Core Insights - Artelo Biosciences is strategically positioned for growth in the $16.3 billion glaucoma market through a fully funded clinical study, highlighting its multi-platform biotech pipeline across various therapeutic areas [1][2][4] Pipeline Overview - The company is advancing three clinical-stage programs targeting oncology support, neuropathic pain, and CNS disorders, while also expanding its lead compound into ophthalmology [2][3] - Artelo's pipeline is based on the principle of modulating lipid-signaling pathways, particularly the endocannabinoid system, to achieve therapeutic outcomes without CNS liabilities [5] Key Compounds - **ART27.13**: A peripheral CB1/CB2 agonist targeting cancer anorexia cachexia, currently in Phase 1b/2a, with European patent protection until 2041. It has shown a 6.4% weight gain in cancer patients compared to a 5.4% loss in the placebo group [6][8][9] - **ART26.12**: A FABP5 inhibitor for chemotherapy-induced peripheral neuropathy, which has completed Phase 1 with no serious adverse events and is preparing for multiple ascending dose studies [10][11][13] - **ART12.11**: A proprietary CBD/tetramethylpyrazine cocrystal with improved pharmacokinetics, entering Phase 1 with favorable regulatory guidance from the UK MHRA [15][16][17] Regulatory Environment - Recent regulatory shifts, including a Presidential executive order expanding CBD research and a Medicare pilot program for CBD reimbursement, create favorable conditions for Artelo's clinical development [19][20][22] Market Opportunities - The total addressable market for Artelo's programs is significant, with the global glaucoma market projected to reach $16.3 billion by 2033, and a notable unmet need in cancer cachexia due to the lack of FDA-approved treatments [24] Intellectual Property - Artelo's strong patent position provides long-term protection for its compounds, with ART27.13's European patent extending through 2041, enhancing its attractiveness for potential partnerships [25][26] Partnership Signals - The company has received unsolicited partnership inquiries from global pharmaceutical companies, indicating external validation of its scientific credibility and potential for collaboration [27][29] Capital Efficiency - Artelo operates with a lean structure, directing a significant portion of its budget to R&D while minimizing overhead costs, which allows for efficient capital use [33][34] Future Milestones - Key upcoming milestones include the commencement of Phase 1 studies for ART12.11 and multiple ascending dose enrollment for ART26.12, with ongoing Phase 2 trials for ART27.13 [30][31]

S-1 1 artl_s1.htm FORM S-1 As filed with the Securities and Exchange Commission on March 24, 2026 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 ...

S-1/A 1 artl_s1a.htm FORM-S-1/A As filed with the Securities and Exchange Commission on March 24, 2026 Registration No. 333-294506 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Artelo Biosciences, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Nevada 7389 33-1220924 (I ...

S-1/A 1 artl_s1a.htm FORM-S-1/A As filed with the Securities and Exchange Commission on March 23 , 2026 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Artelo Biosciences, Inc. (Primary Standard Industrial Classification Code Number) Registration No. 333- 294506 (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Nevada 7389 33-1220924 ...

March 2026 Corporate Presentation Nasdaq:ARTL Pioneering the Science of Lipid Signaling Modulation to Develop Novel Therapeutics Forward Looking Statements Artelo Biosciences, Inc. (the "Company") cautions you that statements contained in this presentation regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: those rela ...

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) (State or other jurisdiction of incorporation or organization) S-1 1 artl_s1.htm FROM-S-1 As filed with the Securities and Exchange Commission on March 20, 2026 Registration No. 333- (Primary Standard Industrial Classification Code Number) Nevada 7389 33-1220924 (I.R.S. Employer Identification ...

Core Insights - Artelo Biosciences, Inc. is advancing its clinical-stage pharmaceutical programs with positive human data and upcoming clinical catalysts, focusing on treatments for cancer, pain, and other conditions [1] Business Highlights - Successful completion of a Phase 1 study for ART26.12, showing a favorable safety profile and predictable pharmacokinetics, with plans to initiate a multiple ascending dose study in Q3 2026 [2] - Positive interim Phase 2 results for ART27.13, demonstrating improvements in body weight, lean body mass, and physical activity in patients with cancer anorexia-cachexia syndrome [3] - Received favorable regulatory guidance from the UK MHRA for ART12.11, with plans to initiate human clinical studies in H1 2027 [4] Clinical Progress - ART26.12 has shown sustained analgesic effects comparable to naproxen without tolerance in preclinical models, positioning it as a non-opioid alternative for pain management [5] - ART27.13 has received a Notice of Allowance from the European Patent Office, extending patent protection through December 2041, which has increased partner interest in its development [5] - ART12.11 has demonstrated robust antidepressant-like activity in preclinical studies, with plans for first-in-human studies early next year [5] Financial Results - Research and development expenses for FY 2025 were $5.4 million, down from $6.0 million in FY 2024 [6] - General and administrative expenses increased to $6.0 million in FY 2025 from $4.1 million in the previous year [6] - The net loss for FY 2025 was $12.9 million, or $12.52 per share, compared to a net loss of $9.8 million in FY 2024 [6] - Cash and investments totaled $0.6 million as of December 31, 2025 [6] Product Information - ART26.12 is a lead FABP5 inhibitor aimed at treating chemotherapy-induced peripheral neuropathy, with a favorable safety profile and dosing flexibility [8] - ART27.13 is a cannabinoid receptor agonist targeting cancer-related anorexia and cachexia, showing a mean weight gain of over 6% in the top dose group compared to a 5% loss in the placebo group [9][10] - ART12.11 is a proprietary cocrystal composition of CBD and TMP, with enhanced pharmacokinetics and plans for clinical studies in 2026 [11]

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 ...

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]