About Artelo Biosciences

Artelo Biosciences, Inc. operates as a clinical stage biopharmaceutical company. The company focuses on the development of therapeutics that target lipid-signaling pathways, including the endocannabinoid system (the ECS), a family of receptors and neurotransmitters that form a biochemical communication network throughout the body. The company's product candidate pipeline broadly leverages leading scientific methodologies and balances risk across mechanism of action and stages of development. The company's programs represent a comprehensive approach in utilizing the power and promise of lipid signaling to develop pharmaceuticals for patients with unmet healthcare needs. The company is developing a dual cannabinoid agonist. This synthetic small molecule program is a G protein-coupled receptor (GPCR) designated ART27.13. The company is developing ART27.13 as a potential treatment for anorexia associated with cancer in a Phase 1b/2a trial, titled the Cancer Appetite Recovery Study (CAReS). The company's second program, ART26.12 is a small molecule and the lead product candidate from its chemical library of inhibitors of fatty acid binding proteins, notably Fatty Acid Binding Protein 5 (FABP5), undergoing pre-clinical research as a potential treatment for painful neuropathies. In addition, ART26.12 may have broad applications as a cancer therapeutic, a treatment for pain and inflammation, and potential use in anxiety-related disorders, including post-traumatic stress disorder. The company is also developing its own invention ART12.11 (the CBD cocrystal). ART 12.11 is the company's patented solid-state composition of cannabidiol (CBD). The company obtained two of its patent protected product candidates through its in-licensing activities. The company's first in-licensed program, ART27.13, is being developed for cancer-related anorexia. ART27.13 is a peripherally-restricted high-potency dual CB 1 and CB 2 receptor full-receptor agonist, which was originally invented at AstraZeneca plc (AstraZeneca). The company exercised its option to exclusively license this GPCR product candidate through the adMare Bioinnovations (adMare), which had obtained rights to ART27.13. In Phase 1, single dose studies in healthy volunteers and a multiple ascending dose study in individuals with chronic low back pain conducted by AstraZeneca, ART27.13 exhibited an attractive pharmacokinetic and absorption, distribution, metabolism, and excretion profile and was well tolerated within the target exposure range. It also exhibited dose-dependent and potentially clinically meaningful increases in body weight. Discussions with the U.K., the U.S. and Canadian regulators indicate there is a potential pathway for the development of ART27.13 for the treatment of cancer-related anorexia, which affects approximately 60% of advanced stage cancer patients. The company commenced enrollment and dosed the first patient in CAReS, its Phase 1b/2a clinical study of cancer-related anorexia with ART27.13 in April 2021. The company has been enrolling patients steadily since that time. The results of the Phase 1b stage are intended to determine the most effective and safe dose recommended for the Phase 2a portion of CAReS. After the company completed enrollment of the planned first three dosing cohorts, per the approved protocol, it elected to enroll a fourth cohort of six patients at a higher dose before making a determination as to which dose is selected for the Phase 2a stage of CAReS. The company experienced minor delays due to COVID-19. The company's second in-licensed patented program is from its platform of small-molecule inhibitors of fatty acid binding proteins, notably FABP5 acquired from Stony Brook University (SBU), and its lead program is designated ART26.12. The company licensed exclusive world-wide rights to inhibitors from SBU in all fields. Through its sponsored research the company has subsequently identified a potential role for FABP5 inhibition to treat anxiety disorders, such as Post Traumatic Stress Disorder (PTSD). The company has also been awarded a research grant in Canada to expand on its earlier research at the University of Western Ontario in this new development area. Based upon recently disclosed positive pre-clinical evidence of promising activity and a differentiated mechanism-of-action for the prevention and treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN), the company has prioritized CIPN as the initial indication for the development of its lead product candidate, ART26.12. The ART26.12 program is in the beginning stages of regulatory-enabling studies. The company anticipates first-in-human studies could begin in the middle of 2024 depending, in part, on the ongoing impact of the COVID-19 global pandemic , the ability of selected contract research organizations to source materials and resources, including animals, in order to perform required studies, and the review and approval process with the regulatory authorities, such as the U.S. Food and Drug Administration (the FDA). In addition to its in-licensed programs, the company has internal discovery research initiatives, which resulted in ART12.11, a proprietary cocrystal composition of CBD. The company has two US patents, one US patent application, and eight foreign patent applications directed to its cocrystal composition of CBD. Composition claims are generally known in the pharmaceutical industry as the most desired type of intellectual property and should provide for long lasting market exclusivity for the company's synthetic CBD cocrystal drug product candidate. The company is developing its product candidates in accordance with traditional regulated drug development standards and expects to make them available to patients via prescription or physician orders only after obtaining marketing authorization from a regulatory authority, such as the FDA. Business Strategy The company intends to pursue technologies and compounds that offer promising therapeutic approaches to known and validated signaling pathways, specifically lipid signaling, which includes compounds that promote the effectiveness of the ECS. Intellectual Property The company is a party to certain license agreements as described below: Patent Estate and Licenses ART27.13 - Synthetic GPCR Agonist: Two (2) issued patents (US) including composition of matter, terms November 3 2024, and September 22, 2025, not including any patent term extension, or PTE; 31 issued (Intl) patents, and one (1) pending (Intl) application. ART26.12 - FABP5 inhibitor: Three (3) patents issued (US), terms June 18, 2031 (includes PTA) and July 19, 2033, not including any PTE. Covers the target, composition of matter, and utility claims. One (1) pending (US) and eleven (11) pending (Intl) applications, and three (3) pending (US) provisional applications. ART12.11 - Synthetic CBD Cocrystal: Issued (1) composition of matter patent (US) with a term through December 10, 2038. Pending applications (US & Intl). The NEOMED Relationship In 2017, the company entered into an agreement with NEOMED (the NEOMED Agreement), which provides it with up to twelve months from the date of receipt by the company of the required materials to conduct certain non-clinical research studies, diligence and technical analyses with NEOMED's proprietary therapeutic compound NEO1940, known as ART27.13 (the Compound) and an option (the NEOMED Option) for an exclusive worldwide license to develop and commercialize products comprising or containing the Compound. In clinical development studies with NEOMED's prior sponsor, ART27.13 was dosed in over 200 subjects. From 2007 to 2008, ART27.13 was evaluated in five phase 1 clinical trials under its original sponsor, AstraZeneca. ART27.13 was administered orally in 205 patients and its safety, tolerability, pharmacokinetics and pharmacodynamics were investigated. Four of these studies were single dose or Single Ascending Dose (SAD) studies. An initial SAD study was conducted in the U.K. The program was completed with another study performed in a Japanese population. The two other single dose studies aimed at measuring a pharmacodynamics effect (Proof-of-Principle or POP studies) on analgesia using the capsaicin test in one case, and the third molar extraction model in the other case. The last phase 1 study was a Multiple Ascending Dose (MAD) study, where patients with chronic lower back pain received ART27.13 for a scheduled period of 12 days. ART27.13 demonstrated, in general, an acceptable safety and tolerability profile in the safety endpoints. The Stony Brook University Relationship In 2018, the company entered into a license agreement (the Stony Brook Agreement) with the Research Foundation at Stony Brook University (the Foundation). The Stony Brook Agreement provides the company with an exclusive license under certain licensed patents of the Foundation to develop, make, manufacture, have made, use, sell, have sold, import, export, and offer for sale Patent Product and Other Product worldwide in all fields, including without limitation the field of human therapeutics. Government Regulations The company's business operations and current and future arrangements with healthcare professionals, consultants, customers and patients, may expose it to broadly applicable state and federal fraud and abuse and other healthcare laws and regulations. These laws constrain the business and financial arrangements and relationships through which the company conducts its operations, including how it researches, markets, sells and distributes its products. Such laws include the U.S. federal Anti-Kickback Statute; the U.S. federal civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act; the U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA); in addition, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and its implementing regulations, imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as health plans, healthcare clearinghouses and certain healthcare providers, as well as their business associates that perform certain services for or on their behalf involving the use or disclosure of individually identifiable health information; and the U.S. Physician Payments Sunshine Act. History The company was founded in 2011. It was incorporated in the state of Nevada in 2011. The company was formerly known as Reactive Medical Inc. and changed its name to Artelo Biosciences, Inc. in 2017.