Weakness in Clearmind Medicine Inc. (NASDAQ: CMND) (CSE: CMND) stock is less a trend than it is an opportunity. In fact, the decline in value over the past two weeks may be well overdone, noting that a series of milestones reached, patents earned, and valuable partnerships ideally position CMND to have its best year in 2023.
Driving that proposition is Clearmind Medicine nearing its goal of delivering a first-to-market psychedelic-based treatment to market, with its lead candidate, MEAI, targeting a $395 alcohol-substitute product market. That product isn't just for those wanting an alternative to alcohol; it can be a lifesaver for those with Alcohol Use Disorder (AUD) market, a condition that claims millions of lives per year worldwide.
Thus, referring to the potential of CMND's treatment candidate as only an alcohol alternative is under-appreciating its vast revenue-generating opportunity. While MEAI does fit that label, it's more accurate to call it a therapeutic that uses cutting-edge psychedelic-based compounds to treat a debilitating physical and social condition. In other words, it's not an alternative taste option, say from Anheuser Busch (NYSE: BUD) to Molson Coors (NYSE: TAP). Instead, it's a complex and proprietary-based formulation that, in pre-clinical trials, showed an ability to mitigate AUD: a condition that encourages a vicious cycle of binge drinking by circumventing specific neural pathways that lead to sensible behavioral decisions.
CMND believes its candidate can effectively change that dynamic.
Video Link: https://www.youtube.com/embed/kzuLCNBGXUE
Ushering In A New Class of Therapeutics: Psychedelics
There are reasons for the company to be optimistic about its prospects. Foremost is that its MEAI treatment candidate is showing promise to potentially innervate neural pathways such as 5-HT1A, which CMND and many in the neurological community believe are linked to facilitating better decisions - especially those caused by addictions. Those beliefs are supported by anecdotal reports and pre-clinical in-vivo results indicating the self-limiting property of MEAI, an important distinction compared to traditional "treat the symptoms, not the conditions" treatments. Notably, CMND is leveraging data that's already showing that 5-HT1A receptors can be controlled, which, when fully validated, would likely translate to excellent news for those with AUD and other addictions.
For many, in other words, MEAI 5-Methoxy-2-aminoindane can be more than a treatment; it can be a safe-to-use lifesaver. Unlike many traditional pharmaceuticals, the psychedelic-based formulation shows no signs of adverse reactions or side effects. In addition to a favorable safety profile, the most wanted benefit of MEAI is that pre-clinical data indicate that CMND's psychoactive molecule may effectively treat AUD by exerting a euphoric alcohol-like experience that CMND believes will translate to a reduced desire to consume alcoholic beverages. Data to date supports that thesis.
In its non-human pre-clinical trials, CMND trained groups of mice to consume alcohol for five weeks. The groups were then given a daily dose of MEAI with intermittent access to alcohol and water. After two weeks, researchers found a significant reduction in alcohol consumption in mice receiving MEAI, and the untreated control group showed no significant decrease in alcohol consumption. Furthermore, no adverse side effects or treatment-related histological changes were observed among all MEAI treatment groups compared to control naive and vehicle animals in all the examined organs.
The better news is that Clearmind expects it can enhance these already impressive results. Those include monitoring specific characteristics that could consist of the ability for self-administration to provide trauma therapy time to work, support of reduction or abstinence goals, an immediate reduction in alcohol use, and no expected adverse interactions with other drugs. More good news on its development is that although MEAI is created utilizing psychedelics, it is non-hallucinogenic and, most important to approval considerations, shows no indications of worsening existing health issues.
While all that's good, the potentially best news from a company and investors perspective: with the preliminary work completed, CMND is closer than ever to clearing MEAI's path to market.
Milestones Reached Expose Value Proposition
That's a result of significant development milestones being reached in the previous year. Those include a series of world-class innovations and partnerships that have done more than differentiate CMND from the competitive landscape; they have made them a leading biotech company in the psychedelic space. Better still, when it comes to its initial targeted indication of AUD, no other company appears close to being a serious competitive threat. Yes, industry behemoths like Pfizer (NYSE: PFE) and Johnson & Johnson (NYSE: JNJ) are exploring the opportunities but aren't targeting AUD. They are, however, validating the potential for psychedelic-based compounds to treat numerous conditions.
Needless to say, having a competitive distance in the AUD market opportunity is a CMND benefit. But that competitive distance can also become a financial windfall for companies ushering in new fields of medical treatment. Considering that an approved proprietary CMND-100, 5-methoxy-2-aminoindane-based treatment (MEAI) could provide relief to the millions worldwide suffering from AUD, CMND looks ideally positioned to exemplify that phenomenon.
Strengthening that consideration is that patient resistance to using MEAI may be mitigated since it could provide effective and well-tolerated relief compared to traditional pharmaceuticals and treatments that are sometimes more debilitating than the condition itself. As noted, the most excellent news is that CMND is getting closer to getting MEAI to the market.
Clearmind Medicine is nearing the more formal clinical stage after completing the non-clinical studies required by the FDA, including conducting a constructive pre-IND meeting and having supportive pre-clinical data. Just as important, CMND has the capital to accelerate its clinical ambitions. While no timeline has been provided for a first-in-human trial, with preliminaries completed and risks of treatment expected to be uneventful, dosing trials could be a potential late 2023 proposition.
Partnerships, Data, Expertise
Clearmind has taken steps to facilitate that happening. They recently announced the appointment of a special advisor, Nicholas Kadysh, to support the regulatory aspect of the development of MEAI as an alcohol substitute. This program is expected to strengthen the company's prospects of securing a significant treatment market opportunity and maximize its chances of generating near-term revenues. There's more empowering CMND's path to market.
Clearmind is also leveraging the strength of strategic partnerships, including those with leading research and medical centers like Yissum, the technology transfer company of the Hebrew University of Jerusalem, and the Gonda Multidisciplinary Brain Research Center located at Bar Ilan University (Israel) through BIRAD (the Bar-Ilan Research and Development Company). They are also engaged with publicly-traded SciSparc Ltd. (Nasdaq: SPRC), a specialty, clinical-stage pharmaceutical company focused on the development of therapies to treat disorders of the central nervous system, with the two already generating promising results from the combination of MEAI and SciSparc's Palmitoylethanolamide (PEA), the active ingredient of its proprietary CannAmide™.
By the way, those who believe that psychedelic-based therapeutics will face massive regulatory resistance should reconsider. Marketing approvals for CBD-based treatments prove that regulatory agencies aren't prejudiced against innovative methods to treat patients better. That's proven by massive market penetration and user adoption of these compounds generating billions in sales and making a once obscure market mainstream. Remember, despite its "psychedelic-based" classification, MEAI is non-hallucinogenic and shows favorable efficacy and tolerability in pre-clinical trials – key factors reminiscent of CBD's rise to prominence and regulatory fast tracks.
A Mission To Make Medical Treatment History
Thus, precedent and inroads made by the CBD sector show that approved psychedelic-based treatments aren't decades away; they could be years away or, for that matter, a single year or less. That's important to the Clearmind Medicine consideration because they are a part of the ushering-in group. And by focusing on the value inherent to a more than $200 billion "AUD" treatment market, CMND stock is more than ripe for appreciation; with updates expected regularly, it's likely to score it. Remember, too, treating AUD is only the company's initial target.
If trials confirm what's already being shown, the path for CMND to treat other addictions is undoubtedly put into near-term play, putting additional multi-billion dollar treatment markets in the development pipeline crosshairs. So, while 2022 was a milestone-rich year for CMND, 2023 could be catalyst-filled.
In fact, with the start of its innovative MEAI-based drug candidate CMND-100 in human clinical trials nearing, that assumption is more than likely; it's probable. More simply stated, for investors looking for growth through catalysts, Clearmind Medicine, Inc. may offer the right prescription.
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