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Ernexa Therapeutics develops cell therapies for advanced cancer and autoimmune disease using engineered induced pluripotent stem cells that are transformed into synthetic allogeneic induced mesenchymal stem cells. News about the company centers on ERNA-101, its lead iMSC candidate for ovarian cancer, including preclinical tumor-model results, immuno-oncology combinations and scientific discussions of the ovarian cancer treatment landscape.
Company updates also cover ERNA-201 for autoimmune inflammation, regulatory interactions tied to cell-therapy development, investor presentations, collaboration or market-entry programs, and capital-structure actions such as common-stock reverse splits and Nasdaq listing compliance.
Ernexa Therapeutics (Nasdaq: ERNA) reported preclinical results for ERNA-101 on May 6, 2026 showing that, in syngeneic ovarian cancer models, ERNA-101 combined with PD-1 blockade achieved complete tumor clearance by bioluminescence and 100% long-term survival.
The data show tumor microenvironment remodeling, increased CD4+/CD8+ infiltration, macrophage reprogramming, reduced ascites, and enhanced T cell persistence. Ernexa plans to advance ERNA-101 toward a first-in-human trial in advanced ovarian cancer and is studying combinations with checkpoint inhibitors.
Ernexa Therapeutics (Nasdaq: ERNA) announced a 1-for-25 reverse stock split effective May 4, 2026 at 12:01 a.m. ET to regain compliance with Nasdaq's $1.00 minimum bid rule. Every 25 pre-split shares will convert into one post-split share; outstanding warrants and authorized shares remain unchanged. The Company had 29,154,431 pre-split shares, which it expects will convert to approximately 1,166,177 post-split shares. Computershare will act as exchange agent; book-entry holders need take no action. The Company attributes the split to strengthening its financial foundation and maintaining Nasdaq listing access.
Ernexa Therapeutics (Nasdaq: ERNA) announced progress advancing its lead engineered iMSC therapy, ERNA-101, toward first-in-human trials in Q4 2026 with an IND submission targeted for Q3 2026.
Preclinical combination data with PD-1 blockade showed high rates of complete tumor regressions and prolonged survival in ovarian cancer models. Company also highlighted a $10.5M financing and a 61% reduction in G&A expenses in 2025.
Ernexa Therapeutics (Nasdaq: ERNA) will present in the Virtual Investor Closing Bell Series on Wednesday, February 25, 2026 at 4:00 PM ET. CEO Sanjeev Luther will give a corporate overview and business outlook, take live questions, and a replay will be available two hours after the live event for 90 days.
Investors may register to attend the live webcast and submit questions during the moderated discussion.
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.