Mira Pharmaceuticals, Inc. announced promising new findings from recent preclinical studies of its novel oral pharmaceutical marijuana analog, MIRA-55, which is being studied as a potential treatment for anxiety and cognitive decline. The new data confirms MIRA's earlier beliefs regarding MIRA-55's pharmacological profile and potential for potency and efficacy. Importantly, however, the new preclinical data compared MIRA-55 directly to THC, the main active component in marijuana, and showed promising results.

MIRA initially focused its marijuana analog preclinical study program around an oral compound called "MIRA1a." As previously disclosed in March 2024, in late 2023, MIRA, based on discussions with its contract manufacturers, began to suspect that MIRA1a was in fact a new molecule with a distinct chemical structure, which MIRA named "MIRA-55". This discovery led to the filing by MIRA of a global provisional patent application for MIRA-55 in March 2024. At that time, MIRA indicated its belief that MIRA-55 displayed enhanced potency and potential for efficacy over MIRA1a but noted that additional testing was required to confirm MIRA's preliminary beliefs.

The new testing results provide such confirmation. The recent preclinical studies, conducted in vitro and through a mouse model, confirm that MIRA-55 offers significant potential advantages over THC. MIRA-55 showed higher efficacy at both the CB1 and CB2 cannabinoid receptors compared to THC.

It also demonstrated a more pronounced and sustained increase in agonist activity as the concentration increases, indicating the potential for greater effectiveness in activating key cannabinoid receptors responsible for its therapeutic effects. MIRA holds the exclusive U.S., Canadian, and Mexican rights for Ketamir-2, a novel, patent-pending oral ketamine analog under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression, major depressive disorder with suicidal ideation, and post-traumatic stress disorder. In addition, MIRA's novel oral pharmaceutical marijuana analog,MIRA-55, is currently under investigation for treating adult patients suffering from neuropathic pain as well as anxiety and cognitive decline, often associated with early-stage dementia.

MIRA-55, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders. The U.S. Drug Enforcement Administration's scientific review of Ketamir-2 and MIRA-55 concluded that each would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. Ketamir-2 andMIRA-55 are in early-stage preclinical development.

There is no assurance that the products will proceed through development or will receive FDA approval for marketing.