- Trial Phase
- Phase 2
- Time to Market
- 5+ years if successful; the Phase 2 CAReS trial is still enrolling, and the company is seeking a development partner to fund pivotal/registration trials.
- Why 4/10
- No hard, dated binary catalyst (PDUFA or pivotal readout) is scheduled within the next ~12 months. The Phase 2 CAReS interim data was presented in September 2025, and the company is pursuing a partnering/licensing deal to fund registration trials. A glaucoma IST is investigator-sponsored and fully funded but small. Without a clear upcoming binary event, the score defaults to 4.
ART27.13 showed encouraging Phase 2 data (weight gain vs placebo loss in cachexia patients), but ARTL is a micro-cap (~$2.6-4M market cap) that has done two reverse splits to maintain Nasdaq listing, raised $11M via a dilutive private placement, and has no analyst Buy ratings. The stock is a speculation that the company will secure a development partner. Watch for partnership announcements, which are the most likely near-term catalyst — not clinical data readouts.
Price Chart
Executive Summary
ART27.13 is Artelo Biosciences' lead drug candidate, a once-daily oral pill targeting cancer-related anorexia and cachexia (CACS) — a condition with no FDA-approved treatment affecting up to 80% of advanced cancer patients. Phase 2 interim data showed patients on the highest dose gained ~6% body weight over 12 weeks while placebo patients lost ~5%, with correlated gains in lean body mass. The company is also exploring ART27.13 in glaucoma (via a fully funded investigator-sponsored trial enrolling in Q2 2026), as a GLP-1 companion therapy for muscle preservation, and in preclinical models of chemotherapy-induced nerve pain. However, ARTL is a micro-cap with roughly $10M cash, has executed two reverse stock splits to maintain Nasdaq listing, underwent dilutive financing, and has zero analyst Buy ratings (3 Hold, 3 Sell/Strong Sell). The company is actively seeking a development partner to fund registration trials — making partnership news the key near-term catalyst.
How It Works
ART27.13 is a synthetic pill that activates the body's cannabinoid receptors (CB1 and CB2) — the same system that THC interacts with — but it is designed to stay in the peripheral tissues (not the brain) to stimulate appetite and preserve muscle without the psychoactive "high." It was originally discovered by AstraZeneca.
Trial Status
The Phase 1b/2a CAReS (Cancer Appetite Recovery Study) trial completed Phase 1b enrollment (Q1 2023) and is conducting Phase 2. Positive interim Phase 2 data was presented in September 2025 (6% weight gain at 1300 µg dose vs 5% weight loss on placebo over 12 weeks). The trial was expanded to 40 patients with a 3:1 randomization. An investigator-sponsored Phase 2 trial for glaucoma (fully funded by Glaucoma UK) began enrolling in Q2 2026. Preclinical data for paclitaxel-induced peripheral neuropathy was published July 2026.
The Two-Sided Case
Upcoming Catalysts
- Full Phase 2 CAReS data readout (trial expanded to 40 patients, 3:1 randomization) — timing unclear but could be late 2026/early 2027.
- Partnership/licensing deal for ART27.13 — the company has publicly stated it is seeking a development partner after positive interim Phase 2 data.
- Glaucoma IST (investigator-sponsored trial): first patient enrollment anticipated Q2 2026.
- Potential expansion of preclinical results for paclitaxel-induced peripheral neuropathy into clinical planning (July 2026 data).
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Artelo Biosciences Press Release ARTL ·Originating report