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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 independently generated preclinical data validating its lead cell therapy candidate ERNA-101 in combination with anti-PD-1 in an immunocompetent ovarian cancer model. An independent contract research organization reproduced earlier MD Anderson findings, showing complete tumor clearance and durable long-term survival in a larger study.
In the new study, 10 of 15 animals (67%) treated with ERNA-101 plus anti-PD-1 achieved complete tumor clearance and long-term survival, while none of the remaining 45 animals receiving ERNA-101 monotherapy, anti-PD-1 alone, or no treatment had complete responses. The study confirmed ERNA-101’s tumor-homing delivery of an engineered IL-7/IL-15 fusion cytokine, remodeling the tumor microenvironment and enhancing checkpoint inhibitor activity. Ernexa plans an IND submission in Q3 2026 and a first-in-human Phase 1 trial in Q4 2026.
Ernexa Therapeutics (Nasdaq: ERNA) released a CEO Corner video in which President and CEO Sanjeev Luther discusses ERNA-101, the company’s lead off-the-shelf induced mesenchymal stem cell (iMSC) therapy candidate for platinum-resistant ovarian cancer and other immunologically “cold” tumors.
The video reviews preclinical data showing complete tumor clearance and 100% long-term survival in ovarian cancer models when ERNA-101 was combined with PD-1 blockade, along with evidence of tumor microenvironment remodeling and increased immune cell infiltration. According to Ernexa, an IND submission for ERNA-101 is planned for Q3 2026, with a first-in-human Phase 1 study anticipated to begin in Q4 2026.
Ernexa Therapeutics (Nasdaq: ERNA) launched a new CEO Corner platform featuring President and CEO Sanjeev Luther. The channel offers deeper insight into company developments, scientific strategy and long-term vision in cell therapies for advanced cancer and autoimmune disease.
The inaugural video reviews Ernexa's mission, focus on engineered off-the-shelf cell therapy platforms, and goals to improve scalability, consistency, accessibility and affordability for patients with serious diseases. CEO Corner content is available on Ernexa's website and social media.
Ernexa Therapeutics (Nasdaq: ERNA) reported progress toward becoming a clinical-stage company with its lead candidate ERNA-101.
GMP manufacturing is underway, IND-enabling work is advancing, and an IND submission is planned for Q3 2026, targeting a Phase 1 first-in-human study in Q4 2026.
In preclinical ovarian cancer models, ERNA-101 plus PD-1 blockade showed complete tumor clearance and 100% long-term survival, with marked immune microenvironment changes. A recent $10.5 million financing is expected to fund near-term milestones, including initial Phase 1 data in the first half of 2027.
Ernexa Therapeutics (Nasdaq: ERNA) featured Scientific Advisory Board member Dr. Ira Winer in a Virtual Investor KOL Connect segment on ovarian cancer. Discussion covered the unmet need in advanced ovarian cancer, challenges of immunologically “cold” tumors and evolving immune and cell therapy approaches.
Dr. Winer outlined the potential of Ernexa’s ERNA-101 program and engineered IL-7/IL-15 fusokine-iMSC platform, emphasizing off-the-shelf, scalable allogeneic cell therapies designed to remodel the tumor microenvironment, activate immune responses and potentially improve affordability and patient access.
Ernexa Therapeutics (Nasdaq: ERNA) announced completion of key manufacturing milestones for its lead candidate ERNA-101, including finished process development and a transition into GMP manufacturing. Technology transfer is underway, supporting a targeted IND submission in Q3 2026 and an anticipated first-in-human clinical study.
Ernexa Therapeutics (Nasdaq: ERNA) released a Virtual Investor KOL Connect segment featuring Dr. Elena Ratner of Yale and Ernexa’s board.
The discussion reviews the ovarian cancer treatment landscape, unmet needs, immunologically “cold” tumors, and preclinical ERNA-101 data showing complete tumor elimination and 100% long-term survival in ovarian cancer models with PD-1 blockade.
Ernexa Therapeutics (Nasdaq: ERNA) released a Virtual Investor KOL Connect segment featuring Chief Scientific Officer Dr. Robert Pierce discussing ovarian cancer, treatment limitations, and the company’s approach.
The company will also join a Virtual Investor Closing Bell event on May 13, 2026, highlighting preclinical ERNA-101 ovarian cancer data showing complete tumor elimination and 100% survival in models when combined with PD-1 blockade.
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.