Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 32

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 32
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 as government health care programs and insurance companies and achieve commercially attractive levels of pricing;

● secure acceptance of SKNY’s product candidates from physicians, health care payers, patients, and the medical community;

● create positive publicity surrounding SKNY’s product candidates;

● manage SKNY’s spending as costs and expenses increase due to clinical trials and commercialization; and

● obtain and enforce sufficient intellectual property rights for SKNY’s product candidates.

SKNY’s failure or delay with respect to any of the factors above could have a material adverse effect on SKNY’s business, results of operations and financial condition.

Results of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results.

Any positive results from future pre-clinical testing of SKNY’s product candidates and potential future clinical trials may not be predictive of the results from Phase I, Phase II or Phase III clinical trials. In addition, SKNY’s interpretation of results derived from clinical data or SKNY’s conclusions based on SKNY’s pre-clinical data may prove inaccurate. Frequently, pharmaceutical and biotechnology companies have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical testing and early phase clinical trials, and SKNY cannot be certain that SKNY will not face similar setbacks. These setbacks may be caused by the fact that pre-clinical and clinical data can be susceptible to varying interpretations and analyses. Furthermore, certain product candidates may perform satisfactorily in pre-clinical studies and clinical trials but nonetheless fail to obtain FDA approval or appropriate approvals by the appropriate regulatory authorities in other countries. If SKNY fails to produce positive results in SKNY’s clinical trials for SKNY’s product candidates, the development timeline and regulatory approval and commercialization prospects for them and as a result SKNY’s business and financial prospects would be materially adversely affected.

We have limited marketing experience, and SKNY does not anticipate at this time establishing a sales force or distribution and reimbursement capabilities, and SKNY may not be able to successfully commercialize any of SKNY’s product candidates if they are approved in the future.

If regulatory approval of SKNY’s products is ever obtained, SKNY’s ability to generate revenues ultimately depends on SKNY’s ability to sell SKNY’s approved products and secure adequate third-party reimbursement. SKNY currently has limited experience in marketing and selling SKNY’s products. SKNY currently does not have any products approved for sale in the United States or in any other country.

The commercial success of SKNY’s product candidates will not even be possible for