CAMBRIDGE, Mass., Feb. 06, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics Inc. (Nasdaq: ERNA) (“Ernexa” or the “Company”), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced the pricing of a best-efforts registered public offering of 21,000,000 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to 21,000,000 shares of common stock, at a combined public offering price of $0.50 per s ...

As filed with the Securities and Exchange Commission on February 5, 2026. Registration No. 333-293150 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ERNEXA THERAPEUTICS INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 31-1103425 (Primary Standard Industrial Classification Code Number) (IRS Employer Identification ...

As filed with the Securities and Exchange Commission on February 3, 2026. Registration No. 333-293150 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 TO FORM S-1 (State or other jurisdiction of incorporation or organization) Delaware 2834 31-1103425 (Primary Standard Industrial Classification Code Number) (Address, including zip code and telephone number, including area code, of registrant's principal executive offices) Sanjeev Luther President and Chief Executive Off ...

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]

As filed with the Securities and Exchange Commission on February 2, 2026. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ERNEXA THERAPEUTICS INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 31-1103425 (Primary Standard Industrial Classification Code Number) (IRS Employer Identification No.) 1035 Cambridge Stree ...

Core Insights - Ernexa Therapeutics has been selected as one of ten companies globally to participate in the Japan Entry Acceleration Program (JEAP), highlighting its innovative cell therapy platform for advanced cancer and autoimmune diseases [1][2]. Group 1: Company Overview - Ernexa Therapeutics focuses on developing novel cell therapies, particularly using induced pluripotent stem cells (iPSCs) to create allogeneic synthetic induced mesenchymal stem cells (iMSCs), which provide scalable treatment solutions [7]. - The company’s lead products include ERNA-101, aimed at enhancing the immune system's ability to target tumors, and ERNA-201, which addresses harmful inflammation in autoimmune diseases [5][8]. Group 2: Program Participation - JEAP is a competitive initiative by the Japan External Trade Organization (JETRO), attracting around 70 companies from 25 countries, emphasizing the high level of competition [2][6]. - Participation in JEAP offers Ernexa access to expert mentoring, market-entry guidance, and opportunities for collaboration with leading Japanese research and development organizations [4][6]. Group 3: Strategic Goals - The program is expected to advance Ernexa's pipeline in Japan, with ERNA-101 entering first-in-human clinical trials for ovarian cancer this year, addressing significant unmet needs in cancer treatment [5]. - The company aims to leverage JEAP to explore strategic partnerships and clinical development opportunities, ultimately striving to deliver hope to patients with serious conditions [3].

Core Insights - Ernexa Therapeutics is on track to initiate its first-in-human trial for ovarian cancer treatment in the second half of 2026 following a successful Pre-IND meeting with the FDA, which provided strong regulatory alignment and a clear pathway for IND submission [1][3] Group 1: Company Developments - The company has accelerated key operational activities post-FDA meeting, with tech transfer already underway to prepare for clinical manufacturing and trial readiness [2] - Ernexa is advancing two synthetic, allogeneic induced mesenchymal stem cell (iMSC) therapies: ERNA-101 for ovarian cancer and ERNA-201 for autoimmune disease, utilizing reprogrammed induced pluripotent stem cells (iPSCs) [3][5] - The initial clinical development will focus on ERNA-101, targeting ovarian cancer, which currently has limited effective therapies and high recurrence rates [4][6] Group 2: Technology and Approach - Ernexa's engineered iMSCs are designed to target tumors or inflamed tissues, delivering therapeutic cytokines directly to the disease site, which aims to overcome limitations of traditional MSC therapies while enabling scalable manufacturing [3][5] - The company's approach provides an off-the-shelf treatment option without the need for patient-specific cell harvesting, enhancing patient accessibility [5][6]

Core Insights - Ernexa Therapeutics announced promising preclinical results for its lead cell therapy candidate, ERNA-101, showing significant survival benefits and immune activation in ovarian cancer models [1][5] - The proprietary platform utilizes induced pluripotent stem cells (iPSCs) to create induced mesenchymal stem cells (iMSCs), which can effectively reprogram immunosuppressive tumor microenvironments into immune-active states [2][4] Company Overview - Ernexa Therapeutics is focused on developing innovative cell therapies for advanced cancer and autoimmune diseases, leveraging a scalable, off-the-shelf approach that does not require patient-specific cell harvesting [7][6] - The company’s lead product, ERNA-101, aims to enhance the immune system's ability to recognize and attack cancer cells, with a specific initial focus on ovarian cancer [8][9] Research Findings - The preclinical study demonstrated that iMSCs engineered to secrete interleukin-7 (IL-7) and interleukin-15 (IL-15) produced cytokine levels approximately 20-fold higher than those reported in engineered T-cell approaches, leading to robust T-cell expansion and activation [4][5] - In an ovarian cancer model, the administration of IL-7/IL-15-secreting iMSCs resulted in significant immune cell infiltration, macrophage polarization towards a pro-inflammatory phenotype, and prolonged survival, indicating a shift from an immune-excluded to a highly inflamed tumor microenvironment [5][6] Future Directions - The company plans to advance ERNA-101 through additional preclinical testing, with first-in-human trials anticipated for the following year [6][4] - Ernexa Therapeutics views the ability to manufacture clonal, gene-modified cells at scale as a competitive advantage in the clinical development of its therapies [4]

Core Insights - Ernexa Therapeutics is set to present data from its innovative cell therapy platform at the 67th ASH Annual Meeting, highlighting its potential in treating advanced cancer and autoimmune diseases [1][2]. Company Overview - Ernexa Therapeutics (NASDAQ: ERNA) focuses on developing novel cell therapies, particularly through engineering induced pluripotent stem cells (iPSCs) into induced mesenchymal stem cells (iMSCs) [4]. - The company aims to provide scalable, off-the-shelf treatment solutions without the need for patient-specific cell harvesting [4]. Lead Products - ERNA-101 is Ernexa's lead cell therapy product, designed to activate and regulate the immune system's response to recognize and attack cancer cells, with an initial focus on ovarian cancer [5]. - ERNA-201 is another cell therapy product aimed at targeting inflammation and treating autoimmune diseases [5]. Presentation Details - The oral presentation will feature preclinical findings supporting ERNA-101, showcasing a unique approach to converting immunosuppressive tumor microenvironments into pro-inflammatory environments that enhance immune response [3]. - The presentation is scheduled for December 6, 2025, from 3:00 PM to 3:15 PM EST at the OCCC - Chapin Theater [3].

Core Insights - Ernexa Therapeutics has appointed Dr. Ira S. Winer to its Scientific and Medical Advisory Board, enhancing its expertise in women's oncology and immunotherapy [1][2][3] Company Overview - Ernexa Therapeutics is focused on developing innovative cell therapies for advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) to create allogeneic induced mesenchymal stem cells (iMSCs) [7] - The company's lead product, ERNA-101, aims to activate the immune system to target cancer cells, with an initial focus on ovarian cancer [8] Leadership and Expertise - Dr. Winer is a recognized gynecologic oncologist and translational scientist, contributing significant clinical and research experience to Ernexa's mission [2][5] - His background includes a Ph.D. in cellular and molecular biology, emphasizing scientific innovation in gynecologic cancers [6] Strategic Goals - Ernexa aims to advance ERNA-101 through first-in-human trials and expand its pipeline into inflammatory and autoimmune indications, leveraging Dr. Winer's strategic guidance [3][4]