SOLANA BEACH, Calif., Dec. 23, 2025 (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 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.
Gregory D. Gorgas, Chief Executive Officer of Artelo, added, “ART12.11 was purpose-built to meet the standards required for federal healthcare integration and prescription-based use, and we believe it represents a next-generation approach to cannabinoid medicine.”
About ART12.11
ART12.11 is Artelo’s wholly owned, proprietary, non-controlled 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 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 19 additional countries.
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.
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: ARTL@crescendo-ir.com
