Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 31

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 31
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 successfully complete the FDA regulatory approval financing to fund SKNY’s planned research, development, and clinical programs. SKNY cannot assure you that any of SKNY’s product candidates will be successfully developed or commercialized.

We may be unable to formulate or scale up any or all of SKNY’s product candidates. There is no guarantee that any of the product candidates will be or are able to be manufactured or produced in a manner to meet the FDA’s criteria for product stability, content uniformity and all other criteria necessary for product approval in the United States and other markets. Any of SKNY’s product candidates may fail to achieve their specified endpoints in clinical trials.

Furthermore, product candidates may not be approved even if they achieve their specified endpoints in clinical trials. The FDA may disagree with SKNY’s trial design and SKNY’s interpretation of data from clinical trials or may change the requirements for approval even after it has reviewed and commented on the design for SKNY’s clinical trials. The FDA may also approve a drug for fewer or more limited indications than SKNY requests or may grant approval contingent on the performance of costly post-approval clinical trials (i.e., Phase IV trials). In addition, the FDA may not approve the labeling claims that SKNY believe is necessary or desirable for the successful commercialization of SKNY’s product candidates.

If SKNY is unable to obtain regulatory approval for its drug candidates within the timeline SKNY anticipates, SKNY will not be able to execute SKNY’s business strategy effectively and SKNY’s ability to substantially grow SKNY’s revenues will be limited, which would have a material adverse impact on SKNY’s long-term business, results of operations, financial condition, and prospects.

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We are dependent on SKNY’s current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.

Our ability to progress SKNY’s plan will depend on SKNY’s ability to clinically develop, gain regulatory approval for and ultimately commercialize SKNY’s product candidates. SKNY’s ability to successfully commercialize SKNY’s product candidates will depend on, among other things, SKNY’s ability to:

● successfully complete pre-clinical and other nonclinical studies and clinical trials in a manner that allows us to progress SKNY’s studies;

● receive IND acceptance and regulatory approvals from the FDA;

● produce, through a validated process, in manufacturing facilities inspected and approved by regulatory authorities, including the FDA, sufficiently large quantities of product candidates to permit successful commercialization;

● obtain reimbursement from payers such