Ernexa Therapeutics Inc (ERNA) is a preclinical-stage biotechnology company developing synthetic allogeneic iMSC-based cell therapies for cancer and autoimmune disease. The company has no product revenue as of its fiscal year ended December 31, 2025, operating entirely on capital raises to fund research and development. Its lead product candidate, ERNA-101, consists of allogeneic IL-7 and IL-15-secreting induced pluripotent stem cell-derived mesenchymal stem cells (iMSCs) designed to exploit the tumor-homing properties of MSCs. The initial target indication is platinum-resistant ovarian cancer. ERNA-101 remains in preclinical development, with no approved products and no commercialization revenue reported in the 10-K filed March 13, 2026. CEO Sanjeev Luther serves as President, Chief Executive Officer, and Director. Charles Cherington is the largest beneficial stockholder at 32.54% of common shares as of the filing date. The company conducted a 1-for-15 reverse stock split effective June 10, 2025, leaving 150 million authorized shares of common stock unchanged.

Revenue model

No product revenue. Ernexa Therapeutics is preclinical-stage and funds operations through equity issuances. No partnerships, royalties, or licensing revenues are disclosed in the 10-K filed March 13, 2026.

Products and services

Lead product candidate ERNA-101: allogeneic IL-7 and IL-15-secreting iMSCs (iPSC-derived mesenchymal stem cells) targeting platinum-resistant ovarian cancer. Patent application FAB-023 covers methods for reprogramming and gene editing cells, including engineered chromatin opening sequences at DNA target sites. All programs are preclinical as of the fiscal year ended December 31, 2025.

Customers and end markets

No commercial customers. Target end markets are oncology (initial indication: platinum-resistant ovarian cancer) and autoimmune disease. Future reimbursement would depend on Medicare, Medicaid, managed care organizations, private commercial health insurers, and pharmacy benefit managers.

Value-chain role

Early-stage drug developer. Ernexa conducts preclinical research internally and would rely on CROs and clinical study sites for future trials. Manufacturing compliance with FDA cGMP requirements and IND submission precede any clinical-stage activity.

Geographic exposure

Incorporated in Delaware, regulated under U.S. FDA requirements. The 10-K filed March 13, 2026 references both U.S. and foreign regulatory pathways but discloses no operating presence outside the United States.

Competitors

Genentech (Avastin/bevacizumab, platinum-resistant ovarian cancer), ImmunoGen (ELAHERE/mirvetuximab soravtansine, platinum-resistant ovarian cancer), Corcept Therapeutics, Daiichi Sankyo, Genmab, Merck & Co., Genelux Corporation

Source: SEC 10-K, filed 2026-03-13

Industry: Pharmaceutical Preparations Peers: Bone Biologics Corp American CryoStem Corp Protagenic Therapeutics Inc NeuBase Therapeutics, Inc. BIOCEPT INC Skye Bioscience Inc MetaVia Inc Transcode Therapeutics Inc