Ernexa Therapeutics Successfully Completes Key Manufacturing and IND Preparation Milestones for ERNA-101 Toward First-in-Human Clinical Development

Company remains on track for anticipated IND filing in Q3 2026, marking a transformative step toward becoming a clinical-stage biotechnology company

CAMBRIDGE, Mass., May 27, 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 significant progress in the development of ERNA-101, the company’s lead therapeutic candidate, achieving multiple critical milestones that position the program for a planned Investigational New Drug (IND) submission in the third quarter of 2026 and the anticipated initiation of its first-in-human clinical study.

The company has successfully completed process development activities for the ERNA-101 manufacturing process and has now transitioned into Good Manufacturing Practice (GMP) manufacturing in preparation for clinical development. In parallel, technology transfer activities for ERNA-101 are actively underway, representing another major operational milestone supporting the planned IND submission timeline.

“These achievements represent a defining moment for Ernexa Therapeutics,” said Sanjeev Luther, CEO of Ernexa Therapeutics. “Completing process development and advancing into GMP manufacturing are critical steps toward IND clearance and the launch of our first-in-human clinical study for ERNA-101. We are executing against our development strategy with urgency and discipline and remain firmly on track for our planned IND filing in the third quarter of 2026, Most importantly, we believe ERNA-101 has the potential to bring new hope to patients and families in need of better therapeutic options.”

The advancement of ERNA-101 reflects continued momentum across the company’s development and manufacturing operations and marks an important evolution in Ernexa’s corporate trajectory toward becoming a clinical-stage biotechnology company.

“With technology transfer now in progress and manufacturing activities advancing as planned, we believe Ernexa is entering a transformational phase,” added CEO, Sanjeev Luther. “These milestones will significantly strengthen our operational readiness and reinforce our confidence in the path toward clinical evaluation of ERNA-101.”

ERNA-101 is being advanced as part of Ernexa Therapeutics’ broader mission to develop innovative therapies designed to address significant unmet medical needs.

Key Highlights

• IND submission for ERNA-101 targeted for Q3 2026
• Technology transfer activities currently in progress
• Process development for ERNA-101 manufacturing successfully completed
• Transition to GMP manufacturing underway in preparation for clinical studies
• Company advancing toward anticipated transformation into a clinical-stage biotechnology company
• Progress supports planned first-in-human clinical study following IND clearance

For more information about ERNA-101 and the Company’s development plans, visit www.ernexatx.com

About Ernexa Therapeutics

Ernexa Therapeutics (NASDAQ: ERNA) is developing innovative cell therapies for the treatment of advanced cancer and autoimmune diseases. Ernexa’s core technology focuses on engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). Ernexa’s allogeneic synthetic iMSCs provide a scalable, off-the-shelf treatment solution, 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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Sharon Golubchik
RAYNZ
sharon@raynzhealth.com

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