Company plans to initiate phase I/IIa in-human clinical trials in Q2 2023

Tel Aviv, Israel / Vancouver, Canada, March 16, 2023 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (NASDAQ: CMND) (CSE: CMND), (FSE: CWY) (“Clearmind”), a biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced it has submitted an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”), requesting approval to initiate its first-in-human Phase I/IIa clinical trial with CMND-100 in patients suffering from alcohol use disorder (“AUD”). Pending regulatory approval, the company plans to initiate the CMND-100 trial in Q2 2023.

The active ingredient in CMND-100 is MEAI (5-methoxy-2-aminoindane), a novel psychoactive molecule that has been reported to reduce the desire to consume alcoholic beverages while exerting a euphoric alcohol-like experience. MEAI was found to interact with the serotonergic receptors 5-HT1a, 5-HT2a and 5-HT2b. The serotonergic system is considered to play a key role in the regulation of alcohol intake, reward, preference, and dependence. MEAI was also found to interact with the alpha-2-adrenergic receptors α2A, α2B and α2C and the plasma membrane monoamine transporters for dopamine (DAT), norepinephrine (NET) and serotonin (SERT); these are believed to participate in mediating alcohol drinking behavior, and therefore could constitute important molecular targets for interventions that target drugs of abuse such as alcohol.

“From studies with MEAI, we believe it has potential to break the vicious drinking cycle at the point of the decision to drink more alcohol, by potentially innervating neural pathways that lead to sensible behavior,” said Dr. Adi Zuloff-Shani, Clearmind’s CEO. “Globally, AUD causes many billions of dollars in healthcare costs and millions of deaths each year. The IND submission to FDA, to initiate our clinical trial, is a milestone showing the huge commitment of the Clearmind team to finding a solution to this abusive disorder. We’re thrilled to be a step closer to helping patients with severely unmet medical needs.”

Almost 28 million people over 18 years of age struggled with alcohol use in the U.S. alone in 2020, according to the National Survey On Drug Use And Health. The condition is most severe among the young: in the 18-25 age group, 15.6 percent (or 5.2 million people) had AUD, compared to 10.3 percent (or 22.4 million people) among those over 25.

According to DelveInsight, the AUD treatment market size in the U.S., Italy, Spain, UK, Germany, France and Japan was $564 million in 2021, which is expected to increase 8.8% by 2032. A recent Organization for Economic Co-operation and Development (“OECD”) study showed that member countries lose about $595 billion calculated (by purchasing power parity) per year, resulting from high alcohol consumption (defined as over 12 grams of alcohol daily for women and 18 grams for men). The economic loss results from missing labor days, resulting diseases, and other consequences of excessive alcohol use.

About Clearmind Medicine Inc.

Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The company’s intellectual portfolio currently consists of 13 patent families. The company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on Nasdaq and the Canadian Securities Exchange under the symbol “CMND” and the Frankfurt Stock Exchange under the symbol “CWY.”

For further information visit: https://www.clearmindmedicine.com or contact:

Investor Relations

invest@clearmindmedicine.com

Telephone: (604) 260-1566

General Inquiries

Info@Clearmindmedicine.com

www.Clearmindmedicine.com

FORWARD-LOOKING STATEMENTS:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. In addition, we cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to us. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F filed with the SEC on February 6, 2023. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

The Regulatory affairs and CRO will oversee the Company’s efforts to secure an IND review of MEAI as a potential treatment for Alcohol Use Disorder and binge drinking

Toronto, Ontario, Oct. 07, 2021 (GLOBE NEWSWIRE) — via InvestorWire — Clearmind Medicine Inc. (CSE: CMND, FSE: CWY0), (“Clearmind” or the “Company“), a psychedelic medicine biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and undertreated health problems, today announced that it has engaged Clinipace Incorporated, a full service Contract Research Organization (CRO), to advise the Company in its pursuit of Food and Drug Administration (FDA) approval for its therapeutics.

Clinipace’s first project will be coordinating the submission of a request for an Investigational New Drug (IND) review by the FDA of the Company’s proprietary MEAI compound for the treatment of alcohol use disorder (AUD) and binge drinking in preparation for Phase I clinical study in humans.

MEAI (5-Methoxy-2-aminoindane) is a novel psychoactive molecule, exerting a euphoric alcohol-like experience and a reduced desire to consume alcoholic beverages. The Company owns six patents covering the use of MEAI for the treatment of AUD and binge behaviors. Pre-clinical study results for MEAI demonstrated a high safety profile and promising efficacy, further supporting the Company’s decision to pursue an IND Review.

Adi Zuloff-Shani, PhD., CEO of Clearmind, commented, “Moving any drug through the FDA approval process requires deep expertise and meticulous attention to detail; this is particularly true for psychedelics. We chose Clinipace as our CRO as they have facilitated dozens of successful regulatory submissions operating at the highest clinical and ethical standards.”

“With this partnership, we are well positioned to advance through the review process in a timely and efficient manner, bringing us closer to establishing MEAI as the basis for changing the way we treat alcohol abuse and other addictive behaviors,” Zuloff-Shani concluded.

About Clearmind Medicine Inc.

Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The Company’s intellectual portfolio currently consists of two patent families. The first, “Binge Behavior Regulators,” has been granted in the U.S., Europe, China and India, with pending divisional applications in Europe and the U.S. The second, “Alcohol Beverage Substitute,” has been approved for a European patent, with pending applications in the U.S., China and India. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on the Canadian Securities Exchange under the symbol “CMND” and the Frankfurt Stock Exchange under the symbol “CWY0.”

For further information, please contact:
Investor Relations,
Email: [email protected]
Telephone: (778) 400-5347
General Inquiries,
[email protected]
www.Clearmindmedicine.com

FORWARD-LOOKING STATEMENTS:

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Such statements include submission of the relevant documentation within the required timeframe to the satisfaction of the relevant regulators and raising sufficient financing to complete the Company’s business strategy. There is no certainty that any of these events will occur. Although such statements are based on management’s reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances.

Investing into early-stage companies inherently carries a high degree of risk, and investment into securities of the Company shall be considered highly speculative.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities in any province in which such offer, solicitation or sale would be unlawful. The securities issued, or to be issued, under the Private Placement have not been, and will not be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Neither the Canadian Securities Exchange (the “CSE”) nor its Regulation Services Provider (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

Wire Service Contact
InvestorWire
Los Angeles, California
www.InvestorWire.com
212.418.1217
[email protected]

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.