Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 33

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 33
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 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.

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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’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