InflaRx Reports First Quarter 2025 Financial Results and Provides Business Update

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].