UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Emerging growth company
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Item 2.02. |
Results of Operations and Financial Condition. |
On October 29, 2024, Invivyd, Inc. (the “Company”) issued a press release entitled “Invivyd Reports Preliminary Third Quarter 2024 Results, Withdraws Prior Financial Guidance, and Targets Near-Term Profitability” (the “Press Release”), which included the Company’s estimated third quarter 2024 PEMGARDA™ (pemivibart) net product revenue and estimated cash and cash equivalents as of September 30, 2024. The amounts included in the Press Release are preliminary and are subject to change upon completion of the Company’s financial closing procedures for the quarter ended September 30, 2024, and finalization of the unaudited interim condensed consolidated financial statements. The preliminary financial data included in the Press Release has been prepared by, and is the responsibility of, the Company’s management. PricewaterhouseCoopers LLP, the Company’s independent registered public accounting firm, has not audited, reviewed, examined, compiled, nor applied agreed-upon procedures with respect to the preliminary financial data. Accordingly, PricewaterhouseCoopers LLP does not express an opinion or any other form of assurance with respect thereto. Additional information and disclosures would be required for a more complete understanding of the Company’s financial position and results of operations as of September 30, 2024. A copy of the Press Release is filed herewith as Exhibit 99.1 and is incorporated by reference in this Item 2.02.
Item 8.01. |
Other Events. |
On October 29, 2024, the Company issued the Press Release, a copy of which is filed herewith as Exhibit 99.1 and is incorporated by reference in this Item 8.01.
On October 29, 2024, the Company issued a press release entitled “Invivyd Phase 3 Long-Term Exploratory Clinical Efficacy Data Shows PEMGARDA™ (pemivibart) Provided Substantial Protection From Symptomatic COVID-19 Versus Placebo Over Six Months of Follow-Up, With No Additional Doses, In Immunocompetent Participants.” A copy of the press release is filed herewith as Exhibit 99.2 and is incorporated by reference in this Item 8.01.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
Exhibit |
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Description |
99.1 |
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99.2 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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: October 29, 2024 By: /s/ Jill Andersen
Jill Andersen
Chief Legal Officer and Corporate Secretary
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