Business Highlights:
Successful Phase 1 study with ART26.12: Reported positive first-in-human Phase 1 single ascending dose (SAD) clinical data demonstrating a favorable safety profile, predictable pharmacokinetics, and dosing flexibility. As a result, the Company is working to complete preparations to open enrollment to the multiple ascending dose (MAD) study in the third quarter of 2026.
Positive interim Phase 2 results with ART27.13: Announced positive interim Phase 2 CAReS data demonstrating improvements in body weight, lean body mass, and physical activity alongside a favorable side-effect profile compared to placebo in patients with cancer anorexia-cachexia syndrome.
Streamlined regulatory pathway for ART12.11: Received favorable UK MHRA regulatory guidance supporting Phase 1 study plans and potential accelerated pathways. Pending outcome of toxicology study results in 2026, the Company plans to initiate human clinical studies with an oral solid dosage form during the first half of 2027.
"2025 was a pivotal year clinically for Artelo, marked by meaningful progress across all our core programs," stated Gregory D. Gorgas, Chief Executive Officer of Artelo, "We successfully completed a first-in-human Phase 1 SAD study for ART26.12 and validated our FABP5 inhibition approach to pain management. These results were further strengthened by positive preclinical efficacy data with ART26.12 which demonstrated sustained analgesic effects without tolerance in an osteoarthritis pain model, with efficacy comparable to naproxen and a potentially safer profile. We are excited to be progressing this program as a differentiated, non-opioid, non-steroidal alternative for pain"
"We were very pleased to report positive interim Phase 2 CAReS data for ART27.13. These results reinforced ART27.13's potential as a meaningful therapeutic strategy to address the significant unmet medical need in patients with cancer anorexia-cachexia syndrome. In addition, we received a Notice of Allowance from the European Patent Office covering the intended commercial formulation of ART27.13 and extending patent protection through December 2041. Together, the clinical progress and enhanced intellectual property position have advanced partner interest in supporting the program's next stage of development."
"In parallel, we were pleased with the UK MHRA's favorable regulatory guidance supporting our Phase 1 clinical plans for ART 12.11. As presented at the 35th Annual International Cannabinoid Research Society Symposium, ART12.11's positive preclinical efficacy was confirmed by its robust antidepressant-like activity in a stress-induced depression model, with efficacy comparable to sertraline (Zoloft) and differentiated cognitive benefits not observed with leading SSRIs. ...
