Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 14

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 14
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 through May 15, 2021 for purposes of obtaining health insurance coverage
through the ACA marketplace. The executive order also instructs certain governmental agencies to review and reconsider their existing
policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs
that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through
Medicaid or the ACA. It is unclear how the Supreme Court ruling, other such litigation and the healthcare reform measures of the Biden
administration will impact the ACA and our business.

Other legislative changes have been proposed and
adopted in the United States since the ACA was enacted. For example, COVID-19 relief legislation suspended the 2% Medicare sequester from
May 1, 2020 through March 31, 2021.

Clinical and preclinical development is uncertain. Our current pre-clinical
and clinical programs may experience delays, or our preclinical and clinical programs may never advance to clinical trials, which would
adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all, which would have
an adverse effect on our business.

Our product candidates are in the pre-clinical
and clinical stage, and their risk of failure is high. Before we can commence clinical trials for a product candidate, it must complete
extensive preclinical testing and studies that support the planned INDs in the United States or similar applications in other jurisdictions.
We cannot be certain of the timely completion or outcome of our preclinical testing and studies and cannot predict if the FDA or other
regulatory authorities will accept the proposed clinical programs or if the outcome of preclinical studies will ultimately support the
further development of the programs. As a result, we cannot be sure that we will be able to submit INDs or similar applications for our
preclinical programs on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will
result in the FDA, the EMA or other regulatory authorities allowing clinical trials to begin.

In addition, clinical trial design for some of
our product candidates can be complex given their characteristics. We will need to design our clinical trial to demonstrate efficacy across
a range of doses to ensure that we can attain optimal potential efficacy. Our trial design may not demonstrate efficacy as we expect,
and this may adversely impact our ability to successfully develop this product candidate.

We also cannot be certain that any of our