InflaRx (IFRX) Investor update summary

Strategic focus and pipeline overview

• Izicopan, an oral C5a/C5aR inhibitor, is prioritized for AAV and other renal diseases, offering rapid onset, high target coverage, clean safety profile, and once-daily dosing convenience, with best-in-class potential over avacopan.

• Differentiation from avacopan includes lack of time-dependent CYP3A4 inhibition, improved metabolic stability, absence of liver toxicity signals, and lower pill burden.

• Market opportunity for AAV is estimated at $1.3 billion, with expansion potential into IgAN, C3G, aHUS, and HS, leveraging strong IP and broad applicability in inflammatory and renal indications.

• Raised $150 million through an underwritten offering to fund pipeline advancement, with participation from new and existing investors.

• Additional programs include vilobelimab, an intravenous anti-C5a monoclonal antibody, and other anti-inflammatory therapeutics targeting the complement system.

Clinical development and trial design

• Phase II and III AAV trials will compare izicopan plus rapid steroid tapering to standard of care, focusing on safety, early proteinuria reduction, eGFR improvement, and time to remission.

• Primary endpoints include safety and non-inferiority in clinical remission (BVAS-0), with secondary endpoints such as early proteinuria reduction, eGFR, and glucocorticoid toxicity.

• Exploring seamless phase II/III registrational approach with FDA to expedite development and market entry.

• Trials will enroll patients early in flare phases, allow severe renal impairment, and use rituximab as standard induction therapy.

• Additional open-label studies in IgAN, C3G, and aHUS to provide early proof-of-concept data, with first results expected as early as next year.

Expansion into broader indications

• Izicopan is being developed for aHUS, IgAN, C3G, and HS, leveraging rapid proof-of-concept basket studies in regions with large patient populations and efficient recruitment.

• In aHUS, ex vivo and in vitro data support C5a/C5aR1 as a key driver of thrombotic microangiopathy, with izicopan showing efficacy in reducing thrombus formation.

• In IgAN and C3G, clinical and preclinical data with C5aR inhibitors demonstrate reductions in proteinuria and improved kidney function.

• Phase 2a data in HS show biologic-like activity within 4 weeks, with significant reductions in abscess/nodule count and pain; FDA supports development of a new endpoint (mHiSCR).

• Izicopan's oral administration, lack of vaccination requirement, and low infection risk differentiate it from other complement inhibitors.