Invivyd outlined its commercial and clinical strategy at the H.C. Wainwright 28th Annual Global Investment Conference on Monday, September 14, 2026, moderated by Patrick Trucchio, senior healthcare analyst at H.C. Wainwright. CEO and Chairman Marc Elia said the company is seeking to expand beyond its current antibody product into a broader prevention market, citing an estimated 10 million to 13 million immunocompromised Americans as a key population for antibody prevention.
The company provided financial detail tied to Pemgarda, also known as pemivibart. Elia said the product is running at an annual pace of $60 million to $70 million and growing 20% to 25% year over year. InvestingPro data cited in the transcript showed last-twelve-month revenue through the second quarter of 2026 of $58.4 million, up 26.3% from the prior-year period, with a gross profit margin of 92.2%. The company's market capitalization was $232 million, while levered free cash flow was negative $109.7 million over the last twelve months. The current ratio was 5.87. Shares had declined 48.8% over the prior six months and were quoted at $0.786, up 1.29%, with after-hours trading at $0.802.
Pemgarda is a commercial preventative monoclonal antibody that requires about one hour of infusion time followed by two hours of monitoring. It is available under an Emergency Use Authorization and carries a black box warning for anaphylaxis. The transcript cited historical efficacy data showing an 84% to 94% reduction against Omicron variants compared with placebo in modern populations, and earlier adintrevimab data showing a 71% reduction in symptomatic disease in a seronegative population.
The company's next-generation candidate, VYD2311, is being developed with a target efficacy range of 70% to 90% reduction in symptomatic disease versus placebo. The Phase III DECLARATION program is a placebo-controlled study with two active arms measuring PCR-positive symptomatic COVID-19 versus placebo. The study was upsized in April 2024 to improve statistical power, and top-line data were expected at the end of the third quarter of 2024. A separate LIBERTY trial is designed to compare the safety and tolerability of a vaccine and an antibody during the first seven days after dosing.
Regulatory considerations were also discussed. The transcript referenced a June decision by Secretary Kennedy ending Emergency Use Authorizations for COVID-19 monoclonal antibodies, affecting availability by mid-2025 unless VYD2311 advances. Invivyd is considering two regulatory paths: full unblinding with a traditional approval pathway, or partial unblinding focused on safety, pharmacokinetics and antiviral activity followed by an accelerated approval filing. Elia said the company's intent is to make VYD2311 functionally interchangeable with a vaccine, given intramuscularly and available with equal standing in pharmacies and minute clinics.
The discussion also covered the company's broader platform and pipeline, including the REVOLUTION program, VMS063 for measles and VYD222 for RSV. Elia said the company believes it runs essentially the world's biggest immune system ex vivo and that almost anything would be practice-changing because people do not normally have access to immune supplementation beyond what their bodies can produce. The transcript also mentioned skier Lindsey Vonn as a partner for public awareness and referenced Regeneron, AstraZeneca and Sidara without additional company-specific detail.
