Leadership discusses recent FDA engagement, the technology underlying ERNA-101 and the development strategy supporting planned first-in-human clinical evaluation
Discussion features Sanjeev Luther, President and Chief Executive Officer; Dr. Christopher Rohde, developer of the technology underlying Ernexa’s platform and member of Ernexa’s Scientific Advisory Board; and Dr. Robert Pierce, Chief Scientific Officer
Access the segment here
CAMBRIDGE, Mass., Oct. 22, 2026 (GLOBE NEWSWIRE) — Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancers, today announced the release of a new Virtual Investor “What This Means” segment highlighting the Company’s progress advancing ERNA-101 toward the clinic and the scientific foundation supporting its broader cell therapy platform.
The discussion brings together Sanjeev Luther, President and Chief Executive Officer; Dr. Christopher Rohde, a member of Ernexa’s Scientific Advisory Board and developer of the technology underlying the Company’s platform; and Dr. Robert Pierce, Chief Scientific Officer, to discuss three key areas central to Ernexa’s next phase of development: regulatory alignment, scientific differentiation and progress toward first-in-human clinical evaluation.
At the center of the conversation is Ernexa’s pre-IND interaction with the U.S. Food and Drug Administration and what that milestone means for ERNA-101’s advancement in ovarian cancer. Mr. Luther discusses the strategic importance of the meeting, while Dr. Pierce provides additional perspective on the FDA feedback and its implications for the scientific and clinical development program.
“ERNA-101 is moving through a critical transition from preclinical development toward the clinic, and our focus is on executing each step with discipline,” said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. “The progress we are making across regulatory planning, IND-enabling development and clinical preparation is bringing us closer to the point where we can begin evaluating this technology in patients.”
The segment also provides a deeper look at the technology underlying Ernexa’s platform. Dr. Rohde discusses why induced mesenchymal stromal cells were selected as the foundation of the platform, the potential advantages of an allogeneic, off-the-shelf approach and the rationale for engineering ERNA-101 to express IL-7 and IL-15 within the tumor microenvironment.
“Our goal from the beginning was to build a cell therapy platform that could combine the flexibility of cellular engineering with an approach designed for practical, off-the-shelf use,” said Dr. Rohde. “ERNA-101 reflects that strategy by pairing an engineered cell platform with immune-modulating biology intended to act where it matters most, within the tumor microenvironment.”
Dr. Pierce further discusses how this underlying biology translates into Ernexa’s preclinical findings, including the program’s potential to recruit immune cells, alter the tumor microenvironment and enhance checkpoint blockade. The conversation also addresses findings from IND-enabling studies related to safety, biodistribution and tumor-homing characteristics as the Company prepares ERNA-101 for clinical development.
“The importance of the platform is not simply what it is engineered to do, but whether the biology translates into meaningful and reproducible activity,” said Dr. Robert Pierce, Chief Scientific Officer of Ernexa Therapeutics. “Our preclinical work is helping us understand that biology in greater depth and build the scientific package needed to support ERNA-101’s advancement into the clinic.”
Looking ahead, the segment outlines what investors can expect between Ernexa’s FDA interaction and initiation of a first-in-human clinical study. The discussion also explores how the underlying technology could potentially be adapted beyond the lead ovarian cancer program across additional solid tumors and therapeutic approaches.
“We believe ERNA-101 represents more than a single development program,” added Mr. Luther. “Our immediate priority is to advance the asset into the clinic, but the broader opportunity lies in demonstrating what this platform can potentially enable across oncology. That is the value we are working to unlock.”
The full Virtual Investor “What This Means” segment is available here.
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 cancers. 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. The company’s initial focus is to develop ERNA-101 for the treatment of ovarian cancer, with the potential to address multiple difficult-to-treat solid tumors.
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.
Media Contact
Sharon Golubchik
RAYNZ
sharon@raynzhealth.com
Investor Contact
Jenene Thomas
JTC Team, LLC
(908) 824-0775
ERNA@jtcir.com
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