Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 1

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 1
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 on our ability to grow our client base, establish sustainable revenues
and succeed overall.

21

We
have yet to achieve a profit and will not achieve a profit in the near future, if at all.

Certain
of our executive officers are not employed by us on a full-time basis.

Conflicts
of interest may arise between us and MIRALOGX.

Risks
Relating to Our Business and Our Industry

Our
future success will largely depend on the success 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
are dependent on our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.

We may not successfully
integrate with SKNY following our potential upcoming acquisition

Results
of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results.

We
have limited marketing experience, and we do not anticipate at this time establishing a sales force or distribution and reimbursement
capabilities, and we may not be able to successfully commercialize any of our product candidates if they are approved in the future.

We
will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in managing
our growth and executing our growth strategy.

We
expect to face intense competition, often from companies with greater resources and experience than we have.

We
have significant and increasing liquidity needs and may require additional funding.

Risks
Related to Development and Regulatory Approval of Our Product Candidates

Clinical
trials for our product candidates are expensive, time-consuming, uncertain, and susceptible to change, delay or termination. The results
of clinical trials are open to differing interpretations.

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

The
regulatory approval processes with the FDA are lengthy and inherently unpredictable.

There
is a high rate of failure for drug candidates proceeding through clinical trials.

Risks
Related to Our Reliance Upon Third Parties

We
rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates.

Our
existing collaboration arrangements and any that we may enter into in the future may not be successful, which could adversely affect
our ability to develop and commercialize our product candidates.

Risks
Relating to the Ownership of Our Common Stock

Because
of the speculative nature of an investment in our company, you may lose your