Pharvaris (PHVS) Morgan Stanley 24th Annual Global Healthcare Conference summary

Clinical development and efficacy highlights

• Deucrictibant demonstrated 87% efficacy in reducing attacks in type 1 and 2 hereditary angioedema (HAE) patients, with 83% efficacy including normal C1 patients, matching injectable therapies' efficacy levels.

• The patient population in the CHAPTER-3 trial was more severe, with a baseline attack rate of 3.6, and achieved significant attack reduction.

• Safety profile showed two cases of Grade 3 liver enzyme elevations, both with confounding factors, and no symptomatic or bilirubin elevations; no additional cardiovascular or GI risks were observed compared to competitors.

• A patient with frequent laryngeal attacks experienced a 90% reduction in attacks and improved quality of life, highlighting efficacy in normal C1 (type 3) patients.

• The drug's mechanism targets B2 receptor antagonism, uniquely addressing normal C1 patients, estimated to be 20% of the HAE population.

Market opportunity and launch strategy

• On-demand and prophylactic formulations are being developed, with on-demand expected to launch first, serving as a stepping stone for the prophylactic market.

• The prophylactic segment is growing, supported by treatment guidelines, but a segment of patients will continue to use on-demand therapy.

• High patient churn from existing oral therapies due to lower efficacy creates a clear opportunity for deucrictibant, especially among those who discontinued ORLADEYO.

• Launch preparations are on track, with a growing commercial team and a compact sales force; an opt-in program has attracted nearly 2,000 patients ahead of launch.

• Pricing will be value-based, with no disruptive strategies anticipated, and commercial supply and regulatory review are progressing as planned.

Regulatory and geographic expansion

• U.S. PDUFA date for on-demand formulation is set for April 2027, with ongoing regulatory interactions and commercial supply preparations.

• European and global launch opportunities are under evaluation, with recognition of significant patient populations in Japan, China, and other territories.

• Expanded access program in the U.S. is underway, driven by physician interest and access challenges.