Invivyd (IVVD) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Company mission and focus

• Aims to deliver antibody-based therapies for viral threats, starting with SARS-CoV-2, targeting immunocompromised populations.

• Pemgarda, the first monoclonal antibody (mAb), received Emergency Use Authorization (EUA) in March 2024 for COVID-19 prevention.

• Focuses on approximately 500,000 high-risk immunocompromised patients in the U.S.

Platform and technology differentiation

• Utilizes the proprietary INVYMAB platform, combining viral surveillance, predictive modeling, and antibody engineering.

• Constantly monitors circulating variants and adapts antibody candidates accordingly.

• Early partnership with Adimab contributed to platform development; current focus is on internal U.S. commercialization.

Regulatory and clinical progress

• Pemgarda advanced from first-in-human trial to EUA in about one year, with phase 3 trial starting September 2023.

• Ongoing communication with the FDA enables rapid fact sheet updates as new variant data emerges.

• Recent data shows strong activity against dominant variants like KP.3.1.1, which accounts for 42% of current cases.