Pharvaris (PHVS) investor relations material

Recent progress and strategic priorities

• Preparing to file for first drug approval in acute HAE based on strong RAPIDe-3 data, with NDA submission planned for the first half of the year.

• Ongoing pivotal prophy trial (CHAPTER-3) is on track for top-line data readout in Q3.

• Enrollment continues for a small pivotal trial in acquired angioedema.

• Commercial launch preparations are underway, including organizational ramp-up and disease awareness campaigns.

• Pre-NDA meeting with regulators has been completed, and filings for both acute and prophy indications are progressing.

Clinical data and competitive positioning

• RAPIDe-3 trial met primary and 11 key secondary endpoints with statistical significance, showing rapid symptom relief (1.28 hours vs. 12+ hours for placebo).

• New endpoint 'End of Progression' demonstrated symptom stabilization in 17.5 minutes, and complete symptom resolution in under 12 hours.

• Deucrictibant's efficacy and convenience position it strongly against injectables and other oral competitors.

• Oral on-demand therapy is expected to drive market growth by reducing barriers to treatment and increasing attack management.

• Having the same API for both on-demand and prophy offers unique flexibility and potential for a broader label, including acquired angioedema and normal C1 patients.

Market dynamics and launch strategy

• Disease awareness campaign 'Deflate HAE' focuses on unmet needs and patient expectations, evolving as approval nears.

• Oral therapies are anticipated to dominate both on-demand and prophy segments due to convenience and efficacy.

• Recent launches of oral and injectable competitors have increased switching dynamics, highlighting ongoing unmet needs.

• Packaging strategy involves two distinct brands for on-demand and prophy, with flexibility for combined or separate use.

• Pricing strategy may allow flexibility due to differentiated dosing and product profile.