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Overview of Artelo Biosciences Inc (ARTL)
Artelo Biosciences Inc is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapeutics. With a strong focus on lipid-signaling pathways and the endocannabinoid system, the company employs a disciplined approach to leverage decades of research and cutting‐edge science. Its innovative platform is designed to modulate complex biochemical networks, aiming to address significant unmet medical needs in conditions such as cancer, pain, anxiety, anorexia, and inflammation.
Core Business and Product Portfolio
At its core, Artelo Biosciences targets lipid-mediated signaling mechanisms to develop proprietary therapies that have the potential to transform patient care. The company’s research spans several therapeutic areas, including:
- Cannabinoid-based Therapeutics: Utilizing a proprietary cocrystal composition that combines cannabidiol (CBD) with tetramethylpyrazine (TMP), the company is innovating in the realm of cannabinoid pharmacology. Their flagship product candidate exhibits superior pharmacokinetic and pharmacodynamic properties compared to conventional CBD formulations.
- FABP Inhibitors: A highlight of the portfolio is the selective inhibition of Fatty Acid Binding Protein 5 (FABP5), an approach designed to provide non-opioid, non-steroidal pain management solutions. These inhibitors are being explored in various pain models including chemotherapy-induced peripheral neuropathy, cancer bone pain, and osteoarthritis-related discomfort.
- Appetite and Cachexia Management: Artelo is developing therapies aimed at supporting patients suffering from cancer-related anorexia. Their efforts focus on improving body weight, appetite, and overall quality of life by targeting specific G-Protein Coupled Receptors (GPCRs) linked to metabolic regulation.
Scientific Innovation and Research Excellence
Artelo Biosciences emphasizes scientific innovation and regulatory discipline. The company strategically leverages world-class research expertise in its collaborations across Europe and North America. This collaborative approach ensures that the preclinical and clinical development of their compounds is built on robust scientific findings. Utilizing advanced drug formulation techniques such as cocrystallization, the company addresses challenges related to solubility and bioavailability, thereby optimizing the delivery and efficacy of their compounds.
Operational Footprint and Global Presence
Headquartered in San Diego, California, and with a significant presence in Dublin, Ireland, Artelo Biosciences has strategically positioned itself at the nexus of global biopharmaceutical innovation. This dual presence facilitates access to premier research institutions and allows the company to foster partnerships with leading academic and commercial entities across both the North American and European markets.
Competitive Position and Industry Significance
In the competitive landscape of clinical-stage biopharmaceutical companies, Artelo Biosciences distinguishes itself through its specialized focus on lipid-signaling and endocannabinoid modulation. By capitalizing on novel mechanisms of action and proprietary technologies, the company aims to fill clinical gaps where existing therapies are inadequate. Its methodical approach to product candidate development, emphasizing improved pharmacological profiles and optimized formulations, positions it as a credible player in the market. In a world where precision medicine and targeted therapies are increasingly important, Artelo’s platform presents a relevant and enduring solution for diverse therapeutic challenges.
Expertise, Experience, and Collaborative Strength
The leadership at Artelo Biosciences is composed of experienced biopharmaceutical executives and renowned researchers with deep domain expertise. This seasoned team guides the company’s multi-disciplinary projects, ensuring that every phase of development integrates regulatory excellence and scientific rigor. Strategic collaborations with academic institutions and industry partners enhance the company’s pipeline by providing access to innovative methodologies and specialized research tools, thus reinforcing its commitment to high-impact therapeutic discoveries.
Research and Development Strategy
Artelo’s R&D strategy is driven by an integrated approach that spans early discovery to clinical development. Each product candidate is supported by extensive preclinical validation, demonstrating efficacy in well-established laboratory models of disease. The company’s emphasis on establishing patent-protected products further underscores its commitment to long-term innovation. Through an agile development process, Artelo continuously refines its drug candidates to enhance safety, dosing precision, and clinical applicability. This systematic approach highlights the company’s regulatory discipline and forward-thinking in addressing complex pathologies.
Addressing Unmet Medical Needs
The challenges in treating conditions such as chemotherapeutic pain, chronic neuropathies, and cancer-associated cachexia underscore a significant need for innovative therapeutic options. Artelo Biosciences’ approach, which modulates upstream lipid-signaling pathways, offers the potential to achieve clinical benefits not attainable with traditional therapies. By focusing on molecular targets that regulate bioactive lipids, the company promises solutions that are less reliant on conventional mechanisms, thereby reducing adverse effects while improving efficacy.
Scientific Integrity and Transparency
In its commitment to scientific integrity and transparency, Artelo Biosciences provides comprehensive disclosure on its research methods and collaborative engagements. The company’s numerous presentations at global scientific symposia demonstrate its dedication to contributing to the broader body of knowledge in cannabinoid research and lipid signaling. This openness reinforces its reputation for expertise and builds trust among stakeholders, including investors, researchers, and clinical practitioners.
Conclusion
Artelo Biosciences Inc is a dynamic and forward-thinking biopharmaceutical company that has built a niche in the development of novel therapies targeting lipid-signaling pathways. With a robust and diversified drug pipeline, a strong scientific foundation, and a global operational footprint, the company continues to contribute valuable insights and therapeutic solutions in areas where patient needs are greatest. By maintaining a clear focus on rigorous research and strategic collaborations, Artelo is well-equipped to sustain its relevance and impact in the evolving landscape of biopharmaceutical innovation.
Artelo Biosciences (NASDAQ: ARTL) has announced that Lead Medicinal Chemist Myles Osborn will present at the 4th ACE Drug Discovery Summit in London on April 3, 2025. The presentation, scheduled for 12:30pm BST, will focus on analyzing multiple datasets regarding Fatty Acid Binding Protein 5 (FABP5) inhibition across various disease models.
The presentation, titled 'Comparative Multi-Omics to Interrogate Consensus Mechanisms of FABP5i Across Diverse Indications,' will explore how FABP5 inhibition affects cellular communication pathways. Research has shown promising activity in treating neuropathic pain, osteoarthritis, cancer, and cancer bone pain.
The company's lead FABP5 inhibitor, ART26.12, is currently in Phase 1 Single Ascending Dose study with healthy volunteers, with data expected in Q2 2025.
Artelo Biosciences (NASDAQ: ARTL) has provided its fiscal 2024 year-end results and business update, highlighting multiple upcoming clinical milestones in 2025. The company reported a net loss of $9.8 million ($3.05 per share) for 2024, compared to $9.3 million in 2023.
Key financial metrics include R&D expenses of $6.0 million (up from $5.7M in 2023), G&A expenses of $4.1 million (down from $4.2M), and cash/investments position of $2.3 million as of December 31, 2024.
Three major clinical programs are advancing:
- ART26.12 (FABP5 inhibitor) Phase 1 study completion expected in Q2 2025
- ART27.13 Phase 2 CAReS trial for cancer anorexia with initial data due by Q2 2025
- ART12.11 (CBD-TMP cocrystal) targeting anxiety and depression, set for human trials in 2H 2025
Artelo Biosciences (NASDAQ: ARTL) has announced new nonclinical results for ART12.11, its proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). The findings, presented at the International Medical Cannabis Conference in Switzerland, demonstrated that ART12.11 tablets achieved CBD and metabolite exposure levels similar or greater to equivalent doses of Epidiolex®, the only FDA-approved CBD therapy.
The company's tablet formulations, containing 100mg of CBD, show potential advantages including improved stability, easier dosing, lower cost-of-goods, and enhanced patient adherence. The cocrystallization approach addresses CBD's physical property challenges, enabling the manufacture of simple compression tablets with high drug loading. These results support ART12.11's potential as an alternative CBD formulation with improved pharmacokinetics and enhanced efficacy in nonclinical studies.
Artelo Biosciences (Nasdaq: ARTL) has announced its upcoming presentation at the International Medical Cannabis Conference (IMCCB-25) in Bern, Switzerland, scheduled for February 13-14, 2025. The company will present new data comparing their proprietary ART12.11 tablets to Epidiolex.
Professor Saoirse O'Sullivan, Vice President Translational Science at Artelo, will deliver a presentation titled 'A Cannabidiol Cocrystal (ART12.11) Tablet Has Comparable Pharmacokinetics to Epidiolex' on February 14, 2025. The presentation will focus on recent pharmacokinetic results from canine studies comparing ART12.11, a proprietary cocrystal composed of cannabidiol (CBD) and tetramethylpyrazine (TMP), with Epidiolex.
Artelo Biosciences specializes in modulating lipid-signaling pathways to develop treatments for cancer, pain, and dermatological or neurological conditions.
Artelo Biosciences (Nasdaq: ARTL) announced the successful completion of the first cohort in its Phase 1 study of ART26.12, a selective Fatty Acid Binding Protein 5 (FABP5) inhibitor. This marks a significant milestone in developing FABP inhibitors as a novel treatment approach for various conditions including cancer, pain, and neuropathies.
The study involved eight healthy volunteers, with the initial safety review completed. ART26.12 is the first-ever selective FABP5 inhibitor to enter clinical trials, targeting an intracellular protein involved in lipid signaling. This mechanism shows promise for managing painful neuropathies non-opioid treatments.
Preclinical studies have shown significant promise in models of Chemotherapy Induced Peripheral Neuropathy (CIPN), Diabetic Neuropathy, cancer bone pain, and osteoarthritis. Encouraged by the preclinical safety profile, Artelo aims to provide initial safety, pharmacokinetic, and biomarker data in the first half of 2025.
The next cohort in the Phase 1 study will offer further insights into the development of ART26.12. The results will help determine suitable doses for a multiple ascending dose study planned for the second half of 2025.
Artelo Biosciences (ARTL) presented Phase 1 data from the CAReS trial for ART27.13, their investigational drug for cancer-related anorexia. The trial demonstrated promising results with two-thirds of participants showing stabilized or reversed weight loss after one month of treatment. The drug was well-tolerated with only mild to moderate adverse events in a minority of participants, with no serious adverse events recorded.
The Phase 2 portion of the trial is currently enrolling participants across fifteen sites in five countries, administering 650 microgram doses with planned escalation up to 1300 micrograms daily. The study will evaluate endpoints including lean body mass, weight gain, quality of life, and safety, with completion expected in the first half of 2025.
Artelo Biosciences (NASDAQ: ARTL) announced its participation in the 7th Cannabinoid-Derived Drug Development Summit, taking place November 18-20, 2024, in Boston. Professor Saoirse O'Sullivan, VP of Translational Sciences, will present key data from three development programs:
1. FABP5 Inhibitors as Novel Therapeutics (ART26.12)
2. ART27.13: A Peripherally Selective CB1/CB2 Agonist for Cancer Cachexia
3. ART12.11: A Novel Cannabidiol Cocrystal comparable to Epidiolex®
The presentations aim to explore business development and collaboration opportunities, showcasing how lipid modification can address serious medical conditions with treatment options.
Artelo Biosciences (ARTL) presented new data on ART26.12, their lead clinical Fatty Acid Binding Protein 5 (FABP5) inhibitor, for osteoarthritis (OA) pain treatment. In preclinical studies at Stony Brook University, ART26.12 showed superior symptom relief compared to naproxen in a surgical rodent OA model, demonstrating significant improvement in weight-bearing across all tested doses. The compound exhibited a clear dose-response relationship, with higher concentrations providing better pain relief.
The FDA has cleared ART26.12 for its first-in-human Phase 1 single ascending dose study, with initial results expected in H1 2025. The treatment targets over 500 million people globally affected by OA, according to WHO, and represents a potential alternative to NSAIDs and opioids.
Artelo Biosciences (NASDAQ: ARTL) reported Q3 2024 financial results and provided updates on its clinical pipeline. The company ended the quarter with $4.9 million in cash and investments. Net loss was $1.1 million ($0.35 per share), compared to $2.4 million in Q3 2023. R&D expenses decreased to $0.3 million from $1.6 million year-over-year. The company received $1.3 million in R&D tax credits from the UK government.
Multiple clinical readouts are expected over the next 15 months. The Phase 2 CAReS trial for ART27.13 in cancer-related anorexia is expected to complete enrollment in early 2025. FDA clearance was received for ART26.12 trials in chemotherapy-induced peripheral neuropathy, with Phase 1 results expected in H1 2025. ART12.11 clinical trials for anxiety and depression are planned for 2025.
Artelo Biosciences (Nasdaq: ARTL) announced that its lead clinical FABP inhibitor, ART26.12, has been accepted into the NIH's Preclinical Screening Platform for Pain (PSPP) program, part of the HEAL Initiative. The PSPP program evaluates non-opioid assets in preclinical pain models and is open to researchers globally. The HEAL Initiative aims to address the overdose epidemic and pain crisis by improving prevention, treatment strategies, and pain management. Artelo previously received FDA clearance for first-in-human studies of ART26.12, with initial results expected in the first half of 2025.
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