Clearmind Announces Successful Pre-IND Meeting with U.S. FDA for CMND-100 for Alcohol Use Disorder

Clearmind Announces Successful Pre-IND Meeting with U.S. FDA for CMND-100 for Alcohol Use Disorder

Clearmind aims to initiate clinical trials with CMND-100 by year’s end

VANCOUVER, May 26, 2022 — Clearmind Medicine Inc. (CSE: CMND, OTC Pink: CMNDF, FSE: CWY0) (“Clearmind” or the “Company“), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, has completed a highly constructive Pre-Investigational New Drug Application (“pre-IND“)meeting with the U.S. Food and Drug Administration (“FDA“) to discuss the development of the Company’s MEAI- based proprietary compound CMND-100.‍

“The FDA’s interest in CMND-100 as a potential therapy for alcohol use disorder was extremely encouraging,” said Dr. Adi Zuloff-Shani, Clearmind’s CEO. “Their feedback to the proposed development program was positive, and we are working diligently towards initiating the clinical trials with CMND-100 by the end of 2022.”‍

CMND-100, Clearmind’s lead product that is based on MEAI, a novel psychoactive compound, exerts a significant reduced desire to consume alcoholic beverages, and the company is developing it as a candidate therapy for the treatment of Alcohol Use Disorder(“AUD“). Clearmind submitted a pre-IND meeting package to the FDA in April; it included an overview of the development program, and questions about the regulatory requirements for opening an investigational new drug (“IND“) application.‍

Opening an IND is required for conducting clinical trials in the United States and ensures that trials are designed in accordance with the data requirements for FDA marketing approval.The written responses, and the responses provided in a teleconference with FDA representatives, were constructive and supportive.‍

“It’s critical to have such open discussions with regulatory officials. It helps us efficiently and effectively follow the requirements and guidance toward approval,”Zuloff-Shani said.‍

AUD is a chronic relapsing brain disorder characterized by an impaired ability to stop or control alcohol use despite negative social, occupational, or health consequences. Alcohol is the third most-common preventable cause of death in the United States, where an estimated 5.8% of the population (over 18 million people) struggle with the condition. It is assumed that CMND- 100 suppresses the desire to drink alcohol by potentially innervating neural pathways such as 5-HT1A that lead to “sensible behavior.”

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 five 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 the Canadian Securities Exchange under the symbol “CMND“,the Frankfurt Stock Exchange under the symbol “CWY0” and on the OTCMarkets under the symbol “CMNDF“.

For further information, please contact:
Investor Relations,
Email: invest@clearmindmedicine.com
Telephone: (604) 260-1566
General Inquiries,
Info@Clearmindmedicine.com
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 CanadianSecurities 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.