Business Highlights
ART26.12 Progressing through Phase 1 studies: Following positive first-in-human Phase 1 single ascending dose and preliminary food-effect data with ART26.12, Artelo continues preparations to initiate the multiple ascending dose study, with enrollment anticipated to begin in the fourth quarter of 2026. ART26.12, a potential first-in-class analgesic with a novel mechanism-of-action, has been well tolerated at all doses tested with predictable pharmacokinetics, thus supporting its potential as a differentiated, non-opioid, non-steroidal treatment for pain. In addition, preclinical findings recently published in the European Journal of Pain demonstrated broad analgesic activity across multiple pain models, including modulation of key pain-related pathways and reduction of pro-inflammatory mediators, further reinforcing the therapeutic potential of ART26.12.
ART27.13 Potential Indications Expansion: The Company continues to build on encouraging interim Phase 2 CAReS data in patients with cancer-related anorexia demonstrating improvements in body weight, lean body mass, and physical activity, along with a favorable tolerability profile. Strategic discussions to support the program's next stage of development are proceeding in parallel. Artelo is also exploring ART27.13 beyond its lead indication, including as a potential GLP-1 companion therapy to help preserve lean body mass, and a third-party, fully funded clinical study in glaucoma.
"Artelo entered 2026 with strong clinical momentum across our pipeline, as we continue to advance multiple programs toward key inflection points," said Gregory D. Gorgas, Chief Executive Officer of Artelo. "We are particularly keen to initiate the next Phase 1 study with ART26.12, our lead FABP5 inhibitor, which we believe has significant potential as a novel mechanism of action for the treatment of pain. Recent preclinical data published in the European Journal of Pain, together with the favorable safety and tolerability profile observed to date, reinforce our confidence in ART26.12 as a compelling, potentially first-in-class approach to pain management."
"As we look ahead, our recent capital raise has strengthened our balance sheet, providing significant cash runway to advance our clinical programs. In addition, we continue to benefit from third-party clinical research grants, notably the fully funded Phase 2 study in glaucoma with ART27.13. We are actively engaged in partnering discussions and are encouraged by the depth of interest and quality of engagement we are seeing across our programs. We believe this positions Artelo to ...
