INmune Bio Inc. Announces 2025 Results and Provides Business Update

Core Insights - INmune Bio Inc. has transitioned from a mid-stage clinical company to a late-stage, registration-directed organization, focusing on harnessing the innate immune system to treat inflammatory diseases [4] - The company is preparing for significant regulatory submissions in 2026 and 2027, with two late-stage assets, CORDStrom™ and XPro™, expected to drive value for patients and shareholders [4] Financial Results - For the year ended December 31, 2025, the net loss attributable to common stockholders was approximately $45.9 million, compared to $42.1 million in 2024 [12] - Research and development expenses were approximately $20.7 million in 2025, down from $33.2 million in 2024, while general and administrative expenses increased to approximately $10.3 million from $9.5 million [12] - The company reported cash and cash equivalents of approximately $24.8 million as of December 31, 2025, an increase from $20.9 million in 2024 [17] CORDStrom™ Platform - CORDStrom™ is on track to file a Marketing Authorization Application (MAA) in the UK by mid-summer 2026, followed by anticipated submissions to the EMA and FDA [5] - The platform is designed to treat recessive dystrophic epidermolysis bullosa (RDEB) and has shown systemic disease-modifying capabilities in clinical trials [5][6] XPro™ Platform - XPro™ is advancing towards an adaptive Phase 2b/3 registrational pathway for early Alzheimer's Disease, with alignment achieved with the FDA [5] - The platform has reported zero cases of ARIA (Amyloid-related imaging abnormalities) across all clinical studies, distinguishing it from other therapies [8] Upcoming Events and Milestones - The company has scheduled a face-to-face meeting with the UK's MHRA in mid-May 2026 as part of its regulatory strategy [11] - INmune Bio's MINDFuL trial data was featured at the AD/PD 2026 conference, highlighting the importance of patient selection in clinical trials [5] Operational Readiness - The company has completed three commercial pilot-scale manufacturing runs at its Stevenage facility, ensuring readiness to supply the market upon regulatory approval [11] - INmune Bio estimates that its current cash position provides a runway through Q1 2027, supporting ongoing operations and clinical development [5]