On June 17, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported significant progress across manufacturing, regulatory and clinical development activities supporting ERNA-101, the Company’s lead oncology candidate.

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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

(Press release, Ernexa Therapeutics, JUN 17, 2026, View Source [SID1234668790])