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VIENNA - INmune Bio Inc. (NASDAQ:INMB), a clinical-stage biotechnology company, presented a poster at the annual International Conference on Alzheimer’s and Parkinson’s Diseases and related neurologic disorders, detailing patient demographics and biomarker status for its MINDFuL Phase II trial. The trial investigates XPro™, a treatment for early Alzheimer’s disease (AD), and is expected to report topline results in June 2025.
The MINDFuL trial has enrolled 208 patients diagnosed with mild cognitive impairment (MCI) or mild AD, with an average age of 72. With the company’s next earnings report due on April 30, 2025, investors following this clinical progress can access comprehensive biotech sector analysis through InvestingPro, which offers exclusive insights on over 1,400 stocks, including detailed research reports and real-time financial metrics. To qualify, participants had to meet criteria for at least one biomarker of inflammation, such as high-sensitivity C-reactive protein (hsCRP) above 1.5 mg/L or an APOE ε4 allele. The study randomized patients 2:1 to receive either XPro™ at a dose of 1.0 mg/kg or a placebo once weekly for 23 weeks.
The primary endpoint of the trial is the change from baseline in cognitive scores, measured by the Early and Mild Alzheimer’s Cognitive Composite (EMACC), a tool designed to objectively measure outcomes in early AD clinical trials. Preliminary analyses of blinded baseline data suggest the enrolment of a well-characterized cohort of patients with early AD and biomarkers indicating immune system dysfunction. About 69.2% of the trial’s participants are APOE ε4 carriers, and 64.4% met inclusion criteria for more than one enrichment biomarker.
CJ Barnum, VP of CNS Drug Development at INmune Bio, stated that the enrolled patients’ characteristics are strikingly similar to those in larger Phase III trials for early AD. Secondary endpoints of the study include other cognitive and functional assessments, as well as blood biomarker and neuroimaging outcomes.
INmune Bio’s approach targets the innate immune system to combat diseases like AD. The company is also exploring treatments for conditions such as treatment-resistant depression and cancer. However, it is important to note that the products, including XPro™, are still in clinical trials and have not been approved by regulatory bodies such as the FDA.
The information provided is based on a press release statement from INmune Bio Inc., and the outcomes of the MINDFuL trial remain to be seen upon the release of the topline results in June 2025. While the company currently reports a loss per share of $2.11, analyst price targets range from $20 to $30, reflecting optimism about the company’s potential. For deeper insights into INmune Bio’s financial health and growth prospects, investors can access detailed analysis and 14 additional ProTips through InvestingPro.
In other recent news, INmune Bio Inc. has reported its Q4 2024 earnings, revealing a net loss of $42.1 million, an increase from $30 million in 2023. This rise in net loss is attributed to heightened research and development expenses, which grew to $33.2 million from $20.3 million the previous year, reflecting the company’s commitment to advancing treatments for Alzheimer’s disease and rare genetic conditions. The company raised $29.9 million through the sale of common stock and warrants in 2024, boosting its financial runway through the third quarter of 2025. Analyst Gary Nachman from Raymond James maintained an Outperform rating on INmune Bio, with a $23 price target, emphasizing the anticipated Phase 2 data for the Alzheimer’s trial as a potential catalyst for value creation.
The company is focused on its lead product candidate, XPro, which aims to halt cognitive decline in early Alzheimer’s patients. The top-line data from this trial is expected in June 2025. Additionally, INmune Bio is addressing CMC/BLA requirements for its CORDStrom program, with a Biologics License Application submission now expected in early 2026. The company also highlighted progress in its INKmune product trials for metastatic castration-resistant prostate cancer, with results anticipated in the second and third quarters of 2025.
INmune Bio’s financial strategy includes the potential use of warrants and additional at-the-market offerings to extend its cash runway. The company’s management has expressed confidence in the XPro trial, citing its unique approach using inflammatory biomarker enrichment and a 24-week trial duration. The company’s CEO, R.J. Tessie, emphasized their strategic focus on neuroinflammation, positioning INmune Bio as a potential leader in this emerging field.
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