Company: MIRA
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0001641172-25-024077
Chunk: 27

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-08-14
Form: 10-Q
Item: Item 2
Chunk 27
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0.

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-psychoactive marijuana
    analog, delivered morphine-comparable pain relief in a validated animal model of inflammatory pain, without inducing local inflammation.

    ●
    On
    July 10, 2025, MIRA announced new preclinical results from SKNY-1, an oral drug candidate for obesity and nicotine addiction currently
    under definitive agreement for acquisition. In a validated behavioral model used to measure Cannabinoid 1 receptor (CB1)-related
    anxiety-like effects, SKNY-1 demonstrated clear reversal of anxiety-related behavior induced by a CB1 activator, distinguishing it
    from earlier CB1-targeting drugs that were discontinued due to unfavorable safety profiles.

    ●
    On
    July 28, 2025, MIRA announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application
    for Ketamir-2, the Company’s novel oral NMDA receptor antagonist for the treatment of neuropathic pain. The clearance enables
    MIRA to initiate U.S.-based clinical trials.

On
July 29, 2025, MIRA announced new preclinical data evaluating the