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Artelo Biosciences Receives Notice of Allowance from European Patent Office for the Patent Claims for the Intended Commercial Formulation of ART27.13
Globenewswire· 2025-08-11 13:15
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]
Artelo Biosciences Announces $9.475 Million At-the-Market Private Placement to Initiate Solana Treasury Strategy, Becoming First Publicly-Traded Pharmaceutical Company to Adopt SOL as a Core Reserve Asset
Globenewswire· 2025-08-04 11:30
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]
Artelo Biosciences Receives Favorable UK MHRA Guidance for a Phase 1 Trial of ART12.11, the Company’s Proprietary CBD:TMP Cocrystal Being Developed for the Treatment of Anxiety and Depression
Globenewswire· 2025-08-01 11:45
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]
Artelo Biosciences Receives Favorable UK MHRA Guidance for a Phase 1 Trial of ART12.11, the Company's Proprietary CBD:TMP Cocrystal Being Developed for the Treatment of Anxiety and Depression
GlobeNewswire News Room· 2025-08-01 11:45
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].
Artelo Biosciences(ARTL) - 2025 Q2 - Quarterly Results
2025-07-11 20:36
Report of Independent Registered Public Accounting Firm [Opinion on the Financial Statements](index=1&type=section&id=Opinion%20on%20the%20Financial%20Statements) The independent auditor issued an unqualified opinion on the financial statements, but noted a 'Going Concern' issue due to recurring losses and net capital deficiency - The auditor provided an unqualified opinion, stating the financial statements are fairly presented[4](index=4&type=chunk) - A 'Going Concern' issue was raised due to the Company's recurring losses from operations and net capital deficiency, creating substantial doubt about its ability to continue[5](index=5&type=chunk) - The auditor determined that there were no critical audit matters arising from the current period audit[10](index=10&type=chunk) Consolidated Financial Statements [Consolidated Balance Sheets](index=2&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2024, Artelo's total assets decreased dramatically to **$4.7 million** from **$13.0 million** in 2023, primarily due to the depletion of cash and marketable securities. Total liabilities saw a modest increase to **$1.8 million**. Consequently, total stockholders' equity plummeted from **$11.8 million** to **$2.9 million**, reflecting the significant net loss incurred during the year Consolidated Balance Sheets (in thousands) | Account | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,338 | $2,815 | | Trading marketable securities | $0 | $7,611 | | Total Current Assets | $2,557 | $10,980 | | **Total Assets** | **$4,698** | **$13,043** | | **Liabilities & Equity** | | | | Total Current Liabilities | $1,772 | $1,291 | | **Total Liabilities** | **$1,841** | **$1,291** | | **Total Stockholders' Equity** | **$2,857** | **$11,752** | | **Total Liabilities and Stockholders' Equity** | **$4,698** | **$13,043** | [Consolidated Statements of Operations and Comprehensive Loss](index=3&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the year ended December 31, 2024, the company reported a net loss of **$9.8 million**, widening from a **$9.3 million** loss in 2023. The increased loss was primarily due to higher research and development expenses, which grew to **$6.0 million**. The company generated no revenue from operations Consolidated Statements of Operations (in thousands) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | General and administrative | $4,115 | $4,234 | | Research and development | $5,993 | $5,696 | | **Total Operating Expenses** | **$10,108** | **$9,930** | | Loss from Operations | ($10,108) | ($9,930) | | **Net Loss** | **($9,826)** | **($9,289)** | | Basic and Diluted Loss per Common Share | ($18.30) | ($18.80) | [Consolidated Statements of Stockholders' Equity](index=3&type=section&id=Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity declined significantly from **$11.8 million** at the end of 2023 to **$2.9 million** by the end of 2024. This **$8.9 million** decrease was driven by the **$9.8 million** net loss for the period, which was partially offset by **$0.8 million** in stock-based compensation and **$0.1 million** from the issuance of common shares Changes in Stockholders' Equity for the year ended Dec 31, 2024 (in thousands) | Description | Amount | | :--- | :--- | | Balance, December 31, 2023 | $11,752 | | Issuance of common shares | $112 | | Stock based compensation | $818 | | Net loss for the period | ($9,826) | | Other comprehensive income | $1 | | **Balance, December 31, 2024** | **$2,857** | [Consolidated Statements of Cash Flows](index=4&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) The company's cash and cash equivalents decreased by **$0.5 million** in 2024, ending the year at **$2.3 million**. A significant cash outflow of **$8.4 million** from operating activities was largely offset by a **$7.8 million** inflow from investing activities, primarily from the sale of marketable securities. Financing activities provided a small inflow of **$0.1 million** Consolidated Statements of Cash Flows (in thousands) | Category | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($8,350) | ($8,207) | | Net cash provided by investing activities | $7,769 | $3,507 | | Net cash provided by financing activities | $112 | $567 | | **Net change in cash and cash equivalents** | **($477)** | **($4,073)** | | Cash and cash equivalents - end of period | $2,338 | $2,815 | Notes to the Consolidated Financial Statements [NOTE 1 – ORGANIZATION AND DESCRIPTION OF BUSINESS](index=4&type=section&id=NOTE%201%20%E2%80%93%20ORGANIZATION%20AND%20DESCRIPTION%20OF%20BUSINESS) Artelo Biosciences is a clinical-stage biopharmaceutical company developing therapeutics targeting lipid-signaling pathways. The note highlights a significant 'going concern' risk due to a history of losses, with a net loss of **$9.8 million** in 2024, and outlines management's funding plans - The company is a clinical-stage biopharmaceutical firm focused on developing therapeutics that modulate the endocannabinoid system (ECS)[25](index=25&type=chunk) - The company's history of losses and need for additional funding raise substantial doubt about its ability to continue as a going concern[28](index=28&type=chunk) - To fund operations, the company has a **$20 million** equity line agreement and a **$75 million** shelf registration statement on Form S-3[26](index=26&type=chunk)[27](index=27&type=chunk) [NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=5&type=section&id=NOTE%202%20-%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note details the company's accounting policies, including R&D tax credit recognition, the absence of marketable securities in 2024, and the exclusion of anti-dilutive securities from EPS calculations - R&D tax credits from the UK government are recognized as an offset to R&D expenses, totaling **$1,349 thousand** in 2024 and **$1,206 thousand** in 2023[33](index=33&type=chunk) - The balance of trading marketable securities decreased from **$7,611 thousand** at the end of 2023 to **$0** at the end of 2024[36](index=36&type=chunk) Anti-Dilutive Common Stock Equivalents Excluded from EPS | Security Type | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Stock options | 128,976 | 86,549 | | Warrants | 23,315 | 40,442 | | **Total** | **152,291** | **126,991** | [NOTE 3 – SEGMENT REPORTING](index=8&type=section&id=NOTE%203%20%E2%80%93%20SEGMENT%20REPORTING) The company operates as a single 'life science' segment, with performance evaluated by the CEO based on consolidated net loss and cash forecasts, and provides a breakdown of operating expenses - The Company operates as a single reporting segment: life science[53](index=53&type=chunk) Breakdown of Operating Expenses (in thousands) | Expense Category | 2024 | 2023 | | :--- | :--- | :--- | | **General and administrative** | | | | Employee and director compensation | $1,173 | $1,091 | | Professional fees | $1,133 | $1,101 | | **Total G&A** | **$4,115** | **$4,234** | | **Research and development** | | | | Professional fees | $5,169 | $4,531 | | R&D tax credits | ($1,349) | ($1,206) | | **Total R&D** | **$5,993** | **$5,696** | [NOTE 4 – RELATED PARTY TRANSACTIONS](index=9&type=section&id=NOTE%204%20%E2%80%93%20RELATED%20PARTY%20TRANSACTIONS) The company engaged in transactions with related parties, including entities owned or influenced by its Senior VP of European Operations and subsidiary directors, primarily for consulting and professional services - A company owned by the Senior VP, European Operations, provided consulting services totaling **$9 thousand** in 2024 and **$12 thousand** in 2023[59](index=59&type=chunk) - A company influenced by a subsidiary director provided professional services totaling **$100 thousand** in 2024 and **$135 thousand** in 2023[60](index=60&type=chunk) - A company controlled by a subsidiary director provided professional services totaling **$78 thousand** in 2024 and **$77 thousand** in 2023[61](index=61&type=chunk) [NOTE 5 - EQUITY](index=9&type=section&id=NOTE%205%20-%20EQUITY) This note details the company's equity activities, including the issuance of shares under its Equity Line, changes in outstanding warrants, and the granting and repricing of stock options in 2024 - In 2024, the Company issued **15,348** shares of Common Stock for aggregate proceeds of **$112 thousand** under its Equity Line agreement[65](index=65&type=chunk) Warrant Activity | Metric | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Outstanding Warrants | 23,315 | 40,442 | | Average Exercise Price | $67.50 | $294.29 | Stock Option Activity | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Options Granted | 42,427 | 34,344 | | Outstanding Options (End of Period) | 128,976 | 86,549 | - In February 2024, **81,372** options were repriced to **$9.30**, which was treated as a modification resulting in **$210 thousand** in additional compensation expense to be amortized[79](index=79&type=chunk) [NOTE 6 – INCOME TAXES](index=12&type=section&id=NOTE%206%20%E2%80%93%20INCOME%20TAXES) Artelo has not provided for income taxes due to its history of net operating losses, accumulating a **$27.4 million** NOL carryforward, against which a full valuation allowance has been established - The company has an aggregate net operating loss carryforward of **$27,433 thousand**, which will begin to expire in 2034[83](index=83&type=chunk) Net Deferred Tax Assets (in thousands) | Component | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Net operating loss carryover | $5,678 | $5,135 | | Valuation allowance | ($5,678) | ($5,135) | | **Net deferred tax asset** | **$0** | **$0** | [NOTE 7– INTANGIBLE ASSET](index=12&type=section&id=NOTE%207%E2%80%93%20INTANGIBLE%20ASSET) The company holds an intangible asset valued at **$2.039 million** for the exclusive license to develop ART27.13, with no impairment recorded for 2024 or 2023 - The company has a capitalized intangible asset of **$2,039 thousand** for the exclusive license to develop and commercialize the compound ART27.13[85](index=85&type=chunk) - No impairment of the intangible asset was recorded at December 31, 2024, and 2023[38](index=38&type=chunk) [NOTE 8 - LEASE](index=12&type=section&id=NOTE%208%20-%20LEASE) This note details the company's operating leases for office space, including the extension of the U.S. lease through August 2027, resulting in total future minimum lease payments of **$115 thousand** - In March 2024, the company amended its U.S. office lease, extending the term to August 2027[87](index=87&type=chunk) Future Minimum Lease Payments (in thousands) | Year Ended Dec 31, | Total | | :--- | :--- | | 2025 | $42 | | 2026 | $43 | | 2027 | $30 | | **Total** | **$115** | [NOTE 9 – COMMITMENTS AND CONTINGENCIES](index=13&type=section&id=NOTE%209%20%E2%80%93%20COMMITMENTS%20AND%20CONTINGENCIES) The company has financial commitments for R&D contracts contingent on milestones and operates without owned properties, laboratories, or manufacturing facilities, relying on leased office spaces - The Company has financial commitments for R&D contracts where payments are dependent on the progress and milestones achieved[96](index=96&type=chunk) - The company does not own any properties, laboratories, or manufacturing facilities and leases its executive office in California and an administrative office in the UK[96](index=96&type=chunk) [NOTE 10 – SUBSEQUENT EVENTS](index=13&type=section&id=NOTE%2010%20%E2%80%93%20SUBSEQUENT%20EVENTS) Following year-end, Artelo engaged in significant corporate and financing activities in 2025, including issuing **$900 thousand** in convertible notes, a 6:1 reverse stock split, a private placement, and granting stock options - On May 1, 2025, the Company issued at-market, unsecured convertible notes with gross proceeds of **$900 thousand**[92](index=92&type=chunk) - On June 13, 2025, the Company executed a **6:1** reverse stock split[93](index=93&type=chunk) - On June 26, 2025, the company closed a private placement for shares, pre-funded warrants, and common warrants[94](index=94&type=chunk) - In July 2025, the company granted options to purchase an aggregate of **98,866** shares to its CEO, employees, and consultants[95](index=95&type=chunk)[97](index=97&type=chunk)
Artelo Biosciences Announces Positive Preclinical Efficacy Data for ART26.12 in Osteoarthritis Pain at the 35th Annual International Cannabinoid Research Society Symposium
Globenewswire· 2025-07-09 11:50
Core Insights - Artelo Biosciences, Inc. presented preclinical data on its lead fatty acid binding protein 5 (FABP5) inhibitor, ART26.12, at the 35th Annual International Cannabinoid Research Society Symposium, demonstrating its potential to alleviate osteoarthritis (OA) pain [1][2][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, pain, and neurological disorders [7] - The company is advancing a portfolio of product candidates aimed at addressing significant unmet medical needs across multiple diseases [7] Product Development - ART26.12 is a first-in-class, non-opioid, non-steroidal analgesic drug candidate that has shown significant efficacy in alleviating OA pain in preclinical models [2][3] - The drug demonstrated comparable efficacy to naproxen, a commonly prescribed NSAID, without developing tolerance over a four-week chronic dosing period [3][5] - ART26.12's administration led to increased plasma levels of endocannabinoids 2-Arachidonoylglycerol (2-AG) and Oleoylethanolamide (OEA), which were positively correlated with pain relief [3] Safety Profile - ART26.12 may offer a safer alternative to NSAIDs, which are associated with gastrointestinal side effects in about one-third of patients and a five-fold increase in gastric ulcer complications [4] - The distinct pharmacological profile of ART26.12 suggests it could provide ongoing pain relief without the adverse effects commonly seen with NSAIDs [4][5] Research Collaboration - The research on ART26.12 was conducted in collaboration with Stony Brook University, highlighting the company's commitment to translational research [3][5] Market Context - Osteoarthritis affects approximately 606.9 million people globally, with over 32 million in the U.S., indicating a significant market opportunity for effective pain management solutions [9]
Artelo Biosciences Analyst See It As An Emerging Biotech
Benzinga· 2025-07-08 19:06
Core Viewpoint - Artelo Biosciences, Inc. has been upgraded from Hold to Buy by D. Boral Capital, with a price target of $20, highlighting its focus on Cachexia and chemotherapy-induced peripheral neuropathy (CIN) [1] Group 1: Drug Development and Pipeline - ART27.13, a Phase 2 asset, is a selective benzimadazole agonist acquired from AstraZeneca, showing potential to stimulate appetite and promote weight gain, which could improve the quality of life for cancer patients [1][2] - ART26.12, another asset licensed from the University of Stonybrook, appears to protect nerves from damage without compromising chemotherapy efficacy, with favorable results from its first-in-human study affirming its safety and pharmacokinetic profile [3] - New preclinical data on ART12.11, a Cannabidiol and Tetramethylpyrazine cocrystal drug candidate, was presented, indicating its potential for treating depression and anxiety, particularly in patients with cognitive dysfunction [4][6] Group 2: Efficacy and Market Position - ART12.11 demonstrated significant behavioral improvements in male rats under chronic stress, showing efficacy comparable to sertraline (Zoloft), a leading SSRI, while also reversing stress-induced memory deficits [6][7] - Artelo Biosciences stock increased by 14.66% to $16.42 following these developments, reflecting positive market sentiment [6]
Artelo Biosciences Announces Positive Preclinical Efficacy with ART12.11 in Stress-Induced Depression Model
Globenewswire· 2025-07-07 11:45
Core Insights - Artelo Biosciences, Inc. presented new preclinical data on its drug candidate ART12.11, a cocrystal of Cannabidiol (CBD) and Tetramethylpyrazine (TMP), at the 35th Annual International Cannabinoid Research Society Symposium, indicating its potential as a next-generation antidepressant [1][2][3] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments for various conditions, including cancer, pain, and neurological disorders, by modulating lipid-signaling pathways [1][9] - The company is advancing a portfolio of therapeutics aimed at addressing significant unmet medical needs across multiple diseases [9] Product Details - ART12.11 is a proprietary cocrystal composition that has shown better pharmacokinetics and efficacy compared to other forms of CBD in nonclinical studies [6][8] - The drug demonstrated robust antidepressant-like effects in a 28-day treatment regimen, significantly reversing behavioral impairments in stressed male rats, comparable to the leading SSRI sertraline [7] - ART12.11 not only restored mood-related behaviors but also reversed cognitive deficits associated with chronic stress, an area where sertraline was less effective [4][7] Research Findings - The preclinical studies indicated that ART12.11 improved depression-related behaviors and cognitive functions, positioning it as a differentiated candidate in the multi-billion-dollar antidepressant market [2][5][7] - The cocrystal's unique dual-action profile suggests it could meet critical needs in mental health by providing both mood-lifting and cognitive benefits [6][7] Intellectual Property - The US issued a composition of matter patent for ART12.11, enforceable until December 10, 2038, with additional patents granted or validated in 19 other countries [8]
Artelo Biosciences Announces Positive First-in-Human Data for ART26.12, a Novel Non-Opioid Treatment Candidate for Persistent Pain
Globenewswire· 2025-06-30 11:45
Core Insights - Artelo Biosciences, Inc. has announced favorable results from its first-in-human study of ART26.12, a novel inhibitor of Fatty Acid Binding Protein 5 (FABP5), which shows promising safety and pharmacokinetic profiles [1][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 pain [1][8] - The company is advancing a portfolio of therapeutics aimed at addressing significant unmet needs in multiple diseases and conditions [8] Product Development - ART26.12 is the first orally administered, selective, and peripherally restricted FABP5 inhibitor to enter human clinical evaluation, targeting chronic pain management [4][5] - The Phase 1 Single Ascending Dose (SAD) study enrolled 49 healthy volunteers to assess the safety, tolerability, and pharmacokinetics of ART26.12 [2][5] Market Opportunity - The chronic pain therapeutics market exceeded $97 billion globally in 2023 and is projected to surpass $159 billion by 2030, driven by increasing prevalence of conditions such as neuropathic pain and arthritis [5] - There is a significant gap in innovation for non-opioid therapies in the pain management market, which ART26.12 aims to fill with its unique mechanism of action [5] Safety and Efficacy Findings - All adverse events reported in the study were mild, transient, and self-resolving, with no drug-related adverse events observed [7] - The pharmacokinetic profile showed dose-dependent, linear absorption, indicating a predictable response to the drug [7] - A wide safety margin was observed between estimated therapeutic plasma concentrations and the highest exposure levels achieved, supporting potential titration for maximum efficacy [7] Future Development Plans - A Multiple Ascending Dose study is expected to commence in the fourth quarter of this year to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing [5]
Artelo Biosciences Announces $1.425 Million At-the-Market Private Placement Financing
Globenewswire· 2025-06-26 12:00
Core Viewpoint - Artelo Biosciences, Inc. has entered into a definitive securities purchase agreement for an At-the-Market private placement, aiming to raise approximately $1.425 million to support clinical data announcements and general corporate purposes [1][2]. Group 1: Securities Offering Details - Artelo will issue 136,844 shares of common stock and 93,179 pre-funded warrants, along with warrants to purchase 460,046 shares at $5.82 per share and 230,023 shares at $10.00 per share [2]. - The offering aims to provide sufficient capital for announcing clinical data regarding two phase 1 studies for ART26.12 and a phase 2 study readout from the CAReS trial for ART27.13 [2]. - The company plans to allocate $250,000 of the net proceeds to purchase the digital currency SOL, with the remainder for general corporate and working capital purposes [2]. Group 2: Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for various conditions, including cancer, pain, and dermatological issues [4]. - The company is advancing a portfolio of product candidates aimed at addressing significant unmet medical needs across multiple diseases [4]. - Artelo is led by experienced biopharmaceutical executives and collaborates with respected researchers and technology experts to develop impactful therapies [4].