Pharvaris (PHVS) Status Update summary

Unmet medical needs and treatment landscape

• HAE patients face significant disease and treatment burdens, including attack unpredictability, stress, and administration challenges.

• Oral therapies are highly desired for both prophylactic and on-demand settings due to convenience and reduced treatment burden.

• Current injectable and IV options, while effective, are associated with needle fatigue and administration discomfort.

• Patients and clinicians seek therapies that normalize life, minimize attacks, and offer discreet, easy administration.

• Efficacy, safety, and improved side effect profiles remain top priorities for new therapies.

Deucrictibant clinical development and data

• Deucrictibant is being developed as both an immediate-release (IR) oral capsule for on-demand use and an extended-release (XR) tablet for prophylaxis.

• Phase 2 data show deucrictibant achieves rapid symptom relief (median 1.1 hours) and high rates of complete attack resolution with a single dose.

• Long-term extension studies report up to 93% attack reduction and 99% symptom-free days with prophylactic use.

• XR formulation enables once-daily dosing, aiming to improve adherence and convenience.

• Deucrictibant is also being evaluated for acquired angioedema, showing strong tolerability and efficacy.

Market dynamics and patient preferences

• HAE market is expected to grow, driven by demand for more convenient, effective therapies.

• Patients show a strong preference for oral therapies with injectable-like efficacy, and many proactively seek such options.

• Flexibility to switch between on-demand and prophylactic formulations with the same active ingredient is seen as a unique advantage.

• Even with high compliance, breakthrough attacks persist, creating opportunities for therapy switching.

• Oral therapies are anticipated to dominate the prophylactic segment, with injectables remaining for those who prefer them.