Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 16

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 16
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 industries may result in more resources being concentrated among a smaller number
of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large and established companies.

30

These
companies may compete with us 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 our research projects.

Product
shipment delays could have a material adverse effect on our business, results of operations and financial condition.

The
shipment, import and export of Ketamir-2 and MIRA-55 and our other product candidates require import and export licenses. In the U.S.,
FDA, U.S. Customs and Border Protection and the DEA, and in other countries similar regulatory authorities, regulate the import and export
of pharmaceutical products that contain controlled substances. Specifically, the import and export process require the issuance of import
and export licenses by the relevant controlled substance authority in both the importing and exporting countries. We may not be granted,
or if granted, maintain such licenses from the authorities in certain countries. Even if we obtain the relevant licenses, shipments of
Ketamir-2 and MIRA-55 and our product candidates may be held up in transit, which could cause significant delays and may lead to product
batches being stored outside required temperature ranges. Inappropriate storage may damage the product shipment resulting in a partial
or total loss of revenue from one or more shipments of Ketamir-2 and MIRA-55 or our other product candidates. A partial or total loss
of revenue from one or more shipments of Ketamir-2 and MIRA-55 or our other product candidates could have a material adverse effect on
our business, results of operations and financial condition. Even though the DEA has confirmed in writing that it conducted a scientific
review of the chemical structure of MIRA1a and Ketamir-2 in accordance with the definitions within the CSA and its implementing regulations
and determined that MIRA1a and Ketamir-2 is not a controlled substance or listed chemical, there is no assurance that the DEA may not
change its position. We have filed the necessary requirements with the DEA to review MIRA-55, however, there can be no assurance that
the DEA will conclude that MIRA-55 is not a controlled substance or listed chemical.

The
manufacture