Ernexa Therapeutics Provides Update on Operational Excellence and Performance

Rhea-AI Summary

Ernexa Therapeutics (NASDAQ: ERNA), a cell therapy company focusing on cancer and autoimmune diseases, reported significant operational improvements for H1 2025. The company achieved a 51% reduction in operating loss to $5.2 million, down from $10.7 million in H1 2024. Total operating expenses decreased by 51% to $5.2 million, with general and administrative expenses dropping 66% to $2.8 million.

The company is advancing two key products: ERNA-101 for ovarian cancer and ERNA-201 for autoimmune disease, both utilizing synthetic allogeneic induced mesenchymal stem cells (iMSCs) for off-the-shelf treatment. Lease expenses saw a dramatic 97% reduction to $0.1 million, primarily due to a sublease termination.

Positive

• Operating loss decreased by 51% year-over-year to $5.2 million
• Total operating expenses reduced by 51% to $5.2 million
• General and administrative expenses decreased by 66% to $2.8 million
• Lease expenses reduced by 97% to $0.1 million

Negative

• Both lead products ERNA-101 and ERNA-201 are still in preclinical stages
• Company continues to operate at a loss despite cost reductions

Insights

Biotech Financial Analyst

Ernexa significantly reduced operating losses by 51% through aggressive cost-cutting while advancing preclinical cell therapy programs.

Ernexa's financial restructuring is yielding substantial improvements in its cash burn rate. The 51% reduction in operating loss (from $10.7 million to $5.2 million) demonstrates effective cost discipline without apparently compromising pipeline development. The most dramatic savings came from lease termination, with lease expenses plummeting 97% from $3.9 million to just $0.1 million.

What's particularly noteworthy is the 66% reduction in G&A expenses, bringing them down from $8.2 million to $2.8 million. This suggests the company has successfully streamlined its organizational structure while maintaining its core R&D capabilities. For a pre-clinical biotech, managing the cash runway is critical, and these expense reductions likely extend Ernexa's operational timeline significantly.

However, investors should note that the press release doesn't mention cash position or runway extension. While operating expenses have decreased dramatically, the company provides no information about its current cash reserves or burn rate, which limits our ability to assess how long they can sustain operations before needing additional financing.

Ernexa's focus on synthetic allogeneic induced mesenchymal stem cells (iMSCs) for off-the-shelf treatments represents a potentially valuable approach in the competitive cell therapy landscape. The company is advancing two preclinical candidates - ERNA-101 for ovarian cancer and ERNA-201 for autoimmune disease - though no specific timelines for clinical entry are provided, which would be a key catalyst for value creation.

The company’s operating loss declined by 51% year-over-year, reflecting a laser focus on relentless execution and significant progress in expense reduction

CAMBRIDGE, Mass., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today provided an update on its operational excellence and performance for the first half of 2025. The company reported its financial results in its Quarterly Report on Form 10-Q for the period ending on June 30, 2025, filed with the Securities and Exchange Commission on August 13, 2025. The substantial year-over-year improvements were driven by focused execution and cost discipline as the company advances its lead cell therapy product, ERNA-101 for ovarian cancer, toward clinical studies, as well as further progressing ERNA-201 for autoimmune disease.

Ernexa is a stronger company today due to the following operational milestones achieved during the first half of this year:

• Operating loss decreased by $5.5 million, or 51%, from $10.7 million during the six months ending on June 30, 2024 to $5.2 million during the six months ending on June 30, 2025.
• Total operating expenses decreased by $5.4 million, or 51%, from $10.6 million during the six months ending on June 30, 2024 to $5.2 million during the six months ending on June 30, 2025.
• General and administrative expenses decreased by $5.4 million, or 66%, from $8.2 million during the six months ending on June 30, 2024 to $2.8 million during the six months ending on June 30, 2025.
• Total lease expense decreased by $3.8 million, or 97%, from $3.9 million during the six months ending on June 30, 2024 to $0.1 million during the six months ending on June 30, 2025, primarily reflecting the termination of a sublease.

“These first half results reflect the discipline we’ve brought to the business. We are operating leaner, prioritizing the programs that matter the most, and positioning Ernexa to execute and thrive,” said Sanjeev Luther, President and CEO of Ernexa Therapeutics. “With our operating expenses down by 51% compared to last year, as well as a streamlined cost structure, we believe we have the right foundation to advance our cell therapies toward the clinical stage and continue building a durable company that can deliver off-the-shelf cell therapies to patients who need better options.”

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.

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.

Media & Investor Relations Contact

investors@ernexatx.com

FAQ

What is Ernexa Therapeutics' (ERNA) operating loss for H1 2025?

Ernexa reported an operating loss of $5.2 million for H1 2025, representing a 51% decrease from $10.7 million in H1 2024.

How much did Ernexa Therapeutics (ERNA) reduce its operating expenses in H1 2025?

Ernexa reduced its total operating expenses by 51%, from $10.6 million in H1 2024 to $5.2 million in H1 2025.

What are the main products in Ernexa Therapeutics' pipeline?

Ernexa is developing ERNA-101 for ovarian cancer and ERNA-201 for autoimmune disease, both utilizing synthetic allogeneic induced mesenchymal stem cells (iMSCs).

What technology is Ernexa Therapeutics using for its cell therapies?

Ernexa uses synthetic, allogeneic induced mesenchymal stem cells (iMSCs) to provide scalable, off-the-shelf treatments without requiring patient-specific cell harvesting.

How much did Ernexa reduce its lease expenses in H1 2025?

Ernexa reduced its lease expenses by 97%, from $3.9 million to $0.1 million, primarily due to a sublease termination.