Patients treated with ART27.13 showed consistent improvements in weight, lean body mass, and activity While clinical benefits were observed in all treated cohorts, the best outcomes in CAReS were observed in patients titrated to the highest dose SOLANA BEACH, Calif., Sept. 29, 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 neuro ...

Core Insights - Artelo Biosciences, Inc. is positioned to secure a development partner for ART27.13 based on positive interim results from its Phase 2 CAReS trial for cancer anorexia-cachexia syndrome (CACS) [1][4] - The interim results show significant improvements in weight, lean body mass, and activity in patients treated with ART27.13 [2] - Artelo does not foresee the need for internal funding for a Phase 3 trial, indicating a preference for a licensing transaction to maximize shareholder value [3] 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 [8] - ART27.13 is a novel benzimidazole derivative aimed at improving body weight, appetite, and quality of life in cancer patients, with a strong safety profile demonstrated in previous studies [5] - The company has a diversified pipeline addressing significant unmet medical needs and is also engaging in digital asset treasury strategies [8] Clinical Trial Insights - The CAReS trial is a Phase 1/2 randomized, placebo-controlled study designed to evaluate ART27.13's effectiveness in treating cancer-related anorexia and weight loss [6] - CACS affects up to 80% of advanced cancer patients and represents a market opportunity exceeding $3 billion, with no current FDA-approved treatments available [7]

Core Insights - Artelo Biosciences, Inc. announced interim results from its Phase 2 Cancer Appetite Recovery Study (CAReS) trial for ART27.13, showing significant improvements in weight gain and lean body mass in cancer patients suffering from anorexia-cachexia syndrome (CACS) [2][4][8] - The study demonstrated a mean weight gain of +6.4% at 12 weeks for ART27.13 compared to a mean weight loss of -5.4% in the placebo group, indicating a compelling drug effect [5][7] - ART27.13 was well tolerated, with adverse events primarily mild or moderate, aligning with previous safety findings [6][8] Company Overview - Artelo Biosciences is focused on developing treatments for cancer, pain, and other conditions by modulating lipid-signaling pathways [2][12] - The company is accelerating its licensing strategy based on the strength of the interim data and a recently allowed patent application for its commercial formulation [8][12] - ART27.13 is a novel agent targeting peripheral cannabinoid receptors, with potential benefits in improving appetite, weight, and quality of life for cancer patients [9][11] Clinical Study Details - The CAReS trial is a Phase 1/2 randomized, placebo-controlled study evaluating ART27.13 in patients with cancer-related anorexia and weight loss [10] - The Phase 2 portion aims to assess the drug's effectiveness in increasing lean body mass and improving appetite compared to placebo [10] - Interim analysis included 18 evaluable patients, primarily with lung and gastrointestinal cancers, showing significant weight gain and lean body mass improvements [5][6] Market Context - CACS affects up to 80% of cancer patients, representing a significant unmet medical need with a market potential exceeding $3 billion [11] - Currently, there are no FDA-approved treatments for CACS, highlighting the importance of ART27.13's development [11]

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, Inc. has received a Notice of Allowance from the European Patent Office for its patent application covering ART27.13, a cannabinoid agonist aimed at treating cancer-related anorexia, which is currently in Phase 2 clinical trials [2][3][4] - The patent protection for ART27.13 is expected to extend through December 2041, enhancing its commercial potential and long-term value creation for the company [3][4] - ART27.13 has shown promising results in early trials, with over 60% of participants in the Phase 1 study experiencing stabilization or reversal of weight loss [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 anorexia [7] - The company is advancing ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss, addressing a significant unmet medical need [5][6] - Artelo has adopted a digital asset treasury strategy, designating Solana as a core reserve asset to enhance liquidity management and diversify its balance sheet [8]

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]

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].

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 ...