form 10-K (File No. 001-40703), filed with the Securities and Exchange Commission on March 5, 2026).

10.6*†

 

Amendment No. 1 to the Second Amended and Restated Commercial Manufacturing Services Agreement by and between the Registrant and WuXi Biologics (Hong Kong) Limited, dated March 4, 2026.

10.7*†

 

Amendment No. 3 to the Cell Line License Agreement by and between the Registrant and WuXi Biologics (Hong Kong) Limited, dated March 4, 2026.

10.8*†

 

Amendment No. 1 to the Clinical Master Services Agreement by and between the Registrant and WuXi Biologics (Hong Kong) Limited, dated March 4, 2026.

31.1*

Certification of Principal Executive Officer and Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1^

Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS*

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.

101.SCH*

 

Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents.

104*

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

*

 

Filed herewith.

†

 

Certain portions of this exhibit (indicated by asterisks) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.

^

 

Furnished herewith and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section. Such certification will not be deemed to be

39


 

 

 

incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent specifically incorporated by reference into such filing.

+

 

Indicates management contract or compensatory plan.

40


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

INVIVYD, INC.

Date: May 14, 2026

 

By:

/s/ William Duke, Jr.

 

 

 

William Duke, Jr.

 

 

 

Chief Financial Officer

 

 

 

(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)

 

 

 

 

 

 

 

 

 

 

41


EX-10.6 2 ivvd-ex10_6.htm EX-10.6 EX-10.6

Exhibit 10.6

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE OF INFORMATION THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

CONFIDENTIAL

 

AMENDMENT NO. 1 TO THE SECOND AMENDED AND RESTATED COMMERCIAL MANUFACTURING SERVICES AGREEMENT

THIS AMENDMENT NO. 1 TO THE SECOND AMENDED AND RESTATED COMMERCIAL MANUFACTURING SERVICES AGREEMENT (this “Amendment No. 1”), effective as of March 4, 2026 (“the Amendment No. 1 Effective Date”), is entered and made by and between WuXi Biologics (Hong Kong) Limited, having an address at Unit 417, 4th Floor, Lippo Centre Tower Two, No. 89 Queensway, Admiralty, Hong Kong (“WuXi Biologics”), and Invivyd, Inc. having its principal place of business at 209 Church St., New Haven, CT 06510 (“Client”). WuXi Biologics and Client may be referred to herein individually as a “Party” and collectively as the “Parties.”

WHEREAS, WuXi Biologics and Client entered into that certain SECOND AMENDED AND RESTATED COMMERCIAL MANUFACTURING SERVICES AGREEMENT, dated as of September 19, 2023 (the “Agreement”); and

WHEREAS, WuXi Biologics’ address was formerly at “Flat/RM826, 8/F Ocean Centre Harbour City, 5 Canton Road TST, Hong Kong” and Client’s address was formerly at “1601 Trapelo Road, Suite 178, Waltham, MA 02451”; and

WHEREAS, the Parties now desire to amend the Agreement as set forth herein;

NOW THEREFORE, in consideration of the mutual covenants and agreements contained herein below, the sufficiency of which is acknowledged by both Parties, the Parties agree as follows:

1.
Section 1.34 of the Agreement is hereby deleted in its entirety and replaced with the following:

1.34 “Products” means each of the Drug Substance and Drug Products, that may be produced by a cell line under the Cell Line License Agreement, set out on a Product Schedule, as may be entered into between the Parties from time to time, that are Manufactured under this Agreement, including any applicable Purchase Order.

2.
Section 19.1 of the Agreement is hereby deleted in its entirety and replaced with the following:
19.1
Term. This Agreement shall enter into effect on the date after both Parties sign this Second Amended and Restated Commercial Manufacturing Services Agreement and will be valid for an initial period until March 1, 2036 (the “Initial Term”), and thereafter may be renewed for further periods to be agreed to by the Parties in a written amendment (the “Renewal Term” and together with the Initial Term, the “Term”), unless terminated earlier as provided for elsewhere in this Agreement. If either Party does not wish to renew this Agreement, notice must

 


CONFIDENTIAL

be provided [***] before the Initial Term or a Renewal Term expire (unless otherwise mutually agreed) to account for the binding forecasts provided under this Agreement and to provide for an orderly wind-down.
3.
A new Section 19.6 and a new Section 19.7 are hereby inserted immediately following Section 19.5 as follows:
19.6
Termination for Convenience. Client may terminate this Agreement or a Purchase Order at any time with [***] advance written notice to WuXi Biologics; provided that to the extent the Agreement is terminated but a Purchase Order is not, this Agreement will remain in force and effect with respect to such Purchase Order until the completion of the Services under such Purchase Order; and provided further that termination of the Agreement or any Purchase Order will not relieve Client of any payment obligations which have accrued pursuant to this Agreement, nor from the binding component of any Forecast Schedule.
19.7
Termination Due to Legal Reasons. If any applicable law (including any Applicable Law) rule, regulation, guideline, or order in effect and as amended from time-to-time, or any newly enacted and in effect applicable law, rule, regulation, guideline, or order, materially prevents Client from being able to enter into or maintain a contract with a United States governmental entity or from receiving grant funds from such a US governmental entity, or materially affects Client’s ability to obtain government insurance coverage, including but not limited to [***], of any Product, in each case, as a result of Provider providing the Services to Client under this Agreement or as a result of Client being a party to this Agreement (any such law, rule, regulation, guideline, or order, new or existing, or any change to any of the foregoing, an “Interfering Law”), Client may terminate this Agreement and/or any Purchase Orders, solely to the extent this Agreement or such Purchase Orders specifically relate to Product intended for sale or use in the US market, upon written notice to WuXi Biologics, effective immediately, with such written notice to describe: (i) the Interfering Law; (ii) the expected adverse effect such Interfering Law could reasonably be expected to have on this Agreement and/or Purchase Order; and (iii) why Client must terminate this Agreement and/or Purchase Order to avoid or mitigate such adverse effect. For clarity, Client shall remain fully liable with respect to the cancellation of any outstanding Purchase Orders, and no termination or cancellation shall relieve Client of any payment obligations which would otherwise have been incurred under the binding portion of any Forecast Schedule to the extent Provider, using Commercially Reasonable Efforts, cannot fill Client’s slot(s) with a Third Party’s reasonable comparable production (including scale, process, duration) and/or return, re-sell or reallocate raw materials, as applicable to mitigate costs. Upon such termination, at Client’s option and expense, WuXi Biologics shall use commercially reasonable efforts to conduct a full Technology Transfer (defined below) to Client or any of its Affiliates or any third-party designee, of all materials and information pursuant to the terms of Section 20.5.

2


CONFIDENTIAL

4.
Section 20.5 of the Agreement is hereby deleted in its entirety and replaced with the following:
20.5
Technical Transfer Assistance. During the Term of this Agreement and for a period of [***] following expiration or termination of this Agreement, WuXi Biologics will provide, upon the request of Client, its full support and cooperation, including but not limited to training, consulting, and troubleshooting in transferring the then-current Manufacturing processes and testing methods to an alternative site controlled by an alternative manufacturer or testing laboratory, designated by Client. This “Technology Transfer” shall include any information specific to the relevant Client Product and reasonably necessary for the Manufacture of such Product by an alternative manufacturer, including, but not limited to, as applicable, all relevant and Product-specific protocols, batch records, test methods, data, results, interpretation of results, Specifications, and cell lines and cell banks. WuXi Biologics shall be entitled to charge Client for its reasonable personnel and out-of-pocket costs in supporting the technical transfer of the Products, at its then-current charge-out rates for similar activities based on a written and accepted quotation. Additionally, in connection with the technical transfer assistance provided pursuant to this Section 20.5, WuXi Biologics shall, upon receiving corresponding payment and licenses, grant to Client and its Affiliates and designees a perpetual, fully-paid, non-exclusive license under any WuXi Biologics Background IP and WuXi Biologics Arising IP which is reasonably necessary for the Manufacture of each Product, solely to the extent necessary to Manufacture the Products. WuXi Biologics’ obligations to support a technical transfer shall continue until such time as Client, or its designee, successfully Manufactures [***] of each Product.
5.
Section 23.9 of the Agreement is hereby deleted in its entirety and replaced with the following:

23.9 Notice. Any notice to be given by either Party under or in connection with this Agreement to the other Party must be in writing in English and shall be: (a) delivered by hand or by courier; (b) sent by pre-paid recorded (i.e. signed for) post or airmail or express overnight courier; or (c) sent by fax, to the addresses set out below (or such other address or number as may be notified to the other Party from time to time):

WuXi Biologics:

 

[***]

 

Client:

 

[***]

 

 

Unless there is evidence that it was received earlier, notices sent in accordance with this Section 23.9 are to be deemed to have been received: if delivered by hand or by courier, when left at the address referred to above; if sent by post to

3


CONFIDENTIAL

an address within the country of postage, [***] after posting it; if sent by airmail or overnight express courier to an address outside the country of postage, [***] after posting it; or if sent by fax, when transmitted, provided that if deemed receipt occurs before 9am on a Working Day the notice shall be deemed to have been received at 9am on that day, and if deemed receipt occurs after 5pm on a Working Day, or on a day which is not a Working Day, the notice shall be deemed to have been received at 9am on the next Working Day.

6.
Except as expressly amended by this Amendment No. 1, the Agreement is and shall remain unchanged and in full force and effect in accordance with its terms and the Parties hereto hereby ratify and reaffirm the Agreement as amended hereby.
7.
The laws of the State of New York, USA, without giving effect to principles of conflict of laws, govern all matters relating to this Amendment No. 1 and the enforcement and interpretation thereof. Any dispute arising out of or in connection with this Amendment No. 1 shall be resolved in accordance with Section 12.8 of the Agreement.
8.
This Amendment No. 1 may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Each Party may rely on the delivery of executed electronic copies of counterpart execution pages of this Amendment No. 1 and such electronic copies shall be legally effective to create a valid and binding agreement among the Parties.
9.
Any capitalized term used in this Amendment No. 1 and not otherwise defined herein shall have the meaning given to that term in the Agreement.

[Signature Page Follows]

4


CONFIDENTIAL

IN WITNESS WHEREOF, the Parties hereto have caused this Amendment No. 1 to be duly executed as of the Amendment No. 1 Effective Date set forth above.

 

WuXi Biologics (Hong Kong) Limited

Invivyd, Inc.

 

By: [***]

Name: [***]

Title: [***]

Date: 4 March, 2026

 

By: [***]

Name: [***]

Title: [***]

Date: 3/4/2026

 

5


EX-10.7 3 ivvd-ex10_7.htm EX-10.7 EX-10.7

Exhibit 10.7

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE OF INFORMATION THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

CONFIDENTIAL

 

AMENDMENT NO. 3 TO THE CELL LINE LICENSE AGREEMENT

THIS AMENDMENT NO. 3 TO THE CELL LINE LICENSE AGREEMENT (this “Amendment No. 3”), effective as of March 4, 2026 (“the Amendment No. 3 Effective Date”), is entered and made by and between WuXi Biologics (Hong Kong) Limited, having an address at Unit 417, 4th Floor, Lippo Centre Tower Two, No. 89 Queensway, Admiralty, Hong Kong (“WuXi Biologics”), and Invivyd, Inc. having its principal place of business at 209 Church Street, New Haven, CT 06510 (“Licensee”). WuXi Biologics and Licensee may be referred to herein individually as a “Party” and collectively as the “Parties.”

WHEREAS, Licensee was formerly known as “Adagio Therapeutics, Inc.” with its principal place of business at 303 Wyman Street, Suite 300, Waltham, MA 02451; and

WHEREAS, WuXi Biologics’ address was formerly at “Flat/RM826, 8/F Ocean Centre Harbour City, 5 Canton Road TST, Hong Kong” and Licensee’s address was formerly at “1601 Trapelo Road, Suite 178, Waltham, MA 02451”; and

WHEREAS, WuXi Biologics and Licensee (then still known as Adagio Therapeutics, Inc.) entered into that certain Cell Line License Agreement, dated as of December 2, 2020, amended as of February 2, 2023 via Amendment No. 1 and as of March 13, 2024 via Amendment No. 2 (the “License Agreement”); and

WHEREAS, the Parties now desire to amend the License Agreement as set forth herein;

NOW THEREFORE, in consideration of the mutual covenants and agreements contained herein below, the sufficiency of which is acknowledged by both Parties, the Parties agree as follows:

1.
Section 5.2 of the License Agreement is hereby deleted in its entirety and replaced with the following:
5.2
Payment in Lieu of Royalty. Notwithstanding the foregoing, during the Term of this Agreement, upon written notice to WuXi Biologics, on a Licensed Cell Line-by-Licensed Cell Line basis, Licensee may exercise the buyout right (“Buyout Right”) for each Licensee Product by choosing to make a one-time lump sum payment in the amount of (a) [***] each for [***]; and (b) [***] each for [***] (“Buyout Fee”) which shall be payable within [***] after first receipt by or on behalf of Licensee or an Affiliate or sublicensee of the [***] of such Licensee Product, which payment shall satisfy all of Licensee’s Royalty payment obligations pursuant to this Agreement with respect to such Licensed Cell Line. Following such payment, Licensee shall have no further payment obligations with respect to any Royalty for Global Sales (including, for clarity, sales by Licensee, its Affiliates or sublicensees) of the applicable Drug Product produced (or otherwise derived from) from such applicable Licensed Cell Line. Further, the license granted from WuXi Biologics to

 


CONFIDENTIAL

Licensee under Article 2 with respect to the applicable Licensee Product, Drug Substance and Drug Product produced (or otherwise derived from) from such applicable Licensed Cell Line shall automatically (i.e. without an obligation to formally amend this Agreement) become fully paid-up, royalty-free, irrevocable and continue in perpetuity notwithstanding any termination or expiration of this Agreement. For clarity, and without limiting the foregoing, unless Licensee chooses to pay a Buyout Fee as described in this Article 5.2 with respect to the applicable Licensed Cell Line, Licensee shall pay the Royalty with respect to applicable Drug Products produced (or otherwise derived from) from such Licensed Cell Line as set forth in this Article 5.
2.
A new Section 5.3 is hereby inserted immediately following Section 5.2 of the License Agreement.
5.3
Regulatory Restriction on Manufacturing. If Licensee’s ability to have a Licensee Product manufactured by WuXi Biologics or WuXi Biologics Affiliates becomes materially restricted due to government actions, including but not limited to law, rule, regulations, guideline or order, in a jurisdiction that materially prevents Licensee from being able to enter into or maintain a contract with a governmental entity or from receiving grant funds from such governmental entity, or materially affects Licensee’s ability to obtain government insurance coverage, including but not limited to in the United States [***], for the Licensee Product, Licensee shall provide WuXi Biologics with written notice describing the applicable government action in reasonable detail and Licensee’s applicable royalty obligations under Section 5 to the extent derived or arising from Licensee Product sold in the United States shall be waived for the relevant Licensee Product. Such waiver in Licensee’s royalty payment obligations under this section with respect to such Licensee Product shall continue only for so long as such government action continues, and Licensee’s full royalty payment obligations with respect to such Licensee Product shall immediately resume upon the government action being resolved, lifted, or ceasing to exist.
3.
Section 14.3 of the License Agreement is hereby deleted in its entirety and replaced with the following:
14.3
Notices. All notices, requests, demands and other communications required under this Agreement must be in writing and will be deemed to have been given or made and sufficient in all respects when delivered by reputable international courier to the following addresses:

To Licensee:

 

[***]

 

To WuXi Biologics:

 

[***]

 

2


CONFIDENTIAL

4.
Except as expressly amended by this Amendment No. 3, the License Agreement is and shall remain unchanged and in full force and effect in accordance with its terms and the Parties hereto hereby ratify and reaffirm the License Agreement as amended hereby.
5.
The laws of the State of New York, USA, without giving effect to principles of conflict of laws, govern all matters relating to this Amendment No. 3 and the enforcement and interpretation thereof. Any dispute arising out of or in connection with this Amendment No. 3 shall be resolved in accordance with Section 14.6 of the License Agreement.
6.
This Amendment No. 3 may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Each Party may rely on the delivery of executed electronic copies of counterpart execution pages of this Amendment No. 3 and such electronic copies shall be legally effective to create a valid and binding agreement among the Parties.
7.
Any capitalized term used in this Amendment No. 3 and not otherwise defined herein shall have the meaning given to that term in the License Agreement.

[Signature Page Follows]

3


CONFIDENTIAL

IN WITNESS WHEREOF, the Parties hereto have caused this Amendment No. 3 to be duly executed as of the Amendment No. 3 Effective Date set forth above.

 

WuXi Biologics (Hong Kong) Limited

Invivyd, Inc.

 

By: [***]

Name: [***]

Title: [***]

Date: 4 March, 2026

 

By: [***]

Name: [***]

Title: [***]

Date: 3/4/2026

 

4


EX-10.8 4 ivvd-ex10_8.htm EX-10.8 EX-10.8

Exhibit 10.8

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE OF INFORMATION THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

CONFIDENTIAL

 

AMENDMENT NO. 1 TO THE MASTER SERVICES AGREEMENT

THIS AMENDMENT NO. 1 TO THE MASTER SERVICES AGREEMENT (this “Amendment No. 1”), effective as of March 4, 2026 (“the Amendment No. 1 Effective Date”), is entered and made by and between WuXi Biologics (Hong Kong) Limited, having an address at Unit 417, 4th Floor, Lippo Centre Tower Two, No. 89 Queensway, Admiralty, Hong Kong (“Provider”), and Invivyd, Inc. having its principal place of business at 209 Church Street, New Haven, CT 06510 (“Client”). Provider and Client may be referred to herein individually as a “Party” and collectively as the “Parties.”

WHEREAS, Client was formerly known as “Adagio Therapeutics, Inc.” with its principal place of business at 303 Wyman Street, Suite 300, Waltham, MA 02451; and

WHEREAS, Provider’s address was formerly at “Flat/RM826, 8/F Ocean Centre Harbour City, 5 Canton Road TST, Hong Kong” and Client’s address was formerly at “1601 Trapelo Road, Suite 178, Waltham, MA 02451”; and

WHEREAS, Provider and Client (then still known as Adagio Therapeutics, Inc.) entered into that certain Master Services Agreement, dated as of July 21, 2020 (the “Agreement”); and

WHEREAS, the Parties now desire to amend the Agreement as set forth herein;

NOW THEREFORE, in consideration of the mutual covenants and agreements contained herein below, the sufficiency of which is acknowledged by both Parties, the Parties agree as follows:

1.
Section 2.1 of the Agreement is hereby deleted in its entirety and replaced with the following:
(a)
Work Orders. Provider shall provide the Services to Client pursuant to each Work Order that is entered into during the term of this Agreement. The preferred form of Work Order is provided in Exhibit A. Each Work Order will automatically incorporate the terms of this Agreement. Work Order(s), when approved in writing by both Parties, shall be deemed an integral part hereof. Work Order(s) may be updated from time to time by mutual agreement. If there is a contradiction between a provision of this Agreement and a Work Order, then the provision in this Agreement will take precedence unless the Work Order specifically states that it takes precedence over the provision.
2.
Section 7.4 of the Agreement is hereby deleted in its entirety and replaced with the following:
7.4
Technology Transfer. During the Term of this Agreement and for a period of [***] following expiration or termination of this Agreement, Client may request transfer of a Product to an alternative or second-source developer or manufacturer or

 


CONFIDENTIAL

testing laboratory. Subject to Client and Provider agreeing to commercially reasonable terms that have been negotiated in good faith on the scope and duration of the technology transfer and at Provider’s then current charge-out rates for similar activities, such agreement to be set out in a separate Work Order and at Client’s expense, Provider shall provide its full support and cooperation, including but not limited to training, consulting, and troubleshooting of the Technology Transfer (as defined below) reasonably necessary for properly skilled personnel of Client, Client’s Affiliate, or a third party manufacturer to develop, manufacture, test, and release Product. The “Technology Transfer” shall include any information specific to the relevant Client Product and reasonably necessary for the manufacturing of the Product, including, but not limited to, as applicable, all relevant and Product-specific protocols, batch records, test methods, data, results, interpretation of results, and Specifications, and will include the cell line and cell banks, subject to a license and executed License Agreement. Client shall be liable for the costs of such Technology Transfer. Additionally, in connection with Technology Transfer pursuant to this Section 7.4, Provider shall, upon receiving corresponding payment, grant to Client and its Affiliates and designees a perpetual, fully-paid, non-exclusive license to all Necessary IP and Optional IP that has been embedded by Provider without Client’s consent pursuant to the terms of Section 7.2(c) solely to the extent necessary for the development, manufacture, and testing of each Product.
3.
Section 11.1 of the Agreement is hereby deleted in its entirety and replaced with the following:
11.1
Term.
(a)
The term of this Agreement commences on the Effective Date and, unless terminated earlier in accordance with this Agreement, expires March 1, 2036 (the “Initial Term”), and thereafter may be renewed for further periods to be agreed to by the Parties in a written amendment (the “Renewal Term(s)” and together with the Initial Term, the “Term”).
(b)
Unless terminated earlier in accordance with this Agreement, the term of each Work Order commences on the date indicated in the Work Order and will terminate upon completion of the Services under such Work Order.
4.
A new Section 11.6 is hereby inserted immediately following Section 11.5 as follows:

11.6 Termination Due to Legal Reasons. If any applicable law (including any Applicable Law) rule, regulation, guideline, or order in effect and as amended from time-to-time, or any newly enacted and in effect applicable law, rule, regulation, guideline, or order, materially prevents Client from being able to enter into or maintain a contract with a United States governmental entity, or from receiving grant funds from such a US governmental entity, or materially affects Client’s ability to obtain government insurance coverage, including but not limited to [***], of any Product, in each case, as a result of Provider providing the Services to Client under this Agreement or any Work Order or as a result of Client being a party to this

2


CONFIDENTIAL

Agreement (any such law, rule, regulation, guideline, or order, new or existing, or any change to any of the foregoing, an “Interfering Law”), Client may terminate this Agreement and/or any Work Orders, solely to the extent this Agreement or such Work Orders specifically relate to Product intended for sale or use in the US market, upon written notice to Provider, effective immediately, with such written notice to describe: (i) the Interfering Law; (ii) the expected adverse effect such Interfering Law could reasonably be expected to have on this Agreement and/or Work Order; and (iii) why Client must terminate this Agreement and/or Work Order to avoid or mitigate such adverse effect. Neither Party will have any liability to the other whatsoever for such termination under this Section 11.6, and, for clarity, Client shall have no further liability with respect to the cancellation of any outstanding Work Orders or purchase orders, and no termination or cancellation fees shall apply. However, Client shall remain responsible for payment for all Services rendered and non-recoverable costs incurred prior to termination pursuant to this Section to the extent Provider, using commercially reasonable efforts, cannot fill Client’s slot(s) with a third party’s reasonable comparable production (including scale, process, duration) and/or return, re-sell or reallocate raw materials, as applicable, to mitigate costs and to the extent such raw materials or work in progress are not included in a Technology Transfer. Upon such termination, at Client’s option and expense, Provider shall use commercially reasonable efforts to conduct a full Technology Transfer to Client or any of its Affiliates or any third-party designee, of all materials and information per the terms of Section 7.4.

5.
Section 14.3 of the Agreement is hereby deleted in its entirety and replaced with the following:

14.3 Notices. All notices, requests, demands and other communications required under this Agreement must be in writing and will be deemed to have been given or made and sufficient in all respects when delivered by reputable international courier to the following addresses:

 

To Client:

[***]

 

To Provider:

 

[***]

 

 

6.
Except as expressly amended by this Amendment No. 1, the Agreement is and shall remain unchanged and in full force and effect in accordance with its terms and the Parties hereto hereby ratify and reaffirm the Agreement as amended hereby.

3


CONFIDENTIAL

7.
The laws of the State of New York, USA, without giving effect to principles of conflict of laws, govern all matters relating to this Amendment No. 3 and the enforcement and interpretation thereof. Any dispute arising out of or in connection with this Amendment No. 1 shall be resolved in accordance with Section 14.7 of the Agreement.
8.
This Amendment No. 1 may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Each Party may rely on the delivery of executed electronic copies of counterpart execution pages of this Amendment No. 1 and such electronic copies shall be legally effective to create a valid and binding agreement among the Parties.
9.
Any capitalized term used in this Amendment No. 1 and not otherwise defined herein shall have the meaning given to that term in the Agreement.

[Signature Page Follows]

4


CONFIDENTIAL

IN WITNESS WHEREOF, the Parties hereto have caused this Amendment No. 1 to be duly executed as of the Amendment No. 1 Effective Date set forth above.

 

WuXi Biologics (Hong Kong) Limited

Invivyd, Inc.

 

By: [***]

Name: [***]

Title: [***]

Date: 4 March, 2026

 

By: [***]

Name: [***]

Title: [***]

Date: 3/4/2026

 

5


EX-31.1 5 ivvd-ex31_1.htm EX-31.1 EX-31.1

Exhibit 31.1

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, William Duke, Jr., certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q of Invivyd, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 14, 2026

By:

/s/ William Duke, Jr.

William Duke, Jr.

 

 

 

Chief Financial Officer

(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)

 

 

 

 


EX-32.1 6 ivvd-ex32_1.htm EX-32.1 EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Invivyd, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2026 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:

(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: May 14, 2026

By:

/s/ William Duke, Jr.

William Duke, Jr.

 

 

 

Chief Financial Officer

(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)

 

This certification accompanies the Report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Report), irrespective of any general incorporation language contained in such filing.


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Mar. 31, 2026
Apr. 30, 2026
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Document Period End Date Mar. 31, 2026  
Document Fiscal Year Focus 2026  
Document Fiscal Period Focus Q1  
Entity Registrant Name INVIVYD, INC.  
Entity Central Index Key 0001832038  
Current Fiscal Year End Date --12-31  
Entity File Number 001-40703  
Entity Tax Identification Number 85-1403134  
Entity Incorporation, State or Country Code DE  
Entity Address, Address Line One 209 Church Street  
Entity Address, City or Town New Haven  
Entity Address, State or Province CT  
Entity Address, Postal Zip Code 06510  
City Area Code 781  
Local Phone Number 819-0080  
Title of 12(b) Security Common Stock, $0.0001 par value per share  
Trading Symbol IVVD  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
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CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) - USD ($)
$ in Thousands
Mar. 31, 2026
Dec. 31, 2025
Current assets:    
Cash and cash equivalents $ 184,153 $ 226,689
Accounts receivable, net [1] 11,648 13,919
Prepaid expenses and other current assets 9,114 6,859
Total current assets 204,915 247,467
Inventory 25,452 25,499
Property and equipment, net 1,693 1,365
Operating lease right-of-use asset 8,526 2,442
Other non-current assets 1,156 110
Total assets 241,742 276,883
Current liabilities:    
Accounts payable [2] 2,022 13,744
Accrued expenses [3] 27,988 19,053
Operating lease liabilities, current 1,592 1,314
Other current liability 56 52
Total current liabilities 31,658 34,163
Operating lease liabilities, non-current 7,034 1,180
Total liabilities 38,692 35,343
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 March 31, 2026 and December 31, 2025 0 0
Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 282,803,863 shares issued and outstanding at March 31, 2026; 281,987,033 shares issued and outstanding at December 31, 2025 28 28
Additional paid-in capital 1,198,942 1,196,036
Accumulated other comprehensive loss (37) (41)
Accumulated deficit (995,883) (954,483)
Total stockholders' equity 203,050 241,540
Total liabilities, preferred stock and stockholders' equity $ 241,742 $ 276,883
[1] Includes an allowance for doubtful accounts of $274 and $323 as of March 31, 2026 and December 31, 2025, respectively.
[2] Includes related-party amounts of $625 and $0 as of March 31, 2026 and December 31, 2025, respectively (see Note 15).
[3] Includes related-party amounts of $551 and $703 as of March 31, 2026 and December 31, 2025, respectively (see Note 15).
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CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (PARENTHETICAL) - USD ($)
$ in Thousands
Mar. 31, 2026
Dec. 31, 2025
Preferred stock par value (in dollars per share) $ 0.0001 $ 0.0001
Preferred stock, shares authorized (in shares) 10,000,000 10,000,000
Preferred stock, shares issued (in shares) 0 0
Preferred stock, shares outstanding (in shares) 0 0
Common stock, par value (in dollars per share) $ 0.0001 $ 0.0001
Common stock, shares authorized (in shares) 1,000,000,000 1,000,000,000
Common stock, shares issued (in shares) 282,803,863 281,987,033
Common stock, shares outstanding (in shares) 282,803,863 281,987,033
Allowance Doubtful accounts $ 274 $ 323
Accounts Payable [Member] | Adimab [Member]    
Related-party amounts 625 0
Accrued Expenses [Member] | Adimab [Member]    
Related-party amounts $ 551 $ 703
XML 12 R4.htm IDEA: XBRL DOCUMENT v3.26.1
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2026
Mar. 31, 2025
Revenue:    
Total revenue $ 13,744 $ 11,304
Operating costs and expenses:    
Cost of product revenue [1] 1,032 834
Research and development [2] 30,731 10,641
Selling, general and administrative 25,117 16,751
Total operating costs and expenses 56,880 28,226
Loss from operations (43,136) (16,922)
Other income:    
Other income, net [3] 1,736 633
Total other income, net 1,736 633
Net loss (41,400) (16,289)
Other comprehensive income (loss)    
Unrealized gain (loss), net of tax 4 (8)
Comprehensive loss $ (41,396) $ (16,297)
Net loss per share attributable to common stockholders, basic $ (0.13) $ (0.14)
Net loss per share attributable to common stockholders,diluted $ (0.13) $ (0.14)
Weighted-average common shares outstanding, basic 309,670,101 119,883,479
Weighted-average common shares outstanding, diluted 309,670,101 119,883,479
Product revenue    
Revenue:    
Total revenue $ 13,744 $ 11,304
[1] Includes related-party amounts of $550 and $452 for the three months ended March 31, 2026 and 2025, respectively (see Note 15).
[2] Includes related-party amounts of $1,127 and $1,128 for the three months ended March 31, 2026 and 2025, respectively (see Note 15).
[3] Includes interest income of $1,743 and $628 for the three months ended March 31, 2026 and 2025, respectively.
XML 13 R5.htm IDEA: XBRL DOCUMENT v3.26.1
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (PARENTHETICAL) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2026
Mar. 31, 2025
Cost of Product Revenue    
Related party expenses $ 550 $ 452
Research and Development    
Related party expenses $ 1,127 $ 1,128
XML 14 R6.htm IDEA: XBRL DOCUMENT v3.26.1
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (UNAUDITED) - USD ($)
$ in Thousands
Total
Common Stock [Member]
Treasury Stock [Member]
Additional Paid-in Capital [Member]
AOCI Attributable to Parent [Member]
Accumulated Deficit [Member]
Balances at Dec. 31, 2024 $ 67,539 $ 12   $ 969,526 $ (5) $ (901,994)
Balances, shares at Dec. 31, 2024   119,835,162        
Treasury stock at Dec. 31, 2024     $ 0      
Treasury Stock, Common, Shares at Dec. 31, 2024     0      
Stock-based compensation expense 2,826     2,826    
Exercise of stock options, shares   36,111        
Exercise of stock options 37     37    
Issuance of common stock under the employee stock purchase plan, shares   90,172        
Issuance of common stock under the employee stock purchase plan 44     44    
Unrealized gain (loss), net of tax (8)       (8)  
Net loss (16,289)         (16,289)
Balances at Mar. 31, 2025 54,149 $ 12   972,433 (13) (918,283)
Balances, shares at Mar. 31, 2025   119,961,445        
Treasury stock at Mar. 31, 2025     $ 0      
Treasury Stock, Common, Shares at Mar. 31, 2025     0      
Balances at Dec. 31, 2024 67,539 $ 12   969,526 (5) (901,994)
Balances, shares at Dec. 31, 2024   119,835,162        
Treasury stock at Dec. 31, 2024     $ 0      
Treasury Stock, Common, Shares at Dec. 31, 2024     0      
Balances at Dec. 31, 2025 241,540 $ 28   1,196,036 (41) (954,483)
Balances, shares at Dec. 31, 2025   281,987,033        
Treasury stock at Dec. 31, 2025     $ 0      
Treasury Stock, Common, Shares at Dec. 31, 2025     0      
Stock-based compensation expense 2,697     2,697    
Issuance of common stock upon restricted stock units vesting, Share   660,999        
Exercise of stock options, shares   60,028        
Exercise of stock options 74     74    
Issuance of common stock under the employee stock purchase plan, shares   95,803        
Issuance of common stock under the employee stock purchase plan 135     135    
Unrealized gain (loss), net of tax 4       4  
Net loss (41,400)         (41,400)
Balances at Mar. 31, 2026 $ 203,050 $ 28   $ 1,198,942 $ (37) $ (995,883)
Balances, shares at Mar. 31, 2026   282,803,863        
Treasury stock at Mar. 31, 2026     $ 0      
Treasury Stock, Common, Shares at Mar. 31, 2026     0      
XML 15 R7.htm IDEA: XBRL DOCUMENT v3.26.1
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)
$ in Thousands
3 Months Ended 12 Months Ended
Mar. 31, 2026
Mar. 31, 2025
Dec. 31, 2025
Cash flows from operating activities:      
Net loss $ (41,400) $ (16,289)  
Adjustments to reconcile net loss to net cash used in operating activities:      
Stock-based compensation expense 2,697 2,826  
Amortization of operating lease right-of-use assets 345 432  
Depreciation and amortization expense 168 306  
Other non-cash adjustments 54 0  
Changes in operating assets and liabilities:      
Accounts receivable 2,221 2,345  
Inventory 47 (58)  
Prepaid expenses and other current assets (2,123) 1,348  
Other non-current assets (1,046) 10  
Accounts payable (11,566) (1,637)  
Accrued expenses 9,184 (10,009)  
Operating lease liabilities (297) (410)  
Other current liabilities 4 7  
Net cash used in operating activities (41,712) (21,129)  
Cash flows from investing activities:      
Purchases of property and equipment (726) (144)  
Net cash used in investing activities (726) (144)  
Cash flows from financing activities:      
Proceeds from exercises of stock options 74 37  
Proceeds from issuance of common stock under the employee stock purchase plan 135 44  
Payments for at-the-market offering costs (76) (71)  
Payments for underwritten public offering costs (231) 0  
Net cash (used in) provided by financing activities (98) 10  
Effect of exchange rate changes on cash and cash equivalents 0 (8)  
Net decrease in cash and cash equivalents (42,536) (21,271)  
Cash and cash equivalents at beginning of period 226,689 69,349 $ 69,349
Cash and cash equivalents at end of period 184,153 48,078 $ 226,689
Supplemental disclosure of cash flow information      
Deferred offering costs in accrued expenses $ 133 $ 0  
XML 16 R8.htm IDEA: XBRL DOCUMENT v3.26.1
Pay vs Performance Disclosure - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2026
Mar. 31, 2025
Pay vs Performance Disclosure    
Net Income (Loss) $ (41,400) $ (16,289)
XML 17 R9.htm IDEA: XBRL DOCUMENT v3.26.1
Insider Trading Arrangements
3 Months Ended
Mar. 31, 2026
Trading Arrangements, by Individual  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
XML 18 R10.htm IDEA: XBRL DOCUMENT v3.26.1
Nature of Business and Basis of Presentation
3 Months Ended
Mar. 31, 2026
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Nature of the Business and Basis of Presentation

1. Nature of the Business and Basis of Presentation

Invivyd, Inc. (the “Company”) is a biopharmaceutical company focused on the discovery, development and commercialization of monoclonal antibody (“mAb”) therapies for the prevention and treatment of serious viral infectious diseases, beginning with SARS-CoV-2, the virus that causes COVID-19, and expanding into other high-need indications, such as respiratory syncytial virus (“RSV”) and measles.

 

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.

 

In January 2024, the Company nominated VYD2311, a next generation mAb candidate for COVID-19, as a drug candidate. VYD2311 is a mAb with high in vitro neutralization potency shown against prominent SARS-CoV-2 variants tested to date. 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 includes three clinical trials, DECLARATION, LIBERTY, and DRUMMER. In December 2025, the Company initiated DECLARATION, which is a Phase 3 randomized, triple-blind, placebo-controlled clinical trial to evaluate VYD2311 safety and efficacy in prevention of symptomatic, RT-PCR-confirmed COVID-19 at three months, with either a single dose or monthly doses of VYD2311, each administered via intramuscular injection, compared to placebo. DECLARATION is designed to support potential Biologics License Application (“BLA”) submission, with top-line data anticipated in the third quarter of 2026. In February 2026, the Company announced alignment with the FDA on LIBERTY, which is designed as a Phase 3, randomized, double-blind clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of (1) VYD2311, (2) an mRNA COVID vaccine, and (3) co-administered VYD2311 with an mRNA COVID vaccine. Additionally, the Company has agreed with the FDA on an initial Pediatric Study Plan for an efficient safety and immunobridging clinical trial to support potential BLA for VYD2311 in children aged 0-11 years. This DRUMMER pediatric clinical trial will be actioned only if the pivotal DECLARATION clinical trial is successful. The FDA has granted “Fast Track” designation for VYD2311 for the prevention of COVID-19 in individuals with underlying risk factors for progression to severe disease. Fast Track designation is a process designed to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need, including eligibility for priority review and rolling review of BLA submissions, if specified criteria are met.

In addition to the Company’s COVID-19 programs, in November 2025, the Company announced the selection of VBY329, a potential best-in-class mAb candidate being developed for the prevention of RSV infections in neonates, infants and children. The Company expects to advance VBY329 toward IND readiness in the second half of 2026. Also, in April 2026, the Company announced the discovery and advancement of VMS063, a novel, highly potent, half-life-extended, high resistance barrier measles mAb candidate. The Company has begun IND-enablement and regulatory outreach to support rapid VMS063 development, with the goal of expedited development with target IND readiness in late 2026. Through the Company’s proprietary technology platform, the Company continues to investigate additional mAbs for protection and treatment of other important infectious diseases.

 

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.

 

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.

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 Agreements (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 three months ended March 31, 2026. As of March 31, 2026, the Company had an accumulated deficit of $995.9 million. The Company may continue to generate operating losses for the foreseeable future.

Based on current operating plans and excluding 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 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 March 31, 2026, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2026 and 2025, the condensed consolidated statements of cash flows for the three months ended March 31, 2026 and 2025 and the condensed consolidated statements of stockholders’ equity for the three months ended March 31, 2026 and 2025 are unaudited.

The accompanying unaudited condensed consolidated financial statements as of March 31, 2026 and for the three months ended March 31, 2026 and 2025 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, 2025 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, 2025, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 5, 2026 (the “2025 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 March 31, 2026 and December 31, 2025, the condensed consolidated results of operations for the three months ended March 31, 2026 and 2025, the condensed consolidated cash flows for the three months ended March 31, 2026 and 2025, and changes in stockholders’ equity for the three months ended March 31, 2026 and 2025 have been made. The Company’s condensed consolidated results of operations for the three months ended March 31, 2026 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2026.

XML 19 R11.htm IDEA: XBRL DOCUMENT v3.26.1
Summary of Significant Accounting Policies
3 Months Ended
Mar. 31, 2026
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

As of March 31, 2026, the Company’s significant accounting policies and estimates, which are detailed in the Company’s 2025 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.

Concentrations of Credit Risk

Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents and accounts receivable. As of March 31, 2026, the Company invested its excess cash in money market funds that are subject to minimal credit and market risks. The Company maintains its existing cash and cash equivalents at two accredited financial institutions. From time to time, these deposits may exceed federally insured limits. The Company has not experienced any losses historically in these accounts. Accordingly, the Company does not believe it is exposed to unusual credit risk related to its existing cash and cash equivalents beyond the normal credit risk associated with commercial banking relationships.

There have been no material changes in customer concentration of accounts receivable from those detailed in the Company’s 2025 Form 10-K. As of March 31, 2026, the Company recorded an allowance for doubtful accounts of $0.3 million related to one direct customer.

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 will remain an emerging growth company until December 31, 2026. 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 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.

XML 20 R12.htm IDEA: XBRL DOCUMENT v3.26.1
Fair Value Measurements
3 Months Ended
Mar. 31, 2026
Fair Value Disclosures [Abstract]  
Fair Value Measurements

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
March 31, 2026:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

181,561

 

 

$

—

 

 

$

—

 

 

$

181,561

 

 

$

181,561

 

 

$

—

 

 

$

—

 

 

$

181,561

 

 

 

Fair Value Measurements at
December 31, 2025:

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

224,172

 

 

$

—

 

 

$

—

 

 

$

224,172

 

 

$

224,172

 

 

$

—

 

 

$

—

 

 

$

224,172

 

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 months ended March 31, 2026.

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 months ended March 31, 2026.

XML 21 R13.htm IDEA: XBRL DOCUMENT v3.26.1
Inventory
3 Months Ended
Mar. 31, 2026
Inventory Disclosure [Abstract]  
Inventory

4. Inventory

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

 

 

March 31,
2026

 

 

December 31,
2025

 

Work in process

 

$

20,769

 

 

$

20,769

 

Finished goods

 

 

4,683

 

 

 

4,730

 

 

$

25,452

 

 

$

25,499

 

 

As of March 31, 2026, $0.3 million of finished goods inventory was classified as a current asset and included within prepaid expenses and other current assets in the condensed consolidated balance sheet. Please refer to Note 5 for additional information.
XML 22 R14.htm IDEA: XBRL DOCUMENT v3.26.1
Prepaid Expenses and Other Current Assets
3 Months Ended
Mar. 31, 2026
Prepaid Expense and Other Assets, Current [Abstract]  
Prepaid Expenses and Other Current Assets

5. Prepaid Expenses and Other Current Assets

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

 

 

March 31,
2026

 

 

December 31,
2025

 

Prepaid external research, development and manufacturing costs

 

$

2,614

 

 

$

3,442

 

Prepaid corporate communication costs

 

 

2,450

 

 

 

—

 

Prepaid insurance

 

 

660

 

 

 

1,024

 

Interest receivable

 

 

561

 

 

 

676

 

Finished goods inventory, current

 

 

262

 

 

 

263

 

Other

 

 

2,567

 

 

 

1,454

 

 

$

9,114

 

 

$

6,859

 

XML 23 R15.htm IDEA: XBRL DOCUMENT v3.26.1
Accrued Expenses
3 Months Ended
Mar. 31, 2026
Accrued Liabilities [Abstract]  
Accrued Expenses

6. Accrued Expenses

Accrued expenses consisted of the following (in thousands):

 

 

March 31,
2026

 

 

December 31,
2025

 

Accrued external research, development and manufacturing costs

 

$

18,492

 

 

$

6,616

 

Accrued professional and consultant fees

 

 

4,498

 

 

 

2,778

 

Accrued employee compensation

 

 

1,793

 

 

 

5,749

 

Other

 

 

3,205

 

 

 

3,910

 

 

$

27,988

 

 

$

19,053

 

XML 24 R16.htm IDEA: XBRL DOCUMENT v3.26.1
License and Collaboration Agreements
3 Months Ended
Mar. 31, 2026
License Agreements [Abstract]  
License and Collaboration Agreements

7. License and Collaboration Agreements

Adimab Assignment Agreement

In July 2020, the Company entered into an Assignment and License Agreement (the “Adimab Assignment Agreement”) with Adimab, LLC (“Adimab”). 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 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 both the three months ended March 31, 2026 and 2025, the Company did not 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 March 31, 2026; however, milestone payments do not accrue for certain in vitro diagnostic devices consisting of or containing CoV Antibodies.

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 March 31, 2026.

During both the three months ended March 31, 2026 and 2025, the Company did not 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 March 31, 2026.

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 months ended March 31, 2026 and 2025, the Company expensed $0.6 million and $0.5 million of royalties, respectively, 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.

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 March 31, 2026 and 2025, the Company recognized $0.6 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 both the three months ended March 31, 2026 and 2025, the Company did not recognize any research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement. During both the three months ended March 31, 2026 and 2025, the Company did not recognize any IPR&D expense related to drug delivery fees, optimization completion fees or option exercise fees. Please refer to Note 15 for additional information.

The Company is obligated to pay Adimab up to $18.0 million upon the achievement of specified development and regulatory milestones for each product under the Adimab Collaboration Agreement that achieves such milestones. The next potential milestone under the Adimab Collaboration Agreement is a low single-digit million-dollar clinical milestone, which was not considered probable under U.S. GAAP and therefore, no expense was recognized as of March 31, 2026. 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 March 31, 2026, 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. 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 March 31, 2026 and 2025, the Company recognized $0.5 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 March 31, 2026.

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 March 31, 2026, 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.

WuXi Biologics Cell Line License Agreement

In December 2020, as amended in February 2023, March 2024 and March 2026, 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 with respect to certain Licensed Products by making a one-time payment in the low eight-figures to WuXi Biologics and with respect to certain other Licensed Products by making a one-time payment in the middle-seven 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. The royalty obligation shall be waived to the extent the royalty obligation is derived or arising from a Licensed Product sold in the U.S. if the Company’s ability to have such Licensed Product manufactured by WuXi Biologics becomes materially restricted due to certain government actions, with such waiver continuing for so long as such government action continues. Through March 31, 2026, 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 not recognize any IPR&D expense under the Cell Line License Agreement during the three months ended March 31, 2026 and 2025.

XML 25 R17.htm IDEA: XBRL DOCUMENT v3.26.1
Population Health Partners, L.P
3 Months Ended
Mar. 31, 2026
Other Commitments [Abstract]  
Population Health Partners, L.P

8. Population Health Partners, L.P.

In November 2022 (the “PHP Effective Date”), the Company entered into a Master Services Agreement with Population Health Partners, L.P. (“PHP”), pursuant to which PHP agreed to provide services and create deliverables for the Company as agreed between the Company and PHP and set forth in one or more work orders under such agreement (the “PHP MSA”). The term of the PHP MSA commenced on the PHP Effective Date 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 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 both the three months ended March 31, 2026 and 2025, the Company did not 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;

 

 

 

 

 

•

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. As of March 31, 2026, no portion of the PHP Warrant had vested.

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.

XML 26 R18.htm IDEA: XBRL DOCUMENT v3.26.1
Commitments and Contingencies
3 Months Ended
Mar. 31, 2026
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

9. Commitments and Contingencies

Operating Lease Commitments

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.

In February 2026, the Company further amended the Newton, MA Lease to add additional dedicated laboratory space, which commenced on March 1, 2026. The amendment provides for incremental annual base rent of $0.3 million for the remainder of the lease term, through December 2027.

In May 2025, the Company entered into a short-term lease agreement for approximately 13,600 square feet of office space in New Haven, Connecticut, with an original term of 12 months. The Company has elected the short-term lease recognition exemption under ASC Topic 842 – Leases and therefore has not recognized a right-of-use asset or lease liability on the balance sheet. For the three months ended March 31, 2026, base rent charges of less than $0.1 million were incurred. There were no related expenses incurred for the three months ended March 31, 2025.

In January 2026, the Company entered into an agreement to lease approximately 33,000 square feet of office space in New Haven, Connecticut (the “New Haven Lease”). The New Haven Lease commenced in March 2026 and has an initial term of one hundred twenty-nine months. The Company’s obligation for the payment of rent for the premises begins six months after the lease commencement date and total future minimum lease payments are expected to be $10.9 million. The lease includes a tenant improvement allowance of approximately $1.0 million.

Under the terms of the New Haven Lease, the Company made a security deposit of $1.0 million in the form of a letter of credit, which will be reduced by 50% in September 2027, following the first twelve months of rent payments.

The components of operating lease expense were as follows (in thousands):

 

 

For the Three Months
Ended March 31,

 

 

For the Three Months
Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Lease cost:

 

 

 

 

 

 

 

Operating lease cost

 

$

423

 

 

$

447

 

 

Variable lease cost

 

 

—

 

 

 

5

 

 

Total lease cost

 

$

423

 

 

$

452

 

 

 

 

 

 

 

 

 

 

Cash paid for amounts included in the measurement of lease liabilities:

 

 

 

 

 

 

 

Operating cash flows related to operating leases

 

$

376

 

 

$

425

 

 

 

 

Future minimum lease payments under the noncancelable leases as of March 31, 2026 was as follows (in thousands):

Year Ending December 31,

Operating Lease

 

2026 (excluding the three months ended March 31, 2026)

$

1,516

 

2027

$

2,549

 

2028

$

917

 

2029

$

1,026

 

2030

$

1,051

 

Thereafter

$

6,594

 

Total lease payments

 

13,653

 

Less: tenant improvement allowance reimbursements yet to be received

 

(956

)

Present value adjustment

 

(4,071

)

Present value of operating lease liability

$

8,626

 

As of March 31, 2026, the Company’s operating leases were measured using a weighted-average incremental borrowing rate of 7.7% over a weighted-average remaining lease term of 7.9 years.

As of March 31, 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 0.6 years.

The total operating liabilities are presented on the Company’s condensed consolidated balance sheet based on maturity dates. As of March 31, 2026, $1.6 million is classified under “operating lease liabilities, current” for the portion due within twelve months, and $7.0 million is classified under “operating lease liabilities, non-current”.

License Agreements

The Company has entered into license agreements with Adimab and WuXi Biologics (see Note 7).

Other 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 March 31, 2026 and December 31, 2025.

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 March 31, 2026, 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 March 31, 2026, the Company had not satisfied certain financial covenants and conditions, including the net product revenue milestone required to be eligible to access proceeds from the Term Facility. Accordingly, as of March 31, 2026, no amounts have been drawn down under the Loan Agreement.

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 will be 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.

XML 27 R19.htm IDEA: XBRL DOCUMENT v3.26.1
Common Stock
3 Months Ended
Mar. 31, 2026
Equity [Abstract]  
Common Stock

10. Common Stock

Shares Reserved for Future Issuance

As of March 31, 2026, the Company had reserved 60,089,902 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, 2021 Employee Stock Purchase Plan and 2026 Inducement 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”). The 2022 Shelf Registration Statement expired upon the effectiveness of the 2025 Shelf Registration Statement (as defined below).

In October 2025, the Company filed a new shelf registration statement on Form S-3 with the SEC and an accompanying base prospectus, which was declared effective by the SEC on December 23, 2025, for the offer and sale of up to $350 million of the Company’s securities (the “2025 Shelf Registration Statement”). As of March 31, 2026, excluding the $75 million allocated to the 2025

ATM Prospectus Supplement (as defined below), $275 million of the Company’s securities remained available for offer and sale under the 2025 Shelf Registration Statement.

August 2025 Underwritten Public Offering

In August 2025, the Company completed an underwritten public offering pursuant to an underwriting agreement (the “August 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 March 31, 2026, there were no exercises of pre-funded warrants that were issued in connection with the August 2025 Underwritten Public Offering.

November 2025 Underwritten Public Offering

In November 2025, the Company completed an underwritten public offering pursuant to an underwriting agreement (the “November Underwriting Agreement” and together with the August Underwriting Agreement, the “Underwriting Agreements”) with Cantor, as representative of the underwriters named therein, pursuant to which it issued and sold an aggregate of 44,000,000 shares of its common stock at a price of $2.50 per share, and pre-funded warrants to purchase up to an aggregate of 6,000,000 shares of common stock at a price of $2.4999 per pre-funded warrant (the “November 2025 Underwritten Public Offering”, and, together with the August 2025 Underwritten Public Offering, the “2025 Underwritten Public Offerings”). The price of $2.4999 per pre-funded warrant represented the $2.50 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 $117.2 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company. As of March 31, 2026, there were no exercises of pre-funded warrants that were issued in connection with the November 2025 Underwritten Public Offering.

In December 2025, and in connection with the November 2025 Underwritten Public Offering, Cantor exercised the option pursuant to the November Underwriting Agreement to purchase 4,675,000 additional shares of common stock at the public offering price of $2.50, less underwriting discounts and commissions. In connection with such exercise, the Company received total net proceeds of approximately $10.9 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company.

ATM Facility

In December 2023, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”) with Cantor, as sales agent, and filed with the SEC a prospectus supplement (the “2023 ATM Prospectus Supplement”) to the 2022 Shelf Registration Statement, pursuant to which the Company could, 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 (the “Securities Act”). Cantor was entitled to a commission of 3% of the gross proceeds from any sales of such shares. In 2024, the Company sold 9,000,000 shares of its common stock under the Sales Agreement and the 2023 ATM Prospectus Supplement, at an average price of $4.50 per share for $39.3 million in proceeds net of commissions. In 2025, the Company sold 23,055,402 shares of its common stock under the Sales Agreement and the 2023 ATM Prospectus Supplement at an average price of $1.49 per share for $33.4 million in proceeds net of commissions. Upon the effectiveness of the 2025 Shelf Registration Statement, all offers and sales under the 2023 ATM Prospectus Supplement were deemed terminated.

In October 2025, in connection with the filing of the 2025 Shelf Registration Statement, the Company filed with the SEC a new prospectus supplement (the “2025 ATM Prospectus Supplement”), 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. Cantor is entitled to a commission of 3% of the gross proceeds from any sales of such shares. The 2025 Shelf Registration Statement was declared effective by the SEC on December 23, 2025, and $75.0 million remained available for sale under the 2025 ATM Prospectus Supplement as of March 31, 2026.

In April 2026, the Company sold 11,803,589 shares of its common stock under the Sales Agreement at an average price of $1.70 per share for $19.4 million in proceeds net of commissions.

XML 28 R20.htm IDEA: XBRL DOCUMENT v3.26.1
Stock-Based Compensation
3 Months Ended
Mar. 31, 2026
Share-Based Payment Arrangement [Abstract]  
Share Based Compensation

11. Stock-Based Compensation

2020 Equity Incentive Plan

The Company’s 2020 Equity Incentive Plan (the “2020 Plan”) provides for the Company to grant incentive stock options, non-qualified stock options, restricted stock awards, 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.

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 March 31, 2026, there were 467,615 shares authorized to be issued upon the exercise of outstanding stock options 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 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, 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. On January 1, 2026, 14,099,351 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 March 31, 2026, there were an aggregate of 28,946,439 shares authorized to be issued upon the exercise of outstanding stock options and vesting of RSU grants and 19,574,167 shares reserved for future issuance under the 2021 Plan.

2026 Inducement Plan

In January 2026, the Company’s board of directors adopted the 2026 Inducement Plan (the “2026 Inducement Plan”). Under the 2026 Inducement Plan, the Company is authorized to issue up to 8,000,000 shares pursuant to inducement grants. The only persons eligible to receive grants under the 2026 Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq Listing Rule 5635(c)(4) and the related guidance under Nasdaq IM 5635-1, including individuals who were not previously an employee or director of the Company (or individuals following a bona fide period of non-employment), in each case as an inducement material to such individual’s agreement to enter into employment with the Company. The 2026 Inducement Plan provides for the discretionary grant of nonstatutory stock options, stock appreciation rights, restricted stock awards, RSUs, performance awards, and certain other awards.

As of March 31, 2026, there were an aggregate of 192,000 shares authorized to be issued upon the exercise of outstanding stock options and 7,808,000 shares reserved for future issuance under the 2026 Inducement Plan.

Stock Option Valuation

The fair value of stock option grants is estimated using the Black-Scholes option-pricing model. Prior to its IPO in August 2021, the Company had been a private company. Due to the proximity to the IPO, the Company continues to lack sufficient company-specific

historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.

The following table presents, on a weighted-average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant date fair value of stock options granted:

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Expected term (in years)

 

 

5.8

 

 

 

5.8

 

 

Expected volatility

 

 

69.3

%

 

 

60.9

%

 

Risk-free interest rate

 

 

3.9

%

 

 

4.4

%

 

Expected dividend yield

 

 

—

%

 

 

—

%

 

Stock Option Activity

The following table summarizes the Company’s stock option activity since December 31, 2025:

 

 

Number of
Shares

 

 

Weighted-
Average
Exercise
Price

 

 

Weighted-
Average
Remaining
Contractual
Term

 

 

Aggregate
Intrinsic
Value

 

 

 

 

 

 

 

 

 

(in years)

 

 

(in thousands)

 

Outstanding at December 31, 2025

 

 

21,351,941

 

 

$

2.96

 

 

 

8.1

 

 

$

15,525

 

Granted

 

 

8,138,250

 

 

$

1.86

 

 

 

 

 

 

 

Exercised

 

 

(60,028

)

 

$

1.23

 

 

 

 

 

 

 

Forfeited

 

 

(602,110

)

 

$

2.20

 

 

 

 

 

 

 

Outstanding at March 31, 2026

 

 

28,828,053

 

 

$

2.67

 

 

 

8.4

 

 

$

1,381

 

Vested and expected to vest at March 31, 2026

 

 

28,828,053

 

 

$

2.67

 

 

 

8.4

 

 

$

1,381

 

Options exercisable at March 31, 2026

 

 

11,529,229

 

 

$

4.08

 

 

 

7.0

 

 

$

392

 

The weighted-average grant date fair value of stock options granted during the three months ended March 31, 2026 and 2025 was $1.19 and $0.93, 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 March 31, 2026 and 2025.

The total intrinsic value of stock options exercised was less than $0.1 million for both the three months ended March 31, 2026 and 2025.

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 certain of its 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, 2025:

 

 

Number
of Shares

 

 

Weighted Average Grant Date Fair Value

 

 

 

 

 

 

 

 

Unvested at December 31, 2025

 

 

1,539,000

 

 

$

1.49

 

Granted

 

 

—

 

 

$

—

 

Vested

 

 

(660,999

)

 

$

1.54

 

Forfeited

 

 

(100,000

)

 

$

1.15

 

Unvested at March 31, 2026

 

 

778,001

 

 

$

1.49

 

 

 

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 March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Research and development

 

$

733

 

 

$

831

 

 

Selling, general and administrative

 

 

1,964

 

 

 

1,995

 

 

 

$

2,697

 

 

$

2,826

 

 

As of March 31, 2026, total unrecognized stock-based compensation expense related to unvested stock options was $17.9 million, which is expected to be recognized over a weighted-average period of 2.4 years.

As of March 31, 2026, the total unrecognized stock-based compensation expense related to unvested RSUs was $0.9 million, which is expected to be recognized over a weighted-average period of 0.5 years.

2021 Employee Stock Purchase Plan

In July 2021, the Company’s board of directors adopted, and its stockholders approved, the 2021 Employee Stock Purchase Plan (the “2021 ESPP”), which became effective immediately prior to and contingent upon the execution of the underwriting agreement related to the Company’s IPO. A total of 1,342,773 shares of common stock were initially reserved for issuance under the 2021 ESPP. 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. On January 1, 2026, the number of shares authorized for issuance under the 2021 ESPP increased by 2,685,546 shares of common stock, pursuant to the evergreen provision thereof. The first offering under the 2021 ESPP was June 6, 2022. As of March 31, 2026, 3,101,681 shares remained available for issuance under the 2021 ESPP. There were 926,638 shares issued under the 2021 ESPP as of March 31, 2026. During both the three months ended March 31, 2026 and 2025, the Company recognized less than $0.1 million in related stock-based compensation expense.

Warrant Expense

In November 2022, the Company entered into the PHP MSA, the PHP Work Order and a warrant agreement with respect to the PHP Warrant. To compensate for the services and deliverables provided by PHP, the Company issued 6,824,712 equity-classified warrants to PHP. Each warrant shall give the right to acquire common stock of the Company at a purchase price of $3.48 per share. Per the agreement, the PHP Warrant is exercisable upon either the achievement of corresponding market capitalization targets or a consummation of a fundamental transaction (as defined in the PHP Warrant); as such, there are no other requirements, including any continuous service requirements, in order for PHP to be entitled to the PHP Warrant, if and when any portion of it vests.

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

There were no warrants issued during the three months ended March 31, 2026 and 2025.

As of March 31, 2026, other than the pre-funded warrants issued in the 2025 Underwritten Public Offerings, 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 6.63 years.

XML 29 R21.htm IDEA: XBRL DOCUMENT v3.26.1
Income Taxes
3 Months Ended
Mar. 31, 2026
Income Tax Disclosure [Abstract]  
Income Taxes

12. Income Taxes

For both the three months ended March 31, 2026 and 2025, 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.

XML 30 R22.htm IDEA: XBRL DOCUMENT v3.26.1
Defined Contribution Plan
3 Months Ended
Mar. 31, 2026
Retirement Benefits [Abstract]  
Defined Contribution Plan

13. Defined Contribution Plan

The Company maintains a 401(k) Plan (the “401(k) Plan”) for the benefit of eligible employees. The 401(k) Plan is a defined contribution plan under Section 401(k) of the Internal Revenue Code of 1986, 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 months ended March 31, 2026 and 2025, the Company contributed $0.3 million and $0.2 million, respectively, to the 401(k) Plan.

XML 31 R23.htm IDEA: XBRL DOCUMENT v3.26.1
Net Loss Per Share
3 Months Ended
Mar. 31, 2026
Earnings Per Share [Abstract]  
Net Loss Per Share

14. Net Loss per Share

Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts):

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Numerator:

 

 

 

 

 

 

 

Net loss attributable to common stockholders

 

$

(41,400

)

 

$

(16,289

)

 

Denominator:

 

 

 

 

 

 

 

Weighted-average common shares outstanding, basic and diluted

 

 

309,670,101

 

 

 

119,883,479

 

 

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

 

$

(0.13

)

 

$

(0.14

)

 

 

The 27,342,442 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.

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 Three Months
Ended March 31,

 

 

For the Three Months
Ended March 31,

 

 

 

2026

 

 

2025

 

Stock options to purchase common stock

 

 

28,828,053

 

 

 

23,014,702

 

Restricted stock units

 

 

778,001

 

 

 

1,700,000

 

Warrants to purchase common stock

 

 

6,824,712

 

 

 

6,824,712

 

 

 

 

36,430,766

 

 

 

31,539,414

 

XML 32 R24.htm IDEA: XBRL DOCUMENT v3.26.1
Related Party Transactions
3 Months Ended
Mar. 31, 2026
Related Party Transactions [Abstract]  
Related Party Transactions

15. Related-Party Transactions

As of March 31, 2026 and December 31, 2025, an aggregate of $1.2 million and $0.7 million, respectively, was due to Adimab, a beneficial owner of more than 5% of the Company’s common stock, 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 accounts payable and accrued expenses. As of March 31, 2026 and December 31, 2025, no amounts were due to the Company from Adimab under the Adimab Assignment Agreement, the Adimab Collaboration Agreement, the Adimab Platform Transfer Agreement, the Adimab DNA Sequencing Services Agreement or the Adimab LCMS Services Agreement (as defined below).

Adimab Assignment Agreement

Under the Adimab Assignment Agreement, Adimab 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 both the three months ended March 31, 2026 and 2025, the Company did not recognize any IPR&D expense with respect to contingent consideration payable under the Adimab Assignment Agreement.

During both the three months ended March 31, 2026 and 2025, the Company did not 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 months ended March 31, 2026 and 2025, the Company expensed $0.6 million and $0.5 million, respectively, of royalties as costs of product revenue, while reserving all rights under the Adimab Assignment Agreement and the applicable law.

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 March 31, 2026 and 2025, the Company recognized $0.6 million of research and development expense related to the quarterly fee under the Adimab Collaboration Agreement.

During both the three months ended March 31, 2026 and 2025, the Company did not recognize any research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.

During both the three months ended March 31, 2026 and 2025, the Company did not recognize any IPR&D expense related to drug delivery fees, optimization completion fees or option exercise fees.

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 March 31, 2026 and 2025, 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

In May 2023, as amended in January 2024, January 2025 and January 2026, 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 both the three months ended March 31, 2026 and 2025, 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.

Adimab LCMS Services Agreement

In November 2023, as amended in December 2025, the Company entered into a Services Agreement with Adimab for Adimab to provide molecular weight determination services and deliver to the Company the resulting data and information (the “Adimab LCMS Services Agreement”). In exchange for the services performed, the Company will pay Adimab a fee for each sample tested.

During both the three months ended March 31, 2026 and 2025, the Company did not recognize any research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab LCMS Services Agreement.

XML 33 R25.htm IDEA: XBRL DOCUMENT v3.26.1
Segment Reporting
3 Months Ended
Mar. 31, 2026
Segment Reporting [Abstract]  
Segment Reporting

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 Company’s reportable segment derives its revenue from sales of its product, PEMGARDA. No asset information has been provided for the reportable segment as the CODM does not regularly review asset information by reportable segment.

The following table presents information about reported segment revenues, and significant segment expenses as provided to the CODM (in thousands). Certain prior period segment expense amounts have been recast to reflect the current year presentation.

 

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Revenue:

 

 

 

 

 

 

 

Product revenue, net

 

$

13,744

 

 

$

11,304

 

 

Total revenue

 

 

13,744

 

 

 

11,304

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

Cost of product revenue

 

 

1,032

 

 

 

834

 

 

Direct, external research and development expenses by program:

 

 

 

 

 

 

 

Pemivibart(1)

 

 

188

 

 

 

1,391

 

 

VYD2311(2)

 

 

22,803

 

 

 

1,502

 

 

VBY329(3)

 

 

164

 

 

 

42

 

 

VMS063(4)

 

 

129

 

 

 

—

 

 

Early-stage programs

 

 

29

 

 

 

85

 

 

Total direct, external research and development expenses by program

 

 

23,313

 

 

 

3,020

 

 

Personnel expense (research and development)

 

 

3,167

 

 

 

3,180

 

 

Stock-based compensation (research and development)

 

 

733

 

 

 

831

 

 

Other research and development expense

 

 

3,518

 

 

 

3,610

 

 

Total research and development expense

 

 

30,731

 

 

 

10,641

 

 

Selling, general and administrative

 

 

 

 

 

 

 

Sales and marketing costs

 

 

5,218

 

 

 

2,960

 

 

Personnel expense (selling, general and administrative)

 

 

7,688

 

 

 

5,490

 

 

Stock-based compensation (selling, general and administrative)

 

 

1,964

 

 

 

1,995

 

 

Other selling, general and administrative expense

 

 

10,247

 

 

 

6,306

 

 

Total selling, general and administrative expense

 

 

25,117

 

 

 

16,751

 

 

Total operating costs and expenses

 

 

56,880

 

 

 

28,226

 

 

Loss from operations

 

 

(43,136

)

 

 

(16,922

)

 

Other income:

 

 

 

 

 

 

 

Other income, net(5)

 

 

1,736

 

 

 

633

 

 

Total other income, net

 

 

1,736

 

 

 

633

 

 

Net loss

 

$

(41,400

)

 

$

(16,289

)

 

(1)
In March 2023, the Company announced the nomination of VYD222 (pemivibart) as a novel mAb therapeutic option for COVID-19.
(2)
In March 2024, the Company announced the nomination of VYD2311 as a novel mAb therapeutic option for COVID-19.
(3)
In November 2025, the Company announced the nomination of VBY329 as an RSV mAb candidate for preclinical development.
(4)
In April 2026, the Company announced the nomination of VMS063 as a measles mAb candidate for preclinical development.
(5)
Includes interest income of $1,743 and $628 for the three months ended March 31, 2026 and 2025, respectively.
XML 34 R26.htm IDEA: XBRL DOCUMENT v3.26.1
Summary of Significant Accounting Policies (Policies)
3 Months Ended
Mar. 31, 2026
Accounting Policies [Abstract]  
Use of Estimates

Use of Estimates

The preparation of the Company’s condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of 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.

Concentrations of Credit Risk

Concentrations of Credit Risk

Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents and accounts receivable. As of March 31, 2026, the Company invested its excess cash in money market funds that are subject to minimal credit and market risks. The Company maintains its existing cash and cash equivalents at two accredited financial institutions. From time to time, these deposits may exceed federally insured limits. The Company has not experienced any losses historically in these accounts. Accordingly, the Company does not believe it is exposed to unusual credit risk related to its existing cash and cash equivalents beyond the normal credit risk associated with commercial banking relationships.

There have been no material changes in customer concentration of accounts receivable from those detailed in the Company’s 2025 Form 10-K. As of March 31, 2026, the Company recorded an allowance for doubtful accounts of $0.3 million related to one direct customer.

Unaudited Interim Financial Information

Unaudited Interim Financial Information

The accompanying condensed consolidated balance sheet as of March 31, 2026, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2026 and 2025, the condensed consolidated statements of cash flows for the three months ended March 31, 2026 and 2025 and the condensed consolidated statements of stockholders’ equity for the three months ended March 31, 2026 and 2025 are unaudited.

The accompanying unaudited condensed consolidated financial statements as of March 31, 2026 and for the three months ended March 31, 2026 and 2025 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, 2025 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, 2025, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 5, 2026 (the “2025 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 March 31, 2026 and December 31, 2025, the condensed consolidated results of operations for the three months ended March 31, 2026 and 2025, the condensed consolidated cash flows for the three months ended March 31, 2026 and 2025, and changes in stockholders’ equity for the three months ended March 31, 2026 and 2025 have been made. The Company’s condensed consolidated results of operations for the three months ended March 31, 2026 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2026.

Recently Issued and Adopted Accounting Pronouncements

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 will remain an emerging growth company until December 31, 2026. 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 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.

XML 35 R27.htm IDEA: XBRL DOCUMENT v3.26.1
Fair Value Measurements (Tables)
3 Months Ended
Mar. 31, 2026
Fair Value Disclosures [Abstract]  
Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis

The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis (in thousands):

 

 

Fair Value Measurements at
March 31, 2026:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

181,561

 

 

$

—

 

 

$

—

 

 

$

181,561

 

 

$

181,561

 

 

$

—

 

 

$

—

 

 

$

181,561

 

 

 

Fair Value Measurements at
December 31, 2025:

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

224,172

 

 

$

—

 

 

$

—

 

 

$

224,172

 

 

$

224,172

 

 

$

—

 

 

$

—

 

 

$

224,172

 

XML 36 R28.htm IDEA: XBRL DOCUMENT v3.26.1
Inventory (Tables)
3 Months Ended
Mar. 31, 2026
Inventory Disclosure [Abstract]  
Schedule of Inventory

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

 

 

March 31,
2026

 

 

December 31,
2025

 

Work in process

 

$

20,769

 

 

$

20,769

 

Finished goods

 

 

4,683

 

 

 

4,730

 

 

$

25,452

 

 

$

25,499

 

XML 37 R29.htm IDEA: XBRL DOCUMENT v3.26.1
Prepaid Expenses and Other Current Assets (Tables)
3 Months Ended
Mar. 31, 2026
Prepaid Expense and Other Assets, Current [Abstract]  
Summary of Prepaid Expenses and Other Current Assets

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

 

 

March 31,
2026

 

 

December 31,
2025

 

Prepaid external research, development and manufacturing costs

 

$

2,614

 

 

$

3,442

 

Prepaid corporate communication costs

 

 

2,450

 

 

 

—

 

Prepaid insurance

 

 

660

 

 

 

1,024

 

Interest receivable

 

 

561

 

 

 

676

 

Finished goods inventory, current

 

 

262

 

 

 

263

 

Other

 

 

2,567

 

 

 

1,454

 

 

$

9,114

 

 

$

6,859

 

XML 38 R30.htm IDEA: XBRL DOCUMENT v3.26.1
Accrued Expenses (Tables)
3 Months Ended
Mar. 31, 2026
Accrued Liabilities [Abstract]  
Schedule of Accrued Expenses

Accrued expenses consisted of the following (in thousands):

 

 

March 31,
2026

 

 

December 31,
2025

 

Accrued external research, development and manufacturing costs

 

$

18,492

 

 

$

6,616

 

Accrued professional and consultant fees

 

 

4,498

 

 

 

2,778

 

Accrued employee compensation

 

 

1,793

 

 

 

5,749

 

Other

 

 

3,205

 

 

 

3,910

 

 

$

27,988

 

 

$

19,053

 

XML 39 R31.htm IDEA: XBRL DOCUMENT v3.26.1
Commitments and Contingencies (Tables)
3 Months Ended
Mar. 31, 2026
Commitments and Contingencies Disclosure [Abstract]  
Schedule of Components of Operating Lease Expense

The components of operating lease expense were as follows (in thousands):

 

 

For the Three Months
Ended March 31,

 

 

For the Three Months
Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Lease cost:

 

 

 

 

 

 

 

Operating lease cost

 

$

423

 

 

$

447

 

 

Variable lease cost

 

 

—

 

 

 

5

 

 

Total lease cost

 

$

423

 

 

$

452

 

 

 

 

 

 

 

 

 

 

Cash paid for amounts included in the measurement of lease liabilities:

 

 

 

 

 

 

 

Operating cash flows related to operating leases

 

$

376

 

 

$

425

 

 

Schedule of Future Minimum Payments Under Non-cancellable Purchase Obligations

Future minimum lease payments under the noncancelable leases as of March 31, 2026 was as follows (in thousands):

Year Ending December 31,

Operating Lease

 

2026 (excluding the three months ended March 31, 2026)

$

1,516

 

2027

$

2,549

 

2028

$

917

 

2029

$

1,026

 

2030

$

1,051

 

Thereafter

$

6,594

 

Total lease payments

 

13,653

 

Less: tenant improvement allowance reimbursements yet to be received

 

(956

)

Present value adjustment

 

(4,071

)

Present value of operating lease liability

$

8,626

 

XML 40 R32.htm IDEA: XBRL DOCUMENT v3.26.1
Stock-Based Compensation (Tables)
3 Months Ended
Mar. 31, 2026
Share-Based Payment Arrangement [Abstract]  
Schedule of Weighted Average Fair Values and Valuation Assumptions

The following table presents, on a weighted-average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant date fair value of stock options granted:

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Expected term (in years)

 

 

5.8

 

 

 

5.8

 

 

Expected volatility

 

 

69.3

%

 

 

60.9

%

 

Risk-free interest rate

 

 

3.9

%

 

 

4.4

%

 

Expected dividend yield

 

 

—

%

 

 

—

%

 

Summary of Stock Option Activity

The following table summarizes the Company’s stock option activity since December 31, 2025:

 

 

Number of
Shares

 

 

Weighted-
Average
Exercise
Price

 

 

Weighted-
Average
Remaining
Contractual
Term

 

 

Aggregate
Intrinsic
Value

 

 

 

 

 

 

 

 

 

(in years)

 

 

(in thousands)

 

Outstanding at December 31, 2025

 

 

21,351,941

 

 

$

2.96

 

 

 

8.1

 

 

$

15,525

 

Granted

 

 

8,138,250

 

 

$

1.86

 

 

 

 

 

 

 

Exercised

 

 

(60,028

)

 

$

1.23

 

 

 

 

 

 

 

Forfeited

 

 

(602,110

)

 

$

2.20

 

 

 

 

 

 

 

Outstanding at March 31, 2026

 

 

28,828,053

 

 

$

2.67

 

 

 

8.4

 

 

$

1,381

 

Vested and expected to vest at March 31, 2026

 

 

28,828,053

 

 

$

2.67

 

 

 

8.4

 

 

$

1,381

 

Options exercisable at March 31, 2026

 

 

11,529,229

 

 

$

4.08

 

 

 

7.0

 

 

$

392

 

Summary of Restricted Stock Unit Activity

The following table summarizes the Company’s RSU activity since December 31, 2025:

 

 

Number
of Shares

 

 

Weighted Average Grant Date Fair Value

 

 

 

 

 

 

 

 

Unvested at December 31, 2025

 

 

1,539,000

 

 

$

1.49

 

Granted

 

 

—

 

 

$

—

 

Vested

 

 

(660,999

)

 

$

1.54

 

Forfeited

 

 

(100,000

)

 

$

1.15

 

Unvested at March 31, 2026

 

 

778,001

 

 

$

1.49

 

 

Summary of Share Based Compensation Expense Recognized

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 March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Research and development

 

$

733

 

 

$

831

 

 

Selling, general and administrative

 

 

1,964

 

 

 

1,995

 

 

 

$

2,697

 

 

$

2,826

 

 

XML 41 R33.htm IDEA: XBRL DOCUMENT v3.26.1
Net Loss per Share (Tables)
3 Months Ended
Mar. 31, 2026
Earnings Per Share [Abstract]  
Schedule of Earnings Per Share, Basic and Diluted

Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts):

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Numerator:

 

 

 

 

 

 

 

Net loss attributable to common stockholders

 

$

(41,400

)

 

$

(16,289

)

 

Denominator:

 

 

 

 

 

 

 

Weighted-average common shares outstanding, basic and diluted

 

 

309,670,101

 

 

 

119,883,479

 

 

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

 

$

(0.13

)

 

$

(0.14

)

 

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated, because including them would have had an anti-dilutive effect:

 

 

For the Three Months
Ended March 31,

 

 

For the Three Months
Ended March 31,

 

 

 

2026

 

 

2025

 

Stock options to purchase common stock

 

 

28,828,053

 

 

 

23,014,702

 

Restricted stock units

 

 

778,001

 

 

 

1,700,000

 

Warrants to purchase common stock

 

 

6,824,712

 

 

 

6,824,712

 

 

 

 

36,430,766

 

 

 

31,539,414

 

XML 42 R34.htm IDEA: XBRL DOCUMENT v3.26.1
Segment Reporting (Tables)
3 Months Ended
Mar. 31, 2026
Segment Reporting [Abstract]  
Schedule of Segment Reported Segment Revenues, and Significant Segment Expenses

The following table presents information about reported segment revenues, and significant segment expenses as provided to the CODM (in thousands). Certain prior period segment expense amounts have been recast to reflect the current year presentation.

 

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2026

 

 

2025

 

 

Revenue:

 

 

 

 

 

 

 

Product revenue, net

 

$

13,744

 

 

$

11,304

 

 

Total revenue

 

 

13,744

 

 

 

11,304

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

Cost of product revenue

 

 

1,032

 

 

 

834

 

 

Direct, external research and development expenses by program:

 

 

 

 

 

 

 

Pemivibart(1)

 

 

188

 

 

 

1,391

 

 

VYD2311(2)

 

 

22,803

 

 

 

1,502

 

 

VBY329(3)

 

 

164

 

 

 

42

 

 

VMS063(4)

 

 

129

 

 

 

—

 

 

Early-stage programs

 

 

29

 

 

 

85

 

 

Total direct, external research and development expenses by program

 

 

23,313

 

 

 

3,020

 

 

Personnel expense (research and development)

 

 

3,167

 

 

 

3,180

 

 

Stock-based compensation (research and development)

 

 

733

 

 

 

831

 

 

Other research and development expense

 

 

3,518

 

 

 

3,610

 

 

Total research and development expense

 

 

30,731

 

 

 

10,641

 

 

Selling, general and administrative

 

 

 

 

 

 

 

Sales and marketing costs

 

 

5,218

 

 

 

2,960

 

 

Personnel expense (selling, general and administrative)

 

 

7,688

 

 

 

5,490

 

 

Stock-based compensation (selling, general and administrative)

 

 

1,964

 

 

 

1,995

 

 

Other selling, general and administrative expense

 

 

10,247

 

 

 

6,306

 

 

Total selling, general and administrative expense

 

 

25,117

 

 

 

16,751

 

 

Total operating costs and expenses

 

 

56,880

 

 

 

28,226

 

 

Loss from operations

 

 

(43,136

)

 

 

(16,922

)

 

Other income:

 

 

 

 

 

 

 

Other income, net(5)

 

 

1,736

 

 

 

633

 

 

Total other income, net

 

 

1,736

 

 

 

633

 

 

Net loss

 

$

(41,400

)

 

$

(16,289

)

 

(1)
In March 2023, the Company announced the nomination of VYD222 (pemivibart) as a novel mAb therapeutic option for COVID-19.
(2)
In March 2024, the Company announced the nomination of VYD2311 as a novel mAb therapeutic option for COVID-19.
(3)
In November 2025, the Company announced the nomination of VBY329 as an RSV mAb candidate for preclinical development.
(4)
In April 2026, the Company announced the nomination of VMS063 as a measles mAb candidate for preclinical development.
(5)
Includes interest income of $1,743 and $628 for the three months ended March 31, 2026 and 2025, respectively.
XML 43 R35.htm IDEA: XBRL DOCUMENT v3.26.1
Nature of Business and Basis of Presentation - Additional Information (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2026
Mar. 31, 2025
Dec. 31, 2025
Organization Consolidation And Presentation Of Financial Statements [Line Items]      
Net loss $ 41,400 $ 16,289  
Accumulated Deficit $ 995,883   $ 954,483
XML 44 R36.htm IDEA: XBRL DOCUMENT v3.26.1
Summary of Significant Accounting Policies - Additional Information (Details)
$ in Millions
Mar. 31, 2026
USD ($)
Accounting Policies [Abstract]  
Allowance for doubtful accounts $ 0.3