CAMBRIDGE, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced the formation of ErnexaTX2, a wholly owned subsidiary based in Texas. The new entity has been established to support ongoing preclinical development of the company's lead program, ERNA-101 for ovarian cancer, and to lay the operational groundwork for anticipated clinical activity in 2026.
"As we continue to progress ERNA-101 through key preclinical milestones, we're also setting the stage for a seamless transition into clinical work," said Sanjeev Luther, President and CEO of Ernexa Therapeutics. "The formation of ErnexaTX2 reflects both our long-term commitment to the Texas ecosystem and our strategic readiness to support clinical manufacturing, regulatory interactions, and site activation in the years ahead."
The subsidiary will support ongoing research being conducted under a sponsored research agreement with Michael Andreeff, M.D., Ph.D., from The University of Texas MD Anderson Cancer Center. Dr. Andreeff is an internationally recognized cell therapy expert and a longtime leader in targeting the tumor microenvironment in ovarian and other solid tumors.
In parallel with scientific advancements, Ernexa continues to evolve its infrastructure in anticipation of future Investigational New Drug (IND)-enabling activities. With its new footprint in Texas, the company is positioned to accelerate clinical partnerships, navigate regulatory planning, and engage local biomanufacturing partners to support scale-up efforts.
ERNA-101 remains on track for IND-enabling studies in 2025, with first-in-human studies targeted for 2026.
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 allogeneic synthetic 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-102 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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