Company: MIRA
Filing Date: 2025-08-08
Form Type: DEFM14A
Source: 0001641172-25-022816
Chunk: 42

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-08-08
Form: DEFM14A
Chunk 42
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 regulatory approvals for SKNY-1 or other product candidates.

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Failure of SKNY’s information technology systems, including cybersecurity attacks or other data security incidents, could significantly disrupt the operation of its business.

SKNY’s business is dependent on critical, complex, and interdependent information technology (“IT”) systems, including internet-based systems, some of which are managed or hosted by third parties, to support business processes as well as internal and external communications. The size and complexity of its IT systems make SKNY potentially vulnerable to IT system breakdowns, malicious intrusion, and computer viruses, which may result in the impairment of its ability to operate its business effectively.

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

SKNY’s ability to commercialize its 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 SKNY’s ability to set prices for our products which it believes are fair, and our ability to generate revenues and achieve and maintain profitability.

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 SKNY’s ability to sell products profitably. For example, the 2010 Affordable Care Act, or the ACA, substantially changed the way healthcare is financed by both governmental and private insurers. The U.S. trade tariffs implemented by President Donald Trump may challenge us, particularly concerning the uncertainty and volatility introduced by these tariffs complicate decision making, planning and forecasting for our customers as well as for us, making it difficult to predict future costs and financial outcomes accurately.

Unfavorable global economic and geopolitical conditions could adversely affect MIRA’s business, financial condition, stock price, and results of operations.

SKNY’s business could be adversely affected by unstable economic and political conditions within the United States and foreign jurisdictions, including as a result of an economic downturn, tariffs, trade wars and geopolitical events, such as changes in U.S. federal policy that affect the geopolitical landscape. Changes to policy implemented by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things