Artelo Bioscience Commends Presidential Executive Order Expanding CBD Research and Access; Highlights ART12.11 as a Leading Pharmaceutical-Grade Cannabidiol Candidate

Rhea-AI Summary

Artelo Biosciences (Nasdaq: ARTL) commented on the Dec 23, 2025 White House Executive Order creating a Medicare pilot for cannabidiol (CBD) reimbursement and structured data collection.

Artelo said the initiative could improve access and generate data to inform research and potential Medicaid expansion. The company highlighted ART12.11, its patented CBD–tetramethylpyrazine cocrystal, stating superior oral bioavailability, more consistent pharmacokinetics, and enhanced efficacy signals in preclinical anxiety and depression models. Artelo reported the Drug Enforcement Agency indicated ART12.11 would not be considered a controlled substance and said it is prepared to complete final steps to advance ART12.11 into human clinical trials.

Positive

• Medicare pilot supports reimbursement and structured CBD data collection
• ART12.11 reported superior oral bioavailability in preclinical data
• DEA indicated ART12.11 would not be a controlled substance
• Company prepared to complete final steps to enter human clinical trials

Negative

• ART12.11 remains at preclinical stage; no human clinical data yet
• Medicare initiative is currently a pilot, not a nationwide reimbursement policy

Market Reality Check

$1.16 Last Close

Volume Volume 68,787 is 0.05x the 20-day average of 1,341,057, indicating limited trading interest before this news. low

Technical Shares at $1.63 are trading below the 200-day MA of $6.42 and remain 94.3% under the 52-week high of $28.60 despite being just above the 52-week low of $1.5206.

Peers on Argus

ARTL was up 3.82% with low volume while key biotech peers showed mixed moves: SILO +13.49%, CERO -15.7%, TNFA -9.72%, HCWB -6.02%, and ADIL 0%, suggesting a stock-specific reaction rather than a coordinated sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 03	Preclinical data update	Positive	-8.3%	Peer-reviewed data showing SBFI103 reduced anxiety and depression behaviors in rats.
Nov 12	Earnings and pipeline	Negative	-8.2%	Q3 2025 results with ongoing losses, low cash and equity financings alongside pipeline updates.
Nov 04	Scientific review article	Positive	-38.0%	Publication on FABP3 role in cancer, highlighting therapeutic potential of FABP inhibition.
Oct 27	Management change	Positive	-0.3%	Appointment of experienced life-sciences CFO to support financial and growth initiatives.
Oct 15	Clinical data presentation	Positive	+1.4%	Expanded ART26.12 safety data and ART27.13 weight-gain benefits in cancer anorexia patients.

Pattern Detected

Recent science- and pipeline-focused announcements have often been followed by negative price reactions, indicating a pattern of divergence between positive R&D news and share performance.

Recent Company History

Over the past few months, Artelo reported multiple R&D and corporate milestones. On Oct 15, 2025, expanded clinical data on ART26.12 and ART27.13 coincided with a modest +1.45% move. Subsequent scientific publications on FABP targets (e.g., Nov 4, Dec 3, 2025) and a new CFO appointment on Oct 27, 2025 saw mostly negative or flat reactions. The Nov Q3 2025 update combined clinical progress with ongoing losses and capital raises, also met with selling. Today’s CBD-focused policy and asset positioning fits the pattern of science-forward news against a pressured stock.

Market Pulse Summary

This announcement ties a new Medicare CBD pilot and data-collection push to Artelo’s ART12.11, which is described as a pharmaceutical-grade cannabidiol cocrystal with improved bioavailability and consistent pharmacokinetics. The company plans to advance it into human trials after regulatory feedback. In context, investors may weigh this strategic fit against recent filings noting losses, limited cash, and Nasdaq compliance challenges, watching for concrete clinical milestones and funding plans.

Key Terms

cannabidiol (CBD) medical

"support reimbursement and structured data collection for cannabidiol (CBD) products."

Cannabidiol (CBD) is a naturally occurring compound extracted from cannabis plants that does not produce a "high"; think of it like a single ingredient from a complex recipe. Investors care because CBD is sold in consumer products (oils, creams, supplements) and is subject to shifting rules, demand trends and clinical research that can quickly change a company’s sales outlook and legal risk.

pharmacokinetics medical

"standardized dosing, consistent pharmacokinetics, and clinical evidence that distinguishes"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

bioavailability medical

"many lack the consistency, bioavailability, and quality controls required for integration"

Bioavailability is the measure of how much and how quickly a substance, such as a medication or nutrient, enters the bloodstream and becomes available for use by the body. For investors, it matters because it influences how effectively a product works and how quickly results are seen, which can impact a company's success and the potential value of related investments. Think of it like how much of a medicine actually reaches your bloodstream after taking it—that determines how well it can do its job.

cocrystal technical

"its proprietary, patented cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine"

A cocrystal is a solid made when a drug molecule and one or more non-drug molecules form a single, ordered crystal, held together by relatively weak chemical attractions rather than new chemical bonds. For investors it matters because cocrystals can change a drug’s stability, how well it dissolves and is absorbed, and how easily it can be manufactured — all of which can affect development costs, regulatory review and the commercial value of a medicine.

tetramethylpyrazine (TMP) medical

"cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). Unlike standard CBD"

Tetramethylpyrazine (TMP) is a small organic compound used as the active ingredient in some medicines and supplements, often derived from traditional herbal sources. It is studied for effects on blood flow, inflammation and tissue protection, so it matters to investors because clinical results, regulatory approvals, quality control and safety data determine whether TMP-based products can reach markets and generate sales—think of it as a key recipe ingredient whose properties drive a product’s commercial success.

preclinical models medical

"enhanced efficacy signals in preclinical models of anxiety and depression."

Laboratory systems—such as cultured cells, tissues, and animal experiments—used to test a drug or medical technology before it is given to people. They act like a prototype or crash-test stage that checks for basic safety, how the treatment works, and whether it’s worth advancing to human trials; investors watch these results because they strongly affect development risk, timelines, and potential costs.

controlled substance regulatory

"absent any controlled substance, ART12.11 would not be considered a controlled drug."

A controlled substance is a drug or chemical whose manufacture, possession, use and distribution are restricted by government law because of potential for abuse, addiction or harm. For investors it matters because these rules shape a company’s ability to sell products, obtain licenses, win approvals and avoid fines or criminal risk — like a speed limit that constrains how fast a business can grow or exposes it to penalties if violated.

pharmaceutical-grade technical

"crystalline formulation of ART12.11 is designed to ensure pharmaceutical-grade purity"

Pharmaceutical-grade describes ingredients or products made to meet strict purity, safety and quality standards required for medicines, meaning they are free of harmful contaminants and consistently manufactured. Think of it like “food-grade” versus “industrial” — pharmaceutical-grade is held to higher controls so it can be used in drugs. Investors care because achieving and maintaining this level affects a medicine’s ability to win regulatory approval, reach markets, avoid recalls, and sustain reliable production and margins.

AI-generated analysis. Not financial advice.

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

FAQ

What did Artelo (ARTL) announce about the Dec 23, 2025 Executive Order on CBD?

Artelo said the Executive Order launching a Medicare CBD pilot could expand access and generate structured data to inform research and reimbursement.

How does the Medicare pilot affect Artelo's ART12.11 (ARTL)?

Artelo views the pilot as aligned with its pharmaceutical-first strategy and potentially helpful for future reimbursement of standardized CBD therapies like ART12.11.

Has ART12.11 been classified as a controlled substance by the DEA for ARTL?

Artelo reported the Drug Enforcement Agency indicated that absent any controlled substance, ART12.11 would not be considered a controlled drug.

What clinical evidence does Artelo cite for ART12.11 (ARTL)?

The company cited preclinical models showing superior oral bioavailability, more consistent pharmacokinetics, and enhanced efficacy signals in anxiety and depression models.

Is ART12.11 in human trials yet for Artelo (ARTL)?

No; Artelo said ART12.11 is prepared to complete final steps to advance into human clinical trials but is not yet in human studies.

What are the investor implications of Artelo's statement on Dec 23, 2025?

The announcement ties federal policy support for CBD data collection to Artelo's development of a pharmaceutical-grade CBD candidate, potentially aiding regulatory and reimbursement pathways if clinical data are produced.