Business
InflaRx Reports First Quarter 2023 Financial and Operating Results and Provides Business Update
Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) for Gohibic (vilobelimab) for treatment of critically ill COVID-19
About this update from Inflarx N.v.
[{"type":"text","content":"Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) for Gohibic (vilobelimab) for treatment of critically ill COVID-19 patientsGohibic planned to be available to patients in the U.S. within the next few weeksPhase III study with vilobelimab in pyoderma gangrenosum (PG) underway; first patient expected to be enrolled mid-2023Cash, cash equivalents and marketable securities approximately €72.3 million as of March 31, 2023Additional €53.5 million in aggregate proceeds subsequently raised under at-the-market (ATM) program and by an underwritten public offering of ordinary shares JENA, Germany, May 11, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three months ended March 31, 2023, and provided a business update. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “These last months have been truly transformative for InflaRx. Upon receiving the EUA for Gohibic (vilobelimab) for the treatment of critically ill patients with COVID-19 last month, we became the first company worldwide with a drug authorized for emergency use for the control of complement factor C5a. We are working diligently to enable physicians to access this treatment option in the U.S. and plan to make the product available to patients within the next few weeks. At the same time, we continue to diligently advance our development pipeline. We expect to treat the first patient in a Phase III trial with vilobelimab in pyoderma gangrenosum, a severe neutrophil-mediated skin disease, around mid-year and are also further developing our small molecule C5aR inhibitor, INF904, which is currently in Phase I testing. The EUA for Gohibic is a great recognition of our scientific approach, and we are excited to continue developing our product candidates to provide patients with other diseases driven by the complement system with new therapeutic options.” Recent Highlights and Business Update Gohibic (vilobelimab): EUA Granted for Treatment of Critically Ill COVID-19 PatientsIn April 2023, the FDA issued an EUA for Gohibic (vilobelimab) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechan...