Core Insights - Artelo Biosciences, Inc. has published an article in Drug Discovery Today discussing the role of fatty acid binding protein 7 (FABP7) in various cancers and its potential as a target for cancer treatment [1][2] - FABP7 is upregulated in several cancers, including breast, brain, and kidney cancers, and is associated with poor patient prognosis [2] - Genetic and pharmacological inhibition of FABP7 has shown to reduce tumor cell growth, migration, and invasion, while improving survival rates in brain cancer models [2] Company Developments - Artelo is advancing research on FABP inhibition, focusing on selective and pan-FABP inhibitors to provide new therapeutic options for cancer and other serious conditions [3] - The lead compound, ART26.12, is a selective inhibitor of FABP5, showing positive preclinical results in cancer and chemotherapy-induced peripheral neuropathy (CIPN) [3][5] - The company plans to file an investigational new drug (IND) application with the FDA for ART26.12 in CIPN during Q2 2024, addressing a significant unmet need as approximately 40% of cancer patients undergoing certain chemotherapies develop neuropathic pain [3][5] Research Focus - Artelo's research emphasizes the therapeutic potential of its extensive library of small molecule FABP inhibitors for treating various conditions, including cancers, pain, and anxiety disorders [5][6] - The company is dedicated to developing proprietary therapeutics that modulate lipid-signaling pathways to address significant unmet medical needs [6]

SOLANA BEACH, Calif., April 22, 2024 (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 and neurological conditions, today announced that Gregory D. Gorgas, President and Chief Executive Officer of Artelo, will be a featured guest on the Benzinga All Access show. Mr. Gorgas is scheduled to appear on Tuesday, April 23, 2024, at approximately ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number 001-38951 Artelo Biosciences, Inc. (Exact name of registrant as specified in its charter) | --- | |------------ ...

SOLANA BEACH, Calif., March 12, 2024 (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, and neurological conditions, today announced its selection as a finalist in Johnson & Johnson's (("J&amp, J's", NYSE:JNJ) Innovation Challenge. This invitation-only event seeks novel approaches to treating atopic dermatitis from around the world. Artelo was awarded th ...

Core Insights - Artelo Biosciences, Inc. announced new research on ART26.12, a novel FABP5 inhibitor aimed at treating Oxaliplatin-Induced Peripheral Neuropathy (OIPN) [1][2] - The global neuropathic pain market is valued at approximately $7.6 billion, indicating a significant demand for innovative non-opioid pain relief therapies [3] 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 neurological disorders [5] - The company is advancing a portfolio of therapeutics designed to address unmet medical needs across various diseases, including cancer and neuropathic pain [5] Product Development - ART26.12 has demonstrated minimal off-target effects and high oral bioavailability in pre-clinical safety studies, with a NOAEL of 1000 mg/kg/day [3] - The company plans to file an Investigational New Drug (IND) application for ART26.12 in the first half of 2024 following a positive pre-IND meeting with the FDA [3] Market Context - Chemotherapy-induced peripheral neuropathy (CIPN) is a significant challenge in cancer treatment, affecting up to 98% of patients treated with Oxaliplatin, often leading to dose reductions or treatment cessation [2][6] - Approximately 30% of patients may experience chronic CIPN lasting a year or more after chemotherapy [6]

SOLANA BEACH, Calif., Jan. 08, 2024 (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, and neurological conditions, today announced that it has selected Worldwide Clinical Trials ("Worldwide"), a global award-winning contract research organization (CRO) therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory ...

```markdown PART I - FINANCIAL INFORMATION Presents the unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements](index=2&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Artelo Biosciences, Inc., including the Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Stockholders' Equity, and Statements of Cash Flows, along with accompanying notes detailing the company's organization, significant accounting policies, related party transactions, equity, intangible assets, leases, commitments, and subsequent events [Condensed Consolidated Balance Sheets](index=2&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Summarizes the company's financial position, including assets, liabilities, and equity, as of September 30, 2023, and December 31, 2022 | Metric | September 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------- | :-------------------------------- | :------------------------------- | | Cash and cash equivalents | $2,639 | $6,888 | | Trading marketable securities | $10,225 | $9,150 | | Total Current Assets | $13,428 | $18,322 | | TOTAL ASSETS | $15,499 | $20,424 | | Accounts payable and accrued liabilities | $840 | $905 | | Total Current Liabilities | $921 | $998 | | Total Stockholders' Equity | $14,578 | $19,403 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details the company's financial performance, including revenues, expenses, and net loss, for the three and nine months ended September 30, 2023 and 2022 | Metric (in thousands) | Three months ended Sep 30, 2023 | Three months ended Sep 30, 2022 | | :-------------------------------- | :------------------------------ | :------------------------------ | | General and administrative | $1,029 | $1,316 | | Research and development | $1,585 | $1,078 | | Total Operating Expenses | $2,614 | $2,394 | | Loss from Operations | $(2,614) | $(2,394) | | Net change in fair value of trading marketable securities | $165 | $69 | | NET LOSS | $(2,449) | $(2,330) | | Basic and Diluted Loss per Common Share | $(0.83) | $(0.82) | | Basic and Diluted Weighted Average Common Shares Outstanding | 2,949 | 2,849 | | Metric (in thousands) | Nine months ended Sep 30, 2023 | Nine months ended Sep 30, 2022 | | :-------------------------------- | :----------------------------- | :----------------------------- | | General and administrative | $3,118 | $4,213 | | Research and development | $3,572 | $2,598 | | Total Operating Expenses | $6,690 | $6,811 | | Loss from Operations | $(6,690) | $(6,811) | | Net change in fair value of trading marketable securities | $474 | $70 | | NET LOSS | $(6,216) | $(6,744) | | Basic and Diluted Loss per Common Share | $(2.15) | $(2.38) | | Basic and Diluted Weighted Average Common Shares Outstanding | 2,887 | 2,833 | [Condensed Consolidated Statements of Stockholders' Equity](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Outlines changes in stockholders' equity, including common shares, additional paid-in capital, and accumulated deficit, for the nine months ended September 30, 2023 | Metric (in thousands) | Balance, Dec 31, 2022 | Balance, Sep 30, 2023 | | :-------------------------------- | :-------------------- | :-------------------- | | Common Shares | 2,856 | 3,162 | | Additional Paid-in Capital | $50,675 | $52,011 | | Accumulated Deficit | $(31,021) | $(37,237) | | Total Stockholders' Equity | $19,403 | $14,578 | - Issuance of common shares contributed **$535 thousand** to additional paid-in capital during the nine months ended September 30, 2023[14](index=14&type=chunk) - Stock-based compensation recognized during the nine months ended September 30, 2023, totaled **$801 thousand**[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Presents the company's cash inflows and outflows from operating, investing, and financing activities for the nine months ended September 30, 2023 and 2022 | Cash Flow Activity (in thousands) | Nine months ended Sep 30, 2023 | Nine months ended Sep 30, 2022 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(5,611) | $(5,715) | | Net cash provided by investing activities | $766 | $1,162 | | Net cash provided by (used in) financing activities | $535 | $(134) | | Effect of exchange rate changes on cash | $61 | $(339) | | Net change in cash and cash equivalents | $(4,249) | $(5,026) | | Cash and cash equivalents - end of period | $2,639 | $7,136 | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=5&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures supporting the financial statements, covering accounting policies, related party transactions, and subsequent events [NOTE 1 – ORGANIZATION AND DESCRIPTION OF BUSINESS](index=5&type=section&id=NOTE%201%20%E2%80%93%20ORGANIZATION%20AND%20DESCRIPTION%20OF%20BUSINESS) Describes the company's corporate structure, business focus on biopharmaceutical development, and financial viability considerations - Artelo Biosciences, Inc. is a Nevada corporation, incorporated on May 2, 2011, and based in San Diego County, California[19](index=19&type=chunk) - The Company is a clinical stage biopharmaceutical company focused on developing and commercializing therapeutics that target lipid-signaling pathways, including the endocannabinoid system (ECS)[20](index=20&type=chunk) - The Company incurred a net loss of **$6,216 thousand** during the nine months ended September 30, 2023[21](index=21&type=chunk) - Existing cash resources are expected to provide sufficient funds into the **first quarter of 2025**, requiring additional funding thereafter[22](index=22&type=chunk) [NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=6&type=section&id=NOTE%202%20-%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Outlines the key accounting principles and methods used in preparing the financial statements, including revenue recognition, R&D, and fair value measurements - The Company's financial statements are prepared in accordance with GAAP and SEC rules, with interim statements following Article 8 of Regulation S-X[24](index=24&type=chunk) - R&D expenses include clinical studies, outside services, and personnel expenses, offset by R&D tax credits from the UK government (**$1,206 thousand** in 9M 2023)[27](index=27&type=chunk) | Marketable Securities (in thousands) | September 30, 2023 | December 31, 2022 | | :----------------------------------- | :----------------- | :---------------- | | Trading marketable securities | $10,225 | $9,150 | | Available-for-sale securities | $0 | $1,495 | | Fair Value Hierarchy (in thousands) | Level 1 | Level 2 | Level 3 | Total | | :---------------------------------- | :------ | :--------- | :------ | :--------- | | **September 30, 2023** | | | | | | Commercial paper | $0 | $6,365 | $0 | $6,365 | | Asset-backed securities | $0 | $1,206 | $0 | $1,206 | | Corporate debt | $0 | $1,470 | $0 | $1,470 | | US Government | $0 | $1,184 | $0 | $1,184 | | Total Trading Securities | $0 | $10,225 | $0 | $10,225 | | Available-for-sale securities | $0 | $0 | $0 | $0 | | **December 31, 2022** | | | | | | Commercial paper | $0 | $9,150 | $0 | $9,150 | | Total Trading Securities | $0 | $9,150 | $0 | $9,150 | | Available-for-sale securities | $0 | $1,495 | $0 | $1,495 | | US Treasury | $0 | $1,495 | $0 | $1,495 | | Common Stock Equivalents | September 30, 2023 | September 30, 2022 | | :----------------------- | :----------------- | :----------------- | | Stock options | 519,105 | 313,109 | | Warrants | 253,319 | 270,053 | | Total | 772,424 | 583,162 | [NOTE 3 – RELATED PARTY TRANSACTIONS](index=9&type=section&id=NOTE%203%20%E2%80%93%20RELATED%20PARTY%20TRANSACTIONS) Details transactions with entities owned or influenced by company executives or directors - The Company engaged in consulting and professional services with companies owned or influenced by its Senior Vice President, European Operations, and a subsidiary director, totaling **$172 thousand** for the nine months ended September 30, 2023[40](index=40&type=chunk) [NOTE 4 - EQUITY](index=9&type=section&id=NOTE%204%20-%20EQUITY) Provides information on common stock, warrants, stock options, and stock-based compensation - As of September 30, 2023, the Company had **3,162,354 shares** of Common Stock issued and outstanding, with **306,666 shares** issued under the Equity Line for **$535 thousand**[41](index=41&type=chunk) | Warrants Activity | Number of shares | Weighted Average Exercise Price | | :---------------------------- | :--------------- | :------------------------------ | | Outstanding, December 31, 2022 | 270,053 | $64.16 | | Expired | (16,734) | $180.00 | | Outstanding, September 30, 2023 | 253,319 | $55.82 | | Stock Option Activity | Number of Options | Weighted Average Exercise Price | | :---------------------------- | :---------------- | :------------------------------ | | Outstanding, December 31, 2022 | 313,109 | $24.15 | | Granted | 205,996 | $3.09 | | Outstanding, September 30, 2023 | 519,105 | $15.79 | | Exercisable options, September 30, 2023 | 214,807 | $29.22 | - Stock-based compensation expense recognized was **$801 thousand** for the nine months ended September 30, 2023, with **$1,533 thousand** remaining unamortized[47](index=47&type=chunk) [NOTE 5 – INTANGIBLE ASSET](index=10&type=section&id=NOTE%205%20%E2%80%93%20INTANGIBLE%20ASSET) Describes the capitalization and nature of the company's exclusive license for ART27.13 - The Company capitalized **$2,039 thousand** for the exclusive worldwide license to develop and commercialize ART27.13, consisting of a **$1,500 thousand** payment and **$539 thousand** fair value of common stock[48](index=48&type=chunk) [NOTE 6 - LEASE](index=10&type=section&id=NOTE%206%20-%20LEASE) Details the company's operating lease commitments for office space, including future minimum payments - The Company has operating leases for office space, with a weighted-average remaining lease term of **0.92 years** and a weighted-average discount rate of **3.00%** as of September 30, 2023[51](index=51&type=chunk) | Future Minimum Lease Payments (in thousands) | Total | | :------------------------------------------- | :---- | | 2023 - Remaining 3 months | $9 | | 2024 | $23 | | Thereafter | $0 | | Total | $32 | [NOTE 7 – COMMITMENTS AND CONTENGENCIES](index=11&type=section&id=NOTE%207%20%E2%80%93%20COMMITMENTS%20AND%20CONTENGENCIES) Outlines financial commitments related to research and development contracts and potential additional payments - The Company has financial commitments related to research and development contracts, with monthly and quarterly invoicing[55](index=55&type=chunk) - Additional payments may be required for R&D contracts based on progress and milestones[55](index=55&type=chunk) [NOTE 8 – SUBSEQUENT EVENTS](index=11&type=section&id=NOTE%208%20%E2%80%93%20SUBSEQUENT%20EVENTS) Reports significant events occurring after the balance sheet date, specifically common stock issuance - Subsequent to September 30, 2023, the Company issued **26,605 shares** of Common Stock under the Equity Line, generating **$33 thousand** in proceeds[54](index=54&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=12&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results, detailing its biopharmaceutical focus, product pipeline, business strategy, and a comparative analysis of financial performance for the three and nine months ended September 30, 2023, alongside discussions on liquidity, capital resources, and critical accounting policies [General Overview](index=13&type=section&id=General%20Overview) Provides an executive summary of the company's biopharmaceutical focus and strategic direction - Artelo Biosciences, Inc. is a clinical stage biopharmaceutical company focused on developing therapeutics targeting lipid-signaling pathways, including the endocannabinoid system (ECS)[64](index=64&type=chunk) [Product Candidate Pipeline](index=13&type=section&id=Product%20Candidate%20Pipeline) Details the company's therapeutic product candidates, their target indications, development phases, and estimated market sizes - ART27.13, a dual cannabinoid agonist, is in a Phase 1b/2a clinical study (CAReS) for cancer-related anorexia, with regulatory approval to increase daily dose and expand Phase 2a to 40 patients[65](index=65&type=chunk)[66](index=66&type=chunk)[67](index=67&type=chunk) - ART26.12, a FABP5 inhibitor, is undergoing pre-clinical research for painful neuropathies (prioritizing Chemotherapy Induced Peripheral Neuropathy, CIPN) and has potential applications in cancer, pain, inflammation, and anxiety disorders[65](index=65&type=chunk)[68](index=68&type=chunk)[70](index=70&type=chunk) - ART12.11, a proprietary synthetic CBD cocrystal, is in pre-clinical development, demonstrating improved stability, solubility, and bioavailability, with US and foreign patents, targeting anxiety, PTSD, epilepsy, insomnia, and IBD[65](index=65&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk) | Product Candidate | Target Indications | Development Phase | Estimated Global Market Size (approx.) | | :---------------- | :------------------------------------------------------------------------------------------------------ | :---------------- | :------------------------------------- | | ART27.13 | Anorexia associated with cancer | Clinical | >$2 billion | | ART26.12 | Chemotherapy Induced Peripheral Neuropathy, Diabetic Neuropathy, Prostate cancer, Breast cancer, pain, and anxiety disorders | Pre-clinical | CIPN: >$1 billion; Prostate cancer: $9 billion; Breast cancer: $18 billion; PTSD: $7 billion | | ART12.11 | Anxiety, Post-Traumatic Stress Disorder (PTSD), Inflammatory Bowel Disease (IBD), and other potential indications | Pre-clinical | Anxiety disorders: >$11 billion; PTSD: $7 billion; IBD: $7 billion | [Background (Endocannabinoid System)](index=15&type=section&id=Background%20(Endocannabinoid%20System)) Explains the Endocannabinoid System (ECS) as a key biological target for the company's therapeutic development - The Endocannabinoid System (ECS) is a widespread modulatory and lipid-signaling network involving cannabinoid receptors (CB1 and CB2), endocannabinoids, and associated enzymes, playing crucial roles in CNS, development, synaptic plasticity, and response to environmental factors[76](index=76&type=chunk)[77](index=77&type=chunk) - Modulation of the ECS can be achieved through selective or non-selective agonists, partial agonists, inverse agonists, and antagonists of CB1 and CB2 receptors, with the Company focusing on synthetic new chemical entities[77](index=77&type=chunk)[78](index=78&type=chunk) [Business Strategy](index=15&type=section&id=Business%20Strategy) Outlines the company's core objective to develop and commercialize ethical pharmaceutical products leveraging lipid signaling modulators - The Company's objective is to develop and commercialize ethical pharmaceutical products that leverage lipid signaling modulators, including those that enhance the effectiveness of the ECS, for a wide range of diseases[80](index=80&type=chunk) [Components of Our Results of Operations](index=15&type=section&id=Components%20of%20Our%20Results%20of%20Operations) Explains the primary drivers of the company's financial performance, including operating expenses and other income - The Company has not generated any revenue to date and does not expect to in the near future[81](index=81&type=chunk) - Operating expenses are classified into research and development (R&D) and general and administrative (G&A) expenses[82](index=82&type=chunk) - Other income (expense) primarily consists of interest income and changes in the fair value of trading marketable securities[83](index=83&type=chunk) [Results of Operations (Three and Nine Months)](index=16&type=section&id=Results%20of%20Operations%20(Three%20and%20Nine%20Months)) Compares the company's financial performance, including operating expenses and net loss, for the three and nine months ended September 30, 2023 and 2022 | Metric (in thousands) | Three months ended Sep 30, 2023 | Three months ended Sep 30, 2022 | Change | | :-------------------------------- | :------------------------------ | :------------------------------ | :----- | | General and administrative | $1,029 | $1,316 | $(287) | | Research and development | $1,585 | $1,078 | $507 | | Total Operating Expenses | $2,614 | $2,394 | $220 | | Loss from Operations | $(2,614) | $(2,394) | $(220) | | Other income | $165 | $64 | $101 | | Net Loss | $(2,449) | $(2,330) | $(119) | - The increase in operating expenses for the three months ended September 30, 2023, was due to increased R&D expenses, partially offset by decreased G&A expenses from lower stock-based compensation[85](index=85&type=chunk) | Metric (in thousands) | Nine months ended Sep 30, 2023 | Nine months ended Sep 30, 2022 | Change | | :-------------------------------- | :----------------------------- | :----------------------------- | :------- | | General and administrative | $3,118 | $4,213 | $(1,095) | | Research and development | $3,572 | $2,598 | $974 | | Total Operating Expenses | $6,690 | $6,811 | $(121) | | Loss from Operations | $(6,690) | $(6,811) | $121 | | Other income (expense) | $474 | $67 | $407 | | Net Loss | $(6,216) | $(6,744) | $528 | - The decrease in operating expenses for the nine months ended September 30, 2023, was primarily due to lower G&A expenses from reduced stock-based compensation, partially offset by increased R&D expenses[87](index=87&type=chunk) [Liquidity and Capital Resources](index=16&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's ability to meet its financial obligations and fund future operations, including financing activities and cash projections - The Company has incurred losses since inception, with a net loss of **$6.2 million** for the nine months ended September 30, 2023[89](index=89&type=chunk) - In May 2022, the Company entered into an Equity Line agreement to sell up to **$20.0 million** of Common Stock, issuing **306,666 shares** for **$0.5 million** as of September 30, 2023[89](index=89&type=chunk) - A **$75.0 million** shelf registration statement on Form S-3 became effective in July 2023, providing flexibility to raise additional capital[90](index=90&type=chunk) - Existing cash resources are projected to fund operations into the **first quarter of 2025**, necessitating additional funding thereafter[91](index=91&type=chunk) [Working Capital](index=17&type=section&id=Working%20Capital) Analyzes the company's short-term financial health by comparing current assets and liabilities | Metric (in thousands) | September 30, 2023 | December 31, 2022 | Change | | :-------------------- | :----------------- | :---------------- | :-------- | | Current Assets | $13,428 | $18,322 | $(4,894) | | Current Liabilities | $921 | $998 | $(77) | | Working Capital | $12,507 | $17,324 | $(4,817) | - The decrease in current assets was primarily due to funding the Company's operating activities[92](index=92&type=chunk) [Cash Flows Analysis](index=17&type=section&id=Cash%20Flows%20Analysis) Examines the sources and uses of cash from operating, investing, and financing activities - Net cash used in operating activities was **$5.6 million** for the nine months ended September 30, 2023, primarily due to a net loss of **$6.2 million**, partially offset by stock-based compensation and changes in operating assets/liabilities[95](index=95&type=chunk) - Net cash provided by investing activities was **$0.8 million** for the nine months ended September 30, 2023, resulting from dispositions of marketable securities offset by purchases[96](index=96&type=chunk) - Net cash provided by financing activities was **$0.5 million** for the nine months ended September 30, 2023, from the issuance of common stock[97](index=97&type=chunk) [Critical Accounting Policies and Estimates](index=18&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Highlights key accounting policies requiring significant management judgment and estimation - The preparation of financial statements requires management to make estimates and assumptions that affect reported amounts, which are evaluated on an ongoing basis[98](index=98&type=chunk)[99](index=99&type=chunk) [New Accounting Standard Adopted](index=18&type=section&id=New%20Accounting%20Standard%20Adopted) Reports on the adoption of ASU 2016-13 (CECL model) and its impact on financial statements - The Company adopted ASU 2016-13 (CECL model) on January 1, 2023, with no impact on its financial statements[100](index=100&type=chunk) [Recent Accounting Pronouncements](index=18&type=section&id=Recent%20Accounting%20Pronouncements) Discusses the potential impact of recently issued accounting standards on the company's financial reporting - The Company is currently assessing the impact of ASU 2022-03 (Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions), effective for fiscal years beginning after December 15, 2023[101](index=101&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=18&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Artelo Biosciences, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - As a 'smaller reporting company,' the Company is not required to provide quantitative and qualitative disclosures about market risk[102](index=102&type=chunk) [Item 4. Controls and Procedures](index=18&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of the Company's disclosure controls and procedures as of September 30, 2023, reports no material changes in internal control over financial reporting, and acknowledges the inherent limitations of control systems [Disclosure Controls and Procedures](index=18&type=section&id=Disclosure%20Controls%20and%20Procedures) Confirms the effectiveness of the company's disclosure controls and procedures as of September 30, 2023 - The Chief Executive Officer concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level as of September 30, 2023[102](index=102&type=chunk) [Changes in Internal Control Over Financial Reporting](index=18&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) Reports no material changes in internal control over financial reporting during the period - There were no changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting during the period[103](index=103&type=chunk) [Inherent Limitations on the Effectiveness of Controls](index=19&type=section&id=Inherent%20Limitations%20on%20the%20Effectiveness%20of%20Controls) Acknowledges that control systems provide reasonable, not absolute, assurance and are subject to inherent limitations - Control systems are designed to provide reasonable, not absolute, assurance, and are subject to inherent limitations such as faulty judgments, simple errors, circumvention by individuals, or unauthorized overrides[104](index=104&type=chunk) PART II - OTHER INFORMATION Presents additional information not covered in the financial statements, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=19&type=section&id=Item%201.%20Legal%20Proceedings) The Company is not currently a party to any legal proceedings that are expected to have a material adverse effect on its business, financial condition, or results of operations - The Company is not currently involved in any legal proceedings deemed likely to have a material adverse effect on its business, financial condition, and results of operations[105](index=105&type=chunk) [Item 1A. Risk Factors](index=19&type=page&id=Item%201A.%20Risk%20Factors) This section outlines significant risks that could materially and adversely affect the Company's business, financial condition, results of operations, and future growth prospects, categorized into risks related to business and product candidates, intellectual property, and securities [Risk Factor Summary](index=19&type=section&id=Risk%20Factor%20Summary) Provides a high-level overview of the key risks related to the company's business, intellectual property, and securities - Risks Related to our Business and Product Candidates: Need for additional financing, R&D tax credits, patent license compliance, regulatory changes, new company difficulties, no mature product candidates, resource limitations[107](index=107&type=chunk)[108](index=108&type=chunk)[239](index=239&type=chunk)[240](index=240&type=chunk)[241](index=241&type=chunk)[242](index=242&type=chunk)[243](index=243&type=chunk) - Risks Related to our Intellectual Property: Inability to obtain/maintain patent protection, compliance with patent agencies, inventorship claims, limitations of IP rights, litigation[107](index=107&type=chunk)[108](index=108&type=chunk)[239](index=239&type=chunk)[240](index=240&type=chunk)[241](index=241&type=chunk)[242](index=242&type=chunk)[243](index=243&type=chunk) - Risks Related to our Securities: Nasdaq delisting, dilution from future financings, price volatility, Rule 144 restrictions, deemed distribution from warrants, no dividends, public company costs[107](index=107&type=chunk)[108](index=108&type=chunk)[239](index=239&type=chunk)[240](index=240&type=chunk)[241](index=241&type=chunk)[242](index=242&type=chunk)[243](index=243&type=chunk) [Risks Related to our Business and Product Candidates](index=20&type=section&id=Risks%20Related%20to%20our%20Business%20and%20Product%20Candidates) Details significant risks concerning the company's operations, product development, regulatory environment, and financial sustainability - The Company will need to raise substantial additional financing to fund operations and commercialization, with no assurance of availability on favorable terms, potentially leading to delays or termination of development programs[110](index=110&type=chunk)[111](index=111&type=chunk)[114](index=114&type=chunk) - Changes in UK R&D tax credit rules, effective April 2024, may reduce or eliminate credits for activities outside the UK, significantly increasing product development costs[116](index=116&type=chunk)[117](index=117&type=chunk) - Failure to comply with obligations under patent license agreements (e.g., with NEOMED Institute, Stony Brook University) could result in loss of vital license rights, adversely affecting business[119](index=119&type=chunk)[120](index=120&type=chunk) - Clinical trials are lengthy, expensive, and uncertain; results from earlier studies may not predict future outcomes, and unforeseen side effects or regulatory changes could cause delays or termination[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk)[144](index=144&type=chunk) - The Company relies heavily on third parties for preclinical research, clinical trials, and manufacturing, reducing control and posing risks of unsatisfactory performance or delays[150](index=150&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk) - Product candidates containing controlled substances are subject to stringent DEA and international regulations, and failure to comply or obtain necessary licenses could severely impact development and commercialization[173](index=173&type=chunk)[174](index=174&type=chunk)[176](index=176&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk)[180](index=180&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk) [Risks Related to our Intellectual Property](index=36&type=section&id=Risks%20Related%20to%20our%20Intellectual%20Property) Outlines risks associated with obtaining, maintaining, and enforcing the company's intellectual property rights - Inability to obtain and maintain effective patent protection for product candidates could allow competitors to commercialize similar products, adversely affecting the Company's ability to commercialize its own[212](index=212&type=chunk)[213](index=213&type=chunk) - Compliance with various procedural measures, document submissions, and fee payments to government patent agencies is critical; non-compliance could lead to reduced or eliminated patent protection[217](index=217&type=chunk)[218](index=218&type=chunk) - The Company may face claims challenging the inventorship of its patents or other intellectual property, potentially leading to litigation costs, loss of valuable rights, and distraction of management[219](index=219&type=chunk)[220](index=220&type=chunk) - Intellectual property rights have limitations and may not adequately protect the business, as competitors could develop non-infringing alternatives or patents could be challenged, invalidated, or expire[221](index=221&type=chunk) [Risks Related to our Securities](index=38&type=section&id=Risks%20Related%20to%20our%20Securities) Addresses risks related to the company's common stock, including market volatility, dilution, and listing compliance - Failure to maintain compliance with Nasdaq's continued listing requirements could result in delisting, negatively impacting stock price, liquidity, and ability to raise capital[227](index=227&type=chunk)[229](index=229&type=chunk) - Future equity financings, including sales under the Equity Line, may cause immediate dilution to existing stockholders and could lead to a decline in stock price[231](index=231&type=chunk) - The price of the Company's securities may be highly volatile, and an active, liquid, and orderly trading market may not continue, making it difficult for investors to sell shares[232](index=232&type=chunk)[233](index=233&type=chunk) - As a former 'shell company,' shares not registered under federal securities laws are subject to Rule 144 resale restrictions, including a 12-month waiting period and ongoing reporting compliance[234](index=234&type=chunk)[235](index=235&type=chunk) - The Company does not plan to declare or pay any dividends in the near future, and future dividend payments are at the discretion of the Board[239](index=239&type=chunk) - Operating as a public company incurs significant legal, accounting, and compliance costs, diverting management time and potentially impacting financial results[240](index=240&type=chunk)[241](index=241&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The Company reports no unregistered sales of equity securities or use of proceeds during the period - No unregistered sales of equity securities or use of proceeds were reported[252](index=252&type=chunk) [Item 3. Defaults Upon Senior Securities](index=42&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reports no defaults upon senior securities during the period - No defaults upon senior securities were reported[252](index=252&type=chunk) [Item 4. Mine Safety Disclosures](index=42&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company - Mine Safety Disclosures are not applicable to the Company[253](index=253&type=chunk) [Item 5. Other Information](index=42&type=section&id=Item%205.%20Other%20Information) The Company reports no other information for this period - No other information was reported[253](index=253&type=chunk) [Item 6. Exhibits](index=42&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including Articles of Incorporation, Bylaws, and Section 302 and 906 Certifications | Exhibit Number | Description | Filed Herewith | | :------------- | :------------------------------------------------------------------------ | :------------- | | 3.1 | Articles of Incorporation, as amended | | | 3.2 | Amended and Restated Bylaws | | | 31.1 | Section 302 Certification | * | | 32.1 | Section 906 Certification | * | | 101.INS | Inline XBRL Instance Document | | | 104 | Cover page Interactive Data File (embedded with the Inline XBRL document) | | SIGNATURES Confirms the official signing and submission of the report by the authorized executive - The report was signed by Gregory D. Gorgas, President, Chief Executive Officer, Chief Financial Officer, Treasurer and Director, on November 13, 2023[255](index=255&type=chunk) ```

Financial Performance - Total operating expenses for Q2 2023 were $1.784 million, a decrease of 27.8% from $2.471 million in Q2 2022[84]. - General and administrative expenses decreased by $383,000 to $1.032 million in Q2 2023 compared to $1.415 million in Q2 2022[84]. - Research and development expenses decreased by $304,000 to $752,000 in Q2 2023 from $1.056 million in Q2 2022[84]. - Net loss for Q2 2023 was $1.599 million, improved by $850,000 from a net loss of $2.449 million in Q2 2022[84]. - Operating expenses for the six months ended June 30, 2023, were $4.1 million, a decrease of 7.7% from $4.4 million in the same period in 2022[87]. - General and administrative expenses decreased by $808,000 to $2.1 million, while research and development expenses increased by $467,000 to $2.0 million for the six months ended June 30, 2023[86]. - The net loss for the six months ended June 30, 2023, was $3.8 million, an improvement of 14.7% compared to a net loss of $4.4 million in the same period in 2022[89]. - Cash used in operating activities was $3.8 million for the six months ended June 30, 2023, compared to $4.0 million for the same period in 2022, reflecting a decrease of $210,000[96]. - The Company has incurred losses since inception, with a net loss of $3.8 million during the six months ended June 30, 2023, and will need to raise additional funds to continue operations beyond the second half of 2024[91]. - The Company expects to continue incurring significant operating and net losses, with expenses anticipated to increase significantly as it pursues its objectives[203]. Funding and Capital Structure - The company has received approximately $8 million in funding from the National Institutes of Health for the development of FABP5 inhibitors[67]. - The Company filed a $75.0 million shelf registration statement on Form S-3, effective July 14, 2023, to provide flexibility for future capital access[90]. - The Company has an Equity Line with Lincoln Park allowing for the sale of up to $20.0 million in shares of Common Stock, but market conditions may not be favorable for such sales[117]. - The Company may face dilution of ownership if additional capital is raised through equity securities or convertible debt[114]. - If the Company issues additional shares at a discount, stockholders may experience immediate dilution, potentially causing a decline in stock price[226]. Market and Product Development - The ART27.13 program is targeting a market size of over $2 billion for cancer anorexia syndrome[73]. - The ART26.12 program is focused on Chemotherapy Induced Peripheral Neuropathy (CIPN) with a market size exceeding $1 billion[73]. - The ART12.11 CBD cocrystal is expected to have improved stability and bioavailability compared to non-cocrystal CBD compositions[70]. - The Company has two US patents and multiple pending applications related to its CBD cocrystal composition, aiming for long-lasting market exclusivity[71]. - The Company currently lacks a marketing and sales organization, which may hinder its ability to generate product revenue if products are approved[151]. - Establishing internal sales and marketing capabilities would require significant resources and time, and the Company may pursue collaborative arrangements instead[152]. - The Company is highly dependent on the acceptance and proliferation of cannabinoid-derived therapeutic treatments, particularly ART12.11, its CBD cocrystal[185]. - The Company faces a highly competitive market with numerous multinational pharmaceutical companies and specialized biotechnology firms developing similar products[194]. Regulatory and Compliance Risks - The Company faces risks related to compliance with patent licenses, which, if not adhered to, could result in the loss of vital license rights[121]. - Changes in regulatory requirements could impact the timing and costs of clinical trials, potentially harming commercial prospects for product candidates[123]. - The Company must obtain various registrations and permits to conduct clinical trials and handle controlled substances, which could lead to delays if not secured[174]. - The Company is subject to DEA regulations, which require annual renewals of registrations for facilities handling controlled substances, impacting operational timelines[171]. - The Company may face significant delays or inability to conduct clinical trials or product launches due to DEA's procurement and production quota requirements for controlled substances[177]. - The Company must navigate evolving laws and regulations regarding cannabinoid-based products, which could disrupt operations and require substantial compliance costs[190]. Operational Challenges - The Company plans to rely on third-party CROs for preclinical research and clinical trials, which may affect control over these activities[148]. - The Company relies on third-party suppliers for clinical and commercial supplies, which may not always meet required standards or availability, potentially delaying operations[154]. - The Company does not own any manufacturing facilities and is dependent on third-party manufacturers, which poses risks if these suppliers fail to meet demands or quality standards[156]. - The Company may encounter challenges in obtaining insurance coverage for its cannabinoid-related research activities, which could expose it to additional risks[192]. - The Company currently has five employees and will need to rapidly expand its workforce to support growth and operational capabilities[200]. Intellectual Property and Litigation Risks - The Company has one US patent and multiple pending patent applications related to its product candidates, which are crucial for its commercial success[157]. - The patent position is uncertain, and the Company may face challenges in maintaining and enforcing its patent rights, which could impact its competitive advantage[160]. - The Company may face litigation concerning intellectual property, which could incur significant expenses and distract management from normal responsibilities[218][219]. - The patent prosecution process is complex and costly, and the Company may not be able to secure necessary patent rights in a timely manner[210]. - The Company may be subject to claims challenging the inventorship of its patents, which could result in loss of valuable intellectual property rights[215]. Market Conditions and Future Outlook - The Company does not have any therapeutic products approved for commercial sale and does not expect to generate significant revenue for several years[131]. - The Company anticipates fluctuations in financial condition and operating results due to various uncontrollable factors[133]. - The trading price of the Company's securities is likely to be highly volatile, influenced by various factors including limited trading volume[228]. - The Company is subject to increased regulatory scrutiny and compliance costs due to its public company status, impacting operational focus[243]. - Future changes in financial accounting standards may lead to unexpected fluctuations in reported results[237]. - The Company received a notice from Nasdaq for not maintaining a minimum bid price of $1.00 per share for 30 consecutive business days, but has since regained compliance[223].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2023 or ☐ TRANSITION REPORT PERSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-38951 ARTELO BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Nevada (State or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number 001-38951 Artelo Biosciences, Inc. (Exact name of registrant as specified in its charter) | --- | --- | |------ ...