Alzheimer's Setback Hits INmune Bio Stock, But FDA Hopes Remain

Core Insights - INmune Bio Inc. is experiencing a significant decline in stock price, trading down 59% at $2.14, with a session volume of 23.2 million shares compared to an average of 1.45 million shares [1][5] - The company announced results from its Phase 2 MINDFuL trial for XPro, a selective soluble TNF inhibitor aimed at early Alzheimer's Disease, which showed cognitive benefits in a specific subpopulation despite not meeting the primary endpoint in the modified intent-to-treat population [2][4] Trial Results - The MINDFuL trial enrolled 208 participants, with the primary endpoint being the change in cognition over 6 months measured by the Early Mild Alzheimer's Cognitive Composite (EMACC) [3] - Although the primary endpoint was not met in the mITT group, significant benefits were observed in a subpopulation of patients with two or more biomarkers of inflammation [4] - Key findings indicated a cognitive benefit for XPro over placebo on the primary endpoint EMACC (effect size: 0.27) and a behavioral benefit on the Neuropsychiatric Inventory (effect size: -0.24) [5] Future Plans - The company plans to file for Breakthrough Therapy Designation with the FDA and schedule an End-of-Phase 2 meeting in Q4 2025 to discuss the path for a pivotal trial to support XPro's approval in early Alzheimer's Disease [5] - INmune Bio announced a registered direct offering of 3 million shares at $6.30 per share, aiming for approximately $19 million in gross proceeds to be used for working capital and general corporate purposes [4][5]