Cambridge, Massachusetts, August 10, 2026
Ernexa Therapeutics announced the appointment of David Polinsky to its Board of Directors as the biotechnology company prepares to transition into the clinical development stage with its lead cell therapy program, ERNA-101. Polinsky brings more than 25 years of experience in biotechnology, oncology, capital markets, mergers and acquisitions, corporate strategy and governance, strengthening Ernexa’s leadership as it prepares for an important development period. The company plans to submit an Investigational New Drug (IND) application for ERNA-101 in the third quarter of 2026 and expects to initiate a Phase 1 clinical study in the fourth quarter of 2026. Ernexa said the board appointment is intended to enhance its strategic and corporate capabilities as it moves from preclinical development toward human clinical testing. ERNA-101 is being developed as an allogeneic cell therapy for advanced cancer, with the company initially focusing on ovarian cancer.
David Polinsky Adds Biotech and Capital Markets Expertise
Polinsky currently serves as Chief Financial Officer of Rafael Holdings, where he oversees finance, legal, corporate strategy and governance. His experience includes strategic transactions, capital allocation, M&A, SEC reporting, investor communications and board governance. He also played a role in establishing Rafael Holdings as an independent NYSE-listed company following its 2018 spin-off and helped lead the company’s 2025 merger with Cyclo Therapeutics and an approximately $25 million rights offering. Before joining Rafael Holdings, Polinsky co-founded Cornerstone Pharmaceuticals, formerly Rafael Pharmaceuticals, and held executive positions including President, General Counsel and Secretary. During that period, he helped develop the organization from an early-stage biotechnology company into a clinical-stage oncology business, with responsibilities spanning corporate strategy, business development, intellectual property, licensing, financing and governance. Ernexa said this combination of biotechnology operating experience and financial expertise could support the company as it approaches clinical development.
ERNA-101 Moves Toward Clinical Development
The board appointment comes as Ernexa advances several activities required to support the transition of ERNA-101 into the clinic. The company said it has generated preclinical data, advanced manufacturing activities, prepared its planned IND submission and developed the operational infrastructure needed for clinical-stage development. ERNA-101 is based on Ernexa’s proprietary cell therapy platform, which involves engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). The company’s allogeneic synthetic iMSCs are designed as an off-the-shelf cell therapy approach, potentially avoiding the need for patient-specific cell harvesting. ERNA-101 is designed to activate and regulate immune responses with the objective of enabling recognition and attack of cancer cells. Ernexa’s initial development focus is ovarian cancer, while the broader platform is intended to support applications across advanced cancer and autoimmune diseases.
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Ernexa Prepares for Key 2026 Milestones
Ernexa’s next major development milestone is the planned ERNA-101 IND submission in Q3 2026, followed by the anticipated initiation of a Phase 1 clinical trial in Q4 2026, subject to regulatory clearance and operational readiness. The move into human studies would represent a significant transition for the company because clinical data will begin to determine whether the preclinical characteristics of ERNA-101 can translate into a viable therapeutic profile. Ernexa is also developing ERNA-201, an investigational cell therapy designed to target inflammation and potentially treat autoimmune diseases. With Polinsky joining the board, the company is adding experienced leadership at a point when regulatory execution, clinical development planning, financing and strategic decision-making become increasingly important. However, ERNA-101 remains investigational, and its safety and efficacy in patients have not yet been established. The upcoming IND process and subsequent Phase 1 study will provide the first clinical assessment of the therapy.
Source: Ernexa Therapeutics press release
