Artelo Biosciences Q2 2024 Financial Results and Business Update

Artelo Biosciences, Inc., a clinical-stage pharmaceutical company based in Solana Beach, California, has announced its financial and operational results for the quarter ending June 30, 2024. The company, which trades under the ticker ARTL on Nasdaq, focuses on developing treatments for cancer, pain, dermatologic, and neurological conditions by modulating lipid-signaling pathways.

According to Gregory D. Gorgas, President and CEO of Artelo Biosciences, the company is entering a highly productive phase in its clinical development efforts. In the next 18 months, multiple clinical readouts are expected across their portfolio. Notably, the U.S. Food and Drug Administration (FDA) has recently cleared Artelo to initiate clinical trials for ART26.12, aimed at treating chemotherapy-induced peripheral neuropathy. Initial results from the Phase 1 trial are anticipated in the first half of 2025. Additionally, the company expects to complete enrollment for the Phase 2a portion of the CAReS trial for their leading clinical asset, ART27.13, by late 2024 or early 2025. Thus far, no serious adverse events related to the study drug have been reported in the CAReS trial.

Artelo is also preparing ART12.11, a proprietary co-crystal of CBD and TMP for the treatment of anxiety and depression, for an early 2025 clinical study. The company has over $5.6 million in cash and cash equivalents as of the end of June 2024, and an additional $1.3 million received from UK government R&D tax credits, positioning them well to advance their asset portfolio.

The company has also presented encouraging data from several preclinical studies at the 34th Annual International Cannabinoid Research Society Symposium. These studies highlighted the efficacy of ART26.12 in treating breast cancer-induced bone pain and demonstrated the potential of their FABP Inhibitor platform. Additionally, ART12.11 has shown significant advantages as a product candidate for anxiety-related disorders. Comparative data suggest that ART12.11 could potentially outperform existing formulations like Epidiolex, which had sales exceeding $700 million in 2023.

Financially, Artelo reported $5.6 million in cash and investments as of June 30, 2024. Research and development (R&D) expenses for the quarter were $1.7 million, up from $0.8 million in the same period of 2023. General and administrative expenses were $0.8 million, slightly down from $1.0 million in the previous year. The net loss for the quarter was $2.4 million, or $0.75 per share, compared to a net loss of $1.6 million, or $0.56 per share, in the same quarter of the previous year. The company also received approximately $1.3 million in R&D tax credits from the UK government in July 2024.

ART27.13, a G-Protein Coupled Receptor (GPCR) agonist targeting CB1 and CB2 receptors, is being developed to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Initially developed by AstraZeneca, ART27.13 has been tested in clinical studies with over 250 subjects, demonstrating a statistically significant increase in body weight. Artelo is currently advancing ART27.13 in the CAReS trial, aimed at treating cancer-related anorexia and weight loss.

ART26.12 is a potent and selective inhibitor of FABP5, being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic. Its initial clinical study will focus on chemotherapy-induced peripheral neuropathy (CIPN). Artelo's library of small molecule inhibitors of FABPs shows promise for treating cancers, neuropathic and nociceptive pain, dermatologic conditions, and anxiety disorders.

ART12.11, Artelo’s proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP), has shown better pharmacokinetics and improved efficacy compared to other forms of CBD in preclinical studies. The company believes that ART12.11’s improved bioavailability profile could lead to increased safety and efficacy in humans.

Artelo Biosciences remains committed to developing and commercializing innovative therapeutics that modulate lipid-signaling pathways, addressing significant unmet needs in multiple diseases and conditions including cancer, pain, and anxiety. The company leverages the expertise of experienced biopharmaceutical executives and respected researchers to advance their high-impact therapies.

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