Invivyd, Inc.

What they do

Invivyd discovers, develops, and commercializes monoclonal antibody (mAb) therapies for the prevention and treatment of serious viral infectious diseases, beginning with SARS-CoV-2. Its first authorized product, PEMGARDA (pemivibart), received FDA emergency use authorization in March 2024 for pre-exposure prophylaxis of COVID-19 in adults and adolescents 12 and older weighing at least 40 kg with moderate-to-severe immune compromise. The company is also advancing VYD2311, a next-generation mAb engineered from adintrevimab, and states intent to expand into other indications such as RSV and measles.

Revenue drivers

• PEMGARDA (pemivibart) net product revenue — The company's only authorized commercial product; Q2 2026 net product revenue was $14.3 million versus $11.8 million in Q2 2025, with growth attributed to increased patient demand. It is authorized only while the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is at or below 90%.
• Full-year 2025 revenue — Revenue rose from $25.4 million in 2024 to $53.4 million in 2025, following $0.00 in 2023, reflecting the first full year of PEMGARDA sales.
• Quarterly revenue trend — Reported revenue was $13.1 million in Q3 2025, $17.2 million in Q4 2025, $13.7 million in Q1 2026, and $14.3 million in Q2 2026.
• VYD2311 (development stage) — No revenue is generated from VYD2311; it remains a clinical candidate intended to support a potential BLA submission for COVID-19 prevention.

Recent performance

For the quarter ended June 30, 2026, Invivyd reported PEMGARDA net product revenue of $14.3 million, up 21% from $11.8 million in Q2 2025. Full-year 2025 revenue was $53.4 million and net loss was $52.5 million, versus 2024 revenue of $25.4 million and net loss of $169.9 million. Operating cash flow improved to negative $58.1 million in 2025 from negative $170.5 million in 2024. At June 30, 2026, the company reported total assets of $218.9 million, total liabilities of $37.8 million, shareholder equity of $181.1 million, and cash and cash equivalents of $160.1 million. Management stated the cash position is anticipated to provide runway through the DECLARATION pivotal data readout and to support potential commercial launch readiness for VYD2311.

Strategy

Invivyd plans to commercialize PEMGARDA for as long as its EUA remains in effect while advancing VYD2311 through its REVOLUTION clinical program, which includes the DECLARATION and LIBERTY trials. Enrollment in the DECLARATION pivotal trial is complete, and the LIBERTY Phase 3 trial is fully dosed with top-line data anticipated in late Q3 2026. The FDA advised in a Type C meeting that a single randomized, placebo-controlled trial evaluating mAb efficacy in preventing RT-PCR-confirmed symptomatic COVID-19 could support a BLA for VYD2311 in a broad population, subject to agreement on safety database size and pending full protocol review. The company also agreed with the FDA on an initial pediatric study plan for VYD2311 in children aged 0-11 (DRUMMER), which would be actioned only if DECLARATION is successful, and announced plans with the SPEAR Study Group for a Phase 2 trial in Long COVID or COVID vaccine injury.

Risks

• Going concern doubt — The company states that, based on current operating plans and excluding future revenue or external financing, existing cash and cash equivalents will not fund operating expenses and capital expenditures for more than one year from issuance of the December 31, 2025 financial statements, and its auditor included an explanatory going concern paragraph.
• PEMGARDA EUA termination — HHS provided advance notice terminating the COVID-19 emergency use declaration effective June 29, 2027, meaning the company's sole commercial product loses its authorization on that timeline absent a change.
• Variant susceptibility limits — PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to it is less than or equal to 90%, so variant evolution can restrict its authorized use.
• Listing-rule and financing risk — The company disclosed a delisting notice or listing-rule failure on July 24, 2026, which could affect its stock price and its ability to raise capital needed to execute current operating plans.

Outlook

Management said the DECLARATION and LIBERTY trials are planned to wrap up in the coming weeks, with top-line data planned later in Q3 2026 for both; the company plans an investor call post study completion in lieu of a Q2 2026 quarterly earnings call. The company expects to complete its heavy clinical investment in the pivotal VYD2311 program shortly and move toward a potential launch of VYD2311 if approved. It also expects continued dialogue with the FDA about next steps for PEMGARDA following the EUA termination notice.