Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 226

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1C
Chunk 226
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55,
two novel drug candidates designed to address unmet medical needs in pain management, depression, PTSD and cognitive function.

The
U.S. Drug Enforcement Administration (DEA)’s scientific review of Ketamir-2 and MIRA-55 concluded that it would not be considered
a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.

We
had net losses of $7.9 million and $12.0 million for the year ended December 31, 2024 and December 31, 2023, respectively.

Reverse
Stock Split

Effective
June 28, 2023, we completed a 1-for-5 reverse stock split of our outstanding common stock. Unless otherwise noted, the share and per
share information in this Report reflects the reverse stock split.

58

Components
of our Results of Operations

Research
and Development Expenses

Research
and development expenses represent costs incurred to conduct research and development of our product candidate. We recognize all research
and development costs as they are incurred. Research and development expenses consist primarily of the following:

    ●
    contracted research and manufacturing;

    ●
    patent-related costs;

    ●
    consulting arrangements; and

    ●
    other expenses incurred to advance our research and development activities.

Our
operating expenses have historically been the costs associated with our patent prosecution and initial investment in pre-clinical research
and development activities. We expect research and development expenses will increase in the future as we advance Ketamir-2 and MIRA-55
into and through clinical trials and pursue regulatory approvals, which will require a significant investment in costs of clinical trials,
regulatory support, and contract manufacturing. In addition, we will evaluate opportunities to acquire or in-license additional product
candidates and technologies, which may result in higher research and development expenses due to license fee and/or milestone payments,
as well as added clinical development costs.

The
process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in timely
development and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be
affected by numerous factors, including clinical data, competition, manufacturing capability and commercial viability. As a result, we
are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue
from the commercialization and sale of our product candidates.

General
and Administrative Expenses

General
and administrative