JENA, Germany, Dec. 11, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the World Health Organization (WHO) has granted the international nonproprietary (generic) name (INN) of “izicopan” to the Company for its orally available C5aR inhibitor, formerly known as INF904, in accordance with the WHO's Procedure for the Selection of Recommended International Nonproprietary Names (I ...

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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 ...

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 - Several biotechnology and pharmaceutical stocks experienced significant price increases during after-hours trading, driven by upcoming data releases, recent earnings reports, and prior corporate updates [1] Company Summaries - InflaRx N.V. (IFRX) saw a surge of 63.41% to $2.01 after hours, following a 2.50% gain at the close, due to plans to release topline data from its Phase 2a trial of oral C5aR inhibitor INF904, expected on Monday morning alongside its third-quarter financial results [2] - Rallybio Corp. (RLYB) rose 12.84% to $0.71 after reporting a third-quarter net income of $16.0 million, or $0.36 per share, reversing a prior-year loss of $11.5 million, although revenue for the quarter was $0.2 million, slightly below the $0.3 million reported in the same period last year [3] - FibroBiologics Inc. (FBLG) climbed 13.51% to $0.40 after hours, building on a 5.13% gain during regular trading, following the release of its third-quarter financial results and a corporate update on October 31 [4] - AbCellera Biologics Inc. (ABCL) advanced 6.51% to $4.16 after hours, recovering from a 13.69% decline earlier in the day, reporting a third-quarter net loss of $57.1 million, or $(0.19) per share, compared to a loss of $51.1 million in the same quarter last year, while revenue increased to $9.0 million from $6.5 million year-over-year [5] - BioRestorative Therapies Inc. (BRTX) gained 11.68% to $1.53 in after-hours trading, following a Notice of Allowance from the Japanese Patent Office for its ThermoStem platform announced on October 27, with third-quarter results scheduled for release on November 12 [6] - Cellectis S.A. (CLLS) rose 6.58% to $3.40 after hours, reporting a third-quarter net income of $589 thousand, or $0.01 per share, compared to a $23.1 million loss in the prior year, with total revenues and other income more than doubling to $37.2 million from $18.1 million [7]

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]