Material Event (Form 8-K)

Item 8.01 Other Events

On May 13, 2026, MIRA Pharmaceuticals, Inc. (the "Company") announced the publication of a peer-reviewed manuscript relating to SKNY-1, the Company's investigational oral drug candidate being evaluated for obesity and nicotine addiction, in the International Journal of Molecular Sciences.

The manuscript, titled "SKNY-1, a THCV Analog, Produces Weight Loss, Lipid Normalization and Attenuation of Reward-Associated Behaviors in an mc4r(G894C) Zebrafish Model of Obesity," describes preclinical in vitro pharmacologic characterization and in vivo findings observed in an MC4R-deficient zebrafish model exhibiting obesity-associated metabolic and reward-related phenotypes.

According to the publication, SKNY-1 demonstrated differential engagement of cannabinoid receptor 1 (CB1) signaling pathways, partial agonist activity at cannabinoid receptor 2 (CB2), and selective in vitro inhibition of monoamine oxidase B (MAO-B) relative to MAO-A.

The publication further reports that oral administration of SKNY-1 in the evaluated preclinical model was associated with dose-dependent reductions in body weight following six days of treatment, including approximately 30% reduction relative to baseline in the higher-dose group. The manuscript also reports no significant reduction in whole-body density during the treatment period.

Additional findings described in the publication include normalization of total cholesterol and low-density lipoprotein (LDL) levels, increased high-density lipoprotein (HDL) levels, reduction of hepatic triglyceride accumulation, modulation of leptin and ghrelin gene expression patterns, and attenuation of compulsive feeding and nicotine-seeking behaviors in multiple behavioral paradigms.

The Company previously reported additional preclinical behavioral findings consistent with SKNY-1's differentiated CB1 pathway engagement, including attenuation of anxiety-like behaviors in a validated zebrafish behavioral model evaluating cannabinoid-related central nervous system effects.

The publication is available online through MDPI at https://www.mdpi.com/1422-0067/27/10/4321.

The findings described in the publication are based on preclinical research conducted in zebrafish models and in vitro systems. SKNY-1 has not been approved by the U.S. Food and Drug Administration ("FDA") for any indication, and the safety and efficacy of SKNY-1 have not been established in humans.