Invivyd (IVVD) highlights FDA pathway for COVID-19 antibody VYD2311

Rhea-AI Filing Summary

Invivyd, Inc. filed a current report describing several disclosures made on August 14, 2025. The company issued a press release with its financial results for the quarter ended June 30, 2025 and recent business highlights, which is included as Exhibit 99.1.

Invivyd also released a separate press release titled “Invivyd Aligns with U.S. FDA on Rapid Pathway to Full Approval (BLA) of Vaccine Alternative Monoclonal Antibody VYD2311 to Protect American Adults and Adolescents from COVID-19,” filed as Exhibit 99.2. In addition, the company posted an updated corporate presentation on its website, furnished as Exhibit 99.3.

Insights

Biopharma regulatory and earnings analyst

Invivyd pairs quarterly results disclosure with an FDA pathway update for its COVID-19 antibody VYD2311.

Invivyd reports that it has released quarterly financial results and business highlights for the period ended June 30, 2025 via a press release. While specific revenue or earnings figures are not described here, this keeps investors informed on operating progress alongside pipeline developments.

The separate press release title indicates Invivyd has aligned with the U.S. FDA on a rapid pathway to full biologics license application (BLA) approval for VYD2311, described as a vaccine alternative monoclonal antibody to protect American adults and adolescents from COVID-19. Alignment on a regulatory pathway can be an important milestone for biopharma companies, as it frames the route toward potential approval without yet representing an approval itself.

The company also posted an updated corporate presentation, suggesting it is packaging these financial and regulatory developments into a broader narrative for stakeholders. Subsequent detailed disclosures in the referenced exhibits and future periodic reports will show how the VYD2311 program and overall financial profile evolve within this FDA pathway framework.

false 0001832038 0001832038 2025-08-14 2025-08-14

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 14, 2025

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.)

1601 Trapelo Road, Suite 178 Waltham, MA		02451
(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 August 14, 2025, Invivyd, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 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 August 14, 2025, the Company issued a press release entitled “Invivyd Aligns with U.S. FDA on Rapid Pathway to Full Approval (BLA) of Vaccine Alternative Monoclonal Antibody VYD2311 to Protect American Adults and Adolescents from COVID-19.” A copy of the press release is filed herewith as Exhibit 99.2 and is incorporated by reference into this Item 8.01.

On August 14, 2025, the Company posted an updated corporate presentation on its website at www.invivyd.com. A copy of the presentation is filed as Exhibit 99.3 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 August 14, 2025
99.2		Press Release, dated August 14, 2025
99.3		Corporate Presentation, dated August 14, 2025
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: August 14, 2025				By:		/s/ Jill Andersen
						Jill Andersen
						Chief Legal Officer and Corporate Secretary

FAQ

What did Invivyd (IVVD) disclose in its latest 8-K filing?

Invivyd reported that it issued a press release with financial results and recent business highlights for the quarter ended June 30, 2025, provided a separate press release on its FDA pathway for VYD2311, and posted an updated corporate presentation.

Which financial period does Invivyd (IVVD) cover in this 8-K?

The company’s press release furnished with the 8-K presents financial results and recent business highlights for the quarter ended June 30, 2025.

What is VYD2311 mentioned in Invivyd’s (IVVD) 8-K filing?

VYD2311 is described in a press release title as a vaccine alternative monoclonal antibody intended to protect American adults and adolescents from COVID-19, for which Invivyd has aligned with the U.S. FDA on a rapid pathway to full BLA approval.

How did Invivyd (IVVD) describe its interaction with the FDA regarding VYD2311?

Invivyd stated in a press release title that it has aligned with the U.S. FDA on a rapid pathway to full approval (BLA) for VYD2311, indicating agreement on a regulatory path but not an approval decision.

What exhibits are included with Invivyd’s (IVVD) 8-K report?

Exhibits include a press release with quarterly financial results and business highlights (99.1), a press release on the FDA pathway for VYD2311 (99.2), a corporate presentation dated August 14, 2025 (99.3), and the cover page interactive data file (104).

Where can investors find Invivyd’s updated corporate presentation?

The 8-K states that Invivyd posted an updated corporate presentation on its website at www.invivyd.com and also filed it as Exhibit 99.3.