Ernexa Therapeutics Selected for Emerging Track at 2026 Cell & Gene Meeting on the Mesa, Highlighting ERNA-101 and Focused Oncology Strategy

The results being highlighted come from animal studies; clinical testing of ERNA-101 has not yet begun.

Rhea-AI Summary

Ernexa Therapeutics (ERNA) was selected for the Emerging Track at the 2026 Cell & Gene Meeting on the Mesa.

Chief Executive Officer Sanjeev Luther will present on October 6, 2026, focusing on ERNA-101 and its planned initial clinical path in platinum-resistant ovarian cancer. Ernexa remains on track for a planned investigational new drug application submission in 2026. Previously announced animal studies found complete tumor clearance and long-term survival in two-thirds of animals treated with ERNA-101 plus anti-PD-1 therapy in an independent study. An earlier ovarian cancer study reported complete tumor clearance and 100% survival through follow-up with the combination.

Key Figures

Combination therapy outcome: Complete tumor clearance and long-term survival in two-thirds of treated animals Complete responses in comparison groups: None observed Survival: 100% through the end of study follow-up +1 more

Combination therapy outcome

Complete tumor clearance and long-term survival in two-thirds of treated animals

Independent study; ERNA-101 combined with anti-PD-1 therapy

Complete responses in comparison groups

None observed

Monotherapy groups and untreated control group

Survival

100% through the end of study follow-up

Earlier ovarian cancer study; ERNA-101 combined with PD-1 blockade

Planned IND submission

2026

ERNA-101

Key Terms

anti-pd-1, contract research organization, monotherapy, investigational new drug application

4 terms

anti-pd-1 medical

"ERNA-101 in combination with anti-PD-1 therapy achieved complete tumor clearance"

Anti-PD-1 is a type of drug that blocks a protein called PD-1 on immune cells, effectively releasing the immune system’s “brakes” so it can better recognize and attack cancer cells. For investors, these drugs matter because they can produce durable responses in multiple cancers, drive large sales if approved, and influence valuations through trial results, regulatory decisions, partnerships and competition in the oncology market.

contract research organization technical

"conducted by an independent contract research organization"

A contract research organization (CRO) is an outside company hired to run medical and scientific work for drug, device or biotech developers—like an experienced project manager and lab team that companies rent instead of building in-house. Investors care because CROs influence development speed, quality and cost: delays or successes in trials affect client spending, regulatory risk and ultimately revenues for both the sponsor and the CRO.

monotherapy medical

"No complete responses were observed in either monotherapy group"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

investigational new drug application regulatory

"planned Investigational New Drug application submission for ERNA-101 in 2026"

An investigational new drug application is a formal request made to regulatory authorities to begin testing a new medication in humans. It is a critical step in the drug development process, as approval indicates the drug has passed initial safety checks and can be studied further. For investors, this signals that a potential new treatment is progressing through its early testing stages, which can impact the company's future growth prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Ernexa selected for the Emerging Track, recognizing the Company among emerging
innovators in the cell and gene therapy sector

President & CEO Sanjeev Luther to deliver an Innovation Spotlight presentation on
October 6, 2026, at 1:30 PM

Presentation to highlight Ernexa’s focused oncology strategy, beginning with ERNA-101
in platinum-resistant ovarian cancer and its potential for broader expansion across
ovarian cancer and other solid tumor indications

Differentiated synthetic iMSC platform designed to provide a scalable, off-the-shelf
treatment solution without the need for patient-specific cell harvesting

ERNA-101 remains on track for planned IND submission in 2026

CAMBRIDGE, Mass., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancers, today announced that the Company has been selected for the Emerging Track at the 2026 Cell & Gene Meeting on the Mesa, taking place October 5–7, 2026, in Mesa, Arizona. As part of this recognition, Chief Executive Officer Sanjeev Luther will deliver an Innovation Spotlight presentation on October 6, 2026, at 1:30 PM.

During the presentation, Mr. Luther will showcase Ernexa’s differentiated off-the-shelf induced mesenchymal stem cell, or iMSC, platform and the Company’s progress toward becoming a clinical-stage oncology company. The presentation will focus on ERNA-101, Ernexa’s lead oncology cell therapy candidate, and the Company’s focused strategy to establish clinical proof of concept initially in platinum-resistant ovarian cancer, with the potential to expand ERNA-101 across the ovarian cancer treatment continuum and into additional solid tumor indications.

Mr. Luther will also highlight the differentiated characteristics of Ernexa’s synthetic iMSC platform, which is designed to provide a scalable, off-the-shelf treatment solution without the need for patient-specific cell harvesting, as well as recently announced preclinical findings supporting the therapeutic potential of ERNA-101, including:

• Independent validation of ERNA-101 combination therapy: In a larger, statistically robust study conducted by an independent contract research organization, ERNA-101 in combination with anti-PD-1 therapy achieved complete tumor clearance and long-term survival in two-thirds of treated animals. No complete responses were observed in either monotherapy group or the untreated control group. 
• Complete tumor elimination and 100% long-term survival in an earlier ovarian cancer study: ERNA-101 in combination with PD-1 blockade achieved complete tumor clearance and 100% survival through the end of the study follow-up period, demonstrating the potential of ERNA-101 to enhance the activity of checkpoint inhibition in an immunologically cold tumor model.
  
• Focused path toward clinical validation: Ernexa remains on track for a planned Investigational New Drug application submission for ERNA-101 in 2026. The Company believes establishing clinical proof of concept in ovarian cancer could provide a foundation for evaluating ERNA-101 across broader oncology indications.
  
  

Emerging Track Innovation Spotlight Presentation Details

Presenter: Sanjeev Luther, President & CEO
Company: Ernexa Therapeutics
Date: October 6, 2026
Time: 1:30 PM
Room: FLW Ballroom G

“We are honored that Ernexa has been selected for the Emerging Track at the 2026 Cell & Gene Meeting on the Mesa, and we look forward to sharing the progress we are making with ERNA-101,” said Mr. Luther. “We believe this recognition reflects the potential of our differentiated approach to cell therapy as we prepare to transition ERNA-101 toward the clinic. Our strategy is focused on advancing one differentiated oncology candidate through a clear initial clinical pathway in platinum-resistant ovarian cancer, supported by a growing body of compelling preclinical evidence and independent validation of ERNA-101’s anti-tumor activity. As we advance toward planned clinical entry, we believe our synthetic, off-the-shelf iMSC platform provides a differentiated foundation to establish clinical proof of concept in ovarian cancer and potentially expand ERNA-101 into broader oncology indications. Most importantly, our focus remains on translating this strong preclinical foundation into a potential new treatment for patients who need better options.”

Presented by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa brings together senior executives, investors, strategic partners and other decision-makers from across the cell and gene therapy industry. The 2026 program is expected to feature more than 100 company presentations and more than 5,000 partnering meetings focused on advancing scientific, clinical and commercial innovation across the sector.

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 cancers. 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. The company’s initial focus is to develop ERNA-101 for the treatment of ovarian cancer, with the potential to address multiple difficult-to-treat solid tumors.

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
ERNA@jtcir.com