Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 30

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 30
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 either
    before or after a trial is commenced;

    ●
    unfavorable
    results from ongoing pre-clinical studies and clinical trials;

    ●
    patients
    or investigators failing to comply with clinical trial protocols;

    ●
    patients
    failing to return for post-treatment follow-up at the expected rate;

    ●
    sites
    participating in an ongoing clinical trial withdraw, requiring us to engage new sites;

    ●
    third-party
    clinical investigators decline to participate in our clinical trials, do not perform the clinical trials on the anticipated schedule,
    or act in ways inconsistent with the established investigator agreement, clinical trial protocol, good clinical practices, and other
    IRB requirements;

    ●
    third-party
    entities do not perform data collection and analysis in a timely or accurate manner or at all; or

    ●
    regulatory
    inspections of our clinical trials require us to undertake corrective action or suspend or terminate our clinical trials.

Any
of the foregoing could have a material adverse effect on our business, results of operations and financial condition.

Any
failure by us to comply with existing regulations could harm our reputation and operating results.

We
are subject to extensive regulation by U.S. federal and state governments in each of the markets where we have product candidates progressing
through the approval process.

We
must also adhere to all regulatory requirements including FDA’s Good Laboratory Practice, Good Clinical Practice, and current Good
Manufacturing Practices requirements (“cGMP”) pharmacovigilance requirements, advertising, and promotion restrictions, reporting
and recordkeeping requirements. If we or our suppliers fail to comply with applicable regulations, including FDA pre-or post-approval
cGMP requirements, then FDA could sanction us. Even if a drug is FDA-approved, regulatory authorities may impose significant restrictions
on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-marketing trials. Ketamir-2
and MIRA-55, and any of our product candidates that may be approved in the U.S. in the future, will be subject to ongoing regulatory
requirements for manufacturing, labeling, packaging, storage, distribution, import, export, advertising, promotion, sampling, recordkeeping
and submission of safety and other post-market information, including both federal and state requirements in the U.S. In addition, manufacturers
and manufacturers’ facilities are required to comply with extensive FDA requirements, including ensuring that quality control and
manufacturing procedures conform to GMP. As such,