Invivyd, Inc.

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.

Invivyd, Inc. announced its participation in three upcoming investor events in June 2026. The company will present at the Jefferies Global Healthcare Conference, the H.C. Wainwright "HCW @ Home" Series, and BTIG Infectious Disease Day 2026. Management will host investor meetings at each event, and webcasts of fireside chats will be available online.

Invivyd, Inc. reported a net loss of $41.4 million for the three months ended March 31, 2026, a significant increase from $16.3 million in the prior year. The company disclosed substantial doubt about its ability to continue as a going concern, indicating insufficient cash to fund operations beyond one year without additional financing. Despite this, product revenue grew 21.6% to $13.7 million, and the company continues to advance its clinical programs for VYD2311, VBY329, and VMS063, with VYD2311 receiving FDA Fast Track designation.

Invivyd, Inc. reported its first quarter 2026 financial results, with PEMGARDA net product revenue growing 22% year-over-year to $13.7 million. The company's net loss increased to $41.4 million, primarily due to higher R&D expenses for the VYD2311 DECLARATION pivotal clinical trial, which achieved full initial enrollment and is now expected to deliver top-line data in Q3 2026. Invivyd also announced positive in vitro neutralization data for pemivibart and VYD2311 against the SARS-CoV-2 BA.3.2.2 variant and initiated development for new monoclonal antibody candidates for measles and RSV.

Invivyd reported Q1 2026 net product revenue of $13.7 million for PEMGARDA, a 22% increase year-over-year. The company posted a net loss of $41.4 million, primarily due to increased R&D costs for the VYD2311 DECLARATION pivotal program. Positive clinical developments include an IDMC recommendation to reduce VYD2311 post-dose monitoring time and the DECLARATION trial upsizing, with top-line data expected in Q3 2026. Invivyd also expanded its pipeline with measles and RSV antibody candidates.

Invivyd, Inc. announced new research demonstrating significantly higher tolerability for its investigational monoclonal antibody adintrevimab compared to mRNA and protein-based COVID-19 vaccines. A post-hoc re-analysis of the EVADE trial showed only 2% Grade 2/3 systemic adverse events for adintrevimab within seven days, versus 91.6% for mRNA vaccines and 83.6% for protein vaccines. This research, available on MedRxiv, highlights the public health challenge of vaccine-induced symptoms. Invivyd plans to build on these findings with the upcoming LIBERTY trial, a head-to-head study comparing VYD2311 (a descendant of adintrevimab) with an mRNA vaccine.

Invivyd, Inc. announced it will host a conference call on Thursday, May 14, 2026, at 8:30 a.m. ET. The call will discuss the company's first quarter 2026 financial results and provide a corporate update. Interested parties can register for the webcast, and a replay will be available on the company's investor website approximately two hours after the call's conclusion.

Invivyd, Inc. announced that it granted options to purchase an aggregate of 731,000 shares of its common stock to 17 newly hired non-executive employees on May 1, 2026. These options, serving as a material inducement for employment, have an exercise price of $1.52 per share, which was the closing price on the grant date. The options will vest over four years and are subject to the terms of the Invivyd, Inc. 2026 Inducement Plan.