Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 32

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 32
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 affect our results. Changing laws, regulations and standards
might also create uncertainty, higher expenses and increase insurance costs. As a result, we intend to invest all reasonably necessary
resources to comply with evolving standards, and this investment might result in increased management and administrative expenses and
a diversion of management time and attention from revenue-generating activities to compliance activities.

We
are subject to federal and state healthcare laws and regulations and implementation of or changes to such healthcare laws and regulations
could adversely affect our business and results of operations.

In
the United States, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could
impact our ability to sell our product candidates. If we are found to be in violation of any of these laws or any other federal or state
regulations, we may be subject to administrative, civil and/or criminal penalties, damages, fines, individual imprisonment, exclusion
from federal health care programs and the restructuring of our operations. Any of these could have a material adverse effect on our business
and financial results. Since many of these laws have not been fully interpreted by the courts, there is an increased risk that we may
be found in violation of one or more of their provisions. Any action against us for violation of these laws, even if we ultimately are
successful in our defense, will cause us to incur significant legal expenses and divert our management’s attention away from the
operation of our business.

We
expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage
criteria and in additional downward pressure on the price that we may receive for any approved product. There have been judicial challenges
to certain aspects of the ACA and numerous legislative attempts to repeal and/or replace the ACA in whole or in part, and we expect there
will be additional challenges and amendments to the ACA in the future. At this time, the full effect that the ACA will have on our business
in the future remains unclear. An expansion in the government’s role in the U.S. healthcare industry may cause general downward
pressure on the prices of prescription drug products, lower reimbursements, or any other product for which we obtain regulatory approval,
reduce product utilization, and adversely affect our business and results of operations. Any reduction in reimbursement from Medicare
or other government programs may result in a similar reduction in payments from private payers. The implementation of cost containment
measures or other healthcare reforms may prevent us from being able to generate revenue,