BOCA RATON, Fla. – INmune Bio Inc. (NASDAQ: INMB), a clinical-stage biotechnology company, announced today that its Phase II trial for Alzheimer's Disease (AD), utilizing the novel cognitive measure EMACC, has shown a highly significant correlation with the Clinical Dementia Rating-Sum of Boxes (CDR-SB), an accepted AD trial endpoint. The independent analysis confirmed this correlation, supporting the use of EMACC as a primary endpoint in the AD02 trial.
The EMACC, developed in partnership with biopharma and neuropsychologist Judith Jaeger, Ph.D., in 2017, aims to objectively measure cognitive changes in early AD patients. It has demonstrated a strong statistical correlation (p
C.J. Barnum, Ph.D., VP of Neuroscience at INmune, stated that the trial's design elements significantly reduce the risk compared to traditional AD drug development trials. The company expects to complete enrollment soon and release topline data about six months after the last patient's enrollment.
EMACC was first reported by Biogen (NASDAQ:BIIB) in 2021 and has been associated with biological markers of inflammation in AD studies. INmune Bio's XPro™, a next-generation inhibitor of tumor necrosis factor, is in clinical trials and may potentially reduce neuroinflammation, improving cognitive function in neurologic diseases.
The company's focus is on treatments that target the innate immune system, with product platforms in clinical trials for cancer, early Alzheimer's disease, and treatment-resistant depression. While these trials are in early stages and outcomes cannot be assured, this recent analysis confirms EMACC's suitability as a primary endpoint for early AD studies.
This report is based on a press release statement from INmune Bio Inc.
In other recent news, INmune Bio Inc. secured approximately $13 million from a registered direct offering, which involved the sale of common stock and corresponding warrants to both new and existing institutional investors, as well as company insiders. The funds raised are anticipated to be used for working capital and general corporate purposes. A.G.P./Alliance Global Partners (NYSE:GLP) served as the sole placement agent for the offering.
Additionally, Scotiabank initiated coverage on INmune Bio with a Sector Outperform rating, underlining the potential of the company's lead drug candidate, XPro, currently in clinical development for Alzheimer's disease. The bank's analysis is based on compelling evidence from medical literature and early clinical results.
Furthermore, INmune Bio reported significant progress in its INKmune memory-like natural killer cell oncology platform and its ongoing Phase II Alzheimer's study during its second quarter 2024 earnings call. The interim analysis of the Phase II trial of XPro in early Alzheimer's disease showed encouraging results. The company also successfully raised approximately $14.5 million in gross proceeds, ensuring sufficient funds for operations until 2025. These are recent developments that underline INmune Bio's commitment to advancing its clinical trials and bringing innovative treatments to the market.
InvestingPro Insights
As INmune Bio Inc. (NASDAQ: INMB) continues to make strides in its clinical trials for Alzheimer's Disease, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, INmune Bio holds a market capitalization of $106.41 million, reflecting its position as a niche player in the biotechnology industry. The company's stock has experienced significant volatility, with a price total return of -51.51% year-to-date as of the latest data, underscoring the stock's recent challenges in the market.
InvestingPro Tips highlight that INmune Bio's stock has taken a substantial hit over the past month, with a decline of -23.42%, and the company is trading near its 52-week low, at 36.57% of the high. Analysts are cautious, noting a projected sales decline and anticipating that the company will not be profitable this year. Despite these short-term challenges, INmune Bio maintains a strong liquidity position, holding more cash than debt on its balance sheet, which could provide some resilience amidst market fluctuations.
For investors seeking a more comprehensive analysis, there are additional InvestingPro Tips available, providing deeper insights into INmune Bio's financial metrics and stock performance. These tips can be accessed through the InvestingPro platform, which includes a total of 14 tips for INMB, offering a more detailed view of the company's investment potential.
InvestingPro's fair value estimate for INMB stands at $5.5, which is in line with the previous close price of $5.39. This fair value estimate offers investors a benchmark for assessing the stock's current trading price and potential future movements.
The company's next earnings date is set for October 30, 2024, which will be a pivotal moment for investors to assess INmune Bio's financial performance and the progress of its clinical trials. With the company's focus on innovative treatments for Alzheimer's Disease and other serious conditions, the outcomes of these trials could have significant implications for the stock's future trajectory.
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