InflaRx (IFRX) investor relations material

Pipeline and clinical development updates

• Upcoming data readouts expected in October for a small oral C5a receptor antagonist in hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU), with potential for best-in-class efficacy based on phase 1 data.

• The molecule is designed for high bioavailability, minimal drug-drug interactions, and the ability to achieve near-complete pathway blockade, which may translate to rapid and robust clinical responses.

• Four-week efficacy data in both HS and CSU will focus on endpoints such as lesion reduction and UAS7, aiming to demonstrate differentiation from placebo and alignment with successful drugs.

• Safety profile is supported by extensive toxicology data, with no known mechanism-related safety issues and encouraging long-term non-human primate results.

• Decision to advance to phase 2 in one or both indications will depend on trial outcomes, with potential for partnerships to support further development.

Commercial and regulatory strategy

• The antibody vilobelimab is approved for COVID-19 ARDS in Europe and under emergency use authorization in the US, with ongoing efforts to secure broader labels and reimbursement pathways.

• US government agencies, including BARDA, are supporting large ARDS trials, which could unlock significant future value if successful.

• In Europe, commercialization is contingent on finding a partner, as the company is not marketing the drug independently.

• In China, a partner is advancing the antibody in ANCA vasculitis, with rapid enrollment and promising data, generating single-digit royalties and retaining global rights outside China.

Strategic outlook and future opportunities

• The company is open to partnerships for both current and broader indications, depending on data quality and strategic fit.

• There is significant unmet need for differentiated mechanisms in HS, especially among patients refractory to existing biologics.

• The PG program was halted for futility, but data will be unblinded and analyzed for potential future use or partnerships, with a focus on meaningful secondary endpoints.

• If sufficient signals are found in PG, discussions with the FDA and potential partners will follow; otherwise, focus remains on the oral C5a receptor antagonist.

• The company maintains flexibility to pursue additional indications or mechanisms as opportunities arise.