CEO Discusses Why the Future of Cancer Treatment May Belong to Combination Approaches and How ERNA-101 Was Designed to Turn Immunologically &#34;Cold&#34; Tumors Into Targets for the Immune System   Video Showcases

ERNA

Ernexa Therapeutics CEO Corner Emphasizes How ERNA-101 Could Help Unlock the Next Generation of Combination Cancer Therapies

Ernexa outlines ERNA-101 path to IND in Q3 2026 and combo rationale

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 <h3>Information</h3>
 CEO Discusses Why the Future of Cancer Treatment May Belong to Combination Approaches and How ERNA-101 Was Designed to Turn Immunologically &amp;#34;Cold&amp;#34; Tumors Into Targets for the Immune System Video Showcases
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 <h3>AI Summary</h3>
 Ernexa describes ERNA-101 as an off-the-shelf cell therapy designed to enhance immunotherapy by modulating the tumor microenvironment. Preclinical results show complete tumor clearance when combined with PD-1 blockade and durable survival in treated animals, supporting a combination strategy. The company reiterates plans for IND submission in Q3 2026 with a Phase 1 study in Q4 2026, initially targeting platinum-resistant ovarian cancer in the US (about 15,000 cases annually).
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 <h3>Key Points</h3>
 <ul><li>ERNA-101 aims to convert immunologically cold tumors into targets; IND planned for Q3 2026.</li><li>Preclinical data show complete tumor elimination with ERNA-101 plus PD-1 blockade.</li><li>Independent validation reports durable survival in two-thirds of treated animals.</li><li>IND-enabling work on track for Q3 2026; Phase 1 anticipated in 4Q26.</li><li>US focus on platinum-resistant ovarian cancer (~15,000 cases per year).</li></ul>
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 <h3>Companies Mentioned</h3>
 <ul><li>Ernexa Therapeutics (ERNA): Lead program ERNA-101; IND planned for Q3 2026; positive preclinical data support combination strategy.</li></ul>
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 <h3>Corporate Developments</h3>
 Category: Corporate Developments. The article provides a strategic overview of ERNA-101 development, IND timing, and supporting preclinical data, aligning with a corporate-trajectory update rather than an earnings revision.
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 <section data-block="market-moving">
 <h3>Market-Moving</h3>
 <ul><li>Indication timing remains the key near-term catalyst: IND filing in Q3 2026.</li><li>Positive preclinical data bolster ERNA-101&#039;s combination-therapy rationale.</li><li>Ovarian cancer focus defines initial addressable market and execution risk.</li><li>Manufacturing progress supports timeline expectations for IND enabling activities.</li></ul>
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 <section data-block="key-facts">
 <h3>Key Facts</h3>
 <ul><li>IND submission planned in Q3 2026.</li><li>Phase 1 clinical study anticipated in Q4 2026.</li><li>Complete tumor elimination with ERNA-101 + PD-1 blockade in initial ovarian cancer study.</li><li>Independent validation: complete clearance and durable survival in ~66% of treated animals.</li><li>Manufacturing process development completed; engineering batch production initiated.</li><li>Initial US addressable market: ~15,000 women diagnosed annually with platinum-resistant ovarian cancer.</li></ul>
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 <section data-block="trading-thesis">
 <h3>Trading Thesis</h3>
 Bullish near-term on IND timing; potential upside if preclinical data translate clinically within 12–18 months.
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<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link>CEO Discusses Why the Future of Cancer Treatment May Belong to Combination Approaches and How ERNA-101 Was Designed to Turn Immunologically &#34;Cold&#34; Tumors Into Targets for the Immune System Video Showcases Differentiated Off-the-Shelf Cell Therapy Platform, Independent Validation of Complete Tumor Clearance in Preclinical Studies and Continued Execution Toward Planned IND Submission in Q3 2026 Access the Ernexa CEO Corner <a href="https://www.globenewswire.com/Tracker?data=9nlc8avy1YelPkZ_9Bse8N4aOvBAPcjeA0D5FJwgTn-rnF3ciqm67GSo7zHDyYImhEp3hajxERA4Ka1Eth5SyD5wpuCWZ95fh3kUXUq6H3Q=" rel="nofollow" target="_blank">here </a> CAMBRIDGE, Mass., July 24, 2026 (GLOBE NEWSWIRE) -- <a href="https://www.globenewswire.com/Tracker?data=PCxy8WlI871v4bx1zm45nEIafIw79m4bdCPSkLZGK6adym8U27zUkSAOqSF3yJNrNBUEzQQiAbtwQ2q-98tpX2drwLP-ZC3ljFsejSedSdo=" rel="nofollow" target="_blank">Ernexa Therapeutics</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/ERNA">ERNA</a>), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today released a new installment of its CEO Corner series featuring President and Chief Executive Officer Sanjeev Luther, who discusses why many of the next major advances in oncology may come from intelligently combining therapies with complementary mechanisms of action and how Ernexa believes ERNA-101 was intentionally designed to play an important role within that evolving treatment paradigm. As immunotherapies and antibody-drug conjugates (ADCs) continue transforming cancer treatment, many solid tumors remain resistant because they evade immune detection. In the video, Mr. Luther explains how ERNA-101 was specifically engineered to address one of oncology&#39;s most significant remaining challenges, the immunosuppressive tumor microenvironment and why the Company believes its novel off-the-shelf cell therapy has the potential to enhance the effectiveness of existing immunotherapies rather than compete with them. The discussion also highlights Ernexa&#39;s growing body of encouraging preclinical data, differentiated allogeneic induced mesenchymal stem cell (iMSC) platform, and continued operational execution as the Company advances toward becoming a clinical-stage biotechnology company. "Cancer treatment continues to evolve, but one of the biggest opportunities still lies ahead helping more patients benefit from the therapies that already exist,&#34; said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. &#34;We believe the future of oncology will increasingly rely on combination therapies that attack cancer from multiple angles, and ERNA-101 was intentionally designed to play that role. By targeting the tumor microenvironment and helping activate an immune response within the tumor itself, we believe ERNA-101 has the potential to work alongside today&#39;s leading immunotherapies and address one of the biggest remaining challenges in solid tumors. Our CEO Corner provides investors with an inside look at the science supporting this strategy, the compelling preclinical data we&#39;ve generated, and the meaningful progress we&#39;re making as we advance toward our planned IND submission and first-in-human clinical study.&#34; During the CEO Corner, Mr. Luther explains how Ernexa&#39;s proprietary allogeneic, off-the-shelf iMSC platform enables ERNA-101 to selectively home to tumors, deliver its therapeutic payload directly within the tumor microenvironment, and potentially convert immunologically &#34;cold&#34; tumors into tumors that can be recognized and attacked by the immune system. The video also reviews compelling preclinical data supporting this differentiated approach, including: <ul type="disc"><li style="margin-bottom:8pt; text-align:justify;">Complete tumor elimination and 100% long-term survival in an initial ovarian cancer study when ERNA-101 was combined with PD-1 blockade.</li><li style="margin-bottom:8pt; text-align:justify;">Independent validation demonstrating complete tumor clearance and durable long-term survival in approximately two-thirds of treated animals, while no complete responses were observed in untreated controls or either monotherapy group, reinforcing the potential value of ERNA-101 as a combination therapy.</li></ul> Mr. Luther also provides investors with an operational update, highlighting that Ernexa has completed manufacturing process development, initiated engineering batch production, continues advancing IND-enabling activities, and remains on track for its planned IND submission in the third quarter of 2026 followed by an anticipated Phase 1 clinical study in the fourth quarter of 2026. The discussion concludes with Ernexa&#39;s commercial strategy, initially targeting the approximately 15,000 women diagnosed annually in the United States with platinum-resistant ovarian cancer, while recognizing the opportunity to potentially expand into the significantly larger platinum-sensitive ovarian cancer population as clinical development progresses. The Ernexa CEO Corner is now accessible on the Company&#39;s website and social media channels. Access it <a href="https://www.globenewswire.com/Tracker?data=PT_rIR0VFUvNOmICYSCr0capopjQhnhM1jZGF4Ws7-b_7yIVEkOH1U06tlNjGpq7rze3deSriFQNqYhbDu3cBOZ1OHzP66J2PGDByJ2oz_8=" rel="nofollow" target="_blank">here</a>. For more information about ERNA-101 and the Company’s development plans, visit <a href="https://www.globenewswire.com/Tracker?data=LqEhkHyTz3viePtEtgPRqjcrqusDTG5HPuv2opUMUTi5ZWhIChyfJmkSiUVSCqHIqohQt_eHfx62T4HKjcvd8clTPPZ-sersfNl2eB8TXCs=" rel="nofollow" target="_blank">www.ernexatx.com</a> About Ernexa Therapeutics Ernexa Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/ERNA">ERNA</a>) 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&#39;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 <a href="https://www.globenewswire.com/Tracker?data=LqEhkHyTz3viePtEtgPRqgbJQGJ_lktFYHFWNLgb85iGZOBw40gcfhmr6YrORwliLtWbjuYjYQfCO5xW36Pl7D9q-2t-C-RAZsZn1mp_CO8=" rel="nofollow" target="_blank">www.ernexatx.com</a>. 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 &#34;believe,&#34; &#34;may,&#34; &#34;will,&#34; &#34;estimate,&#34; &#34;continue,&#34; &#34;anticipate,&#34; &#34;design,&#34; &#34;intend,&#34; &#34;expect,&#34; &#34;could,&#34; &#34;plan,&#34; &#34;potential,&#34; &#34;predict,&#34; &#34;seek,&#34; &#34;should,&#34; &#34;would,&#34; &#34;contemplate,&#34; &#34;project,&#34; &#34;target,&#34; &#34;objective,&#34; 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&#39;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&#39;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&#39;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 <a href="https://www.globenewswire.com/Tracker?data=UkELTJEvxrKe53N4PSerE68Z81YyZYjU-KrbdZYyXkM9Voi1ywnAJSL5_aqpRbzft5CAK-XSrdXlmmdmBzvU7Hzf2iDQVtBzvTIC5COyGeY=" rel="nofollow" target="_blank">sharon@raynzhealth.com</a> Investor Contact Jenene Thomas JTC Team, LLC (908) 824-0775 <a href="https://www.globenewswire.com/Tracker?data=LiFw-gqNZyln1_w_HVUR8Fx1Qa8fPiDPLQ_OHt6GDXZa_XBgfek0nEflK6MfOgIJ2ZtiYeLm2l4ZFD1auOZhvA==" rel="nofollow" target="_blank">ERNA@jtcir.com</a> <img alt="" class="__GNW8366DE3E__IMG" src="https://www.globenewswire.com/newsroom/ti?nf=OTc2NzY4MSM3NzIxMzMzIzIyMTAyODA="></img> <img alt="" src="https://ml.globenewswire.com/media/MTM4M2VjMjQtMjdhZS00MzY3LWE4ZjUtMjhiODEyYzJkNGFlLTEyMjE4MzMtMjAyNi0wNy0yNC1lbg==/tiny/Ernexa-Therapeutics-Inc-.png" referrerpolicy="no-referrer-when-downgrade"></img><a href="https://www.globenewswire.com/NewsRoom/AttachmentNg/bb12f9ec-b7e7-4d8c-92df-cf27e238c398"><img src="https://ml.globenewswire.com/media/bb12f9ec-b7e7-4d8c-92df-cf27e238c398/small/ernexa-color-png.png" border="0" width="150" height="83" alt="Primary Logo"></img></a>

Ernexa describes ERNA-101 as an off-the-shelf cell therapy designed to enhance immunotherapy by modulating the tumor microenvironment. Preclinical results show complete tumor clearance when combined with PD-1 blockade and durable survival in treated animals, supporting a combination strategy. The company reiterates plans for IND submission in Q3 2026 with a Phase 1 study in Q4 2026, initially targeting platinum-resistant ovarian cancer in the US (about 15,000 cases annually).

News insight

Ernexa Therapeutics CEO Corner Emphasizes How ERNA-101 Could Help Unlock the Next Generation of Combination Cancer Therapies

AI summary

Sentiment rationale

Key facts

Corporate Developments