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Artelo BiosciencesF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-13
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Investor releaseQuarter not tagged2026-08-13

Artelo Biosciences Provides Business Update and Reports 2026 Second Quarter Financial Results

GlobeNewswire
Clinical and Scientific Progress Across the Pipeline Supports Multiple Upcoming Milestones SOLANA BEACH, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“Artelo” or the “Company”), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological, or neurological conditions, today provided a business update and announced its financial and operational results for the second quarter ended June 30, 2026. Business Highlights ART26.12: Advancing Toward Multiple-Dose Clinical Evaluation: Artelo continues preparations to initiate a Phase 1 multiple ascending dose study in the fourth quarter of 2026. First-in-human data showed favorable safety and tolerability, linear and dose-proportional pharmacokinetics, exposure above projected therapeutic levels, and a wide potential therapeutic margin. Human metabolite profiling identified only three low-level metabolites, representing approximately 7% of total drug-related exposure, with no human-specific metabolites or safety concerns. Growing Evidence for the Treatment of Chronic Pain: New nonclinical findings broaden the program beyond chemotherapy-induced peripheral neuropathy. In an osteoarthritis model, ART26.12 provided pain relief comparable to naproxen with significantly less gastric tissue damage. Separate spinal cord injury research showed reductions in mechanical hypersensitivity and spontaneous pain behaviors. Together with AI-enabled biomarker analyses of Artelo’s proprietary datasets, these findings further support the potential of selective FABP5 inhibition as a differentiated, non-opioid approach for the treatment chronic pain. ART27.13: More Opportunity Beyond Cancer Supportive Care: Encouraging interim Phase 2 CAReS data showed improvement in body weight, lean body mass and physical activity, particularly at the highest dose. New nonclinical results in a paclitaxel-induced peripheral neuropathy model also demonstrated reductions in pain-related behaviors. In addition to conducting a fully funded Phase 2 clinical study in glaucoma, the Company is evaluating additional development opportunities, including as a potential GLP-1 companion therapy for muscle preservation. ART12.11: Supported by Peer-Reviewed CBD Analysis: A recent review of more than 50 studies found that low-dose CBD…Read full document

Clinical and Scientific Progress Across the Pipeline Supports Multiple Upcoming Milestones SOLANA BEACH, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“Artelo” or the “Company”), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological, or neurological conditions, today provided a business update and announced its financial and operational results for the second quarter ended June 30, 2026. Business Highlights ART26.12: Advancing Toward Multiple-Dose Clinical Evaluation: Artelo continues preparations to initiate a Phase 1 multiple ascending dose study in the fourth quarter of 2026. First-in-human data showed favorable safety and tolerability, linear and dose-proportional pharmacokinetics, exposure above projected therapeutic levels, and a wide potential therapeutic margin. Human metabolite profiling identified only three low-level metabolites, representing approximately 7% of total drug-related exposure, with no human-specific metabolites or safety concerns. Growing Evidence for the Treatment of Chronic Pain: New nonclinical findings broaden the program beyond chemotherapy-induced peripheral neuropathy. In an osteoarthritis model, ART26.12 provided pain relief comparable to naproxen with significantly less gastric tissue damage. Separate spinal cord injury research showed reductions in mechanical hypersensitivity and spontaneous pain behaviors. Together with AI-enabled biomarker analyses of Artelo’s proprietary datasets, these findings further support the potential of selective FABP5 inhibition as a differentiated, non-opioid approach for the treatment chronic pain. ART27.13: More Opportunity Beyond Cancer Supportive Care: Encouraging interim Phase 2 CAReS data showed improvement in body weight, lean body mass and physical activity, particularly at the highest dose. New nonclinical results in a paclitaxel-induced peripheral neuropathy model also demonstrated reductions in pain-related behaviors. In addition to conducting a fully funded Phase 2 clinical study in glaucoma, the Company is evaluating additional development opportunities, including as a potential GLP-1 companion therapy for muscle preservation. ART12.11: Supported by Peer-Reviewed CBD Analysis: A recent review of more than 50 studies found that low-dose CBD products generally failed to achieve adequate therapeutic exposure, while highlighting drug-drug interaction considerations. The findings support the rationale for ART12.11, Artelo’s patented CBD:TMP cocrystal, which is designed to improve bioavailability and enable more consistent, titratable exposure. The Company is advancing preclinical preparations for human studies. “We entered the second half of 2026 from a position of strength, having reinforced our balance sheet through a successful $11.0 million financing and progressing each of our development programs,” said Gregory D. Gorgas, President and Chief Executive Officer. “Specifically, ART26.12 continues to generate compelling data that strengthens our confidence in its potential as a differentiated, non-opioid therapy for chronic pain, while ART27.13 and ART12.11 continue to achieve progress. With several key catalysts on the horizon, we believe Artelo is well positioned to deliver meaningful value for patients and shareholders.” Q2 2026 Financial Results R&D Expenses: Research and development expenses were $0.9 million for the quarter ended June 30, 2026, compared to $1.9 million for the quarter ended June 30, 2025. G&A Expenses: General and administrative expenses were $1.6 million for the quarter ended June 30, 2026, compared to $1.3 million in the quarter ended June 30, 2025. Net Loss: For the quarter ended June 30, 2026, net loss was $2.4 million, or $0.89 per basic and diluted common share, compared to a net loss of $3.2 million for the quarter ended June 30, 2025. Cash and Investments: Cash and investments totaled $4.2 million as of June 30, 2026. 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, 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, commercial, and treasury management practices, including digital assets, to maximize stakeholder value. More information is available at www.artelobio.com and X: @ArteloBio. About ART26.12 ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is under development as a novel, peripherally acting, non-opioid, non-steroidal analgesic, initially for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). Human studies with ART26.12 have demonstrated a favorable safety profile with no serious adverse events, as well as predictable, linear pharmacokinetics and dosing flexibility in both fed and fasted states. Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. In addition to ART26.12, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. About ART27.13ART27.13 is a novel cannabinoid receptor agonist being developed as supportive care for people with cancer experiencing anorexia and cachexia. Administered orally once daily, the treatment goals with ART27.13 are to improve appetite, body weight, and activity levels while preserving muscle and elevating quality of life. Initially developed by AstraZeneca plc, ART27.13 selectively targets peripheral cannabinoid (CB1 and CB2) receptors to avoid the psychoactive side effects typically associated with some cannabinoids. While exhibiting a favorable safety profile at all doses in the CAReS trial, interim analysis from the blinded and randomized Phase 2 study demonstrated a mean weight gain of over 6% for participants that received the top dose of ART27.13 compared to a 5% loss in the placebo group. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to therapy. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome. ART27.13 is also being evaluated in a Phase 2 study as an oral treatment to lower intraocular pressure in glaucoma patients. About CAReSThe Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in people with cancer experiencing 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. Interim data from the Phase 2 portion of CAReS showed improvements in lean body mass, weight gain, and activity among patients treated with all doses of ART27.13, particularly at the highest dose, compared to the participants administered placebo. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817) 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. Artelo has received favorable UK MHRA regulatory guidance supporting Phase 1 study plans and potential accelerated pathways with plans to initiate human clinical studies in the first half of 2026. Greatly enhanced 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, and has now been granted or validated in 21 additional countries. 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 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: [email protected]

Investor releaseQuarter not tagged2026-07-16

Artelo Biosciences Announces Results from a Nonclinical Osteoarthritis Study Supporting ART26.12 as a Potential First-in-Class New Therapy for Chronic Pain Conditions

GlobeNewswire
Osteoarthritic Pain Model Results Further Validate FABP5 as a Novel Therapeutic Target in Pain Management SOLANA BEACH, Calif., July 16, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“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 new data supporting the therapeutic potential of ART26.12, its proprietary and selective fatty acid binding protein 5 (FABP5) inhibitor, as a novel product candidate for the treatment of osteoarthritis (OA) pain. Martin Kaczocha, Ph.D., Professor of Anesthesiology at Stony Brook University, New York, presented the research results at the International Cannabinoid Research Society 2026 Annual Symposium recently held in Dijon, France. In the nonclinical OA study, oral administration of ART26.12 significantly reduced osteoarthritis-associated pain behaviors following both acute and chronic dosing over a 4-week period, demonstrating efficacy comparable to naproxen, a widely prescribed nonsteroidal anti-inflammatory drug (NSAID) used to treat OA. ART26.12 produced distinct changes in endocannabinoids and other related bioactive lipids and proteins compared to naproxen, supporting a novel mechanism of action for ART26.12. Importantly, animals treated with ART26.12 exhibited significantly less stomach tissue damage, including non-glandular hyperkeratosis, compared to those receiving naproxen. Non-glandular hyperkeratosis is considered an early indicator of erosions and gastric ulcers, a well-recognized and potentially serious complication associated with chronic NSAID use. These findings suggest ART26.12 may offer effective pain relief with the potential for an improved gastrointestinal safety profile. Professor Kaczocha commented, “Osteoarthritis affects more than 30 million Americans and a novel drug such as ART26.12 could provide a new option for patients to achieve pain relief with potentially fewer side-effects compared to existing NSAIDs.” Long-term treatment options for OA remain constrained by the safety concerns associated with chronic NSAID use, including gastrointestinal complications that contribute to significant morbidity and healthcare costs each year. These limitations highlight the need for differentiated therapies, and…Read full document

Osteoarthritic Pain Model Results Further Validate FABP5 as a Novel Therapeutic Target in Pain Management SOLANA BEACH, Calif., July 16, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“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 new data supporting the therapeutic potential of ART26.12, its proprietary and selective fatty acid binding protein 5 (FABP5) inhibitor, as a novel product candidate for the treatment of osteoarthritis (OA) pain. Martin Kaczocha, Ph.D., Professor of Anesthesiology at Stony Brook University, New York, presented the research results at the International Cannabinoid Research Society 2026 Annual Symposium recently held in Dijon, France. In the nonclinical OA study, oral administration of ART26.12 significantly reduced osteoarthritis-associated pain behaviors following both acute and chronic dosing over a 4-week period, demonstrating efficacy comparable to naproxen, a widely prescribed nonsteroidal anti-inflammatory drug (NSAID) used to treat OA. ART26.12 produced distinct changes in endocannabinoids and other related bioactive lipids and proteins compared to naproxen, supporting a novel mechanism of action for ART26.12. Importantly, animals treated with ART26.12 exhibited significantly less stomach tissue damage, including non-glandular hyperkeratosis, compared to those receiving naproxen. Non-glandular hyperkeratosis is considered an early indicator of erosions and gastric ulcers, a well-recognized and potentially serious complication associated with chronic NSAID use. These findings suggest ART26.12 may offer effective pain relief with the potential for an improved gastrointestinal safety profile. Professor Kaczocha commented, “Osteoarthritis affects more than 30 million Americans and a novel drug such as ART26.12 could provide a new option for patients to achieve pain relief with potentially fewer side-effects compared to existing NSAIDs.” Long-term treatment options for OA remain constrained by the safety concerns associated with chronic NSAID use, including gastrointestinal complications that contribute to significant morbidity and healthcare costs each year. These limitations highlight the need for differentiated therapies, and new preclinical findings further validate FABP5 as a promising target for the treatment of chronic pain while reinforcing the broad therapeutic potential of ART26.12. The data demonstrated that inhibition of FABP5 significantly alleviated osteoarthritis-associated pain, expanding the potential clinical utility of ART26.12 beyond neuropathic pain into one of the largest and most prevalent chronic pain markets. Importantly, ART26.12 delivered pain relief comparable to naproxen while exhibiting significantly less gastric tissue damage in preclinical studies, supporting the potential for an improved gastrointestinal safety profile. Collectively, these findings further support the continued development of ART26.12 as a differentiated, non-opioid pain therapy with the potential to address multiple chronic pain indications through its novel mechanism of action. “Chronic pain remains one of the largest areas of unmet medical need, with patients continuing to rely on therapies that often provide inadequate relief or carry significant safety concerns,” said Andy Yates, PhD, Chief Scientific Officer of Artelo. “The growing body of evidence supporting ART26.12 across multiple pain models, along with a low toxicological non-clinical risk and a well-tolerated clinical profile, reinforces our belief that selective FABP5 inhibition may represent a differentiated approach to treating chronic pain and inflammatory disorders. These findings continue to strengthen the scientific rationale for ART26.12 as a potential first-in-class analgesic candidate with utility across multiple disease settings.” Preparations are underway for conducting a clinical multiple ascending repeat dose study to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 in healthy volunteers. Artelo anticipates enrollment will commence during the fourth quarter of this year. About ART26.12ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is under development as a novel, peripherally acting, non-opioid, non-steroidal analgesic, initially for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). Human studies with ART26.12 have demonstrated a favorable safety profile with no serious adverse events, as well as predictable, linear pharmacokinetics and dosing flexibility in both fed and fasted states. Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. In addition to ART26.12, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. 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, 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 practices to maximize stakeholder value. More information is available at www.artelobio.com and X: @ArteloBio. 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: [email protected]

Investor releaseQuarter not tagged2026-07-13

Artelo Biosciences Announces Positive Results with ART27.13 in a Nonclinical Model of Paclitaxel-Induced Peripheral Neuropathy

GlobeNewswire
Expands potential benefit for treating neuropathic pain in cancer patients, particularly those experiencing weight loss due to cancer Findings suggest broader utility in cancer supportive care, building on interim findings from CAReS Phase 2 clinical study which demonstrated improvements in body weight, lean body mass and activity levels SOLANA BEACH, Calif., July 13, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“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 promising results from nonclinical studies in neuropathic pain with ART27.13, the Company's proprietary peripherally restricted cannabinoid receptor agonist, currently in Phase 2 clinical development evaluating patients experiencing cancer-related anorexia cachexia syndrome (CACS). To determine whether ART27.13 has the potential to address neuropathic pain in cancer patients, researchers at Artelo investigated its proprietary dual cannabinoid agonist in a nonclinical model of paclitaxel-induced peripheral neuropathy, a debilitating side effect that affects approximately 60%-80% of patients receiving paclitaxel1. Results demonstrated that repeated dosing with ART27.13 reduced neuropathic pain-associated behaviors (mechanical allodynia and thermal hyperalgesia) in both male and female paclitaxel-treated animals, supporting further exploration of the compound in oncology supportive care settings. “Chemotherapy-induced peripheral neuropathy can significantly affect patient quality of life and may limit cancer treatment adherence,” said George Warren, Ph.D., lead scientist at Artelo Biosciences and presenter of the pain study results at the International Cannabinoid Research Society (ICRS) 2026 Annual Symposium recently held in Dijon, France. “The results observed in this model suggest that ART27.13 may have broader applications in cancer supportive care beyond CACS. We have incorporated several pain endpoints into the Cancer Appetite Recovery Study (CAReS) trial and, we look forward to reviewing these upon study completion to determine if the analgesic potential of ART27.13 in a cancer setting translates into the clinic.” CACS affects up to 80% of patients with advanced malignancies2 and is associated with…Read full document

Expands potential benefit for treating neuropathic pain in cancer patients, particularly those experiencing weight loss due to cancer Findings suggest broader utility in cancer supportive care, building on interim findings from CAReS Phase 2 clinical study which demonstrated improvements in body weight, lean body mass and activity levels SOLANA BEACH, Calif., July 13, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“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 promising results from nonclinical studies in neuropathic pain with ART27.13, the Company's proprietary peripherally restricted cannabinoid receptor agonist, currently in Phase 2 clinical development evaluating patients experiencing cancer-related anorexia cachexia syndrome (CACS). To determine whether ART27.13 has the potential to address neuropathic pain in cancer patients, researchers at Artelo investigated its proprietary dual cannabinoid agonist in a nonclinical model of paclitaxel-induced peripheral neuropathy, a debilitating side effect that affects approximately 60%-80% of patients receiving paclitaxel1. Results demonstrated that repeated dosing with ART27.13 reduced neuropathic pain-associated behaviors (mechanical allodynia and thermal hyperalgesia) in both male and female paclitaxel-treated animals, supporting further exploration of the compound in oncology supportive care settings. “Chemotherapy-induced peripheral neuropathy can significantly affect patient quality of life and may limit cancer treatment adherence,” said George Warren, Ph.D., lead scientist at Artelo Biosciences and presenter of the pain study results at the International Cannabinoid Research Society (ICRS) 2026 Annual Symposium recently held in Dijon, France. “The results observed in this model suggest that ART27.13 may have broader applications in cancer supportive care beyond CACS. We have incorporated several pain endpoints into the Cancer Appetite Recovery Study (CAReS) trial and, we look forward to reviewing these upon study completion to determine if the analgesic potential of ART27.13 in a cancer setting translates into the clinic.” CACS affects up to 80% of patients with advanced malignancies2 and is associated with reduced treatment tolerance, diminished physical functioning and poorer clinical outcomes. There are currently no FDA-approved treatment options available for CACS. ART27.13 is being evaluated in the CAReS and interim results also presented at ICRS demonstrated encouraging trends across several clinically meaningful endpoints, including improvements in body weight and lean body mass, increased activity levels, and favorable safety profile at doses up to 1300 µg/day. “Interim CAReS results, and the new data in neuropathic pain, suggests peripheral cannabinoid receptor modulation may influence multiple pathways associated with appetite regulation, metabolism, body composition and symptom management, particularly chemotherapy-induced neuropathic pain, in patients with cancer,” said Professor Saoirse E. O'Sullivan, Vice President of Translational Science at Artelo Biosciences and presenter of the interim results from CAReS. “Importantly, the supportive care opportunity for ART27.13 may extend beyond appetite stimulation and weight maintenance, as demonstrated by additional research presented at ICRS.” “Despite its significant impact on patient outcomes and quality of life, CACS remains an area of substantial unmet medical need with limited therapeutic options available to patients and physicians,” continued Professor O’Sullivan. “The trends observed in body composition and activity measures from CAReS are particularly encouraging given the profound impact these factors can have on patients living with CACS.” https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2026.1762734/full?utm_source https://www.cancer.gov/about-cancer/treatment/research/cachexia?utm_source= About ART27.13ART27.13 is a novel cannabinoid receptor agonist being developed as supportive care for people with cancer experiencing anorexia and cachexia. Administered orally once daily, the treatment goals with ART27.13 are to improve appetite, body weight, and activity levels while preserving muscle and elevating quality of life. Initially developed by AstraZeneca plc, ART27.13 selectively targets peripheral cannabinoid (CB1 and CB2) receptors to avoid the CNS side effects typically associated with some cannabinoids. While exhibiting a favorable safety profile at all doses in the CAReS trial, interim analysis from the blinded and randomized Phase 2 study demonstrated a mean weight gain of over 6% for participants that received the top dose of ART27.13 compared to a 5% loss in the placebo group. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to therapy. Currently, there areno FDA approved treatments for cancer anorexia cachexia syndrome. About CAReSThe Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in people with cancer experiencing 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. Interim data from the Phase 2 portion of CAReS showed improvements in lean body mass, weight gain, and activity among patients treated with all doses of ART27.13, particularly at the highest dose, compared to the participants administered placebo. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817) 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, 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 practices to maximize stakeholder value. More information is available at www.artelobio.com and X: @ArteloBio. 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: [email protected]

Investor releaseQuarter not tagged2026-05-15

Artelo Biosciences Provides Business Update Outlining Upcoming Milestones and Reports 2026 First Quarter Financial Results

GlobeNewswire
Strengthened balance sheet and advancing clinical pipeline with multiple catalysts expected through 2027 SOLANA BEACH, Calif., May 14, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“Artelo” or the “Company”), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological, or neurological conditions, today provided a business update and announced its financial and operational results for the quarter ended March 31, 2026, and outlined upcoming milestones across its portfolio. Business Highlights ART26.12 Progressing through Phase 1 studies: Following positive first-in-human Phase 1 single ascending dose and preliminary food-effect data with ART26.12, Artelo continues preparations to initiate the multiple ascending dose study, with enrollment anticipated to begin in the fourth quarter of 2026. ART26.12, a potential first-in-class analgesic with a novel mechanism-of-action, has been well tolerated at all doses tested with predictable pharmacokinetics, thus supporting its potential as a differentiated, non-opioid, non-steroidal treatment for pain. In addition, preclinical findings recently published in the European Journal of Pain demonstrated broad analgesic activity across multiple pain models, including modulation of key pain-related pathways and reduction of pro-inflammatory mediators, further reinforcing the therapeutic potential of ART26.12. ART27.13 Potential Indications Expansion: The Company continues to build on encouraging interim Phase 2 CAReS data in patients with cancer-related anorexia demonstrating improvements in body weight, lean body mass, and physical activity, along with a favorable tolerability profile. Strategic discussions to support the program’s next stage of development are proceeding in parallel. Artelo is also exploring ART27.13 beyond its lead indication, including as a potential GLP-1 companion therapy to help preserve lean body mass, and a third-party, fully funded clinical study in glaucoma. “Artelo entered 2026 with strong clinical momentum across our pipeline, as we continue to advance multiple programs toward key inflection points,” said Gregory D. Gorgas, Chief Executive Officer of Artelo. “We are particularly keen to initiate the next Phase 1 study with ART26.12, our lead FABP5 inhibitor, which we believe has…Read full document

Strengthened balance sheet and advancing clinical pipeline with multiple catalysts expected through 2027 SOLANA BEACH, Calif., May 14, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“Artelo” or the “Company”), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological, or neurological conditions, today provided a business update and announced its financial and operational results for the quarter ended March 31, 2026, and outlined upcoming milestones across its portfolio. Business Highlights ART26.12 Progressing through Phase 1 studies: Following positive first-in-human Phase 1 single ascending dose and preliminary food-effect data with ART26.12, Artelo continues preparations to initiate the multiple ascending dose study, with enrollment anticipated to begin in the fourth quarter of 2026. ART26.12, a potential first-in-class analgesic with a novel mechanism-of-action, has been well tolerated at all doses tested with predictable pharmacokinetics, thus supporting its potential as a differentiated, non-opioid, non-steroidal treatment for pain. In addition, preclinical findings recently published in the European Journal of Pain demonstrated broad analgesic activity across multiple pain models, including modulation of key pain-related pathways and reduction of pro-inflammatory mediators, further reinforcing the therapeutic potential of ART26.12. ART27.13 Potential Indications Expansion: The Company continues to build on encouraging interim Phase 2 CAReS data in patients with cancer-related anorexia demonstrating improvements in body weight, lean body mass, and physical activity, along with a favorable tolerability profile. Strategic discussions to support the program’s next stage of development are proceeding in parallel. Artelo is also exploring ART27.13 beyond its lead indication, including as a potential GLP-1 companion therapy to help preserve lean body mass, and a third-party, fully funded clinical study in glaucoma. “Artelo entered 2026 with strong clinical momentum across our pipeline, as we continue to advance multiple programs toward key inflection points,” said Gregory D. Gorgas, Chief Executive Officer of Artelo. “We are particularly keen to initiate the next Phase 1 study with ART26.12, our lead FABP5 inhibitor, which we believe has significant potential as a novel mechanism of action for the treatment of pain. Recent preclinical data published in the European Journal of Pain, together with the favorable safety and tolerability profile observed to date, reinforce our confidence in ART26.12 as a compelling, potentially first-in-class approach to pain management.” “As we look ahead, our recent capital raise has strengthened our balance sheet, providing significant cash runway to advance our clinical programs. In addition, we continue to benefit from third-party clinical research grants, notably the fully funded Phase 2 study in glaucoma with ART27.13. We are actively engaged in partnering discussions and are encouraged by the depth of interest and quality of engagement we are seeing across our programs. We believe this positions Artelo to drive meaningful value creation through both upcoming clinical milestones and potential strategic partnerships,” concluded Mr. Gorgas. Q1 2026 Financial Results R&D Expenses: Research and development expenses were $0.8 million for the quarter ended March 31, 2026, compared to $1.4 million for the quarter ended March 31, 2025. G&A Expenses: General and administrative expenses were $1.9 million for the quarter ended March 31, 2026, compared to $1.0 million in the quarter ended March 31, 2025. Net Loss: For the quarter ended March 31, 2026, net loss was $3.0 million, or $4.00 per basic and diluted common share, compared to a net loss of $2.4 million for the quarter ended March 31, 2025. Cash and Investments: Cash and investments totaled $10.3 million as of March 31, 2026. 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, 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, commercial, and treasury management practices, including digital assets, to maximize stakeholder value. More information is available at www.artelobio.com and X: @ArteloBio. About ART26.12 ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is under development as a novel, peripherally acting, non-opioid, non-steroidal analgesic, initially for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). Human studies with ART26.12 have demonstrated a favorable safety profile with no serious adverse events, as well as predictable, linear pharmacokinetics and dosing flexibility in both fed and fasted states. Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. In addition to ART26.12, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. About ART27.13 ART27.13 is a novel cannabinoid receptor agonist being developed as supportive care for people with cancer experiencing anorexia and cachexia. Administered orally once daily, the treatment goals with ART27.13 are to improve appetite, body weight, and activity levels while preserving muscle and elevating quality of life. Initially developed by AstraZeneca plc, ART27.13 selectively targets peripheral cannabinoid (CB1 and CB2) receptors to avoid the psychoactive side effects typically associated with some cannabinoids. While exhibiting a favorable safety profile at all doses in the CAReS trial, interim analysis from the blinded and randomized Phase 2 study demonstrated a mean weight gain of over 6% for participants that received the top dose of ART27.13 compared to a 5% loss in the placebo group. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to therapy. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome. About CAReS The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in people with cancer experiencing 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. Interim data from the Phase 2 portion of CAReS showed improvements in lean body mass, weight gain, and activity among patients treated with all doses of ART27.13, particularly at the highest dose, compared to the participants administered placebo. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817) About ART12.11 ART12.11 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. Artelo has received favorable UK MHRA regulatory guidance supporting Phase 1 study plans and potential accelerated pathways with plans to initiate human clinical studies in the first half of 2026. Greatly enhanced 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, and has now been granted or validated in 21 additional countries. 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 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, LLC Tel: 212-671-1020 Email: [email protected]

Investor releaseQuarter not tagged2026-02-24

Artelo Biosciences Provides Business Update Highlighting Clinical Progress and Reports Fiscal 2025 Year-End Financial Results

GlobeNewswire
Positive human data and upcoming clinical catalysts across portfolio SOLANA BEACH, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“Artelo” or the “Company”), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological, or neurological conditions, today provided a business update and announced its financial and operational results for the fiscal year ended December 31, 2025. Business Highlights: Successful Phase 1 study with ART26.12: Reported positive first-in-human Phase 1 single ascending dose (SAD) clinical data demonstrating a favorable safety profile, predictable pharmacokinetics, and dosing flexibility. As a result, the Company is working to complete preparations to open enrollment to the multiple ascending dose (MAD) study in the third quarter of 2026. Positive interim Phase 2 results with ART27.13: Announced positive interim Phase 2 CAReS data demonstrating improvements in body weight, lean body mass, and physical activity alongside a favorable side-effect profile compared to placebo in patients with cancer anorexia-cachexia syndrome. Streamlined regulatory pathway for ART12.11: Received favorable UK MHRA regulatory guidance supporting Phase 1 study plans and potential accelerated pathways. Pending outcome of toxicology study results in 2026, the Company plans to initiate human clinical studies with an oral solid dosage form during the first half of 2027. “2025 was a pivotal year clinically for Artelo, marked by meaningful progress across all our core programs,” stated Gregory D. Gorgas, Chief Executive Officer of Artelo, “We successfully completed a first-in-human Phase 1 SAD study for ART26.12 and validated our FABP5 inhibition approach to pain management. These results were further strengthened by positive preclinical efficacy data with ART26.12 which demonstrated sustained analgesic effects without tolerance in an osteoarthritis pain model, with efficacy comparable to naproxen and a potentially safer profile. We are excited to be progressing this program as a differentiated, non-opioid, non-steroidal alternative for pain” “We were very pleased to report positive interim Phase 2 CAReS data for ART27.13. These results reinforced ART27.13’s potential as a meaningful therapeutic strategy to address the significant u…Read full document

Positive human data and upcoming clinical catalysts across portfolio SOLANA BEACH, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“Artelo” or the “Company”), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological, or neurological conditions, today provided a business update and announced its financial and operational results for the fiscal year ended December 31, 2025. Business Highlights: Successful Phase 1 study with ART26.12: Reported positive first-in-human Phase 1 single ascending dose (SAD) clinical data demonstrating a favorable safety profile, predictable pharmacokinetics, and dosing flexibility. As a result, the Company is working to complete preparations to open enrollment to the multiple ascending dose (MAD) study in the third quarter of 2026. Positive interim Phase 2 results with ART27.13: Announced positive interim Phase 2 CAReS data demonstrating improvements in body weight, lean body mass, and physical activity alongside a favorable side-effect profile compared to placebo in patients with cancer anorexia-cachexia syndrome. Streamlined regulatory pathway for ART12.11: Received favorable UK MHRA regulatory guidance supporting Phase 1 study plans and potential accelerated pathways. Pending outcome of toxicology study results in 2026, the Company plans to initiate human clinical studies with an oral solid dosage form during the first half of 2027. “2025 was a pivotal year clinically for Artelo, marked by meaningful progress across all our core programs,” stated Gregory D. Gorgas, Chief Executive Officer of Artelo, “We successfully completed a first-in-human Phase 1 SAD study for ART26.12 and validated our FABP5 inhibition approach to pain management. These results were further strengthened by positive preclinical efficacy data with ART26.12 which demonstrated sustained analgesic effects without tolerance in an osteoarthritis pain model, with efficacy comparable to naproxen and a potentially safer profile. We are excited to be progressing this program as a differentiated, non-opioid, non-steroidal alternative for pain” “We were very pleased to report positive interim Phase 2 CAReS data for ART27.13. These results reinforced ART27.13’s potential as a meaningful therapeutic strategy to address the significant unmet medical need in patients with cancer anorexia-cachexia syndrome. In addition, we received a Notice of Allowance from the European Patent Office covering the intended commercial formulation of ART27.13 and extending patent protection through December 2041. Together, the clinical progress and enhanced intellectual property position have advanced partner interest in supporting the program’s next stage of development.” “In parallel, we were pleased with the UK MHRA’s favorable regulatory guidance supporting our Phase 1 clinical plans for ART 12.11. As presented at the 35th Annual International Cannabinoid Research Society Symposium, ART12.11’s positive preclinical efficacy was confirmed by its robust antidepressant-like activity in a stress-induced depression model, with efficacy comparable to sertraline (Zoloft) and differentiated cognitive benefits not observed with leading SSRIs. Our team is therefore preparing to initiate first-in-human studies with an oral solid dosage form early next year.” Gorgas concluded by stating that “Looking ahead, we are firmly focused on disciplined clinical execution, strategic collaboration, and prudent capital management to drive shareholder value.” Fiscal 2025 Year-End Financial Results R&D Expenses: Research and development expenses were $5.4 million for the year ended December 31, 2025, compared to $6.0 million for the year ended December 31, 2024. G&A Expenses: General and administrative expenses were $6.0 million for the year ended December 31, 2025, compared to $4.1 million in the prior year. Net Loss: For the year ended December 31, 2025, net loss was 12.9 million, or $12.52 per basic and diluted common share, compared to a net loss of $9.8 million for the year ended December 31, 2024. Cash and Investments: Cash and investments totaled $0.6 million as of December 31, 2025. 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, 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, commercial, and treasury management practices, including digital assets, to maximize stakeholder value. More information is available at www.artelobio.com and X: @ArteloBio. About ART26.12 ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is under development as a novel, peripherally acting, non-opioid, non-steroidal analgesic, initially for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). Human studies with ART26.12 have demonstrated a favorable safety profile with no serious adverse events, as well as predictable, linear pharmacokinetics and dosing flexibility in both fed and fasted states. Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. In addition to ART26.12, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. About ART27.13 ART27.13 is a novel cannabinoid receptor agonist being developed as supportive care for people with cancer experiencing anorexia and cachexia. Administered orally once daily, the treatment goals with ART27.13 are to improve appetite, body weight, and activity levels while preserving muscle and elevating quality of life. Initially developed by AstraZeneca plc, ART27.13 selectively targets peripheral cannabinoid (CB1 and CB2) receptors to avoid the psychoactive side effects typically associated with some cannabinoids. While exhibiting a favorable safety profile at all doses in the CAReS trial, interim analysis from the blinded and randomized Phase 2 study demonstrated a mean weight gain of over 6% for participants that received the top dose of ART27.13 compared to a 5% loss in the placebo group. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to therapy. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome. About CAReS The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in people with cancer experiencing 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. Interim data from the Phase 2 portion of CAReS showed improvements in lean body mass, weight gain, and activity among patients treated with all doses of ART27.13, particularly at the highest dose, compared to the participants administered placebo. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817) About ART12.11 ART12.11 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. Artelo has received favorable UK MHRA regulatory guidance supporting Phase 1 study plans and potential accelerated pathways with plans to initiate human clinical studies in the first half of 2026. Greatly enhanced 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 and has now been granted or validated in 21 additional countries. 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 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, LLC Tel: 212-671-1020 Email: [email protected]

Investor releaseQuarter not tagged2025-11-12

Artelo Biosciences Provides Business Update and Reports Third Quarter 2025 Financial Results

GlobeNewswire
Encouraging Clinical Progress, Including Positive Interim Phase 2 Results for the Treatment of Cancer Anorexia Cachexia Syndrome SOLANA BEACH, Calif., Nov. 12, 2025 (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, or neurological conditions, today provided a business update and announced its financial and operational results for the three months ended September 30, 2025. “We continue to deliver on our clinical and strategic objectives, advancing three differentiated programs with strong potential to address large, underserved markets,” said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “We were very pleased with the interim Phase 2 data with ART27.13 showing restoration in body weight versus continued weight loss in people suffering from cancer-related anorexia. Importantly, this data has attracted meaningful partnering interest from several pharmaceutical companies. In addition, partnering interest continues to expand for ART26.12, our lead FABP5 inhibitor, as more companies become aware of its broad therapeutic potential. With ART26.12’s progress toward a multiple ascending dose study, we believe our clinical pipeline is well-positioned to create substantial value for patients and shareholders.” Business Highlights: ART26.12 – Following Successful Single Ascending Dose (SAD) Study, Multiple Ascending Dose (MAD) Study Protocol being Finalized The MAD study aims to confirm the favorable safety profile and dose-linear pharmacokinetics observed in the SAD study under multiple dose scenarios while providing further information on dosing frequency and biomarker strategy. Preliminary food-effect results support future development with dosing in either fed or fasted states. ART27.13 –Positive Interim Phase 2 CAReS Data Driving Partnering Interest Interim Phase 2 Cancer Appetite Recovery Study (CAReS) results demonstrated meaningful efficacy, safety, and functional benefit in cancer-related anorexia and weight loss. Patients receiving top dose ART27.13 achieved an average +6.4% weight gain versus a -5.4% loss on placebo, showed +4.2% lean body mass increase, and improved activity levels aligned with potential regulatory endpoints. ART27.13 was well tolerated with…Read full document

Encouraging Clinical Progress, Including Positive Interim Phase 2 Results for the Treatment of Cancer Anorexia Cachexia Syndrome SOLANA BEACH, Calif., Nov. 12, 2025 (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, or neurological conditions, today provided a business update and announced its financial and operational results for the three months ended September 30, 2025. “We continue to deliver on our clinical and strategic objectives, advancing three differentiated programs with strong potential to address large, underserved markets,” said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “We were very pleased with the interim Phase 2 data with ART27.13 showing restoration in body weight versus continued weight loss in people suffering from cancer-related anorexia. Importantly, this data has attracted meaningful partnering interest from several pharmaceutical companies. In addition, partnering interest continues to expand for ART26.12, our lead FABP5 inhibitor, as more companies become aware of its broad therapeutic potential. With ART26.12’s progress toward a multiple ascending dose study, we believe our clinical pipeline is well-positioned to create substantial value for patients and shareholders.” Business Highlights: ART26.12 – Following Successful Single Ascending Dose (SAD) Study, Multiple Ascending Dose (MAD) Study Protocol being Finalized The MAD study aims to confirm the favorable safety profile and dose-linear pharmacokinetics observed in the SAD study under multiple dose scenarios while providing further information on dosing frequency and biomarker strategy. Preliminary food-effect results support future development with dosing in either fed or fasted states. ART27.13 –Positive Interim Phase 2 CAReS Data Driving Partnering Interest Interim Phase 2 Cancer Appetite Recovery Study (CAReS) results demonstrated meaningful efficacy, safety, and functional benefit in cancer-related anorexia and weight loss. Patients receiving top dose ART27.13 achieved an average +6.4% weight gain versus a -5.4% loss on placebo, showed +4.2% lean body mass increase, and improved activity levels aligned with potential regulatory endpoints. ART27.13 was well tolerated with predominantly mild or moderate adverse events. Following positive Phase 2 results and coverage by UK and USA media outlets, Artelo has received multiple expressions of potential collaboration interest from global and regional pharmaceutical companies. European Patent Office issued a Notice of Allowance covering the intended commercial formulation of ART27.13 through 2041. ART12.11 – First-in-Human Study Expected to Commence in 1H 2026 Received clear guidance from MHRA, the regulatory authority in the UK, on a streamlined pathway to the clinic. First-in-human study anticipated to start in first half of 2026. Presentation of new preclinical data at the 35th Annual International Cannabinoid Research Society Symposium demonstrating an antidepressant-like activity on par with and improved cognitive benefits over sertraline (Zoloft®); a leading standard-of-care therapy. Publication of new preclinical data conducted in collaboration with researchers at Western Ontario University in Progress in Neuro-Psychopharmacology and Biological Psychiatry, which highlighted that ART12.11 significantly outperformed cannabidiol (CBD) alone in reducing stress-induced depression and anxiety symptoms, while also achieving superior oral bioavailability. Q3 2025 Financial Results (Unaudited) R&D Expenses: Research and development expenses were $1.3 million for the quarter ended September 30, 2025, compared to $0.3 million for the same period in 2024, during which $1.3 million of UK tax credits were received. G&A Expenses: General and administrative expenses were $1.8 million for the quarter ended September 30, 2025, compared to $0.9 million in 2024. Net Loss: For the quarter ended September 30, 2025, net loss was $3.1 million, or $3.97 per basic and diluted common share, which included $0.4 million of non-cash expenses, compared to a net loss of $1.1 million, or $2.10 per basic and diluted common share for the quarter ended September 30, 2024, which included $0.2 million of non-cash expenses. Cash and Investments: Cash and investments totaled $1.7 million as of September 30, 2025. In July 2025, the Company entered into an At-The-Market Offering Agreement under which the Company can offer and sell up to $6.5 million of shares of common stock from time to time through an “at the market” offering program. During the quarter ended September 30, 2025, common stock was sold under the agreement for gross proceeds of $0.4 million. In September 2025, the Company completed a confidentially marketed public offering of common stock with gross proceeds of $3.0 million. About ART26.12 ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is under development as a novel, peripherally acting, non-opioid, non-steroidal analgesic, initially for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) under an investigational new drug application opened with the FDA. Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. FABP is overexpressed and associated with abnormal lipid signaling in a number of pathologies. In addition to ART26.12 in CIPN, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. About ART27.13 ART27.13 is a novel benzimidazole derivative being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Initially developed by AstraZeneca plc, ART27.13 has been in seven clinical studies with over 280 participants. A statistically significant and dose-dependent increase in body weight was observed in people 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 conducting a Phase 2 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 CAReS The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 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 1 portion of the CAReS study was designed to determine the most effective and safest dose of ART27.13 for dosing in the Phase 2 stage. Currently enrolling, the Phase 2 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 ART12.11 ART12.11 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. Greatly enhanced 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 and has now been granted or validated in 19 additional countries. 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, 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, commercial, and treasury management practices, including digital assets, to maximize stakeholder value. More information is available at www.artelobio.com and X: @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, LLC Tel: 212-671-1020 Email: [email protected]

Investor releaseQuarter not tagged2025-09-03

Artelo Biosciences Affirms Strong Partnering Outlook for ART27.13 Following Positive Interim Phase 2 CAReS Results

GlobeNewswire
SOLANA BEACH, Calif., Sept. 03, 2025 (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, or neurological conditions, affirms that, based on the strength of the positive interim results from its Phase 2 CAReS trial of ART27.13 for cancer anorexia-cachexia syndrome (CACS) and the strong interest expressed by multiple pharmaceutical companies awaiting these results, it is well positioned to secure a development partner for ART27.13. CACS, a leading cause of death in cancer patients and affecting up to 80% of those living with cancer, currently has no FDA-approved treatment. This morning, Artelo announced positive interim Phase 2 results demonstrating compelling improvements in weight, lean body mass, and activity in patients treated with ART27.13. That full release is available here: Artelo Biosciences Announces Positive Interim Phase 2 CAReS Results. As a result of ongoing discussions with potential partners and the supportive clinical profile of ART27.13 for CACS, Artelo does not envision the need to internally fund a Phase 3 trial and believes a licensing transaction represents the most value-accretive path forward for shareholders. “This morning’s interim results highlight the potential of ART27.13 to become an FDA and internationally approved therapy for cancer anorexia-cachexia syndrome, an underserved, multi-billion-dollar potential market,” said Gregory D. Gorgas, President and CEO of Artelo. “Based on strong interest from multiple pharmaceutical companies, and given the strength of our newly released data, our immediate strategy is to secure a development partner to efficiently advance ART27.13 through registrational trials. We plan to provide further updates as soon as practical.” About ART27.13 ART27.13 is a novel benzimidazole derivative being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Initially developed by AstraZeneca plc, ART27.13 has been in seven clinical studies with over 280 participants. A statistically significant and dose-dependent increase in body weight was observed in people with back pain who…Read full document

SOLANA BEACH, Calif., Sept. 03, 2025 (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, or neurological conditions, affirms that, based on the strength of the positive interim results from its Phase 2 CAReS trial of ART27.13 for cancer anorexia-cachexia syndrome (CACS) and the strong interest expressed by multiple pharmaceutical companies awaiting these results, it is well positioned to secure a development partner for ART27.13. CACS, a leading cause of death in cancer patients and affecting up to 80% of those living with cancer, currently has no FDA-approved treatment. This morning, Artelo announced positive interim Phase 2 results demonstrating compelling improvements in weight, lean body mass, and activity in patients treated with ART27.13. That full release is available here: Artelo Biosciences Announces Positive Interim Phase 2 CAReS Results. As a result of ongoing discussions with potential partners and the supportive clinical profile of ART27.13 for CACS, Artelo does not envision the need to internally fund a Phase 3 trial and believes a licensing transaction represents the most value-accretive path forward for shareholders. “This morning’s interim results highlight the potential of ART27.13 to become an FDA and internationally approved therapy for cancer anorexia-cachexia syndrome, an underserved, multi-billion-dollar potential market,” said Gregory D. Gorgas, President and CEO of Artelo. “Based on strong interest from multiple pharmaceutical companies, and given the strength of our newly released data, our immediate strategy is to secure a development partner to efficiently advance ART27.13 through registrational trials. We plan to provide further updates as soon as practical.” About ART27.13 ART27.13 is a novel benzimidazole derivative being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Initially developed by AstraZeneca plc, ART27.13 has been in seven clinical studies with over 280 participants. A statistically significant and dose-dependent increase in body weight was observed in people 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 conducting a Phase 2 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 CAReS The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 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. The Phase 1 portion of the CAReS study was designed to determine the most effective and safest initial dose of ART27.13 in the Phase 2 stage. The Phase 2 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 compared to placebo. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817) About CACS Cancer Anorexia-Cachexia Syndrome (CACS) is a condition marked by loss of appetite, weight loss, and the breakdown of muscle and fat, affecting up to 80% of patients with advanced cancer- representing a greater than $3 billion addressable market. This loss of appetite, known as anorexia, may result from the cancer itself or from treatments such as radiation and chemotherapy. The resulting weight loss can weaken the immune system, cause discomfort and dehydration, and lower a patient’s ability to tolerate treatment. Losing more than 5% of body weight is associated with poorer outcomes and reduced response to chemotherapy. While drugs that stimulate appetite have been used to help manage cancer-related anorexia, there are currently no approved treatments in the US, UK, or EU for this condition. 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, with a diversified pipeline addressing significant unmet needs in anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Complementing its scientific innovation, Artelo has adopted a forward-looking corporate finance initiative whereby it is deploying a portion of its excess capital into Solana under its digital asset treasury strategy. Led by an experienced executive team collaborating with world-class researchers and digital-asset technology partners, Artelo applies rigorous scientific, regulatory, commercial, and treasury management practices to maximize stakeholder value. More information is available at www.artelobio.com and X: @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, including future plans in respect to ART27.13, potential transactions with pharmaceutical companies or other strategic counterparties in respect of ART27.13, 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: [email protected]

Investor releaseQuarter not tagged2025-09-03

Artelo Biosciences Announces Positive Interim Phase 2 CAReS Results for the Treatment of Cancer Anorexia-Cachexia Syndrome (CACS)

GlobeNewswire
Catalyst for Advancing Discussions with Pharmaceutical Companies that have Expressed Interest in ART27.13 for CACS Consistent Improvements in Weight Gain, Lean Body Mass, and Activity were Observed Across Treated Patients including +6.4% Mean Weight Gain at 12 Weeks vs −5.4% Mean Weight Loss on Placebo Safety Results Showed ART27.13 was Well Tolerated SOLANA BEACH, Calif., Sept. 03, 2025 (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, or neurological conditions, today announced highly encouraging interim results from its Phase 2 Cancer Appetite Recovery Study (CAReS) trial with ART27.13, the Company’s peripherally acting cannabinoid receptor agonist for the treatment of cancer anorexia-cachexia syndrome (CACS). Affecting up to 80% of people living with cancer, CACS is marked by loss of appetite, weight loss, and breakdown of muscle and fat. This leading cause of death in cancer patients has no FDA-approved treatment. The CAReS interim data comparing ART27.13 to placebo supports acceleration of the Company’s partnering initiatives with its lead clinical program. Highlights: Weight Gain: Patients escalated to the 1300 microgram dose achieved a +6.38% mean weight gain after 12 weeks, compared to a -5.42% average loss on placebo. The maximum gain observed was +18.5% on ART27.13 versus only +0.4% on placebo. Lean Body Mass: At one month, patients treated with ART27.13 experienced a +4.23% increase in lean body mass, while placebo patients lost -3.15%. Activity: Patients receiving treatment showed improvements in activity scores and in moderate and vigorous activity, the latter being an endpoint that may be required by regulators for drug approval. Safety: ART27.13 was well tolerated. The most common adverse events were mild or moderate. No new safety signals were observed and interim safety results were consistent with Phase 1 of CAReS. Barry Laird, Professor of Palliative Medicine, Oslo University Hospital - Radium Hospital and University of Oslo, Norway, and Chief Investigator in CAReS said, "The findings from the CAReS Phase 2 interim analysis build on the strong safety profile and signal from the Phase 1 trial and provide encouraging data supporting efficacy of ART27.13 on weight and physi…Read full document

Catalyst for Advancing Discussions with Pharmaceutical Companies that have Expressed Interest in ART27.13 for CACS Consistent Improvements in Weight Gain, Lean Body Mass, and Activity were Observed Across Treated Patients including +6.4% Mean Weight Gain at 12 Weeks vs −5.4% Mean Weight Loss on Placebo Safety Results Showed ART27.13 was Well Tolerated SOLANA BEACH, Calif., Sept. 03, 2025 (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, or neurological conditions, today announced highly encouraging interim results from its Phase 2 Cancer Appetite Recovery Study (CAReS) trial with ART27.13, the Company’s peripherally acting cannabinoid receptor agonist for the treatment of cancer anorexia-cachexia syndrome (CACS). Affecting up to 80% of people living with cancer, CACS is marked by loss of appetite, weight loss, and breakdown of muscle and fat. This leading cause of death in cancer patients has no FDA-approved treatment. The CAReS interim data comparing ART27.13 to placebo supports acceleration of the Company’s partnering initiatives with its lead clinical program. Highlights: Weight Gain: Patients escalated to the 1300 microgram dose achieved a +6.38% mean weight gain after 12 weeks, compared to a -5.42% average loss on placebo. The maximum gain observed was +18.5% on ART27.13 versus only +0.4% on placebo. Lean Body Mass: At one month, patients treated with ART27.13 experienced a +4.23% increase in lean body mass, while placebo patients lost -3.15%. Activity: Patients receiving treatment showed improvements in activity scores and in moderate and vigorous activity, the latter being an endpoint that may be required by regulators for drug approval. Safety: ART27.13 was well tolerated. The most common adverse events were mild or moderate. No new safety signals were observed and interim safety results were consistent with Phase 1 of CAReS. Barry Laird, Professor of Palliative Medicine, Oslo University Hospital - Radium Hospital and University of Oslo, Norway, and Chief Investigator in CAReS said, "The findings from the CAReS Phase 2 interim analysis build on the strong safety profile and signal from the Phase 1 trial and provide encouraging data supporting efficacy of ART27.13 on weight and physical activity in patients with advanced cancer.” The Phase 2 CAReS study is evaluating ART27.13 as a once-daily oral treatment aimed at improving weight, appetite, activity, and quality of life in cancer patients who had lost a minimum of 5% of their body weight in the prior six months. Effectiveness was measured by changes in lean body mass, weight, appetite, and activity over 12 weeks and at a 30-day follow-up. Activity and quality of life were assessed using wearable monitors and standardized questionnaires, while safety was closely tracked through adverse event reporting, laboratory tests, vital signs, visual analogue scales, and ECGs. In the interim analysis, 18 evaluable patients—primarily with lung and gastrointestinal cancers not receiving cyclic chemotherapy—were included. After 12 weeks of treatment in patients who titrated to the top dose evaluated of 1300 micrograms (n=5), ART27.13 demonstrated compelling increases in mean body weight of 6.38% (Standard Deviation or SD 9.50) compared to patients on placebo (n=6) who lost -5.42% (SD 8.17). The maximum weight gain in the ART27.13 group reached 18.5%, versus only 0.4% in placebo. The maximum weight loss in the placebo arm was -17.4%, compared to just -3.0% in the ART27.13 group. Additional benefits were seen in lean body mass, with a +4.23% increase (SD 5.37) in the treatment group versus a -3.15% loss (SD 4.89) in placebo at one month, as well as qualitative improvements in total and weekly activity scores. Safety results were consistent with prior findings. Among the 32 participants enrolled in the CAReS Phase 2 trial to date, 7 patients (22%) experienced adverse events that may be related to ART27.13. All were mild or moderate, with the exception of a single case of severe malaise, and no drug-related serious adverse events were reported. These data are aligned with safety outcomes observed in Phase 1 of CAReS, supporting ART27.13’s overall favorable tolerability and acceptable safety profile. “These data represent a reassuring and convincing drug effect for the highest dose of ART27.13 tested,” stated Steven Reich, MD, Chief Medical Officer of Artelo. “For patients facing the devastating effects of cancer anorexia and cachexia, we believe these findings are particularly promising, especially for the Phase 2 protocol patients that had intra-patient dose-escalation. With these interim results, we are evaluating plans to advance the ART27.13 program by starting patients at the highest dose, which has the greatest treatment effect and acceptable safety.” Gregory D. Gorgas, President and CEO of Artelo, commented, “Based on the strength of this data and the recently announced Notice of Allowance for the patent application covering our intended commercial formulation through 2041, we are rapidly accelerating our licensing strategy as the most value-accretive path forward. We are in the process of sharing these results with global and regional pharmaceutical companies already familiar with ART27.13 who were awaiting this randomized data from the CAReS trial. Through this targeted effort we aim to speed development and maximize value for our shareholders.” About ART27.13 ART27.13 is a novel benzimidazole derivative being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Initially developed by AstraZeneca plc, ART27.13 has been in seven clinical studies with over 280 participants. A statistically significant and dose-dependent increase in body weight was observed in people 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 conducting a Phase 2 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 CAReS The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 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. The Phase 1 portion of the CAReS study was designed to determine the most effective and safest initial dose of ART27.13 in the Phase 2 stage. The Phase 2 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 compared to placebo. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817) About CACS Cancer Anorexia-Cachexia Syndrome (CACS) is a condition marked by loss of appetite, weight loss, and the breakdown of muscle and fat, affecting up to 80% of patients with advanced cancer- representing a greater than $3 billion addressable market. This loss of appetite, known as anorexia, may result from the cancer itself or from treatments such as radiation and chemotherapy. The resulting weight loss can weaken the immune system, cause discomfort and dehydration, and lower a patient’s ability to tolerate treatment. Losing more than 5% of body weight is associated with poorer outcomes and reduced response to chemotherapy. While drugs that stimulate appetite have been used to help manage cancer-related anorexia, there are currently no approved treatments in the US, UK, or EU for this condition. 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, with a diversified pipeline addressing significant unmet needs in anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Complementing its scientific innovation, Artelo has adopted a forward-looking corporate finance initiative whereby it is deploying a portion of its excess capital into Solana under its digital asset treasury strategy. Led by an experienced executive team collaborating with world-class researchers and digital-asset technology partners, Artelo applies rigorous scientific, regulatory, commercial, and treasury management practices to maximize stakeholder value. More information is available at www.artelobio.com and X: @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, including future plans in respect to ART27.13, potential transactions with pharmaceutical companies or other strategic counterparties in respect of ART27.13, 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: [email protected]

Investor releaseQuarter not tagged2025-08-13

Artelo Biosciences Provides Business Update and Reports Second Quarter 2025 Financial Results

GlobeNewswire
Multiple Announcements of Clinical Data Results Anticipated in Q3 2025 SOLANA BEACH, Calif., Aug. 13, 2025 (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, or neurological conditions, today provided a business update and announced its financial and operational results for the three months ended June 30, 2025. Business Highlights: ART26.12 –Advancing Toward Multi-dose Phase 1 Safety Study Successfully completed a Phase 1 Single Ascending Dose (SAD) study in 49 healthy volunteers. Data confirmed positive safety results, with only mild, transient adverse events, no drug-related issues, and predictable, dose-linear pharmacokinetics. The wide therapeutic window supports dose titration flexibility and advancement to the next clinical stage. Preparations are underway for a Multiple Ascending Dose (MAD) study to start in Q4 2025 Presented new data at the British Pain Society Conference, validating the therapeutic potential of FABP inhibitors in osteoarthritis (OA). In a surgical rat model of OA, both single and repeat oral doses of ART26.12 significantly improved weight-bearing function, with effects sustained up to four weeks. Announced publication of a comprehensive review in Neurobiology of Disease, titled “Fatty acid binding proteins and their involvement in anxiety and mood disorders,” underscoring the potential of FABP inhibitors in treating mood and anxiety disorders, expanding ART26.12’s therapeutic relevance beyond pain. ART27.13 –Phase 2 Readout Anticipated in Q3 2025 On track to report initial data from the Phase 2 CAReS study of ART27.13, its peripherally acting cannabinoid receptor agonist, in Q3 2025. Following a successful Phase 1 trial demonstrating safety in cancer patients, ART27.13 is positioned to address significant unmet needs in cancer anorexia-cachexia syndrome, a condition currently lacking any FDA-approved therapies. ART12.11 – Progress Targeting Depression and Anxiety At the 35th Annual International Cannabinoid Research Society (ICRS) Symposium, presented compelling preclinical data for ART12.11, a novel Cannabidiol:Tetramethylpyrazine (CBD:TMP) cocrystal, highlighting dual-action efficacy in alleviating depressive-like behaviors and restoring cognitive function in anim…Read full document

Multiple Announcements of Clinical Data Results Anticipated in Q3 2025 SOLANA BEACH, Calif., Aug. 13, 2025 (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, or neurological conditions, today provided a business update and announced its financial and operational results for the three months ended June 30, 2025. Business Highlights: ART26.12 –Advancing Toward Multi-dose Phase 1 Safety Study Successfully completed a Phase 1 Single Ascending Dose (SAD) study in 49 healthy volunteers. Data confirmed positive safety results, with only mild, transient adverse events, no drug-related issues, and predictable, dose-linear pharmacokinetics. The wide therapeutic window supports dose titration flexibility and advancement to the next clinical stage. Preparations are underway for a Multiple Ascending Dose (MAD) study to start in Q4 2025 Presented new data at the British Pain Society Conference, validating the therapeutic potential of FABP inhibitors in osteoarthritis (OA). In a surgical rat model of OA, both single and repeat oral doses of ART26.12 significantly improved weight-bearing function, with effects sustained up to four weeks. Announced publication of a comprehensive review in Neurobiology of Disease, titled “Fatty acid binding proteins and their involvement in anxiety and mood disorders,” underscoring the potential of FABP inhibitors in treating mood and anxiety disorders, expanding ART26.12’s therapeutic relevance beyond pain. ART27.13 –Phase 2 Readout Anticipated in Q3 2025 On track to report initial data from the Phase 2 CAReS study of ART27.13, its peripherally acting cannabinoid receptor agonist, in Q3 2025. Following a successful Phase 1 trial demonstrating safety in cancer patients, ART27.13 is positioned to address significant unmet needs in cancer anorexia-cachexia syndrome, a condition currently lacking any FDA-approved therapies. ART12.11 – Progress Targeting Depression and Anxiety At the 35th Annual International Cannabinoid Research Society (ICRS) Symposium, presented compelling preclinical data for ART12.11, a novel Cannabidiol:Tetramethylpyrazine (CBD:TMP) cocrystal, highlighting dual-action efficacy in alleviating depressive-like behaviors and restoring cognitive function in animals. The results support ART12.11’s potential entry into the multi-billion-dollar antidepressant market. Received clear guidance from MHRA, the regulatory authority in the UK, on a streamlined pathway to the clinic. First-in-human study anticipated to start in first half 2026. Gregory D. Gorgas, President and CEO of Artelo Biosciences, commented on the results of the second quarter, “We are very pleased with the momentum across our pipeline, highlighted by the growing body of evidence supporting our first-in-class FABP5 inhibitor, ART26.12. The successful completion of our Phase 1 SAD study demonstrated positive safety and pharmacokinetics, laying the groundwork for our upcoming MAD study.” “We are also on track to report Phase 2 data from our CAReS study of ART27.13 during the current third quarter and to collect data demonstrating dual-action efficacy of our preclinical candidate ART12.11 in treating depression and cognitive decline to support our plans to initiate human trials early next year. These achievements reflect our commitment to addressing large unmet medical needs through novel science and thoughtful clinical development,” concluded Mr. Gorgas. Q2 2025 Financial Results (Unaudited) R&D Expenses: Research and development expenses were $1.9 million for the quarter ended June 30, 2025, compared to $1.7 million for the same period in 2024. G&A Expenses: General and administrative expenses were $1.3 million for the quarter ended June 30, 2025, compared to $0.8 million in 2024. Net Loss: For the quarter ended June 30, 2025, net loss was $3.2 million, or $5.61 per basic and diluted common share, which included $0.2 million of non-cash expenses, compared to a net loss of $2.4 million, or $4.52 per basic and diluted common share for the quarter ended June 30, 2024, which included $0.1 million of non-cash expenses. Cash and Investments: Cash and investments totaled $2.1 million as of June 30, 2025. In May 2025, the Company issued $0.9 million at-market convertible notes. On June 26, 2025, the Company completed a private placement for gross proceeds of $1.425 million. Subsequent to June 30, 2025, the Company completed an at-the-market PIPE (private investment in public equity) for gross proceeds of $9.475 million. In connection with the two PIPE transactions, the Company has adopted a Digital Asset Treasury strategy whereby it plans to purchase the digital currency known as Solana (“SOL”) complementing the Company’s expectation to hold and maintain at least one year of cash in traditional instruments to fund its biopharmaceutical develop operations. About ART26.12 ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic. Cleared by the FDA for a first-in-human study in the US, a Phase 1 trial with ART26.12 was initiated in late 2024. The initial clinical development planned is for chemotherapy-induced peripheral neuropathy (CIPN). Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. FABP is overexpressed and associated with abnormal lipid signaling in a number of pathologies. In addition to ART26.12 in CIPN, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. About ART27.13 ART27.13 is a novel benzimidazole derivative being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Initially developed by AstraZeneca plc, ART27.13 has been in six clinical studies with over 250 participants. A statistically significant and dose-dependent increase in body weight was observed in people 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 Phase 2 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 CAReS The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 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 1 portion of the CAReS study was designed to determine the most effective and safest dose of ART27.13 for dosing in the Phase 2 stage. Currently enrolling, the Phase 2 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 ART12.11 ART12.11 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. Greatly enhanced pharmaceutical properties, including physicochemical, pharmacokinetic, and pharmacodynamic advantages have been observed with ART12.11. Artelo believes a more consistent and improved bioavailability profile in a solid dosage form may ultimately lead to increased safety and efficacy in humans, thus making ART12.11 a preferred CBD pharmaceutical composition. The U.S. 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, with a diversified pipeline addressing significant unmet needs in anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Complementing its scientific innovation, Artelo has adopted a forward-looking corporate finance initiative whereby it is deploying a portion of its excess capital into Solana under a newly authorized digital asset treasury strategy. As the first publicly traded pharmaceutical company to designate Solana as a core reserve asset, Artelo intends to leverage Solana’s high-performance, decentralized blockchain to diversify its balance sheet, enhance liquidity management, and position the Company for long-term value creation in parallel with its therapeutic programs. Guided by disciplined risk controls and staged investments approved by the Board of Directors, this Solana-centric strategy is designed to preserve working capital for the continued advancement and commercialization of Artelo’s product candidates while affording shareholders exposure to a next-generation monetary network. Led by an experienced executive team collaborating with world-class researchers and digital-asset technology partners, Artelo applies rigorous scientific, regulatory, commercial, and treasury management practices to maximize stakeholder value. More information is available at www.artelobio.com and X: @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, LLC Tel: 212-671-1020 Email: [email protected]

Investor releaseQuarter not tagged2025-06-30

Artelo Biosciences Says Study of Non-Opioid Pain Treatment Shows Positive Results; Shares Climb

MT Newswires

Artelo Biosciences (ARTL) said Monday the first in-human study of its novel non-opioid analgesic ART

Investor releaseQuarter not tagged2025-05-13

Artelo Biosciences Provides Business Update and Reports First Quarter 2025 Financial Results

GlobeNewswire
Several Key Clinical Readouts in Addition to New Study Initiations Expected in 2025 SOLANA BEACH, Caif., May 13, 2025 (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, or neurological conditions, today provided a business update and announced its financial and operational results for the three months ended March 31, 2025. Business Highlights: ART26.12: The first selective fatty acid binding protein 5 (FABP5) inhibitor to enter clinical trials completed enrollment of its Phase I safety study in healthy volunteers. Data readout remains on track for the second quarter of 2025. Newly published peer-reviewed data revealed ART26.12’s potential in psoriasis, expanding its potential therapeutic applications beyond oncology and pain associated with cancer treatments. ART27.13: Initial data from its Phase 2 CAReS study in cancer anorexia-cachexia syndrome, expected during the third quarter of 2025. ART12.11 Reported new data showing that ART12.11, the Company’s proprietary cannabidiol cocrystal tablet, achieved improved pharmacokinetics compared to Epidiolex® in a head-to-head comparison study in canines. Preparations are underway to initiate human clinical studies with an oral solid dosage form planned for the second half of 2025. “All of our lead programs are expected to achieve important milestones over the next 12 months,” said Gregory D. Gorgas, President and CEO of Artelo Biosciences. “With additional published preclinical studies demonstrating the utility of FABP5 in oncology and dermatology, we are eager to share the results of our Phase 1 safety trial of ART26.12 in the next few weeks. ART26.12 represents the first product candidate to enter the clinic from our extensive library of selective FABP inhibitors, each with potential tailored use across multiple therapeutic areas, including cancer and inflammatory diseases.” “During the third quarter of this year, we also look forward to initial results from our Phase 2 CAReS study evaluating ART27.13 in the treatment of cancer-related anorexia and cachexia. This series of near-term milestones highlights the accelerating momentum across our innovative pipeline as well as the remarkable productivity of our scientific leadership an…Read full document

Several Key Clinical Readouts in Addition to New Study Initiations Expected in 2025 SOLANA BEACH, Caif., May 13, 2025 (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, or neurological conditions, today provided a business update and announced its financial and operational results for the three months ended March 31, 2025. Business Highlights: ART26.12: The first selective fatty acid binding protein 5 (FABP5) inhibitor to enter clinical trials completed enrollment of its Phase I safety study in healthy volunteers. Data readout remains on track for the second quarter of 2025. Newly published peer-reviewed data revealed ART26.12’s potential in psoriasis, expanding its potential therapeutic applications beyond oncology and pain associated with cancer treatments. ART27.13: Initial data from its Phase 2 CAReS study in cancer anorexia-cachexia syndrome, expected during the third quarter of 2025. ART12.11 Reported new data showing that ART12.11, the Company’s proprietary cannabidiol cocrystal tablet, achieved improved pharmacokinetics compared to Epidiolex® in a head-to-head comparison study in canines. Preparations are underway to initiate human clinical studies with an oral solid dosage form planned for the second half of 2025. “All of our lead programs are expected to achieve important milestones over the next 12 months,” said Gregory D. Gorgas, President and CEO of Artelo Biosciences. “With additional published preclinical studies demonstrating the utility of FABP5 in oncology and dermatology, we are eager to share the results of our Phase 1 safety trial of ART26.12 in the next few weeks. ART26.12 represents the first product candidate to enter the clinic from our extensive library of selective FABP inhibitors, each with potential tailored use across multiple therapeutic areas, including cancer and inflammatory diseases.” “During the third quarter of this year, we also look forward to initial results from our Phase 2 CAReS study evaluating ART27.13 in the treatment of cancer-related anorexia and cachexia. This series of near-term milestones highlights the accelerating momentum across our innovative pipeline as well as the remarkable productivity of our scientific leadership and disciplined execution,” Mr. Gorgas concluded. Q1 2025 Financial Results (Unaudited) R&D Expenses: Research and development expenses were $1.4 million for the quarter ended March 31, 2025, compared to $1.5 million for the same period in 2024. G&A Expenses: General and administrative expenses were $1.0 million for the quarter ended March 31, 2025, compared to $1.1 million in 2024. Net Loss: For the quarter ended March 31, 2025, net loss was $2.4 million, or $0.72 per basic and diluted common share, which included $0.2 million of non-cash expenses, compared to a net loss of $2.5 million, or $0.78 per basic and diluted common share for the quarter ended March 31, 2024, which included $0.1 million of non-cash expenses. Cash and Investments: Cash and investments totaled $0.7 million as of March 31, 2025. In early May 2025, the Company issued $0.9 million at-market convertible notes. This funding is expected to be sufficient to fund Company operations until additional financing is completed. About ART26.12ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic. Cleared by the FDA for a first-in-human study in the US, a Phase 1 trial with ART26.12 was initiated in late 2024. The initial clinical development planned is for chemotherapy-induced peripheral neuropathy (CIPN). Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. FABP is overexpressed and associated with abnormal lipid signaling in a number of pathologies. In addition to ART26.12 in CIPN, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. About ART27.13ART27.13 is a novel benzimidazole derivative being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Initially developed by AstraZeneca plc, ART27.13 has been in six clinical studies with over 250 participants. A statistically significant and dose-dependent increase in body weight was observed in people 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 Phase 2 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 1/2 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 1 portion of the CAReS study was designed to determine the most effective and safest dose of ART27.13 for dosing in the Phase 2 stage. Currently enrolling, the Phase 2 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 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. Greatly enhanced pharmaceutical properties, including physicochemical, pharmacokinetic, and pharmacodynamic advantages have been observed with ART12.11. Artelo believes a more consistent and improved bioavailability profile in a solid dosage form may ultimately lead to increased safety and efficacy in humans, thus making ART12.11 a preferred CBD pharmaceutical composition. The U.S. 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 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: [email protected]

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook