ARTELO BIOSCIENCES, INC.

The company, incorporated in Nevada on May 2, 2011, and based in San Diego, California, is a clinical-stage biopharmaceutical company. It focuses on developing and commercializing treatments that target lipid-signaling modulation pathways, including the endocannabinoid system. The company's product pipeline utilizes scientific methodologies to develop pharmaceuticals for patients with unmet healthcare needs. Its primary program involves ART27.13, a novel, benzimidazole dual cannabinoid (CB) agonist that targets both the CB1 and CB2 peripheral receptors. This synthetic small molecule, a G protein-coupled receptor (GPCR), was initially developed by AstraZeneca plc. The company is developing ART27.13 as a potential treatment for cancer-related anorexia and it is currently in a Phase 1b/2a trial called the Cancer Appetite Recovery Study (CAReS). An interim analysis of the ongoing Phase 2a CAReS trial showed that patients with cancer anorexia receiving ART27.13 had a mean weight gain of over 6% compared to a 5% loss in the placebo group, while maintaining a safety profile similar to Phase 1b, even at doses up to twice the previous maximum. There is currently no FDA-approved treatment for cancer anorexia cachexia syndrome. The company's second program, ART26.12, is a small molecule and the lead product candidate from its chemical library of inhibitors of fatty acid binding proteins, specifically Fatty Acid Binding Protein 5 (FABP5). The company received U.S. Food & Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for ART26.12 in July 2024 and has completed enrollment for a Phase 1 clinical trial in healthy subjects. This trial supports the development of ART26.12 as an agent intended to treat chemotherapy-induced peripheral neuropathy (CIPN).