Financial Data and Key Metrics Changes - The preliminary results of the voting indicated that the compensation of the named executive officer was approved on an advisory basis [12] - The appointment of MaloneBailey, LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026, was ratified [13] Business Line Data and Key Metrics Changes - No specific financial data or key metrics related to business lines were provided in the meeting [2][3] Market Data and Key Metrics Changes - No specific market data or key metrics were discussed during the meeting [2][3] Company Strategy and Development Direction - The company is focused on good corporate practices, as evidenced by the advisory vote on executive compensation and the ratification of the auditor's appointment [10][11] Management Comments on Operating Environment and Future Outlook - Management noted that forward-looking statements regarding future events or financial performance involve risks and uncertainties, and actual results could differ materially from predictions [14] Other Important Information - The meeting was held virtually, and all necessary procedures for voting and quorum were followed [5][6] - The company emphasized the importance of investor sentiment regarding executive compensation [9][10] Q&A Session Summary - No questions were submitted by stockholders during the Q&A session, leading to the conclusion of the meeting [15]

Financial Data and Key Metrics Changes - The preliminary results of the voting indicated that the compensation of the named executive officer has been approved on an advisory basis [12] - The appointment of MaloneBailey, LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2026, has been ratified [13] Business Line Data and Key Metrics Changes - No specific data or metrics related to individual business lines were discussed during the meeting Market Data and Key Metrics Changes - No specific market data or metrics were provided in the meeting Company Strategy and Development Direction and Industry Competition - The company is focused on good corporate practices, as evidenced by the advisory vote on executive compensation and the ratification of the independent auditor [11] Management's Comments on Operating Environment and Future Outlook - Management noted that forward-looking statements regarding future events or financial performance involve risks and uncertainties, and actual results could differ materially from predictions [14] Other Important Information - The meeting was held virtually, and all necessary procedures for voting and quorum were followed [5][6] - The company emphasized the importance of stockholder participation and the advisory nature of certain proposals [9][10] Q&A Session Summary - No questions were submitted by stockholders during the Q&A session, leading to the conclusion of the meeting without any inquiries [15]

Financial Data and Key Metrics Changes - The company held its annual meeting to discuss various proposals and the election of directors, but specific financial data and key metrics were not disclosed during this meeting [2][12]. Business Line Data and Key Metrics Changes - No specific data or key metrics related to individual business lines were provided in the meeting [2][12]. Market Data and Key Metrics Changes - There was no discussion of market data or key metrics during the meeting [2][12]. Company Strategy and Development Direction - The company is focused on good corporate governance practices, as evidenced by the advisory vote on executive compensation and the ratification of the independent auditor [9][10]. Management Comments on Operating Environment and Future Outlook - Management indicated that forward-looking statements regarding future events or financial performance may involve risks and uncertainties, and actual results could differ materially from predictions [13]. Other Important Information - The meeting included the election of two Class II directors, approval of executive compensation on an advisory basis, and ratification of the independent auditor for the fiscal year ending December 31, 2026 [11][12]. Q&A Session All Questions and Answers Question: No questions were submitted by stockholders during the Q&A session - The company noted that no questions were received, leading to the conclusion of the meeting [14][15].

Core Viewpoint - Artelo Biosciences, Inc. sees the White House's Executive Order on a Medicare pilot program for cannabidiol (CBD) products as a significant milestone for recognizing CBD's therapeutic potential and improving access to cannabinoid-based treatments for vulnerable populations [2][3] Company Positioning - Artelo is positioned to address the need for standardized, effective CBD therapies through its proprietary product ART12.11, which has shown superior oral bioavailability and consistent pharmacokinetics compared to standard CBD formulations [4][5] - The company emphasizes the importance of rigorous clinical studies to establish the safety and efficacy of CBD-based treatments, distinguishing them from consumer-grade products [3][6] Product Development - ART12.11 is a patented cocrystal composition of CBD and tetramethylpyrazine (TMP), designed to ensure pharmaceutical-grade purity and potency, essential for clinical development and potential reimbursement [5][7] - Following positive feedback from regulatory authorities, Artelo is ready to advance ART12.11 into human clinical trials, aligning with the goals of the Executive Order to provide data-driven confidence in medical CBD use [6][7] Market Opportunity - The Executive Order's focus on data collection for CBD products indicates a growing demand for safe and effective cannabinoid therapies, particularly for aging and medically vulnerable populations [2][3] - Artelo's ART12.11 is expected to meet the standards required for federal healthcare integration and prescription-based use, representing a next-generation approach to cannabinoid medicine [7]

As filed with the Securities and Exchange Commission on November 17, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Artelo Biosciences, Inc. (Exact name of registrant as specified in its charter) Nevada 7389 33-1220924 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 505 Lomas Santa ...

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]