Regulatory alignment supports rapid progress, tech transfer already underway to accelerate clinical readiness

Company on track to initiate first-in-human (FIH) trial for the treatment of ovarian cancer in the second half of 2026

CAMBRIDGE, Mass., Jan. 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 the successful completion of its recent Pre-Investigational New Drug Application (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA). Feedback from the FDA provided strong regulatory alignment on Ernexa’s development approach and set a clear pathway toward submitting the IND and initiating its first-in-human (FIH) trial for the treatment of ovarian cancer, expected in the second half of 2026.

Following the meeting, Ernexa has accelerated key operational activities. Tech transfer – one of the most significant milestones in preparing for clinical manufacturing – is already underway, positioning the company to rapidly advance toward production of clinical-grade material and trial readiness.

“We are very pleased with the outcome of our engagement with the FDA,” said Sanjeev Luther, President and CEO of Ernexa Therapeutics. “The Agency’s feedback validates our development strategy and gives us the green light to move forward with urgency. With tech transfer now in progress, we are operating at full speed to bring our first-in-human studies online in 2026. This is a major step toward delivering transformative cell therapies to patients with serious and underserved diseases.”

Ernexa is currently advancing two synthetic, allogeneic induced mesenchymal stem cell (iMSC) therapies – ERNA-101 for ovarian cancer and ERNA-201 for autoimmune disease. Built from reprogrammed induced pluripotent stem cells (iPSCs), Ernexa’s engineered iMSCs are designed to actively home in on tumors or inflamed tissues and deliver potent therapeutic cytokines directly to the disease site. This targeted, off-the-shelf approach aims to overcome key limitations of traditional MSC therapies while enabling scalable manufacturing and broad patient accessibility.

The company’s initial clinical development will focus on ERNA-101 for the treatment of ovarian cancer, a disease with limited effective targeted therapies and high recurrence rates.

About Ernexa Therapeutics

Ernexa Therapeutics (NASDAQ: ERNA) is developing innovative stem cell therapies for the treatment of advanced cancer and autoimmune disease. Ernexa’s core technology focuses on engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). Ernexa’s synthetic, allogeneic iMSCs provide a scalable, off-the-shelf treatment, without needing patient-specific cell harvesting.

ERNA-101 is the company’s lead cell therapy product, designed to activate and regulate the immune system's response to recognize and attack cancer cells. ERNA-201 is a cell therapy product designed to target inflammation and treat autoimmune disease. The company’s initial focus is to develop ERNA-101 for the treatment of ovarian cancer.

For more information, visit www.ernexatx.com .

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "objective," or the negative version of these words and similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Ernexa's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: progress and possible outcomes of the Company’s lead research project, ERNA-101, and future research projects. Forward-looking statements are based upon Ernexa's current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Ernexa's risks and uncertainties, you are encouraged to review its documents filed with the SEC including its recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Ernexa does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as required by applicable law.

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