Company: MIRA
Filing Date: 2025-05-14
Form Type: 10-Q
Source: 0001641172-25-010301
Chunk: 15

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-05-14
Form: 10-Q
Item: Item 8
Chunk 15
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 discussion and analysis should be read in conjunction with the Condensed Financial Statements and Notes thereto included elsewhere
in this Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company’s
actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a
result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Report and in the Company’s
other filings with the SEC. See “Cautionary Note Regarding Forward Looking Statements” above.

As
used in this Management’s Discussion and Analysis of Financial Condition and Results of Operations, unless otherwise indicated,
the terms “the Company”, “we”, “us”, “our” and similar terminology refer to MIRA Pharmaceuticals,
Inc.

Background
of our Company

We are a clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range
of neurologic and neuropsychiatric disorders. We hold exclusive license rights in the U.S., Canada, and Mexico for Ketamir-2, a novel,
patent-pending oral ketamine analog currently under clinical investigation. Ketamir-2 is being developed for the treatment of neuropathic
pain, with a Phase 1 clinical trial currently underway in healthy subjects. Preclinical studies have been conducted and are ongoing as
part of the oral development program to further evaluate its potential in treating depression and post-traumatic stress disorder (PTSD).
In addition, we have successfully formulated a topical cream version of Ketamir-2 and will be initiating preclinical studies to evaluate
its efficacy in treating inflammatory pain.

Additionally,
our novel oral pharmaceutical marijuana molecule, MIRA-55, is being studied for its potential to alleviate anxiety and cognitive decline,
symptoms commonly associated with early-stage dementia. If approved by the FDA, MIRA-55 could represent a significant advancement in
the treatment of various neuropsychiatric, inflammatory, and neurologic disorders.

The
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 CSA and its governing regulations. 

We
were incorporated under the laws of the State of Florida in September 2020 and commenced substantive operations, including our pharmaceutical
development program, in late 2020.

Highlights-
First Quarter and Beyond

●March
                                            4, 2025: We announced the approval and upcoming initiation of our Phase 1 clinical
                                            trial for Ketamir-2,