Invivyd, Inc.

Invivyd, Inc. reported a net loss of $(44.4) million for the second quarter of 2026, significantly wider than the $(14.7) million loss in the same period last year, despite product revenue increasing to $14.3 million. The company disclosed substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows. Research and development and selling, general and administrative expenses saw significant increases, while cash and cash equivalents declined to $160.1 million.

Invivyd reported Q2 2026 PEMGARDA net product revenue of $14.3 million, marking a 21% increase from Q2 2025. The company's cash and cash equivalents were $160.1 million as of June 30, 2026, providing runway through key clinical trial readouts. Net loss for the quarter increased to $44.4 million, driven by higher R&D and SG&A expenses as the company advanced its VYD2311 clinical program. Invivyd announced the completion of enrollment for its DECLARATION and LIBERTY clinical trials, with top-line data for both anticipated in late Q3 2026, and received 12 months' notice of PEMGARDA's Emergency Use Authorization termination.

Invivyd reported Q2 2026 PEMGARDA net product revenue of $14.3 million, a 21% increase year-over-year. The company announced the completion of enrollment for its DECLARATION pivotal clinical trial and LIBERTY clinical trial, with top-line data for both expected in late Q3 2026. Cash and cash equivalents stood at $160.1 million, projected to fund operations through the DECLARATION data readout. However, the company's net loss widened to $44.4 million due to increased R&D and SG&A expenses, and it received notice of PEMGARDA's EUA termination effective June 29, 2027.

Invivyd, Inc. received a deficiency letter from Nasdaq on July 23, 2026, notifying the company that its common stock had traded below the $1.00 minimum bid price requirement for 30 consecutive business days. The company has until January 19, 2027, to regain compliance by maintaining a closing bid price of at least $1.00 for a minimum of ten consecutive business days. Failure to comply could lead to delisting, though an additional 180-day period may be available under certain conditions.

Invivyd, Inc. announced that the FDA issued a notice of termination for the Emergency Use Authorization (EUA) of its COVID-19 prophylactic, PEMGARDA®, effective June 29, 2027. This follows the U.S. Department of Health and Human Services' advanced notice of termination for the broader COVID-19 EUA declaration. Invivyd is actively engaging with the FDA to determine next steps and plans to pursue a Biologics License Application (BLA) for full approval of PEMGARDA, citing strong clinical and post-authorization data.

Invivyd, Inc. announced that the FDA issued a Notice of Termination for its PEMGARDA Emergency Use Authorization (EUA), effective June 29, 2027. This follows the U.S. Department of Health and Human Services' broader termination of the COVID-19 EUA declaration. PEMGARDA, authorized since March 2024 for pre-exposure prophylaxis of COVID-19 in immunocompromised individuals, will have a twelve-month transition period. Invivyd plans to pursue a Biologics License Application (BLA) for permanent approval, expressing confidence in its clinical data and ongoing dialogue with the FDA.

Invivyd, Inc. announced the grant of stock options to 14 newly hired non-executive employees on July 1, 2026. These options cover an aggregate of 493,000 shares of common stock, serving as a material inducement for their employment. The options have an exercise price of $0.8544 per share, vest over four years, and have a 10-year term, in accordance with Nasdaq Listing Rule 5635(c)(4) and the company's 2026 Inducement Plan.

Invivyd, Inc. announced the completion of enrollment for its Phase 3 LIBERTY clinical trial, which compares the safety and tolerability of its investigational COVID-19 monoclonal antibody VYD2311 with an mRNA COVID-19 vaccine. The company expects to report topline data from the study in the third quarter of 2026. VYD2311 is being developed as a potential alternative to vaccines for preventing COVID-19, with the aim of offering an improved side effect profile and tolerability advantage.

Invivyd, Inc. announced that the first participants have been dosed in the LIBERTY Phase 3 clinical trial for VYD2311, its investigational monoclonal antibody for COVID-19 prevention. The randomized, double-blind study will evaluate the comparative safety, tolerability, and immunology of VYD2311 alone, an mRNA COVID-19 vaccine alone, and VYD2311 co-administered with a vaccine in healthy adults. Invivyd expects to report topline data from LIBERTY in Q3 2026, coinciding with data from the pivotal DECLARATION trial, as part of its broader REVOLUTION clinical program aimed at establishing VYD2311 as a preferred COVID-19 prevention option.

Invivyd, Inc. announced the completion of enrollment for its Phase 3 DECLARATION clinical trial evaluating VYD2311, an investigational monoclonal antibody for the prevention of symptomatic COVID-19. The trial, which includes both single and monthly intramuscular dosing arms, was upsized by approximately 500 subjects following a pre-specified sample size re-estimation. Top-line results for the trial remain on track for approximately late Q3 2026.