Company: MIRA
Filing Date: 2025-07-29
Form Type: PRER14A
Source: 0001641172-25-021434
Chunk: 35

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-29
Form: PRER14A
Chunk 35
---
 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 the foreseeable future and will depend on a number of factors beyond SKNY’s control, including the willingness of physicians to prescribe SKNY’s products to patients, payers’ willingness and ability to pay for the drugs, the level of pricing achieved, patients’ response to SKNY’s drugs and the ability of SKNY’s marketing partners to generate sales. There can be no guarantee that SKNY will be able to establish or maintain the personnel, systems, arrangements and capabilities necessary to successfully commercialize SKNY’s product candidates that may be approved by the FDA in the future. If SKNY fails to establish or maintain successful marketing, sales and reimbursement capabilities or fail to enter into successful marketing arrangements with third parties, SKNY’s product revenues may suffer.

| 16 |

Should SKNY later determine that it is in SKNY’s best interest to develop a sales force, SKNY may be unable to effectively train and equip SKNY’s sales force, therefore SKNY