Invivyd (IVVD) H.C. Wainwright “HCW @ Home” Series summary

Strategic vision and pipeline overview

• Focus on monoclonal antibody therapies for viral infectious diseases, with initial emphasis on COVID-19 and a growing pipeline targeting RSV, measles, long COVID, and other pathogens.

• PEMGARDA (pemivibart) is currently authorized for COVID-19 pre-exposure prophylaxis in immunocompromised patients under EUA.

• VYD2311, a next-generation intramuscular antibody, is in phase III (DECLARATION trial), with top-line data expected in Q3 2026.

• Additional programs include LIBERTY (combination with vaccines), DRUMMER (pediatrics), and SPEAR (long COVID/post-vaccine syndrome).

• RSV and measles monoclonal candidates are expected to enter clinical trials in 2027.

Scientific rationale and clinical insights

• Monoclonal antibodies offer targeted, durable protection, potentially outperforming vaccines in certain populations.

• Controlled studies show antibody prophylaxis can achieve 94–95% protection, comparable to peak vaccine efficacy.

• VYD2311 is designed for high potency, long duration, and ease of administration (IM or potentially subcutaneous).

• DECLARATION trial includes both single-dose and monthly-dose arms to maximize flexibility and address regulatory needs.

• LIBERTY will assess safety and immunologic profile of combining antibody and vaccine, with a focus on tolerability.

Commercialization and market opportunity

• PEMGARDA’s commercial experience highlighted logistical challenges with IV infusion and specialty distribution.

• VYD2311 aims to address broader populations with easier administration and improved tolerability, targeting both immunocompromised and general at-risk groups.

• The addressable market includes 10–13 million immunocompromised Americans, with potential expansion to 170 million at-risk individuals.

• Reimbursement discussions are ongoing, with potential for federal support and ACIP schedule inclusion, modeled after Beyfortus for RSV.

• Company is well-capitalized through key data readouts and is exploring non-equity funding options.