FABP5

SOLANA BEACH, Calif., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic and neurological conditions, today reported its financial and operating results for the three months ended June 30, 2024 and provided a business update. “Artelo is entering an unprecedented phase of productivity in clinical development,” commented Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “Specifically, we look forward to multiple clinical readouts over the next 18 months across our portfolio. Most recently, we received clearance from the U.S. Food and Drug Administration (FDA) to initiate clinical trials for ART26.12 for the treatment of chemotherapy-induced peripheral neuropathy and Phase 1 trial results are expected during the first half of 2025. In addition, we anticipate full enrollment in the Phase 2a portion of the CAReS trial with our lead clinical asset, ART27.13, for the treatment of cancer-related anorexia near the end of 2024 or early 2025. To date, there have been no serious adverse events reported related to the study drug in CAReS. Finally, ART12.11, our proprietary cocrystal of CBD and TMP intended for the treatment of anxiety and depression, is in the final stages of product formulation as an oral solid, creating the potential to enter a clinical study early next year.” “With over $5.6 million of cash and cash equivalents as of June 30, 2024, and the receipt of approximately $1.3 million in cash from the UK government from R&D tax credits on July 10, 2024, we have the momentum to meaningfully advance our asset portfolio over the coming months,” concluded Mr. Gorgas. Other Company Highlights: Presented data from multiple preclinical studies at the 34th Annual International Cannabinoid Research Society Symposium Efficacy of ART26.12 in Breast Cancer-Induced Bone PainResults supporting broad potential utility of FABP Inhibitor platformMultiple studies confirming ART12.11’s potential advantages as a product candidate for the treatment of anxiety related disorders Presented highly encouraging data towards developing a solid dosage form of ART12.11, including comparative data to the Epidiolex formulation of CBD. Epidiolex had annual sales in excess of $700 million in 2023Announced publication of peer-reviewed article highlighting FABP7 as a promising novel target in cancer therapy Financial Results for Quarter Ended June 30, 2024 Cash and Investments: Cash and investments totaled $5.6 million as of June 30, 2024.R&D Expenses: Research and development expenses were $1.7 million for the three months ended June 30, 2024, compared to $0.8 million for the same period in 2023.G&A Expenses: General and administrative expenses were $0.8 million for the three months ended June 30, 2024, compared to $1.0 million for the same period in 2023.Net Loss: For the three months ended June 30, 2024, net loss was $2.4 million, or $0.75 per basic and diluted common share, which included $0.1 million of non-cash expenses, compared to a net loss of $1.6 million, or $0.56 per basic and diluted common share for the three months ended June 30, 2023, which included $0.2 million of non-cash expenses.R&D Tax Credit: Subsequent to the end of the quarter, the Company received approximately $1.3 million in cash on July 10, 2024, from the UK government related to qualified prior research and development expenses. About ART27.13ART27.13 is a G-Protein Coupled Receptor (GPCR) agonist, a highly potent, peripherally restricted new chemical entity, targeting CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Originally developed by AstraZeneca plc, ART27.13 has been in clinical studies with over 250 subjects. A statistically significant and dose-dependent increase in body weight was observed in patients with back pain who were otherwise healthy. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Having completed a Phase 1 study in cancer patients where ART27.13 demonstrated an excellent safety profile, Artelo is now advancing it in the CAReS trial as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Currently, there is no FDA-approved treatment for cancer anorexia cachexia syndrome. About CAReSThe Cancer Appetite Recovery Study (CAReS) is a Phase 1b/2a randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in patients with cancer anorexia and weight loss. Cancer-related anorexia, or the lack or loss of appetite in the person with cancer, may result from the cancer and/or its treatment with radiation or chemotherapy. It is common for people with cancer to lose weight. Anorexia and the resulting weight loss can affect a patient’s health, often weakening their immune system and causing discomfort and dehydration. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to chemotherapy. Now completed, the Phase 1b portion of the CAReS study was designed to determine the most effective and safest dose of ART27.13 for dosing in the Phase 2a stage. Currently enrolling, the Phase 2a portion of the CAReS study is designed to determine estimates of activity of ART27.13 in terms of lean body mass, weight gain, and improvement of anorexia. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817) About ART26.12Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids including endocannabinoids and fatty acids. FABP is overexpressed and associated with abnormal lipid signaling in a number of pathologies. ART26.12, Artelo’s lead FABP inhibitor cleared by FDA to initiate first-in-human studies, is a potent and selective inhibitor of FABP5 being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic, with an initial clinical study planned for chemotherapy-induced peripheral neuropathy (CIPN). Beyond ART26.12, Artelo’s extensive library of small molecule inhibitors of FABPs have shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, dermatologic conditions, and anxiety disorders. About ART12.11ART12.11 is Artelo’s wholly owned, proprietary 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. Superior 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. 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. Artelo is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the Company applies leading-edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at www.artelobio.com and Twitter: @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 statement 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, LLCTel: 212-671-1020Email: ARTL@crescendo-ir.com

ART26.12 seeks to address a critical need in painful neuropathies, including chemotherapy-induced peripheral neuropathy for which there is no FDA-approved treatment Phase 1 trial results expected in the first half of 2025 July 15, 2024 -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic and neurological conditions, today announced that the U.S. Food and Drug Administration (FDA) has issued a “Study May Proceed” letter for the Company’s Investigational New Drug (IND) application for ART26.12, for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). FDA clearance of the ART26.12 IND application enables the Company to initiate its first-in-human Phase 1 single ascending dose study. Study startup activities have been initiated in collaboration with the internationally known contract research organization Worldwide Clinical Trials. ART26.12 is the lead compound in the Company’s proprietary Fatty Acid Binding Protein (FABP) platform and the first selective FABP5 inhibitor to enter clinical trials. The FABP5 target is an intracellular protein involved in lipid signaling and represents a promising mechanism of action for drug candidates that can modify the cellular lipidome. ART26.12 is being developed as a non-opioid approach to the management of painful neuropathies. The Company’s FABP inhibitor platform, and ART26.12 in particular, has garnered interest from a range of potential partners due to its preclinical demonstation of efficacy, novel mechanism, and strong patent estate. “Receiving IND clearance validates our development efforts and underscores the potential impact of ART26.12 to improve patients’ lives,” said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “We look forward to sharing the initial clinical results with ART26.12 next year. As the leading company pursuing FABP inhibiton we are committed to building on the unique, lipid-modulating mechanism of our FABP inhibitor platform to address life-altering pathologies for which there are few, if any, safe and effective pharmaceutical treatments.” Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids involved in cellular signaling. FABPs are often overexpressed and associated with abnormal lipid signaling in a number of pathologies. ART26.12, Artelo’s lead FABP inhibitor program in clinical development, is a potent and selective small molecule inhibitor of FABP5 being developed as an orally delivered, peripherally acting, non-opioid, new chemical entity for cancer patients suffering from chemotherapy- induced peripheral neuropathy. Invented by Distinguished Professor Iwao Ojima working in collaboration with Professor Martin Kaczocha, both at Stony Brook University, the extensive library of FABP inhibitors was exclusively licensed to Artelo with global rights. Preclinical evidence to date suggest FABP inhibition has broad therapeutic promise for the treatment of multiple cancers, painful neuropathies, cancer bone pain, dermatologic conditions and anxiety disorders. Chemotherapy-induced peripheral neuropathy (CIPN) is a type of neuropathic pain caused by chemotherapy. Some chemotherapies result in CIPN with 90% frequency. CIPN often results in dose reduction or cessation of the cancer treatment leading to negative impacts on efficacy and survival. Acute CIPN occurs during chemotherapy treatment while chronic CIPN can last months to years. No FDA- approved treatment currently exists for CIPN. A new treatment or preventative intervention for CIPN holds promise to not only address debilitating pain, but also serve as an enabler of essential anti-cancer therapy. Artelo Biosciences, Inc. is a clinical-stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways. Artelo is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the Company applies leading-edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at www.artelobio.com and Twitter: @ArteloBio. The content above comes from the network. if any infringement, please contact us to modify.

Inhibition of FABP5 Demonstrates Activity in Cancer, Psoriasis, and Anxiety Disorders Results from Several Research Studies Presented at the Annual ICRS Symposium SOLANA BEACH, Calif., July 02, 2024 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic and neurological conditions, today announced that George Warren, Ph.D., Principal Scientist at Artelo, Myles Osborn, Medicinal Chemist at Artelo, and Matthew Jones, Ph.D. candidate from the Laviolette laboratory at the University of Western Ontario, Canada, each presented results from research studies demonstrating the broad therapeutic potential of Fatty Acid Binding Protein 5 (FABP5) inhibition at the 34th Annual International Cannabinoid Research Society (ICRS) Symposium. The ICRS Symposium is being held June 30 – July 5, 2024 in Salamanca, Spain. Targeting FABP5, a promising new approach to treat cancer, was featured in the presentation “Efficacy of ART26.12, a Novel Fatty Acid Binding Protein 5 Inhibitor, in an Orthotopic HCT-116-LUC Human Colon Cancer Model.” Myles Osborn discussed novel preclinical data showing a direct anti-tumoral effect of oral treatment with ART26.12. These data are also supportive of Artelo’s planned development of ART26.12 in chemotherapy-induced peripheral neuropathy, where ART26.12 may be able to aid in treatment of the underlying cancer, in addition to the debilitating effects of painful neuropathies. Beyond development for pain and cancer, ART26.12 has also shown the potential for therapeutic activity in dermatologic conditions. FABP5 was first identified in psoriatic lesions and there is evidence to suggest that upregulation of FABP5 contributes to the pathology of psoriasis. Regarding the data in his presentation, “A Novel Fatty Acid-binding Protein 5 Inhibitor Shows Efficacy in Preclinical Models of Psoriasis,” George Warren, Ph.D. commented, “We are pleased to share novel data showing that our lead FABP5 inhibitor, ART26.12, demonstrated compelling data in preclinical models of psoriasis. In this study, ART26.12 reduced the severity of histopathological markers of skin damage and reduced markers of oxidative stress, chemokines, cytokines, and keratinocyte proliferation, and increased antimicrobial peptides. Results were obtained using a standard imiquimod mouse model, which demonstrated ART26.12 had similar levels of activity as Sotyktu (deucravacitinib), an oral tyrosine kinase 2 inhibitor approved by the U.S. Food and Drug Administration in 2022 to treat psoriasis. Sales of Sotyktu may reach $4 billion by the end of the decade, according to Bristol Myers Squibb.” In addition to ART26.12, another one of Artelo’s FABP5 inhibitors was featured in a presentation entitled, “Inhibition of Fatty Acid Binding Protein 5 Prevents Stress-induced Anxiety and Depressive-Like Behavioral Symptoms and Reverses Stress-induced Inhibition of Hippocampal Neurogenesis” where Matthew Jones discussed new results from ongoing studies being conducted at the laboratory of Dr. Steven Laviolette. The data showed that Artelo’s FABP5 inhibitor SBFI103 improved depressive-like behaviors in rats after chronic unpredictable stress, associated with increases in markers of neurogenesis, a critical process in which newly formed neural cells are added to the existing neural network. “This new data supports our laboratory’s earlier work showing SBFI103 reduces anxiety and increased fear memory extinction. These studies implicate a role for the cannabinoid receptor 2 mediating the effects of FABP5 inhibition in the brain,” concluded Jones. “We are pleased to share the expanding evidence for the potential utility of inhibiting FABP5,” stated Gregory D. Gorgas, President and Chief Executive Officer of Artelo. “These important scientific advances show that lipid modulation is a promising therapeutic strategy across multiple diseases where overactivity of the lipidome contributes to the pathology of the disease or where modulation of the lipidome leads to increased levels of analgesic and anxiolytic lipids. We are grateful for the opportunity to share our data and why we believe development of FABP5 inhibitors from our extensive library could have significant impact for a wide range of diseases. We expect to report on first-in-human trials with ART26.12 next year.” About ART26.12Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids including endocannabinoids and fatty acids. FABP is overexpressed and associated with abnormal lipid signaling in a number of pathologies. ART26.12, Artelo’s lead FABP inhibitor, is a potent and selective inhibitor of FABP5 being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic, with an initial clinical study planned for chemotherapy-induced peripheral neuropathy (CIPN). Beyond ART26.12, Artelo’s extensive library of small molecule inhibitors of FABPs have shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, and anxiety disorders. About the International Cannabinoid Research SocietyThe International Cannabinoid Research Society (ICRS) is the premier global scientific association with more than 650 international members from 40 countries, all active researchers in the field of endogenous, plant-derived, and synthetic cannabinoids and related bioactive lipids. In addition to acting as a source for impartial information on cannabis and the cannabinoids, the main role of the ICRS is to provide an open forum for researchers to meet and discuss their research. The ICRS Symposium is being held June 30 – July 5, 2024 in Salamanca, Spain. 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 including the endocannabinoid system. Artelo is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the company applies leading edge scientific, regulatory, and commercial discipline to develop high-impact therapies. For more information and to view available publications, please visit https://artelobio.com/science/. Forward Looking StatementsThis 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 statement 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, LLCTel: 212-671-1020Email: ARTL@crescendo-ir.com