Company: MIRA
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0001641172-25-024077
Chunk: 16

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-08-14
Form: 10-Q
Item: Item 8
Chunk 16
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 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. Initial preclinical studies evaluating its efficacy in
treating inflammatory pain have been initiated and completed, with additional studies currently ongoing to further assess its therapeutic
potential.

Our
second development program, MIRA-55, is a novel oral pharmaceutical marijuana molecule being studied for its potential to alleviate anxiety
and cognitive decline, symptoms commonly associated with early-stage dementia. We have conducted, and continue to evaluate, preclinical
studies to assess MIRA-55’s potential efficacy in treating inflammatory pain. 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-
Second Quarter and Beyond

    ●
    On
    May 28, 2025, MIRA announced that its lead pharmaceutical candidate, Ketamir-2, a next-generation oral ketamine analog, is currently
    in an ongoing Phase 1 clinical trial. The second dosing cohort has been successfully completed, and the Company is preparing to initiate
    the third cohort. MIRA anticipates beginning a Phase IIa clinical trial in neuropathic pain by the end of 2025, advancing the development
    of what it believes could be a safe and effective treatment for chronic pain.

    ●
    On
    June 30, 2025, MIRA announced new animal study results from SKNY-1, a next-generation oral therapeutic the Company is under definitive
    agreement to acquire from SKNY Pharmaceuticals, Inc. In a zebrafish model that mimics human obesity and craving behaviors, SKNY-1
    demonstrated weight loss, suppression of appetite and craving for high-calorie diets, and reversal of nicotine-seeking behavior—all
    achieved within six days of oral treatment.

15

    ●
    On
    July 2, 2025, MIRA announced preclinical results demonstrating that its proprietary drug candidate, Mira-55, a non-