Artelo Biosciences

Company at a glance

• Industry: Clinical-stage biopharmaceutical company focused on lipid-signaling modulation pathways, including the endocannabinoid system (ECS).
• Focus: Development of small-molecule and cocrystal cannabinoid-related therapeutics that target lipid signaling for unmet medical needs.
• Headquarters: 505 Lomas Santa Fe, Suite 160, Solana Beach, CA 92075.
• Corporate structure: Incorporated in Nevada; operates through Artelo Biosciences, Inc. and wholly owned subsidiaries: Trinity Reliant Ventures Limited (Ireland), Artelo Biosciences Limited (UK), and Artelo Biosciences Corporation (Canada).

Product candidate pipeline and status

• ART27.13 (synthetic dual CB1/CB2 GPCR agonist; peripheral CB1/CB2 activity)

  • Origin: In-licensed from NEOMED/adMare; originally developed by AstraZeneca.
  • Indication: Cancer-related anorexia and cancer anorexia-cachexia syndrome.
  • Development stage: Phase 1b/2a (CAReS trial).
  • CAReS interim results (Sept 3, 2025): In 18 evaluable patients, mean weight gain with ART27.13 was 6.38% versus a −5.42% change with placebo over 12 weeks at the top titration dose; maximum ART27.13 weight gain reached 18.5% versus a 0.4% loss with placebo. Lean body mass increased 4.23% with ART27.13 versus −3.15% with placebo at one month. Safety was consistent with prior cannabinoid findings; 7 of 32 enrolled patients (22%) had adverse events possibly related to ART27.13, most were mild or moderate, with one case of severe malaise and no drug-related serious adverse events reported.
  • Enrollment: 32 participants enrolled in the Phase 2 portion as of December 31, 2025.

• ART26.12 (FABP5 inhibitor)

  • Mechanism: Inhibitor of fatty acid binding protein 5 (FABP5); synthetic small molecule intended to modulate endocannabinoid signaling.
  • Indications: Chemotherapy-induced peripheral neuropathy (CIPN), with potential oncology, pain, inflammation, dermatology, and anxiety-related disorder applications.
  • Development stage: IND accepted by FDA (July 2024); Phase 1 in healthy subjects completed.
  • Study data: Phase 1 Single Ascending Dose completed April 2025 with 49 healthy volunteers; no drug-related adverse events reported in the blinded dataset; dose-dependent, linear absorption and a wide safety margin between therapeutic and highest exposures, supporting potential titration in future studies.

• ART12.11 (CBD–TMP cocrystal)

  • Nature: Proprietary cocrystal of cannabidiol (CBD) and tetramethylpyrazine (TMP) designed to improve pharmacokinetic and pharmacodynamic properties.
  • Indications: Targeted for anxiety disorders and PTSD; potential applications in epilepsy and insomnia.
  • Development stage: Preclinical/early development; supported by ongoing intellectual property protection.

Intellectual property and licensing

• ART27.13: Exclusive worldwide license from NEOMED/adMare with up-front payments and milestone and royalty provisions. Potential milestone payments up to $200 million tied to regulatory and commercial events. Royalties: low single-digit percentages on net sales.
• FABP5 inhibitors (ART26.12): Global exclusive license covering FABP5 inhibitors; multiple U.S. and foreign patents and approximately 25 related patent applications pending across jurisdictions and fields.
• ART12.11 CBD cocrystal: U.S. composition-of-matter and methods-of-use patents issued; foreign patents issued and several U.S. and international applications pending.
• Additional collaborations: License with Stony Brook University (Stony Brook Foundation) for platform-related FABP5 inhibitors, including upfront fees, annual maintenance fees, royalties, and milestone payments; ongoing NEOMED collaboration tied to ART27.13 commercialization milestones.

Financial snapshot (year ended December 31, 2025)

• Cash and cash equivalents: approximately $0.6 million.
• Working capital: negative approximately $3.3 million.
• Net loss: approximately $12.9 million for 2025.
• Cash used in operations: approximately $8.5 million in 2025.
• Revenue: No substantial product revenues reported to date.
• Going concern: The company reports substantial doubt about its ability to continue as a going concern without additional financing.
• Financing needs: The company expects to raise additional capital through equity, debt, strategic partnerships, or licensing to fund continued clinical development and operations.

Human resources

• Employees: Seven (7) as of December 31, 2025.
• Organization: No union representation; operations supported through contractors, consultants, and CRO relationships in addition to the core team.

Operations and regulatory context

• Geographic footprint: Based in the San Diego area with international subsidiaries and collaborations in Ireland, the UK, and Canada, and partnerships with universities and research institutes.
• Regulatory pathway: Programs advance under FDA/IND processes with the aim of potential NDA submissions; regulatory considerations and development risks are reflected in the company's disclosures.

Summary

Artelo Biosciences is a clinical-stage biopharmaceutical company developing lipid-signaling modulators, including therapeutics that target the endocannabinoid system. Lead programs include ART27.13, a peripheral CB1/CB2 dual agonist in Phase 1b/2a for cancer-related anorexia with interim CAReS data showing weight gain in treated patients; ART26.12, a FABP5 inhibitor that completed Phase 1 healthy volunteer studies and is intended for CIPN and related indications; and ART12.11, a CBD–TMP cocrystal in preclinical development targeting anxiety and related disorders. The company advances its programs through licenses and collaborations and requires additional financing to continue clinical development and pursue commercialization.