Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 30

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 30
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 gain market share.

Moreover, as generic versions of drug products enter the market, the price for such medicines may be expected to decline rapidly and substantially. Even if SKNY-1 is the first to obtain FDA approval of one of its product candidates, the future potential approval of generics could adversely affect the price SKNY is able to charge, and the profitability of SKNY’s product(s) will likely decline.

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in more resources being concentrated among a smaller number of SKNY’s competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

These companies may compete with SKNY in recruiting and retaining qualified scientific, management and commercial personnel, utilizing contract manufacturing facilities or contract research organizations (CROs), or establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary to SKNY’s research projects.

Risks Relating to SKNY’s Business and SKNY’s Industry

Our future viability will largely depend on the positive development of SKNY-1, and any future product candidates, which development will require significant capital resources and years of clinical development effort.

We currently have no drug products on the market, and SKNY’s drug development projects is in a pre-clinical stage of development or moving into clinical stages. SKNY’s business depends almost entirely on the successful pre-clinical and clinical development, FDA regulatory approval, and commercialization of SKNY’s product candidate, SKNY-1. Investors need to be aware that substantial additional investments including pre-clinical and clinical development and FDA regulatory submission and approval efforts will be required before SKNY is permitted to undertake clinical studies and market and commercialize SKNY’s product candidates, if ever. It may be several years before SKNY can commence clinical trials, if ever. Any clinical trial will be subject to extensive and rigorous review and regulation by numerous government authorities in the United States and other jurisdictions where SKNY intends, if approved, to market SKNY’s product candidates. Before obtaining regulatory approvals for any of SKNY’s product candidates, SKNY must demonstrate through pre-clinical testing and clinical trials that the product candidate is safe and effective for its specific application. This process can take many years and may include post-marketing studies and surveillance, which would require the expenditure of substantial resources. Of the large number of drugs in development for approval in the United States (and the rest of the world), only a small percentage will