Core Insights - Artelo Biosciences, Inc. has reported positive interim Phase 2 results for ART27.13, a treatment for cancer-related anorexia, showing significant weight gain in patients compared to placebo [2][6] - The company is advancing three differentiated clinical programs, with ART26.12 and ART27.13 attracting substantial partnering interest from pharmaceutical companies [2][3] - Financial results for Q3 2025 indicate a net loss of $3.1 million, with cash and investments totaling $1.7 million as of September 30, 2025 [11] Clinical Developments - ART27.13 demonstrated an average weight gain of +6.4% in patients versus a -5.4% loss in the placebo group, along with a +4.2% increase in lean body mass [6] - The multiple ascending dose (MAD) study for ART26.12 is being finalized to confirm safety and pharmacokinetics observed in the single ascending dose (SAD) study [3][6] - The first-in-human study for ART12.11 is expected to commence in the first half of 2026 [4] Financial Performance - Research and development expenses for Q3 2025 were $1.3 million, up from $0.3 million in the same period in 2024 [5] - General and administrative expenses increased to $1.8 million for Q3 2025, compared to $0.9 million in 2024 [11] - The company raised $3.0 million through a public offering in September 2025 and has an At-The-Market Offering Agreement for up to $6.5 million [11] Product Pipeline - ART26.12 is being developed as a non-opioid analgesic for chemotherapy-induced peripheral neuropathy, with potential applications in various pathologies [7] - ART27.13 is a novel agent targeting peripheral CB1 and CB2 receptors, aimed at improving appetite and quality of life in cancer patients [8] - ART12.11, a proprietary cocrystal of CBD and TMP, has shown improved pharmacokinetics and efficacy compared to other CBD forms [10]

Core Insights - Artelo Biosciences is advancing its clinical programs for two key drug candidates, ART26.12 and ART27.13, aimed at addressing significant medical needs in cancer-related conditions [1][4] Group 1: ART26.12 Development - ART26.12, a Fatty Acid Binding Protein 5 (FABP5) inhibitor, has shown no safety concerns and predictable linear plasma exposure in a Phase 1 Single Ascending Dose (SAD) study, with doses up to 1050 milligrams being safe and well tolerated [2][5] - The study indicated potential dosing flexibility for ART26.12 in both fed and fasted conditions, supporting its advancement into multiple ascending dose studies and proof-of-principle pain studies [2][5] Group 2: ART27.13 Development - Interim Phase 2 data from the Cancer Appetite Recovery Study (CAReS) showed that patients receiving ART27.13 gained over 6% in weight compared to placebo participants who lost an additional 5%, indicating a statistically significant effect [3][8] - ART27.13 is positioned as the most clinically advanced small-molecule treatment for cancer anorexia, with no approved treatments currently available in the US, UK, or EU [3][7] Group 3: Clinical Study Insights - The CAReS study is designed to evaluate ART27.13's effectiveness in improving lean body mass, weight gain, and appetite in cancer patients suffering from anorexia and weight loss [8] - The Phase 1 portion of CAReS established the safest initial dose for the Phase 2 stage, which is crucial for determining the drug's activity compared to placebo [8]

Core Insights - Artelo Biosciences, Inc. presented interim data from its Phase 2 Cancer Appetite Recovery Study (CAReS) for ART27.13, showing significant improvements in weight, lean body mass, and daily activity in patients with cancer anorexia-cachexia syndrome (CACS) [1][2][4] Summary by Sections Interim Data Highlights - Patients treated with the highest dose of ART27.13 (1300 µg) achieved an average weight gain of +6% over 12 weeks, while placebo patients lost approximately 5% [7] - Improvements in lean body mass were consistent with total weight gains, indicating muscle preservation or accrual [7] - Digital wearable data confirmed that treated patients exhibited greater daily activity metrics compared to placebo [7] - ART27.13 maintained a favorable safety profile, with adverse events primarily mild to moderate and no serious drug-related events reported [7][8] About ART27.13 - ART27.13 is a novel benzimidazole derivative and dual cannabinoid agonist, designed for once-daily oral administration, targeting peripheral CB1 and CB2 receptors [6] - The drug aims to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients [6] - Previous studies have shown a statistically significant and dose-dependent increase in body weight in healthy individuals with back pain [6] About CAReS - The CAReS study is a Phase 1/2 randomized, placebo-controlled trial assessing ART27.13 in patients with cancer anorexia and weight loss [9] - Anorexia and weight loss in cancer patients can lead to weakened immune systems and increased discomfort, with a weight loss of over 5% predicting poorer outcomes [9][10] - The Phase 2 stage aims to evaluate ART27.13's effectiveness in improving lean body mass, weight gain, and anorexia compared to placebo [9] Market Opportunity - CACS affects up to 80% of patients with advanced cancer, representing a market opportunity exceeding $3 billion [10] - Currently, there are no FDA-approved treatments for cancer anorexia-cachexia syndrome in the US, UK, or EU [10] Company Overview - Artelo Biosciences is focused on developing therapeutics that modulate lipid-signaling pathways, addressing significant unmet needs in various conditions including anorexia and cancer [11] - The company collaborates with world-class researchers and applies rigorous scientific and regulatory practices to maximize stakeholder value [11]

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].

Core Insights - Artelo Biosciences, Inc. is focused on developing treatments for cancer, pain, dermatologic, and neurological conditions through modulation of lipid-signaling pathways [1][12] - The company anticipates significant milestones for its lead programs within the next 12 months, including results from its Phase 1 safety trial of ART26.12 and initial results from the Phase 2 CAReS study for ART27.13 [3][6] Business Highlights - ART26.12, a lead candidate, is a Fatty Acid Binding Protein 5 (FABP5) inhibitor, cleared by the FDA for a first-in-human study, targeting chemotherapy-induced peripheral neuropathy (CIPN) [5][8] - The Phase 1 safety study for ART26.12 has completed enrollment, with data readout expected in Q2 2025 [6] - ART27.13 is being evaluated in the Phase 2 CAReS study for cancer-related anorexia and cachexia, with initial data expected in Q3 2025 [6][10] Financial Results - For Q1 2025, research and development expenses were $1.4 million, a slight decrease from $1.5 million in Q1 2024 [7] - General and administrative expenses were $1.0 million, down from $1.1 million in the same period last year [7] - The net loss for Q1 2025 was $2.4 million, or $0.72 per share, compared to a net loss of $2.5 million, or $0.78 per share, in Q1 2024 [7] Cash Position - As of March 31, 2025, cash and investments totaled $0.7 million [7] - In early May 2025, the company issued $0.9 million in at-market convertible notes to support operations until further financing is secured [7]