Pharvaris (PHVS) investor relations material

Key clinical data and endpoints

• RAPIDe-3 trial showed deucrictibant IR achieved primary endpoint: symptom relief in 1.28 hours and all 11 key secondary endpoints with statistical significance.

• End of progression occurred in 17.5 minutes, providing rapid psychological reassurance to patients.

• Complete symptom resolution was achieved in less than 12 hours; 83% of attacks resolved with a single dose.

• Open-label extension data suggest real-world use may yield even faster resolution due to earlier treatment.

• Deucrictibant numerically outperformed standard of care (icatibant) and the recently approved oral EKTERLY across endpoints, though no head-to-head studies exist.

Market dynamics and commercial strategy

• Oral therapies are expected to increase the proportion of treated attacks by reducing treatment burden and improving convenience.

• NDA filing for deucrictibant IR is on track for the first half of the year, with a standard review period anticipated.

• U.S. commercial infrastructure is being built out, targeting 70 people for launch, including 30-40 sales staff.

• Strategy includes patient segmentation, physician profiling, and raising treatment expectations for efficacy, tolerability, and convenience.

• Programs like quick start, free sampling, and expanded access aim to facilitate trial and adoption.

Competitive positioning and switching opportunities

• Deucrictibant offers the same mechanism as icatibant but with potentially improved efficacy and convenience.

• Efficacy in normal C1 patients matches that in HAE Types I and II, broadening the eligible patient base.

• Key switch opportunities identified among current users of icatibant, C1 replacement, and EKTERLY, focusing on single-dose durability and faster symptom relief.