Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 29

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 29
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 found to cause
similar or different unacceptable side effects that prevent their further development.

It is possible that as we test our product candidates
in larger, longer and more extensive clinical trials, or as the use of these product candidates becomes more widespread if they receive
regulatory approval, illnesses, injuries, discomforts and other AEs that were not observed in earlier trials, as well as conditions that
did not occur or went undetected in previous trials, may be reported by subjects. If such side effects become known later in development
or upon approval, if any, such findings may harm our business, financial condition, results of operations and prospects significantly.

Additionally, adverse developments in clinical
trials of pharmaceutical, biopharmaceutical or biotechnology products conducted by others may cause the FDA or other regulatory oversight
bodies to suspend or terminate our clinical trials or to change the requirements for approval of any of our product candidates.

In addition to side effects caused by the product
candidate, the administration process or related procedures also can cause adverse side effects. If any such AEs occur, our clinical trials
could be suspended or terminated. If we are unable to demonstrate that any AEs were caused by the administration process or related procedures,
the FDA, the European Commission, the EMA, or other regulatory authorities could order us to cease further development of, or deny approval
of, a product candidate for any or all targeted indications. Even if we can demonstrate that all future serious adverse events, or SAEs,
are not product-related, such occurrences could affect patient recruitment or the ability of enrolled patients to complete the trial.
Moreover, if we elect, or are required, to not initiate, delay, suspend or terminate any future clinical trial of any of our product candidates,
the commercial prospects of such product candidates may be harmed and our ability to generate product revenues from any of these product
candidates may be delayed or eliminated. Any of these occurrences may harm our ability to develop other product candidates, and may harm
our business, financial condition, results of operations and prospects significantly.

Additionally, if any of our product candidates
receives marketing authorization, the FDA could impose contraindications or a boxed warning in the labeling of the product. For any of
our drug product candidates receiving marketing authorization, the FDA could require us to adopt a risk evaluation and mitigation strategy,
or REMS, and could apply elements to assure safe use to ensure that the benefits of the product outweigh its risks, which may include,
among other things, a Medic