Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 43

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 43
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 terms or to comply with cGMP could adversely affect our business in a number of ways, including:

    ●
    An
    inability to initiate or continue clinical trials of our product candidates under development;

    ●
    Delay
    in submitting regulatory applications, or receiving marketing approvals, for our product candidates;

    ●
    Loss
    of the cooperation of future collaborators;

    ●
    Subjecting
    third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities;

    ●
    Requirements
    to cease development or to recall batches of our product candidates; and

    ●
    In
    the event of approval to market and commercialize our product candidates, an inability to meet commercial demands for our product
    or any other future product candidates.

If
any CMO or CDMO with whom we contract fails to perform its obligations, we may be forced to enter into an agreement with a different
CMO or CDMO, which we may not be able to do on reasonable terms, if at all. In such scenario, our clinical trials supply could be delayed
significantly as we establish alternative supply sources. In some cases, the technical skills required to manufacture our products or
product candidates may be unique or proprietary to the original CMO or CDMO and we may have difficulty, or there may be contractual restrictions
prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all.
In addition, if we are required to change CMOs or CDMOs for any reason, we will be required to verify that the new CMO or CDMO maintains
facilities and procedures that comply with quality standards and with all applicable regulations. We will also need to verify, such as
through a manufacturing comparability study, that any new manufacturing process will produce our product candidate according to the specifications
previously submitted to the FDA or another regulatory authority. The delays associated with the verification of a new CMO or CDMO could
negatively affect our ability to develop product candidates or commercialize our products in a timely manner or within budget. In addition,
changes in manufacturers often involve changes in manufacturing procedures and processes, which could require that we conduct bridging
studies between our prior clinical supply used in our clinical trials and that of any new manufacturer. We may be unsuccessful in demonstrating
the comparability of clinical supplies which could require the conduct of additional clinical trials.

We
rely