STOCK TITAN

Artelo Biosciences Secures Notice of Allowance in Japan for Patent Claims for the Intended Commercial Formulation of ART27.13

(Positive)
Tags

Artelo Biosciences (Nasdaq: ARTL) reported that the Japanese Patent Office issued a notification of allowance with a Decision to Grant for patent claims covering the intended commercial formulation of ART27.13, a peripherally selective dual cannabinoid agonist dispersed in polyethylene glycol.

The allowed claims align with those in the United States and Europe, with all three jurisdictions expected to provide protection through 2041, strengthening ART27.13’s global intellectual property position. ART27.13 is in two Phase 2 trials: CAReS in cancer-related anorexia, which has shown early weight-stabilizing signals, and DREAM in glaucoma or ocular hypertension, with initial results anticipated in the fourth quarter.

Loading...
Loading translation...

Positive

  • Japanese patent allowance for ART27.13 formulation with expected protection through 2041
  • ART27.13 IP now at issued or allowance status in United States, Europe, and Japan
  • Prior Phase 1 study in Japan reported no major safety or tolerability concerns
  • CAReS Phase 1 showed ART27.13 was well tolerated with early weight-loss stabilization in 60%+ of participants
  • CAReS Phase 2 interim: highest 1300 µg dose reversed anorexia while placebo group continued losing weight
  • DREAM Phase 2 glaucoma study externally funded with initial results expected in Q4

Negative

  • None.

News Explained

The Japanese allowance applies to ART27.13, which Artelo says was fully licensed to it in 2019; the disclosure adds patent status to an existing license relationship, rather than announcing a new transaction involving the company’s common ownership.

Market Context

A prior U.S. patent allowance produced a -8.76% 24-hour reaction, so the platform record adds a hist...
Analysis

A prior U.S. patent allowance produced a -8.76% 24-hour reaction, so the platform record adds a history of uneven responses to IP updates. Low short positioning remains a risk context; upcoming clinical results warrant attention.

Key Figures

Patent protection horizon: 2041 Phase 2 trials: Two Phase 2 clinical trials Participants with early weight effects: More than 60% +3 more
6 metrics
Patent protection horizon 2041 United States, Japan, and Europe
Phase 2 trials Two Phase 2 clinical trials ART27.13 development program
Participants with early weight effects More than 60% Phase 1 stage of ART27.13
Highest CAReS dose 1300 µg Phase 2 interim results
DREAM daily dose 600 µg Pilot Phase 2 glaucoma or ocular hypertension study
ART27.13 license date 2019 Fully licensed to Artelo

Historical Context

5 past events · Latest: Aug 17 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Aug 17 U.S. patent allowance Positive -8.8% U.S. patent allowance for ART27.13 commercial formulation preceded a negative 24-hour reaction.
Aug 13 Quarterly earnings report Neutral +3.5% Quarterly results and pipeline update accompanied an $11.0 million financing.
Aug 10 Phase 2 trial launch Positive -2.2% First patient was dosed in the DREAM Phase 2 glaucoma study.
Jul 22 CBD efficacy analysis Negative -4.5% Review of over 50 studies found low-dose CBD generally lacked therapeutic evidence.
Jul 16 Nonclinical pain study Positive -0.9% Nonclinical ART26.12 study reported pain reduction and reduced stomach tissue damage.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

ARTL's recent news reactions were mixed, including negative responses to several positive or potentially positive development updates.

Key Terms

notice of allowance, decision to grant, polyethylene glycol, intraocular pressure, +1 more
5 terms
notice of allowance regulatory
"the Japanese Patent Office has issued a notification of allowance"
A notice of allowance is an official confirmation from a patent office that a patent application has met all necessary requirements and is approved for granting. It signals that the invention is likely to receive legal protection soon, which can be important for investors considering the value and exclusivity of a new product or technology. Think of it as a green light indicating that the invention is on track to become legally protected.
decision to grant regulatory
"a notification of allowance with a Decision to Grant"
A decision to grant is an official determination by a regulator, authority, or governing body to award permission, a licence, approval, or right that an organization has applied for. It matters to investors because such approvals can unlock revenue, allow products or services to enter a market, or protect intellectual property—similar to a gatekeeper opening a door that lets a business operate or expand where it previously could not.
polyethylene glycol technical
"ART27.13 dispersed in polyethylene glycol"
A synthetic polymer used widely in pharmaceuticals and medical products as a solvent, thickener, stabilizer and laxative; it comes in different chain lengths and grades that change its texture and behavior. For investors, polyethylene glycol matters because it is a common ingredient in drug formulations and medical devices, affecting manufacturing processes, product stability, regulatory filings and supply-chain risk much like a key baking ingredient affects a recipe’s texture and shelf life.
intraocular pressure medical
"potential at a 600 µg orally administered daily dose to reduce intraocular pressure"
Intraocular pressure is the fluid pressure inside the eye, similar to the air pressure in a tire or the tension in a water balloon that helps the eye keep its shape. It matters to investors because sustained high pressure can lead to glaucoma and vision loss, driving demand for drugs, surgical devices, diagnostics and related regulatory approvals and reimbursements, which directly affect company revenues and risk profiles.
peripherally selective dual cannabinoid agonist medical
"ART27.13, Artelo’s peripherally selective dual cannabinoid agonist"
A peripherally selective dual cannabinoid agonist is a drug that activates two types of cannabinoid receptors while largely acting outside the brain and spinal cord, so it targets tissues like nerves, immune cells, or organs rather than causing central nervous system effects. For investors, that pharmacology matters because it can change the drug’s safety profile, clinical trial design, regulatory scrutiny, and potential market size—think of it as a targeted tool that aims to get therapeutic benefit where needed while minimizing effects on the brain.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google

SOLANA BEACH, Calif., Aug. 20, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“Artelo” or the “Company”), a clinical-stage pharmaceutical company focused on modulating lipid-signalling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological conditions, today announced that the Japanese Patent Office has issued a notification of allowance with a Decision to Grant for the Company’s patent application covering the intended commercial formulation of ART27.13, Artelo’s peripherally selective dual cannabinoid agonist currently being evaluated in two Phase 2 clinical trials.

The allowed claims in Japan protect compositions of ART27.13 dispersed in polyethylene glycol. These claims are consistent with those previously allowed in the United States and Europe, and all jurisdictions are expected to provide patent protection through 2041. This brings Artelo’s intellectual property estate for ART27.13 to issued or allowance status in three major pharmaceutical markets, the United States, Japan, and Europe, and further strengthens the program’s global IP position while supporting its long-term commercial potential.

“Receiving this allowance decision in Japan represents another important advancement in our global intellectual property and clinical development strategy for ART27.13,” said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “The innovator of our investigational drug, AstraZeneca, previously conducted a Phase 1 safety study with ART27.13 in Japan, with no major safety or tolerability concerns, and had concluded the plasma exposure and adverse event profiles were comparable between Japanese and Caucasian participants.” ART27.13 was fully licensed to Artelo in 2019.

Currently being evaluated in the Phase 2 portion of CAReS targeting cancer-related anorexia, ART27.13 was well-tolerated in the Phase 1 stage and showed early signs of stabilizing or reversing weight loss in more than 60% of participants. Interim results from the CAReS Phase 2 demonstrated the ability of the drug to reverse cancer-related anorexia in all patients taking the highest dose of 1300 µg whereas the all the participants on placebo continued to lose weight throughout the study.

ART27.13 is also being evaluated in the DREAM study, a pilot Phase 2 in people with glaucoma or ocular hypertension. Funded by Glaucoma UK and the HSC R&D Division in the UK, the investigator-led study is evaluating ART27.13's potential at a 600 µg orally administered daily dose to reduce intraocular pressure, alongside additional assessments of visual acuity, body weight, mood, safety and tolerability. Initial results are anticipated in the fourth quarter of this year.

“With allowances now secured in the United States, Europe and Japan for claims covering our intended commercial formulation, we believe we have established a strong foundation for ART27.13 across three of the world’s major pharmaceutical markets. This growing patent estate further enhances the strategic and commercial value of the program as ART27.13 advances in multiple potential indications,” concluded Mr. Gorgas.

About ART27.13
ART27.13 is a dual cannabinoid agonist and novel benzimidazole derivative. Initially developed by AstraZeneca plc, ART27.13 has been in over seven clinical studies with nearly 300 participants. It is primarily being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CBreceptors, with the potential to reduce muscle degeneration while improving body weight, appetite, and quality of life in cancer patients. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Artelo is conducting a Phase 2 named the Cancer Appetite Recovery Study (CAReS) evaluating ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Interim Phase 2 data revealed patients who had lost at least 5% of body weight to be included in CAReS and titrated to the highest ART27.13 dose (1300 µg) achieved an average +6% weight gain over 12 weeks, while patients on placebo lost an additional ~5%. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome. In addition to CAReS, ART27.13 is also being evaluated in a Phase 2 study in people with glaucoma, called the DREAM study. In DREAM, ART27.13 is administered orally at a daily dose of 600 µg.  

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, and commercial expertise 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 Biosciences (NASDAQ: ARTL) announce on August 20, 2026 about ART27.13?

Artelo Biosciences announced a Japanese Patent Office notification of allowance for patent claims covering the intended commercial formulation of ART27.13. According to Artelo, this Decision to Grant strengthens ART27.13’s intellectual property in Japan and aligns with previously allowed claims in the United States and Europe, extending expected protection to 2041.

How long could ART27.13 patent protection last in Japan for Artelo Biosciences (ARTL)?

The ART27.13 formulation patent in Japan is expected to provide protection through 2041. According to Artelo, these Japanese claims, covering ART27.13 dispersed in polyethylene glycol, are consistent with earlier allowances in the United States and Europe, collectively supporting the program’s long-term commercial potential in major markets.

What is ART27.13 and how is it being developed by Artelo Biosciences (NASDAQ: ARTL)?

ART27.13 is a peripherally selective dual cannabinoid agonist being developed for cancer-related anorexia and eye disease. According to Artelo, it is in Phase 2 CAReS for cancer-related anorexia and the DREAM pilot Phase 2 study in people with glaucoma or ocular hypertension at a 600 µg daily oral dose.

What is the DREAM Phase 2 study of ART27.13 mentioned by Artelo Biosciences (ARTL)?

The DREAM study is a pilot Phase 2 trial of ART27.13 in glaucoma or ocular hypertension. According to Artelo, it is investigator-led, funded by Glaucoma UK and the HSC R&D Division, and evaluates a 600 µg daily oral dose, focusing on intraocular pressure with initial results expected in the fourth quarter.

How does the new Japanese patent allowance affect Artelo Biosciences’ IP strategy for ART27.13 (ARTL)?

The Japanese allowance consolidates ART27.13’s patent estate across three major pharmaceutical markets. According to Artelo, having claims allowed in the United States, Europe, and Japan for its intended commercial formulation provides a stronger global IP position and supports the program’s strategic and commercial value.

What prior safety data on ART27.13 in Japanese participants did Artelo Biosciences (ARTL) reference?

Artelo referenced a prior AstraZeneca Phase 1 safety study of ART27.13 in Japan. According to Artelo, this study reported no major safety or tolerability concerns and found plasma exposure and adverse event profiles comparable between Japanese and Caucasian participants, supporting ongoing development in Japanese and global populations.