{"success":true,"data":{"pressRelease":{"id":"143881","rtpr_id":"nGNX8w2pHD-20260915","ticker":"ERNA","exchange":"NASDAQ","all_tickers":["ERNA"],"title":"Ernexa Therapeutics Reports Positive Disease Modifying ERNA-201 Preclinical Data, Reinforcing iMSC Platform as Company Accelerates Oncology Strategy and ERNA-101 Toward First-in-Human Dosing","author":"Globe Newswire","published_at":"2026-09-15T12:42:00.138Z","article_body":"ERNA-201 demonstrated encouraging disease-modifying activity in the\nindustry-standard collagen-induced arthritis model, providing meaningful\nproof-of-concept for Ernexa's engineered synthetic iMSC platform beyond\noncology\n\nPositive ERNA-201 findings add to a growing body of preclinical evidence\nsupporting the versatility of Ernexa's synthetic iMSC platform and its ability\nto deliver engineered therapeutic factors in disease\n\nCompany is concentrating near-term resources on ERNA-101 while broadening its\noncology strategy and advancing next-generation iMSC candidates across\nadditional high-need cancer indications\n\nERNA-201 remains an important platform asset with demonstrated preclinical\nproof-of-concept, preserving future development and strategic optionality\n\nCAMBRIDGE, Mass., Sept. 15, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics\n(https://www.globenewswire.com/Tracker?data=PkSlm0gAiL2xLUNhOiC3OPyBrWIqV_qYZoX0QgO-uFqgU4M-tJ8N8UdoEvfnOk61ULkgKd2PCutiD6ts7cDbLki_Olbv2Kp8miiJe43EwmQ=)\n(Nasdaq: ERNA), an industry innovator developing novel cell therapies for the\ntreatment of advanced cancers, today announced positive preliminary\npreclinical results for ERNA-201, its synthetic, allogeneic induced\nmesenchymal stem cell (iMSC) therapy engineered to express anti-inflammatory\nfactors, while outlining a sharpened oncology strategy designed to accelerate\nthe Company's transition into the clinic and expand the long-term potential of\nits proprietary synthetic iMSC platform.\n\nIn preliminary studies using the collagen-induced arthritis (CIA) model, an\nindustry-standard preclinical model for rheumatoid arthritis and inflammatory\njoint disease, several ERNA-201 lead candidates demonstrated reductions in\ndisease severity relative to untreated controls, including improvements in\nclinical arthritis scores consistent with the therapy's intended\nanti-inflammatory mechanism of action.\n\nErnexa believes these results represent an important scientific milestone:\nERNA-201 demonstrated meaningful preclinical proof-of-concept in inflammatory\ndisease, providing additional evidence that the Company's engineered iMSC\nplatform can be programmed to deliver therapeutically relevant factors across\ndistinct disease settings.\n\nWith this platform validation in hand, Ernexa is concentrating its near-term\ncapital and operational resources on what management believes represents the\nCompany's most immediate opportunity to create value for patients and\nshareholders: advancing ERNA-101 into a first-in-human clinical study in\nplatinum-resistant ovarian cancer (PROC).\n\nImportantly, the decision to prioritize ERNA-101 does not reflect a change in\nErnexa's conviction in ERNA-201 or its underlying biology. Rather, following\nthe positive ERNA-201 proof-of-concept results, the Company believes it has\nreached an appropriate point to preserve the program while directing near-term\nresources toward achieving clinical validation of its platform in oncology.\n\n\"We believe the ERNA-201 results are an important validation of both the\nprogram and the broader potential of our synthetic iMSC platform,\" said\nSanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics.\n\"ERNA-201 did what we wanted to see at this stage: it generated an encouraging\nproof-of-concept signal in an established inflammatory disease model and\ndemonstrated the potential to engineer our iMSCs for therapeutic activity\nbeyond cancer. That success gives us the confidence to preserve the\nsignificant future opportunity represented by ERNA-201 while concentrating our\nresources on the milestone directly ahead of us, bringing ERNA-101 into the\nclinic.\"\n\nMr. Luther continued, \"Our objective is bigger than advancing a single\ncandidate. We are building a differentiated oncology company around a\nscalable, off-the-shelf cell therapy platform. With ERNA-101 on track for FDA\nIND submission before year end, we believe Ernexa is approaching a potentially\ndefining inflection point. We intend to execute against that milestone with\nurgency while broadening our oncology pipeline and identifying additional\ncancers where our platform could make a meaningful difference.\"\n\nERNA-201: Positive Data Strengthen Validation of Ernexa's iMSC Platform\n\nERNA-201 is engineered to express anti-inflammatory factors designed to target\ninflammation and treat autoimmune disease. In completed preliminary studies,\nERNA-201 was evaluated in the CIA model, which is widely used to assess\npotential therapies for rheumatoid arthritis and other inflammatory joint\ndiseases.\n\nMice treated with several ERNA-201 lead candidates demonstrated reductions in\ndisease severity relative to untreated controls, including improvements in\nclinical arthritis scores. Ernexa believes the findings are consistent with\nthe candidate's intended anti-inflammatory mechanism and provide meaningful\nproof-of-concept support for the use of synthetic, cytokine-engineered iMSCs\nin inflammatory and autoimmune disease.\n\n\"Seeing disease-modifying activity from ERNA-201 in the collagen-induced\narthritis model is an encouraging scientific result,\" said Robert H. Pierce,\nM.D., Chief Scientific Officer of Ernexa Therapeutics. \"These findings support\nthe underlying thesis that engineered iMSCs can serve as a versatile\ntherapeutic delivery platform. We designed ERNA-201 to deliver\nanti-inflammatory factors in disease, and the preliminary activity we observed\nis consistent with that objective. From a scientific perspective, these data\nincrease our confidence in the program and provide another important\nvalidation point for the broader platform.\"\n\nThe ERNA-201 results are particularly important to Ernexa because the program\nemploys the same fundamental synthetic iMSC platform architecture that\nunderpins the Company's broader pipeline. While ERNA-201 is engineered for\nanti-inflammatory activity and ERNA-101 is engineered to stimulate an immune\nresponse against cancer, both programs demonstrate the potential versatility\nof an allogeneic, scalable cell platform that can be engineered for distinct\ntherapeutic purposes.\n\nBuilding Momentum Toward the Clinic: ERNA-101 Advancing Toward Planned IND\nSubmission in Q4 2026\n\nWith ERNA-201 generating positive preliminary proof-of-concept data, Ernexa is\nprioritizing the next major milestone in the Company's evolution: advancing\nERNA-101 toward a planned IND submission for a first-in-human clinical study\nin platinum-resistant ovarian cancer.\n\nERNA-101 is Ernexa's lead oncology cell therapy candidate, engineered to\nexpress an IL-7/IL-15 fusion cytokine designed to activate and regulate the\nimmune system's response to recognize and attack cancer cells.\n\nThe Company is focused on advancing ERNA-101 toward a planned IND submission\nin the fourth quarter of 2026. Ernexa believes achieving this milestone would\nrepresent an important step toward the Company's transition from a preclinical\ndevelopment company to a clinical-stage oncology company and the generation of\nhuman clinical evidence necessary to evaluate the therapeutic potential of its\nplatform.\n\nClinical data from the ERNA-101 PROC study are expected in Q4 2027, providing\nthe Company with a series of potential clinical and operational milestones\nover the coming 12–18 months.\n\nA Focused Oncology Strategy Built Around One Scalable Platform\n\nErnexa's strategy extends beyond a single indication or product candidate. The\nCompany's proprietary platform begins with induced pluripotent stem cells\n(iPSCs), which are engineered and transformed into synthetic induced\nmesenchymal stem cells. The resulting allogeneic iMSCs are designed to provide\na scalable, off-the-shelf therapeutic approach without the need for\npatient-specific cell harvesting.\n\nManagement believes this architecture creates the potential to engineer iMSCs\nwith different therapeutic factors and apply the platform across multiple\ndiseases. The positive preliminary ERNA-201 findings provide additional\nsupport for that platform thesis, while ERNA-101 now represents the Company's\nmost advanced opportunity to demonstrate its potential in patients.\n\nAs Ernexa moves toward the clinic, the Company intends to broaden the scope of\nits oncology program by evaluating additional high-need cancer indications and\nadvancing next-generation iMSC candidates designed to build on the Company's\nexisting scientific and manufacturing capabilities.\n\nThe Company will prioritize opportunities based on scientific rationale, unmet\npatient need, commercial potential and capital efficiency, including\nopportunities that may be pursued internally or through strategic\ncollaborations.\n\nDisciplined Capital Allocation: Advancing the Nearest Value-Creating\nMilestones\n\nFollowing the encouraging ERNA-201 results, Ernexa has elected to pause\nadditional preclinical development expenditures on ERNA-201 at this time and\npreserve the program while concentrating near-term resources on ERNA-101 and\nthe expansion of its oncology pipeline.\n\nThe decision is a capital allocation priority rather than a scientific\ndecision to discontinue ERNA-201. The Company believes the positive\npreliminary results provide a foundation from which ERNA-201 could potentially\nbe advanced in the future as resources, strategic priorities and development\nopportunities warrant.\n\n\"We have achieved an important objective with ERNA-201 by generating\nencouraging proof-of-concept data,\" Luther said. \"The question for us now is\nnot whether we believe in the program. We do. The question is where each\nincremental dollar and each hour of our team's effort can have the greatest\nimpact today. With ERNA-101 approaching the clinic, we believe concentrating\nresources behind first-patient dosing and expanding our oncology opportunity\nis the most disciplined path forward.\"\n\n\"We are preserving ERNA-201's future potential while accelerating the program\nthat is closest to human clinical validation. We believe that the combination\nof scientific validation, disciplined execution and a clear path into the\nclinic positions Ernexa for an important next chapter.\"\n\nMultiple Potential Catalysts Ahead\n\nOver the coming 12–18 months, Ernexa intends to:\n* Submit ERNA-101 IND in Q4 2026 for a first-in-human clinical study in\nplatinum-resistant ovarian cancer;\n* Generate clinical data from the ERNA-101 PROC program, currently expected in\nQ4 2027;\n* Continue generating translational and preclinical evidence designed to\nstrengthen validation of the synthetic iMSC platform;\n* Evaluate opportunities to expand the platform into additional high-need\noncology indications;\n* Advance next-generation synthetic iMSC oncology candidates;\n* Explore strategic collaborations that could accelerate or broaden the\napplication of Ernexa's technology; and\n* Maintain disciplined capital allocation focused on milestones management\nbelieves can create the greatest value for patients and shareholders.\n\"We believe we are entering one of the most consequential periods in Ernexa's\ndevelopment,\" Luther concluded. \"ERNA-201 has provided encouraging evidence\nthat our engineering approach can translate into therapeutic activity in a\nwell-established disease model. ERNA-101 is approaching the clinic. And behind\nit is a platform we believe can be engineered and deployed against multiple\nhigh-need cancers. Our focus now is execution, reaching the clinic, generating\nhuman data and building a broader oncology pipeline capable of creating\nsustainable value.\"\n\nFor more information about ERNA-101 and the Company's development plans, visit\nwww.ernexatx.com.\n\nAbout Ernexa Therapeutics\n\nErnexa Therapeutics (NASDAQ: ERNA) is developing innovative cell therapies for\nthe treatment of advanced cancers. Ernexa’s core technology focuses on\nengineering induced pluripotent stem cells (iPSCs) and transforming them into\ninduced mesenchymal stem cells (iMSCs). Ernexa’s allogeneic synthetic iMSCs\nprovide a scalable, off-the-shelf treatment solution, without needing\npatient-specific cell harvesting.\n\nERNA-101 is the company’s lead cell therapy product, designed to activate\nand regulate the immune system's response to recognize and attack cancer\ncells. The company’s initial focus is to develop ERNA-101 for the treatment\nof ovarian cancer, with the potential to address multiple difficult-to-treat\nsolid tumors.\n\nFor more information, visit www.ernexatx.com.\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements within the meaning of\nSection 27A of the Securities Act of 1933, as amended, and Section 21E of the\nSecurities Exchange Act of 1934, as amended, which are intended to be covered\nby the safe harbor provisions of the Private Securities Litigation Reform Act\nof 1995. Forward-looking statements, in some cases, can be identified by terms\nsuch as \"believe,\" \"may,\" \"will,\" \"estimate,\" \"continue,\" \"anticipate,\"\n\"design,\" \"intend,\" \"expect,\" \"could,\" \"plan,\" \"potential,\" \"predict,\" \"seek,\"\n\"should,\" \"would,\" \"contemplate,\" \"project,\" \"target,\" \"objective,\" or the\nnegative version of these words and similar expressions. Forward-looking\nstatements involve known and unknown risks, uncertainties and other factors\nthat may cause Ernexa's actual results, performance or achievements to be\nmaterially different from future results, performance or achievements\nexpressed or implied by the forward-looking statements in this press release,\nincluding, without limitation, risks and uncertainties related to: the\nCompany’s ability to advance ERNA-101 toward and submit an IND application\nto the FDA, including the planned submission in Q4 2026; the timing, design\nand outcomes of the planned first-in-human clinical study of ERNA-101 in\nplatinum-resistant ovarian cancer, including the expected availability of\nclinical data in Q4 2027; the Company’s ability to transition from a\npreclinical-stage company to a clinical-stage company; expectations regarding\nthe versatility and therapeutic potential of the Company’s synthetic iMSC\nplatform, including its ability to be engineered for distinct therapeutic\npurposes across oncology and other disease areas; the Company’s plans to\nbroaden its oncology pipeline by evaluating additional high-need cancer\nindications and advancing next-generation iMSC candidates; the Company’s\nability to identify, develop and advance additional product candidates; the\nCompany’s capital allocation strategy, including the decision to pause\nadditional preclinical development expenditures on ERNA-201 and concentrate\nnear-term resources on ERNA-101 and oncology pipeline expansion; the potential\nfor ERNA-201 to be advanced in the future; the Company’s ability to enter\ninto strategic collaborations or partnerships; the sufficiency of the\nCompany’s capital resources to fund planned operations and achieve\nanticipated milestones; the Company’s ability to obtain and maintain\nregulatory approvals for its product candidates; the Company’s ability to\nattract and retain qualified personnel; the Company’s ability to protect its\nintellectual property and proprietary technology; competition from other\ncompanies developing therapies for the same or similar indications; and\ngeneral market, political and economic conditions. Forward-looking statements\nare based upon Ernexa's current expectations and involve assumptions that may\nnever materialize or may prove to be incorrect. All forward-looking statements\nare expressly qualified in their entirety by these cautionary statements. For\na detailed description of Ernexa's risks and uncertainties, you are encouraged\nto review its documents filed with the SEC including its recent filings on\nForm 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue\nreliance on forward-looking statements, which speak only as of the date on\nwhich they were made. Ernexa does not undertake any obligation to update the\nforward-looking statements contained herein to reflect events that occur or\ncircumstances that exist after the date hereof, except as required by\napplicable law.\n\nMedia Contact\nSharon Golubchik\nRAYNZ \nsharon@raynzhealth.com\n\nInvestor Contact\nJenene Thomas \nJTC Team, LLC\n(908) 824-0775\nERNA@jtcir.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/bb12f9ec-b7e7-4d8c-92df-cf27e238c398)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX8w2pHD-20260915","title":"Ernexa Therapeutics Reports Positive Disease Modifying ERNA-201 Preclinical Data, Reinforcing iMSC Platform as Company Accelerates Oncology Strategy and ERNA-101 Toward First-in-Human Dosing","author":"Globe Newswire","ticker":"ERNA","created":"2026-09-15T12:42:00.138Z","tickers":["ERNA"],"exchange":"NASDAQ","article_body":"ERNA-201 demonstrated encouraging disease-modifying activity in the\nindustry-standard collagen-induced arthritis model, providing meaningful\nproof-of-concept for Ernexa's engineered synthetic iMSC platform beyond\noncology\n\nPositive ERNA-201 findings add to a growing body of preclinical evidence\nsupporting the versatility of Ernexa's synthetic iMSC platform and its ability\nto deliver engineered therapeutic factors in disease\n\nCompany is concentrating near-term resources on ERNA-101 while broadening its\noncology strategy and advancing next-generation iMSC candidates across\nadditional high-need cancer indications\n\nERNA-201 remains an important platform asset with demonstrated preclinical\nproof-of-concept, preserving future development and strategic optionality\n\nCAMBRIDGE, Mass., Sept. 15, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics\n(https://www.globenewswire.com/Tracker?data=PkSlm0gAiL2xLUNhOiC3OPyBrWIqV_qYZoX0QgO-uFqgU4M-tJ8N8UdoEvfnOk61ULkgKd2PCutiD6ts7cDbLki_Olbv2Kp8miiJe43EwmQ=)\n(Nasdaq: ERNA), an industry innovator developing novel cell therapies for the\ntreatment of advanced cancers, today announced positive preliminary\npreclinical results for ERNA-201, its synthetic, allogeneic induced\nmesenchymal stem cell (iMSC) therapy engineered to express anti-inflammatory\nfactors, while outlining a sharpened oncology strategy designed to accelerate\nthe Company's transition into the clinic and expand the long-term potential of\nits proprietary synthetic iMSC platform.\n\nIn preliminary studies using the collagen-induced arthritis (CIA) model, an\nindustry-standard preclinical model for rheumatoid arthritis and inflammatory\njoint disease, several ERNA-201 lead candidates demonstrated reductions in\ndisease severity relative to untreated controls, including improvements in\nclinical arthritis scores consistent with the therapy's intended\nanti-inflammatory mechanism of action.\n\nErnexa believes these results represent an important scientific milestone:\nERNA-201 demonstrated meaningful preclinical proof-of-concept in inflammatory\ndisease, providing additional evidence that the Company's engineered iMSC\nplatform can be programmed to deliver therapeutically relevant factors across\ndistinct disease settings.\n\nWith this platform validation in hand, Ernexa is concentrating its near-term\ncapital and operational resources on what management believes represents the\nCompany's most immediate opportunity to create value for patients and\nshareholders: advancing ERNA-101 into a first-in-human clinical study in\nplatinum-resistant ovarian cancer (PROC).\n\nImportantly, the decision to prioritize ERNA-101 does not reflect a change in\nErnexa's conviction in ERNA-201 or its underlying biology. Rather, following\nthe positive ERNA-201 proof-of-concept results, the Company believes it has\nreached an appropriate point to preserve the program while directing near-term\nresources toward achieving clinical validation of its platform in oncology.\n\n\"We believe the ERNA-201 results are an important validation of both the\nprogram and the broader potential of our synthetic iMSC platform,\" said\nSanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics.\n\"ERNA-201 did what we wanted to see at this stage: it generated an encouraging\nproof-of-concept signal in an established inflammatory disease model and\ndemonstrated the potential to engineer our iMSCs for therapeutic activity\nbeyond cancer. That success gives us the confidence to preserve the\nsignificant future opportunity represented by ERNA-201 while concentrating our\nresources on the milestone directly ahead of us, bringing ERNA-101 into the\nclinic.\"\n\nMr. Luther continued, \"Our objective is bigger than advancing a single\ncandidate. We are building a differentiated oncology company around a\nscalable, off-the-shelf cell therapy platform. With ERNA-101 on track for FDA\nIND submission before year end, we believe Ernexa is approaching a potentially\ndefining inflection point. We intend to execute against that milestone with\nurgency while broadening our oncology pipeline and identifying additional\ncancers where our platform could make a meaningful difference.\"\n\nERNA-201: Positive Data Strengthen Validation of Ernexa's iMSC Platform\n\nERNA-201 is engineered to express anti-inflammatory factors designed to target\ninflammation and treat autoimmune disease. In completed preliminary studies,\nERNA-201 was evaluated in the CIA model, which is widely used to assess\npotential therapies for rheumatoid arthritis and other inflammatory joint\ndiseases.\n\nMice treated with several ERNA-201 lead candidates demonstrated reductions in\ndisease severity relative to untreated controls, including improvements in\nclinical arthritis scores. Ernexa believes the findings are consistent with\nthe candidate's intended anti-inflammatory mechanism and provide meaningful\nproof-of-concept support for the use of synthetic, cytokine-engineered iMSCs\nin inflammatory and autoimmune disease.\n\n\"Seeing disease-modifying activity from ERNA-201 in the collagen-induced\narthritis model is an encouraging scientific result,\" said Robert H. Pierce,\nM.D., Chief Scientific Officer of Ernexa Therapeutics. \"These findings support\nthe underlying thesis that engineered iMSCs can serve as a versatile\ntherapeutic delivery platform. We designed ERNA-201 to deliver\nanti-inflammatory factors in disease, and the preliminary activity we observed\nis consistent with that objective. From a scientific perspective, these data\nincrease our confidence in the program and provide another important\nvalidation point for the broader platform.\"\n\nThe ERNA-201 results are particularly important to Ernexa because the program\nemploys the same fundamental synthetic iMSC platform architecture that\nunderpins the Company's broader pipeline. While ERNA-201 is engineered for\nanti-inflammatory activity and ERNA-101 is engineered to stimulate an immune\nresponse against cancer, both programs demonstrate the potential versatility\nof an allogeneic, scalable cell platform that can be engineered for distinct\ntherapeutic purposes.\n\nBuilding Momentum Toward the Clinic: ERNA-101 Advancing Toward Planned IND\nSubmission in Q4 2026\n\nWith ERNA-201 generating positive preliminary proof-of-concept data, Ernexa is\nprioritizing the next major milestone in the Company's evolution: advancing\nERNA-101 toward a planned IND submission for a first-in-human clinical study\nin platinum-resistant ovarian cancer.\n\nERNA-101 is Ernexa's lead oncology cell therapy candidate, engineered to\nexpress an IL-7/IL-15 fusion cytokine designed to activate and regulate the\nimmune system's response to recognize and attack cancer cells.\n\nThe Company is focused on advancing ERNA-101 toward a planned IND submission\nin the fourth quarter of 2026. Ernexa believes achieving this milestone would\nrepresent an important step toward the Company's transition from a preclinical\ndevelopment company to a clinical-stage oncology company and the generation of\nhuman clinical evidence necessary to evaluate the therapeutic potential of its\nplatform.\n\nClinical data from the ERNA-101 PROC study are expected in Q4 2027, providing\nthe Company with a series of potential clinical and operational milestones\nover the coming 12–18 months.\n\nA Focused Oncology Strategy Built Around One Scalable Platform\n\nErnexa's strategy extends beyond a single indication or product candidate. The\nCompany's proprietary platform begins with induced pluripotent stem cells\n(iPSCs), which are engineered and transformed into synthetic induced\nmesenchymal stem cells. The resulting allogeneic iMSCs are designed to provide\na scalable, off-the-shelf therapeutic approach without the need for\npatient-specific cell harvesting.\n\nManagement believes this architecture creates the potential to engineer iMSCs\nwith different therapeutic factors and apply the platform across multiple\ndiseases. The positive preliminary ERNA-201 findings provide additional\nsupport for that platform thesis, while ERNA-101 now represents the Company's\nmost advanced opportunity to demonstrate its potential in patients.\n\nAs Ernexa moves toward the clinic, the Company intends to broaden the scope of\nits oncology program by evaluating additional high-need cancer indications and\nadvancing next-generation iMSC candidates designed to build on the Company's\nexisting scientific and manufacturing capabilities.\n\nThe Company will prioritize opportunities based on scientific rationale, unmet\npatient need, commercial potential and capital efficiency, including\nopportunities that may be pursued internally or through strategic\ncollaborations.\n\nDisciplined Capital Allocation: Advancing the Nearest Value-Creating\nMilestones\n\nFollowing the encouraging ERNA-201 results, Ernexa has elected to pause\nadditional preclinical development expenditures on ERNA-201 at this time and\npreserve the program while concentrating near-term resources on ERNA-101 and\nthe expansion of its oncology pipeline.\n\nThe decision is a capital allocation priority rather than a scientific\ndecision to discontinue ERNA-201. The Company believes the positive\npreliminary results provide a foundation from which ERNA-201 could potentially\nbe advanced in the future as resources, strategic priorities and development\nopportunities warrant.\n\n\"We have achieved an important objective with ERNA-201 by generating\nencouraging proof-of-concept data,\" Luther said. \"The question for us now is\nnot whether we believe in the program. We do. The question is where each\nincremental dollar and each hour of our team's effort can have the greatest\nimpact today. With ERNA-101 approaching the clinic, we believe concentrating\nresources behind first-patient dosing and expanding our oncology opportunity\nis the most disciplined path forward.\"\n\n\"We are preserving ERNA-201's future potential while accelerating the program\nthat is closest to human clinical validation. We believe that the combination\nof scientific validation, disciplined execution and a clear path into the\nclinic positions Ernexa for an important next chapter.\"\n\nMultiple Potential Catalysts Ahead\n\nOver the coming 12–18 months, Ernexa intends to:\n* Submit ERNA-101 IND in Q4 2026 for a first-in-human clinical study in\nplatinum-resistant ovarian cancer;\n* Generate clinical data from the ERNA-101 PROC program, currently expected in\nQ4 2027;\n* Continue generating translational and preclinical evidence designed to\nstrengthen validation of the synthetic iMSC platform;\n* Evaluate opportunities to expand the platform into additional high-need\noncology indications;\n* Advance next-generation synthetic iMSC oncology candidates;\n* Explore strategic collaborations that could accelerate or broaden the\napplication of Ernexa's technology; and\n* Maintain disciplined capital allocation focused on milestones management\nbelieves can create the greatest value for patients and shareholders.\n\"We believe we are entering one of the most consequential periods in Ernexa's\ndevelopment,\" Luther concluded. \"ERNA-201 has provided encouraging evidence\nthat our engineering approach can translate into therapeutic activity in a\nwell-established disease model. ERNA-101 is approaching the clinic. And behind\nit is a platform we believe can be engineered and deployed against multiple\nhigh-need cancers. Our focus now is execution, reaching the clinic, generating\nhuman data and building a broader oncology pipeline capable of creating\nsustainable value.\"\n\nFor more information about ERNA-101 and the Company's development plans, visit\nwww.ernexatx.com.\n\nAbout Ernexa Therapeutics\n\nErnexa Therapeutics (NASDAQ: ERNA) is developing innovative cell therapies for\nthe treatment of advanced cancers. Ernexa’s core technology focuses on\nengineering induced pluripotent stem cells (iPSCs) and transforming them into\ninduced mesenchymal stem cells (iMSCs). Ernexa’s allogeneic synthetic iMSCs\nprovide a scalable, off-the-shelf treatment solution, without needing\npatient-specific cell harvesting.\n\nERNA-101 is the company’s lead cell therapy product, designed to activate\nand regulate the immune system's response to recognize and attack cancer\ncells. The company’s initial focus is to develop ERNA-101 for the treatment\nof ovarian cancer, with the potential to address multiple difficult-to-treat\nsolid tumors.\n\nFor more information, visit www.ernexatx.com.\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements within the meaning of\nSection 27A of the Securities Act of 1933, as amended, and Section 21E of the\nSecurities Exchange Act of 1934, as amended, which are intended to be covered\nby the safe harbor provisions of the Private Securities Litigation Reform Act\nof 1995. Forward-looking statements, in some cases, can be identified by terms\nsuch as \"believe,\" \"may,\" \"will,\" \"estimate,\" \"continue,\" \"anticipate,\"\n\"design,\" \"intend,\" \"expect,\" \"could,\" \"plan,\" \"potential,\" \"predict,\" \"seek,\"\n\"should,\" \"would,\" \"contemplate,\" \"project,\" \"target,\" \"objective,\" or the\nnegative version of these words and similar expressions. Forward-looking\nstatements involve known and unknown risks, uncertainties and other factors\nthat may cause Ernexa's actual results, performance or achievements to be\nmaterially different from future results, performance or achievements\nexpressed or implied by the forward-looking statements in this press release,\nincluding, without limitation, risks and uncertainties related to: the\nCompany’s ability to advance ERNA-101 toward and submit an IND application\nto the FDA, including the planned submission in Q4 2026; the timing, design\nand outcomes of the planned first-in-human clinical study of ERNA-101 in\nplatinum-resistant ovarian cancer, including the expected availability of\nclinical data in Q4 2027; the Company’s ability to transition from a\npreclinical-stage company to a clinical-stage company; expectations regarding\nthe versatility and therapeutic potential of the Company’s synthetic iMSC\nplatform, including its ability to be engineered for distinct therapeutic\npurposes across oncology and other disease areas; the Company’s plans to\nbroaden its oncology pipeline by evaluating additional high-need cancer\nindications and advancing next-generation iMSC candidates; the Company’s\nability to identify, develop and advance additional product candidates; the\nCompany’s capital allocation strategy, including the decision to pause\nadditional preclinical development expenditures on ERNA-201 and concentrate\nnear-term resources on ERNA-101 and oncology pipeline expansion; the potential\nfor ERNA-201 to be advanced in the future; the Company’s ability to enter\ninto strategic collaborations or partnerships; the sufficiency of the\nCompany’s capital resources to fund planned operations and achieve\nanticipated milestones; the Company’s ability to obtain and maintain\nregulatory approvals for its product candidates; the Company’s ability to\nattract and retain qualified personnel; the Company’s ability to protect its\nintellectual property and proprietary technology; competition from other\ncompanies developing therapies for the same or similar indications; and\ngeneral market, political and economic conditions. Forward-looking statements\nare based upon Ernexa's current expectations and involve assumptions that may\nnever materialize or may prove to be incorrect. All forward-looking statements\nare expressly qualified in their entirety by these cautionary statements. For\na detailed description of Ernexa's risks and uncertainties, you are encouraged\nto review its documents filed with the SEC including its recent filings on\nForm 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue\nreliance on forward-looking statements, which speak only as of the date on\nwhich they were made. Ernexa does not undertake any obligation to update the\nforward-looking statements contained herein to reflect events that occur or\ncircumstances that exist after the date hereof, except as required by\napplicable law.\n\nMedia Contact\nSharon Golubchik\nRAYNZ \nsharon@raynzhealth.com\n\nInvestor Contact\nJenene Thomas \nJTC Team, LLC\n(908) 824-0775\nERNA@jtcir.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/bb12f9ec-b7e7-4d8c-92df-cf27e238c398)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-15T12:42:00.193756533Z","server_sent_at_ms":1789476120193},"received_at":"2026-09-15T12:42:01.418Z","source_url":null},"analysis":{"id":"132713","press_release_id":"143881","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["All data are preclinical (mouse CIA model); no human evidence for either candidate yet","ERNA-201 preclinical development expenditures paused — program deprioritized for capital-allocation reasons","Pre-revenue micro-cap with next hard catalysts not until Q4 2026 IND and Q4 2027 clinical data; forward-looking statements explicitly cite sufficiency of capital resources as a risk"],"eventType":"clinical_trial","narrative":"Ernexa Therapeutics reported positive preliminary preclinical data for ERNA-201, its anti-inflammatory engineered iMSC therapy, in the collagen-induced arthritis mouse model, with several lead candidates showing reduced disease severity versus untreated controls.\n\nThe company is pausing additional preclinical spending on ERNA-201 while preserving the program, and redirecting near-term capital toward ERNA-101, its lead oncology candidate for platinum-resistant ovarian cancer.\n\nERNA-101 remains on track for a planned FDA IND submission in Q4 2026, with first clinical data from the PROC study expected in Q4 2027, giving the pre-revenue biotech a 12-18 month runway of potential catalysts.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Micro-cap biotech preclinical win and pipeline triage — the real catalyst is the ERNA-101 IND in Q4 2026, not mouse data."},"keyFigures":{"customDimensions":{"er201_status":"preclinical spend paused, program preserved","catalyst_window":"12-18 months","er101_indication":"platinum-resistant ovarian cancer (PROC)","clinical_data_timing":"Q4 2027","ind_submission_timing":"Q4 2026"}},"quotedText":"ERNA-201 did what we wanted to see at this stage","namedEntities":{"people":[{"name":"Sanjeev Luther","role":"President and CEO"},{"name":"Robert H. Pierce, M.D.","role":"Chief Scientific Officer"},{"name":"Sharon Golubchik","role":"Media Contact (RAYNZ)"},{"name":"Jenene Thomas","role":"Investor Contact (JTC Team)"}],"products":["ERNA-201","ERNA-101","synthetic iMSC platform","IL-7/IL-15 fusion cytokine"],"companies":[{"name":"Ernexa Therapeutics","ticker":"ERNA","relationship":"filer"},{"name":"RAYNZ","relationship":"media contact agency"},{"name":"JTC Team, LLC","relationship":"investor relations firm"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Positive preclinical proof-of-concept for ERNA-201 in a mouse arthritis model plus a stated pivot of resources toward ERNA-101's IND, but there is no human data, no financial figures, and the company remains pre-revenue. Meaningful pipeline news for a micro-cap biotech, but not a market-moving event."},"tickerRelevance":{"others":[],"primary":"ERNA"},"globalImportance":18,"audienceRelevance":12,"eventTypeSecondary":["operations_update"],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"positive preclinical data plus capital-allocation pivot toward IND","sectorWeight":"biotech preclinical pipeline update","issuerAuthored":true,"dataStageAdjustment":"animal model only, no human data","clinicalStageTransitionPending":true}},"event_type":"clinical_trial","event_type_secondary":["operations_update"],"sentiment":"bullish","material_impact_score":2,"narrative":"Ernexa Therapeutics reported positive preliminary preclinical data for ERNA-201, its anti-inflammatory engineered iMSC therapy, in the collagen-induced arthritis mouse model, with several lead candidates showing reduced disease severity versus untreated controls.\n\nThe company is pausing additional preclinical spending on ERNA-201 while preserving the program, and redirecting near-term capital toward ERNA-101, its lead oncology candidate for platinum-resistant ovarian cancer.\n\nERNA-101 remains on track for a planned FDA IND submission in Q4 2026, with first clinical data from the PROC study expected in Q4 2027, giving the pre-revenue biotech a 12-18 month runway of potential catalysts.","key_figures":{"customDimensions":{"er201_status":"preclinical spend paused, program preserved","catalyst_window":"12-18 months","er101_indication":"platinum-resistant ovarian cancer (PROC)","clinical_data_timing":"Q4 2027","ind_submission_timing":"Q4 2026"}},"named_entities":{"people":[{"name":"Sanjeev Luther","role":"President and CEO"},{"name":"Robert H. Pierce, M.D.","role":"Chief Scientific Officer"},{"name":"Sharon Golubchik","role":"Media Contact (RAYNZ)"},{"name":"Jenene Thomas","role":"Investor Contact (JTC Team)"}],"products":["ERNA-201","ERNA-101","synthetic iMSC platform","IL-7/IL-15 fusion cytokine"],"companies":[{"name":"Ernexa Therapeutics","ticker":"ERNA","relationship":"filer"},{"name":"RAYNZ","relationship":"media contact agency"},{"name":"JTC Team, LLC","relationship":"investor relations firm"}],"dollarAmounts":[]},"model_name":"glm-5.3-flash","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-15T12:42:46.330Z","global_importance":18,"audience_relevance":12,"importance_components":{"tickerTier":"micro-cap","eventGravity":"positive preclinical data plus capital-allocation pivot toward IND","sectorWeight":"biotech preclinical pipeline update","issuerAuthored":true,"dataStageAdjustment":"animal model only, no human data","clinicalStageTransitionPending":true}},"durationMs":44900,"modelName":"glm-5.3-flash"}}