Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 36

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 36
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 traded on a public market.

SKNY may fail to expand its manufacturing capability in time to meet market demand for SKNY’s products and product candidates, and the FDA may refuse to accept SKNY’s facilities or those of its contract manufacturers as being suitable for the production of SKNY’s products and product candidates. Any problems in SKNY’s manufacturing process could have a material adverse effect on MIRA’s business, results of operations and financial condition.

Before SKNY can begin commercial manufacture of any product candidates for sale in the U.S., it must obtain FDA regulatory approval for the product, which requires a successful FDA inspection of its manufacturing facilities and those of its contract manufacturers, processes, and quality systems in addition to other product-related approvals. Although SKNY may successfully navigate this pre-approval inspection process in the U.S., pharmaceutical manufacturing facilities are continuously subject to post-approval inspection by the FDA and foreign regulatory authorities. Due to the complexity of the processes used to manufacture SKNY’s product candidates, SKNY may be unable to initially or continue to pass federal, state or international regulatory inspections in a cost-effective manner. If SKNY is unable to comply with manufacturing regulations, SKNY may be subject to fines, unanticipated compliance expenses, recall or seizure of approved products, total or partial suspension of production and/or enforcement actions, including injunctions, and criminal or civil prosecution. These possible sanctions would adversely affect SKNY’s business, results of operations and financial condition.

Business interruptions could delay the process of developing SKNY’s product candidates and could disrupt product sales.

SKNY’s research and development activities are conducted through outside contractors and manufacturers. Loss of SKNY’s contracted manufacturing facilities, stored inventory or laboratory facilities through fire, theft or other causes, or loss of access to raw materials, could have an adverse effect on SKNY’s ability to continue product development activities and to conduct its business. Failure to supply SKNY’s partners with commercial product may lead to adverse consequences, including the right of partners to take over responsibility for product supply. SKNY currently does not have insurance coverage to compensate it for such business interruptions.

If product liability lawsuits are successfully brought against SKNY, it will incur substantial liabilities and may be required to limit the commercialization of SKNY’s product candidates.

Although SKNY has never had any product liability claims or lawsuits brought against it, SKNY faces potential product liability exposure related to the testing of its product candidates in human clinical trials. SKNY may face exposure to claims by an even greater number of persons when it begins to market and distribute