ARTELO BIOSCIENCES, INC.

SUMMARY This summary is not complete and does not contain all of the information that you should consider before investing in the securities offered by this prospectus. You should read this summary together with the entire prospectus carefully, including “Risk Factors” and our financial statements and the related notes incorporated by reference into this prospectus, before making an investment decision. See “Risk Factors” for a discussion of the risks involved in investing in our securities. Corporate Overview We are a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics that target lipid-signaling modulation pathways, including the endocannabinoid system (the “ECS”), a network of receptors and neurotransmitters that form a biochemical communication system throughout the body. Our product candidate pipeline broadly leverages leading scientific methodologies and balances risk across mechanisms of action and stages of development. Our programs represent a comprehensive approach in utilizing the power and promise of lipid signaling to develop pharmaceuticals for patients with unmet healthcare needs. We are currently developing a dual cannabinoid (CB) agonist that targets both the CB1 and CB2 receptors. This synthetic small molecule program is a G protein-coupled receptor (“GPCR”) designated ART27.13. We are developing ART27.13 as a potential treatment for cancer-related anorexia and it is currently in a Phase 1b/2a trial, titled the Cancer Appetite Recovery Study (“CAReS”). Our second program, ART26.12 is a small molecule and the lead product candidate from our chemical library of inhibitors of fatty acid binding proteins, notably Fatty Acid Binding Protein 5 (“FABP5”). We received U.S. Food & Drug Administration (the “FDA”) clearance for our Investigational New Drug (“IND”) application for ART26.12 in July 2024 and have completed enrolment to a Phase 1 clinical trial in healthy subjects to support the development towards an agent intended to treat chemotherapy-induced peripheral neuropathy. In addition, ART26.12 may have broad applications as a cancer therapeutic, as a treatment for dermatologic conditions, such as psoriasis, as a treatment for pain and inflammation, and potential use in anxiety-related disorders, including post-traumatic stress disorder. In June 2025, we announced favorable results from our first-in-human study evaluating ART26.12. The Phase 1 Single Ascending Dose (SAD) study was designed to assess the safety, tolerability, and pharmacokinetics of ART26.12 in healthy volunteers and enrolled 49 subjects. All adverse events (AEs) were mild, transient, and self-resolving. No drug-related AEs were observed in the blinded dataset, and no tolerability issues or safety signals were detected across multiple assessments (vital signs, ECGs, clinical laboratory tests, physical examinations, and visual analogue mood scales). In addition, full dose-exposure profiles were successfully explored. Plasma analysis confirmed dose-dependent, linear absorption across the evaluated range. A wide safety margin was observed between estimated therapeutic plasma concentrations and the highest exposure levels achieved, supporting potential titration for maximum efficacy in future studies. We are also developing our own invention ART12.11 (the “CBD cocrystal”). ART12.11 is our patented solid-state composition of cannabidiol (“CBD”) and tetramethylpyrazine (“TMP”). TMP serves as the coformer in the CBD cocrystal. ART12.11 may be considered by the regulatory authorities as a fixed drug combination instead of a new chemical entity (“NCE”). We obtained two of our patent protected product candidates through our in-licensing activities. Our first in-licensed program, ART27.13, is being developed for cancer-related anorexia. ART27.13 is a peripherally-selective high-potency dual CB1 and CB2 full-receptor agonist, which was originally invented at AstraZeneca plc (“AstraZeneca”). We exercised our option to exclusively license this product candidate through the NEOMED Institute (“NEOMED”), a Canadian not-for-profit corporation, renamed adMare Bioinnovations (“adMare”) in June 2019, which had obtained rights to ART27.13 from AstraZeneca. In Phase 1, single dose studies in healthy volunteers and a multiple ascending dose study in individuals with chronic low back pain conducted by AstraZeneca, ART27.13 exhibited an attractive pharmacokinetic and absorption, distribution, metabolism, and excretion profile and was well tolerated within the target exposure range. It also exhibited dose-dependent and potentially clinically meaningful increases in body weight. Importantly, the changes in body weight were not associated with fluid retention or other adverse effects and occurred at exposures without central nervous system (“CNS”) side effects. Discussions with United Kingdom (“UK”), U.S. and Canadian regulators indicate there is a potential pathway for development of ART27.13 for the treatment of cancer-related anorexia, which affects approximately 60% of advanced stage cancer patients.

We commenced enrollment and dosed the first patient in CAReS, our Phase 1b/2a clinical study of cancer-related anorexia with ART27.13 in April 2021 and completed enrolling patients in the Phase 1b during the first quarter of 2023. Data from the Phase 1b stage was used to determine the most effective and safe dose selected as the starting dose for the Phase 2a portion of CAReS. We received approval from the regulatory authorities in the UK, Ireland and Norway to increase the daily dose from the starting dose of 650 micrograms to 1,000 micrograms after 4 weeks and up to 1,300 micrograms initiated at 8 weeks in patients for whom intra-patient dose escalation is expected to be well tolerated. We also received approval from the regulatory authorities to enroll 40 evaluable patients into the Phase 2a stage with a 3:1 randomization of ART27.13 to placebo. We initiated the Phase 2a portion of CAReS during April 2023. As of May 6, 2025, 18 clinical sites across five countries were open for enrollment. As of June 30, 2025, 32 participants have been enrolled. On September 3, 2025, we announced interim results from the Phase 2a CAReS trial. In the interim analysis, 18 evaluable patients-primarily with lung and gastrointestinal cancers not receiving cyclic chemotherapy-were included. After 12 weeks of treatment in patients who titrated to the top dose evaluated of 1300 micrograms (n=5), ART27.13 demonstrated compelling increases in mean body weight of 6.38% (Standard Deviation or SD 9.50) compared to patients on placebo (n=6) who lost -5.42% (SD 8.17). The maximum weight gain in the ART27.13 group reached 18.5%, versus only 0.4% in placebo. The maximum weight loss in the placebo arm was -17.4%, compared to just -3.0% in the ART27.13 group. Additional benefits were seen in lean body mass, with a +4.23% increase (SD 5.37) in the treatment group versus a -3.15% loss (SD 4.89) in placebo at one month, as well as qualitative improvements in total and weekly activity scores. Safety results were consistent with prior findings. Among the 32 participants enrolled in the CAReS Phase 2 trial to date, 7 patients (22%) experienced adverse events that may be related to ART27.13. All were mild or moderate, with the exception of a single case of severe malaise, and no drug-related serious adverse events were reported. These data are aligned with safety outcomes observed in Phase 1 of CAReS, supporting ART27.13’s overall favorable tolerability and acceptable safety profile. Our second in-licensed patented program is being advanced from our platform of small-molecule inhibitors of fatty acid binding proteins, notably FABP5. Fatty acid binding proteins (“FABPs”) are attractive therapeutic targets, however, the high degree of sequence and structural similarities among family members made the creation of drugs targeting specific FABPs challenging. FABP5 is believed to specifically target and regulate one of the body’s endogenous cannabinoids, anandamide (“AEA”). While searching for a FABP5 inhibitor to regulate AEA, researchers at Stony Brook University (“SBU”) discovered the chemistry for creating a large library of compounds which we believe to be highly specific and potent small molecule inhibitors of FABP5 and other isoforms. SBU received approximately $8.0 million in funding from the National Institutes of Health to develop FABP5 inhibitor candidates including a $4.2 million grant in 2020 to advance research of FABP5 inhibition in prostate cancer. We licensed the rights to world-wide intellectual property in all fields and certain know-how to these inhibitors from SBU. Our lead FABP5 inhibitor program is designated ART26.12. Preclinical research with ART26.12 showed evidence of activity in multiple pain models including osteoarthritis, cancer bone pain, and neuropathic pain. Based upon positive preclinical evidence from five separate studies showing promising activity and a differentiated mechanism-of-action for the prevention and treatment of painful neuropathies, including diabetic neuropathy and Chemotherapy Induced Peripheral Neuropathy (“CIPN”), we prioritized CIPN as the initial indication for development of ART26.12. Treatment and/or prevention of CIPN is a significant unmet need, often resulting in anti-cancer treatment delays or discontinuations, and there are currently no approved treatments for CIPN by the regulatory authorities in the U.S., UK or EU. We submitted an IND application for ART26.12 to the FDA on 10th of June 2024 and received a study may proceed notice from the FDA on the 8th of July 2024. First-in-human studies for ART26.12 began in Q4 of 2024 and we successfully completed dosing all 48 healthy volunteers planned for the Phase 1 Single Ascending Dose study at the end of April 2025. In addition to its potential as a synthetic endocannabinoid modulator with development targeting pain, inflammation, dermatologic conditions such as psoriasis, FABP5 is understood to play an important role in lipid signaling and is believed to be an attractive strategy for drug development in oncology. Large amounts of human biomarker and animal model data support FABP5 as an oncology target, including triple negative breast cancer, ovarian cancer, cervical cancer, and castration-resistant prostate cancer. Through our sponsored research we have also subsequently identified a potential role for FABP5 inhibition to treat anxiety disorders, such as Post Traumatic Stress Disorder (“PTSD”). We have been awarded a research grant in Canada to expand on our earlier research at the University of Western Ontario in this new development area.

May 2025 Private Placement Effective May 1, 2025, we entered into the May 2025 Subscription Agreement with each of the Selling Securityholders named in this prospectus, pursuant to which we issued and sold to the Selling Securityholders, and the Selling Securityholders purchased convertible notes (the “May 2025 Notes”) in an aggregate principal amount of $900,000. A portion of the May 2025 Notes was convertible into Common Stock, at the election of each Selling Securityholders, pursuant to the Voluntary Conversion (defined below) and the remaining portion of each May 2025 Note was converted into the $6.24 Warrants. The sale and issuance of the May 2025 Notes closed on May 1, 2025. The May 2025 Notes accrued interest at a rate of 12% per annum. All unpaid principal, together with any then unpaid and accrued interest and other amounts payable thereunder, was due and payable on October 28, 2025 (the “May 2025 Notes’ Maturity Date”). On the May 2025 Notes’ Maturity Date, the Selling Securityholder had the right (at the Selling Securityholder’s sole option) to convert all of that certain unpaid portions of principal and accrued interest of the Selling Securityholder’s May 2025 Note into shares of Common Stock (the “Voluntary Conversion”), as provided in the May 2025 Notes. Should the Selling Securityholder not elect Voluntary Conversion, such portion of the unpaid principal balance and any accrued interest of each May 2025 Note subject to Voluntary Conversion would be immediately due and payable in cash. No Selling Securityholder elected their right to Voluntary Conversion. Further, each Selling Securityholder entered into the October 2025 Subscription Agreement (as defined below) pursuant to which they agreed to convert all or a portion of the unconverted “Voluntary Conversion” portion of unpaid principal balance and accrued interest due to the Selling Securityholders upon the maturity of the May 2025 Notes into the Notes. On the May 2025 Notes’ Maturity Date, that portion of the unpaid principal balance and any accrued interest of each Note not subject to the Voluntary Conversion was automatically converted into the $6.24 Warrants. Each $6.24 Warrant shall be immediately exercisable after issuance for five (5) years. Each $6.24 Warrant will be exercisable by payment of the exercise price in cash or on a cashless basis if at the time of exercise there is no effective resale registration statement and will contain customary anti-dilution provisions (in the case of stock splits, dividends, recapitalizations, mergers and similar transactions). A holder of a $6.24 Warrant may not exercise any such $6.24 Warrant to the extent that such conversion or exercise would result in the number of shares of Common Stock beneficially owned by such holder and its affiliates exceeding 9.9% of the total number of shares of Common Stock outstanding immediately after giving effect to the conversion or exercise, which percentage may be increased or decreased at the holder’s election not to exceed 19.9%. Pursuant to the May 2025 Subscription Agreement, we agreed (i) to file a registration statement (the “May 2025 Registration Statement”) with the SEC under the Securities Act of 1933, as amended (the “Securities Act”) on or before the 45th calendar day following the May 2025 Notes’ Maturity Date (subject to certain exceptions) for purposes of registering the resale of the shares of Common Stock issuable upon Conversion of the May 2025 Notes, if any, and the shares of Common Stock issuable pursuant to the $6.24 Warrants (collectively, the “May 2025 Registrable Shares”), (ii) to use our reasonable best efforts to have such registration statement declared effective within the time period set forth in the May 2025 Subscription Agreement, and (iii) to keep the May 2025 Registration Statement effective until the May 2025 Registrable Shares covered by such May 2025 Registration Statement may be sold without volume or manner-of-sale restrictions pursuant to Rule 144, subject to certain conditions.

The offer and sale of the securities pursuant to the May 2025 Subscription Agreement were not registered under the Securities Act, or any state securities laws. We relied on an exemption from the registration requirements of the Securities Act provided by Section 4(a)(2) thereof and Rule 506(b) of Regulation D promulgated thereunder. Each of the Selling Securityholders has represented to us that such Selling Securityholder is an “accredited investor,” as defined in Regulation D of the Securities Act, and that the securities purchased by such Selling Securityholder were being acquired solely for such selling stockholder’s own account and for investment purposes and not with a view to its future sale or distribution. The description of the May 2025 Subscription Agreement, the May 2025 Notes and $6.24 Warrants are not complete and are qualified in their entirety by reference to the subscription agreement, form of convertible note and the form of warrant, which were filed as exhibits to our Current Report on Form 8-K, filed on May 1, 2025. See “Where You Can Find More Information” and “Information Incorporated by Reference.” The representations, warranties and covenants made by us in such agreements were made solely for the benefit of the parties to such agreements, including, in some cases, for the purpose of allocating risk among the parties thereto, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were made as of an earlier date. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs. October 2025 Private Placement Effective October 28, 2025, we entered into the October 2025 Subscription Agreement with the Selling Securityholders named in this prospectus, pursuant to which we issued and sold to the Selling Securityholders, and the Selling Securityholders purchased (by converting all or a portion of the unconverted “Voluntary Conversion” portion of unpaid principal balance and accrued interest due to the Selling Securityholders upon the maturity of the May 2025 Notes): (i) The Notes in an aggregate principal amount of $690,154.69; and (ii) the $3.40 Warrants to purchase an aggregate of 438,182 shares of Common Stock, at an exercise price of $3.40 per share. The sale and issuance of the Notes and $3.40 Warrants closed effective as of October 28, 2025 (the “Closing Date”). The Notes will accrue interest at a rate of 12% per annum, which will adjust to 20% upon an Event of Default (as defined in the Notes). All unpaid principal, together with any then unpaid and accrued interest and other amounts payable thereunder, shall be due and payable six months after the Closing Date (the “Maturity Date”). At any time prior to the Maturity Date, all or any portion of the outstanding principal amount of the Notes, together with the accrued and unpaid interest, shall be convertible, in whole or in part, into shares of Common Stock, at a conversion price of $3.40. Each $3.40 Warrant shall be immediately exercisable after issuance for five (5) years. Each $3.40 Warrant will be exercisable by payment of the exercise price in cash or on a cashless basis if at the time of exercise there is no effective resale registration statement and will contain customary anti-dilution provisions (in the case of stock splits, dividends, recapitalizations, mergers A holder of a Note or $3.40 Warrant may not convert or exercise any such Note or $3.40 Warrant to the extent that such conversion or exercise would result in the number of shares of Common Stock beneficially owned by such holder and its affiliates exceeding 4.9% of the total number of shares of Common Stock outstanding immediately after giving effect to the conversion or exercise, which percentage may be increased or decreased at the holder’s election not to exceed 19.9%. Pursuant to the Subscription Agreement, the Company agreed (i) to file a registration statement (the “October 2025 Registration Statement”) with the with the SEC under the Securities Act on or before the 20th calendar day following the Closing Date (subject to certain exceptions) for purposes of registering the resale of the shares of Common Stock issuable upon Conversion of the Notes, if any, and the shares of Common Stock issuable pursuant to the $3.40 Warrants (collectively, the “October 2025 Registrable Shares”), (ii) to use its reasonable best efforts to have such registration statement declared effective within the time period set forth in the Subscription Agreement, and (iii) to keep the October 2025 Registration Statement effective until the October 2025 Registrable Shares covered by such October 2025 Registration Statement may be sold without volume or manner-of-sale restrictions pursuant to Rule 144, subject to certain conditions.

The offer and sale of the securities pursuant to the October 2025 Subscription Agreement were not registered under the Securities Act, or any state securities laws. We relied on an exemption from the registration requirements of the Securities Act provided by Section 3(a)(9) and/or Section 4(a)(2) thereof and Rule 506(b) of Regulation D promulgated thereunder. Each of the Selling Securityholders has represented to us that such Selling Securityholder is an “accredited investor,” as defined in Regulation D of the Securities Act, and that the securities purchased by such Selling Securityholder were being acquired solely for such selling stockholder’s own account and for investment purposes and not with a view to its future sale or distribution. The description of the October 2025 Subscription Agreement, the Notes and $3.40 Warrants are not complete and are qualified in their entirety by reference to the subscription agreement, form of convertible note and the form of warrant, which were filed as exhibits to our Current Report on Form 8-K, filed on October 31, 2025. See “Where You Can Find More Information” and “Information Incorporated by Reference.” The representations, warranties and covenants made by us in such agreements were made solely for the benefit of the parties to such agreements, including, in some cases, for the purpose of allocating risk among the parties thereto, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were made as of an earlier date. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs. Recent Developments On October 26, 2025, our board of directors appointed Mark Spring, effective November 1, 2025, as our Chief Financial Officer and Treasurer as well as its principal financial officer and principal accounting officer. Mr. Spring replaced Gregory Gorgas in the roles of Treasurer, principal financial officer and principal accounting officer. On October 15, 2025, we entered into a cooperation letter agreement (the “Cooperation Agreement”) with Daniel S. Farb and certain of his affiliates (collectively, the “Farb Parties”). Pursuant to the Cooperation Agreement, Mr. Farb agreed to irrevocably withdraw his nomination of candidates for election to our board of directors at the 2025 annual meeting of stockholders. Additionally, the Farb Parties agreed to certain standstill restrictions and voting commitments during the Restricted Period (as defined in the Agreement), including, among other things, (i) an obligation to vote shares of our common stock beneficially owned by the Farb Parties, and that the Farb Parties have the right to vote, subject to certain limited exceptions, in favor of the election of each person nominated by our board of directors for election as a director, against any proposals to remove any member of our board of directors, and in accordance with the recommendation of our board of directors on all other proposals or business, and (ii) a restriction on the ability of the Farb Parties to acquire beneficial ownership of more than 8.0% of the then-outstanding shares of the Company’s common stock. Corporate Information We were incorporated in the State of Nevada on May 2, 2011, as Knight Knox Development Corp. On January 19, 2017, we changed our name to Reactive Medical, Inc. and on April 14, 2017, we changed our name to Artelo Biosciences, Inc. Our principal executive office is located at 505 Loma Santa Fe, Suite 160, Solana Beach, California 92075 and our telephone number is (858) 925-7049. Our corporate website address is www.artelobio.com. Information contained on, or that can be accessed through, our website is not incorporated by reference into this prospectus, and you should not consider information on our website to be part of this prospectus. Implications of Being a Smaller Reporting Company Additionally, we are a “smaller reporting company” as defined in Rule 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our Common Stock held by non-affiliates equals or exceeds $250 million as of the end of that year’s second fiscal quarter, or (2) our annual revenues equaled or exceeded $100 million during such completed fiscal year and the market value of our Common Stock held by non-affiliates equals or exceeds $700 million as of the end of that year’s second fiscal quarter.