Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 65

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 65
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 our contract manufacturers cannot successfully
manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, we will not be able
to secure or maintain regulatory authorization for our product candidates manufactured at these manufacturing facilities. In addition,
we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified
personnel. If the FDA, the EMA or another comparable foreign regulatory agency does not approve these facilities for the manufacture of
our product candidates or if any agency withdraws its approval in the future, we may need to find alternative manufacturing facilities,
which would negatively impact our ability to develop, obtain regulatory authorization for or market our product candidates, if approved.

Our product candidates may compete with other product
candidates and marketed products for access to manufacturing facilities. Any performance failure on the part of our existing or future
manufacturers could delay clinical development, marketing approval or commercialization. Our current and anticipated future dependence
upon others for the manufacturing of our product candidates may adversely affect our future profit margins and our ability to commercialize
any product candidates that receive marketing approval on a timely and competitive basis.

If the contract manufacturing facilities on which we rely do not
continue to meet regulatory requirements or are unable to meet our supply demands, our business will be harmed.

All entities involved in the preparation of product
candidates for clinical trials or commercial sale, including our existing CMOs for our product candidates, are subject to extensive regulation.
Components of a finished drug or product approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance
with cGMP, or similar regulatory requirements outside the United States. These regulations govern manufacturing processes and procedures,
including recordkeeping, and the implementation and operation of quality systems to control and assure the quality of investigational
products and products approved for sale. Poor control of production processes can lead to the introduction of contaminants or to inadvertent
changes in the properties or stability of our product candidates. Our failure, or the failure of third-party manufacturers, to comply
with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties,
delays, suspension or withdrawal of approvals, license revocation, suspension of production, seizures or recalls of product candidates
or marketed drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect clinical or
commercial supplies of our product candidates.

We and our CMOs must supply all necessary documentation,
as applicable, in support of a marketing application