MIRA PHARMACEUTICALS, INC.

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical development company advancing a pipeline of novel oral therapeutics targeting neurologic, neuropsychiatric, metabolic, and addiction-related disorders. The company maintains its website at www.mirapharmaceuticals.com.

The company holds exclusive rights in the United States, Canada, and Mexico to three primary drug candidates. Ketamir-2 is a next-generation oral NMDA receptor modulator that has completed Phase 1 clinical trials in healthy volunteers, with both single-ascending-dose and multiple-ascending-dose cohorts showing no serious adverse events or dose-limiting toxicities to date. The company is preparing to initiate a Phase 2a clinical trial in chemotherapy-induced peripheral neuropathy in the first half of 2026. MIRA-55 is a novel oral, non-psychoactive cannabinoid analog in preclinical development for inflammatory pain and central nervous system conditions, including anxiety and cognitive impairment. In validated preclinical models, MIRA-55 demonstrated analgesic effects comparable to morphine while producing anti-inflammatory activity not observed with opioid treatment. The company is advancing MIRA-55 through IND-enabling development activities targeting an Investigational New Drug submission for inflammatory pain.

In September 2025, MIRA acquired SKNY Pharmaceuticals, Inc., a private company developing SKNY-1, a preclinical-stage oral therapeutic candidate designed to modulate CB1 and CB2 receptor signaling and selectively inhibit monoamine oxidase B. SKNY-1 targets pathways involved in energy balance, lipid metabolism, appetite regulation, reward, and craving-related behaviors. In preclinical models, SKNY-1 demonstrated reductions in body weight and food consumption without measurable muscle loss, along with decreased nicotine-seeking behavior. The company is conducting additional preclinical studies and advancing SKNY-1 toward IND-enabling development activities, targeting an IND submission in 2026.

The U.S. Drug Enforcement Administration has completed its scientific review and concluded that Ketamir-2, MIRA-55, and SKNY-1 are not currently considered controlled substances under the Controlled Substances Act, potentially facilitating clinical development and commercialization. MIRA operates as a smaller reporting company and is classified as a non-accelerated filer.