Artelo Biosciences Q1 2024 Financial Results and Business Update

Artelo Biosciences, a clinical-stage pharmaceutical company based in Solana Beach, California, has announced its financial and operational results for the quarter ending March 31, 2024. The company, which focuses on developing treatments for cancer, pain, dermatologic, and neurological conditions through the modulation of lipid-signaling pathways, is making significant strides in its development portfolio.

Gregory D. Gorgas, President and CEO of Artelo Biosciences, expressed satisfaction with the progress in their clinical and preclinical development efforts. He highlighted the near completion of their Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ART26.12. ART26.12 is their leading Fatty Acid Binding Protein 5 (FABP5) inhibitor aimed at treating neuropathic pain.

ART26.12 has shown substantial potential in preclinical studies for treating and preventing oxaliplatin-induced peripheral neuropathy, as documented in the Journal of Pain. Additionally, Artelo was a finalist in the Johnson & Johnson Innovation Challenge, showcasing positive preclinical results for ART26.12 in psoriasis treatment to the Johnson & Johnson dermatology team. The company has partnered with Worldwide Clinical Trials, a contract research organization with expertise in neurology, to support Phase 1 studies once the IND is approved.

Artelo is optimistic about its financial position, with over $7.6 million in cash and equivalents, which should support the IND submission for ART26.12 and the initiation of Phase 1 research by mid-year. The company also aims to complete enrollment for the Phase 2a portion of its Cancer Appetite Recovery Study (CAReS) evaluating ART27.13 for cancer-related anorexia and weight loss by the end of the year. Further preclinical data for ART12.11 is expected in the coming months.

For the quarter ending March 31, 2024, Artelo reported cash and investments totaling $7.6 million. Research and development expenses increased to $1.5 million, up from $1.2 million in the same period the previous year. General and administrative expenses remained steady at $1.1 million. The net loss for the quarter was $2.5 million, or $0.78 per share, compared to a net loss of $2.2 million, or $0.76 per share, in the same period in 2023.

ART27.13 is a G-Protein Coupled Receptor (GPCR) agonist developed to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Originally developed by AstraZeneca, ART27.13 has been tested in more than 250 subjects, showing a significant and dose-dependent increase in body weight among patients with back pain. The drug has demonstrated systemic metabolic effects while minimizing central nervous system toxicity. Following a successful Phase 1 study in cancer patients, Artelo is advancing ART27.13 in the CAReS trial to support care for cancer patients with anorexia and weight loss. There is currently no FDA-approved treatment for cancer anorexia cachexia syndrome.

The CAReS study is a multi-phase trial designed to evaluate ART27.13's effectiveness in cancer-related anorexia and weight loss. The Phase 1b portion has been completed, determining the optimal dose for the Phase 2a stage, which is currently enrolling participants. The primary goals are to assess ART27.13's impact on lean body mass, weight gain, and anorexia improvement.

ART26.12, a selective FABP5 inhibitor, is being developed as a non-opioid, non-steroidal analgesic for chemotherapy-induced peripheral neuropathy (CIPN). Beyond CIPN, Artelo's library of FABP inhibitors shows potential for treating cancers, pain, and anxiety disorders.

ART12.11, a proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP), has shown enhanced pharmacokinetics and efficacy over other CBD forms in nonclinical studies. Artelo aims to leverage ART12.11's superior properties to achieve better safety and efficacy profiles in humans. The U.S. patent for ART12.11 is valid until December 10, 2038.

Artelo Biosciences continues to advance its diverse portfolio of product candidates, leveraging scientific, regulatory, and commercial expertise to address significant unmet medical needs across various conditions.