Ernexa Therapeutics Presents New Preclinical Data at American Society of Hematology (ASH) Annual Meeting on Lead Cell Therapy Candidate for Treatment of Ovarian Cancer

Rhea-AI Summary

Ernexa Therapeutics (Nasdaq: ERNA) presented preclinical data at the American Society of Hematology Annual Meeting on Dec 8, 2025 showing its lead candidate ERNA-101 (iPSC-derived MSCs) reprogrammed immunosuppressive tumor microenvironments into pro-inflammatory states.

The study reported IL-7/IL-15-secreting iMSCs produced supraphysiologic cytokine levels ~20-fold higher than prior engineered T-cell approaches, drove robust T-cell expansion, sustained STAT5 signaling, macrophage polarization to a pro-inflammatory phenotype, and prolonged survival in an immunocompetent ovarian cancer model. The company said ERNA-101 supports an off-the-shelf, scalable approach and plans first-in-human trials next year.

Key Figures

Cytokine production level 20-fold higher IL-7/IL-15-secreting iMSCs vs engineered T-cell approaches in preclinical study

Market Reality Check

$1.32 Last Close

Volume Volume 31,636 is at 0.56x the 20-day average of 56,238, indicating subdued trading activity. low

Technical Shares at $1.32 are trading below the 200-day MA of $2.27 and remain 90.83% under the 52-week high.

Peers on Argus 1 Up

ERNA is up 4.76% while key biotech peers show mixed moves: several are up (e.g., KZIA +11.48%, BOLT +5.99%) but MBIO is down 3.85%. Momentum scanner only flags MRKR at +7.58%, suggesting today’s action is more stock-specific than a broad sector wave.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 03	Conference presentation	Positive	-4.2%	Announcement of oral ASH presentation featuring preclinical ERNA-101 TME data.
Dec 02	Board appointment	Positive	-4.0%	Added leading gynecologic oncologist to advisory board to support ERNA-101.
Nov 11	Conference participation	Positive	-5.4%	CEO presentation at Cell 2025 on translating iMSC therapies into clinics.
Nov 10	Quarterly update	Positive	-4.6%	Reported lower operating loss and detailed ERNA-101 advancement timelines.
Nov 06	Partnership update	Positive	+2.4%	Showcased Cellipont partnership to support ERNA-101 clinical manufacturing.

Pattern Detected

Recent ERNA news has generally been positive, but 4 of the last 5 announcements were followed by negative 24-hour price reactions, indicating a pattern of selling into strength.

Recent Company History

This announcement adds detailed preclinical efficacy data for ERNA-101 to a series of recent milestones. In November and early December, ERNA highlighted its ASH oral presentation, advisory board expansion, conference participation, and quarterly progress, including a 44% year-over-year operating loss decline and a 58.2% preclinical survival advantage for ERNA-101. Despite these seemingly constructive updates and clear plans toward first-in-human trials, prior news often saw short-term share price declines, underscoring investor caution.

Market Pulse Summary

This announcement provides detailed preclinical evidence that ERNA-101’s iMSC platform can reprogram ovarian tumor microenvironments and deliver IL-7/IL-15 at 20-fold higher levels than prior engineered T-cell approaches. It builds on earlier disclosures about survival advantages and plans for first-in-human trials. Investors may monitor progress of IND-enabling work, clinical start timelines, and how the company addresses going-concern language and funding needs highlighted in recent filings.

Key Terms

hematologic malignancies medical

"applications, including hematologic malignancies"

Hematologic malignancies are types of cancers that start in the blood or the organs responsible for blood production, like the bone marrow and lymph nodes. They matter because they can disrupt normal blood functions, leading to issues like weakness, infections, or abnormal growths, and often require specialized treatments.

AI-generated analysis. Not financial advice.

Positive results of ERNA-101 in ovarian cancer models demonstrated promising survival benefit and immune activation, underscoring the potential for broad oncology applications, including hematologic malignancies

CAMBRIDGE, Mass., Dec. 08, 2025 (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 presentation of new preclinical data on its lead cell therapy candidate, ERNA-101, at the American Society of Hematology (ASH) Annual Meeting. The data demonstrated that its proprietary cell therapy platform can rapidly and durably reprogram immunosuppressive tumor microenvironments (TMEs) into immune-active, pro-inflammatory states to combat cancer.

The platform engineers induced pluripotent stem cells (iPSCs) and transforms them into induced mesenchymal stem cells (iMSCs). The preclinical findings underscore the platform’s potential to overcome resistance in both solid tumors and hematologic malignancies and highlight a scalable, off-the-shelf approach to local cytokine delivery.

The abstract titled, ”Gene-modified iPSC-derived MSCs convert immunosuppressive tumor microenvironments (TMEs) into distinct pro-inflammatory TMEs,” was recently presented in an oral presentation by Michael Andreeff, M.D., Ph.D., Professor of Medicine, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center and lead author on the study.

“These data represent an important validation of our platform and reinforce our belief that iPSC-derived MSCs can be engineered into powerful immune-modulating agents,” said Sanjeev Luther, President & CEO of Ernexa Therapeutics. “We view this as a platform-level advance that has the potential to support multiple oncology programs, including drug-resistant cancers where immunotherapy has historically underperformed. We believe our ability to manufacture clonal, gene-modified cells at scale gives us a meaningful competitive advantage as we advance toward clinical development.”

“These data highlight the potential of iPSC-derived MSCs and their ability to be repurposed from their historical immunosuppressive roles into highly effective, immune-activating delivery vehicles,” said Dr. Andreeff. “The ability to deliver cytokines directly into tumors and reprogram the immune ecosystem represents a powerful and clinically relevant strategy. We are pleased with these results and look forward to further evaluation to understand the full potential of ERNA-101.”

The preclinical study, conducted in collaboration with investigators at MD Anderson Cancer Center, demonstrated that iMSCs engineered to secrete the cytokines interleukin-7 (IL-7) and interleukin-15 (IL-15) achieved supraphysiologic cytokine production levels that were approximately 20-fold higher than levels previously reported in engineered T-cell approaches. These levels corresponded to robust T-cell expansion and activation, sustained STAT5 signaling, and upregulation of survival pathways critical to immune persistence.

In an immunocompetent ovarian cancer model, intraperitoneal administration of IL-7/IL-15-secreting iMSCs resulted in significant immune cell infiltration into tumors, macrophage polarization toward a pro-inflammatory phenotype, and prolonged survival. Importantly, tumors transitioned from an immune-excluded (“cold”) state to a highly inflamed (“hot”) microenvironment, a key prerequisite for responsiveness to modern immunotherapies.

Ernexa is advancing a best-in-class approach using synthetic, allogeneic iMSCs to provide a scalable, off-the-shelf treatment without needing patient-specific cell harvesting. The Company continues to advance its lead program, ERNA-101, through additional preclinical testing, with first-in-human trials planned for next year.

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.

Media Contact
Sharon Golubchik
RAYNZ
sharon@raynzhealth.com

Investor Contact
Jenene Thomas
JTC Team, LLC
(908) 824-0775
ENRA@jtcir.com

FAQ

What did Ernexa Therapeutics (ERNA) report about ERNA-101 at ASH on Dec 8, 2025?

Ernexa reported that IL-7/IL-15-secreting iMSCs reprogrammed cold TMEs into inflamed TMEs and improved survival in an immunocompetent ovarian cancer model.

How much higher were cytokine levels from ERNA-101 iMSCs compared with engineered T-cell approaches?

The preclinical data showed approximately 20-fold higher supraphysiologic cytokine production versus previously reported engineered T-cell approaches.

What immune effects did ERNA-101 produce in the ovarian cancer model reported by ERNA?

ERNA-101 induced robust T-cell expansion, sustained STAT5 signaling, increased immune cell tumor infiltration, and polarized macrophages to a pro-inflammatory phenotype.

Does Ernexa plan clinical testing for ERNA-101 and when?

The company said it is advancing ERNA-101 through additional preclinical testing with first-in-human trials planned next year.

What delivery approach does ERNA use for ERNA-101 and why is it notable?

Ernexa uses allogeneic, iPSC-derived MSCs to enable a scalable, off-the-shelf local cytokine delivery without patient-specific cell harvesting.

What tumor types did Ernexa highlight ERNA-101 could address in addition to ovarian cancer?

Ernexa highlighted potential applicability across solid tumors and hematologic malignancies, based on the platform's ability to reprogram immunosuppressive TMEs.