InflaRx (IFRX) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Strategic shift and market opportunity

• Advanced focus on ANCA vasculitis, leveraging strong research on C5a/C5aR1 as a validated target and recent competitor withdrawals in major markets.

• INF904 designed for improved pharmacokinetics, immediate plasma presence, and reduced hepatotoxicity risk compared to avacopan.

• Vilobelimab offers a bridging opportunity, especially if avacopan is withdrawn, with supportive data from China and potential for rapid market entry.

• Ongoing and scheduled FDA interactions to align clinical development and trial design for both INF904 and vilobelimab.

• Clear unmet need to reduce corticosteroid use in ANCA vasculitis, with strong physician and patient support for alternatives.

Clinical development and regulatory considerations

• BVAS remission remains the accepted FDA endpoint, but ambiguity exists due to investigator judgment on residual symptoms.

• Superiority on BVAS is challenging due to high response rates with current therapies; non-inferiority plus renal endpoints may be more feasible.

• Renal function (eGFR) improvement is a promising secondary or co-primary endpoint, especially for patients with renal involvement.

• Maintenance therapy with INF904 could address ongoing corticosteroid use for minor flares, with potential for label expansion.

• Phase II study preparations are underway, with site initiation targeted for early next year; additional studies in aHUS and a renal basket are being considered.

Broader pipeline and future directions

• INF904 and related molecules have potential in broader renal indications, with oral administration and no need for vaccination or increased infection risk.

• Early data in other inflammatory and immune (I&I) diseases, such as CSU and HS, are promising but currently paused to prioritize renal focus.

• The company aims to establish a first approval in ANCA vasculitis before expanding to other indications.