Artelo Biosciences Provides Business Update Highlighting Clinical Progress and Reports Fiscal 2025 Year-End Financial Results

Core Insights - Artelo Biosciences, Inc. is advancing its clinical-stage pharmaceutical programs with positive human data and upcoming clinical catalysts, focusing on treatments for cancer, pain, and other conditions [1] Business Highlights - Successful completion of a Phase 1 study for ART26.12, showing a favorable safety profile and predictable pharmacokinetics, with plans to initiate a multiple ascending dose study in Q3 2026 [2] - Positive interim Phase 2 results for ART27.13, demonstrating improvements in body weight, lean body mass, and physical activity in patients with cancer anorexia-cachexia syndrome [3] - Received favorable regulatory guidance from the UK MHRA for ART12.11, with plans to initiate human clinical studies in H1 2027 [4] Clinical Progress - ART26.12 has shown sustained analgesic effects comparable to naproxen without tolerance in preclinical models, positioning it as a non-opioid alternative for pain management [5] - ART27.13 has received a Notice of Allowance from the European Patent Office, extending patent protection through December 2041, which has increased partner interest in its development [5] - ART12.11 has demonstrated robust antidepressant-like activity in preclinical studies, with plans for first-in-human studies early next year [5] Financial Results - Research and development expenses for FY 2025 were $5.4 million, down from $6.0 million in FY 2024 [6] - General and administrative expenses increased to $6.0 million in FY 2025 from $4.1 million in the previous year [6] - The net loss for FY 2025 was $12.9 million, or $12.52 per share, compared to a net loss of $9.8 million in FY 2024 [6] - Cash and investments totaled $0.6 million as of December 31, 2025 [6] Product Information - ART26.12 is a lead FABP5 inhibitor aimed at treating chemotherapy-induced peripheral neuropathy, with a favorable safety profile and dosing flexibility [8] - ART27.13 is a cannabinoid receptor agonist targeting cancer-related anorexia and cachexia, showing a mean weight gain of over 6% in the top dose group compared to a 5% loss in the placebo group [9][10] - ART12.11 is a proprietary cocrystal composition of CBD and TMP, with enhanced pharmacokinetics and plans for clinical studies in 2026 [11]