Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 15

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 15
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 Competitive therapeutic treatments include those that have already been approved by medicines regulators and accepted
by the medical community and any new treatments that may enter the market. For some of our drug development programs / areas of therapeutic
interest, other treatment options are currently available, under development, and may become commercially available in the future. If
any of our product candidates are approved for the diseases and conditions we are currently pursuing, they may compete with a range of
medicines or therapeutic treatments that are either in development, will be developed in the future or currently marketed.

Established
companies may have a competitive advantage over us due to their size and experiences, financial resources, and institutional networks.
Many of our competitors may have significantly greater financial, technical, and human resources than we do. Due to these factors, our
competitors may have an advantage in marketing their approved drugs and may obtain regulatory approval of their drug candidates before
we are able to, which may limit our ability to develop or commercialize our drug candidates. Our competitors may also develop drugs /
medicines that are safer, more effective, more widely used and less expensive than ours. These advantages could materially impact our
ability to develop and, if approved, commercialize our product candidates successfully. Furthermore, some of these competitors may make
acquisitions or establish collaborative relationships among themselves or with third parties to increase their ability to rapidly gain
market share.

Our
product candidates may compete with other synthetic cannabinoids, as well as with cannabinoid or cannabis-based drugs, in addition to
competing with state-licensed medical and recreational marijuana, in markets where the recreational and/or medical use of marijuana is
legal. There is continuing support in the U.S. for further state legalization of marijuana. In markets where recreational and/or medical
marijuana is not legal, our product candidates, once approved by regulators, may compete with marijuana or marijuana-based products purchased
in the illegal drug market. This may or may not affect the commercial price that we may be able to achieve for our synthetic regulatory-approved
medicines, should they be approved by the FDA.

Moreover,
as generic versions of drug products enter the market, the price for such medicines may be expected to decline rapidly and substantially.
Even if we are the first to obtain FDA approval of one of our product candidates, the future potential approval of generics could adversely
affect the price we are able to charge, and the profitability of our product(s) will likely decline.

Mergers
and acquisitions in the pharmaceutical and biotechnology