INmune Bio submits manuscript on Phase 2 Alzheimer’s trial results

Published 29/09/2025, 13:06
INmune Bio submits manuscript on Phase 2 Alzheimer’s trial results

BOCA RATON - INmune Bio, Inc. (NASDAQ:INMB), a clinical-stage biotech company with a current market capitalization of $53.4 million, has submitted a manuscript detailing results from its Phase 2 MINDFuL trial of XPro in early Alzheimer’s disease to npj Dementia, a Nature Portfolio journal, the company announced Monday. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet.

While the overall study did not meet its primary endpoint, the clinical-stage inflammation and immunology company reported promising signals in a prespecified subgroup of patients with both amyloid pathology and high inflammatory burden, referred to as the ADi population. This development comes as InvestingPro analysis shows the company is quickly burning through cash, with a current ratio of 4.2 indicating sufficient short-term liquidity to fund operations.

The manuscript, titled "XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial," highlights findings from testing the company’s selective soluble TNF neutralizer.

Key findings in the biomarker-enriched ADi population included positive trends across cognitive, neuropsychiatric, and biological endpoints. The company also reported a complete absence of amyloid-related imaging abnormalities (ARIA), a side effect commonly associated with amyloid-targeting therapies.

"Data in the subgroup analysis strongly suggests XPro will benefit the trial’s target patient population while also providing a strong rationale for our upcoming end-of-Phase 2 discussions with regulatory authorities," said David Moss, CEO of INmune Bio. The company’s stock has experienced significant volatility, declining over 73% in the past six months, though InvestingPro analysis suggests the stock is currently trading near its Fair Value. Investors can access detailed financial analysis and 8 additional ProTips through InvestingPro’s comprehensive research report.

The company expects to receive regulatory feedback from the FDA in the first quarter of 2026, according to the press release statement.

XPro is a next-generation inhibitor of tumor necrosis factor that neutralizes soluble TNF without affecting trans-membrane TNF or TNF receptors, potentially offering a different mechanism of action than currently available TNF inhibitors.

In other recent news, INmune Bio announced its Q2 2025 earnings, which showed a notable shortfall in both earnings per share (EPS) and revenue expectations. The company reported an EPS of -$1.05, significantly lower than the anticipated -$0.40. Additionally, revenue came in at $0, falling short of the projected $3,000. These results mark a considerable deviation from analyst forecasts and highlight the company’s current financial challenges. The earnings call revealed that the company’s financial performance did not meet market expectations, which could impact investor sentiment. The lack of revenue and the larger-than-expected loss per share are critical factors for stakeholders to consider. These recent developments are crucial for investors monitoring the company’s financial health and future prospects.

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