Company: MIRA
Filing Date: 2025-07-29
Form Type: PRER14A
Source: 0001641172-25-021434
Chunk: 33

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-29
Form: PRER14A
Chunk 33
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We currently have no drug products on the market, and SKNY’s drug development projects is in a pre-clinical stage of development or moving into clinical stages. SKNY’s business depends almost entirely on the successful pre-clinical and clinical development, FDA regulatory approval, and commercialization of SKNY’s product candidate, SKNY-1. Investors need to be aware that substantial additional investments including pre-clinical and clinical development and FDA regulatory submission and approval efforts will be required before SKNY is permitted to undertake clinical studies and market and commercialize SKNY’s product candidates, if ever. It may be several years before SKNY can commence clinical trials, if ever. Any clinical trial will be subject to extensive and rigorous review and regulation by numerous government authorities in the United States and other jurisdictions where SKNY intends, if approved, to market SKNY’s product candidates. Before obtaining regulatory approvals for any of SKNY’s product candidates, SKNY must demonstrate through pre-clinical testing and clinical trials that the product candidate is safe and effective for its specific application. This process can take many years and may include post-marketing studies and surveillance, which would require the expenditure of substantial resources. Of the large number of drugs in development for approval in the United States (and the rest of the world), only a small percentage will 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 postapproval clinical trials (i.e., Phase IV trials). In addition, the FDA may not approve the labeling claims that