Artelo Biosciences Responds to White House Executive Order on CBD Research

On December 23, 2025, Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company, applauded the recent Executive Order from the White House that initiates a Medicare pilot program aimed at facilitating reimbursement and structured data collection for cannabidiol (CBD) products. This development is seen as a pivotal step in acknowledging the therapeutic potential of CBD and enhancing access to cannabinoid-based treatments for medically vulnerable and aging populations.

Significance of the Executive Order

Artelo Biosciences welcomes this Executive Order as a major milestone in the journey towards establishing CBD as a legitimate medical treatment. The federal government's focus on data collection is crucial for informing future research and potentially extending these benefits to Medicaid and wider patient populations. According to Gregory D. Gorgas, Chief Executive Officer of Artelo, “This Executive Order represents meaningful validation of medical CBD and reinforces the need to pair expanded access with rigorous science.”

Need for Rigorous Clinical Research

Artelo emphasizes the necessity for well-controlled, peer-reviewed clinical studies to confirm the safety and efficacy of CBD treatments. Despite the widespread availability of consumer CBD products, many lack the consistency and quality control required for integration into federal healthcare programs. The company aims to address these gaps through its proprietary product, ART12.11, a patented cocrystal composition of CBD and tetramethylpyrazine (TMP).

Overview of ART12.11's Advantages

• Superior Bioavailability: ART12.11 has shown enhanced oral bioavailability compared to traditional CBD formulations.
• Consistent Pharmacokinetics: The product demonstrates predictable pharmacokinetics, essential for reliable therapeutic applications.
• Enhanced Efficacy Signals: Preclinical models indicate ART12.11 can improve symptoms of anxiety and depression more effectively than standard CBD.
• Regulatory Compliance: The Drug Enforcement Administration has confirmed that ART12.11, absent controlled substances, is not classified as a controlled drug.

Advancing to Clinical Trials

In response to feedback from regulatory authorities, Artelo is preparing to finalize the necessary steps to advance ART12.11 into human clinical trials. This strategy aligns closely with the goals outlined in the new Executive Order, focusing on providing data-driven confidence in the medical use of CBD.

Conclusion: A Next-Generation Approach to Cannabinoid Medicine

Gregory D. Gorgas further stated, “ART12.11 was purpose-built to meet the standards required for federal healthcare integration and prescription-based use.” As Artelo Biosciences continues to navigate the evolving landscape of cannabinoid medicine, ART12.11 represents a promising step forward, with the potential to satisfy the increasing demand for effective, pharmaceutical-grade cannabidiol therapies.

About Artelo Biosciences and ART12.11

Artelo Biosciences, Inc. is committed to developing proprietary therapies that modulate lipid-signaling pathways, targeting significant unmet needs in cancer, anxiety, pain, and other conditions. ART12.11 is a leading, non-controlled cocrystal composition that has been patented in the U.S. through 2038 and validated in multiple countries, solidifying its position as a preferred CBD pharmaceutical option.