Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 15

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 15
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 product
candidates will be successful in clinical trials or receive the necessary regulatory approval. Further, our product candidates may not
receive regulatory approval even if they are successful in clinical trials. If we do not receive regulatory approvals for our product
candidates, we may not be able to continue operations.

In
February 2024 and in July 2024, we announced that we were granted approval to initiate our first-in-human Phase I/IIa clinical trial with
CMND-100 in patients suffering from AUD by the Israeli Ministry of Health and by the FDA, respectively. Subsequently, in May 2023 we initiated
the CM-CMND-001 clinical trial in both Israel and the United States, including at the Yale School of Medicine’s Department of Psychiatry
and Johns Hopkins University School of Medicine. The CM-CMND-001 clinical trial is designed to be a multinational, multi-center, Phase
I/IIa single- and multiple-dose tolerability, safety and pharmacokinetic study in healthy volunteers and AUD subjects. In October 2024
and December 2024, we announced that we received Institutional Review Board, or IRB, approvals from Johns Hopkins University and Yale
University, respectively, our clinical sites for part A of our Phase I/IIa clinical trial in the United States for treating patients suffering
from AUD. Upon completion of the Phase I/IIa studies, if successful, we
will be required to conduct additional clinical trials subject to securing additional financing.

Future clinical trials of our product candidates may be delayed,
and certain programs may never advance in the clinic or may be more costly to conduct than we anticipate, any of which can affect our
ability to fund our operations and would have a material adverse impact on our platform or our business.

Clinical testing is expensive, time consuming and
subject to uncertainty. We cannot guarantee that any of our planned clinical trials will be conducted as planned or completed on schedule,
if at all. Moreover, even if these trials are initiated or conducted on a timely basis, issues may arise that could result in the suspension
or termination of such clinical trials. A failure of one or more clinical trials can occur at any stage of testing, and our clinical trials
may not be successful. Events that may prevent successful or timely initiation or completion of clinical trials include:

  inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials;  

  delays in confirming target engagement, patient selection or other