Core Insights - Artelo Biosciences, Inc. announced new preclinical data on ART12.11, a proprietary cocrystal of cannabidiol and tetramethylpyrazine, showing significant improvements over conventional CBD in treating stress-induced depression and anxiety [1][2][4] Group 1: Study Findings - The peer-reviewed study demonstrated that ART12.11 significantly outperformed CBD alone in reducing symptoms of stress-induced depression and anxiety, while also achieving superior oral bioavailability [2][4] - ART12.11 reversed stress-induced behavioral deficits and produced robust anti-depressant and anxiolytic-like effects, superior to CBD alone, TMP alone, or a non-crystalline mixture of CBD and TMP [7] - Mechanistic insights revealed that ART12.11 enhances activation of endocannabinoid and serotonergic systems in brain regions critical to mood regulation, suggesting a selective influence that maximizes therapeutic benefits while minimizing side effects [5][7] Group 2: Regulatory and Developmental Aspects - The UK regulatory authority, MHRA, has agreed that Artelo may rely on existing nonclinical and clinical evidence for CBD and leverage legacy data for TMP, which is expected to streamline the development plan for ART12.11 [5][6] - The guidance from MHRA is anticipated to reduce costs and enable rapid advancement towards the proposed first human study with ART12.11 planned for next year [5][6] Group 3: Company Overview - Artelo Biosciences is focused on developing proprietary therapeutics that modulate lipid-signaling pathways, addressing significant unmet needs in various medical conditions [8] - The company has adopted a digital asset treasury strategy, designating Solana as a core reserve asset to enhance liquidity management and long-term value creation [8]

Business Highlights: ART26.12 –Advancing Toward Multi-dose Phase 1 Safety Study 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 ...

Core Insights - Artelo Biosciences has received positive feedback from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) regarding the development of ART12.11, a novel cocrystal of Cannabidiol (CBD) and Tetramethylpyrazine (TMP) [1][2][4] - The MHRA has indicated that ART12.11 may qualify for the Innovative Licensing and Access Pathway (ILAP), which could accelerate its development and patient access [3][4] Regulatory Feedback - The MHRA supports a streamlined clinical trial application based on existing nonclinical and clinical evidence for CBD and TMP, providing a clear path for the first-in-human (FIH) study design [2] - The proposed FIH study design is a single-dose, multi-formulation crossover study, deemed methodologically sound for characterizing ART12.11's pharmacokinetic profile [2] Development Strategy - The company plans to evaluate a formal application for ART12.11 to enter the ILAP, aligning with the program's criteria to address unmet needs in anxiety and depression [3] - The regulatory assurance from the MHRA is expected to reduce expenses for the ART12.11 program and potentially extend market exclusivity until the end of 2038 due to existing patents [5] Product Profile - ART12.11 is a proprietary cocrystal composition that has shown improved pharmacokinetics and efficacy compared to other forms of CBD in nonclinical studies [6] - The cocrystal has demonstrated efficacy comparable to sertraline (Zoloft) in preclinical depression models and superior cognitive restoration compared to leading SSRIs [4] Company Overview - Artelo Biosciences is focused on developing therapeutics that modulate lipid-signaling pathways to address significant unmet medical needs across various conditions, including cancer, anxiety, and pain [8]

Core Viewpoint - Artelo Biosciences has received positive feedback from the UK's MHRA regarding its clinical study plans for ART12.11, a novel cocrystal of Cannabidiol (CBD) and Tetramethylpyrazine (TMP), which may accelerate its development and market access [1][2][3][4]. Group 1: Regulatory Feedback - The MHRA has agreed that existing nonclinical and clinical evidence for CBD and TMP supports a streamlined clinical trial application for ART12.11 [2]. - The agency confirmed that the proposed first-in-human study design is methodologically sound for characterizing ART12.11's pharmacokinetic profile [2]. - Specific guidance was provided by the MHRA for completing the data package for the Phase 1 trial [2]. Group 2: Innovative Licensing and Access Pathway (ILAP) - ART12.11 may qualify for the ILAP, which aims to accelerate the development and patient access of new therapies through collaboration with regulatory and health bodies [3]. - Artelo plans to evaluate a formal application for ILAP in the coming months, aligning with the program's criteria due to ART12.11's potential to address unmet needs in anxiety and depression [3]. Group 3: Clinical Efficacy and Comparison - Nonclinical studies have shown ART12.11's promising profile compared to traditional antidepressants and CBD alone [4]. - In a depression model, ART12.11 demonstrated efficacy comparable to sertraline (Zoloft) and superior cognitive restoration [4]. - In a rodent model of stress-induced anxiety and depression, ART12.11 outperformed CBD alone, even at a higher dosage of CBD [4]. Group 4: Financial and Market Implications - The regulatory assurance from the MHRA is expected to reduce expenses for the ART12.11 program [5]. - An accelerated development strategy could lead to a longer period of market exclusivity, with patents valid in 20 countries until the end of 2038 [5]. - Artelo aims to finalize preparations to initiate clinical studies for ART12.11 early next year [5]. Group 5: Product Overview - ART12.11 is a proprietary cocrystal composition of CBD and TMP, exhibiting better pharmacokinetics and improved efficacy compared to other CBD forms [6]. - Enhanced pharmaceutical properties of ART12.11 may lead to increased safety and efficacy in humans, making it a preferred CBD pharmaceutical composition [6]. - The U.S. patent for ART12.11 is enforceable until December 10, 2038, with additional patents granted in 19 countries [6].

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 Overview - U.S. stocks experienced a decline, with the Dow Jones index falling over 400 points, down 1% to 44,379.69, NASDAQ down 0.85% to 20,426.99, and S&P 500 down 0.39% to 6,255.16 [1] - In commodities, oil increased by 0.7% to $67.44, while gold decreased by 0.5% to $3,325.80, silver fell 0.8% to $36.795, and copper dropped 2.7% to $5.0025 [5] Company News - Cogent Biosciences, Inc. announced positive topline results from Part 2 of the SUMMIT trial for bezuclastinib, showing significant improvements across primary and key secondary endpoints [2] - Mustang Bio, Inc. shares surged 319% to $4.99 after receiving FDA Orphan Drug Designation for MB-101 in astrocytomas and glioblastoma [9] - Artelo Biosciences, Inc. saw a 79% increase in shares to $17.98 following preclinical efficacy results with ART12.11 in a stress-induced depression model [9] - LogProstyle Inc. shares rose 155% to $2.08 after reporting year-over-year financial growth for FY25 [9] - Core Scientific, Inc. shares dropped 21% to $14.21 after CoreWeave announced plans to acquire the company in an all-stock deal [9] - Jasper Therapeutics, Inc. shares fell 51% to $3.2964 after reporting an 89% response rate in its Urticaria study and the decision to halt the program [9] - Apogee Therapeutics, Inc. shares decreased by 16% to $40.03 following the release of 16-week data from Part A of the Phase 2 APEX clinical trial for APG777 [9] Regional Market Performance - European shares showed positive movement, with the eurozone's STOXX 600 rising 0.43%, Spain's IBEX 35 Index up 0.43%, London's FTSE 100 gaining 0.01%, Germany's DAX 40 increasing by 1%, and France's CAC 40 up 0.39% [6] - Asian markets closed mixed, with Japan's Nikkei down 0.56%, Hong Kong's Hang Seng down 0.12%, while China's Shanghai Composite gained 0.02% and India's BSE Sensex increased by 0.01% [7]

Core Insights - Artelo Biosciences, Inc. presented new preclinical data on its drug candidate ART12.11, a cocrystal of Cannabidiol (CBD) and Tetramethylpyrazine (TMP), at the 35th Annual International Cannabinoid Research Society Symposium, indicating its potential as a next-generation antidepressant [1][2][3] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments for various conditions, including cancer, pain, and neurological disorders, by modulating lipid-signaling pathways [1][9] - The company is advancing a portfolio of therapeutics aimed at addressing significant unmet medical needs across multiple diseases [9] Product Details - ART12.11 is a proprietary cocrystal composition that has shown better pharmacokinetics and efficacy compared to other forms of CBD in nonclinical studies [6][8] - The drug demonstrated robust antidepressant-like effects in a 28-day treatment regimen, significantly reversing behavioral impairments in stressed male rats, comparable to the leading SSRI sertraline [7] - ART12.11 not only restored mood-related behaviors but also reversed cognitive deficits associated with chronic stress, an area where sertraline was less effective [4][7] Research Findings - The preclinical studies indicated that ART12.11 improved depression-related behaviors and cognitive functions, positioning it as a differentiated candidate in the multi-billion-dollar antidepressant market [2][5][7] - The cocrystal's unique dual-action profile suggests it could meet critical needs in mental health by providing both mood-lifting and cognitive benefits [6][7] Intellectual Property - The US issued a composition of matter patent for ART12.11, enforceable until December 10, 2038, with additional patents granted or validated in 19 other countries [8]

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 Highligh ...