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BOCA RATON - INmune Bio Inc. (NASDAQ:INMB), a $124 million market cap biotech company, announced Monday that its Phase 2 MINDFuL trial of XPro in early Alzheimer’s disease patients showed mixed results, with the primary cognitive endpoint not met in the overall study population but positive outcomes observed in a predefined subgroup. The announcement comes as the stock has experienced a 14% decline over the past week, according to InvestingPro data.
The trial evaluated XPro, a selective soluble TNF inhibitor, in 208 participants with early-stage Alzheimer’s disease. While the modified intent-to-treat population (n=200) did not achieve the primary cognitive endpoint, a subset of amyloid-positive patients with two or more biomarkers of inflammation (n=100) demonstrated benefits in cognitive, behavioral, and biological measures. InvestingPro analysis shows the company maintains a strong liquidity position with a current ratio of 2.64, indicating sufficient resources to continue its research programs.
In this inflammatory subgroup, XPro showed an effect size of 0.27 on the primary endpoint, the Early Mild Alzheimer’s Cognitive Composite (EMACC), and an effect size of -0.24 on the Neuropsychiatric Inventory. The treatment also demonstrated a biological benefit on pTau217 levels, a blood biomarker of Alzheimer’s pathology.
"These results highlight the potential of XPro," said RJ Tesi, MD, CEO of INmune Bio, in the press release statement.
The drug was well-tolerated with no instances of ARIA-E or ARIA-H, side effects commonly associated with other Alzheimer’s treatments. The most frequent adverse events were injection site reactions, which occurred in 80% of patients receiving XPro compared to less than 20% in the placebo group.
The company plans to present additional analyses at the Alzheimer’s Association International Conference in Toronto (July 27-31, 2025) and will submit for Breakthrough Therapy designation with the FDA. INmune Bio also intends to schedule an End-of-Phase 2 meeting with regulators in Q4 2025 to define the path for a pivotal trial.
XPro represents a novel approach to Alzheimer’s treatment by targeting neuroinflammation rather than directly addressing amyloid or tau pathology. Despite recent stock volatility, analysts maintain optimistic price targets ranging from $20 to $30, suggesting significant potential upside from current levels. For deeper insights into INMB’s financial health and growth prospects, investors can access comprehensive analysis through InvestingPro’s detailed research reports, which cover over 1,400 US stocks.
In other recent news, INmune Bio has secured agreements with institutional investors to raise approximately $19 million through a registered direct offering. The funds, derived from selling 3,000,000 shares at $6.30 each, will be used for working capital and general corporate purposes. In addition to this financial development, INmune Bio is preparing to release top-line results from its Phase 2 MINDFuL trial for early Alzheimer’s disease. The company plans to host a conference call to discuss the data, which could have significant implications for its treatment pipeline. This trial evaluates the XPro treatment, focusing on patients with biomarkers of elevated neuroinflammation.
Furthermore, recent research presented at a conference highlighted XPro’s potential in reducing Alzheimer’s-like pathology in mice following traumatic brain injury. This adds to the growing interest in XPro as a promising treatment option. In light of these developments, Lucid Capital Markets has initiated coverage on INmune Bio with a Buy rating, citing the urgent need for effective Alzheimer’s treatments. The analyst firm set a price target of $25, reflecting optimism about the company’s future prospects.
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