STOCK TITAN

Invivyd names chair CEO, grants 10.7M-share option

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Invivyd, Inc. (IVVD) announced leadership and governance changes and provided an update on its COVID-19 antibody program. The board appointed Chairman Marc Elia as Chief Executive Officer effective August 30, 2026, with CFO William Duke, Jr. continuing as principal financial and accounting officer. Elia’s employment agreement includes a substantial option grant, cash compensation, and change-in-control protections. The board named Ajay Royan Lead Independent Director and added Ian Sheffield as an independent director, who joined the Audit and Compensation Committees. Invivyd also highlighted that its Phase 3 VYD2311 studies, DECLARATION and LIBERTY, are approaching completion, with top-line data from VYD2311 expected around the end of Q3 2026 and potential Biologics License Application filings under either traditional or Accelerated Approval pathways, subject to FDA review.

Positive

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Negative

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Filing Explained

The CEO appointment adds a 10.7 million-share option and cash commitments, but this disclosure does not issue those shares.

This Form 8-K reports that Invivyd appointed Marc Elia as chief executive officer effective August 30, 2026; William Duke, Jr. remains principal financial and accounting officer.

The appointment adds a $750,000 annual base salary, a target annual bonus equal to 70% of salary, a $500,000 sign-on bonus, and conditional severance and change-in-control benefits.

The company granted Elia an option for 10,700,000 common shares and Ian Sheffield an option for 100,000 shares; these are awards rather than issued shares, but exercise would increase the share count and reduce existing holders' percentage ownership absent offsetting changes.

As of June 30, 2026, the latest quarterly record showed $160.08 million of cash and $43.005 million of quarterly operating cash outflow, which equals 338.7 days of the last reported operating cash use at that rate.

The Elia option vests over four years, with 25% vesting on the first anniversary and the remainder in monthly installments; it expires on the tenth anniversary unless earlier terminated, making vesting and any later exercise the relevant follow-up mechanics.

Sources and calculations
  • Invivyd Form 8-K (2026-09-01)
  • Form 8-K purpose (current)
  • Dilution (current)
  • Invivyd second-quarter 2026 fundamentals (2026-06-30)
  • Available liquidity against the last reported quarterly operating outflow, in days at that rate $160,080,000 / ($43,005,000 / 91) = 338.7 days
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers Governance
Key personnel changes including departures, elections, or appointments of directors and executive officers.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
CEO annual base salary $750,000 Annual base salary for Marc Elia under his Employment Agreement
CEO target bonus percentage 70% of annual base salary Initial target annual cash bonus for Marc Elia
CEO option grant 10,700,000 shares of common stock Option grant to Marc Elia, vesting over four years
CEO sign-on bonus $500,000 One-time cash sign-on bonus for Marc Elia
Transaction bonus range 0.5% to 1.5% of equity value One-time transaction bonus for qualifying Change in Control deals of at least $5.0 billion
Equity value thresholds for transaction bonus $5.0 billion and $20.0 billion No bonus below $5.0 billion; maximum percentage at $20.0 billion or more
DECLARATION trial enrollment approximately 2,400 participants Total enrollment for the Phase 3 DECLARATION trial of VYD2311
LIBERTY trial enrollment approximately 210 participants Total enrollment for the Phase 3 LIBERTY trial of VYD2311
Change in Control financial
"one-time transaction bonus in connection with certain qualifying Change in Control"
A "change in control" occurs when the ownership or management of a company shifts significantly, such as through a merger, acquisition, or sale of a large part of its assets. This change can impact how the company is run and may influence its future direction. For investors, it matters because it can affect the company's stability, strategy, and value, often signaling potential changes in investment risk or opportunity.
Biologics License Application (BLA) regulatory
"submit a Biologics License Application (BLA) towards traditional product approval"
A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.
Accelerated Approval regulatory
"submit a BLA towards Accelerated Approval on the basis of antiviral activity"
Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.
emergency use authorization (EUA) regulatory
"granted emergency use authorization in the U.S. for the pre-exposure prophylaxis"
monoclonal antibody (mAb) medical
"VYD2311 is a novel monoclonal antibody (mAb) candidate being developed"
A monoclonal antibody (mAb) is a lab-made protein engineered to recognize and stick to one specific molecule in the body, like a guided missile or a key fitting a single lock. For investors, mAbs matter because their clinical trial results, regulatory approvals, patent position and manufacturing complexity can drive a company’s future sales, costs and risk profile, making them major value drivers in healthcare stocks.
triple-blind medical
"DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial"
Triple-blind describes a clinical trial design in which three parties—usually the patients, the clinicians giving the treatments, and the people who evaluate the results or analyze the data—are kept unaware of who received the active treatment or the control. Using an everyday analogy, it’s like a cooking contest where the chef, the judge, and the scorekeeper all don’t know which recipe used the secret ingredient. For investors, triple-blind trials reduce bias and increase confidence that reported safety and effectiveness findings are reliable, which affects a drug or device’s regulatory prospects and commercial value.

FAQ

What executive leadership change did Invivyd (IVVD) announce?

Invivyd appointed Marc Elia, previously Chairman of the Board, as Chief Executive Officer effective August 30, 2026. He will serve as both Chairman and CEO, while William Duke, Jr. remains the company’s principal financial officer and principal accounting officer.

What are the key compensation terms for Invivyd (IVVD) CEO Marc Elia?

Marc Elia receives an annual base salary of $750,000, an initial target annual bonus equal to 70% of base salary, a one-time $500,000 sign-on bonus, and an option to purchase 10,700,000 shares of common stock vesting over four years, subject to continued service.

What change-in-control benefits could Invivyd (IVVD) CEO Marc Elia receive?

If terminated without cause or for good reason during the Change in Control Period, Marc Elia is eligible for a lump-sum cash severance equal to 18 months of base salary plus his target bonus, up to 18 months of benefits continuation, and full acceleration of time-based equity awards, subject to a release.

What transaction bonus opportunity does Invivyd (IVVD) provide to its CEO?

Marc Elia may receive a one-time transaction bonus in certain qualifying Change in Control deals, ranging from 0.5% to 1.5% of the company’s equity value for transactions with equity values of $5.0 billion or more, with the maximum percentage applying at $20.0 billion or higher.

Who is the new independent director on Invivyd’s (IVVD) board and how is he compensated?

Invivyd appointed Ian Sheffield as an independent director effective August 30, 2026. Under the current policy he receives a $40,000 annual board retainer, additional retainers of $7,500 for Audit Committee and $5,000 for Compensation Committee service, and an option to purchase 100,000 shares.

What is the status of Invivyd’s (IVVD) VYD2311 clinical program?

Invivyd stated that its VYD2311 Phase 3 studies DECLARATION and LIBERTY are approaching completion and that it continues to expect top-line data from the VYD2311 program around the end of Q3 2026, with potential Biologics License Application filings under traditional or Accelerated Approval pathways.

How large are Invivyd’s (IVVD) DECLARATION and LIBERTY trials for VYD2311?

DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial with total enrollment of approximately 2,400 participants. LIBERTY is a Phase 3, randomized, double-blind trial with total enrollment of approximately 210 participants.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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0001832038false00018320382026-08-302026-08-30

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): August 30, 2026

Invivyd, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

 

Delaware

001-40703

85-1403134

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

205 Church Street

New Haven, CT

06510

(Address of Principal Executive Offices)

(Zip Code)

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

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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, par value $0.0001 per share

IVVD

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. 


Item 5.02.

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Appointment of Marc Elia as Chief Executive Officer

 

On August 30, 2026, the Board of Directors (the “Board”) of Invivyd, Inc. (the “Company”) appointed Marc Elia, Chairman of the Board, as the Company’s Chief Executive Officer, effective as of August 30, 2026 (the “Effective Date”). Mr. Elia will serve as the Company’s principal executive officer, a role previously held by William Duke, Jr., the Company’s Chief Financial Officer, who remains the Company’s principal financial officer and principal accounting officer. In connection with the appointment of Mr. Elia as Chief Executive Officer, the Board appointed Ajay Royan as the Lead Independent Director of the Board, effective as of the Effective Date. The Board also appointed Mr. Royan to replace Mr. Elia as Chairperson of the Nominating and Corporate Governance Committee of the Board (the “Nominating and Corporate Governance Committee”).

 

Mr. Elia, age 50, has served as a member of the Board since June 2022 and as Chairman of the Board since July 2022. He previously served as a member of the Board from July 2020 to April 2021. Mr. Elia is the founder and chief investment officer of M28 Capital Management L.P., a healthcare sector investment fund, positions he has held since September 2019. Prior to that, from January 2012 to September 2019, Mr. Elia served as a partner at Bridger Capital, an investment fund. Mr. Elia currently serves on the board of directors of Fractyl Health, Inc., a publicly-traded metabolic therapeutics company. He previously served on the boards of directors of SQZ Biotechnologies Company and Adimab, LLC. Prior to his career in investing, Mr. Elia held various roles across the biotechnology industry at N30 Pharmaceuticals, Chiron Corporation, and L.E.K. Consulting. Mr. Elia holds a B.A. in Economics from Carleton College.

 

In connection with Mr. Elia’s appointment, the Company entered into an employment agreement with Mr. Elia (the “Employment Agreement”). Pursuant to the Employment Agreement, Mr. Elia is entitled to receive an annual base salary of $750,000, which will be reviewed at least annually and will be subject to adjustment from time to time, as determined by the Board or the Compensation Committee of the Board (the “Compensation Committee”). In addition, pursuant to the Employment Agreement, Mr. Elia is eligible to receive an annual cash bonus, which is based on the achievement of certain performance goals and objectives as reasonably determined by the Board or the Compensation Committee, calculated as a percentage of his annual base salary, and which will be determined by the Board or the Compensation Committee. Mr. Elia’s initial target annual bonus is 70% of his annual base salary. For calendar year 2026, Mr. Elia will be eligible to earn an annual cash bonus, which, if granted, would not be pro-rated.

 

In addition, the Company granted Mr. Elia an option to purchase 10,700,000 shares of the Company’s common stock (the “Common Stock”) at an exercise price equal to the closing sales price for the Common Stock as quoted on the Nasdaq Stock Market on August 28, 2026, which was the last trading day prior to the date of grant (the “Elia Option Grant”). The Elia Option Grant vests over a four-year period, with 25% of the shares underlying the Elia Option Grant vesting on the first anniversary of the Effective Date and the remaining shares underlying the Elia Option Grant vesting over the subsequent three-year period in substantially equal monthly installments at a rate of 1/48th of the total shares subject to the Elia Option Grant each month, subject to Mr. Elia’s continuous service with the Company as of each vesting date. The Elia Option Grant expires on the tenth anniversary of the grant date, unless earlier terminated in accordance with its terms. The Elia Option Grant was made pursuant to, and is subject to the terms of, the Company’s 2021 Equity Incentive Plan (the “Plan”) and the Company’s form of option award agreement for executive officers (the “Elia Option Award Agreement”).

 

Pursuant to the Employment Agreement, Mr. Elia is entitled to receive a one-time sign-on bonus of $500,000 as soon as practicable after the Effective Date (the “Sign-On Bonus”). The Sign-On Bonus is subject to potential repayment as contemplated by the Employment Agreement. In addition, pursuant to the Employment Agreement and subject to the conditions set forth therein, Mr. Elia is eligible to receive a one-time transaction bonus in connection with certain qualifying Change in Control (as defined in the Plan) transactions. The transaction bonus is based on the equity value of the Company determined in connection with the applicable transaction and ranges from 0.5% to 1.5% of such equity value for transactions with equity values of $5.0 billion or more, with the maximum percentage applicable to transactions with equity values of at least $20.0 billion. No transaction bonus is payable for a Change in Control transaction with an equity value of less than $5.0 billion.


 

The term of the Employment Agreement commenced on the Effective Date and continues until Mr. Elia is terminated in accordance therewith. The Company may terminate Mr. Elia’s employment at any time without cause, and Mr. Elia may terminate his employment at any time, upon written notice.

 

The Employment Agreement provides for standard Company benefits, such as paid time off, reimbursement of business expenses, and participation in the Company’s employee benefit plans and programs. In the event that Mr. Elia’s employment terminates due to death or a disability, he will be entitled to accrued obligations, and payment of any unpaid annual bonus for the preceding calendar year earned based on achievement of the applicable performance goals and objectives if his employment terminates after the completion of the preceding calendar year but prior to the date of payment of the bonus (the “Earned Bonus”). In the event that Mr. Elia’s employment is terminated, other than during the Change in Control Period (as defined below), by the Company without “cause” or by him for “good reason” (each as defined in the Employment Agreement), and subject to the delivery to the Company of a separation agreement that includes a general release of claims and such separation agreement becoming fully effective, Mr. Elia will receive cash severance equal to 12 months of his base salary, as well as the Earned Bonus, if applicable, and 12 months continuation of benefits. In addition, the unvested portion of any outstanding time-based equity awards held by Mr. Elia as of the date of termination would remain outstanding for three months following such date of termination and, if the Company enters into a definitive Change in Control agreement during that period, would remain outstanding and vest upon the consummation of the resulting Change in Control, subject to the terms and conditions of the Employment Agreement.

 

In the event that Mr. Elia’s employment is terminated by the Company without cause or by him for good reason, in either case, during the period commencing on the earlier of (x) the signing of a definitive agreement that, if closed, would result in a Change in Control and (y) the date that is three months prior to the closing of a Change in Control and ending on the date that is 12 months following a Change in Control (the “Change in Control Period”), and subject to his delivery to the Company of a separation agreement that includes a general release of claims and subject to such separation agreement becoming fully effective, Mr. Elia will receive cash severance equal to the sum of 18 months of his base salary and his target bonus for the year of termination, payable in a lump sum, as well as the Earned Bonus, if applicable, and 18 months continuation of benefits. In such case, Mr. Elia will also be entitled to immediate acceleration and full vesting of any time-based equity awards, as if his employment continued until the later of the date of termination (or, if later, the Change in Control) or the effective date of the separation agreement.

 

In connection with his appointment, Mr. Elia also entered into the Company’s standard form of Employee Proprietary Information and Inventions Assignment Agreement (the “PIIAA”), which, among other things, prohibits him from competing with the Company, soliciting the Company’s employees and customers and disclosing confidential information during the term of his employment and for a specified time thereafter. As a member of the Board, Mr. Elia previously entered into the Company’s standard form of indemnification agreement, a copy of which was filed as Exhibit 10.5 to the Company’s Annual Report on Form 10-K (File No. 001-40703) filed with the U.S. Securities and Exchange Commission (“SEC”) on March 5, 2026 (the “Elia Indemnification Agreement”).

 

Other than with respect to the Employment Agreement, the Elia Option Award Agreement, the PIIAA, and the Elia Indemnification Agreement, there are no arrangements or understandings between Mr. Elia and any other person pursuant to which Mr. Elia was appointed as Chief Executive Officer of the Company. There are also no family relationships between Mr. Elia and any director or executive officer of the Company, and Mr. Elia has no direct or indirect interest in any transaction or proposed transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.

 

The description of the Employment Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Employment Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference in this Item 5.02.

 

Appointment of Ian Sheffield to the Board of Directors

 

On August 30, 2026, the Board, upon the recommendation of the Nominating and Corporate Governance Committee, increased the size of the Board from six directors to seven directors and appointed Ian Sheffield as a director to fill the resulting vacancy, effective as of August 30, 2026, with his term expiring at the Company’s 2027


annual meeting of stockholders. The Board also appointed Mr. Sheffield to the Compensation Committee and as a replacement for Mr. Elia on the Audit Committee of the Board (the “Audit Committee”).

 

Mr. Sheffield’s compensation as a director will be consistent with the compensation provided to all of the Company’s non-employee directors. Under the Company’s current non-employee director compensation policy, Mr. Sheffield will receive an annual cash retainer of $40,000 for his Board service. Mr. Sheffield will receive additional annual cash retainers of $7,500 for his service on the Audit Committee and $5,000 for his service on the Compensation Committee. In addition, under the Company’s current non-employee director compensation policy, on August 31, 2026 (the “Sheffield Grant Date”), which was the first trading day following Mr. Sheffield’s appointment to the Board, the Company granted Mr. Sheffield an option to purchase 100,000 shares of Common Stock at an exercise price equal to the closing sales price for the Common Stock as quoted on the Nasdaq Stock Market on the Sheffield Grant Date (the “Sheffield Option Grant”). The Sheffield Option Grant vests over a three-year period, with one-third of the shares vesting on the first anniversary of the Sheffield Grant Date and 1/36th of the total shares vesting in substantially equal monthly installments thereafter, subject to Mr. Sheffield’s continuous service with the Company through each such vesting date. The Sheffield Option Grant expires on the tenth anniversary of the grant date, unless earlier terminated in accordance with its terms. The Sheffield Option Grant was made pursuant to, and is subject to the terms of, the Plan and the Company’s form of option award agreement for non-employee directors (the “Sheffield Option Award Agreement”).

 

In connection with his appointment, Mr. Sheffield entered into the Company’s standard form of indemnification agreement, a copy of which was filed as Exhibit 10.5 to the Company’s Annual Report on Form 10-K (File No. 001-40703) filed with the SEC on March 5, 2026 (the “Sheffield Indemnification Agreement”).

 

Other than with respect to the Company’s non-employee director compensation policy, the Sheffield Option Award Agreement, and the Sheffield Indemnification Agreement, there are no arrangements or understandings between Mr. Sheffield and any other person pursuant to which Mr. Sheffield was appointed a director of the Company. There are no relationships or transactions in which Mr. Sheffield has or will have an interest, or was or is a party, requiring disclosure under Item 404(a) of Regulation S-K.

 

Item 8.01.

Other Events.

 

On September 1, 2026, the Company issued a press release entitled, “Invivyd Appoints Chairman Marc W. Elia as Chief Executive Officer; Approaches Results of VYD2311 studies DECLARATION and LIBERTY.” A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.

 

Item 9.01.

Financial Statements and Exhibits.

 

(d) Exhibits

 

 

 

 

Exhibit
No.

Description

 

 

10.1*

Employment Agreement, dated August 30, 2026, by and between Invivyd, Inc. and Marc Elia

 

 

99.1

Press Release, dated September 1, 2026

 

 

104

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

 

* Certain schedules to this agreement have been omitted in accordance with Item 601(a)(5) of Regulation S-K. A copy of any omitted schedules will be furnished supplementally to the SEC upon request.


SIGNATURES

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

 

 

 

 

 

 

 

 

 

INVIVYD, INC.

 

 

 

 

Date: September 1, 2026

 

By:

/s/ Jill Andersen

 

 

 

Jill Andersen

 

 

 

Chief Legal Officer and Corporate Secretary

 


Exhibit 99.1

img59752938_0.jpg

 

Invivyd Appoints Chairman Marc W. Elia as Chief Executive Officer; Approaches Results of VYD2311 studies DECLARATION and LIBERTY

Mr. Elia has served as Chairman of Invivyd’s Board of Directors since June of 2022; has architected Invivyd’s scientific and corporate strategy
Ajay Royan, Founder of Mithril Capital and a founding, long-term investor in Invivyd, appointed Lead Independent Director
Ian Sheffield appointed to Invivyd’s Board of Directors as an independent director
DECLARATION and LIBERTY studies of VYD2311 approaching completion with further updates expected within weeks

 

NEW HAVEN, Conn., Sept. 01, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the company has appointed Marc Elia, current Chairman of the Invivyd Board of Directors, as Chief Executive Officer (CEO) of the company. He will serve as Chairman and CEO of Invivyd going forward.

“Invivyd is transforming the way people are protected from serious viral infectious disease and requires a leader who has an expansive vision for how to improve public health and the ability to persuade others to bring the vision to life. That leader is Marc Elia,” said Ajay Royan, Lead Independent Director of Invivyd. “Marc has been a significant contributor to Invivyd since joining the Board and becoming Chairman. I’m eager to see the success he will bring to the company and to humanity as the Chief Executive Officer.”

“Invivyd and its antibody technologies have the potential to revolutionize COVID prevention, and infectious disease medicine more broadly,” commented Marc Elia, Chairman and CEO of Invivyd. “Invivyd has been purpose-built to offer Americans and the world a new way to stay well by reliably accessing high quality, targeted, monoclonal antibody immune support that can provide protection from disease beyond the limits of vaccinology. Our current status quo involves too many Americans left to be sick too often, and many Americans, including myself, have struggled with the effects of Long COVID for years. Now more than ever we need companies that can bring forward medicines that advance our society past a need to repeatedly get sick from viruses we can prevent and treat with monoclonal antibodies. It’s an honor to lead the charge at Invivyd.”

Joining the Invivyd Board of Directors as a new independent director is Ian Sheffield, founder and Managing Partner of North Country Holdings, a private investment firm. Mr. Sheffield has more than 20 years of experience as a healthcare investor and medical technology executive, previously holding senior roles at Ashler Capital (Citadel), Bridger Capital, Great Point Partners, and Versant Ventures.

Invivyd continues to expect top-line data from the VYD2311 program around the end of Q3 2026. At that time, Invivyd plans to either unblind the DECLARATION study in its entirety and submit a Biologics License Application (BLA) towards traditional product approval, or partially unblind the study (leaving clinical events blinded) and submit a BLA towards Accelerated Approval on the basis of antiviral activity and safety, with greater statistical power expected to be achieved in a post-approval confirmatory clinical cohort. Preparing such options for filing pathway will substantially reduce the risk that play of chance related to the statistical powering in


 

DECLARATION intrudes into the near-term availability of VYD2311, a highly active anti-COVID-19 monoclonal antibody that is functionally identical to prior Invivyd antibodies adintrevimab and pemivibart. The company has been in discussions with FDA about potential paths forward and believes that either route can provide a near-term pathway to make VYD2311 available for millions of Americans, subject to FDA review and approval. Invivyd will provide further updates in the coming weeks as previously guided.

About VYD2311

VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration.

VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19.

About DECLARATION

DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without risk factors for progression to severe COVID-19 at three months. Participants will receive either a single dose or monthly doses of VYD2311, each administered via intramuscular (IM) injection, compared to placebo. Total enrollment of the trial is approximately 2,400 participants.

About LIBERTY

LIBERTY is a Phase 3, randomized, double-blind clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of VYD2311, an mRNA COVID vaccine, and co-administered VYD2311 with an mRNA COVID vaccine. Total enrollment of the trial is approximately 210 participants.

About Invivyd

Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more.

Trademarks are the property of their respective owners.

 

 


 

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “plans,” “potential,” “predicts,” “projects,” “future,” and “target” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the anticipated contributions of the company’s Chief Executive Officer; plans related to the company’s research and development activities, and the timing and potential results thereof; expectations regarding the company’s clinical trial designs, event accumulation and progress, regulatory pathway, product profile, indication, patient populations, and administration paradigm for VYD2311; the company’s plans to provide future updates and the timing thereof; expectations regarding the public health landscape and potential benefits of mAbs; the potential of Invivyd and its antibody technologies to revolutionize COVID prevention, and infectious disease medicine more broadly; the potential of VYD2311 as a novel mAb candidate that may be able to deliver clinically meaningful titer levels through more patient-friendly means; the company’s business strategies and objectives; the company’s future prospects; and other statements that are not historical fact. The company may not actually achieve the plans, intentions, or expectations disclosed in the company’s forward-looking statements, and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing, progress, and results of the company’s discovery, preclinical, and clinical development activities; uncertainties regarding clinical trial event accumulation rates and statistical powering; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; unexpected safety or efficacy data observed during preclinical studies or clinical trials; whether or not any preclinical candidate identified by the company is determined to be suitable for clinical development; changes in the regulatory environment; the outcome of the company’s engagement with regulators; uncertainties related to the regulatory approval process, and available development and regulatory pathways; the company’s ability to generate the data needed to support a potential BLA submission for VYD2311; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitope that VYD2311 targets remains structurally intact and the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the ability to maintain a continued acceptable safety, tolerability, and efficacy profile of any product candidate following regulatory authorization or approval; the risk that a lack of awareness of mAb therapies and regulatory scrutiny of mAb therapies may adversely impact the development or commercial success of the company’s product candidates; changes in expected or existing competition; the company’s reliance on third parties; complexities of manufacturing mAb therapies; macroeconomic and political uncertainties; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026,


 

each as filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

Contacts:

Media Relations
(781) 208-0160
media@invivyd.com

Investor Relations
(781) 208-1747
investors@invivyd.com

 

 

 


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