Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 34

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 34
---
 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 and retain enough talented employees;

● manage its clinical trials effectively;

● manage its external manufacturing operations with contract research organizations effectively and in a cost-effective manner; and

● manage its development efforts effectively while carrying out its contractual obligations to contractors and other third parties.

In addition, SKNY may utilize the services of part-time outside consultants and contractors to perform several tasks for it, including tasks related to compliance programs, clinical trial management, regulatory affairs, formulation development and other drug development functions. Its growth strategy may entail expanding its use of consultants and contractors to implement these and other tasks going forward. If SKNY is not able to effectively expand its organization by hiring new employees and expanding its consultants and contractors, it may be unable to successfully implement the tasks necessary to effectively execute on its planned research, development, manufacturing, and commercialization activities and, accordingly, may not achieve its research, development and commercialization goals.

Risks Related to the Merger

There is no assurance when or if the Merger will be completed.

The completion of the Merger is subject to the satisfaction or waiver of a number of conditions as set forth in the Merger Agreement, including, among others, the receipt of the MIRA Stockholder Approval and the approval of NASDAQ. Further, at the time of the completion of the Merger, under the terms of the Merger Agreement, SKNY must have cash and marketable securities valued at $5 million. There can be no assurance that any conditions, consents, clearances or approvals necessary or advisable to be obtained in connection with the Merger will be obtained in a timely manner or at all, or whether