InflaRx N.V. - IFRX STOCK NEWS

InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company focusing on anti-inflammatory therapeutics, has announced it will release its second quarter 2024 financial and operating results on August 8, 2024, before the market opens. No conference call is scheduled for this report.

InflaRx specializes in developing inhibitors of the complement activation factor C5a and its receptor C5aR. Their lead product candidate, vilobelimab, is an intravenously delivered anti-C5a monoclonal antibody that has shown promising clinical activity in various indications. The company is also developing INF904, an oral small molecule inhibitor of the C5a receptor.

Founded in 2007, InflaRx has offices in Jena and Munich, Germany, and Ann Arbor, MI, USA.

InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company focusing on anti-inflammatory therapeutics, will present preclinical data on INF904, their novel oral C5aR inhibitor, at the 2024 European Meeting on Complement in Human Diseases (EMCHD) in Lübeck, Germany, from September 2-6, 2024. The company will showcase two poster presentations, participate in a C5a/C5aR-focused panel discussion, and speak at a satellite symposium.

INF904 is an orally administered, small molecule inhibitor of the C5a receptor that has demonstrated anti-inflammatory effects in preclinical models. A first-in-human study showed that INF904 is well-tolerated and exhibits no safety concerns in single doses from 3 mg to 240 mg or multiple doses from 30 mg QD to 90 mg BID for 14 days. The drug achieved ≥90% blockade of C5a-induced neutrophil activation over the 14-day dosing period, supporting its potential as a best-in-class treatment.

InflaRx announced that its drug GOHIBIC (vilobelimab) has been selected by BARDA for a Phase 2 clinical trial aimed at treating acute respiratory distress syndrome (ARDS). The trial will be conducted at around 60 U.S. sites, enrolling 600 adults with ARDS from various causes. Vilobelimab will be one of three drugs tested, with each drug's safety and efficacy evaluated separately against a placebo. Key endpoints include all-cause mortality at Day 28, hospitalization duration, ICU days, and other efficacy measures. The results will inform Phase 3 trial designs and identify patient subpopulations likely to benefit from these treatments.

InflaRx hosted a virtual R&D event showcasing their oral small molecule C5aR inhibitor, INF904. The event detailed its potential in treating Chronic Spontaneous Urticaria (CSU) and Hidradenitis Suppurativa (HS), both representing multi-billion-dollar markets. INF904's Phase 2a clinical trial for CSU and HS will start by late 2024, with results expected by summer 2025. The trial aims to evaluate safety, pharmacokinetics, and clinical benefits. InflaRx expects their strong financial position to fund operations into 2026, supporting further clinical advancements. The company sees INF904 as a pipeline-in-a-product, potentially addressing broader therapeutic areas.

InflaRx N.V. (Nasdaq: IFRX) presented new data at the ATS 2024 International Conference showing significant improvements in mortality rates for critically ill COVID-19 patients treated with vilobelimab in combination with tocilizumab or baricitinib. The analysis, derived from the PANAMO Phase III trial, demonstrates an 84.6% relative reduction in 28-day all-cause mortality and a 66.7% relative reduction in 60-day all-cause mortality compared to placebo. Safety assessments revealed no major concerns related to the combination therapy. This data further supports the FDA's emergency use authorization for vilobelimab in critically ill COVID-19 patients.

InflaRx N.V. reported financial results for Q1 2024 and provided updates on INF904 and Phase III vilobelimab trials. They highlighted plans to initiate Phase IIa in CSU and HS by 2024 end, with data availability in 2025. The vilobelimab trial for PG is ongoing, with an interim analysis in 2025. Cash reserves of €85.8 million expected to fund operations into 2026.

InflaRx N.V. (Nasdaq: IFRX) will report its first quarter 2024 financial and operating results on May 8, 2024. They will host a virtual R&D event on June 5, 2024, focusing on the development of their new oral small molecule C5aR inhibitor, INF904, and its potential in treating chronic spontaneous urticaria and hidradenitis suppurativa. Key opinion leaders will provide insights into the commercial opportunity and therapeutic potential of INF904.