Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 29

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 29
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;

    ●
    inability
    or unwillingness of medical investigators to follow our clinical protocols; or

    ●
    difficulty
    in maintaining contact with patients during or after treatment, which may result in incomplete data.

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

Clinical
trials of synthetic cannabinoid drug candidates and ketamine analogs are novel with very limited or non-existing history; we face a significant
risk that the trials will not result in commercially viable drugs and treatments.

At
present, there is only a very limited documented clinical trial history from which we can derive any scientific conclusions for our product
candidates or prove that our present assumptions for the current and planned research are scientifically compelling. The active pharmaceutical
ingredient (or API) content shown in INDs can vary from one IND to another - hence it is not necessarily possible to extrapolate results
from studies with one product and predict efficacy of safety with another product containing a similar API and different source. Whilst
the principal synthetic cannabinoid component may be similar, the APIs may differ in terms of minor cannabinoid content, impurity profiles
or degradant profiles. While we are encouraged by the results of clinical trials by others (where they exist), there can be no assurance
that any pre-clinical study or clinical trial will result in in commercially viable drugs or treatments.

Clinical
trials are expensive, time consuming and difficult to design and implement. We, as well as the regulatory authorities, may suspend, delay
or terminate our clinical trials at any time, may require us, for various reasons, to conduct additional clinical trials, or may require
a particular clinical trial to continue for a longer duration than originally planned, including, among others:

    ●
    lack
    of effectiveness of any API, formulation, or delivery system during clinical trials;

38

    ●
    discovery
    of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues;

    ●
    slower
    than expected rates of subject recruitment and enrollment rates in clinical trials;

    ●
    delays
    or inability in manufacturing or obtaining sufficient quantities of GMP-grade materials for use in clinical trials due to regulatory
    and manufacturing constraints;

    ●
    delays
    in obtaining regulatory authorization to commence a trial, including Institutional Review Board (“IRB”) approvals or
    DEA approvals, licenses required for obtaining and using synthetic cannabinoids or cannabinoid-like substances for research,