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INmune Bio Inc Issues Shareholder Letter Reviewing 2025 Milestones and Outlining 2026 Strategic Initiatives
Globenewswire· 2026-01-27 14:25
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]