InflaRx N.V.(IFRX)
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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 ...
InflaRx Showcases Vilobelimab’s Role in Immuno-Dermatology at the 2025 AAD Annual Meeting
Globenewswire· 2025-03-07 13:00
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]
InflaRx to Showcase Vilobelimab’s Role in Immuno-Dermatology at the 2025 AAD Annual Meeting
Globenewswire· 2025-02-28 14:00
JENA, Germany, Feb. 28, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced acceptance of all submitted abstracts, featuring the role of vilobelimab in pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS), to be presented during the 2025 American Academy of Dermatology (AAD) Annual Meeting, March 7 - 11, in Orlando, FL. Camilla Chong, MD, Chief Medical Officer of InflaRx, commented ...
InflaRx to Report Full Year 2024 Results on March 20 and Announces Participation in March Investor Conferences
Globenewswire· 2025-02-25 12:30
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]