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]

InflaRx to prioritize izicopan as its leading pipeline asset, with a goal of continuing toward Phase 2b readiness in hidradenitis suppurativa (HS)To broaden signal-finding activities for izicopan in additional I&I (inflammation and immunology) indications, InflaRx intends to conduct a PK bridging study in China in 2026 to enable expedited proof of concept studies in China and additional geographiesToward the goal of fast-tracking izicopan development across all applicable I&I indications, InflaRx continues ...

FDA Approvals & Rejections - ARS Pharma's neffy, a needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions, received approval in China, with commercial availability expected in spring 2026. The product generated $31.3 million in U.S. revenue in Q3 2025 [3][4]. - Vanda Pharmaceuticals' NEREUS, an oral NK-1 receptor antagonist for preventing motion-induced vomiting, received FDA approval, marking the first new treatment for motion sickness in over 40 years. The drug demonstrated a meaningful reduction in vomiting in clinical trials [5][6]. Clinical Trials - Breakthroughs & Setbacks - InflaRx's analyses from a halted Phase 3 trial of Vilobelimab in pyoderma gangrenosum indicated potential efficacy signals with longer treatment duration, prompting plans to discuss alternative endpoints with the FDA [15][17]. - SELLAS reported that survival in its Phase 3 REGAL trial for Galinpepimut-S (GPS) in acute myeloid leukaemia is extending longer than anticipated, potentially increasing the likelihood of a positive outcome [18][19]. - Ultragenyx announced that its Phase 3 studies for Setrusumab in Osteogenesis Imperfecta failed to meet primary endpoints, leading to a decline in investor confidence [20][21]. - Genmab decided to discontinue clinical development of Acasunlimab to focus on higher-priority programs, with no impact expected on its full-year 2025 financial guidance [22][23]. Corporate Actions - FONAR Corporation agreed to be taken private by a CEO-led acquisition group for $19.00 per share, valuing the transaction at a significant premium. The deal is expected to close in Q3 2026, subject to shareholder approval [12][13][14].

While the Phase 3 trial of vilobelimab in ulcerative pyoderma gangrenosum (PG) was terminated earlier this year due to futility regarding its prespecified primary endpoint (as previously disclosed), subsequent post-hoc analyses suggest a positive trend in favor of vilobelimab, with signals indicating a potentially consistent treatment effectInflaRx anticipates meeting with the FDA to determine a potential development path forward in PG, which the Company anticipates would only be conducted in collaboration ...

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]

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. This article is intended to provide informational content and should not be viewed as an exhaustive an ...

Summary of InflaRx Conference Call Company Overview - **Company**: InflaRx - **Presenters**: Niels Riedemann (CEO), Thomas Taapken (CFO), John Medina (VP of IR) Key Industry and Company Insights Indications Discussed - **Hidradenitis Suppurativa (HS)** - **Chronic Spontaneous Urticaria (CSU)** Efficacy Data - **HS Data**: - Consistent improvement across all groups over time, particularly in lesions that typically do not respond to placebo, such as draining tunnels [3][4] - Pain scores and life quality index showed significant improvement [3] - Over 180 patients treated without safety concerns, indicating strong safety profile [3] - The mechanism involves a small oral C5aR inhibitor with best-in-class potential [3][6] - **CSU Data**: - A 60 mg dose showed a clear, consistent effect differentiated from placebo on the Urticaria Activity Score [5] - Subgroup analysis indicated stronger responses in more severe patients [5] Drug Comparison - InflaRx's drug shows a **10x area under the curve increase** in exposure compared to Amgen's Avacopan, with a faster pharmacokinetic profile [9][10] - InflaRx's drug reaches effective plasma levels much quicker than Avacopan, which takes 13 weeks to reach a steady state [9][10] Patient Population Insights - The HS patient population in the study had a higher severity score (IHS4 score of 30-38) compared to larger trials [14] - The average AN count in the high dose group was reported at 18, indicating a more severe patient population [14][15] Dose Response and Future Studies - The high dose (120 mg) consistently outperformed lower doses in efficacy measures [17] - Future studies will likely include a larger phase 2b trial with multiple doses versus placebo [23][24] - Open label extensions are being considered to assess long-term efficacy [29] Financial Position - InflaRx reported **EUR 44.4 million** (approximately **$50 million**) in cash at the end of Q3, sufficient to fund operations into 2027 [36] - The company is exploring business development and financing options [36] Market Context - There is growing industry interest in the C5aR mechanism, as evidenced by recent acquisitions in the space [40] - Amgen's Avacopan is successfully generating sales in ANCA-associated vasculitis, with a run rate of **$400 million**, but limited activity in other indications [42] Conclusion - InflaRx is optimistic about its drug's potential in HS and CSU, with promising data supporting efficacy and safety. The company is well-positioned financially to advance its clinical programs and explore further market opportunities.

PresentationI would like to now turn the call over to Niels Riedemann, CEO and Founder of InflaRx. Niels, please go ahead.Good morning and good afternoon, everyone. Thank you for standing by, and thank you for joining our conference call to discuss our top line data for INF904 in HS and CSU. [Operator Instructions] And please note that today's call is being recorded. [Operator Instructions]Niels RiedemannCo-Founder, CEO & Executive Director Good morning, everyone. It's my pleasure to welcome you as well to ...

InflaRx (NasdaqGS:IFRX) Update / Briefing November 10, 2025 08:00 AM ET Speaker0Good morning, everyone. It's my pleasure to welcome you as well to our conference call this morning on our top-line phase two AE data. We're thrilled to share these data with you, and we're very happy that we got to this point. So we will dive right in. Before we do so, just two notes here: I will be joined by our Chief Medical Officer, Dr. Camilla Chong. Dr. Chong will present the data in chronic spontaneous urticaria, and I wi ...

INF904 Topline Phase 2a Data Hidradenitis suppurativa (HS) & chronic spontaneous urticaria (CSU) NOVEMBER 10, 2025 NIELS RIEDEMANN, M.D., PH.D. 1 Speakers PROF. JOHN INGRAM Clinical Professor & Consultant Dermatologist, Cardiff University & Specialty Lead for Dermatology, Health and Care Research Wales CAMILLA CHONG, M.D. Chief Medical Officer, InflaRx Chief Executive Officer, Founder, InflaRx This presentation contains forward-looking statements. All statements other than statements of historical fact are ...