Invivyd (IVVD) Study update summary

COVID-19 Monoclonal Antibody Program and REVOLUTION Updates

• VYD2311, a next-generation monoclonal antibody for COVID-19, is in the pivotal DECLARATION study, which has reached ~50% progress and accumulated enough blinded PCR-positive events to support high anticipated efficacy, with a sample size increase triggered by interim analysis for robust statistical power.

• The study includes single and multi-dose arms, with topline data expected in Q3 2026 following the addition of ~500 subjects.

• FDA collaboration has led to alignment on pediatric studies (DRUMMER trial), which will assess immunogenicity and safety in children 0–11 years, with efficacy extrapolated from DECLARATION and initiation planned for Q2 2026, pending DECLARATION success.

• LIBERTY study protocol, comparing VYD2311, mRNA vaccine, and their combination, has been submitted to the FDA, with operational start-up underway to inform regulatory guidance for vulnerable populations.

• VYD2311 is engineered for potent neutralization of contemporary COVID-19 lineages, including BA.3.2.2 (Cicada), and is administered via intramuscular injection.

COVID-19 Variant Landscape and Antibody Performance

• The BA.3.2.2 (Cicada) variant is considered virologically unfit and unlikely to drive significant waves; VYD2311 shows promising neutralization against it.

• The antibody platform is designed to address broad viral variation, with the potential for a single antibody to remain effective without frequent updates.

• Recent independent data support VYD2311's potency against contemporary and recycled variants.

Measles Monoclonal Antibody (VMS063) Discovery and Development

• VMS063 is a novel, highly potent, half-life-extended monoclonal antibody targeting a conserved epitope on the measles F protein, advancing toward IND-enabling studies with IND readiness targeted for late 2026.

• VMS063 demonstrates strong in vitro neutralization across all tested measles variants and is positioned for both treatment and prevention, including post-exposure and pre-exposure settings.

• U.S. measles cases have surged to a 30-year high, with over 2,200 cases in 2025 and more than 1,500 in Q1 2026; vaccine coverage among kindergartners has dropped below herd immunity threshold.

• Current treatments (IVIG, vitamin A, pooled plasma immune globulin) are inadequate, with variable efficacy and limited use cases; VMS063 could fill significant unmet needs as population immunity wanes.

• VMS063 aims to fill the gap for populations not covered by vaccination, including infants, pregnant women, immunocompromised, vaccine-hesitant, and other high-risk groups.