Core Viewpoint - Artelo Biosciences, Inc. has announced the commencement of an underwritten public offering of its common stock and/or pre-funded warrants, aimed at raising capital for its clinical-stage pharmaceutical developments [1] 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 dermatologic issues [1][6] - The company has a diversified pipeline addressing significant unmet medical needs in areas such as anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation [6] - Artelo is also implementing a digital asset treasury strategy, deploying excess capital into Solana [6] Offering Details - The offering is being managed by R.F. Lafferty & Co., Inc. as the sole book-running manager [2] - The shares are being offered under a "shelf" registration statement filed with the U.S. Securities and Exchange Commission (SEC) [2] - A prospectus supplement detailing the terms of the public offering will be filed with the SEC [3] Additional Information - Copies of the prospectus supplement and accompanying prospectus will be available on the SEC's website and from R.F. Lafferty & Co., Inc. [4] - The press release clarifies that it does not constitute an offer to sell or solicit offers to buy any of the securities described [5] - For investor relations, Crescendo Communications, LLC is the contact point [8]

Core Insights - Artelo Biosciences, Inc. is positioned to secure a development partner for ART27.13 based on positive interim results from its Phase 2 CAReS trial for cancer anorexia-cachexia syndrome (CACS) [1][4] - The interim results show significant improvements in weight, lean body mass, and activity in patients treated with ART27.13 [2] - Artelo does not foresee the need for internal funding for a Phase 3 trial, indicating a preference for a licensing transaction to maximize shareholder value [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 and pain [8] - ART27.13 is a novel benzimidazole derivative aimed at improving body weight, appetite, and quality of life in cancer patients, with a strong safety profile demonstrated in previous studies [5] - The company has a diversified pipeline addressing significant unmet medical needs and is also engaging in digital asset treasury strategies [8] Clinical Trial Insights - The CAReS trial is a Phase 1/2 randomized, placebo-controlled study designed to evaluate ART27.13's effectiveness in treating cancer-related anorexia and weight loss [6] - CACS affects up to 80% of advanced cancer patients and represents a market opportunity exceeding $3 billion, with no current FDA-approved treatments available [7]

Core Insights - Artelo Biosciences, Inc. announced interim results from its Phase 2 Cancer Appetite Recovery Study (CAReS) trial for ART27.13, showing significant improvements in weight gain and lean body mass in cancer patients suffering from anorexia-cachexia syndrome (CACS) [2][4][8] - The study demonstrated a mean weight gain of +6.4% at 12 weeks for ART27.13 compared to a mean weight loss of -5.4% in the placebo group, indicating a compelling drug effect [5][7] - ART27.13 was well tolerated, with adverse events primarily mild or moderate, aligning with previous safety findings [6][8] Company Overview - Artelo Biosciences is focused on developing treatments for cancer, pain, and other conditions by modulating lipid-signaling pathways [2][12] - The company is accelerating its licensing strategy based on the strength of the interim data and a recently allowed patent application for its commercial formulation [8][12] - ART27.13 is a novel agent targeting peripheral cannabinoid receptors, with potential benefits in improving appetite, weight, and quality of life for cancer patients [9][11] Clinical Study Details - The CAReS trial is a Phase 1/2 randomized, placebo-controlled study evaluating ART27.13 in patients with cancer-related anorexia and weight loss [10] - The Phase 2 portion aims to assess the drug's effectiveness in increasing lean body mass and improving appetite compared to placebo [10] - Interim analysis included 18 evaluable patients, primarily with lung and gastrointestinal cancers, showing significant weight gain and lean body mass improvements [5][6] Market Context - CACS affects up to 80% of cancer patients, representing a significant unmet medical need with a market potential exceeding $3 billion [11] - Currently, there are no FDA-approved treatments for CACS, highlighting the importance of ART27.13's development [11]

Core Insights - Artelo Biosciences, Inc. has announced positive results from its preliminary food effect evaluation of ART26.12, a selective oral small molecule fatty acid binding protein 5 (FABP5) inhibitor, which is aimed at treating various conditions including cancer and pain [2][5] - The single ascending dose (SAD) Phase 1 clinical trial showed no drug-related adverse events, indicating a favorable safety profile for ART26.12 [3][8] - The company is preparing to initiate a multiple ascending dose (MAD) study to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing [6] Safety and Pharmacokinetics - The food effect study assessed the pharmacokinetics and safety profile of ART26.12 in healthy volunteers under both fed and fasted conditions, confirming that dosing can occur in either state [3][5] - Participants in the SAD study received three single doses of ART26.12 with no serious adverse events reported, and all adverse events were mild and self-limiting [8] - Data indicated consistent exposure levels under fasted conditions, suggesting low inter-subject variability and effective administration with or without food [8] Clinical Development - The results from the SAD and food effect study provide a strong foundation for advancing to the upcoming MAD study, which is planned to commence in the fourth quarter of this year [6][8] - ART26.12 represents a new therapeutic class with a non-opioid, non-steroidal analgesic approach targeting novel mechanisms in pain modulation [7] - The initial clinical development is focused on chemotherapy-induced peripheral neuropathy (CIPN), with potential applications in other conditions such as cancer and anxiety disorders [7] Company Overview - Artelo Biosciences is dedicated to developing therapeutics that modulate lipid-signaling pathways, addressing significant unmet needs in various medical conditions [9] - The company is also leveraging a digital asset treasury strategy to enhance liquidity management and support its therapeutic programs [9]

[Report Overview](index=1&type=section&id=Report%20Overview) This section provides an overview of the company's filing details, status, and key corporate information as of the report date [Filing Information](index=1&type=section&id=Filing%20Information) This is a Quarterly Report on Form 10-Q for Artelo Biosciences, Inc., covering the period ended June 30, 2025 - The report is a **Quarterly Report on Form 10-Q** for the period ended **June 30, 2025**[2](index=2&type=chunk) - Artelo Biosciences, Inc. is incorporated in **Nevada** with Commission File Number **001-38951**[3](index=3&type=chunk) Company Filing Status | Status | Indication | | :---------------------- | :--------- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Smaller reporting company | ☒ | | Emerging growth company | ☐ | | Non-accelerated filer | ☒ | [Company Details](index=1&type=section&id=Company%20Details) Artelo Biosciences, Inc. is headquartered in Solana Beach, CA, with common stock traded on Nasdaq under the symbol ARTL - The company's principal executive offices are located in **Solana Beach, CA**[3](index=3&type=chunk) Securities Registered | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, $0.001 par value per share | ARTL | The Nasdaq Stock Market, LLC | - As of **August 12, 2025**, **1,321,552** shares of common stock were issued and outstanding[6](index=6&type=chunk) [PART I - FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents the company's consolidated financial statements, management's analysis, market risk disclosures, and internal controls [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Artelo Biosciences reported a net loss of **$5.593 million** for the six months ended June 30, 2025, resulting in a **stockholders' deficit of $1.406 million** due to increased liabilities Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Total Assets | $4,357 | $4,698 | | Total Liabilities | $5,763 | $1,841 | | Total Stockholders' (Deficit) Equity | $(1,406) | $2,857 | | Cash and cash equivalents | $2,066 | $2,338 | Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Operating Expenses | $3,150 | $2,512 | $5,529 | $5,101 | | Net Loss | $(3,221) | $(2,433) | $(5,593) | $(4,916) | | Basic and Diluted Loss per Common Share | $(5.61) | $(4.52) | $(9.80) | $(9.17) | Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(2,111) | $(5,005) | | Net cash provided by investing activities | $0 | $3,019 | | Net cash provided by financing activities | $1,816 | $55 | | Cash and cash equivalents - end of period | $2,066 | $881 | [Consolidated Balance Sheets](index=2&type=section&id=Consolidated%20Balance%20Sheets) This section presents the company's consolidated balance sheets as of June 30, 2025, and December 31, 2024 [Consolidated Statements of Operations and Comprehensive Loss](index=3&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's consolidated statements of operations and comprehensive loss for the periods presented [Consolidated Statements of Stockholders' (Deficit) Equity](index=4&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20(Deficit)%20Equity) This section outlines changes in the company's consolidated stockholders' (deficit) equity for the periods presented [Consolidated Statements of Cash Flows](index=4&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This section provides the company's consolidated statements of cash flows for the periods presented [Notes to the Consolidated Financial Statements](index=5&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) This section provides detailed notes explaining the significant accounting policies and financial statement items [NOTE 1 – ORGANIZATION AND DESCRIPTION OF BUSINESS](index=5&type=section&id=NOTE%201%20%E2%80%93%20ORGANIZATION%20AND%20DESCRIPTION%20OF%20BUSINESS) Artelo Biosciences is a clinical-stage biopharmaceutical company focused on lipid-signaling pathways, facing substantial doubt about its going concern ability due to losses and recent financing activities - The Company is a **clinical-stage biopharmaceutical company** focused on developing therapeutics targeting **lipid-signaling pathways** and the **endocannabinoid system (ECS)**[23](index=23&type=chunk) - The Company incurred a net loss of **$5,593 thousand** for the six months ended June 30, 2025, with cash and cash equivalents of **$2,066 thousand**, raising **substantial doubt about its ability to continue as a going concern**[24](index=24&type=chunk)[30](index=30&type=chunk) - Key financing activities include **$900 thousand** in convertible notes issued on **May 1, 2025**, a private placement yielding **$1,079 thousand** net proceeds on **June 24, 2025**, and a subsequent **at-the-market PIPE offering** on **August 4, 2025**, for approximately **$9,475 thousand**, with net proceeds designated for **Solana (SOL) purchases**[26](index=26&type=chunk)[27](index=27&type=chunk)[29](index=29&type=chunk) - A **one-for-six (1-for-6) reverse stock split** was effective on **June 13, 2025**, reducing authorized common stock from **50,000,000** to **8,333,333** shares and outstanding shares from **3,280,000** to approximately **546,667**[32](index=32&type=chunk)[34](index=34&type=chunk) [NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=7&type=section&id=NOTE%202%20-%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) The company prepares its financial statements in accordance with GAAP and SEC regulations, consolidating its wholly-owned subsidiaries and recognizing R&D expenses as incurred - The Company's financial statements adhere to **GAAP and SEC rules**, consolidating wholly-owned subsidiaries including Trinity Reliant Ventures Limited, Artelo Biosciences Limited, and Artelo Biosciences Corporation[35](index=35&type=chunk)[37](index=37&type=chunk) - Research and development expenses are recognized as incurred, with **$704 thousand** in **UK R&D tax credits** received during the six months ended **June 30, 2025**[38](index=38&type=chunk)[39](index=39&type=chunk) Cash and Cash Equivalents (in thousands) | Date | Amount | | :---------------- | :----- | | June 30, 2025 | $2,066 | | December 31, 2024 | $2,338 | - The company operates as a **single life science segment**, and **1,028,720 common stock equivalents** were excluded from diluted net loss per share computation for the six months ended June 30, 2025, as they were **anti-dilutive**[55](index=55&type=chunk)[56](index=56&type=chunk)[58](index=58&type=chunk) [NOTE 3 – SEGMENT REPORTING](index=9&type=section&id=NOTE%203%20%E2%80%93%20SEGMENT%20REPORTING) Artelo Biosciences operates as a single life science segment, has not generated revenue since inception, and expects continued losses, with increased general and administrative and R&D expenses - The Company operates as a **single life science segment**, focused on developing therapeutics targeting **lipid-signaling modulation pathways**[58](index=58&type=chunk) - The Company has generated **no revenue since inception** and anticipates **continued losses** into the foreseeable future[60](index=60&type=chunk) Operating Expenses (in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------- | :----------------------------- | :----------------------------- | | General and administrative | $2,274 | $1,909 | | Research and development | $3,255 | $3,192 | - The increase in general and administrative expenses for the six months ended June 30, 2025, was primarily due to higher **professional fees associated with capital raising efforts**[62](index=62&type=chunk) [NOTE 4 – RELATED PARTY TRANSACTIONS](index=10&type=section&id=NOTE%204%20%E2%80%93%20RELATED%20PARTY%20TRANSACTIONS) The company engaged in various related party transactions, including consulting and professional services from entities owned or influenced by its Senior Vice President and subsidiary directors - A company owned by the Senior Vice President, European Operations, provided consulting services totaling **$11 thousand** during the six months ended June 30, 2025[64](index=64&type=chunk) - Professional services totaling **$55 thousand** and **$38 thousand** were provided by companies influenced or controlled by subsidiary directors during the six months ended June 30, 2025[65](index=65&type=chunk)[66](index=66&type=chunk) Outstanding Related Party Balances (in thousands) | Related Party | June 30, 2025 | December 31, 2024 | | :------------------------------------------------ | :------------ | :---------------- | | Company owned by SVP, European Operations | $1 | $1 | | Company influenced by subsidiary director | $19 | $36 | | Company controlled by subsidiary director | $6 | $24 | | **Total Due to related parties (Balance Sheet)** | **$26** | **$61** | [NOTE 5 – CONVERTIBLE NOTES](index=11&type=section&id=NOTE%205%20%E2%80%93%20CONVERTIBLE%20NOTES) In May 2025, Artelo Biosciences issued **$900 thousand** in convertible notes with a **12% annual interest rate** and a **180-day maturity**, convertible into common stock or warrants - Between **April 27, 2025, and May 1, 2025**, the Company issued convertible notes with an aggregate principal amount of **$900 thousand**[67](index=67&type=chunk) - The notes accrue interest at **12% per annum** (20% upon default), mature in **180 days**, and are convertible into common stock at **$7.74 per share** or warrants at **$6.24 per share**[68](index=68&type=chunk)[69](index=69&type=chunk) Convertible Notes Summary (in thousands) | Metric | Amount | | :--------------------------------- | :----- | | Aggregate Principal Amount Issued | $900 | | Net Carrying Value (June 30, 2025) | $791 | | Interest Expense (H1 2025) | $72 | [NOTE 6 - EQUITY](index=11&type=section&id=NOTE%206%20-%20EQUITY) As of June 30, 2025, Artelo Biosciences had **704,425 common shares outstanding**, with a private placement generating **$1.079 million** net proceeds from stock and warrant issuances Common Stock and Preferred Stock (as of June 30, 2025) | Stock Type | Authorized Shares | Issued and Outstanding Shares | | :---------------- | :---------------- | :---------------------------- | | Preferred Stock | 69,445 | 0 | | Common Stock | 8,333,333 | 704,425 | - A private placement on **June 26, 2025**, issued **136,843 common shares**, **93,180 pre-funded warrants**, and **690,069 other warrants**, generating **$1,079 thousand** in net proceeds[74](index=74&type=chunk)[75](index=75&type=chunk) Warrants and Stock Options (as of June 30, 2025) | Instrument | Number Outstanding | Weighted Average Exercise Price | Intrinsic Value (in thousands) | | :---------------- | :----------------- | :------------------------------ | :----------------------------- | | Warrants | 806,564 | $8.12 | $5,416 | | Stock Options | 128,976 | $11.02 | $526 | [NOTE 7– INTANGIBLE ASSET](index=12&type=section&id=NOTE%207%E2%80%93%20INTANGIBLE%20ASSET) Artelo Biosciences capitalized **$2.039 million** for the exclusive worldwide license to develop and commercialize ART27.13, with no additional capitalization costs incurred during the period - The Company capitalized **$2,039 thousand** for the exclusive worldwide license to develop and commercialize products containing **ART27.13** as an intangible asset[81](index=81&type=chunk) - No additional costs were capitalized as an intangible asset during the six months ended **June 30, 2025**[82](index=82&type=chunk) [NOTE 8 - LEASE](index=12&type=section&id=NOTE%208%20-%20LEASE) The company's U.S. office lease was extended until August 2027, with operating lease costs of **$17 thousand** and total liabilities of **$88 thousand** as of June 30, 2025 - The U.S. office lease was extended until **August 2027** via an amendment on **March 6, 2024**[84](index=84&type=chunk) Operating Lease Information (as of June 30, 2025, in thousands) | Metric | Amount/Value | | :------------------------------------------ | :----------- | | Operating lease cost (six months ended) | $17 | | Weighted-average remaining lease term (year) | 2.08 | | Weighted-average discount rate | 7.50% | | Total Operating lease liabilities | $88 | | Operating lease liability - current | $38 | | Operating lease liability - non-current | $50 | [NOTE 9 – COMMITMENTS AND CONTINGENCIES](index=13&type=section&id=NOTE%209%20%E2%80%93%20COMMITMENTS%20AND%20CONTINGENCIES) Artelo Biosciences has financial commitments for R&D contracts and office leases, with **$250 thousand** from recent financing committed to purchasing SOL - The Company has financial commitments for **research and development contracts**, including monthly/quarterly invoices and potential milestone payments[86](index=86&type=chunk)[87](index=87&type=chunk) - The principal executive office lease in **Solana Beach, CA**, extends through **August 2027**, while a **Manchester, UK**, office operates on a month-to-month lease[87](index=87&type=chunk) - **$250 thousand** from the **June 26, 2025**, financing proceeds is committed to purchasing **SOL**[87](index=87&type=chunk) [NOTE 10 – SUBSEQUENT EVENTS](index=13&type=section&id=NOTE%2010%20%E2%80%93%20SUBSEQUENT%20EVENTS) Subsequent to the reporting period, on August 4, 2025, Artelo Biosciences entered an at-the-market PIPE offering for approximately **$9.475 million**, with net proceeds designated for SOL purchases - On **August 4, 2025**, the Company entered an **at-the-market PIPE** agreement for expected gross proceeds of approximately **$9,475 thousand**[86](index=86&type=chunk) - The net proceeds from this PIPE offering are designated for **SOL purchases**[86](index=86&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company, a clinical-stage biopharmaceutical firm, faces significant operating losses and negative cash flows, adopting a new Digital Asset Treasury strategy while developing its product pipeline - Artelo Biosciences is a **clinical-stage biopharmaceutical company** focused on therapeutics targeting **lipid-signaling modulation pathways**, including the **endocannabinoid system (ECS)**[96](index=96&type=chunk) - The company's pipeline includes **ART27.13** (Phase 1b/2a), **ART26.12** (Phase 1), and **ART12.11** (patented CBD cocrystal) for various therapeutic indications[97](index=97&type=chunk)[98](index=98&type=chunk)[99](index=99&type=chunk) - The company adopted a **Digital Asset Treasury (DAT) strategy** to purchase **Solana (SOL)** using recent financing proceeds, with **$250 thousand** already expended and further PIPE proceeds designated for SOL[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - Artelo Biosciences has incurred **significant operating losses** and **negative cash flows** since inception, with a net loss of **$5.6 million** for the six months ended June 30, 2025, raising **substantial doubt about its ability to continue as a going concern**[104](index=104&type=chunk)[137](index=137&type=chunk)[143](index=143&type=chunk) [General Overview](index=15&type=section&id=General%20Overview) This section provides a general overview of Artelo Biosciences' business, strategic focus, and financial performance [Recent Developments](index=16&type=section&id=Recent%20Developments) This section outlines recent key developments impacting the company's operations and financial position [Digital Asset Treasury Strategy — Solana (SOL)](index=17&type=section&id=Digital%20Asset%20Treasury%20Strategy%20%E2%80%94%20Solana%20(SOL)) This section details the company's new strategy to invest in Solana (SOL) as part of its treasury management [Governance and Controls](index=18&type=section&id=Governance%20and%20Controls) This section discusses the company's governance structure and internal control environment [Key Trends and Factors Affecting Comparability Between Periods](index=19&type=section&id=Key%20Trends%20and%20Factors%20Affecting%20Comparability%20Between%20Periods) This section identifies significant trends and factors influencing the comparability of financial results across reporting periods [Components of Our Results of Operations](index=19&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section breaks down the key components contributing to the company's financial results [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) This section analyzes the company's ability to meet its short-term and long-term financial obligations and funding sources [Contractual Obligations and Commitments](index=23&type=section&id=Contractual%20Obligations%20and%20Commitments) This section details the company's significant contractual obligations and financial commitments [Off-Balance Sheet Arrangements](index=23&type=section&id=Off-Balance%20Sheet%20Arrangements) This section describes any off-balance sheet arrangements that could impact the company's financial condition [Critical Accounting Policies and Estimates](index=23&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section outlines the critical accounting policies and estimates that require significant management judgment [New Accounting Standard Adopted](index=24&type=section&id=New%20Accounting%20Standard%20Adopted) This section discusses any new accounting standards adopted by the company and their impact [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Artelo Biosciences, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a **'smaller reporting company,'** Artelo Biosciences, Inc. is **not required** to provide quantitative and qualitative disclosures about market risk[169](index=169&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO, concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Management, with CEO participation, concluded that **disclosure controls and procedures were effective** at a reasonable assurance level as of **June 30, 2025**[170](index=170&type=chunk)[171](index=171&type=chunk) - No material changes in **internal control over financial reporting** occurred during the period[172](index=172&type=chunk) - The company acknowledges that control systems provide **reasonable, but not absolute, assurance** due to inherent limitations[173](index=173&type=chunk) [PART II - OTHER INFORMATION](index=25&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, and other required disclosures [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) Artelo Biosciences is not currently a party to any legal proceedings that management believes would have a material adverse effect on its business, though litigation can incur costs and divert resources - The Company is **not currently a party to any legal proceedings** likely to have a material adverse effect on its business or financial condition[175](index=175&type=chunk) - Litigation, regardless of outcome, can adversely impact the company through **defense and settlement costs** and **diversion of management resources**[175](index=175&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including going concern doubts, high volatility from its Digital Asset Treasury strategy, and uncertainties in clinical development and intellectual property protection - The company's financial condition raises **substantial doubt about its ability to continue as a going concern**, requiring additional financing[178](index=178&type=chunk)[185](index=185&type=chunk)[187](index=187&type=chunk) - The **Digital Asset Treasury (DAT) strategy** involving **Solana (SOL)** introduces significant risks due to **high volatility**, **regulatory uncertainty**, and potential **resource diversion**[180](index=180&type=chunk)[184](index=184&type=chunk)[299](index=299&type=chunk)[303](index=303&type=chunk)[311](index=311&type=chunk) - Clinical drug development is **lengthy, expensive, and uncertain**, facing risks from adverse side effects, unpredictable trial outcomes, and regulatory or supply chain delays[217](index=217&type=chunk)[218](index=218&type=chunk)[227](index=227&type=chunk)[233](index=233&type=chunk) - Intellectual property protection is crucial but uncertain, facing challenges from **patent law changes**, **compliance requirements**, and potential **litigation**[182](index=182&type=chunk)[353](index=353&type=chunk)[357](index=357&type=chunk)[358](index=358&type=chunk)[361](index=361&type=chunk) [Risk Factor Summary](index=25&type=section&id=Risk%20Factor%20Summary) This section provides a concise summary of the primary risks facing Artelo Biosciences [Risks Related to our Business and Product Candidates](index=27&type=section&id=Risks%20Related%20to%20our%20Business%20and%20Product%20Candidates) This section details risks associated with the company's core biopharmaceutical business and product development pipeline [Risk Factors Related to our DAT Strategy](index=45&type=section&id=Risk%20Factors%20Related%20to%20our%20DAT%20Strategy) This section outlines specific risks arising from the company's Digital Asset Treasury (DAT) strategy, particularly concerning Solana (SOL) [Risks Related to our Intellectual Property](index=52&type=section&id=Risks%20Related%20to%20our%20Intellectual%20Property) This section addresses risks concerning the protection, enforcement, and potential infringement of the company's intellectual property [Risks Related to our Securities](index=54&type=section&id=Risks%20Related%20to%20our%20Securities) This section covers risks pertinent to the company's common stock and other securities [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=60&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities by Artelo Biosciences during the second quarter of 2025 that had not been previously reported - No sales of unregistered securities occurred during the **second quarter of 2025** that were not previously reported in Form 10-Q and Form 8-K filings[402](index=402&type=chunk) [Item 3. Defaults Upon Senior Securities](index=60&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Artelo Biosciences reported no defaults upon senior securities during the period - There were **no defaults upon senior securities**[403](index=403&type=chunk) [Item 4. Mine Safety Disclosures](index=60&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine Safety Disclosures are not applicable to Artelo Biosciences, Inc - **Mine Safety Disclosures are not applicable** to the Company[404](index=404&type=chunk) [Item 5. Other Information](index=60&type=section&id=Item%205.%20Other%20Information) During the last fiscal quarter, none of Artelo Biosciences' directors or executive officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - During the last fiscal quarter, no directors or officers adopted or terminated any **Rule 10b5-1** or **non-Rule 10b5-1 trading arrangements**[405](index=405&type=chunk) [Item 6. Exhibits](index=60&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including organizational documents, various agreements related to recent financings, and certifications - Exhibits include **Articles of Incorporation**, **Bylaws**, and agreements for **At-The-Market Offering**, **Securities Purchase Agreement**, **Subscription Agreement**, and various **warrants and convertible notes**[407](index=407&type=chunk) - **Section 302** and **Section 906 Certifications** are included as exhibits[407](index=407&type=chunk) [SIGNATURES](index=61&type=section&id=SIGNATURES) The report is duly signed on behalf of Artelo Biosciences, Inc. by Gregory D. Gorgas, who serves as President, Chief Executive Officer, Chief Financial Officer, Treasurer, and Director - The report is signed by **Gregory D. Gorgas**, serving as President, CEO, CFO, Treasurer, and Director[410](index=410&type=chunk)

Business Highlights: ART26.12 –Advancing Toward Multi-dose Phase 1 Safety Study Multiple Announcements of Clinical Data Results Anticipated in Q3 2025 SOLANA BEACH, Calif., Aug. 13, 2025 (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, or neurological conditions, today provided a business update and announced its financial and operational ...

Core Insights - Artelo Biosciences, Inc. has received a Notice of Allowance from the European Patent Office for its patent application covering ART27.13, a cannabinoid agonist aimed at treating cancer-related anorexia, which is currently in Phase 2 clinical trials [2][3][4] - The patent protection for ART27.13 is expected to extend through December 2041, enhancing its commercial potential and long-term value creation for the company [3][4] - ART27.13 has shown promising results in early trials, with over 60% of participants in the Phase 1 study experiencing stabilization or reversal of weight loss [4][5] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for various conditions, including cancer and anorexia [7] - The company is advancing ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss, addressing a significant unmet medical need [5][6] - Artelo has adopted a digital asset treasury strategy, designating Solana as a core reserve asset to enhance liquidity management and diversify its balance sheet [8]

Core Insights - Artelo Biosciences, Inc. has entered into a securities purchase agreement for a PIPE, raising approximately $9.475 million through the sale of 906,687 shares of common stock and associated warrants [1][5] - The company plans to utilize the proceeds to launch a Solana-centric digital asset treasury strategy, marking it as the first publicly traded pharmaceutical company to adopt Solana's native cryptocurrency, SOL, as a reserve asset [2][13] - Bartosz Lipiński, a key figure in the Solana ecosystem, will serve as a technical partner for Artelo's treasury initiative, emphasizing the strategic importance of this move for the company's growth [3][4] Financial Strategy - The funds raised will support Artelo's ongoing business and its innovative treasury initiative, which aims to diversify its balance sheet and enhance liquidity management [2][5] - The treasury strategy is designed to preserve working capital for the continued development of Artelo's proprietary therapeutics while providing exposure to a next-generation monetary network [13] Market Positioning - Artelo's adoption of SOL positions the company at the intersection of biotechnology and decentralized finance, showcasing its commitment to forward-thinking financial management [2][4] - The integration of SOL into Artelo's treasury strategy is expected to enhance shareholder value and demonstrate leadership in the evolving capital landscape of the biotech sector [5][13] Solana Overview - Solana, launched in 2020, is recognized for its high-performance blockchain capabilities, processing over 35.99 million daily transactions and boasting a Total Value Locked (TVL) of $89.417 billion, surpassing Ethereum [11][10] - The network's scalability and decentralized infrastructure are highlighted as key advantages, making it a cornerstone of the future financial ecosystem [4][10]

Core Insights - Artelo Biosciences has received positive feedback from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) regarding the development of ART12.11, a novel cocrystal of Cannabidiol (CBD) and Tetramethylpyrazine (TMP) [1][2][4] - The MHRA has indicated that ART12.11 may qualify for the Innovative Licensing and Access Pathway (ILAP), which could accelerate its development and patient access [3][4] Regulatory Feedback - The MHRA supports a streamlined clinical trial application based on existing nonclinical and clinical evidence for CBD and TMP, providing a clear path for the first-in-human (FIH) study design [2] - The proposed FIH study design is a single-dose, multi-formulation crossover study, deemed methodologically sound for characterizing ART12.11's pharmacokinetic profile [2] Development Strategy - The company plans to evaluate a formal application for ART12.11 to enter the ILAP, aligning with the program's criteria to address unmet needs in anxiety and depression [3] - The regulatory assurance from the MHRA is expected to reduce expenses for the ART12.11 program and potentially extend market exclusivity until the end of 2038 due to existing patents [5] Product Profile - ART12.11 is a proprietary cocrystal composition that has shown improved pharmacokinetics and efficacy compared to other forms of CBD in nonclinical studies [6] - The cocrystal has demonstrated efficacy comparable to sertraline (Zoloft) in preclinical depression models and superior cognitive restoration compared to leading SSRIs [4] Company Overview - Artelo Biosciences is focused on developing therapeutics that modulate lipid-signaling pathways to address significant unmet medical needs across various conditions, including cancer, anxiety, and pain [8]

Core Viewpoint - Artelo Biosciences has received positive feedback from the UK's MHRA regarding its clinical study plans for ART12.11, a novel cocrystal of Cannabidiol (CBD) and Tetramethylpyrazine (TMP), which may accelerate its development and market access [1][2][3][4]. Group 1: Regulatory Feedback - The MHRA has agreed that existing nonclinical and clinical evidence for CBD and TMP supports a streamlined clinical trial application for ART12.11 [2]. - The agency confirmed that the proposed first-in-human study design is methodologically sound for characterizing ART12.11's pharmacokinetic profile [2]. - Specific guidance was provided by the MHRA for completing the data package for the Phase 1 trial [2]. Group 2: Innovative Licensing and Access Pathway (ILAP) - ART12.11 may qualify for the ILAP, which aims to accelerate the development and patient access of new therapies through collaboration with regulatory and health bodies [3]. - Artelo plans to evaluate a formal application for ILAP in the coming months, aligning with the program's criteria due to ART12.11's potential to address unmet needs in anxiety and depression [3]. Group 3: Clinical Efficacy and Comparison - Nonclinical studies have shown ART12.11's promising profile compared to traditional antidepressants and CBD alone [4]. - In a depression model, ART12.11 demonstrated efficacy comparable to sertraline (Zoloft) and superior cognitive restoration [4]. - In a rodent model of stress-induced anxiety and depression, ART12.11 outperformed CBD alone, even at a higher dosage of CBD [4]. Group 4: Financial and Market Implications - The regulatory assurance from the MHRA is expected to reduce expenses for the ART12.11 program [5]. - An accelerated development strategy could lead to a longer period of market exclusivity, with patents valid in 20 countries until the end of 2038 [5]. - Artelo aims to finalize preparations to initiate clinical studies for ART12.11 early next year [5]. Group 5: Product Overview - ART12.11 is a proprietary cocrystal composition of CBD and TMP, exhibiting better pharmacokinetics and improved efficacy compared to other CBD forms [6]. - Enhanced pharmaceutical properties of ART12.11 may lead to increased safety and efficacy in humans, making it a preferred CBD pharmaceutical composition [6]. - The U.S. patent for ART12.11 is enforceable until December 10, 2038, with additional patents granted in 19 countries [6].