Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 26

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 26
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financial condition and results of operations.

Research and development of drugs targeting the CNS is particularly
difficult, which makes it difficult to predict and understand why the drug has a positive effect on some patients but not others.

Discovery and development of new drug candidates
designed to target CNS disorders are particularly difficult and time-consuming, evidenced by the higher failure rate for new drugs for
CNS disorders compared with most other areas of drug discovery. For example, Pharmos, Roche, Allegran’s NMDA and Merck have all
failed to meet their end points. Any such setbacks in our clinical development could have a material adverse effect on our business and
operating results. In addition, our later-stage clinical trials may present challenges related to conducting adequate and well-controlled
clinical trials, particularly as it regards managing placebo effects.

If we encounter difficulties enrolling patients in clinical trials,
our clinical development activities could be delayed or otherwise adversely affected.

Identifying and qualifying trial participants to
participate in clinical studies is critical to our success. The timing of our clinical studies depends, among other things, on the speed
at which we can recruit trial participants to participate in testing our product candidates and our ability to enroll a sufficient number
of patients who remain in the trial until its conclusion. Delays in enrollment and withdrawals from the trial may result in increased
costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely
affect our ability to advance the development of our product candidates. If trial participants are unwilling to participate in our studies
because of negative publicity from adverse events in our trials or other trials of similar products, or those related to specific therapeutic
area, or for other reasons, including competitive clinical studies for similar patient populations, the timeline for recruiting trial
participants, conducting studies, and obtaining regulatory approval of potential products may be delayed. These delays could result in
increased costs, delays in advancing our product candidate development, delays in testing the effectiveness of these product candidates,
or termination of the clinical studies altogether.

We may not be able to identify, recruit and enroll
a sufficient number of trial participants, or those with required or desired characteristics to achieve diversity in a study, to initiate
and complete any future clinical studies in a timely manner. Patient and subject enrollment is affected by factors including:

  the size and nature of a patient population;  

  the patient eligibility criteria defined in the applicable clinical trial protocols, which may limit the patient populations eligible for clinical trials