Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 63

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 63
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 completed clinical trials on a government-sponsored database, ClinicalTrials. gov,
within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

Furthermore, the third parties conducting clinical
trials on our behalf are not our employees, and except for remedies available to us under the agreements with such contractors, we cannot
control whether or not such contractors devote sufficient time, skill and resources to their ongoing development programs. These contractors
may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials
or other drug or medical device development activities, which could impede their ability to devote appropriate time to our clinical programs.
If these third parties, including clinical investigators, do not successfully carry out their contractual duties, meet expected deadlines
or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we may not be able to obtain, or may
be delayed in obtaining, regulatory approvals for our product candidates. If that occurs, we will not be able to, or may be delayed in
our efforts to, successfully commercialize our product candidates. In such an event, our financial results and the commercial prospects
for any product candidates that we seek to develop could be harmed, our costs could increase and our ability to generate revenues could
be delayed, impaired or foreclosed.

Our use of third parties to manufacture and develop our product
candidates for preclinical studies and clinical trials may increase the risk that we will not have sufficient quantities of our product
candidates, products, or necessary quantities of such materials on time or at an acceptable cost.

We do not currently have, nor do we plan to acquire,
the infrastructure or capability internally to manufacture drug supplies for our ongoing clinical trials or any future clinical trials
that they may conduct, and we lack the resources to manufacture any product candidates on a commercial scale. In May 2023, we announced
that we had entered into a clinical supply agreement with IMP for the Phase I/IIa clinical study. Pursuant to the clinical supply agreement,
IMP is responsible for the global clinical supply chain of CMND-100 from manufacture to the various clinical sites. Clinical drug supply
is a critical factor for trial success so collaboration with best-in-class clinical drug supply vendor forestalls the possibility of it
being a bottleneck to successful drug delivery. Moreover, it can also deliver enormous benefits, including better investigator and patient
experiences as well as cost savings in clinical drug supply. See “ Item 4. B.