INmune Bio (NASDAQ: INMB) Phase 2 Alzheimer’s trial results failed to meet the primary endpoint

INmune Bio Inc. (NASDAQ: INMB) stock fell 60% in pre-market trading Monday after the company reported mixed results from its Phase 2 MINDFuL trial of XPro in early Alzheimer’s disease patients.

The clinical-stage immunology company announced that its selective soluble TNF inhibitor failed to meet the primary endpoint in the modified intent-to-treat population of 200 patients. However, the company highlighted positive effects in a predefined subgroup of 100 patients with two or more biomarkers of inflammation at baseline.

In this subgroup, XPro showed modest benefits over placebo on the primary endpoint Early Mild Alzheimer’s Cognitive Composite (EMACC) with an effect size of 0.27, and on the Neuropsychiatric Inventory with an effect size of -0.24. The drug also demonstrated a biological benefit on pTau217, a blood biomarker of Alzheimer’s pathology, with an effect size of -0.20.

The timing of the announcement raised concerns among investors, as INmune Bio had completed a $19 million registered direct offering just one day before releasing these results.

Despite the disappointing primary outcome, INmune Bio’s CEO RJ Tesi expressed optimism about the findings, stating that XPro may benefit Alzheimer’s patients across all age groups regardless of comorbidities, medications, or ApoE4 status.

The company plans to file for Breakthrough Therapy Designation with the FDA and schedule an End-of-Phase 2 meeting in the fourth quarter of 2025 to discuss the path forward for a pivotal trial. Additional analyses from the trial will be presented at the Alzheimer’s Association International Conference in July 2025.