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About Lexaria Bioscience Corp.
Lexaria Bioscience Corp. (NASDAQ:LEXX, NASDAQ:LEXXW) is a global innovator in drug delivery technology, specializing in its patented DehydraTECH™ platform. This groundbreaking technology enhances the way active pharmaceutical ingredients (APIs) are absorbed into the bloodstream, offering faster onset times, improved bioavailability, and reduced side effects. DehydraTECH is applicable across a wide range of APIs, including cannabinoids, antiviral drugs, nicotine, and GLP-1 receptor agonists, making it a versatile solution in the pharmaceutical and biotechnology industries.
Core Technology: DehydraTECH™
DehydraTECH™ is a patented drug delivery formulation and processing platform that optimizes the oral delivery of APIs. By improving bio-absorption rates—up to 27 times higher for cannabinoids in some cases—and reducing onset times from hours to minutes, the technology addresses critical challenges in drug delivery. It has also demonstrated the ability to facilitate the transport of APIs across the blood-brain barrier, a significant advantage for treating neurological conditions.
Market Applications
Lexaria’s technology is particularly impactful in high-growth markets:
- GLP-1 Drugs: DehydraTECH has shown promise in enhancing the oral delivery of GLP-1 receptor agonists like semaglutide, liraglutide, and tirzepatide, which are used to treat diabetes, obesity, and cardiovascular diseases. By enabling oral formulations, Lexaria aims to replace the widely disliked injectable versions of these drugs.
- Neurological Disorders: The technology's ability to cross the blood-brain barrier positions it as a valuable tool in treating conditions like epilepsy and Alzheimer’s disease.
- Cannabinoids: DehydraTECH optimizes the delivery of cannabinoids for therapeutic applications, including pain management and seizure mitigation.
Business Model and Revenue Streams
Lexaria operates through four primary segments:
- Intellectual Property Licensing: The company licenses its technology to pharmaceutical and nutraceutical companies, generating recurring revenue.
- B2B Production: Lexaria produces DehydraTECH-enhanced formulations for business partners.
- Research and Development: The company conducts extensive R&D to expand its technology’s applications and validate its efficacy.
- Corporate Operations: This includes strategic planning and partnerships to drive growth.
Competitive Landscape
In the GLP-1 drug market, Lexaria competes with pharmaceutical giants like Novo Nordisk and Eli Lilly. However, its ability to deliver APIs effectively through oral formulations offers a distinct competitive edge. The company’s focus on reducing gastrointestinal side effects and improving patient compliance further strengthens its market position.
Intellectual Property
Lexaria boasts a robust intellectual property portfolio with 48 granted patents and numerous pending applications worldwide. These patents cover a wide range of applications, from epilepsy treatment to GLP-1 drug delivery, reinforcing the company’s authority in drug delivery innovation.
Research and Development
Lexaria operates a licensed in-house research laboratory, conducting preclinical and clinical studies to validate its technology. Recent studies have shown promising results in enhancing the performance of GLP-1 drugs, cannabinoids, and antiviral formulations. The company is also exploring new applications in cardiovascular and neurological health.
Geographical Reach
Lexaria generates revenue primarily from the United States and Canada, with plans to expand its global footprint through strategic partnerships and licensing agreements.
Conclusion
Lexaria Bioscience Corp. is at the forefront of drug delivery innovation, leveraging its patented DehydraTECH™ technology to address critical challenges in the pharmaceutical industry. By enabling more effective oral formulations, the company is poised to disrupt markets dominated by injectable drugs, offering significant benefits to patients and healthcare providers alike.
Lexaria Bioscience continues progressing its second GLP-1 human pilot study (GLP-1-H24-2), with the second dosing arm now complete for all nine participants. The study, a three-arm crossover investigation, compares three 7 mg semaglutide dose formulations: a positive control Rybelsus® tablet, DehydraTECH-semaglutide swallowed capsules, and an innovative in-mouth dissolvable DehydraTECH-semaglutide oral tablet. This is the first study to investigate if DehydraTECH-enhanced semaglutide can be absorbed systemically via sublingual/buccal tissues, potentially offering better absorption and fewer side effects than swallowed administration. Lexaria plans to complete the final study arm by early July 2024.
Lexaria Bioscience has awarded a contract for its third human pilot study to a contract research organization. This study will evaluate the dual action glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) using a DehydraTECH-processed tirzepatide in an oral capsule format versus the injected tirzepatide (Zepbound® by Eli Lilly). The study aims to determine the absorption, human tolerability, and blood sugar level effects of the oral DehydraTECH-processed tirzepatide. This marks the first study of its kind for Lexaria, potentially paving the way for an FDA-approved oral dosage format of tirzepatide. Manufacturing for the study's test articles is expected to complete within 30 days, pending Independent Review Board approval.
Lexaria Bioscience has announced the receipt of two new US patents in the medical fields of hypertension and epilepsy. The first patent, part of Lexaria's patent family #21, focuses on compositions and methods for treating hypertension using DehydraTECH-processed cannabidiol (CBD). The second patent, part of patent family #24, pertains to treating epilepsy, highlighting DehydraTECH-CBD's efficacy in mitigating epileptic seizures and its superior absorption compared to Epidiolex. Both patents are valid until 2042. Lexaria now holds a total of 43 patents globally, reinforcing its strategic business objectives.
Lexaria Bioscience Corp. (NASDAQ: LEXX) has commenced dosing in a 12-week animal study, WEIGHT-A24-1, to evaluate the effectiveness of DehydraTECH-processed GLP-1 drugs, including semaglutide and liraglutide, in diabetic preconditioned rats. The study aims to determine whether these processed drugs improve brain absorption, weight loss, and blood sugar control, especially when combined with cannabidiol (CBD). The study consists of 12 arms, with initial evaluations focusing on pure and reformulated compositions of semaglutide and liraglutide. Subsequent study arms will explore the best-performing drug combinations and include placebo and positive control groups.
Lexaria Bioscience Corp. has commenced its second GLP-1 human pilot study, comparing different formulations of semaglutide for improved drug delivery. The study aims to test the effectiveness of DehydraTECH technology in enhancing oral absorption rates of GLP-1 drugs. The company has successfully completed the first dosing visit for all nine participants and expects the study to conclude by mid-June.
Lexaria Bioscience Corp. announces a research program with the National Research Council of Canada to evaluate DehydraTECH-GLP-1 drugs. The program will assess the molecular characteristics of semaglutide processed with DehydraTECH and its performance in simulated gastric conditions. The partnership aims to accelerate the integration of DehydraTECH with GLP-1 drugs into the pharmaceutical industry. Testing methods include PAGE, SEC, MALDI MS, and DLS to study the oligomerization potential of DehydraTECH-processed semaglutide. Initial results show increased peak levels of semaglutide in blood with reduced adverse events and improved blood sugar control compared to unprocessed Rybelsus® tablets.
Lexaria Bioscience Corp. (NASDAQ: LEXX) announces a warrant exercise agreement with an investor, resulting in $4.7 million in gross proceeds. The company will issue new warrants at $4.75 per share, extending its operational runway into 2025. The funds will be used for working capital and general corporate purposes.
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