Clinical and Scientific Progress Across the Pipeline Supports Multiple Upcoming Milestones
SOLANA BEACH, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) — Artelo Biosciences, Inc. (Nasdaq: ARTL) (“Artelo” or the “Company”), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological, or neurological conditions, today provided a business update and announced its financial and operational results for the second quarter ended June 30, 2026.
Business Highlights
ART26.12:
- Advancing Toward Multiple-Dose Clinical Evaluation: Artelo continues preparations to initiate a Phase 1 multiple ascending dose study in the fourth quarter of 2026. First-in-human data showed favorable safety and tolerability, linear and dose-proportional pharmacokinetics, exposure above projected therapeutic levels, and a wide potential therapeutic margin. Human metabolite profiling identified only three low-level metabolites, representing approximately 7% of total drug-related exposure, with no human-specific metabolites or safety concerns.
- Growing Evidence for the Treatment of Chronic Pain: New nonclinical findings broaden the program beyond chemotherapy-induced peripheral neuropathy. In an osteoarthritis model, ART26.12 provided pain relief comparable to naproxen with significantly less gastric tissue damage. Separate spinal cord injury research showed reductions in mechanical hypersensitivity and spontaneous pain behaviors. Together with AI-enabled biomarker analyses of Artelo’s proprietary datasets, these findings further support the potential of selective FABP5 inhibition as a differentiated, non-opioid approach for the treatment chronic pain.
ART27.13:
- More Opportunity Beyond Cancer Supportive Care: Encouraging interim Phase 2 CAReS data showed improvement in body weight, lean body mass and physical activity, particularly at the highest dose. New nonclinical results in a paclitaxel-induced peripheral neuropathy model also demonstrated reductions in pain-related behaviors. In addition to conducting a fully funded Phase 2 clinical study in glaucoma, the Company is evaluating additional development opportunities, including as a potential GLP-1 companion therapy for muscle preservation.
ART12.11:
- Supported by Peer-Reviewed CBD Analysis: A recent review of more than 50 studies found that low-dose CBD products generally failed to achieve adequate therapeutic exposure, while highlighting drug-drug interaction considerations. The findings support the rationale for ART12.11, Artelo’s patented CBD:TMP cocrystal, which is designed to improve bioavailability and enable more consistent, titratable exposure. The Company is advancing preclinical preparations for human studies.
“We entered the second half of 2026 from a position of strength, having reinforced our balance sheet through a successful $11.0 million financing and progressing each of our development programs,” said Gregory D. Gorgas, President and Chief Executive Officer. “Specifically, ART26.12 continues to generate compelling data that strengthens our confidence in its potential as a differentiated, non-opioid therapy for chronic pain, while ART27.13 and ART12.11 continue to achieve progress. With several key catalysts on the horizon, we believe Artelo is well positioned to deliver meaningful value for patients and shareholders.”
Q2 2026 Financial Results
- R&D Expenses: Research and development expenses were $0.9 million for the quarter ended June 30, 2026, compared to $1.9 million for the quarter ended June 30, 2025.
- G&A Expenses: General and administrative expenses were $1.6 million for the quarter ended June 30, 2026, compared to $1.3 million in the quarter ended June 30, 2025.
- Net Loss: For the quarter ended June 30, 2026, net loss was $2.4 million, or $0.89 per basic and diluted common share, compared to a net loss of $3.2 million for the quarter ended June 30, 2025.
- Cash and Investments: Cash and investments totaled $4.2 million as of June 30, 2026.
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, with a diversified pipeline addressing significant unmet needs in anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by an experienced executive team collaborating with world-class researchers and technology partners, Artelo applies rigorous scientific, regulatory, commercial, and treasury management practices, including digital assets, to maximize stakeholder value. More information is available at www.artelobio.com and X: @ArteloBio.
About ART26.12
ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is under development as a novel, peripherally acting, non-opioid, non-steroidal analgesic, initially for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). Human studies with ART26.12 have demonstrated a favorable safety profile with no serious adverse events, as well as predictable, linear pharmacokinetics and dosing flexibility in both fed and fasted states. Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. In addition to ART26.12, 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 cannabinoid receptor agonist being developed as supportive care for people with cancer experiencing anorexia and cachexia. Administered orally once daily, the treatment goals with ART27.13 are to improve appetite, body weight, and activity levels while preserving muscle and elevating quality of life. Initially developed by AstraZeneca plc, ART27.13 selectively targets peripheral cannabinoid (CB1 and CB2) receptors to avoid the psychoactive side effects typically associated with some cannabinoids. While exhibiting a favorable safety profile at all doses in the CAReS trial, interim analysis from the blinded and randomized Phase 2 study demonstrated a mean weight gain of over 6% for participants that received the top dose of ART27.13 compared to a 5% loss in the placebo group. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to therapy. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome. ART27.13 is also being evaluated in a Phase 2 study as an oral treatment to lower intraocular pressure in glaucoma patients.
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 people with cancer experiencing 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. Interim data from the Phase 2 portion of CAReS showed improvements in lean body mass, weight gain, and activity among patients treated with all doses of ART27.13, particularly at the highest dose, compared to the participants administered placebo. (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. Artelo has received favorable UK MHRA regulatory guidance supporting Phase 1 study plans and potential accelerated pathways with plans to initiate human clinical studies in the first half of 2026. 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 may ultimately lead to increased safety and efficacy in humans, thus making ART12.11 a preferred CBD pharmaceutical composition. The US issued composition of matter patent for ART12.11 is enforceable until December 10, 2038, and has now been granted or validated in 21 additional countries.
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 statements 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.
Investor Relations Contact:
Crescendo Communications, LLC
Tel: 212-671-1020
Email: [email protected]
