Received European Commission approval for GOHIBIC® (vilobelimab) for the treatment of SARS-CoV-2-induced acute respiratory distress syndrome (ARDS)Achieved 30-patient recruitment milestone in Phase 3 vilobelimab trial in pyoderma gangrenosum (PG) to enable an expected interim analysis for trial size adaptation or futility by the end of May 2025Dosed first patient in Phase 2a trial for oral C5aR inhibitor, INF904, with topline data in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) expe ...

Core Insights - InflaRx N.V. presented multiple data sets at the 2025 American Academy of Dermatology Annual Meeting, highlighting the potential of vilobelimab in treating inflammatory conditions such as pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS) [1][2] Group 1: Vilobelimab in Pyoderma Gangrenosum (PG) - Safety data from a Phase 2a dose-finding study indicated that adverse events (AEs) were mostly mild to moderate, with vilobelimab being well tolerated across all doses [3] - Pharmacokinetic (PK) and pharmacodynamic (PD) analyses showed a significant reduction in C5a concentrations, with approximately 90% reduction observed by Day 15 across all dose groups [4] - The ongoing Phase 3 trial is utilizing vilobelimab dosed at 2400 mg bi-weekly to suppress C5a in ulcerative PG patients [4] Group 2: Vilobelimab in Hidradenitis Suppurativa (HS) - A post-hoc analysis from the Phase 2b SHINE trial demonstrated vilobelimab's effectiveness in reducing draining tunnels (dT) by 63.2% compared to 18.0% for placebo, with a 3.1x relative improvement in complete resolution of dT [5] - Safety analysis showed that vilobelimab was well tolerated, with similar rates and severity of AEs compared to placebo [6] - PK/PD analysis indicated that administration of 800 mg vilobelimab resulted in significant reductions in C5a concentrations, which remained lower than baseline during follow-up [7]

Core Insights - InflaRx N.V. announced the acceptance of all submitted abstracts for vilobelimab at the 2025 American Academy of Dermatology Annual Meeting, highlighting its role in treating pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS) [1][2] Company Overview - InflaRx is a biopharmaceutical company focused on developing anti-inflammatory therapeutics, particularly targeting the complement system with its lead product vilobelimab, a first-in-class monoclonal antibody [14] - The company has received orphan drug designation for vilobelimab from both the FDA and EMA for the treatment of PG, as well as fast track designation from the FDA [7][8] Clinical Developments - The abstracts accepted for presentation include studies on vilobelimab's safety and efficacy in PG and HS, with specific focus on the reduction of draining tunnels in HS patients [2][4] - A Phase 2a explorative dose-finding study on vilobelimab's safety in PG patients will be presented, along with pharmacokinetic and pharmacodynamic analyses [3][5] - The company is also conducting a Phase 3 trial for PG, indicating ongoing commitment to advancing vilobelimab's clinical development [7] Regulatory Status - In the U.S., vilobelimab (marketed as GOHIBIC) has received Emergency Use Authorization for treating COVID-19 in hospitalized adults, although it remains investigational and not fully approved for any indication [9][10] - In the EU, GOHIBIC has been granted marketing authorization under exceptional circumstances for treating ARDS in COVID-19 patients, supported by positive results from the Phase 3 PANAMO trial [11][12]

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 C5aR [3] - InflaRx's lead product candidate, vilobelimab, is a first-in-class anti-C5a monoclonal antibody that has shown disease-modifying clinical activity in various studies [3] Financial and Operational Updates - InflaRx plans to publish its financial and operating results for Q4 and full year 2024 on March 20, 2025, with no conference call scheduled [1] - The company will participate in two upcoming investor conferences, including the Leerink Global Healthcare Conference from March 9-12, 2025, and the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025 [1][2] Product Development - InflaRx is also developing INF904, an orally administered small molecule inhibitor of the C5a receptor [3] - The company was founded in 2007 and has offices in Jena and Munich, Germany, as well as Ann Arbor, MI, USA [3][4]

JENA, Germany, Feb. 18, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, announced today that it has completed its underwritten public offering of 8,250,000 ordinary shares of the Company at a public offering price of $2.00 per ordinary share and in lieu of ordinary shares to certain investors, pre-funded warrants to purchase up to 6,750,000 of the Company’s ordinary shares. The purcha ...

JENA, Germany, Feb. 13, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, announced today the pricing of its underwritten public offering of 8,250,000 ordinary shares of the Company at an offering price of $2.00 per ordinary share and in lieu of ordinary shares to certain investors, pre-funded warrants to purchase up to 6,750,000 of the Company’s ordinary shares. The purchase price of e ...

JENA, Germany, Feb. 13, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (NASDAQ:IFRX) (the "Company"), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, announced today that it has commenced an underwritten public offering of ordinary shares of the Company, and in lieu of ordinary shares to certain investors, pre-funded warrants to purchase the Company's ordinary shares. The purchase price of each pre-funded warrant will equal the price per share at which ordinary ...

Company Overview - InflaRx is a biopharmaceutical company specializing in anti-inflammatory therapeutics by targeting the complement system, particularly focusing on the C5a and C5aR pathways [2] - The company's lead product candidate, vilobelimab, is a first-in-class anti-C5a monoclonal antibody delivered intravenously, showing disease-modifying clinical activity and tolerability in multiple studies [2] - InflaRx is also developing INF904, an orally administered small molecule inhibitor of the C5a receptor [2] - Founded in 2007, the company has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA [2] - InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc (USA) are wholly owned subsidiaries of InflaRx NV [3] Upcoming Events - InflaRx will participate in the Guggenheim SMID Cap Biotech Conference, scheduled for February 5-6, 2025, in New York, NY [1] Contact Information - Jan Medina, CFA, serves as Vice President and Head of Investor Relations at InflaRx NV [4] - MC Services AG handles media and investor relations for InflaRx, with contacts including Katja Arnold, Laurie Doyle, and Dr Regina Lutz [4]

InflaRx N.V. (IFRX) shares gained 7.7% on Wednesday following the European Commission's (EC) approval of marketing authorization, under exceptional circumstances, for Gohibic (vilobelimab) to treat adult patients with acute respiratory distress syndrome (ARDS) caused by SARS-CoV-2. The targeted patient population in the EU comprises individuals receiving systemic corticosteroids as standard-of-care therapy and undergoing invasive mechanical ventilation, with or without extracorporeal membrane oxygenation.Th ...

JENA, Germany, Jan. 15, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receivin ...