Artelo Biosciences Plans Clinical Development Of ART12.11 CBD Therapy Following White House Medicare Pilot Executive Order

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 commented on the White House's recent Executive Order establishing a Medicare pilot program to support reimbursement and structured data collection for cannabidiol (CBD) products.

Artelo views the Administration's action as a significant milestone in the recognition of CBD's therapeutic potential and an important step toward improving access to cannabinoid-based treatments for aging and medically vulnerable populations. The Company believes the federal government's emphasis on data collection to inform future research and potential expansion to Medicaid and broader patient populations highlights a growing demand for safe, effective, and well-characterized CBD therapies.

"This Executive Order represents meaningful validation of medical CBD and reinforces the need to pair expanded access with rigorous science," said Gregory D. Gorgas, Chief Executive Officer of Artelo. "Physicians and patients need standardized dosing, consistent pharmacokinetics, and clinical evidence that distinguishes true therapeutic candidates from consumer-grade wellness products."

Artelo believes the initiative highlights an urgent need for well-controlled, peer-reviewed clinical studies to establish the safety, efficacy, and reliability of CBD-based treatments. While consumer CBD products are widely available, many lack the consistency, bioavailability, and quality controls required for integration into federal healthcare programs and physician-guided care.  

Artelo is uniquely positioned to address this need through ART12.11, its proprietary, patented cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). Unlike standard CBD formulations, ART12.11 has demonstrated superior oral bioavailability, more consistent and predictable pharmacokinetics, and enhanced efficacy signals in preclinical models of anxiety and depression.

The solid-state, crystalline formulation of ART12.11 is designed to ensure pharmaceutical-grade purity and potency, characteristics essential for clinical development and potential reimbursement within regulated healthcare systems. Furthermore, the Drug Enforcement Agency informed the Company that absent any controlled substance, ART12.11 would not be considered a controlled drug. Due to its unique and patented crystalline structure and the cocrystalization process, there has never any amount of THC or any other controlled substance detected in ART12.11.

Following recent constructive feedback from regulatory authorities, Artelo is prepared to complete the final steps required to advance ART12.11 into human clinical trials. The Company's pharmaceutical-first development strategy aligns closely with the goals outlined in the Executive Order, which seeks to provide physicians, payors, and patients with data-driven confidence in the medical use of CBD.