FABP5

SOLANA BEACH, Calif., Jan. 23, 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, and neurological conditions, today announced new research published in the peer-reviewed Journal of Pain. The research article, titled “Discovery and preclinical evaluation of a novel inhibitor of FABP5, ART26.12, effective in Oxaliplatin-induced Peripheral Neuropathy,” highlights Artelo’s pre-clinical asset, ART26.12, and its potential ability to treat and prevent Oxaliplatin-Induced Peripheral Neuropathy (OIPN) in a series of separate studies. ART26.12 is a Fatty Acid Binding Protein 5 (FABP5) inhibitor in development for the treatment of chemotherapy-induced peripheral neuropathy (CIPN), a type of neuropathic pain caused by chemotherapy as well as non-chemotherapy cancer treatments such as immunomodulating drugs. Oxaliplatin (OXA) is a commonly used platinum-based antineoplastic agent that causes oxaliplatin-induced peripheral neuropathy (OIPN) in up to 98% of patients treated with OXA, oftentimes resulting in treatment dose reduction, cessation of anti-cancer treatment prematurely, or can result in a painful persistent peripheral neuropathy even after chemotherapy is stopped. “In pre-clinical safety studies, ART26.12 has shown minimal off target effects, high oral bioavailability, and a NOAEL (no-observed-adverse-effect-level) of 1000 mg/kg/day administration,” commented Andy Yates, PhD, Senior Vice President and Chief Scientific Officer at Artelo. “We are highly encouraged by the four research studies presented in this paper demonstrating ART26.12, our patented and novel treatment approach to inhibiting FABP5, was effective in treating and preventing the painful condition of OIPN.” According to Coherent Market Insights, the global neuropathic pain market is estimated to be valued at $7.6 billion, demonstrating the need for an innovative therapy that has the potential to provide non-opioid pain relief. Artelo has conducted multiple pre-clinical studies in painful neuropathies, including diabetic neuropathy, paclitaxel-induced peripheral neuropathy, and OIPN, the latter two of which has no FDA-approved treatment. The Company previously reported a positive pre-IND (investigational new drug) meeting with the Food and Drug Administration (FDA) and anticipates filing the IND for ART26.12 in the first half of 2024. About ART26.12 Fatty 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 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. More information is available at and Twitter: @ArteloBio. About CIPN Chemotherapy induced peripheral neuropathy (CIPN) is a type of neuropathic pain caused by chemotherapy as well as non-chemotherapy cancer treatments such as immunomodulating drugs. CIPN is a major challenge with many oncological treatments, sometimes resulting in dose reduction or cessation of the cancer treatment, negatively impacting efficacy and survival. Acute CIPN occurs during chemotherapy and chronic CIPN can last months to years. Around 30% of patients will still have CIPN a year, or more, after finishing chemotherapy. 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, LLC Tel: 212-671-1020 Email: ARTL@crescendo-ir.com

SOLANA BEACH, Calif., Jan. 08, 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, and neurological conditions, today announced that it has selected Worldwide Clinical Trials (“Worldwide”), a global award-winning contract research organization (CRO) therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease, to support the Company’s planned Phase 1 trial with ART26.12, its Fatty Acid Binding Protein 5 (FABP5) inhibitor in development for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). “We look forward to working with Worldwide once we obtain approval from the FDA to advance ART16.12 into Phase 1 clinical development,” commented Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “With Worldwide’s extensive experience in the neurology space and successful track record of assisting companies progress through trials, we believe we are well positioned to leverage ART26.12’s positive profile observed in multiple animal models of painful neuropathies to progress to human studies.” “We are excited to partner with the Artelo Biosciences team on their important advancement with ART26.12,” stated Peter Benton, President and Chief Executive Officer of Worldwide Clinical Trials. “Given the broad potential of lipid-signaling in therapeutics development and more specifically the prospects for ART26.12 as a non-opioid pain drug, we look forward to supporting Artelo in the evaluation of safety with their promising FABP5 inhibitor.” According to Coherent Market Insights, the global neuropathic pain market is estimated to be valued at $7.6 billion, demonstrating the need for an innovative therapy that has the potential to provide relief for pain patients with few treatment options. Artelo has conducted five pre-clinical studies in painful neuropathies, including diabetic neuropathy and chemotherapy-induced peripheral neuropathy, the latter of which has no FDA-approved treatment. The Company previously reported a positive pre-IND (investigational new drug) meeting with the Food and Drug Administration and anticipates filing the IND for ART26.12 in the first half of this 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 Worldwide Clinical TrialsWorldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. Worldwide is therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease. Its global footprint spans nearly 60 countries with more than 3,400 team members. For more information, visit www.worldwide.com. 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. More information is available at www.artelobio.com and Twitter: @ArteloBio. About CIPNChemotherapy induced peripheral neuropathy (CIPN) is a type of neuropathic pain caused by chemotherapy as well as non-chemotherapy cancer treatments such as immunomodulating drugs. CIPN is a major challenge with many oncological treatments, sometimes resulting in dose reduction or cessation of the cancer treatment, negatively impacting efficacy and survival. Acute CIPN occurs during chemotherapy and chronic CIPN can last months to years. Around 30% of patients will still have CIPN a year, or more, after finishing chemotherapy. 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

$12.9 Million in Cash and Investments as of September 30, 2023;Runway Expected to Reach Meaningful Development Milestones On Track to Submit IND Application with the FDA for ART26.12 During the First Half of 2024 SOLANA BEACH, Calif., Nov. 13, 2023 (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, and neurological conditions, today reported financial and operating results for the three months ended September 30, 2023 and provided a business update. “We are pleased to report continued progress toward achieving meaningful milestones,” commented Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “Specifically, we are on track to complete patient enrollment in our Cancer Appetite Recovery Study (CAReS) Phase 2a trial, evaluating our lead clinical program ART27.13 for the treatment of cancer-related anorexia and weight loss, in the second half of next year.” Artelo also has two product candidates, ART26.11 and ART12.11 advancing toward the clinic. New data on ART26.12, a Fatty Acid Binding Protein 5 (FABP5) inhibitor, and ART12.11, the Company’s proprietary cocrystal of cannabidiol (CBD) and tetramethylpyrazine (TMP), were presented at prominent conferences including the Gordon Research Conference, the 6th Cannabinoid-Derived Drug Development Summit, and the 13th Congress of European Pain Federation during the quarter. Notably, ART12.11 demonstrated improved pharmaceutical properties in preclinical chronic stress models due to its novel co-crystallization. These improved properties result in better solubility, dissolution, and absorption compared to CBD alone. In addition, ART26.12 shows promise as a potential treatment for pain resulting from peripheral neuropathy based on its ability to activate multiple receptors implicated in pain signaling. The Company intends to submit its IND (Investigational New Drug) application to the Food and Drug Administration (FDA) during the first half of 2024 to support first-in-human clinical trials of ART26.12. “Furthermore, we maintained a strong balance sheet with over $12.9 million in cash and cash equivalents, which we believe will support operations into the first quarter of 2025. We continue to carefully manage our resources in order to reach significant development milestones and attract partner interest across our entire portfolio,” Mr. Gorgas concluded. Financial Results Ended September 30, 2023 Operating expenses for the three months ended September 30, 2023, were $2.6 million compared to $2.4 million for the same period in 2022. The increase in operating expenses for the three months ended September 30, 2023, was primarily related to an increase in research and development expense as a result of increased salaries to internal research and development staff along with increased payments to third-party service providers offset by a decrease in general and administrative expenses associated with a decrease in the year-over-year service cost of stock-based compensation, a non-cash expense. Net loss was approximately $2.4 million, or $0.83 per basic and diluted share, for the three months ended September 30, 2023, compared to a net loss of $2.3 million, or $0.82 per basic and diluted share, for the three months ended September 30, 2022. As of September 30, 2023, the Company had approximately $12.9 million in cash and investments, compared to $17.5 million as of December 31, 2022. About Artelo BiosciencesArtelo 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, neuropathy, 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. 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) 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 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, LLCTel: 212-671-1020Email: ARTL@crescendo-ir.com