Core Viewpoint - Artelo Biosciences, Inc. has announced a 6-for-1 reverse stock split to increase the price per share to meet Nasdaq's minimum listing requirement of $1.00 per share, effective June 13, 2025 [1][2]. 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 dermatological issues [3]. - The company is advancing a portfolio of product candidates aimed at addressing significant unmet medical needs across multiple diseases [3]. Reverse Stock Split Details - The reverse stock split will automatically convert every six shares of the company's common stock into one share, maintaining shareholders' pro-rata ownership [2]. - Post-split, approximately 546,667 shares of common stock will be issued and outstanding [2].

Core Insights - Artelo Biosciences, Inc. presented new data at the British Pain Conference, highlighting the therapeutic potential of Fatty Acid Binding Protein (FABP) inhibitors for treating osteoarthritis (OA) pain [1][2] - The lead FABP5 inhibitor, ART26.12, demonstrated analgesic effects comparable to naproxen in animal studies, with sustained effects over 28 days [4][3] - OA affects approximately 606.9 million people globally, with over 32 million in the U.S., leading to significant mobility loss and reduced quality of life [5] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing therapeutics that modulate lipid-signaling pathways for various conditions, including cancer, pain, and inflammation [7] - The company is advancing a portfolio of product candidates aimed at addressing unmet medical needs across multiple diseases [7] - ART26.12 is currently undergoing human trials, with initial clinical development targeting chemotherapy-induced peripheral neuropathy (CIPN) [6]

Core Insights - Artelo Biosciences, Inc. is focused on developing treatments for cancer, pain, and neuropsychiatric conditions through modulation of lipid-signaling pathways [1][5] - A recent publication highlights the therapeutic potential of Fatty Acid Binding Protein (FABP) inhibitors in treating mood and anxiety disorders, emphasizing the role of FABP5, FABP3, and FABP7 in neuroinflammatory signaling [2][3] Company Developments - Artelo's lead candidate, ART26.12, is a FABP5 inhibitor aimed at treating chemotherapy-induced peripheral neuropathy (CIPN) and is expected to report Phase 1 trial results in Q2 2025 [4] - The company has completed enrollment for a Phase 1 Single Ascending Dose study of ART26.12 with nearly 50 healthy volunteers, with data announcements anticipated this quarter [3][4] - Artelo's proprietary platform includes several backup and follow-on leads targeting FABP5 to elevate endogenous anandamide levels, which may provide anxiety-reducing and antidepressant effects without cognitive side effects [3][4] Research and Clinical Evidence - The peer-reviewed article co-authored by Doctor Steven Laviolette presents extensive preclinical evidence supporting the role of FABPs in the pathophysiology of anxiety and depression [2] - The findings suggest that inhibition of FABP5 can significantly elevate anandamide levels and modulate stress-related neurocircuits, indicating a promising avenue for neuropsychiatric treatment [3]

Drug Development - Artelo Biosciences is developing a dual cannabinoid agonist, ART27.13, for cancer-related anorexia, with Phase 1b enrollment completed in Q1 2023 and Phase 2a initiation in April 2023[91]. - The company received FDA clearance for ART26.12 in July 2024, with Phase 1 clinical trials for chemotherapy-induced peripheral neuropathy (CIPN) completed in April 2025[87][93]. - ART12.11, a proprietary cocrystal of CBD and TMP, is expected to have improved stability and bioavailability compared to non-cocrystal CBD compositions, with multiple potential indications being explored[94][95]. - Approximately 60% of advanced stage cancer patients are affected by cancer-related anorexia, highlighting the market need for ART27.13[90]. - ART26.12 has shown promising preclinical evidence in multiple pain models, prioritizing CIPN as the initial indication due to the lack of approved treatments[93]. - The company plans to develop ART12.11 for indications including PTSD, depression, epilepsy, and insomnia[95]. - The company has established a comprehensive approach to drug development, leveraging lipid signaling modulation pathways[86]. Intellectual Property - Artelo has secured two U.S. patents and multiple foreign patents for its CBD cocrystal composition, aiming for long-lasting market exclusivity[95]. Financial Performance - The company has not generated any revenue to date and may not do so in the near future[105]. - Total operating expenses for Q1 2025 were $2.4 million, a decrease of $0.2 million from $2.6 million in Q1 2024[108]. - The net loss for Q1 2025 was $2.4 million, compared to a net loss of $2.5 million in Q1 2024, reflecting a decrease of $0.1 million[108]. - Current assets decreased to $1.4 million as of March 31, 2025, from $2.6 million as of December 31, 2024[120]. - Current liabilities increased to $2.8 million as of March 31, 2025, from $1.8 million as of December 31, 2024[120]. - Cash used in operating activities for Q1 2025 was $1.6 million, down from $2.9 million in Q1 2024[122]. - The total working capital as of March 31, 2025, was negative $1.4 million, a decrease of $2.2 million from positive $0.8 million in 2024[119]. Capital and Funding - The company has issued a total of 425,344 shares under the Equity Line, generating aggregate proceeds of $679,000[111]. - The company filed a $75.0 million shelf registration statement effective for three years to provide flexibility for capital access[112]. - The company plans to pursue additional funding through equity or debt offerings to support ongoing operations[115]. Accounting and Reporting - Financial statements prepared in accordance with GAAP, requiring management estimates and assumptions[127]. - Actual results may differ from estimates due to inherent unpredictability and uncertainties[128]. - No new accounting standards adopted during the three months ended March 31, 2025[129]. - As a smaller reporting company, not required to provide detailed market risk disclosures[130]. - No off-balance sheet arrangements that materially affect financial condition or results of operations[126]. Management and Strategy - Artelo's management team has experience in developing and commercializing first-in-class therapeutics, with plans to retain rights for internal development[96]. - The company is actively pursuing collaborations in the biopharmaceutical industry to maximize shareholder value[96].

Several Key Clinical Readouts in Addition to New Study Initiations Expected in 2025 SOLANA BEACH, Caif., May 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 results for the three months ended March 31, 2025. Business Highligh ...

Core Insights - Artelo Biosciences, Inc. announced positive research results for ART26.12, a treatment for psoriasis, showing efficacy comparable to existing immunomodulatory drugs with serious side effects [1][2][3] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for various conditions, including cancer, pain, and dermatological issues [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 an orally active small-molecule inhibitor of Fatty Acid Binding Protein 5 (FABP5), which has shown efficacy in preclinical psoriasis models [2][4] - Pre-clinical studies suggest a low toxicological risk for ART26.12, indicating it may be a safer and less costly treatment option for chronic diseases like psoriasis [4] - A Phase 1 Single Ascending Dose study in healthy volunteers has completed enrollment, with data expected to be announced in the current quarter [4][5] Market Potential - Psoriasis affects approximately 2-3% of the global population and is associated with significant quality of life impacts [6] - The global psoriasis market was valued at $27.2 billion in 2024 and is projected to grow to $57.68 billion by 2032 [6]

Company Overview - Artelo Biosciences, Inc. 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 aimed at addressing significant unmet medical needs across various diseases, including anorexia, cancer, anxiety, pain, neuropathy, and inflammation [5] Product Development - Artelo's lead product, ART26.12, is a Fatty Acid Binding Protein 5 (FABP5) inhibitor, which is being developed as a non-opioid, non-steroidal analgesic for chemotherapy-induced peripheral neuropathy (CIPN) [4] - A Phase 1 Single Ascending Dose study of ART26.12 in healthy volunteers is nearing completion, with data expected in Q2 2025 [3] - The inhibition of FABP5 has shown potential therapeutic activity in models of neuropathic pain, osteoarthritis, cancer, and cancer bone pain [3] Upcoming Events - Myles Osborn, Lead Medicinal Chemist at Artelo, will present at the 4th ACE Drug Discovery Summit on April 3, 2025, discussing the impact of FABP5 inhibition across various disease models [2][6] - The presentation will provide insights into the consensus mechanisms of FABP5 inhibition and its implications for therapeutic development [2] Industry Context - The 4th ACE Drug Discovery Summit serves as a platform for global scientists and researchers to discuss advancements and challenges in drug discovery, emphasizing collaboration and innovation in the pharmaceutical and technology sectors [6]

Product Development and Pipeline - The company is developing ART27.13, a dual cannabinoid GPCR agonist for cancer-related anorexia, with a global market size exceeding $2 billion[33]. - ART26.12, a FABP5 inhibitor, targets chemotherapy-induced peripheral neuropathy (CIPN) and has a market potential of over $1 billion, with additional applications in prostate cancer and breast cancer, which have market sizes of approximately $9 billion and $18 billion respectively[33]. - The company has initiated a Phase 1 clinical trial for ART26.12, with the first-in-human studies beginning in Q4 2024 after receiving FDA approval for the IND application[29]. - The Phase 1b portion of the CAReS study for ART27.13 was completed in Q1 2023, and the Phase 2a portion is expected to enroll 40 evaluable patients across 15 clinical sites in five countries[27]. - ART12.11, a synthetic CBD cocrystal, is in pre-clinical development targeting anxiety and PTSD, with a market potential exceeding $11 billion[33]. - The company has a comprehensive product candidate pipeline that balances risk across various mechanisms of action and stages of development[22]. - The company is focused on developing therapeutics that target lipid-signaling modulation pathways, including the endocannabinoid system[21]. - The company is focused on developing ethical pharmaceutical products that leverage lipid signaling modulation, particularly within the endocannabinoid system (ECS) to address various medical conditions[41]. - The company has a pipeline that includes ART27.13, which has been dosed in over 200 subjects across five phase 1 clinical trials, demonstrating safety and tolerability[49]. - The company plans to develop synthetic new chemical entities targeting receptor binding and endocannabinoid transport modulation, expanding its therapeutic approaches[39]. - The company aims to address a wide range of diseases through lipid-signaling modulation, including neurological diseases and dermatologic conditions[41]. - The company has a total of 27 pending applications related to the ART26.12 program, indicating ongoing research and development efforts[44]. - The company is committed to building a pipeline of product candidates associated with lipid signaling through licensing agreements with pharmaceutical and biotechnology companies[42]. - The company entered into a license agreement with Stony Brook University, providing an exclusive license for developing and commercializing patent products worldwide[52]. Financial Performance - Total current assets decreased from $10,980,000 in 2023 to $2,557,000 in 2024, a decline of approximately 77%[353]. - Total liabilities increased from $1,291,000 in 2023 to $1,841,000 in 2024, representing a rise of about 42.5%[355]. - Net loss for the year ended December 31, 2024, was $9,826,000, compared to a net loss of $9,289,000 in 2023, indicating an increase in loss of approximately 5.8%[357]. - Total operating expenses rose to $10,108,000 in 2024 from $9,930,000 in 2023, reflecting an increase of about 1.8%[357]. - Cash and cash equivalents decreased from $2,815,000 at the end of 2023 to $2,338,000 at the end of 2024, a reduction of approximately 16.9%[362]. - Basic and diluted loss per common share improved slightly from $(3.14) in 2023 to $(3.05) in 2024[359]. - The company reported a total comprehensive loss of $9,825,000 for 2024, compared to $9,238,000 in 2023, an increase of about 6.4%[357]. - Stock-based compensation expenses were $818,000 in 2024, down from $1,020,000 in 2023, a decrease of approximately 19.8%[362]. - The total stockholders' equity decreased from $11,752,000 in 2023 to $2,857,000 in 2024, a decline of approximately 75.7%[355]. - The Company incurred a net loss of $9,826,000 for the year ended December 31, 2024[368]. - The Company raised $18,262,000 from an equity offering completed in November 2021[368]. - The Company received R&D tax credits of $1,349,000 and $1,206,000 for the years ended December 31, 2024, and 2023, respectively[375]. - The Company filed a $75,000,000 shelf registration statement effective for three years, allowing for the sale of various securities[369]. - The Company issued 425,344 shares of Common Stock under the Equity Line, generating proceeds of $679,000[368]. - The Company has significant doubt about its ability to continue as a going concern within one year after the issuance of the financial statements[370]. - The Company has not generated any revenue since its inception and expects to continue incurring losses into the foreseeable future due to ongoing research and development activities[395]. Regulatory and Compliance - Regulatory compliance is critical, with extensive requirements for drug approval processes in the U.S. and other jurisdictions[66][67]. - The FDA aims to review and act on a standard NDA for a new molecular entity within ten months from the filing date, typically taking 12 months in total[79]. - The FDA may issue a Complete Response Letter if the NDA has deficiencies, requiring additional clinical data or studies before resubmission[82]. - Market exclusivity provisions can delay the submission and approval of marketing applications for products with the same active ingredient, allowing for patent term restoration of up to five years[90]. - Pediatric exclusivity can provide an additional six months of marketing exclusivity if clinical trials in children are conducted in response to an FDA request[92]. - The FDA may withdraw product approval if compliance with regulatory requirements is not maintained or if new safety risks are discovered post-marketing[86]. - The FDA conducts inspections of manufacturing facilities and clinical sites to ensure compliance with cGMP and GCP standards before approving an NDA[81]. - The centralized procedure in the EU allows for a single marketing authorization valid across all EU Member States for certain medicinal products[95]. - Companies must submit annual progress reports to the FDA summarizing clinical trial results while the IND is active[77]. - The FDA may refer a novel drug application to an advisory committee for independent expert evaluation and recommendations[80]. - Changes to approved products, such as new indications, require prior FDA review and approval[85]. - The Foreign Corrupt Practices Act (FCPA) prohibits U.S. businesses from offering bribes to foreign officials, impacting international operations and requiring compliance with accounting provisions[96]. - The U.S. federal Anti-Kickback Statute prohibits remuneration to induce referrals for services covered by U.S. healthcare programs, with violations potentially leading to significant penalties[100]. - The American Rescue Plan Act of 2021 eliminated the Medicaid drug rebate cap, which may require pharmaceutical manufacturers to pay more in rebates than received on product sales[108]. - The Inflation Reduction Act of 2022 allows the federal government to negotiate maximum fair prices for certain high-priced Medicare drugs, potentially impacting revenue generation and profitability[110]. - Biologics are afforded an additional four years on the market before being subjected to price negotiations under the Inflation Reduction Act, compared to small-molecule drugs[113]. - Legislative changes may impose aggregate reductions to Medicare payments of up to 2% per fiscal year through 2032, affecting financial performance[106]. - Compliance with international privacy laws regarding health information access and disclosure is critical, as violations could significantly impact business operations[98]. - Increased scrutiny over drug pricing and transparency measures may lead to greater compliance burdens and potential liabilities for the company[109]. - Future healthcare reforms and regulatory changes could materially affect the company's ability to commercialize product candidates and achieve profitability[103]. Operational and Employment Information - As of December 31, 2024, the company had six employees, with no labor union representation, and relies on contractors and consultants for day-to-day operations[116]. - Total general and administrative expenses for the year ended December 31, 2024, were $4,115, a decrease of 2.8% from $4,234 in 2023[397]. - Total research and development expenses for the year ended December 31, 2024, were $5,993, an increase of 5.2% from $5,696 in 2023[397]. - The Company incurred an aggregate net operating loss of $27,433, with net operating loss carryforwards beginning to expire in varying amounts starting in 2034[420]. - The Company has capitalized costs associated with acquiring an exclusive worldwide license for the compound ART27.13 as an intangible asset valued at $2,039 as of December 31, 2024, and 2023[422]. - As of December 31, 2024, the Company had 3,281,032 shares of Common Stock issued and outstanding, an increase from 3,188,959 shares in 2023[403]. - The Company granted 254,500 stock options during the year ended December 31, 2024, with an average exercise price of $1.48[417]. - The intrinsic value of the warrants outstanding as of December 31, 2024, is $0, with all outstanding warrants being exercisable[404]. - The Company recognized stock-based compensation expense of $818 for the year ended December 31, 2024, down from $1,020 in 2023[418]. - The Company has not recorded any deferred income tax assets as of December 31, 2024, due to uncertainties in generating future taxable income[420]. - The Company capitalized a total of $1,500 and the fair value of 4,087 shares of Common Stock valued at $539[423]. - Operating lease cost for the year ended December 31, 2024, was $32, down from $40 in 2023, representing a decrease of 20%[426]. - Cash paid for operating leases was $30 in 2024, compared to $40 in 2023, indicating a 25% reduction[426]. - Right-of-use assets obtained in exchange for new operating lease liability amounted to $111 in 2024, while there were none in 2023[426]. - The weighted-average remaining lease term for operating leases increased to 2.58 years in 2024 from 0.67 years in 2023[426]. - The weighted-average discount rate for operating leases rose to 7.50% in 2024 from 3.00% in 2023[426]. - Future minimum lease payments under operating lease liability total $115, with $42 due in 2025 and $43 in 2026[426]. - The Company has ongoing financial commitments related to research and development contracts, with additional payments dependent on program milestones[427]. - An additional 484,155 shares of common stock were reserved for issuance under the 2018 Plan as of February 28, 2025[429].

Core Insights - Artelo Biosciences, Inc. is focused on developing treatments for cancer, pain, dermatologic, and neurological conditions through modulation of lipid-signaling pathways, with multiple clinical milestones expected in 2025 [2][11] Business Highlights - The Phase 1 study of ART26.12, a Fatty Acid Binding Protein (FABP) inhibitor, is progressing rapidly and is expected to conclude in Q2 2025 [2][6] - Initial data from the Phase 2 CAReS study of ART27.13 in cancer anorexia is anticipated in Q2 2025, with promising safety and efficacy observed in earlier studies [2][6][8] - ART12.11, a CBD-TMP cocrystal targeting anxiety and depression, is set to begin clinical trials in 2H 2025 [2][6] Financial Results - Research and development expenses for the year ended December 31, 2024, were $6.0 million, up from $5.7 million in 2023 [7] - General and administrative expenses were $4.1 million for the year ended December 31, 2024, slightly down from $4.2 million in 2023 [7] - The net loss for the year ended December 31, 2024, was $9.8 million, or $3.05 per share, compared to a net loss of $9.3 million, or $3.14 per share in 2023 [7] Product Development - ART26.12 is being developed as a non-opioid, non-steroidal analgesic for chemotherapy-induced peripheral neuropathy (CIPN) [4] - ART27.13 is a once-daily oral agent targeting peripheral CB1 and CB2 receptors, with potential benefits for cancer patients experiencing weight loss and appetite issues [5][10] - ART12.11 has shown improved pharmacokinetics and efficacy compared to other CBD forms, with a patent enforceable until December 10, 2038 [9]

SOLANA BEACH, Calif., Feb. 14, 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, dermatological or neurological conditions, today announced nonclinical results on ART12.11, its proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). The findings were presented by Professor Saoirse O’Sullivan, Vice President of Translat ...