Safety and Pharmacokinetic Data Support Dosing ofART26.12 in Fed or Fasted Conditions Completion of Positive Single Ascending Dose Study with a Preliminary Food Effect Assessment Advances ART26.12 Toward Multiple Ascending Dose Trial SOLANA BEACH, Calif., Aug. 25, 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, dermatological or neurological co ...

Core Insights - Artelo Biosciences, Inc. presented preclinical data on its lead fatty acid binding protein 5 (FABP5) inhibitor, ART26.12, at the 35th Annual International Cannabinoid Research Society Symposium, demonstrating its potential to alleviate osteoarthritis (OA) pain [1][2][5] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for various conditions, including cancer, pain, and neurological disorders [7] - The company is advancing a portfolio of product candidates aimed at addressing significant unmet medical needs across multiple diseases [7] Product Development - ART26.12 is a first-in-class, non-opioid, non-steroidal analgesic drug candidate that has shown significant efficacy in alleviating OA pain in preclinical models [2][3] - The drug demonstrated comparable efficacy to naproxen, a commonly prescribed NSAID, without developing tolerance over a four-week chronic dosing period [3][5] - ART26.12's administration led to increased plasma levels of endocannabinoids 2-Arachidonoylglycerol (2-AG) and Oleoylethanolamide (OEA), which were positively correlated with pain relief [3] Safety Profile - ART26.12 may offer a safer alternative to NSAIDs, which are associated with gastrointestinal side effects in about one-third of patients and a five-fold increase in gastric ulcer complications [4] - The distinct pharmacological profile of ART26.12 suggests it could provide ongoing pain relief without the adverse effects commonly seen with NSAIDs [4][5] Research Collaboration - The research on ART26.12 was conducted in collaboration with Stony Brook University, highlighting the company's commitment to translational research [3][5] Market Context - Osteoarthritis affects approximately 606.9 million people globally, with over 32 million in the U.S., indicating a significant market opportunity for effective pain management solutions [9]

Core Viewpoint - Artelo Biosciences, Inc. has been upgraded from Hold to Buy by D. Boral Capital, with a price target of $20, highlighting its focus on Cachexia and chemotherapy-induced peripheral neuropathy (CIN) [1] Group 1: Drug Development and Pipeline - ART27.13, a Phase 2 asset, is a selective benzimadazole agonist acquired from AstraZeneca, showing potential to stimulate appetite and promote weight gain, which could improve the quality of life for cancer patients [1][2] - ART26.12, another asset licensed from the University of Stonybrook, appears to protect nerves from damage without compromising chemotherapy efficacy, with favorable results from its first-in-human study affirming its safety and pharmacokinetic profile [3] - New preclinical data on ART12.11, a Cannabidiol and Tetramethylpyrazine cocrystal drug candidate, was presented, indicating its potential for treating depression and anxiety, particularly in patients with cognitive dysfunction [4][6] Group 2: Efficacy and Market Position - ART12.11 demonstrated significant behavioral improvements in male rats under chronic stress, showing efficacy comparable to sertraline (Zoloft), a leading SSRI, while also reversing stress-induced memory deficits [6][7] - Artelo Biosciences stock increased by 14.66% to $16.42 following these developments, reflecting positive market sentiment [6]

Market Performance - U.S. stocks traded higher with the Nasdaq Composite gaining over 0.3% on Monday, the Dow up 0.45% to 44,014.63, and the S&P 500 rising 0.33% to 6,193.57 [1] - Financials shares increased by 0.8% while consumer discretionary stocks fell by 0.8% [1] Company News - Hewlett Packard Enterprise Company (HPE) and Juniper Networks, Inc. (JNPR) reached an agreement with the U.S. Department of Justice (DOJ) to resolve a lawsuit challenging HPE's acquisition of Juniper, pending court approval [2] Commodity Market - Oil prices decreased by 0.8% to $65.03, while gold prices increased by 0.5% to $3,304.40 [5] - Silver fell by 0.5% to $36.20 and copper dropped by 0.8% to $5.0820 [5] International Markets - European shares were lower, with the eurozone's STOXX 600 down 0.42% and major indices like London's FTSE 100 and Germany's DAX 40 also declining [6] - Asian markets closed mixed, with Japan's Nikkei gaining 0.84% and Hong Kong's Hang Seng Index falling 0.87% [7] Notable Stock Movements - Bitmine Immersion Technologies, Inc. (BMNR) shares surged 442% to $23.10 after announcing a $250 million private placement [9] - Artelo Biosciences, Inc. (ARTL) shares increased by 102% to $13.70 following positive data from a first-in-human study [9] - Joby Aviation, Inc. (JOBY) shares rose 15% to $10.81 after completing test flights in Dubai [9] - Fortive Corporation (FTV) shares dropped 5% to $51.03 after announcing leadership changes [9] - INmune Bio, Inc. (INMB) shares fell 59% to $2.1680 after a trial did not meet its primary endpoint [9] - Chemed Corporation (CHE) shares decreased by 15% to $475.29 after a price target cut by B of A Securities [9]

Core Insights - Artelo Biosciences, Inc. has announced favorable results from its first-in-human study of ART26.12, a novel inhibitor of Fatty Acid Binding Protein 5 (FABP5), which shows promising safety and pharmacokinetic profiles [1][4][5] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for various conditions including cancer and pain [1][8] - The company is advancing a portfolio of therapeutics aimed at addressing significant unmet needs in multiple diseases and conditions [8] Product Development - ART26.12 is the first orally administered, selective, and peripherally restricted FABP5 inhibitor to enter human clinical evaluation, targeting chronic pain management [4][5] - The Phase 1 Single Ascending Dose (SAD) study enrolled 49 healthy volunteers to assess the safety, tolerability, and pharmacokinetics of ART26.12 [2][5] Market Opportunity - The chronic pain therapeutics market exceeded $97 billion globally in 2023 and is projected to surpass $159 billion by 2030, driven by increasing prevalence of conditions such as neuropathic pain and arthritis [5] - There is a significant gap in innovation for non-opioid therapies in the pain management market, which ART26.12 aims to fill with its unique mechanism of action [5] Safety and Efficacy Findings - All adverse events reported in the study were mild, transient, and self-resolving, with no drug-related adverse events observed [7] - The pharmacokinetic profile showed dose-dependent, linear absorption, indicating a predictable response to the drug [7] - A wide safety margin was observed between estimated therapeutic plasma concentrations and the highest exposure levels achieved, supporting potential titration for maximum efficacy [7] Future Development Plans - A Multiple Ascending Dose study is expected to commence in the fourth quarter of this year to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing [5]

Core Viewpoint - Artelo Biosciences, Inc. has entered into a definitive securities purchase agreement for an At-the-Market private placement, aiming to raise approximately $1.425 million to support clinical data announcements and general corporate purposes [1][2]. Group 1: Securities Offering Details - Artelo will issue 136,844 shares of common stock and 93,179 pre-funded warrants, along with warrants to purchase 460,046 shares at $5.82 per share and 230,023 shares at $10.00 per share [2]. - The offering aims to provide sufficient capital for announcing clinical data regarding two phase 1 studies for ART26.12 and a phase 2 study readout from the CAReS trial for ART27.13 [2]. - The company plans to allocate $250,000 of the net proceeds to purchase the digital currency SOL, with the remainder for general corporate and working capital purposes [2]. Group 2: Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for various conditions, including cancer, pain, and dermatological issues [4]. - The company is advancing a portfolio of product candidates aimed at addressing significant unmet medical needs across multiple diseases [4]. - Artelo is led by experienced biopharmaceutical executives and collaborates with respected researchers and technology experts to develop impactful therapies [4].

Core Insights - Artelo Biosciences, Inc. presented new data at the British Pain Conference, highlighting the therapeutic potential of Fatty Acid Binding Protein (FABP) inhibitors for treating osteoarthritis (OA) pain [1][2] - The lead FABP5 inhibitor, ART26.12, demonstrated analgesic effects comparable to naproxen in animal studies, with sustained effects over 28 days [4][3] - OA affects approximately 606.9 million people globally, with over 32 million in the U.S., leading to significant mobility loss and reduced quality of life [5] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing therapeutics that modulate lipid-signaling pathways for various conditions, including cancer, pain, and inflammation [7] - The company is advancing a portfolio of product candidates aimed at addressing unmet medical needs across multiple diseases [7] - ART26.12 is currently undergoing human trials, with initial clinical development targeting chemotherapy-induced peripheral neuropathy (CIPN) [6]