Several Key Clinical Readouts in Addition to New Study Initiations Expected in 2025
SOLANA BEACH, Caif., May 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 March 31, 2025.
Business Highlights:
ART26.12:
The first selective fatty acid binding protein 5 (FABP5) inhibitor to enter clinical trials completed enrollment of its Phase I safety study in healthy volunteers. Data readout remains on track for the second quarter of 2025.
Newly published peer-reviewed data revealed ART26.12’s potential in psoriasis, expanding its potential therapeutic applications beyond oncology and pain associated with cancer treatments.
ART27.13:
Initial data from its Phase 2 CAReS study in cancer anorexia-cachexia syndrome, expected during the third quarter of 2025.
ART12.11
Reported new data showing that ART12.11, the Company’s proprietary cannabidiol cocrystal tablet, achieved improved pharmacokinetics compared to Epidiolex® in a head-to-head comparison study in canines.
Preparations are underway to initiate human clinical studies with an oral solid dosage form planned for the second half of 2025.
“All of our lead programs are expected to achieve important milestones over the next 12 months,” said Gregory D. Gorgas, President and CEO of Artelo Biosciences. “With additional published preclinical studies demonstrating the utility of FABP5 in oncology and dermatology, we are eager to share the results of our Phase 1 safety trial of ART26.12 in the next few weeks. ART26.12 represents the first product candidate to enter the clinic from our extensive library of selective FABP inhibitors, each with potential tailored use across multiple therapeutic areas, including cancer and inflammatory diseases.”
“During the third quarter of this year, we also look forward to initial results from our Phase 2 CAReS study evaluating ART27.13 in the treatment of cancer-related anorexia and cachexia. This series of near-term milestones highlights the accelerating momentum across our innovative pipeline as well as the remarkable productivity of our scientific leadership and disciplined execution,” Mr. Gorgas concluded.
Q1 2025 Financial Results (Unaudited)
R&D Expenses: Research and development expenses were $1.4 million for the quarter ended March 31, 2025, compared to $1.5 million for the same period in 2024.
G&A Expenses: General and administrative expenses were $1.0 million for the quarter ended March 31, 2025, compared to $1.1 million in 2024.
Net Loss: For the quarter ended March 31, 2025, net loss was $2.4 million, or $0.72 per basic and diluted common share, which included $0.2 million of non-cash expenses, compared to a net loss of $2.5 million, or $0.78 per basic and diluted common share for the quarter ended March 31, 2024, which included $0.1 million of non-cash expenses.
Cash and Investments: Cash and investments totaled $0.7 million as of March 31, 2025.
In early May 2025, the Company issued $0.9 million at-market convertible notes. This funding is expected to be sufficient to fund Company operations until additional financing is completed.
About ART26.12 ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic. Cleared by the FDA for a first-in-human study in the US, a Phase 1 trial with ART26.12 was initiated in late 2024. The initial clinical development planned is for chemotherapy-induced peripheral neuropathy (CIPN). Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. FABP is overexpressed and associated with abnormal lipid signaling in a number of pathologies. In addition to ART26.12 in CIPN, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders.
About ART27.13 ART27.13 is a novel benzimidazole derivative being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Initially developed by AstraZeneca plc, ART27.13 has been in six clinical studies with over 250 participants. A statistically significant and dose-dependent increase in body weight was observed in people with back pain who were otherwise healthy. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Having completed a Phase 1 study in cancer patients where ART27.13 demonstrated an excellent safety profile, Artelo is now advancing it in the Phase 2 CAReS trial as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome.
About CAReS The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in patients with cancer anorexia and weight loss. Cancer-related anorexia, or the lack or loss of appetite in the person with cancer, may result from the cancer and/or its treatment with radiation or chemotherapy. It is common for people with cancer to lose weight. Anorexia and the resulting weight loss can affect a patient’s health, often weakening their immune system and causing discomfort and dehydration. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to chemotherapy. Now completed, the Phase 1 portion of the CAReS study was designed to determine the most effective and safest dose of ART27.13 for dosing in the Phase 2 stage. Currently enrolling, the Phase 2 portion of the CAReS study is designed to determine estimates of activity of ART27.13 in terms of lean body mass, weight gain, and improvement of anorexia. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817)
About ART12.11 ART12.11 is Artelo’s wholly owned, proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). Isolated as a single crystalline form, ART12.11 has exhibited better pharmacokinetics and improved efficacy compared to other forms of CBD in nonclinical studies. Greatly enhanced pharmaceutical properties, including physicochemical, pharmacokinetic, and pharmacodynamic advantages have been observed with ART12.11. Artelo believes a more consistent and improved bioavailability profile in a solid dosage form may ultimately lead to increased safety and efficacy in humans, thus making ART12.11 a preferred CBD pharmaceutical composition. The U.S. issued composition of matter patent for ART12.11 is enforceable until December 10, 2038.
About Artelo Biosciences Artelo Biosciences, Inc. is a clinical stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways. Artelo is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the company applies leading edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at www.artelobio.com and Twitter: @ArteloBio.
Forward Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission, including our ability to raise additional capital in the future. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by applicable securities laws.
