INmune Bio presented new Phase 2 grey‑matter imaging data from its MINDFuL trial of XPro1595 at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Diego on December 1–2 2025. The data were generated using the PerpDP+ MRI technique and focus on patients with early Alzheimer’s disease and elevated neuroinflammation.
The PerpDP+ analysis shows a trend toward slowed neurodegeneration in the dose‑compliant subgroup, reflected by reduced cortical disarray—a hallmark of neurodegeneration. Earlier MINDFuL reports already highlighted cognitive, behavioral, and biomarker benefits in the high‑inflammation subgroup, and the new imaging data reinforce the hypothesis that selective soluble TNF neutralization can interrupt the neurodegenerative cascade.
Dr. CJ Barnum, INmune Bio’s Head of Neuroscience, noted that the PerpDP+ data “represent one of the clearest signals yet that selectively neutralizing soluble TNF can interrupt the neurodegenerative cascade at its micro‑structural root in AD driven by inflammation.” President and CEO David J. Moss added that the subgroup findings “strongly suggest XPro™ will benefit the trial’s target patient population and provide a robust rationale for upcoming end‑of‑Phase 2 discussions with the FDA, EMA, and MHRA.”
In its most recent quarterly earnings, INmune Bio beat expectations with an EPS of –$0.24 versus the consensus estimate of –$0.31, a beat of $0.07. The improvement was driven by disciplined cost management and a modest reduction in R&D spend relative to the prior year, despite the company’s ongoing clinical investments. Cash and cash equivalents stood at $27.7 million, underscoring the need for additional funding to sustain the program and other pipeline assets. The market reacted strongly, with the company’s shares climbing 17.57% over the week leading up to the conference, largely driven by the positive imaging data and the company’s clear path toward regulatory engagement.
INmune Bio plans to present additional MRI analyses in 2026 to broaden the view of XPro1595’s impact on both grey‑ and white‑matter integrity. The company also anticipates an end‑of‑Phase 2 meeting with the FDA in Q1 2026, positioning the drug for potential regulatory approval. The data strengthen the company’s strategy of targeting neuroinflammation in Alzheimer’s, a large and underserved patient population, while the company continues to develop complementary platforms such as CORDStrom for RDEB and INKmune for oncology.
The combination of a promising clinical signal, disciplined financial performance, and a clear regulatory roadmap positions INmune Bio to advance XPro1595 toward disease‑modifying status, while the company’s diversified pipeline and focus on unmet medical needs reinforce its long‑term growth prospects.
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