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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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MIRA PHARMACEUTICALS, INC. | ||
| Dated: May 13, 2026 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |