Ernexa Therapeutics Positioned to Become a Clinical-Stage Biotechnology Company as ERNA-101 On Track for Planned Q3 2026 IND Submission and First-in-Human Study

CAMBRIDGE, Mass., June 17, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (NASDAQ:ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today highlighted significant progress across manufacturing, regulatory and clinical development activities supporting ERNA-101, the Company's lead oncology candidate.

With manufacturing process development completed, GMP production underway, IND-enabling activities advancing and an Investigational New Drug (IND) submission planned for the third quarter of 2026, Ernexa believes it is well-positioned to initiate its first-in-human Phase 1 clinical study in the fourth quarter of 2026 and transition into a clinical-stage biotechnology company.

"ERNA-101 continues to advance toward the clinic as we execute across manufacturing, regulatory and clinical development activities," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "With GMP manufacturing underway, technology transfer activities progressing and our IND submission expected in the third quarter of 2026, we believe we are entering one of the most important periods in the Company's history."

ERNA-101: A Novel Approach to Treating Immunologically Cold Tumors

ERNA-101 is an engineered, allogeneic induced mesenchymal stem cell (iMSC) therapy derived from induced pluripotent stem cells (iPSCs) and designed to selectively home to tumors while delivering a proprietary IL-7/IL-15 fusion cytokine directly into the tumor microenvironment.

The therapy is designed to address one of the most significant challenges in cancer treatment: immunologically "cold" tumors that evade immune recognition and often fail to respond to existing therapies. By activating T cells and natural killer (NK) cells while reshaping the local tumor environment, ERNA-101 is intended to enhance anti-tumor activity and potentially improve responses to checkpoint inhibitors.

Manufacturing and Regulatory Activities Continue to Advance

Ernexa recently achieved several key operational milestones supporting planned clinical entry, including:

• Completion of ERNA-101 manufacturing process development
• Transition of ERNA-101 into GMP manufacturing for clinical supply production
• Initiation of technology transfer activities to support future manufacturing scalability
• Advancement of IND-enabling studies and regulatory documentation
• Continued execution of clinical readiness activities for Phase 1 study initiation
• Maintenance of timeline toward planned Q3 2026 IND submission

These accomplishments build upon the successful completion of the Company's FDA Pre-IND meeting and support continued advancement toward regulatory submission and clinical evaluation.

Compelling Preclinical Data Support Clinical Advancement

Preclinical studies evaluating ERNA-101 in combination with PD-1 blockade demonstrated:

• Complete elimination of detectable tumors
• 100% long-term survival through study follow-up
• Significant remodeling of the tumor microenvironment from immunosuppressive to immune-activated
• Increased infiltration of CD4+ and CD8+ T cells
• Enhanced T-cell persistence and anti-tumor activity
• Reprogramming of tumor-associated macrophages into a tumor-fighting phenotype
• Significant reductions in tumor burden and malignant ascites
  
  

Importantly, ERNA-101 demonstrated substantially greater anti-tumor activity when combined with PD-1 blockade compared to either treatment alone, supporting its potential as a complementary immunotherapy platform designed to enhance responses in difficult-to-treat solid tumors.

Strong Financial Position Supports Development Objectives

Following the completion of a $10.5 million financing, Ernexa believes it has sufficient resources to execute its near-term development strategy and pursue several anticipated value-driving milestones over the next 12 to 18 months.

Expected 2026 Milestones

Q3 2026

• Release of first GMP clinical product batch
• Completion of required IND-enabling studies
• Submission of IND application for ERNA-101
  
  

Q4 2026

• FDA review of IND application
• Initiation of first-in-human Phase 1 clinical study
• First patient enrollment in platinum-resistant ovarian cancer
• Pre-IND meeting with FDA for ERNA-201 autoimmune disease program

Expected 2027 Milestones

First Half 2027

• Initial clinical data from ERNA-101 Phase 1 study
  
  

Second Half 2027

• Potential advancement into Phase 2 development
• Potential strategic partnership opportunities
• Potential expansion into additional solid tumor indications
  
  

"The anticipated initiation of our first-in-human study in the fourth quarter of 2026 will represent a defining milestone for Ernexa and the beginning of clinical validation for our engineered iMSC platform," Luther added. "We believe ERNA-101 has the potential not only to improve outcomes for patients with platinum-resistant ovarian cancer, but also to establish a new approach for treating immunologically cold tumors across multiple oncology indications."

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 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. 

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