Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 17

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 17
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 of our product candidates is complex and uncertain, and until we develop a validated manufacturing process, we may encounter
difficulties in supplying our planned and future clinical trials. If we encounter such difficulties, or fail to meet quality standards,
our ability to meet clinical timelines and expand our development strategy could be impacted.

The
processes involved in manufacturing Ketamir-2, MIRA-55 and other product candidates are complex, expensive, highly regulated and subject
to multiple risks and uncertainties. We have been faced with issues such as this in the initial synthesis of MIRA-55 (which we initially
believed was based on our patented MIRA1a molecule).

In
addition, as product candidates are developed through early to late-stage clinical trials and then to approval and commercialization,
it is common that various aspects of the development program, such as manufacturing methods, are modified along the way to optimize the
scale, process and results. Any changes to the manufacturing processes carry the risk that they will not achieve these intended objectives,
or that the product candidates may not meet the rigorous quality standards necessary for use in our pre-clinical or clinical trials.

Also,
if planned or future manufacturing of Ketamir-2, MIRA-55 or other product candidates fails to meet the quality standards for use in our
pre-clinical or clinical trials, or the active drug substance does not meet our quality specifications, it could impact our timelines
and limit our development strategy. For example, and as discussed above, in the first quarter of 2024, we concluded that during the manufacturing
and scale-up process of MIRA1a, the intended MIRA1a compound was in fact synthesized as MIRA-55.

Moreover,
our contract manufacturing organizations (“CMOs”) or contract development and manufacturing organization (“CDMOs”)
may be unable to successfully increase the manufacturing scale for our product candidates in a timely or cost-effective manner and may
experience delays due to limited manufacturing capacity. In addition, quality issues may arise during manufacturing activities. If our
CMOs or CDMOs are unable to successfully manufacture our product candidates in sufficient quantity in a timely manner or produce active
drug substances that do not meet our quality specifications, our planned pre-clinical or clinical trials may be delayed or modified.

31

We
may fail to expand our manufacturing capability in time to meet market demand for our products and product candidates, and the FDA may
refuse to accept our facilities or those of our contract manufacturers as being suitable for