Company: ARTL
Filing Date: 2025-09-03
Form Type: 8-K
Source: 0001640334-25-001617
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Company: ARTELO BIOSCIENCES, INC.
Filing Date: 2025-09-03
Form: 8-K
Item: Item 8.01
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Item 8.01 Other Information

Announcement of Interim Phase 2 CAReS Results for the Treatment of Cancer Anorexia-Cachexia Syndrome (CACS)

On September 3, 2025, Artelo Biosciences, Inc. (the “ Company”)announced interim results from its Phase 2 Cancer Appetite Recovery Study (CAReS) trial with ART27.13, the Company’s peripherally acting cannabinoid receptor agonist for the treatment of cancer anorexia-cachexia syndrome (CACS). Affecting up to 80% of people living with cancer, CACS is marked by loss of appetite, weight loss, and breakdown of muscle and fat. This leading cause of death in cancer patients has no FDA-approved treatment. The Company believes the CAReS interim data comparing ART27.13 to placebo supports acceleration of the Company’s partnering initiatives with its lead clinical program.

The Phase 2 CAReS study is evaluating ART27.13 as a once-daily oral treatment aimed at improving weight, appetite, activity, and quality of life in cancer patients who had lost a minimum of 5% of their body weight in the prior six months. Effectiveness was measured by changes in lean body mass, weight, appetite, and activity over 12 weeks and at a 30-day follow-up. Activity and quality of life were assessed using wearable monitors and standardized questionnaires, while safety was closely tracked through adverse event reporting, laboratory tests, vital signs, visual analogue scales, and ECGs.

In the interim analysis, 18 evaluable patients - primarily with lung and gastrointestinal cancers not receiving cyclic chemotherapy - were included. After 12 weeks of treatment in patients who titrated to the top dose evaluated of 1300 micrograms (n=5), ART27.13 demonstrated compelling increases in mean body weight of 6.38% (Standard Deviation or SD 9.50) compared to patients on placebo (n=6) who lost -5.42% (SD 8.17). The maximum weight gain in the ART27.13 group reached 18.5%, versus only 0.4% in placebo. The maximum weight loss in the placebo arm was -17.4%, compared to just -3.0% in the ART27.13 group. Additional benefits were seen in lean body mass, with a +4.23% increase (SD 5.37) in the treatment group versus a -3.15