InflaRx (IFRX) investor relations material

Strategic direction and therapeutic focus

• Shifted focus to ANCA vasculitis, leveraging strong research on C5a/C5aR1 as a validated target and market opportunity following competitor withdrawal.

• Developed new C5aR1 inhibitor (izicopan/INF904) to address shortcomings of avacopan, with improved pharmacokinetics and safety profile.

• Exploring both oral (izicopan) and antibody (vilobelimab) approaches, with vilobelimab positioned as a potential bridge if rapid oral approval is delayed.

• Ongoing phase III trial in China with vilobelimab (BDB-001) for corticosteroid replacement, showing promising early results.

• Active engagement with FDA to discuss clinical plans and trial designs for both molecules.

Scientific rationale and clinical differentiation

• C5aR1 is a well-established target in ANCA vasculitis, with strong preclinical and clinical evidence supporting its role in disease pathology and renal damage.

• INF904 designed for better plasma presence, metabolic stability, and reduced hepatotoxicity compared to avacopan.

• No significant liver enzyme elevations observed in nearly 200 patients treated with INF904 to date.

• INF904 offers potential for more convenient dosing and fewer drug-drug interactions.

• Vilobelimab offers a safe, IV-administered alternative for remission induction, especially relevant if oral options are delayed.

Regulatory and clinical development strategy

• Engaged in early and ongoing discussions with FDA to optimize trial design and endpoints for ANCA vasculitis.

• Recognizes the challenge of BVAS endpoint adjudication and aims for consistent, committee-based assessment.

• Considering both non-inferiority and superiority strategies, with renal function (eGFR) as a potential co-primary or secondary endpoint.

• Maintenance therapy with izicopan is a key area of interest, aiming to reduce corticosteroid use and prevent flares.

• Phase II study preparations underway, with site initiation targeted for early next year.