Pharvaris (PHVS) H.C. Wainwright 28th Annual Global Investment Conference summary

Company overview and product focus

• Focused on bradykinin-mediated disorders, starting with hereditary angioedema (HAE) types 1 and 2, with plans to expand to normal C1 and acquired angioedema.

• Lead candidate deucrictibant is under FDA review for on-demand HAE treatment, with a PDUFA date of April 23 next year.

• Deucrictibant targets the B2 receptor, blocking bradykinin and addressing multiple genetic mutations causing excess bradykinin.

• Two formulations: immediate-release for acute attacks and extended-release for prophylaxis.

• Commercial team buildout is underway, aiming for readiness at launch.

Clinical trial results and efficacy

• CHAPTER-3 phase III trial showed 83% attack reduction across HAE types 1, 2, and 3, with significant improvements in quality of life.

• In HAE types 1 and 2, an 87% attack reduction was demonstrated, matching efficacy of leading injectables.

• Deucrictibant is positioned as a best-in-class oral prophylactic, with lower expected attrition compared to current oral therapies.

• Four-pronged commercial approach targets new starters, current oral users, those who discontinued orals, and injectable users.

• Consistent efficacy observed in adolescents and adults, with potential for broad label coverage.

Regulatory and commercial strategy

• NDA for immediate-release capsule accepted by FDA; MAA validated in Europe, both with anticipated approvals in April next year.

• Manufacturing and commercial infrastructure are being finalized to enable immediate launch upon approval.

• Label expected to cover HAE types 1, 2, 3, and adolescents 12+, with data supporting use in normal C1 patients.

• Strategy includes using both formulations for comprehensive patient management, with ongoing studies to support combination use.

• Cash runway extends through mid-2028, covering both product launches and commercial buildout.