Company: MIRA
Filing Date: 2025-07-29
Form Type: PRER14A
Source: 0001641172-25-021434
Chunk: 34

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-29
Form: PRER14A
Chunk 34
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 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 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