InflaRx N.V. announced the commercial launch of Gohibic (vilobelimab) in the U.S. In April 2023, Gohibic was granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). The data supporting the EUA were based on the previously announced results of the multicenter Phase III PANAMO trial, which showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set. The data have been published in The Lancet Respiratory Medicine.

Gohibic is currently the only drug directed against the complement factor C5a that is authorized for the treatment of certain critically ill COVID-19 patients. InflaRx is continuing discussions with the FDA related to the submission of a Biologics License Application (BLA) for a potential future full approval of Gohibic. InflaRx has also completed encouraging meetings with the rapporteur and co-rapporteur member state teams of the European Committee for Medicinal Products for Human Use (CHMP) related to a planned Marketing Authorization Application with the European Medicines Agency (EMA).

The Company will provide updates on the status of regulatory submissions in the U.S. and elsewhere once available.