InflaRx (IFRX) Piper Sandler 36th Annual Healthcare Conference summary

Key product updates and clinical progress

• GOHIBIC (vilobelimab) received a positive CHMP opinion for SARS-CoV-2-induced ARDS and is available in the U.S.; it showed a 23.9% relative survival benefit in critically ill COVID-19 patients in the PANAMO trial.

• Emergency use authorization for GOHIBIC in the U.S. may lead to broader ARDS indications pending further research.

• Phase III trial of vilobelimab in pyoderma gangrenosum (PG) is ongoing, with an interim analysis expected in Q2 next year.

• INF904, an oral C5aR1 inhibitor, is entering Phase IIa studies in hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU), with top-line data anticipated in summer next year.

• Company ended Q3 with €62 million, funding operations into 2026 and supporting key clinical milestones.

Differentiation and scientific rationale

• Targeting the C5a/C5aR axis offers more specific inhibition than upstream complement inhibitors like Soliris, potentially reducing infection risk and preserving immune defense.

• Vilobelimab is a first-in-class monoclonal antibody targeting C5a, while INF904 is a highly selective oral C5aR1 inhibitor designed for improved efficacy and safety.

• INF904 demonstrated superior preclinical efficacy and pharmacokinetics compared to avacopan, with less liver enzyme interaction and rapid therapeutic exposure.

Clinical trial design and regulatory outlook

• The pivotal Phase III PG trial uses an adaptive design with a placebo arm on low-dose corticosteroids, aiming for ethical feasibility and robust efficacy assessment.

• Interim analysis after 30 patients may lead to trial adaptation or continuation, with a cap at 100 patients; positive interim results would prompt regulatory discussions.

• Orphan and fast track designations in the U.S. and Europe position the PG program for potential expedited review.

• INF904 Phase IIa studies are short-term, open-label, and dose-ranging to inform future Phase IIb trials in HS and CSU.