Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 18

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 18
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 the clinical trial operations
or trial site by the FDA, the EMA or other comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen
safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations
or administrative actions or lack of adequate funding to continue the clinical trial.

Delays in the initiation, conduct or completion
of any clinical trial of our product candidates will increase our costs, slow down the product candidate development and approval process
and delay or potentially jeopardize our ability to commence product sales and generate revenue. In addition, many of the factors that
cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval
of our product candidates. In the event we identify any additional product candidates to pursue, we cannot be sure that submission of
an IDE, IND, CTA or equivalent application, as applicable, will result in the FDA, the EMA or comparable foreign regulatory authority
allowing clinical trials to begin in a timely manner, if at all. Any of these events could have a material adverse effect on our business,
prospects, financial condition and results of operations.

Our current product candidates and future therapeutic candidates
contain psychedelic substances, and may be subject to controlled substance laws and regulations in the territories where the product will
be marketed, such as the United States and Europe, and failure to comply with these laws and regulations, or the cost of compliance with
these laws and regulations, may adversely affect the results of our business operations, both during clinical development and post approval,
and our financial condition.

Our product candidates contain psychedelic substances.
The psychedelic drug industry is a fairly new treatment industry and we cannot predict the impact of the ever-evolving compliance regime
in respect of this industry. Similarly, we cannot predict the time required to secure all appropriate regulatory approvals for future
products, or the extent of testing and documentation that may, from time to time, be required by governmental authorities. The impact
of compliance regimes, any delays in obtaining, or failure to obtain regulatory approvals may significantly delay or impact the development
of markets, its business and products, and sales initiatives and could have a material adverse effect on the business, financial condition
and operating results of the Corporation.

Our product candidates may be regulated by the
U. S. Drug Enforcement Administration, or DEA, as “ Controlled Substances” or scheduled substances, under the Comprehensive
Drug Abuse Prevention and Control Act