Management to host conference call and webcast at 4:30 pm ET on that day Boca Raton, Florida, March 24, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company, today announced that it will host a conference call on Monday, March 30th, 2026 at 4:30pm EDT to discuss results for its year ended December 31, 2025, and to provide a corporate update. Conference Call Information To participate in this event, dial approximately 5 to 10 minutes b ...

Plenary Presentation Highlights How Aligning Inflammatory Biomarker Enrichment with Mechanism of Action Offers a Blueprint for Success in Alzheimer’s Drug Development Boca Raton, FL, March 19, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (“INmune Bio” or the “Company”), a clinical-stage inflammation and immunology company, today announced that Malú Gámez Tansey, Ph.D., Professor of Neurology at the Stark Neuroscience Research Institute at Indiana University School of Medicine, will feature the Co ...

Core Insights - INmune Bio is a clinical stage biotechnology company focused on developing therapies for neuroinflammation in neurodegenerative diseases, with its lead program XPro1595 being a first-in-class selective soluble TNF inhibitor [1] Group 1: Clinical Development - The objective of the recent webinar was to demonstrate how the clinical results from the Phase II MINDFuL trial will inform the registration program for XPro1595 [2] - A productive end of Phase II meeting with the FDA confirmed alignment on the core elements of the Phase III registration program [2] Group 2: Trial Design and Outcomes - The MINDFuL trial was a strategic proof-of-concept study designed to address two critical variables: biologic signal and patient selection in Alzheimer's disease [3] - The trial aimed to determine if XPro1595 shows biologic activity in patients with Alzheimer's disease and inflammation biomarkers, and whether the right patient population for a registration trial could be identified [3] - Results indicated that XPro1595 demonstrated biologic activity and validated a precision medicine roadmap for the Phase III registration program [3]

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]

Summary of INmune Bio Conference Call on February 26, 2026 Company and Industry Overview - **Company**: INmune Bio (NasdaqCM:INMB) - **Industry**: Cellular therapy, specifically targeting Recessive Dystrophic Epidermolysis Bullosa (RDEB) Key Points and Arguments Clinical Trial Updates - **Mission EB Phase III Clinical Trial**: Focused on CORDStrom for treating RDEB, a severe skin condition characterized by fragile skin and blistering [1][2] - **CORDStrom**: A pooled umbilical cord-derived mesenchymal stromal cell product, showing promise as a disease-modifying therapy for RDEB [4][5] - **Trial Results**: - 30 patients completed the trial with no serious adverse events reported [14] - Significant reductions in itch: 21% at 3 months and 26% at 6 months [15] - Pain reduction: Average pain improved by 22% and worst pain by 28% [16] - Sustained improvements in skin scores observed at 6 months [17] Mechanism of Action - **CORDStrom's Mechanism**: Suppresses inflammation, enhances wound healing, and potentially reduces fibrosis [5][27] - **Cytokine Release**: CORDStrom secretes various cytokines that may facilitate the transition from pro-inflammatory M1 macrophages to anti-inflammatory M2 macrophages, promoting healing [36][42] Market Opportunity - **Current Treatments**: Existing treatments like Filsuvez and Vyjuvek are limited in effectiveness and accessibility, highlighting the urgent need for systemic anti-inflammatory therapies [10][11][12] - **Commercialization Path**: INmune Bio is preparing for market entry with plans for regulatory submissions and scaling up production [44][45][48] Future Directions - **Open Label Study**: A new study, Mission EB Deliver, will treat all children who participated in the trial, with plans for ongoing data collection [22] - **Potential for Other EB Types**: Discussions are ongoing about the applicability of CORDStrom for other types of EB, such as junctional EB [65][75] Additional Important Information - **Patient Feedback**: Qualitative data from parents and children indicate significant improvements in quality of life, with many reporting less pain and better overall well-being [19][20][21] - **Regulatory Engagement**: Continuous communication with regulatory bodies like the FDA and MHRA to ensure compliance and facilitate approval processes [45][46] - **Combination Therapy Potential**: CORDStrom is seen as a critical component of a broader treatment strategy for EB, potentially used alongside other therapies [72][74] This summary encapsulates the pivotal updates and insights shared during the conference call, emphasizing the potential impact of CORDStrom on the treatment landscape for RDEB and the company's strategic direction moving forward.

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]