INmune Bio Inc. (NASDAQ:INMB) saw its stock plunge 60% in premarket trading Monday, following the release of mixed data from its Phase 2 MINDFuL trial evaluating XPro, a therapy aimed at treating early-stage Alzheimer’s disease.
The biotech company, which specializes in immunological approaches to neurodegenerative conditions, disclosed that XPro did not achieve the primary endpoint in the study’s full analysis group, which included 200 patients in the modified intent-to-treat population.
However, a closer look at a predefined subgroup of 100 patients—those with elevated inflammation markers at the beginning of the trial—revealed more encouraging results. Within this group, XPro showed modest improvements over placebo in several areas, including cognitive function as measured by the Early Mild Alzheimer’s Cognitive Composite (EMACC) (effect size of 0.27), behavioral symptoms via the Neuropsychiatric Inventory (effect size of -0.24), and reductions in pTau217, a blood biomarker associated with Alzheimer’s pathology (effect size of -0.20).
Despite these subgroup gains, the market reacted sharply, likely exacerbated by timing: INmune had just completed a $19 million registered direct offering the day before the data release.
INmune Bio’s CEO, RJ Tesi, maintained a positive outlook, saying that XPro could offer broad benefits for Alzheimer’s patients regardless of age, existing health conditions, medications, or genetic risk factors such as ApoE4.
The company intends to apply for Breakthrough Therapy Designation with the FDA and is targeting an End-of-Phase 2 meeting in Q4 2025 to discuss moving the treatment into a pivotal Phase 3 trial. More detailed findings from the study are expected to be shared at the Alzheimer’s Association International Conference in July 2025.