JENA, Germany, Aug. 21, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced it will participate in two investor conferences in September 2025. Details are as follows: Contacts: InflaRx will also conduct one-on-one investor meetings on September 4th. A link to view the fireside chat live stream and its replay is available here. H.C. Wainwright 27th Annual Global Investment Conference Se ...

Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system [2] - The company utilizes proprietary anti-C5a and anti-C5a receptor technologies to create specific inhibitors of the complement activation factor C5a [2] - InflaRx has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody, which has shown disease-modifying clinical activity in multiple studies [2] Upcoming Financial Results - InflaRx will report its second quarter 2025 financial and operating results on August 7, 2025, before the market opens [1] - No conference call is planned for this earnings report [1] Product Development - InflaRx is also developing INF904, an orally administered small molecule inhibitor targeting C5a-induced signaling [2] - The company was founded in 2007 and has offices in Jena and Munich, Germany, as well as Ann Arbor, MI, USA [2][3]

JENA, Germany, July 11, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it has received a written notice (the “Notice”), dated July 11, 2025, from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty (30) consecutive business days, the bid price for the Company’s common shares had closed below the minimum $1.00 pe ...

Core Viewpoint - InflaRx N.V. announced the termination of the Phase 3 trial for vilobelimab in pyoderma gangrenosum due to futility as recommended by the Independent Data Monitoring Committee (IDMC) [1][2] Group 1: Trial and Development Updates - The IDMC's recommendation was based on an analysis of the first 30 patients, with no unexpected adverse events reported [2] - InflaRx will discontinue further development of vilobelimab for pyoderma gangrenosum and will focus on INF904, with Phase 2a data readouts expected in chronic spontaneous urticaria and hidradenitis suppurativa this summer [2] - The company is considering additional cost savings and resource redirection to extend its cash runway [3] Group 2: Regulatory and Market Status - GOHIBIC (vilobelimab) is still available in the U.S. under Emergency Use Authorization for COVID-19 in hospitalized adults [3] - In the EU, GOHIBIC has received marketing authorization under exceptional circumstances for treating adult patients with SARS-CoV-2-induced acute respiratory distress syndrome [4] - InflaRx is exploring commercial partnerships and distribution options in the EU without expecting a negative impact on its cash burn rate [4] Group 3: Financial Position - In February, InflaRx completed a public offering of 8.25 million shares at $2.00 per share, raising approximately $30 million in gross proceeds [4] - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling €65.7 million, indicating sufficient funds for planned operations into 2027 [7] Group 4: Stock Performance - Following the announcement, IFRX stock experienced a significant decline of 52.8%, trading at $0.86 during the premarket session [5]

Core Viewpoint - InflaRx N.V. announced the discontinuation of the Phase 3 trial for vilobelimab in pyoderma gangrenosum due to futility, based on an interim analysis of the first 30 patients, with no unexpected adverse events reported [1][2] Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics targeting the complement system, specifically through its proprietary anti-C5a and anti-C5aR technologies [5] - The lead product candidate, vilobelimab, is a first-in-class anti-C5a monoclonal antibody that has shown clinical activity in various studies [5][17] - The company was founded in 2007 and has offices in Jena and Munich, Germany, as well as Ann Arbor, MI, USA [5] Product Development - Following the trial's discontinuation, InflaRx will prioritize resources on INF904, an oral inhibitor of C5aR, with Phase 2a data readouts expected in chronic spontaneous urticaria and hidradenitis suppurativa this summer [2] - The company is also considering cost-saving measures to extend its cash runway [2] Regulatory Status of Vilobelimab - Vilobelimab (GOHIBIC) has received Emergency Use Authorization from the FDA for treating COVID-19 in hospitalized adults when initiated within 48 hours of invasive mechanical ventilation or ECMO [3][7] - In the EU, vilobelimab has been granted marketing authorization under exceptional circumstances for treating adult patients with SARS-CoV-2-induced acute respiratory distress syndrome who are receiving systemic corticosteroids and invasive mechanical ventilation [4][9] Clinical Trial Results - The EU approval of vilobelimab is supported by results from the Phase 3 PANAMO trial, which demonstrated a 23.9% relative reduction in 28-day all-cause mortality compared to placebo in invasively mechanically ventilated COVID-19 patients [9][10]

JENA, Germany, May 22, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the Company will participate in multiple investor conferences in June and July 2025. Jefferies Global Healthcare ConferenceJune 3 - 5, 2025 in New York, NY InflaRx will conduct an investor presentation on June 4th at 7:35 AM ET and will participate in one-on-one investor meetings. A link to register for the ...

Core Viewpoint - InflaRx N.V. is advancing its anti-inflammatory therapeutics, with significant upcoming milestones for its key programs, particularly vilobelimab and INF904, which could enhance the company's pipeline and create substantial value for patients with chronic inflammatory conditions [2][3]. Financial Highlights - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling €65.7 million, providing sufficient funds for operations into 2027 [7][20]. - The company incurred a net loss of €8.3 million, or €0.13 per ordinary share, for Q1 2025, an improvement from a net loss of €9.7 million, or €0.17 per ordinary share, in Q1 2024 [19][24]. - Revenue for the three months ended March 31, 2025, was zero, a decrease of €36 thousand compared to the same period in 2024 [11]. - Research and development expenses decreased to €7.0 million, down €0.3 million from the previous year, primarily due to lower third-party expenses related to INF904 [14]. Business Updates - The interim analysis for the Phase 3 trial of vilobelimab in pyoderma gangrenosum (PG) is expected to be announced by the end of May to early June 2025, which will assess trial size adaptation or futility [3][4]. - Topline data for the Phase 2a study of INF904 in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) is anticipated in summer 2025 [5]. - Vilobelimab has received orphan drug designation from both the FDA and EMA for PG, along with fast track designation from the FDA [4][42]. Market Potential - The company estimates that CSU and HS each represent potential addressable markets of over $1 billion for INF904, with additional opportunities in immuno-dermatology and other indications [7][8]. - GOHIBIC (vilobelimab) has been granted EU marketing authorization for treating SARS-CoV-2-induced acute respiratory distress syndrome (ARDS), marking it as the first approved treatment for this condition in the EU [9][31]. Recent Developments - InflaRx completed a public offering in February 2025, raising gross proceeds of €28.7 million ($30.0 million) [10]. - The company successfully completed required toxicology studies for INF904, indicating no safety concerns for long-term dosing [6].

JENA, Germany, April 30, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it will report its first quarter 2025 financial and operating results on May 7, 2025, before the market opens. No conference call is planned. About InflaRx InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR tec ...

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]