VANCOUVER, Canada – Clearmind Medicine Inc. (NASDAQ:CMND), (CSE:CMND), (FSE:CWY), a biotechnology company specializing in psychedelic therapeutics, today announced that the Israeli Ministry of Health has granted approval for the company’s Phase I/IIa clinical trial. This study will examine the safety and effectiveness of CMND-100, an oral capsule containing MEAI’s proprietary molecule (5-methoxy-2-aminoindan), for patients with alcohol use disorder (AUD).
The study, led by Professor Mark Weiser, MD, at Sheba Medical Center in Ramat Gan, Israel, will evaluate the tolerability, safety and pharmacokinetics of CMND-100 in both healthy volunteers and subjects with AUD. The clinical trial also includes sites in the United States at the Department of Psychiatry at Yale Medical School and Johns Hopkins University School of Medicine.
The primary endpoint of CMND-100 is to determine the tolerated dose and characterize the safety profile of single and repeat doses in study participants. Secondary objectives include assessing preliminary effectiveness in reducing drinking habits and cravings in people with moderate to severe AUD.
CMND-100’s active ingredient, MEAI, is a psychoactive substance that is not hallucinogenic and has demonstrated potential in preclinical studies to reduce the desire to drink alcohol. MEAI acts on the serotonergic system, which is involved in the regulation of alcohol consumption and alcohol dependence, and interacts with alpha-2 adrenergic receptors and monoamine transporters associated with dopamine, norepinephrine and serotonin.
This approval marks an important milestone for Clearmind on its path to becoming a clinical-stage pharmaceutical company. Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine, expressed enthusiasm for the study’s potential to address the global need for innovative addiction treatments.
Clearmind is committed to developing regulated medicines based on psychedelic compounds and owns an intellectual property portfolio consisting of fifteen patent families. The company’s shares are traded on several exchanges, including Nasdaq, the Canadian Securities Exchange and the Frankfurt Stock Exchange.
The information in this article is based on a press statement from Clearmind Medicine Inc.
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Clearmind Medicine Inc. (NASDAQ:CMND) is navigating challenging market conditions, as evidenced by its latest financials and stock performance. As of the trailing twelve months ending in the fourth quarter of 2023, the company’s market capitalization is just $5.81 million, reflecting its small-cap status in the biotech sector. Despite the excitement surrounding the clinical trial approval, it’s important to note that the company’s shares have experienced significant volatility, with a return of 37.78% over the past week and an impressive return of 87.88% over the past month. Such stock price swings are not uncommon for companies in the early stages of drug development, where investor sentiment can change quickly based on clinical trial results and regulatory news.
Investors should also know that Clearmind Medicine’s price to book ratio for the trailing twelve months is 5.93, which suggests the stock is trading at a premium to the company’s book value. This may be a consideration for value-oriented investors. Moreover, the company does not pay dividends to shareholders, which is typical for growth-oriented biotech companies that prefer to reinvest any profits into research and development.
For those interested in taking a deeper dive into a company’s financial health and future prospects, InvestingPro offers additional information. Notably, Clearmind Medicine has more cash than debt on its balance sheet, which is a positive sign for its financial strength. However, the company is burning through cash quickly and has not been profitable in the last twelve months, which is a common problem for early-stage biotech companies that have yet to commercialize their products.
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