Artelo Biosciences Provides Business Update and Reports Second Quarter 2025 Financial Results
SOLANA BEACH, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological conditions, today provided a business update and announced its financial and operational results for the three months ended June 30, 2025.
Business Highlights:
ART26.12, Advancing Toward Multi-dose Phase 1 Safety Study
Successfully completed a Phase 1 Single Ascending Dose (SAD) study in 49 healthy volunteers. Data confirmed positive safety results, with only mild, transient adverse events, no drug-related issues, and predictable, dose-linear pharmacokinetics. The wide therapeutic window supports dose titration flexibility and advancement to the next clinical stage.
Preparations are underway for a Multiple Ascending Dose (MAD) study to start in Q4 2025
Presented new data at the British Pain Society Conference, validating the therapeutic potential of FABP inhibitors in osteoarthritis (OA). In a surgical rat model of OA, both single and repeat oral doses of ART26.12 significantly improved weight-bearing function, with effects sustained up to four weeks.
Announced publication of a comprehensive review in Neurobiology of Disease, titled "Fatty acid binding proteins and their involvement in anxiety and mood disorders," underscoring the potential of FABP inhibitors in treating mood and anxiety disorders, expanding ART26.12's therapeutic relevance beyond pain.
ART27.13, Phase 2 Readout Anticipated in Q3 2025
On track to report initial data from the Phase 2 CAReS study of ART27.13, its peripherally acting cannabinoid receptor agonist, in Q3 2025. Following a successful Phase 1 trial demonstrating safety in cancer patients, ART27.13 is positioned to address significant unmet needs in cancer anorexia-cachexia syndrome, a condition currently lacking any FDA-approved therapies.
ART12.11, Progress Targeting Depression and Anxiety
At the 35th Annual International Cannabinoid Research Society (ICRS) Symposium, presented compelling preclinical data for ART12.11, a novel Cannabidiol:Tetramethylpyrazine (CBD:TMP) cocrystal, highlighting dual-action efficacy in alleviating depressive-like behaviors and restoring cognitive function in animals. The results support ART12.11's potential entry into the multi-billion-dollar antidepressant market.
Received clear guidance from MHRA, the regulatory authority in the UK, on a streamlined pathway to the clinic. First-in-human study anticipated to start in first half 2026.
Gregory D. Gorgas, President and CEO of Artelo Biosciences, commented on the results of the second quarter, "We are very pleased with the momentum across our pipeline, highlighted by the growing body of evidence supporting our first-in-class FABP5 inhibitor, ART26.12. The successful completion of our Phase 1 SAD study demonstrated positive safety and pharmacokinetics, laying the groundwork for our upcoming MAD study."
"We are also on track to report Phase 2 data from our CAReS study of ART27.13 during the current third quarter and to collect data demonstrating dual-action efficacy of our preclinical candidate ART12.11 in treating depression and cognitive decline to support our plans to initiate human trials early next year. These achievements reflect our commitment to addressing large unmet medical needs through novel science and thoughtful clinical development," concluded Mr. Gorgas.
Q2 2025 Financial Results (Unaudited)
R&D Expenses: Research and development expenses were $1.9 million for the quarter ended June 30, 2025, compared to $1.7 ...
