InflaRx (NasdaqGS:IFRX) FY Conference February 25, 2026 08:40 AM ET Company ParticipantsNiels C. Riedemann - CEO and FounderConference Call ParticipantsAndreas Argyrides - Executive Director and Senior AnalystAndreas ArgyridesAll right. Hey, good morning, everyone. Welcome to Oppenheimer's 36th Annual Healthcare Life Sciences Conference. My name is Andreas Argyrides. I'm one of the senior biotech analysts at Oppenheimer, and today I have the pleasure to be joined by Niels C. Riedemann, CEO, and Jan Medina, ...

Summary of InflaRx Conference Call Company Overview - **Company**: InflaRx - **Industry**: Biotechnology - **Headquarters**: Germany and the U.S. - **IPO**: Listed on NASDAQ in 2017 - **Focus**: Development of drugs targeting terminal complement inhibition, specifically C5a and C5a receptor 1 Key Molecules - **Vilobelimab**: Antibody targeting C5a - **Izicopan**: Small molecule targeting C5a receptor 1 - Recently completed a positive proof of concept Phase 2a study [2][5] Differentiation of Izicopan - **Pharmacological Properties**: - Higher bioavailability and plasma levels compared to avacopan (Amgen's drug) - Faster onset of receptor inhibition, achieving peak levels in days versus avacopan's 13 weeks [5][6] - Significantly lower inhibition of CYP3A4, reducing potential drug-drug interactions [6] - **Safety Profile**: - No observed hepatotoxicity in 200 treated patients, contrasting with avacopan's reported issues [8][9] Market Opportunities - **Potential Market Impact**: If avacopan were withdrawn, InflaRx sees an opportunity to position izicopan favorably [13] - **Hidradenitis Suppurativa (HS)**: - Conducted a 28-day study showing promising results, including reduction of draining tunnels and pain [15][16] - Data compared favorably to existing treatments, indicating a potential best-in-class profile [27] Future Development Plans - **Next Steps**: - Planning a Phase 2B study, as the initial four-week trial does not suffice for pivotal trials [23] - Ongoing discussions with the FDA regarding dosing and trial design [21][25] - **Capital Markets Day**: Expected in spring, with disclosures on HS and other indications [24][36] Financial Position - **Cost Reduction**: Fixed costs reduced by approximately 30% due to the deprioritization of vilobelimab and related activities [33] Additional Indications - **Chronic Spontaneous Urticaria (CSU)**: Encouraging data suggests potential for further trials, contingent on resources [30][32] Conclusion InflaRx is positioned to leverage its differentiated drug izicopan in the competitive landscape of autoimmune diseases, particularly HS and potentially CSU, while maintaining a strong safety profile and reducing operational costs. The upcoming Capital Markets Day will provide further insights into their strategic direction and clinical development plans.

Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system [3] - The company utilizes proprietary anti-C5a and anti-C5aR technologies to create specific inhibitors of the complement activation factor C5a and its receptor [3] - InflaRx's lead program is izicopan (INF904), an orally administered small molecule inhibitor that has shown promising pharmacokinetic and pharmacodynamic characteristics in clinical studies [3] - The company is also developing vilobelimab, a first-in-class anti-C5a monoclonal antibody that has demonstrated clinical activity and tolerability [3] Upcoming Events - InflaRx will participate in the Guggenheim Securities Emerging Outlook: Biotech Summit 2026 on February 11-12, 2026, with a fireside chat scheduled for February 11 at 11:30 AM ET [1] - The company will conduct one-on-one investor meetings on February 11 during the same summit [1] - InflaRx will also present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, 2026, with a virtual presentation on February 25 at 8:40 AM ET [2] - One-on-one investor meetings will also be held on February 25 [2]

Core Insights - InflaRx N.V. has conducted multiple data analyses of its Phase 3 study for vilobelimab in pyoderma gangrenosum (PG), which was terminated due to futility as recommended by the Independent Data Monitoring Committee (IDMC) [1][7] Study Overview - The Phase 3 study enrolled 54 patients, with 30 completing 6 months of treatment. The primary endpoint of complete target ulcer closure showed a difference of 20.8% for vilobelimab versus 16.7% for placebo, though this was not statistically significant [3] - Key secondary endpoints indicated improvement for vilobelimab, including complete disease remission (20.8% vs. 5.6%, p=NS) and >50% reduction in target ulcer volume at week 26 (36.4% vs. 16.7%, p=NS) [3] Efficacy Signals - Post-hoc analyses revealed an overall treatment effect with vilobelimab, showing an average percent change in target ulcer volume of -45.4% (p=0.0428) from Weeks 2 to 26 [4] - Significant treatment differences were noted from Week 14 (-57.6%, p=0.0357) to Week 26 (-63.2%, p=0.0122) for vilobelimab compared to placebo [4] Tolerability and Safety - Vilobelimab was well tolerated, with treatment-emergent adverse events (TEAEs) mostly mild to moderate. Serious related TEAEs were reported at 6.3% in the vilobelimab arm and 4.5% in the placebo arm [3] Future Development Plans - InflaRx plans to meet with the FDA to discuss potential development pathways for vilobelimab in PG, which may involve collaboration with a partner [7][9] - The company is prioritizing the development of izicopan (INF904) and does not expect to allocate significant resources towards vilobelimab's development independently [9] Company Background - InflaRx is a biopharmaceutical company focused on anti-inflammatory therapeutics, utilizing proprietary technologies to develop inhibitors of the complement activation factor C5a and its receptor [11] - Vilobelimab is a first-in-class monoclonal antibody targeting C5a, demonstrating disease-modifying clinical activity in various studies [10]

Core Viewpoint - InflaRx N.V. has received the international nonproprietary name "izicopan" for its C5aR inhibitor, previously known as INF904, from the World Health Organization, indicating a significant step in the drug's development process [1][2] Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system, specifically through its proprietary anti-C5a and anti-C5aR technologies [4] - The company has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody, and is also advancing izicopan (INF904), an orally administered small molecule inhibitor [4][5] Product Details - Izicopan (INF904) is an orally administered small molecule that inhibits the C5a receptor, demonstrating anti-inflammatory effects in pre-clinical models and human studies [3] - Clinical trials have shown izicopan to be well tolerated, with no safety concerns reported across various dosing regimens, including single doses from 3 mg to 240 mg and multiple doses from 30 mg to 90 mg for 14 days [3] - Phase 2a data indicates that izicopan has the potential for best-in-class efficacy, achieving over 90% blockade of C5a-induced neutrophil activation during the dosing period [3] Clinical Efficacy - In patients with hidradenitis suppurativa, izicopan treatment resulted in significant reductions in abscesses and nodules, with improvements in pain scores and sustained responses observed four weeks post-treatment [3] - For chronic spontaneous urticaria, substantial reductions in the Urticaria Activity Score (UAS7) were noted, particularly among patients with severe disease, indicating improved disease control [3]

Core Insights - InflaRx N.V. announced positive topline data from a Phase 2a basket study of INF904 for hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU), indicating strong efficacy and safety profiles [1][2][19] - The company plans to advance INF904 into Phase 2b trials in HS and expand its clinical program in CSU, highlighting the drug's potential as a "pipeline-in-a-product" [2][11][20] Phase 2a Data in HS - The Phase 2a trial involved 31 HS patients, with efficacy data reported from 29 patients across three dosing cohorts: 60 mg BID, 90 mg BID, and 120 mg BID [3][12] - Key clinical endpoints included reductions in abscesses and nodules (AN), draining tunnels (dT), and improvements in pain and quality of life measures [4][5][10] - INF904 demonstrated rapid and consistent reductions in ANs and dTs, with the highest dosing cohort showing the strongest clinical activity [5][6][10] - Safety data indicated no serious adverse events, with only mild adverse events reported [9][10] Phase 2a Data in CSU - The Phase 2a trial for CSU included 31 patients, with efficacy data reported from 30 patients across 60 mg BID and 120 mg BID dosing cohorts [15][22] - Clinical endpoints included changes in the Urticaria Activity Score (UAS7) and Urticaria Control Test (UCT7), with significant reductions observed, particularly in patients with severe CSU [17][19][22] - Safety data showed no serious adverse events, reinforcing the drug's safety profile [19][22] Market Potential - InflaRx estimates the addressable market for INF904 could exceed $1 billion, emphasizing the need for novel therapies in HS and CSU [11][20] - The company is actively engaging with potential collaborators to expedite development goals for INF904 [6][20] Future Plans - InflaRx aims to complete the 4-week post-treatment observation period and present final results at major scientific meetings [1][22] - A Capital Markets Event is planned to showcase the potential of INF904 [1][2]

Core Insights - InflaRx N.V. is set to report topline data from its Phase 2a clinical trial of oral C5aR inhibitor INF904 for hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU) on November 10, 2025 [1] - The company will host a webcast/conference call on the same day to discuss the clinical data and feature insights from key opinion leaders [2] - InflaRx will also publish its third quarter 2025 financial and operating results via Form 6-K on the same day [3] Company Overview - InflaRx is a biopharmaceutical company focused on anti-inflammatory therapeutics, utilizing proprietary anti-C5a and anti-C5aR technologies to develop specific inhibitors targeting the complement activation factor C5a and its receptor C5aR [4] - The company has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody, and is also working on INF904, an orally administered small molecule inhibitor [4] - Founded in 2007, InflaRx has offices in Jena and Munich, Germany, and Ann Arbor, MI, USA [5]

Core Insights - InflaRx N.V. is participating in the Guggenheim Securities 2nd Annual Healthcare Innovation Conference scheduled for November 10 - 12, 2025, in Boston, MA, with a fireside chat on November 11 at 2:30 PM ET and one-on-one investor meetings on the same day [1] Company Overview - InflaRx is a biopharmaceutical company focused on anti-inflammatory therapeutics, utilizing proprietary anti-C5a and anti-C5a receptor technologies to develop specific inhibitors targeting the complement activation factor C5a [2] - The company has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody, which has shown disease-modifying clinical activity and tolerability in multiple studies [2] - InflaRx is also working on INF904, an orally administered small molecule inhibitor that targets C5a-induced signaling via the C5a receptor [2] - Founded in 2007, InflaRx has offices in Jena and Munich, Germany, and Ann Arbor, MI, USA [3]

Core Points - InflaRx N.V. has regained compliance with Nasdaq's minimum bid price requirement as of September 11, 2025, after its ordinary shares closed at $1.00 or greater for 10 consecutive business days from August 27, 2025, to September 10, 2025 [1][2] Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system, specifically through its proprietary anti-C5a and anti-C5a receptor technologies [3] - The company has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody that has shown disease-modifying clinical activity and tolerability in multiple studies [3] - InflaRx is also working on INF904, an orally administered small molecule inhibitor targeting C5a-induced signaling via the C5a receptor [3] - Founded in 2007, InflaRx has offices in Jena and Munich, Germany, and Ann Arbor, MI, USA [4]

Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system [3] - The company has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody, which has shown disease-modifying clinical activity and tolerability in multiple studies [3] - InflaRx is also working on INF904, an orally administered small molecule inhibitor of C5a-induced signaling [3] Upcoming Events - InflaRx will participate in the Cantor Global Healthcare Conference from September 3 to 5, 2025, with a fireside chat scheduled for September 4 at 9:10 AM ET [1] - The company will also conduct one-on-one investor meetings on September 4 during the Cantor conference [1] - Additionally, InflaRx will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025, with a presentation on September 9 at 3:30 PM ET [2] - One-on-one investor meetings will also take place on September 9 at the H.C. Wainwright conference [2]