On October 1, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancers, reported a new installment of its CEO Corner series featuring President and Chief Executive Officer Sanjeev Luther. The discussion highlights the recent appointment of Robert J. Spiegel, M.D., FACP, to the Company’s Board of Directors and how his deep oncology, clinical development and regulatory experience strengthens Ernexa as it sharpens its oncology focus and advances lead program ERNA-101 toward the clinic.

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Dr. Spiegel brings decades of experience spanning oncology, clinical development, regulatory strategy and pharmaceutical leadership, including more than 25 years at Schering-Plough Research Institute, where he ultimately served as Chief Medical Officer.

"We believe Ernexa is entering one of the most important periods in our evolution, and Dr. Spiegels’s addition to the Board comes at a highly relevant time," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "His experience aligns directly with where we are headed as we move ERNA-101 toward the clinic. With meaningful development milestones ahead and a broader opportunity across difficult-to-treat solid tumors, we believe we are building a strong foundation for Ernexa’s next stage of growth."

ERNA-101 is initially being developed for platinum-resistant ovarian cancer and is designed to leverage the tumor-homing properties of iMSCs to deliver immune-enhancing cytokines directly into the tumor microenvironment. The program is also designed to address immunologically "cold" tumors, supporting potential expansion into additional difficult-to-treat solid tumors.

Ernexa has completed IND-enabling preclinical studies for ERNA-101, clinical-grade manufacturing is underway, and the Company is targeting an IND submission in the fourth quarter of 2026, followed by initiation of a first-in-human study in the first quarter of 2027.

The CEO Corner also highlights encouraging preclinical findings supporting ERNA-101. In an ovarian cancer model, ERNA-101 in combination with anti-PD-1 demonstrated complete tumor clearance and 100% survival, further supporting the scientific rationale for the program as Ernexa prepares for clinical development.

Dr. Spiegel’s experience across first-in-human, proof-of-concept and registration-stage development is particularly relevant as Ernexa approaches clinical evaluation.

"ERNA-101 represents a compelling approach to addressing some of the persistent challenges in ovarian cancer," said Dr. Spiegel. "I am encouraged by the progress Ernexa has made as ERNA-101 approaches clinical development and look forward to contributing my experience as the Company advances this program and its broader oncology strategy." His appointment further strengthens Ernexa’s oncology, regulatory and clinical development expertise as the Company approaches key milestones."

Beyond ERNA-101, Ernexa is advancing next-generation oncology assets, including ERNA-102 and ERNA-103, as it works to build a differentiated portfolio of engineered iMSC therapies across solid tumors.

As Ernexa advances its oncology strategy, hope and accessibility remain central to the Company’s vision. Its allogeneic, off-the-shelf approach is designed with scalability in mind, with the goal of expanding accessibility while bringing meaningful new options and renewed hope to patients facing difficult-to-treat cancers.

The CEO Corner concludes with Mr. Luther outlining Ernexa’s priorities: advancing ERNA-101 into the clinic, generating human data and building a differentiated oncology company around the broader potential of its synthetic iMSC platform.

The Ernexa CEO Corner is now accessible on the Company’s website and social media channels. Access it here.

(Press release, Ernexa Therapeutics, OCT 1, 2026, View Source [SID1234671236])