CAMBRIDGE, Mass. - Ernexa Therapeutics (NASDAQ:ERNA) announced today it has completed process development for ERNA-101, its lead cell therapy candidate, and transitioned into GMP manufacturing for clinical development.
The company remains on track to submit an Investigational New Drug application in Q3 2026. Technology transfer activities are underway.
ERNA-101 activates the immune system to recognize and attack cancer cells, initially targeting ovarian cancer.
"Completing process development and advancing into GMP manufacturing are critical steps toward IND clearance," said CEO Sanjeev Luther.
According to Bond.az data, the company has a market cap of $13.3 million and is burning cash but maintains more cash than debt.
The company develops cell therapies for advanced cancer and autoimmune diseases. ERNA-201 targets autoimmune conditions.
The IND filing would mark the transition to a clinical-stage company. Shares have fallen 87% over the past year but gained 26% in the last week.
