ERNA News & Events

Ernexa Therapeutics announced the pricing of a best-efforts registered public offering of 21,000,000 shares of its common stock and warrants to purchase up to 21,000,000 shares of common stock, at a combined public offering price of $0.50 per share and accompanying warrant. The warrants will have an exercise price of $0.68 per share, will be exercisable upon issuance, and will expire on the earlier to occur of the five-year anniversary of the initial issuance date, or the 180th calendar day following the public release by the Company of clinical trial data from the first cohort of the Phase 1 study of ERNA-101. The closing of the offering is expected to occur on or about February 10, subject to the satisfaction of customary closing conditions. Brookline Capital Markets, a division of Arcadia Securities is acting as the exclusive placement agent for the offering.

Ernexa Therapeutics announced it has been selected as one of only ten companies worldwide to participate in the Japan Entry Acceleration Program, JEAP, an initiative launched by the Japan External Trade Organization, JETRO. As a selected participant, Ernexa will receive expert-led mentoring and market-entry guidance focused on Japan's regulatory, clinical and commercial landscape. The program also provides direct engagement opportunities with leading Japanese research and development organizations, including CDMOs and CROs, to explore potential collaborations across development, manufacturing and clinical execution.

Ernexa Therapeutics announced the completion of its recent Pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration. Feedback from the FDA provided strong regulatory alignment on Ernexa's development approach and set a clear pathway toward submitting the IND and initiating its first-in-human trial for the treatment of ovarian cancer, expected in the second half of 2026. Following the meeting, Ernexa has accelerated key operational activities. Tech transfer - one of the most significant milestones in preparing for clinical manufacturing - is already underway, positioning the company to rapidly advance toward production of clinical-grade material and trial readiness. Ernexa is currently advancing two synthetic, allogeneic induced mesenchymal stem cell therapies - ERNA-101 for ovarian cancer and ERNA-201 for autoimmune disease. Built from reprogrammed induced pluripotent stem cells, Ernexa's engineered iMSCs are designed to actively home in on tumors or inflamed tissues and deliver potent therapeutic cytokines directly to the disease site. This targeted, off-the-shelf approach aims to overcome key limitations of traditional MSC therapies while enabling scalable manufacturing and broad patient accessibility. The company's initial clinical development will focus on ERNA-101 for the treatment of ovarian cancer, a disease with limited effective targeted therapies and high recurrence rates.