BOCA RATON, Fla. - INmune Bio Inc. (NASDAQ: INMB), a clinical-stage biotechnology company, announced initial results from its ongoing Phase I/II trial for INKmune™, a Natural Killer (NK) cell therapy for men with metastatic Castration-Resistant Prostate Cancer (mCRPC). The first patient cohort has completed treatment with indications of a positive safety profile and immunologic effects.
The CaRe PC trial, which is examining the efficacy of INKmune™, has shown that the first three patients experienced changes in NK cell phenotype and function. Notably, two of these patients had an increase in activated NK cells, and all three demonstrated enhanced NK cell function for over 40 days following the last infusion. Additionally, one patient exhibited a 21% decrease in Prostate-Specific Antigen (PSA), a marker of prostate cancer progression, in correlation with improved NK cell activity.
INKmune™ is a novel treatment designed to convert a patient’s resting NK cells into memory-like NK cells (mlNK cells) that can persist for over 100 days and function in the tumor microenvironment without the need for pre-medication or additional therapies. It is administered intravenously as an outpatient procedure.
The trial has recently completed dosing in its second cohort and is preparing to initiate the third cohort with increased dosages. Eight clinical sites are part of this study, with further results anticipated from the higher dose cohorts.
The company emphasizes that while these findings are promising, the trial is still in early stages, and there is no guarantee of specific outcomes. INmune Bio's portfolio also includes other clinical-stage therapies targeting the innate immune system for various diseases.
This report is based on a press release statement from INmune Bio Inc. and reflects the company's current progress in its clinical trials. The therapies mentioned, including INKmune™, are under investigation and have not yet received approval from the U.S. Food and Drug Administration or any other regulatory body.
In other recent news, INmune Bio Inc., a clinical-stage biotechnology company, has made significant strides in its Phase II trial for Alzheimer's disease. The trial, which utilizes the novel cognitive measure EMACC, has shown a highly significant correlation with the Clinical Dementia Rating-Sum of Boxes, an accepted Alzheimer's trial endpoint. This development was supported by an independent analysis and received positive assessments from both Scotiabank and BTIG, which maintain Buy ratings on INmune Bio shares.
In addition to its Alzheimer's research, INmune Bio reported progress in its INKmune memory-like natural killer cell oncology platform during its second quarter 2024 earnings call. The company also successfully raised approximately $14.5 million in gross proceeds, ensuring sufficient funds for operations until 2025.
Furthermore, INmune Bio secured approximately $13 million from a registered direct offering, involving 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. 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) garners attention for its promising early-stage clinical trial results for INKmune™, investors and industry observers are closely monitoring the company's financial health and stock performance. According to recent data from InvestingPro, INmune Bio holds a market capitalization of $107.54 million, reflecting its position as a niche player in the biotechnology industry.
The company's financials show a challenging landscape, with revenue for the last twelve months as of Q2 2024 at a mere $0.09 million, a significant decline of 69.53% from the previous period. The gross profit margin remains at 100%, indicating that while revenues are low, the cost of goods sold is negligible. However, the operating income margin is deeply negative at -44457.65%, underscoring the substantial operating losses incurred by the company.
InvestingPro Tips highlight that INmune Bio is trading near its 52-week low, with the stock price having taken significant hits over various time frames, including a 31.06% decrease over the last month. These movements underscore the stock's volatility, an important consideration for potential investors. Additionally, the company's liquid assets exceed its short-term obligations, suggesting a level of financial stability in meeting immediate liabilities.
For those considering investment in INmune Bio, it's noteworthy that analysts do not anticipate the company will be profitable this year, and net income is expected to drop. The company also does not pay a dividend to shareholders, which may influence investment decisions for those seeking income-generating stocks.
For more detailed analysis and additional InvestingPro Tips on INmune Bio Inc., investors can visit https://www.investing.com/pro/INMB, where over ten tips are available, offering a deeper dive into the company's financials and market performance.
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