Ernexa Therapeutics Participates in Virtual Investor “What This Means” Segment Highlighting Recent Successful Pre-IND Meeting with U.S. FDA

Core Insights - Ernexa Therapeutics is advancing its lead cell therapy, ERNA-101, towards a first-in-human trial for ovarian cancer following a successful Pre-IND meeting with the FDA [2][3] - The FDA's regulatory alignment provides a clear pathway for Ernexa to submit an Investigational New Drug application and initiate clinical testing in the second half of 2026 [3] - The company is currently engaged in technology transfer for clinical-grade manufacturing, enhancing operational readiness for its synthetic, allogeneic induced mesenchymal stem cell (iMSC) therapies [3] Company Overview - Ernexa Therapeutics focuses on developing innovative cell therapies for advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) to create induced mesenchymal stem cells (iMSCs) [5] - The company's lead product, ERNA-101, is designed to activate and regulate the immune system's response to cancer cells, while ERNA-201 targets inflammation for autoimmune disease treatment [6] - Ernexa's allogeneic synthetic iMSCs offer a scalable, off-the-shelf treatment solution without the need for patient-specific cell harvesting [5]