AI Earnings Predictions for Invivyd Inc. (IVVD)

EX-99.1

2 ivvd-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Invivyd Reports Second Quarter 2026 Financial Results and Recent Business Highlights

• Achieved Q2 2026 PEMGARDA® (pemivibart) net product revenue of $14.3 million, representing 21% growth versus Q2 2025 net product revenue of $11.8 million

• Completed rapid enrollment in VYD2311 DECLARATION clinical trial expansion cohort and LIBERTY clinical trial, driven by strong subject demand

• DECLARATION pivotal clinical trial enrollment is complete; the ongoing study is approaching its planned analysis, and in lieu of a Q2 2026 quarterly earnings call, Invivyd plans to hold an investor call post study completion

• LIBERTY study fully dosed with top-line data anticipated in late Q3 2026

• Strong balance sheet with Q2 2026 ending cash and cash equivalents of $160.1 million anticipated to provide runway through DECLARATION pivotal data readout and support potential commercial launch readiness for VYD2311

NEW HAVEN, Conn., August 13, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the second quarter ended June 30, 2026, and recent business highlights.

“With our VYD2311 DECLARATION and LIBERTY clinical trials planned to wrap up in the coming weeks, we are looking forward to the next steps for vulnerable Americans,” said Marc Elia, Chairman of the Board of Invivyd. “The public health need for antibody-based protection with attractive safety is enormous, and we are confident that many public health leaders and policy makers in the United States understand the importance of having non-vaccine options available for the American public health.”

“We are pleased with continued growth of PEMGARDA, especially in the face of understandably diminished COVID vaccine utilization,” commented Bill Duke, Chief Financial Officer of Invivyd. “We are pleased with our strong cash position as we approach planned top-line data for our VYD2311 pivotal program later this quarter. We have continued to diligently manage expenses, albeit during a period of critical heavy clinical investment in our pivotal VYD2311 program, which we expect to complete shortly as we move toward potential launch of VYD2311, if approved.”

Second Quarter 2026 and Recent Company Highlights

PEMGARDA® Commercial Performance & Regulatory Update

• PEMGARDA net product revenue was $14.3 million for the quarter ended June 30, 2026, compared to $11.8 million in for the quarter ended June 30, 2025. Growth of 21% was driven by increased patient demand.

• In July 2026, Invivyd announced receipt of twelve months’ advanced notice of emergency use authorization (EUA) termination for PEMGARDA and that the company is in dialogue with the U.S. Food and Drug Administration (FDA) about appropriate next steps.

Research & Development (R&D) Highlights

COVID-19

• Invivyd continued to advance its REVOLUTION program, which is Invivyd’s development program for VYD2311 that is designed to elaborate the profile of monoclonal antibody-mediated prophylaxis from COVID-19 and the potential medical benefits to vulnerable Americans:

• DECLARATION: Following trial initiation in late 2025, the DECLARATION pivotal clinical trial recruitment progressed rapidly with full initial enrollment achieved in March 2026. In April 2026, Invivyd announced it had conducted a prospectively designed, conservative, algorithmic sample size re-estimation pooled, blinded analysis for the DECLARATION clinical trial aimed at supporting adequate COVID-19 clinical events and associated statistical power given the variability of COVID-19 attack rates, and, in June 2026, Invivyd announced completion of enrollment in the upsized DECLARATION clinical trial. DECLARATION is designed to support potential Biologics License Application (BLA) submission, with top-line data planned later in Q3 2026.

• LIBERTY: In June 2026, Invivyd announced first participants dosed and completion of enrollment in LIBERTY, a Phase 3 clinical trial to evaluate the safety and tolerability of VYD2311 antibody versus mRNA COVID vaccine and to characterize the safety and immunology of antibody and mRNA vaccine co-administration. The LIBERTY study is now fully dosed, with top-line data anticipated in late Q3 2026.

• DRUMMER: Invivyd agreed with the FDA on an initial pediatric study plan to support potential BLA submission for VYD2311 in children aged 0-11 years; the DRUMMER pediatric clinical trial will be actioned only if the pivotal DECLARATION clinical trial is successful.

• Long COVID: In January 2026, Invivyd and the SPEAR (Spike Protein Elimination and Recovery) Study Group announced the plan 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.

Measles

• In April 2026, Invivyd announced advancement of a measles monoclonal antibody candidate, VMS063. VMS063 is a novel, highly potent, broadly in vitro neutralizing

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8-K

false 0001832038 0001832038 2026-03-05 2026-03-05

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): March 5, 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.)

209 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 2.02. Results of Operations and Financial Condition.

On March 5, 2026, Invivyd, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2025, and recent business highlights. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 2.02. The information furnished pursuant to this Item 2.02, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any of the Company’s filings with the Securities and Exchange Commission under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

On March 5, 2026, the Company posted an updated corporate presentation on its website at www.invivyd.com. A copy of the presentation is filed as Exhibit 99.2 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

99.1

Press Release, dated March 5, 2026

99.2

Corporate Presentation, dated March 5, 2026

104

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

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: March 5, 2026

By:

/s/ Jill Andersen

Jill Andersen

Chief Legal Officer and Corporate Secretary