ERNA

Landmark data positions ERNA-101 as a potential game-changing immunotherapy and a major catalyst for future clinical and shareholder value CAMBRIDGE, Mass., May 06, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced new preclinical data demonstrating that its lead cell therapy candidate, ERNA-101, in combination with PD-1 blockade, drives complete tumor clearance and 100% long-term survival in syngeneic ovarian cancer models. “This data represents a significant step forward,” said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. “We are not just seeing strong response, we are seeing complete tumor eradication and durable survival, driven by a powerful immune activation mechanism within the tumor itself. These findings underscore the potential of ERNA-101 to overcome one of the biggest challenges in ovarian cancer – an immunologically ‘cold’ TME – and to unlock the full potential of checkpoint inhibition. Subsequent to a positive clinical proof-of-concept trial in collaboration with the MD Anderson Cancer Center in platinum-resistant ovarian cancer, we anticipate broadening the scope of indications to include other solid tumors, where strong immunosuppression in the tumor microenvironment limits the clinical benefit of anti-PD-1 therapy.” In the study, treatment with ERNA-101 in combination with anti-PD-1 therapy resulted in complete tumor clearance (i.e., loss of detectable tumor signal by bioluminescence imaging) and 100% survival through long-term follow-up. These outcomes significantly exceeded those observed with either therapy alone and suggest potential curative activity. The data further demonstrate that ERNA-101 remodels the TME from immunosuppressive to immune-activated, enabling robust and sustained anti-tumor immune responses. “What we are seeing goes beyond expectations. Achieving complete tumor elimination and 100% survival in a model where current approaches typically fall short reinforces both the strength of the data and the underlying mechanism driving this response. These results give us increased confidence in ERNA-101’s ability to meaningfully enhance the activity of checkpoint inhibitors and potentially shift treatment outcomes in ovarian cancer. This approach may also extend...

The Company’s operating loss declined by 44% year-over-year, reflecting its continued laser focus on relentless execution and progress in operational excellence Continued progress with lead program, ERNA-101, toward first-in-human Phase 1 study in platinum-resistant ovarian cancer (PROC), anticipated in H2 2026 CAMBRIDGE, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced its financial results for the three- and nine-month periods ended September 30, 2025, and highlighted its continued operational execution. Recent Highlights Announced a cell therapy manufacturing partnership to advance ERNA-101 toward clinical trials in ovarian cancer Presented new positive data of ERNA-101 for PROC in ASCO-2025, AACR-2025 annual meetings, demonstrating how ERNA-101 addresses a significant unmet need with rapid disease progression, poor outcomes, and limited treatment options Continued engagement with scientific, investor, and industry communities at a number of conferences, including Cell & Gene Meeting on the Mesa, iPSC Drug Development Summit, and AACR Special Conference in Cancer Research Expanded its Scientific Advisory Board to a combined Scientific and Medical Advisory Board as the Company advances toward clinical trials in ovarian cancer and autoimmune disease “We continue to operate with financial discipline, focusing our resources on advancing our cell therapy programs toward the clinical stage,” said Sanjeev Luther, President and CEO of Ernexa Therapeutics. “This approach gives us the flexibility to pursue strategic collaborations and progress our lead programs, including ERNA-101 for ovarian cancer and ERNA-201 for autoimmune disease. We are well-positioned to advance our clinical and regulatory strategies toward our first-in-human study next year.” Ernexa recently announced a partnership with Cellipont Bioservices, marking a significant step in advancing ERNA-101. The Company also reported substantial year-over-year financial performance improvements, supporting the continued development of its lead cell therapy programs for patients with high unmet needs. Development Program Highlights Ernexa is advancing a best-in-class approach using synthetic, allogeneic induced mesenchymal stem cells (iMSCs) to provide a scalable, off-...

Explore Ernexa Therapeutics's Fair Values from the Community and select yours Net loss: US$11.3m (loss narrowed by 6.9% from 1H 2024). US$2.91 loss per share (improved from US$33.78 loss in 1H 2024). This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Ernexa Therapeutics shares are down 1.7% from a week ago. You still need to take note of risks, for example - Ernexa Therapeutics has 5 warning signs (and 3 which are significant) we think you should know about. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.