{"success":true,"data":{"pressRelease":{"id":"127930","rtpr_id":"nGNE2h7wXr","ticker":"INMB","exchange":"NASDAQ","all_tickers":["INMB"],"title":"INmune Bio Advances Ebstrocel™ Toward European Marketing Authorization with EMA Regulatory Filings","author":"Globe Newswire","published_at":"2026-08-26T11:00:00.504Z","article_body":"Orphan Drug Designation application and pre-MAA Scientific Advice package\nsubmitted for Ebstrocel™ in RDEB\nFilings support a planned EU MAA in Q1 2027; orphan designation, if granted\nand maintained through approval, may provide regulatory incentives and 10\nyears of market exclusivity\n\nBOCA RATON, Fla., Aug. 26, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ:\nINMB) (\"INmune Bio\" or the \"Company\"), a late-stage biotechnology company\nfocused on inflammation and immunology, today announced that it has submitted\ntwo regulatory packages to the European Medicines Agency (EMA) for\nEbstrocel™: an application for Orphan Drug Designation and a Scientific\nAdvice package to streamline the upcoming Marketing Authorization Application\n(MAA) in Europe. Ebstrocel™, the first product from the Company’s\nCORDStrom™ platform, is an investigational pooled, allogeneic, umbilical\ncord-derived mesenchymal stromal cell therapy being developed as a systemic\ntreatment for recessive dystrophic epidermolysis bullosa (RDEB).\n\nThe EMA filings are intended to support the Company’s planned EU MAA in Q1\n2027 and form part of a coordinated global registration strategy that includes\na planned UK MAA in Q4 2026 and a planned U.S. Biologics License Application\n(BLA) in Q1 2027.\n\n“These EMA submissions are another execution milestone as we move Ebstrocel\nfrom late-stage clinical development toward potential commercialization,”\nsaid David Moss, co-founder and Chief Executive Officer of INmune Bio. “Our\nfocus is on converting the clinical, regulatory and manufacturing progress\nachieved to date into a defined sequence of registration milestones across the\nUK, European Union and United States. Each step advances Ebstrocel toward\npatients and provides an opportunity to validate the broader regulatory and\ncommercial potential of the CORDStrom platform.”\n\nRegulatory and Strategic Highlights\n* EU orphan designation: The application seeks orphan medicinal product\ndesignation for Ebstrocel™ in RDEB in Europe to align with the ODD already\ngranted in USA. If granted, sponsors may receive incentives that include\nprotocol assistance and fee reductions. If Ebstrocel™ later receives\nmarketing authorization and maintains orphan status, the approved orphan\nindication may benefit from 10 years of EU market exclusivity, subject to\napplicable requirements.\n* Pre-MAA engagement: The Scientific Advice package is intended to support\ndialogue with EMA on scientific, regulatory and procedural requirements before\nthe planned MAA, helping the Company identify and address key questions\nearlier in the filing process.\n* Defined global catalyst sequence: The Company is targeting a UK MAA in Q4\n2026, followed by planned EU MAA and U.S. BLA submissions in Q1 2027.\n* Platform leverage: Ebstrocel™ is the first disease-specific CORDStrom™\nproduct to advance toward potential marketing authorization. Progress with\nEbstrocel™ is expected to inform development of additional scalable,\noff-the-shelf therapies from the platform.\nRDEB and the Ebstrocel™ Opportunity\n\nRDEB is a rare, debilitating genetic disease characterized by extreme skin\nfragility, chronic wounds, scarring and significant systemic complications.\nEbstrocel™ is being developed as a systemic therapy intended to address\ndisease manifestations beyond topical wound care.\n\n“RDEB is a systemic disease with substantial unmet need beyond the visible\nmanifestations of skin injury,” said Mark Lowdell, Ph.D., Chief Scientific\nOfficer of INmune Bio and inventor of the CORDStrom™ platform. “Advancing\nEbstrocel through European regulatory pathways is important for patients and\nfor CORDStrom. Ebstrocel is our first opportunity to demonstrate how a pooled,\nscalable, off-the-shelf stromal cell platform can progress through late-stage\nregulatory development.”\n\nAbout the European Regulatory Submissions\n\nOrphan Drug Designation in the European Union is intended to support the\ndevelopment of medicines for rare, serious conditions. If granted, the\ndesignation can provide access to regulatory incentives during development.\nMarket exclusivity is available only after marketing authorization and\nmaintenance of orphan status at the time of approval.\n\nThe pre-MAA Scientific Advice process is designed to facilitate interaction\nwith EMA in advance of an MAA submission and to help sponsors address\nscientific, regulatory and procedural considerations as they prepare a\nmarketing authorization package.\n\nAbout Ebstrocel™ and CORDStrom™\n\nEbstrocel™ is the RDEB-specific investigational product from INmune Bio’s\nproprietary CORDStrom™ platform. CORDStrom™ is a platform of pooled,\nallogeneic, human umbilical cord-derived mesenchymal stromal cell therapies\ndesigned to reduce donor variability and manufacturing inconsistency. The\nCompany’s fully closed, semi-automated manufacturing approach is intended to\nsupport scalable, reproducible and off-the-shelf products that can be tailored\nfor different therapeutic applications and routes of administration.\n\nINmune Bio plans to continue its interactions with European regulators as it\nadvances toward the planned MAA for Ebstrocel™.\n\nAbout INmune Bio Inc.\n\nINmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology\ncompany focused on developing treatments that target the innate immune system\nto fight disease. Moving beyond early-stage exploration, the Company’s\nclinical-development strategy centers on advanced precision medicine, matching\ndrug mechanisms directly to patient biology to optimize clinical outcomes.\n\nINmune Bio is actively advancing two late-stage product platforms toward\nregistrational milestones:\n* CORDStrom™: A proprietary, pooled, allogeneic, human umbilical\ncord-derived mesenchymal stromal cell platform engineered to address the\nhistorical clinical challenges of donor variability and manufacturing\ninconsistency. Following successful clinical readouts in RDEB, the platform is\ntransitioning to regulatory filing phases, with a UK MAA planned for 2026 and\nan EU MAA and U.S. BLA planned for Q1 2027.\n* XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform\nthat selectively neutralizes soluble TNF (sTNF) to eliminate neuroinflammation\nwithout compromising protective immune function. Backed by FDA Fast Track\ndesignation and regulatory alignment from an End-of-Phase 2 meeting,\nXPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive\nregistrational program in neuroinflammation-enriched early Alzheimer’s\ndisease.\nTo learn more about INmune Bio’s pipeline and its approach to harnessing the\ninnate immune system, please visit www.inmunebio.com.\n\nForward Looking Statements\n\nThe Company’s product candidates are in clinical development and there is no\nassurance that any specific outcome will be achieved. Any statements contained\nin this press release related to the development or commercialization of\nproduct candidates and other business and financial matters, including without\nlimitation, trial results and data, including the timing of key milestones,\nfuture plans or expectations, and the prospects for receiving regulatory\napproval or commercializing or selling any product or drug candidates, may\nconstitute forward-looking statements as that term is defined in the Private\nSecurities Litigation Reform Act of 1995. Any forward-looking statements\ncontained herein are based on current expectations but are subject to several\nrisks and uncertainties. Actual results and the timing of certain events and\ncircumstances may differ materially from those described by the\nforward-looking statements because of these risks and uncertainties.\nCORDStrom™, XPro1595™ (XPro™, pegipanermin), and INKmune™ have either\nfinished clinical trials, are still in clinical trials or are preparing to\nstart clinical trials and have not been approved by the U.S. Food and Drug\nAdministration (FDA), the UK MHRA or any regulatory body and there cannot be\nany assurance that they will be approved by the FDA, the UK MHRA or any\nregulatory body or that any specific results will be achieved. The factors\nthat could cause actual future results to differ materially from current\nexpectations include, but are not limited to, risks and uncertainties relating\nto the Company’s ability to produce more drug for clinical trials; the\navailability of substantial additional funding for the Company to continue its\noperations and to conduct research and development, clinical studies and\nfuture product commercialization; and the Company’s business, research,\nproduct development, regulatory approval, marketing and distribution plans and\nstrategies. These and other factors are identified and described in more\ndetail in the Company’s filings with the Securities and Exchange Commission,\nincluding the Company’s Annual Report on Form 10-K, the Company’s\nQuarterly Reports on Form 10-Q and the Company’s Current Reports on Form\n8-K. The Company assumes no obligation to update any forward-looking\nstatements to reflect any event or circumstance that may arise after the date\nof this release.\n\nINmune Bio Contacts\n\nDavid Moss\nChief Executive Officer\n(561) 710-0512\ninfo@inmunebio.com\n\nDaniel Carlson\nHead of Investor Relations\n(415) 509-4590\ndcarlson@inmunebio.com","article_body_html":"","raw_payload":{"data":{"id":"nGNE2h7wXr","title":"INmune Bio Advances Ebstrocel™ Toward European Marketing Authorization with EMA Regulatory Filings","author":"Globe Newswire","ticker":"INMB","created":"2026-08-26T11:00:00.504Z","tickers":["INMB"],"exchange":"NASDAQ","article_body":"Orphan Drug Designation application and pre-MAA Scientific Advice package\nsubmitted for Ebstrocel™ in RDEB\nFilings support a planned EU MAA in Q1 2027; orphan designation, if granted\nand maintained through approval, may provide regulatory incentives and 10\nyears of market exclusivity\n\nBOCA RATON, Fla., Aug. 26, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ:\nINMB) (\"INmune Bio\" or the \"Company\"), a late-stage biotechnology company\nfocused on inflammation and immunology, today announced that it has submitted\ntwo regulatory packages to the European Medicines Agency (EMA) for\nEbstrocel™: an application for Orphan Drug Designation and a Scientific\nAdvice package to streamline the upcoming Marketing Authorization Application\n(MAA) in Europe. Ebstrocel™, the first product from the Company’s\nCORDStrom™ platform, is an investigational pooled, allogeneic, umbilical\ncord-derived mesenchymal stromal cell therapy being developed as a systemic\ntreatment for recessive dystrophic epidermolysis bullosa (RDEB).\n\nThe EMA filings are intended to support the Company’s planned EU MAA in Q1\n2027 and form part of a coordinated global registration strategy that includes\na planned UK MAA in Q4 2026 and a planned U.S. Biologics License Application\n(BLA) in Q1 2027.\n\n“These EMA submissions are another execution milestone as we move Ebstrocel\nfrom late-stage clinical development toward potential commercialization,”\nsaid David Moss, co-founder and Chief Executive Officer of INmune Bio. “Our\nfocus is on converting the clinical, regulatory and manufacturing progress\nachieved to date into a defined sequence of registration milestones across the\nUK, European Union and United States. Each step advances Ebstrocel toward\npatients and provides an opportunity to validate the broader regulatory and\ncommercial potential of the CORDStrom platform.”\n\nRegulatory and Strategic Highlights\n* EU orphan designation: The application seeks orphan medicinal product\ndesignation for Ebstrocel™ in RDEB in Europe to align with the ODD already\ngranted in USA. If granted, sponsors may receive incentives that include\nprotocol assistance and fee reductions. If Ebstrocel™ later receives\nmarketing authorization and maintains orphan status, the approved orphan\nindication may benefit from 10 years of EU market exclusivity, subject to\napplicable requirements.\n* Pre-MAA engagement: The Scientific Advice package is intended to support\ndialogue with EMA on scientific, regulatory and procedural requirements before\nthe planned MAA, helping the Company identify and address key questions\nearlier in the filing process.\n* Defined global catalyst sequence: The Company is targeting a UK MAA in Q4\n2026, followed by planned EU MAA and U.S. BLA submissions in Q1 2027.\n* Platform leverage: Ebstrocel™ is the first disease-specific CORDStrom™\nproduct to advance toward potential marketing authorization. Progress with\nEbstrocel™ is expected to inform development of additional scalable,\noff-the-shelf therapies from the platform.\nRDEB and the Ebstrocel™ Opportunity\n\nRDEB is a rare, debilitating genetic disease characterized by extreme skin\nfragility, chronic wounds, scarring and significant systemic complications.\nEbstrocel™ is being developed as a systemic therapy intended to address\ndisease manifestations beyond topical wound care.\n\n“RDEB is a systemic disease with substantial unmet need beyond the visible\nmanifestations of skin injury,” said Mark Lowdell, Ph.D., Chief Scientific\nOfficer of INmune Bio and inventor of the CORDStrom™ platform. “Advancing\nEbstrocel through European regulatory pathways is important for patients and\nfor CORDStrom. Ebstrocel is our first opportunity to demonstrate how a pooled,\nscalable, off-the-shelf stromal cell platform can progress through late-stage\nregulatory development.”\n\nAbout the European Regulatory Submissions\n\nOrphan Drug Designation in the European Union is intended to support the\ndevelopment of medicines for rare, serious conditions. If granted, the\ndesignation can provide access to regulatory incentives during development.\nMarket exclusivity is available only after marketing authorization and\nmaintenance of orphan status at the time of approval.\n\nThe pre-MAA Scientific Advice process is designed to facilitate interaction\nwith EMA in advance of an MAA submission and to help sponsors address\nscientific, regulatory and procedural considerations as they prepare a\nmarketing authorization package.\n\nAbout Ebstrocel™ and CORDStrom™\n\nEbstrocel™ is the RDEB-specific investigational product from INmune Bio’s\nproprietary CORDStrom™ platform. CORDStrom™ is a platform of pooled,\nallogeneic, human umbilical cord-derived mesenchymal stromal cell therapies\ndesigned to reduce donor variability and manufacturing inconsistency. The\nCompany’s fully closed, semi-automated manufacturing approach is intended to\nsupport scalable, reproducible and off-the-shelf products that can be tailored\nfor different therapeutic applications and routes of administration.\n\nINmune Bio plans to continue its interactions with European regulators as it\nadvances toward the planned MAA for Ebstrocel™.\n\nAbout INmune Bio Inc.\n\nINmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology\ncompany focused on developing treatments that target the innate immune system\nto fight disease. Moving beyond early-stage exploration, the Company’s\nclinical-development strategy centers on advanced precision medicine, matching\ndrug mechanisms directly to patient biology to optimize clinical outcomes.\n\nINmune Bio is actively advancing two late-stage product platforms toward\nregistrational milestones:\n* CORDStrom™: A proprietary, pooled, allogeneic, human umbilical\ncord-derived mesenchymal stromal cell platform engineered to address the\nhistorical clinical challenges of donor variability and manufacturing\ninconsistency. Following successful clinical readouts in RDEB, the platform is\ntransitioning to regulatory filing phases, with a UK MAA planned for 2026 and\nan EU MAA and U.S. BLA planned for Q1 2027.\n* XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform\nthat selectively neutralizes soluble TNF (sTNF) to eliminate neuroinflammation\nwithout compromising protective immune function. Backed by FDA Fast Track\ndesignation and regulatory alignment from an End-of-Phase 2 meeting,\nXPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive\nregistrational program in neuroinflammation-enriched early Alzheimer’s\ndisease.\nTo learn more about INmune Bio’s pipeline and its approach to harnessing the\ninnate immune system, please visit www.inmunebio.com.\n\nForward Looking Statements\n\nThe Company’s product candidates are in clinical development and there is no\nassurance that any specific outcome will be achieved. Any statements contained\nin this press release related to the development or commercialization of\nproduct candidates and other business and financial matters, including without\nlimitation, trial results and data, including the timing of key milestones,\nfuture plans or expectations, and the prospects for receiving regulatory\napproval or commercializing or selling any product or drug candidates, may\nconstitute forward-looking statements as that term is defined in the Private\nSecurities Litigation Reform Act of 1995. Any forward-looking statements\ncontained herein are based on current expectations but are subject to several\nrisks and uncertainties. Actual results and the timing of certain events and\ncircumstances may differ materially from those described by the\nforward-looking statements because of these risks and uncertainties.\nCORDStrom™, XPro1595™ (XPro™, pegipanermin), and INKmune™ have either\nfinished clinical trials, are still in clinical trials or are preparing to\nstart clinical trials and have not been approved by the U.S. Food and Drug\nAdministration (FDA), the UK MHRA or any regulatory body and there cannot be\nany assurance that they will be approved by the FDA, the UK MHRA or any\nregulatory body or that any specific results will be achieved. The factors\nthat could cause actual future results to differ materially from current\nexpectations include, but are not limited to, risks and uncertainties relating\nto the Company’s ability to produce more drug for clinical trials; the\navailability of substantial additional funding for the Company to continue its\noperations and to conduct research and development, clinical studies and\nfuture product commercialization; and the Company’s business, research,\nproduct development, regulatory approval, marketing and distribution plans and\nstrategies. These and other factors are identified and described in more\ndetail in the Company’s filings with the Securities and Exchange Commission,\nincluding the Company’s Annual Report on Form 10-K, the Company’s\nQuarterly Reports on Form 10-Q and the Company’s Current Reports on Form\n8-K. The Company assumes no obligation to update any forward-looking\nstatements to reflect any event or circumstance that may arise after the date\nof this release.\n\nINmune Bio Contacts\n\nDavid Moss\nChief Executive Officer\n(561) 710-0512\ninfo@inmunebio.com\n\nDaniel Carlson\nHead of Investor Relations\n(415) 509-4590\ndcarlson@inmunebio.com"},"type":"article","timestamp":"2026-08-26T11:00:00.591562283Z","server_sent_at_ms":1787742000591},"received_at":"2026-08-26T11:00:00.639Z","source_url":null},"analysis":{"id":"116847","press_release_id":"127930","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"INmune Bio submitted an Orphan Drug Designation application and a pre-MAA Scientific Advice package to the European Medicines Agency for Ebstrocel™ in RDEB.\n\nThese filings support a planned EU Marketing Authorization Application in Q1 2027, part of a coordinated global strategy that includes a UK MAA in Q4 2026 and a U.S. BLA in Q1 2027.\n\nIf granted, the orphan designation could provide 10 years of market exclusivity in Europe upon approval, aligning with the incentives already secured in the U.S.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"EMA filings set stage for Ebstrocel's 2027 EU launch and 10 years of exclusivity."},"keyFigures":{"drugName":"Ebstrocel™","customDimensions":{"eu_maa_timeline":"Q1 2027","uk_maa_timeline":"Q4 2026","us_bla_timeline":"Q1 2027","market_exclusivity_years":10}},"quotedText":"These EMA submissions are another execution milestone as we move Ebstrocel from late-stage clinical development toward potential commercialization","namedEntities":{"people":[{"name":"David Moss","role":"Co-founder and Chief Executive Officer"},{"name":"Mark Lowdell","role":"Chief Scientific Officer"},{"name":"Daniel Carlson","role":"Head of Investor Relations"}],"products":["Ebstrocel™","CORDStrom™","XPro1595™"],"companies":[{"name":"INmune Bio Inc.","ticker":"INMB"},{"name":"European Medicines Agency","relationship":"regulatory body"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"The submission of Orphan Drug Designation and pre-MAA packages to the EMA is a significant execution milestone that de-risks the Ebstrocel regulatory pathway and establishes a clear timeline for the EU MAA in Q1 2027. The potential for 10 years of market exclusivity adds material long-term value if approved."},"tickerRelevance":{"others":[],"primary":"INMB"},"globalImportance":25,"audienceRelevance":20,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"regulatory_submission","sectorWeight":"biotech"}},"event_type":"regulatory","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"INmune Bio submitted an Orphan Drug Designation application and a pre-MAA Scientific Advice package to the European Medicines Agency for Ebstrocel™ in RDEB.\n\nThese filings support a planned EU Marketing Authorization Application in Q1 2027, part of a coordinated global strategy that includes a UK MAA in Q4 2026 and a U.S. BLA in Q1 2027.\n\nIf granted, the orphan designation could provide 10 years of market exclusivity in Europe upon approval, aligning with the incentives already secured in the U.S.","key_figures":{"drugName":"Ebstrocel™","customDimensions":{"eu_maa_timeline":"Q1 2027","uk_maa_timeline":"Q4 2026","us_bla_timeline":"Q1 2027","market_exclusivity_years":10}},"named_entities":{"people":[{"name":"David Moss","role":"Co-founder and Chief Executive Officer"},{"name":"Mark Lowdell","role":"Chief Scientific Officer"},{"name":"Daniel Carlson","role":"Head of Investor Relations"}],"products":["Ebstrocel™","CORDStrom™","XPro1595™"],"companies":[{"name":"INmune Bio Inc.","ticker":"INMB"},{"name":"European Medicines Agency","relationship":"regulatory body"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-26T11:05:05.137Z","global_importance":25,"audience_relevance":20,"importance_components":{"tickerTier":"small-cap","eventGravity":"regulatory_submission","sectorWeight":"biotech"}},"durationMs":87210,"modelName":"glm-4.7"}}