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

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 10
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 duration of hostilities stemming from such conflicts, including the potential effects
of sanctions and countersanctions, or retaliatory cyber-attacks on the world economy and markets, have contributed to increased market
volatility and uncertainty, which could have an adverse impact on macroeconomic factors that affect our business and operations, such
as pre-clinical study issues, manufacturer delays or shipping delays. 

Moreover,
the conflict between Palestine and Israel could impact future business decisions to locate potential clinical trials in Israel. It is
not possible to predict the short and long-term implications of military conflicts or wars or geopolitical tensions which could include
further sanctions, uncertainty about economic and political stability, increases in inflation rate and energy prices, cyber-attacks,
supply chain challenges and adverse effects on currency exchange rates and financial markets.

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

Any
positive results from future pre-clinical testing of our product candidates and potential future clinical trials may not necessarily
be predictive of the results from Phase I, Phase II or Phase III clinical trials. In addition, our interpretation of results derived from
clinical data or our conclusions based on our pre-clinical data may prove inaccurate. Frequently, pharmaceutical and biotechnology companies
have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical testing and early phase clinical
trials, and we cannot be certain that we will not face similar setbacks. These setbacks may be caused by the fact that pre-clinical and
clinical data can be susceptible to varying interpretations and analyses. Furthermore, certain product candidates may perform satisfactorily
in pre-clinical studies and clinical trials but nonetheless fail to obtain FDA approval or appropriate approvals by the appropriate regulatory
authorities in other countries. If we fail to produce positive results in our clinical trials for our product candidates, the development
timeline and regulatory approval and commercialization prospects for them and as a result our business and financial prospects would
be materially adversely affected.

27

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.

If
regulatory approval of our products is ever obtained, our ability to generate revenues ultimately depends on our ability to sell our
approved products and secure adequate third-party reimbursement. We currently have limited experience in marketing and selling our products.
We currently do not have