Company: MIRA
Filing Date: 2025-07-29
Form Type: PRER14A
Source: 0001641172-25-021434
Chunk: 36

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-29
Form: PRER14A
Chunk 36
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’s ability to successfully commercialize SKNY’s products may be harmed.

We may be required to expend significant time and resources to train SKNY’s sales force to be credible, persuasive and compliant with applicable laws in marketing SKNY’s product candidates to physicians for their approved uses. In addition, SKNY must continue to train its sales force to ensure that a consistent and appropriate message about SKNY’s product candidates delivered to SKNY’s potential customers. If MIRA is unable to effectively train its sales force and equip them with effective materials, including medical and sales literature, to help them inform and educate potential customers about the benefits of Ketamir-2 and MIRA-55 and SKNY’s product candidates and its proper administration, SKNY’s efforts to successfully commercialize its product candidates could be jeopardized, which would negatively impact SKNY’s ability to generate product revenues.

The manufacture of SKNY’s product candidates is complex and uncertain, and until SKNY develops a validated manufacturing process, SKNY may encounter difficulties in supplying its planned and future clinical trials. If SKNY encounters such difficulties, or fails to meet quality standards, SKNY’s ability to meet clinical timelines and expand its development strategy could be impacted.

The processes involved in manufacturing SKNY’s other product candidates are complex, expensive, highly regulated and subject to multiple risks and uncertainties. In addition, as product candidates are developed through early to late-stage clinical trials and then to approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are modified along the way to optimize the scale, process and results. Any changes to the manufacturing processes carry the risk that they will not achieve these intended objectives, or that the product candidates may not meet the rigorous quality standards necessary for use in SKNY’s pre-clinical or clinical trials.

Also, if planned or future manufacturing of SKNY’s product candidates fails to meet the quality standards for use in its pre-clinical or clinical trials, or the active drug substance does not meet its quality specifications, it could impact SKNY’s timelines and limit its development strategy.

SKNY’s management and personnel, systems, and facilities currently in place may not be adequate to support its business plan and future growth. As a result, SKNY may need to further expand certain areas of its organization.

SKNY’s operations, growth and various projects requires that it:

| ● | continue                                                                                   
 to improve its operational, financial, management and regulatory compliance controls and   
 reporting systems and procedures;                                                          |
| ● | attract