Artelo Biosciences Presents ART26.12 Human Metabolite Data Demonstrating Favorable Drug Metabolism Characteristics Associated with Clinical Development Success

Artelo’s lead medicinal chemist reveals findings at the Royal Society of Chemistry-BMCS/DMDG Medicinal Chemistry Conference in London

SOLANA BEACH, Calif., June 10, 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, announces that Myles Osborn, Lead Medicinal Chemist at Artelo, is delivering an oral presentation today highlighting encouraging metabolite identification and profiling data from the Company’s lead FABP inhibitor candidate, ART26.12, during the 7th RSC-BMCS/DMDG New Perspectives in DMPK and Medicinal Chemistry Conference, held at the Burlington House in London.

The presentation features results from metabolite identification studies conducted using plasma samples obtained from healthy volunteers enrolled in the recently completed Single Ascending Dose (SAD) clinical study of ART26.12. Since drug metabolism and pharmacokinetic properties are critical factors contributing to successful clinical development, early characterization of ART26.12’s metabolite profile provides valuable insight that may help streamline future development activities and reduce program risk.

Key findings include:

• Only three metabolites were detected from the plasma of healthy volunteers administered a single 900 mg oral dose of ART26.12.
• Total metabolite exposure represented approximately 7% of overall drug-related exposure, indicating that the vast majority of circulating drug-related material was the parent compound, ART26.12.
• The primary metabolite detected, accounting for approximately 5% of total drug-related exposure, was successfully identified and shown to have biological activity comparable to ART26.12.
• All three metabolites identified in humans were previously detected in the nonclinical species used in the ART26.12 toxicology program and are of no safety concern.
• Collectively, these findings suggest a low-risk metabolite profile, which may simplify future development activities and further support advancement of ART26.12 through clinical development.

“Understanding the metabolic fate of ART26.12 early in clinical development has been an important objective for our team,” said Myles Osborn, Lead Medicinal Chemist at Artelo. “It was important for us to quantify and gain early structural and biological knowledge of the metabolites, which we believe will de-risk and significantly simplify future development of ART26.12.”

“Up to 40% of drug development failures have historically been attributed to challenges associated with pharmacokinetics and ADME (i.e. Absorption, Distribution, Metabolism and Excretion) properties,” said Andrew Yates, Ph.D., Chief Scientific Officer of Artelo. “These data further strengthen our confidence in ART26.12, adding to the positive dose-proportional pharmacokinetics, safety and tolerability observations we have already reported from our SAD study ART26.12-100. Importantly, the absence of human-specific metabolites and the low overall metabolite burden with ART26.12 is expected to reduce future development complexity, timelines, and cost.”

In summary, the ART26.12 metabolite profile characterized from healthy volunteers is comprised of low plasma levels of only three metabolites previously observed and qualified in its toxicology program. These results suggest that these low level metabolites do not present a safety concern and, together with the remarkable safety profile observed in the SAD study, support the continued development of ART26.12 for the treatment of pain.

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.

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:
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