Neurona Therapeutics Secures $102 Million to Propel Phase 3 EPIC Trial

Neurona Therapeutics, a biotherapeutics company, has successfully raised $102 million in an upsized and oversubscribed private financing round to advance its lead allogeneic cell therapy candidate, NRTX-1001. This financing round, involving major investors such as Fidelity Management, The Column Group, Ysios Capital, and others, follows a positive clinical signal from Neurona’s ongoing Phase 1/2 trial. The proceeds will support the crucial Phase 3 EPIC trial, designed to be a pivotal trial for regulatory submission, which aims to demonstrate the efficacy of NRTX-1001 in treating drug-resistant mesial temporal lobe epilepsy (MTLE). The Phase 3 trial will adopt a randomized and double-blind design, with the potential for participants in the control group to cross over and receive the therapy. Neurona’s commitment to advancing this therapy has been further buoyed by prior discussions with the FDA and the RMAT designation granted earlier. Results to date from the Phase 1/2 trial have shown impressive seizure reduction without cognitive impairments. The company aims to begin recruitment for the Phase 3 trial in late 2025.