Invivyd (IVVD) H.C. Wainwright 28th Annual Global Investment Conference summary

Platform and pipeline overview

• Focuses on monoclonal antibody technology for infectious disease prevention, especially COVID-19, with a platform leveraging viral surveillance and predictive modeling.

• Current marketed product PEMGARDA (pemivibart) targets immunocompromised individuals but is considered a stepping stone to more scalable solutions.

• Next-generation candidate VYD2311 is designed for broader use, aiming for functional interchangeability with vaccines and easier administration (IM instead of infusion).

• Pipeline includes additional candidates for measles and RSV, expanding beyond COVID-19.

Clinical development and regulatory strategy

• Phase III DECLARATION trial for VYD2311 is complete, with top-line data expected soon; study evaluates reduction in symptomatic COVID-19 versus placebo.

• Statistical power for the lower end of target vaccine efficacy (VE) may be limited, prompting consideration of full or partial unblinding and potential accelerated approval.

• Ongoing dialogue with regulators and potential for confirmatory studies if accelerated approval is pursued.

• LIBERTY trial explores combination of vaccine and antibody, with a focus on safety and tolerability comparisons.

Efficacy targets and dosing flexibility

• Target efficacy for VYD2311 is a 70%-90% reduction in symptomatic disease versus placebo.

• Both single and monthly dosing arms are evaluated, with flexibility intended to accommodate different risk profiles and preferences.

• Duration of protection is expected to extend beyond three months, with ongoing studies to determine annual or semi-annual dosing potential.