Clinical Development - The company is developing a dual cannabinoid agonist, ART27.13, for cancer-related anorexia, currently in Phase 1b/2a trials, with 32 participants enrolled as of June 30, 2025[104][110]. - Interim results from the Phase 2a CAReS trial showed a mean body weight increase of 6.38% in the ART27.13 group compared to a -5.42% decrease in the placebo group after 12 weeks[110]. - The company received FDA clearance for ART26.12, targeting chemotherapy-induced peripheral neuropathy, with first-in-human studies completed in April 2025[105][113]. - ART26.12 demonstrated a favorable safety profile in a Phase 1 study with no drug-related serious adverse events reported among 49 subjects[105][111]. - The company has a pipeline that includes ART12.11, a patented CBD cocrystal, which may be considered a fixed drug combination by regulatory authorities[106]. - The company has licensed rights to FABP5 inhibitors from Stony Brook University, with preclinical evidence supporting their use in multiple pain models[112][113]. - The company aims to address significant unmet needs in treating chemotherapy-induced peripheral neuropathy, as there are currently no approved treatments in the U.S., UK, or EU[113]. - The company’s clinical programs leverage lipid-signaling modulation pathways, targeting unmet healthcare needs in oncology and pain management[103][104]. - The company plans to develop its synthetic CBD cocrystal for multiple indications, including anxiety disorders, PTSD, and depression[115]. Financial Performance - The company has not generated any revenue to date and may not do so in the near future[127]. - Operating expenses for the three months ended September 30, 2025, were $3.1 million, an increase of $1.9 million compared to $1.2 million for the same period in 2024[131]. - For the nine months ended September 30, 2025, total operating expenses were $8.6 million, up $2.3 million from $6.3 million in the same period in 2024[133]. - The net loss for the nine months ended September 30, 2025, was $8.7 million, compared to a net loss of $6.0 million for the same period in 2024[135]. - The company has not generated any revenue to date and anticipates substantial increases in expenses and capital requirements due to ongoing research and development activities[145]. - The company faces significant uncertainty regarding its ability to continue as a going concern without raising additional funds[144]. - Working capital as of September 30, 2025, was $(3.0) million, a decrease of $3.8 million from the previous year[149]. - Cash used in operating activities was $5.6 million for the nine months ended September 30, 2025, compared to $5.8 million for the same period in 2024, with a net loss of $8.7 million[152]. - Cash flows provided by financing activities were $5.3 million for the nine months ended September 30, 2025, compared to $0.1 million in 2024, driven by proceeds from common shares and convertible notes[155]. Funding and Capital Structure - The company closed an underwritten offering on October 1, 2025, raising approximately $2 million through the sale of 441,210 shares of common stock at $4.40 per share[117]. - The company issued convertible notes with gross proceeds of $0.9 million on May 1, 2025, bearing interest at 12%[138]. - The company has committed to using $250,000 to acquire Solana's native token, SOL, as part of its digital asset treasury strategy[119]. - The company entered into an At-The-Market Offering Agreement to sell up to $6.5 million of common stock, with 50,858 shares sold for net proceeds of $0.4 million during the quarter ended September 30, 2025[141]. - A securities purchase agreement for an at-the-market PIPE was initiated for the purchase of 906,687 shares at $10.45, expected to raise approximately $9.5 million, but was terminated on August 19, 2025[142]. - An Underwriting Agreement was executed for an offering of 640,924 shares at $4.40 per share, resulting in gross proceeds of approximately $3.0 million and net proceeds of $2.9 million after expenses[143]. Assets and Liabilities - As of September 30, 2025, the company had cash and cash equivalents of $1.7 million[135]. - Current assets decreased from $2.6 million as of December 31, 2024, to $1.8 million as of September 30, 2025, primarily due to funding operating activities[149]. - Current liabilities increased significantly from $1.8 million to $4.9 million during the same period, attributed to a cash preservation strategy[150]. - The company has two U.S. patents and six foreign patents related to its proprietary cocrystal composition of CBD, which is expected to provide long-lasting market exclusivity[115]. Accounting and Compliance - Stock-based compensation expense is recognized over the requisite service period, estimated using the Black-Scholes option pricing model[166]. - The fair value of equity awards is influenced by variables such as risk-free interest rate and expected stock price volatility[166]. - No new accounting standards were adopted during the nine months ended September 30, 2025[168].

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, Inc. has published a peer-reviewed article on the role of Fatty Acid Binding Protein 3 (FABP3) in cancer, highlighting its significance in cancer progression and potential as a therapeutic target [1][2][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, pain, and neurological disorders [1][4] - The company is advancing a portfolio of selective, dual, and pan inhibitors targeting FABP3, FABP5, and FABP7, positioning itself to explore multiple therapeutic opportunities across oncology and other indications [3][4] Research Findings - The publication emphasizes that FABP3, like FABP5 and FABP7, plays a significant role in cancer progression through mechanisms related to lipid metabolism, hypoxia, and ferroptosis, which are critical for cancer cell survival [2][3] - Genetic and pharmacological inhibition of FABP3 has shown therapeutic benefits in preclinical cancer models, indicating its potential as a target for cancer treatment [2][3] Strategic Direction - The company is committed to advancing innovative therapeutics to address unmet medical needs, with a focus on its lead program, ART26.12, targeting FABP5 for pain treatment while also exploring broader applications of its FABP inhibitor portfolio in various cancers and diseases [4]

Core Insights - Artelo Biosciences, Inc. has appointed Mark Spring as Chief Financial Officer effective November 1, 2025, enhancing the company's financial leadership as it progresses its clinical pipeline and corporate growth initiatives [1][3] Company Overview - Artelo Biosciences, Inc. 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] Leadership Experience - Mark Spring brings 30 years of experience in life sciences, having held financial leadership roles in both private and public companies, including significant experience in mergers and acquisitions [2][3] - His previous roles include interim CFO for LENZ Therapeutics and co-founder and CFO of Secura Bio, among others [2] Strategic Impact - Since joining as a financial consultant in December 2024, Mark Spring has strengthened Artelo's financial operations and supported the execution of its capital strategy [3] - His leadership is expected to be crucial in advancing the company's product candidates and enhancing shareholder value [3]

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. has successfully closed a public offering of 441,210 shares of common stock at a price of $4.40 per share, along with pre-funded warrants for an additional 13,335 shares at $4.399 each, generating approximately $2.0 million in gross proceeds before expenses [1][2]. Offering Details - The offering included a 45-day option for underwriters to purchase up to an additional 68,181 shares to cover over-allotments [2]. - The shares and warrants were offered under a "shelf" registration statement filed with the SEC, which became effective on July 14, 2023 [3]. - The final prospectus supplement and accompanying base prospectus were filed with the SEC on October 1, 2025 [4]. 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 dermatologic issues [7]. - The company aims to address significant unmet medical needs through a diversified pipeline and is led by an experienced executive team [7].

Core Points - Artelo Biosciences, Inc. has announced the pricing of its public offering of 441,210 shares of common stock at $4.40 per share and pre-funded warrants at $4.399 per warrant, aiming for gross proceeds of approximately $2.0 million [1] - The offering is managed by R.F. Lafferty & Co., Inc. and is conducted under a "shelf" registration statement filed with the SEC [2] - The offering is expected to close on October 1, 2025, pending customary closing conditions [1] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for conditions such as cancer, pain, and dermatologic issues [6] - The company has a diversified pipeline addressing significant unmet medical needs, including anorexia, anxiety, and inflammation [6] - Artelo is led by an experienced executive team and collaborates with world-class researchers and digital-asset technology partners to maximize stakeholder value [6]

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 - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - 89bio, Inc. (ETNB) increased by 83% to $14.84 [3] - Aptevo Therapeutics Inc. (APVO) rose by 75% to $2.47 [3] - Psyence Biomedical Ltd. (PBM) saw a 29% increase to $4.82 [3] - Beam Global (BEEM) gained 27% reaching $3.23 [3] - MicroAlgo Inc. (MLGO) was up 14% at $13.06 [3] - Akero Therapeutics, Inc. (AKRO) increased by 12% to $47.50 [3] - Hyperion DeFi, Inc. (HYPD) rose by 11% to $13.69 [3] - Sonnet BioTherapeutics Holdings, Inc. (SONN) increased by 11% to $7.85 [3] - FuelCell Energy, Inc. (FCEL) was up 9% at $8.34 [3] - Robo.ai Inc. (AIIO) gained 6% to $2.05 [3] Premarket Losers - Presidio Property Trust, Inc. (SQFT) decreased by 14% to $7.58 [4] - Aeluma, Inc. (ALMU) fell by 10% to $15.18 [4] - FGI Industries Ltd. (FGI) dropped 10% to $7.65 [4] - Lazydays Holdings, Inc. (GORV) was down 9% at $2.26 [4] - StableX Technologies, Inc. (SBLX) decreased by 8% to $5.40 [4] - Artelo Biosciences, Inc. (ARTL) fell by 8% to $4.48 [4] - SciSparc Ltd. (SPRC) decreased by 8% to $4.10 [4] - Cracker Barrel Old Country Store, Inc. (CBRL) was down 7% at $45.75 [4] - Columbus Circle Capital Corp I (BRR) fell by 7% to $9.42 [4] - Visionary Holdings Inc. (GV) decreased by 7% to $2.58 [4]

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]