Company: ARTL
Filing Date: 2025-09-05
Form Type: 424B5
Source: 0001640334-25-001629
Chunk: 12

Company: ARTELO BIOSCIENCES, INC.
Filing Date: 2025-09-05
Form: 424B5
Chunk 12
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, on August 19, 2025, we entered into a Termination Agreement (the “ABK Labs Termination Agreement”) pursuant to which the parties mutually agreed to terminate, effective as of August 16, 2025 (the “Termination Date”), the Consultant Agreement and the ABK Labs Warrant and provided mutual releases of claims relating thereto. No cash payments, penalties, or other consideration were paid in connection with the termination.   We have adopted a Digital Asset Treasury strategy whereby we will purchase the digital currency known as Solana. As of August 6, 2025, the Company has expended $250,000 to purchase Solana.   On September 3, 2025, we announced interim results from the Phase 2 CAReS trial, which 32 participants have been enrolled in as of June 30, 2025. 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% loss (SD 4.89) in placebo at one month, as well as qualitative improvements in total and weekly activity scores.   Safety results were consistent with prior findings. Among the 32 participants enrolled in the CAReS Phase 2 trial to date, 7 patients (22%) experienced adverse events that may be related to ART27.13. All were mild or moderate, with the exception of a single case of severe malaise, and no drug-related serious adverse events were reported. These data are aligned with safety outcomes observed in Phase 1 of CAReS, supporting ART27.13’s overall favorable tolerability and acceptable safety profile.   On September 4,