Core Insights - The presentation focuses on pivotal updates regarding the MissionEB Phase III clinical trial and the impact of CORDStrom on Recessive Dystrophic Epidermolysis Bullosa (RDEB) [1] Group 1: Company Overview - David Moss serves as the President, CEO, Treasurer, Secretary, and Director of INmune Bio, highlighting the company's leadership structure [1] - The event is being recorded and will be available on the company's YouTube channel later, indicating a commitment to transparency and communication with stakeholders [2] Group 2: Key Personnel - Dr. Mark Lowdell is introduced as the inventor of CORDStrom and a pioneer in cellular therapy, emphasizing his significant contributions to the development of advanced medicinal products [3] - Dr. Anna Martinez is the clinical lead for the MissionEB trial and a leading expert in the field of Epidermolysis Bullosa, showcasing the expertise driving the clinical program [4]

INmune Bio (NasdaqCM:INMB) Update / briefing February 26, 2026 01:00 PM ET Company ParticipantsAnna Martinez - Principal Investigator of the MissionEB Clinical TrialDavid Moss - Co-founder and CEOMark Lowdell - Chief Scientific Officer and Co-FounderDavid MossHi, everyone. Thanks for joining. I just want to let you know that we'll get started in about 1 minute or so. Good afternoon, everyone, thank you for joining us. I'm David Moss, CEO of INmune Bio. Today, we're proud to share pivotal updates regarding o ...

Core Viewpoint - INmune Bio Inc. is advancing its clinical development of XPro1595 for early Alzheimer's disease, with a webinar scheduled to discuss the registrational pathway and recent trial results [1][2]. Group 1: Clinical Development - The Phase 2 MINDFuL trial has been completed, and feedback from the FDA supports moving to a registrational study for Alzheimer's patients with inflammation biomarkers [2]. - XPro1595 is a next-generation selective soluble TNF inhibitor aimed at restoring immune homeostasis in the brain without affecting transmembrane TNF or TNF receptors [3][10]. Group 2: Webinar Details - The webinar will cover three main topics: results from the MINDFuL trial, the design of the registrational study, and the strategic roadmap to Phase 3, including global partnership opportunities [3][4][5]. - Featured speakers include Dr. Michael Woodward and Dr. Sharon Cohen, both recognized experts in Alzheimer's disease research [6]. Group 3: Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system, with three product platforms: CORDStrom™, XPro™, and INKmune® [11].

Core Insights - INmune Bio Inc. is hosting a webinar on February 26, 2026, to discuss CORDStrom for treating recessive dystrophic epidermolysis bullosa (RDEB) and present new data from the MissionEB clinical study [1][2] Group 1: CORDStrom Overview - CORDStrom™ is a patent-pending cell medicine made from aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) designed for injection or infusion [4] - The platform utilizes proprietary techniques for screening, pooling, and expanding hucMSCs, allowing for the creation of off-the-shelf medicines for complex inflammatory and autoimmune diseases [4] - CORDStrom™ products aim to provide consistent, scalable, and affordable cellular medicines with optimized characteristics for various indications [4] Group 2: Clinical Trial Insights - The upcoming webinar will highlight the systemic disease-modifying capabilities of CORDStrom™ in RDEB patients, contrasting it with current standard-of-care options that focus on topical treatments [2] - Key clinical benchmarks to be discussed include improvements in the EBDASI (EB Disease Activity and Scarring Index), nutritional and weight gain data in pediatric patients, reductions in pain and itch, and enhancements in quality of life [6] - Principal investigators, including Dr. Anna Martinez and Prof. Mark Lowdell, will provide insights from the MissionEB study, emphasizing the systemic nature of RDEB and the scientific rationale for using CORDStrom™ [6][3] Group 3: Company Background - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system, with three product platforms: CORDStrom™, XPro™, and INKmune® [7] - The company is publicly traded on NASDAQ under the ticker INMB and is dedicated to advancing therapies for various diseases [7]

Core Insights - The FDA has provided regulatory clarity on INmune Bio's integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer's Disease, confirming CDR-SB as the sole primary endpoint for registrational development [1][2][5] FDA Alignment Highlights - The FDA's feedback validates the enrichment-led design and primary endpoint, supporting the scientific and clinical strategy of the company [2][5] - The Phase 2b study will include approximately 300 participants over a nine-month evaluation period, utilizing the Early Mild Alzheimer's Cognitive Composite (EMACC) and plasma p-tau-217 as key measures [4][5] - CDR-SB will serve as the sole primary efficacy endpoint for the Phase 3 segment, aligning with its established role in Alzheimer's therapies [5][6] Integrated Phase 2b/3 Framework - The FDA indicated no objection to the integrated Phase 2b/3 design under a single master protocol, with the full program expected to enroll around 1,000 participants [5] - The Phase 3 portion will evaluate XPro1595 over an 18-month period [5] - An exploratory cohort of non-enriched early Alzheimer's patients will be included to assess broader effects, comprising approximately 20% of total enrollment [5] XPro™ Overview - XPro™ is a next-generation TNF inhibitor that selectively neutralizes soluble TNF, potentially reducing neuroinflammation and improving cognitive function in neurological diseases [8] Company Background - INmune Bio Inc. is a late-stage clinical biotechnology company focused on developing treatments targeting the innate immune system, with three product platforms including XPro™ [9]

Core Viewpoint - INmune Bio has submitted a pre-submission package for CORDStrom to the UK's Medicines and Healthcare Products Regulatory Agency, aiming to expedite the Marketing Authorization Application process for a potential systemic therapy for a severe skin disease [1] Group 1: Regulatory Engagement - The pre-submission package is intended to gather targeted scientific, regulatory, and procedural feedback, which may streamline the full Marketing Authorization Application process [1] - The company plans to file a full Marketing Authorization Application with MHRA after receiving pre-submission feedback, expected by mid-summer 2026 [1] Group 2: Manufacturing Readiness - INmune Bio has completed three commercial pilot-scale manufacturing runs at the CGT Catapult facility, demonstrating consistent product characteristics that met predefined release criteria [1] - These manufacturing results confirm the company's readiness for commercial supply [1] Group 3: Future Regulatory Submissions - Following the MHRA submission, the company anticipates subsequent regulatory submissions in the EU and U.S. in Q4 2026, contingent on regulatory alignment and manufacturing readiness [1]

Core Insights - INmune Bio Inc. has submitted a pre-submission package for CORDStrom™ to the UK Medicines and Healthcare Products Regulatory Agency (MHRA), aiming to expedite the approval process for a potential systemic therapy for recessive dystrophic epidermolysis bullosa (RDEB) [1][3] - CORDStrom is being developed as a disease-modifying treatment for RDEB, a rare genetic disorder affecting approximately 1 in 1 million births globally, with no approved systemic therapies currently available [2][5] - The company has completed three commercial pilot-scale manufacturing runs, confirming readiness for commercial supply and plans to file a full Marketing Authorization Application (MAA) with MHRA by mid-summer 2026 [3][4] Regulatory and Legislative Context - CORDStrom has received Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation in the U.S., which are significant due to the recent reauthorization of the FDA's Rare Pediatric Disease Priority Review Voucher (PRV) program through September 30, 2029 [4][5] - The reauthorization of the PRV program strengthens incentives for developing therapies for rare pediatric diseases, potentially benefiting INmune Bio as it prepares for a Biologics License Application (BLA) submission later this year [5] Product and Technology Overview - CORDStrom™ is a patent-pending cell medicine utilizing pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs), designed for injection or infusion to treat complex inflammatory and autoimmune diseases [7] - The platform allows for the creation of indication-specific products that can be optimized for various therapeutic characteristics, addressing severe unmet needs in RDEB patients [7][8]

Core Insights - INmune Bio, Inc. has made significant progress in 2025, focusing on developing therapies for neuroinflammatory and immunologic diseases, particularly through its programs XPro™ for Alzheimer's disease and CORDStrom™ for Recessive Dystrophic Epidermolysis Bullosa (RDEB) [1][10] CORDStrom™ Program - CORDStrom™, an allogeneic umbilical cord-derived mesenchymal stromal cell therapy for RDEB, achieved substantial progress in 2025, including successful completion of three commercial pilot-scale runs in preparation for regulatory filings [2] - The company plans to submit a Marketing Authorization Application (MAA) to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) by mid-summer 2026, followed by a Biologics License Application (BLA) to the U.S. FDA towards the end of 2026 [2][3] XPro™ Program - XPro™ demonstrated potential as a differentiated therapy for Alzheimer's disease, with a Phase 2 study (MINDFuL) revealing meaningful signals in a predefined subpopulation of amyloid-positive early AD patients [4][6] - In this subpopulation, XPro™ showed an effect size of 0.27 on the EMACC cognitive scale after 6 months, which compares favorably to the effect sizes of approved anti-amyloid therapies [6][7] - The results support XPro's proposed mechanism of action, which involves selectively inhibiting soluble TNF to reduce neuroinflammation while preserving beneficial TNF signaling [8] Financial Position - As of September 30, 2025, INmune Bio had approximately $27.7 million in cash and cash equivalents, positioning the company well for continued execution and enabling it to achieve key milestones through year-end 2026 [9]

Core Insights - INmune Bio, Inc. has published an overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies, particularly focusing on its CORDStrom™ platform, in the journal Cytotherapy [1][2] Group 1: Research and Development - The article reviews current knowledge and identifies critical gaps in MSC therapies to enhance their development, including topics like systemic delivery and in vivo persistence [2] - CORDStrom™ is initially being developed for recessive dystrophic epidermolysis bullosa (RDEB), with plans to file a Biologics License Application (BLA) and Marketing Authorization Application (MAA) in 2026 [3] - The publication provides important scientific background for the future development of the CORDStrom™ platform, which may significantly impact various indications such as inflammation and wound healing [3] Group 2: CORDStrom™ Platform - CORDStrom™ is a patent-pending cell medicine made from aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) designed for injection or infusion [4] - The platform utilizes proprietary techniques for screening, pooling, and expanding hucMSCs, aiming to create consistent, scalable, and affordable cellular medicines for complex diseases [4] - CORDStrom™ products are designed to be indication-specific, optimizing characteristics for anti-inflammatory and immunomodulatory effects [4] Group 3: Company Overview - INmune Bio Inc. is a publicly traded clinical-stage biotechnology company focused on developing treatments targeting innate immune dysfunction [5] - The company's pipeline includes CORDStrom™, DN-TNF Platform (XPro™/XPro1595) for neuroinflammatory conditions, and INKMune™ for cancer treatment [7]

Core Insights - INmune Bio, Inc. announced new neuroimaging data from its Phase 2 MINDFuL trial of XPro1595 in early Alzheimer's disease patients with elevated neuroinflammation, to be presented at the 18th Clinical Trials on Alzheimer's Disease conference [1][2] Group 1: Clinical Trial Results - The new analyses support XPro1595's mechanism of selectively neutralizing soluble TNF (sTNF), validating the strategy of targeting inflammation-driven Alzheimer's disease, which represents a significant unmet need [2][9] - PerpPD+ MRI imaging analysis indicated a trend towards slowed neurodegeneration progression in patients receiving XPro1595, particularly in those with early Alzheimer's and high inflammatory burden [3][8] - Findings suggest reduced cortical disarray, an imaging hallmark of neurodegeneration, reinforcing previously reported improvements across biological, cognitive, and neuropsychiatric endpoints [4][5] Group 2: Future Developments - Additional MRI analyses from the MINDFuL trial are ongoing and will provide a broader understanding of XPro1595's impact on gray- and white-matter integrity in Alzheimer's patients [7] - The totality of data generated to date positions XPro1595 as a promising first-in-class disease-modifying therapy for Alzheimer's patients with elevated neuroinflammation, a population with limited treatment options [9][10] Group 3: Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting innate immune dysfunction to combat diseases [11] - The company's pipeline includes XPro1595, an inhibitor of soluble TNF that aims to restore healthy innate immune function without the immunosuppressive effects of traditional TNF inhibitors [10]