Welcome to our dedicated page for Ernexa news (Ticker: ERNA), a resource for investors and traders seeking the latest updates and insights on Ernexa stock.
Ernexa Therapeutics Inc. (NASDAQ: ERNA) generates news primarily around its development of cell therapies for advanced cancer and autoimmune disease. Company announcements emphasize progress with its iPSC-derived iMSC platform, preclinical data readouts, regulatory interactions, and collaborations that support the transition from research to clinical testing.
A central theme in Ernexa’s news flow is the advancement of its lead program, ERNA-101, for ovarian cancer, including platinum-resistant ovarian cancer. Updates have covered positive preclinical data demonstrating immune activation and survival benefits in ovarian cancer models, presentations at major scientific meetings such as the American Society of Hematology Annual Meeting, and participation in conferences focused on cell and gene therapies and iPSC-based drug development.
Investors and observers can also expect news on Ernexa’s broader platform and pipeline, including ERNA-201 for autoimmune and inflammatory diseases. Releases have highlighted how the company’s engineered iMSCs are designed to deliver cytokines directly into tumors or inflamed tissues, reprogram tumor microenvironments, and potentially address unmet medical needs in oncology and autoimmune indications.
Additional news topics include regulatory milestones like the successful completion of a Pre-IND meeting with the U.S. Food and Drug Administration for ERNA-101, operational updates on technology transfer and manufacturing readiness, and strategic partnerships such as the collaboration with Cellipont Bioservices for engineering, differentiation, and production activities. Financial updates, including quarterly performance and operating discipline, also appear in Ernexa’s disclosures.
For readers tracking ERNA, this news page offers a focused view of scientific presentations, preclinical results, regulatory progress, manufacturing partnerships, and corporate developments that shape the company’s efforts to bring its iMSC-based therapies toward first-in-human trials and beyond.
Ernexa Therapeutics (Nasdaq: ERNA) priced a best-efforts public offering of 21,000,000 common shares and accompanying warrants at a combined price of $0.50 per unit, with aggregate gross proceeds of approximately $10.5 million.
Warrants carry a $0.68 exercise price, are exercisable on issuance, and expire at the earlier of five years or 180 days after public release of first-cohort Phase 1 ERNA-101 clinical data. Closing expected on or about February 10, 2026. Proceeds intended for program advancement, working capital, and general corporate purposes.
Ernexa Therapeutics (Nasdaq: ERNA) said it participated in a Virtual Investor "What This Means" segment after a successful Pre-IND meeting with the U.S. FDA. The company reported FDA regulatory alignment on development strategy for lead cell therapy ERNA-101, targeting a first-in-human ovarian cancer trial.
Ernexa indicated it plans to submit an IND and initiate clinical testing in H2 2026, and that clinical-grade manufacturing technology transfer is underway to accelerate operational readiness for its allogeneic iMSC programs.
Ernexa Therapeutics (Nasdaq: ERNA) was selected as one of 10 global companies to join JETRO’s Japan Entry Acceleration Program (JEAP) on Jan 27, 2026, chosen from about 70 regenerative medicine applicants across 25 countries. JEAP provides mentor-led market-entry guidance, connections with Japanese CDMOs and CROs, and targeted support on regulatory, clinical and commercial pathways to accelerate business co-creation in regenerative medicine and oncology. Ernexa said the program will help advance its pipeline in Japan, anchored by two lead cell therapy programs: ERNA-101, entering first-in-human trials in ovarian cancer this year, and ERNA-201, targeting pathogenic inflammation in autoimmune disease.
Ernexa Therapeutics (Nasdaq: ERNA) completed a Pre-IND meeting with the FDA on Jan 6, 2026, securing regulatory alignment on its development approach for cell therapies.
The company said the FDA set a clear pathway toward an IND and the first-in-human (FIH) trial for ovarian cancer is expected in the second half of 2026. Tech transfer for clinical manufacturing is already underway to accelerate production of clinical-grade material and trial readiness.
Ernexa is advancing two allogeneic iMSC programs: ERNA-101 (ovarian cancer) and ERNA-201 (autoimmune disease), with initial clinical development focused on ERNA-101.
Ernexa Therapeutics (Nasdaq: ERNA) presented preclinical data at the American Society of Hematology Annual Meeting on Dec 8, 2025 showing its lead candidate ERNA-101 (iPSC-derived MSCs) reprogrammed immunosuppressive tumor microenvironments into pro-inflammatory states.
The study reported IL-7/IL-15-secreting iMSCs produced supraphysiologic cytokine levels ~20-fold higher than prior engineered T-cell approaches, drove robust T-cell expansion, sustained STAT5 signaling, macrophage polarization to a pro-inflammatory phenotype, and prolonged survival in an immunocompetent ovarian cancer model. The company said ERNA-101 supports an off-the-shelf, scalable approach and plans first-in-human trials next year.
Ernexa Therapeutics (Nasdaq: ERNA) will present preclinical data from its iPSC-derived iMSC platform in an oral presentation at the 67th ASH Annual Meeting in Orlando, Dec 6-9, 2025. The talk, titled "Gene-modified iPSC-derived MSCs convert immunosuppressive tumor microenvironments into distinct Pro-inflammatory TMEs," (abs25-15026) is scheduled for Dec 6, 2025, 3:00–3:15 PM EST in Chapin Theater (320).
The presentation covers preclinical findings supporting ERNA-101, Ernexa's lead ovarian cancer candidate and its approach to reprogram TMEs to stimulate T-cell anti-tumor activity.
Ernexa Therapeutics (Nasdaq: ERNA) appointed Dr. Ira S. Winer, M.D., Ph.D., FACOG, to its Scientific and Medical Advisory Board on December 2, 2025. Dr. Winer is a gynecologic oncologist and translational scientist who serves as Professor (Clinician Educator) at Wayne State University School of Medicine and practices at Barbara Ann Karmanos Cancer Institute.
The appointment strengthens clinical and translational expertise as Ernexa advances its iMSC cell therapy platform and lead program ERNA-101 toward first-in-human trials, with a focus on ovarian cancer and expansion into inflammatory and autoimmune indications.
Ernexa Therapeutics (Nasdaq: ERNA) will present at Oxford Global's Cell 2025 in London on November 11–12, 2025. Sanjeev Luther, President and CEO, will give an oral talk titled "Preparing Cell Therapies for Clinics" on Nov 12 at 12:50 PM GMT and join a panel on Nov 12 at 4:35 PM GMT addressing development, funding, and regulatory strategies for its engineered induced mesenchymal stem cell (iMSC) platform. Presentations focus on trial design, early regulatory engagement, partnerships, and scalable design to translate cell therapies into clinical practice.
Ernexa Therapeutics (Nasdaq: ERNA) reported continued operational progress and preclinical advancement on Nov 10, 2025. The company said its operating loss declined 44% year-over-year for the nine months ended Sept 30, 2025, and highlighted a partnership with Cellipont Bioservices to advance lead program ERNA-101 toward clinical trials.
Key program milestones disclosed include a 58.2% preclinical survival advantage for ERNA-101, planned completion of IND-enabling studies and an IND submission by Q1 2026, and a targeted first-in-human Phase 1 start in H2 2026. ERNA-201 remains in preclinical development with a pre-IND meeting anticipated by Q1 2026.
Ernexa Therapeutics (Nasdaq: ERNA) participated in a Virtual Investor “What This Means” segment on Nov. 6, 2025 to discuss a recently announced partnership with Cellipont Bioservices.
The agreement covers Engineering, Differentiation, and Production (EDP) activities to advance ERNA-101, Ernexa’s lead cell therapy for ovarian cancer, into clinical manufacturing and clinical trials. President and CEO Sanjeev Luther represented the company in the segment. The presentation recording is available via the Virtual Investor platform.
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