JENA, Germany, Oct. 21, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced its participation in the Guggenheim Securities 2nd Annual Healthcare Innovation Conference. Details are as follows: Guggenheim Securities 2nd Annual Healthcare Innovation ConferenceNovember 10 - 12, 2025 in Boston, MAFireside chat on November 11 at 2:30 PM ET InflaRx will also conduct one-on-one investor meetin ...

Core Points - InflaRx N.V. has regained compliance with Nasdaq's minimum bid price requirement as of September 11, 2025, after its ordinary shares closed at $1.00 or greater for 10 consecutive business days from August 27, 2025, to September 10, 2025 [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-C5a receptor technologies [3] - The company has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody that has shown disease-modifying clinical activity and tolerability in multiple studies [3] - InflaRx is also working on INF904, an orally administered small molecule inhibitor targeting C5a-induced signaling via the C5a receptor [3] - Founded in 2007, InflaRx has offices in Jena and Munich, Germany, and Ann Arbor, MI, USA [4]

Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system [3] - 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 [3] - InflaRx is also working on INF904, an orally administered small molecule inhibitor of C5a-induced signaling [3] Upcoming Events - InflaRx will participate in the Cantor Global Healthcare Conference from September 3 to 5, 2025, with a fireside chat scheduled for September 4 at 9:10 AM ET [1] - The company will also conduct one-on-one investor meetings on September 4 during the Cantor conference [1] - Additionally, InflaRx will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025, with a presentation on September 9 at 3:30 PM ET [2] - One-on-one investor meetings will also take place on September 9 at the H.C. Wainwright conference [2]

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]

Core Points - InflaRx N.V. has received a notice from Nasdaq indicating that its common shares have closed below the minimum bid price of $1.00 for the last 30 consecutive business days [1] - The company has until January 7, 2026, to regain compliance with the Minimum Bid Price Rule, with the possibility of transferring to the Nasdaq Capital Market for an additional compliance period [2] - The notice does not have an immediate effect on the listing or trading of the company's shares, and InflaRx plans to monitor its share price and explore options for compliance [3] Company Overview - InflaRx is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system, specifically through its proprietary anti-C5a and anti-C5a receptor technologies [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 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]

Core Insights - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics targeting the complement system [1][5] - The company will participate in several investor conferences in June and July 2025, including presentations and one-on-one meetings [1][2][3][4] Company Overview - InflaRx specializes in anti-C5a and anti-C5aR technologies to create inhibitors for the complement activation factor C5a, which is linked to various inflammatory diseases [5] - The lead product candidate, vilobelimab, is a first-in-class anti-C5a monoclonal antibody that has shown clinical activity and tolerability in multiple studies [5] - InflaRx is also developing INF904, an orally administered small molecule inhibitor of the C5a receptor [5] - The company was founded in 2007 and has offices in Jena and Munich, Germany, as well as Ann Arbor, MI, USA [5][6] Upcoming Events - InflaRx will present at the Jefferies Global Healthcare Conference from June 3-5, 2025, with a presentation scheduled for June 4 at 7:35 AM ET [2] - The company will participate in the Oppenheimer Innovators in I&I Summit on June 25, 2025, focusing on advances in dermatology [3] - InflaRx will also attend the Leerink Partners Therapeutics Forum on July 8-9, 2025, with one-on-one investor meetings on June 8 [4]

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].

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-C5aR technologies to create specific inhibitors of the complement activation factor C5a and its receptor C5aR [2] - InflaRx's lead product candidate, vilobelimab, is a first-in-class, intravenously delivered anti-C5a monoclonal antibody that has shown clinical activity and tolerability in various studies [2] Upcoming Financial Reporting - InflaRx will report its first quarter 2025 financial and operating results on May 7, 2025, before the market opens [1] - No conference call is planned for this financial report [1] Subsidiaries - InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. [3]