Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 41

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 41
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 data they obtain are compromised due to the failure to adhere to our clinical protocols,
regulatory requirements or for other reasons, any such clinical trials may be extended, delayed or terminated, and we may not be able
to obtain regulatory approval for, or successfully commercialize, Ketamir-2, MIRA-55 or our other product candidates. As a result, our
financial results and the commercial prospects for Ketamir-2 MIRA-55 or our other product candidates would be harmed, our costs could
increase and our ability to generate revenue could be delayed.

45

We
rely and expect to continue to rely on third parties to manufacture our clinical product supplies and clinical candidates, and we may
rely on third parties for at least a portion of the manufacturing process of our product candidates, if approved. Our business could
be harmed if those third parties fail to provide us with sufficient quantities of product supplies or product candidates or fail to do
so at acceptable quality levels or prices.

We
do not currently own any facility that may be used as a clinical-scale manufacturing and processing facility, and we rely on outside
vendors and collaborators to manufacture supplies and process our product candidates. For certain of our components or product candidates,
we rely on single suppliers or manufacturers to supply or manufacture, but we plan to expand the number of suppliers and manufacturers
as we advance our product candidates through clinical development. Our product candidates are not yet manufactured or processed on a
commercial scale and we may remain unable to do so for any of our product candidates. Although in the future we may develop our own manufacturing
facilities, we may also continue to use third parties as part of our manufacturing processes and may, in any event, never be successful
in developing our own manufacturing facilities. Our anticipated reliance on third-party manufacturers exposes us to the following risks:

    ●
    We
    may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and
    the FDA must inspect any manufacturers for current cGMP.

    ●
    Non-compliance
    of our third-party manufacturers with requirements of our marketing application(s). In addition, a new manufacturer would have to
    be educated in, or develop substantially equivalent processes for, the production of our product candidates.

    ●
    Third-party
    manufacturers may have little or no experience with our product candidates and therefore may require a significant amount of support
    from us in order to implement and maintain the infrastructure and processes required to manufacture