ARTL

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...

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...

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...

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...

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...

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...

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

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 exec...