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InflaRx N.V.(IFRX)
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InflaRx Ends Lead Asset Development After Failed Study For Rare And Painful Skin Disease
Benzinga· 2025-05-28 15:00
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]
InflaRx Announces Outcome of Interim Analysis for Vilobelimab Phase 3 Trial in Pyoderma Gangrenosum
Globenewswire· 2025-05-28 05:30
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]
InflaRx to Participate in Upcoming Investor Conferences
Globenewswire· 2025-05-22 11:30
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]
InflaRx Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-07 11:30
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].
InflaRx to Report First Quarter 2025 Results on May 7, 2025
Globenewswire· 2025-04-30 11:30
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]
InflaRx (IFRX) Loses -15.29% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner
ZACKS· 2025-03-26 14:35
InflaRx N.V. (IFRX) has been beaten down lately with too much selling pressure. While the stock has lost 15.3% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier.How to Determine if a Stock is OversoldWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a momentum oscillator t ...
InflaRx N.V.(IFRX) - 2024 Q4 - Annual Report
2025-03-20 11:50
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report Commission file number: 001-38283 OR ☒ ANNUAL RE ...
InflaRx N.V.(IFRX) - 2024 Q4 - Annual Report
2025-03-20 11:38
InflaRx Reports Full Year 2024 Results and Highlights Key Achievements and Expected Milestones Jena, Germany, March 20, 2025 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced its financial results for the year ended December 31, 2024, highlighting recent operational achievements and expected milestones for 2025. Exhibit 99.1 Vilobelimab in PG – Pivotal Phase 3 trial interim analysis expected by the end of ...
InflaRx Reports Full Year 2024 Results and Highlights Key Achievements and Expected Milestones
Globenewswire· 2025-03-20 11:30
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 ...
InflaRx Reports Full Year 2024 Results and Highlights Key Achievements and Expected Milestones
Newsfilter· 2025-03-20 11:30
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 ...