Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 17

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 17
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 the Controlled Substances Act and its governing regulations. This regulatory distinction significantly enhances their commercial and clinical viability, removing potential barriers associated with controlled substances and positioning both compounds for streamlined clinical development and commercialization.

MIRA remains committed to advancing Ketamir-2 and MIRA-55 through clinical development with a focus on addressing major unmet medical needs and improving patient outcomes.

Preclinical Studies and Pharmacology of Ketamir-2

MIRA has conducted extensive preclinical studies to characterize the pharmacological profile, safety, and therapeutic potential of Ketamir-2, an investigational compound targeting neuropathic pain, treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDD-SI), and post-traumatic stress disorder (PTSD). These studies, performed in accordance with ICH and FDA regulatory guidelines, include in vitro and in vivo assessments to evaluate receptor binding, efficacy, selectivity, pharmacokinetics, metabolism, general pharmacology and toxicology.

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Mechanism of Action and Receptor Selectivity Ketamir-2 has been identified as a low-affinity NMDA receptor antagonist, selectively binding to the PCP-site with an IC50 of approximately 100 µM. Its primary metabolite, Nor-Ketamir, also binds to the PCP-site and does not exhibit affinity for NMDA site, with an IC50 of approximately 300 µM. This targeted receptor interaction differentiates Ketamir-2 from ketamine, which exhibits broader receptor binding, including opioid and monoaminergic receptors, and binds to NMDA receptors with significantly higher affinity (0.5–1 µM). SKNY Pharmaceuticals, Inc. 3014 West Palmira Ave., Suite 302 Tampa, FL 33629 (504) 931-6427 Overview SKNY Pharmaceuticals, Inc. (“SKNY”) is a preclinical-stage pharmaceutical development company focused on next-generation oral therapeutics targeting cannabinoid and dopamine-related pathways. Its lead candidate, SKNY-1, is being developed as a novel oral treatment designed to modulate cannabinoid receptors CB1 and CB2, as well as monoamine oxidase B (MAO-B)—an enzyme involved in dopamine metabolism and addiction regulation. This dual mechanism offers potential applications in both metabolic and addiction-related disorders. If successful, SKNY-1 could address the growing demand for safe and effective therapeutic solutions in areas such as weight management and smoking cessation. In particular:

| ● | SKNY-1,                                                                                           
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