ARTL

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

Artelo’s ART27.13 gains Japan patent allowance, strengthening global IP moat

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    <h3>Information</h3>
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    <h3>AI Summary</h3>
    <p>Artelo announced Japan granted an allowance for ART27.13’s intended commercial formulation, joining US/Europe allowances and extending protection to 2041. This strengthens the program’s global IP position as CAReS and DREAM Phase 2 progress, with DREAM data anticipated in Q4 2026. The milestone could lift ARTL’s valuation if results or licensing opportunities emerge, though near-term upside depends on trial readouts and funding.</p>
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    <h3>Key Points</h3>
    <ul><li>Japan patent allowance for ART27.13 formulation extends IP to 2041.</li><li>US and Europe allowances are already in place, positions three major markets.</li><li>CAReS Phase 2 shows &gt;60% weight stabilization; 1300 µg reverses weight loss vs placebo.</li><li>DREAM Phase 2 in glaucoma: 600 µg daily; results expected Q4 2026.</li><li>IP estate strengthened; ART27.13 licensed from AstraZeneca in 2019.</li></ul>
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    <h3>Companies Mentioned</h3>
    <ul><li><strong>Artelo Biosciences, Inc. (ARTL)</strong>: IP expansion strengthens ART27.13 program; CAReS and DREAM readouts remain key catalysts.</li><li><strong>AstraZeneca plc (AZN)</strong>: Original developer; ART27.13 licensed to Artelo in 2019; potential implications for royalties/licensing.</li></ul>
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    <h3>Corporate Developments</h3>
    <p>Category: Corporate Developments. The news centers on patent allowances and IP strategy for ART27.13, underpinning long-term value and potential partnerships rather than near-term earnings.</p>
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    <h3>Market-Moving</h3>
    <ul><li>Japan allowance adds to US/Europe IP, expanding optionality and licensing upside.</li><li>CAReS Phase 2 weight gain data support therapeutic potential at higher dose.</li><li>DREAM glaucoma results due Q4 2026 may trigger valuation re-rating.</li><li>No FDA approval yet; stock remains high-risk but positively positioned on IP.</li></ul>
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  <section data-block="key-facts">
    <h3>Key Facts</h3>
    <ul><li>ART27.13 IP: US, EU allowances; Japan grant; protection through 2041.</li><li>CAReS Phase 2: interim data show +6% weight gain at 1300 µg after 12 weeks; placebo ~-5%.</li><li>DREAM Phase 2: 600 µg daily; initial results expected in Q4 2026.</li><li>Artelo licensed ART27.13 from AstraZeneca in 2019.</li><li>No FDA-approved treatment for cancer anorexia cachexia syndrome.</li></ul>
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    <h3>Trading Thesis</h3>
    <p>Positive IP expansion and near-term DREAM readouts could re-rate ARTL within 3–6 months.</p>
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    <h2>Artelo Biosciences Receives Japan Patent Office Allowance for ART27.13 Formulation (ARTL)</h2>
    <p>SOLANA BEACH, Calif., Aug. 20, 2026 (GLOBE NEWSWIRE) -- <strong>Artelo Biosciences, Inc.</strong> <strong>(Nasdaq: ARTL)</strong> ("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.</p>
    <ul>
      <li>Patent protection extends through <strong>2041</strong> in multiple jurisdictions.</li>
      <li>IP estate for ART27.13 is now <strong>issued or allowance status</strong> in the United States, Japan, and Europe.</li>
      <li>The protection covers ART27.13 compositions dispersed in polyethylene glycol.</li>
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    <h2>Global IP Position Strengthened by Japanese Allowance</h2>
    <p>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 <strong>2041</strong>. 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.</p>
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    <h2>CEO Commentary and Background on ART27.13</h2>
    <p>"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. <em>"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.</em></p>
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    <h2>Clinical Progress: CAReS Phase 2 and DREAM Study</h2>
    <p>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 <strong>60%</strong> 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 <strong>1300 µg</strong> whereas the all the participants on placebo continued to lose weight throughout the study.</p>
    <p>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&amp;D Division in the UK, the investigator-led study is evaluating ART27.13's potential at a <strong>600 µg</strong> 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.</p>
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    <h2>Strategic Implications of Global Allowances</h2>
    <p>"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.</p>
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    <h2>About ART27.13</h2>
    <p><strong>ART27.13</strong> 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 CB2 receptors, 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. </p>
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    <h2>About Artelo Biosciences</h2>
    <p>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 <a href="https://www.artelobio.com" target="_blank" rel="noopener">www.artelobio.com</a> and X: @ArteloBio.</p>
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  <section>
    <h2>Forward-Looking Statements</h2>
    <p><em>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...</em></p>
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Artelo announced Japan granted an allowance for ART27.13’s intended commercial formulation, joining US/Europe allowances and extending protection to 2041. This strengthens the program’s global IP position as CAReS and DREAM Phase 2 progress, with DREAM data anticipated in Q4 2026. The milestone could lift ARTL’s valuation if results or licensing opportunities emerge, though near-term upside depends on trial readouts and funding.

News insight

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

AI summary

Sentiment rationale

Key facts

Corporate Developments