Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 8

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 8
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 opportunities
should be presented to us.

25

Risks
Relating to Our Business and Our Industry

Our
future viability will largely depend on the positive development of Ketamir-2 and MIRA-55, and any future product candidates, which development
will require significant capital resources and years of clinical development effort.

We
currently have no drug products on the market, and all of our drug development projects are in a pre-clinical stage of development or
moving into clinical stages. Our business depends almost entirely on the successful pre-clinical and clinical development, FDA regulatory
approval, and commercialization of our product candidates, principally Ketamir-2 and MIRA-55. Investors need to be aware that substantial
additional investments including pre-clinical and clinical development and FDA regulatory submission and approval efforts will be required
before we are permitted to undertake clinical studies and market and commercialize our product candidates, if ever. It may be several
years before we can commence clinical trials, if ever. Any clinical trial will be subject to extensive and rigorous review and regulation
by numerous government authorities in the United States and other jurisdictions where we intend, if approved, to market our product candidates.
Before obtaining regulatory approvals for any of our product candidates, we must demonstrate through pre-clinical testing and clinical
trials that the product candidate is safe and effective for its specific application. This process can take many years and may include
post- marketing studies and surveillance, which would require the expenditure of substantial resources. Of the large number of drugs
in development for approval in the United States (and the rest of the world), only a small percentage will successfully complete the
FDA regulatory approval financing to fund our planned research, development, and clinical programs, we cannot assure you that any of
our product candidates will be successfully developed or commercialized.

We
may be unable to formulate or scale up any or all of our product candidates. There is no guarantee that any of the product candidates
will be or are able to be manufactured or produced in a manner to meet the FDA’s criteria for product stability, content uniformity
and all other criteria necessary for product approval in the United States and other markets. Any of our product candidates may fail
to achieve their specified endpoints in clinical trials.

Furthermore,
product candidates may not be approved even if they achieve their specified endpoints in clinical trials. The FDA may disagree with our
trial design and our interpretation of data from clinical trials or may change the requirements for approval even after it has