Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 24

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 24
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 the General Data Protection Regulation in the European Union, or GDPR, government enforcement actions
and regulatory penalties. Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to process
samples, provide test results, share and monitor safety data, bill payers or patients, provide customer support services, conduct research
and development activities, process and prepare company financial information, manage various general and administrative aspects of our
business and may damage our reputation, any of which could adversely affect our business, financial condition and results of operations.

Legislative
or regulatory reform of the health care system in the U.S. may affect our ability to profitably sell our products, if approved.

Our
ability to commercialize our future products successfully, alone or with collaborators, will depend in part on the extent to which coverage
and reimbursement for the products will be available from government and health administration authorities, private health insurers and
other third-party payers. The continuing efforts of the U.S. government, insurance companies, managed care organizations and other payers
for health care services to contain or reduce health care costs may adversely affect our ability to set prices for our products which
we believe are fair, and our ability to generate revenues and achieve and maintain profitability.

35

Specifically,
in the U.S., there have been a number of legislative and regulatory proposals to change the health care system in ways that could affect
our ability to sell our products profitably. For example, certain states in the U.S. are proposing legislation mandating publicly funded
health program coverage of medical cannabis. In addition, the 2010 Affordable Care Act, or the ACA, substantially changed the way healthcare
is financed by both governmental and private insurers. Both Congress and the U.S. President have already taken some actions that are
intended to significantly limit the ACA, and we expect efforts to further modify or repeal the ACA to continue. The success and potential
effects of these efforts to repeal or modify the ACA are not clear.

We
expect additional federal and state legislative proposals for health care reform, which could limit the prices that can be charged for
the products we develop and may limit our commercial opportunity.

The
continuing efforts of government and other third-party payers to contain or reduce the costs of health care through various means may
limit our commercial opportunity. It will be time-consuming and expensive for us to go through the process of seeking coverage and reimbursement
from Medicare, Medicaid, and other governmental health programs and from private payers. Our