Ernexa Therapeutics Reports Strong Quarterly Performance, Highlighting Operational Execution and Progress Toward First-in-Human Cell Therapy Trials

Rhea-AI Summary

Ernexa Therapeutics (Nasdaq: ERNA) reported continued operational progress and preclinical advancement on Nov 10, 2025. The company said its operating loss declined 44% year-over-year for the nine months ended Sept 30, 2025, and highlighted a partnership with Cellipont Bioservices to advance lead program ERNA-101 toward clinical trials.

Key program milestones disclosed include a 58.2% preclinical survival advantage for ERNA-101, planned completion of IND-enabling studies and an IND submission by Q1 2026, and a targeted first-in-human Phase 1 start in H2 2026. ERNA-201 remains in preclinical development with a pre-IND meeting anticipated by Q1 2026.

Positive

• Operating loss down 44% for nine months ended Sept 30, 2025
• General & administrative expenses down 68% for nine months
• Preclinical ERNA-101 survival +58.2% reported
• IND submission targeted by Q1 2026 and Phase 1 planned H2 2026

Negative

• Programs remain preclinical; no human data yet
• Financial improvement partly due to one-time sublease and legal expense reductions
• Company still reporting a net operating loss ($7.2M nine months)

Insights

Cell‑therapy financial analyst

Reduced operating loss and IND timeline advance make this a constructive operational and clinical de‑risking update.

Ernexa shows tangible cost compression and clearer clinical timing: operating loss fell $5.8 million year‑to‑date, a 44% decline, driven mainly by lower rent and legal costs. The firm also announced a manufacturing partnership and plans to complete IND‑enabling work for ERNA‑101 with an IND submission target of Q1 2026 and first‑in‑human study in H2 2026.

Key dependencies and risks include successful completion of IND‑enabling studies, regulatory alignment, and operational execution of the Cellipont partnership; none are resolved by this release. Watch for confirmation of IND filing by Q1 2026, any FDA feedback, and initial clinical trial start timing in H2 2026 as near‑term milestones that will materially change program risk and valuation assumptions.

The Company’s operating loss declined by 44% year-over-year, reflecting its continued laser focus on relentless execution and progress in operational excellence

Continued progress with lead program, ERNA-101, toward first-in-human Phase 1 study in platinum-resistant ovarian cancer (PROC), anticipated in H2 2026

CAMBRIDGE, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced its financial results for the three- and nine-month periods ended September 30, 2025, and highlighted its continued operational execution.

Recent Highlights

• Announced a cell therapy manufacturing partnership to advance ERNA-101 toward clinical trials in ovarian cancer
• Presented new positive data of ERNA-101 for PROC in ASCO-2025, AACR-2025 annual meetings, demonstrating how ERNA-101 addresses a significant unmet need with rapid disease progression, poor outcomes, and limited treatment options
• Continued engagement with scientific, investor, and industry communities at a number of conferences, including Cell & Gene Meeting on the Mesa, iPSC Drug Development Summit, and AACR Special Conference in Cancer Research    
• Expanded its Scientific Advisory Board to a combined Scientific and Medical Advisory Board as the Company advances toward clinical trials in ovarian cancer and autoimmune disease

“We continue to operate with financial discipline, focusing our resources on advancing our cell therapy programs toward the clinical stage,” said Sanjeev Luther, President and CEO of Ernexa Therapeutics. “This approach gives us the flexibility to pursue strategic collaborations and progress our lead programs, including ERNA-101 for ovarian cancer and ERNA-201 for autoimmune disease. We are well-positioned to advance our clinical and regulatory strategies toward our first-in-human study next year.”
     
Ernexa recently announced a partnership with Cellipont Bioservices, marking a significant step in advancing ERNA-101. The Company also reported substantial year-over-year financial performance improvements, supporting the continued development of its lead cell therapy programs for patients with high unmet needs.

Development Program Highlights

Ernexa is advancing a best-in-class approach using synthetic, allogeneic induced mesenchymal stem cells (iMSCs) to provide a scalable, off-the-shelf treatment without needing patient-specific cell harvesting. The Company’s two highly innovative cell therapy products, focused on targeting ovarian cancer and autoimmune disease, are currently advancing through preclinical stages.

ERNA-101: Allogeneic iMSCs engineered to secrete pro-inflammatory fusion cytokines (IL-7/IL-15), currently in preclinical development for the treatment of PROC     

• Sponsored research agreement with MD Anderson Cancer Center
• Leverages MSCs' tumor-homing ability to deliver pro-inflammatory cytokines (IL-7/IL-15) directly to the tumor, enhancing T-cell anti-tumor activity while minimizing systemic toxicity
• Demonstrated promising preclinical results with 58.2% survival advantage
• Expecting to complete Investigational New Drug (IND) enabling studies and submit an IND for its Phase 1 study in PROC by Q1 2026
• Targeting commencement of first-in-human Phase 1 study in H2 2026
  

ERNA-201: Allogeneic iMSCs secreting the anti-inflammatory cytokine IL-10, currently in preclinical development for rheumatoid arthritis (RA) and other inflammatory diseases     

• Capitalizes on MSCs ability to home at the site of inflammation and deliver IL-10 and other intrinsic and synthetic anti-inflammatory factors to reduce inflammation and stimulate healing and regeneration
• Engaged in ongoing lead optimization activities
• Anticipated a pre-IND meeting to obtain regulatory alignment by Q1 2026
  

Summary of Financial Results for the Three- and Nine-Month Periods Ended September 30, 2025

• Operating loss decreased $0.3 million, or 12%, from $2.3 million during the three months ended September 30, 2024 to $2.0 million during the three months ended September 30, 2025.
• Operating loss decreased $5.8 million, or 44%, from $13.0 million during the nine months ended September 30, 2024 to $7.2 million during the nine months ended September 30, 2025.
• General and administrative expenses decreased $2.4 million, or 72%, from $3.4 million during the three-month period ended September 30, 2024 to $1.0 million during the three-month period ended September 30, 2025 primarily due to a decrease in rent expense of $1.3 million related to a sublease termination in 2024 as well as a reduction in legal fees of approximately $0.9 million.
• General and administrative expenses decreased $7.9 million, or 68%, from $11.6 million during the nine-month period ended September 30, 2024 to $3.4 million during the nine months ended September 30, 2025 primarily due to a $5.0 million reduction in rent expense from the sublease termination and a $2.4 million in legal and consulting fees.

About Ernexa Therapeutics

Ernexa Therapeutics (NASDAQ: ERNA) is developing innovative 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-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.

Contacts:

Media Contact
Sharon Golubchik
RAYNZ
sharon@raynzhealth.com

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

FAQ

What clinical milestone did Ernexa (ERNA) target for ERNA-101 by Q1 2026?

Ernexa is targeting completion of IND-enabling studies and an IND submission by Q1 2026 for ERNA-101.

When does Ernexa plan to start first-in-human trials for ERNA-101 (ERNA)?

The company targets commencement of a first-in-human Phase 1 study in H2 2026 for ERNA-101 in platinum-resistant ovarian cancer.

How much preclinical benefit did Ernexa report for ERNA-101 (ERNA)?

Ernexa reported a 58.2% survival advantage in preclinical results for ERNA-101.

What drove Ernexa’s year-to-date operating loss improvement for 2025 (ERNA)?

The company cited cost reductions including a sublease termination and lower legal and consulting fees as primary drivers.

What is the development status of Ernexa’s autoimmune program ERNA-201 (ERNA)?

ERNA-201 is in preclinical development for rheumatoid arthritis with a pre-IND meeting expected by Q1 2026.

Did Ernexa announce manufacturing support for ERNA-101 (ERNA)?

Yes, Ernexa announced a cell therapy manufacturing partnership with Cellipont Bioservices to advance ERNA-101 toward clinical trials.