Lexaria Bioscience Corp Stock Price, News & Analysis

Lexaria Bioscience Corp. (NASDAQ:LEXX) has initiated dosing for its third human pilot study, investigating an oral dose format of DehydraTECH-processed tirzepatide from Zepbound®. The study involves up to 10 healthy volunteers and consists of two seven-day dosing phases with a multi-week washout period in between. The first phase is set to conclude on October 13, 2024, with the second phase to begin in mid-November. No serious adverse events have been reported. The study will evaluate tolerability, blood absorption levels, and blood sugar control. Tirzepatide, marketed under Zepbound® and Mounjaro® by Eli Lilly™, is expected to generate $15 billion in 2024. Lexaria aims to demonstrate significant absorption rates for oral tirzepatide, building on previous studies showing improved absorption and reduced adverse events for DehydraTECH-processed semaglutide.

Lexaria Bioscience Corp. (NASDAQ:LEXX) provides an update on the rapidly growing GLP-1 receptor agonist market. The market has expanded from less than $4 billion in 2020 to a projected $44.5-$49.3 billion in 2024, with analysts forecasting up to $471.1 billion by 2033. Currently, over 95% of the market is dominated by two drugs: semaglutide and tirzepatide. The oral tablet form of these drugs, which currently comprises only 10% of the market, is expected to grow significantly.

Lexaria's DehydraTECH drug delivery system aims to lead in oral GLP-1/GIP drug delivery. Recent studies have shown GLP-1 drugs' potential in reducing cardiovascular risks and improving outcomes for chronic kidney disease patients, suggesting possible expanded therapeutic applications in the future.

Lexaria Bioscience Corp. (NASDAQ:LEXX & LEXXW) has appointed Michael Shankman, CPA, as its new Chief Financial Officer (CFO), effective immediately. Mr. Shankman brings extensive financial and regulatory experience to the role, having previously worked with Lexaria on financial reporting and auditing. From 2021 to 2024, he provided outsourced CFO and Controller services for various public and private companies across multiple industries.

CEO Richard Christopher expressed enthusiasm about the appointment, citing Shankman's accomplishments and the company's expectations for strong growth into 2025. Shankman himself expressed excitement about joining Lexaria, noting the company's potential for advancements and his eagerness to contribute to its pharmaceutical research and development program.

Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) has received independent review board approval for human pilot study #3, investigating a DehydraTECH-processed version of tirzepatide in an oral dose format. The study will compare a single injected dose of Zepbound® (tirzepatide) to 7 consecutive days of daily oral dosing of DehydraTECH-processed Zepbound® in up to 10 healthy volunteers.

The study will evaluate tolerability, blood absorption levels, and blood sugar control. Lexaria aims to demonstrate meaningful absorption rates of tirzepatide in a swallowed oral format, which is currently unavailable in the market. The company expects to begin subject recruitment shortly, with first dosing anticipated in late October and final doses in late November.

Additionally, Lexaria's CRO has submitted information for ethics review of the 12-week study GLP-1-H24-4, expected to be a Phase 1b registrational study by the FDA, with first-in-patient dosing anticipated this winter in Australia.

Lexaria Bioscience Corp. (NASDAQ:LEXX) announces a strategic update as CEO Chris Bunka steps down. Key points include:

• New focus on pharmaceutical studies in cardiometabolic and GLP-1 sectors
• Appointment of Richard Christopher as new CEO with pharma/biotech operations experience
• FDA clearance for Phase 1b hypertension study using DehydraTECH-CBD
• Over $8.5 million raised in 2024 through equity raises and warrant exercises
• Market cap growth from $5 million in June 2023 to $60 million
• Ongoing GLP-1 studies with promising results
• Plans for two Phase 1 studies in 2025
• Material Transfer Agreement with a pharmaceutical company

Bunka will continue as Executive Strategic Advisor and Chairman of the Board.

Lexaria Bioscience Corp. (NASDAQ:LEXX) announces a significant leadership change, with Richard Christopher appointed as the new CEO, effective August 31, 2024. Christopher, an industry veteran with over 30 years of experience in medical devices and pharmaceuticals, replaces Chris Bunka, who will remain as Chairman of the Board and Executive Strategic Advisor. The transition aligns with Lexaria's focus on advancing drug delivery in the GLP-1 marketplace and pharmaceutical industry collaborations.

The company's 100-day plan includes executing a Material Transfer Agreement with a pharmaceutical company, ongoing GLP-1 research studies, and preparing for a 2025 FDA-cleared Phase 1b hypertension study. Lexaria's DehydraTECH™ technology, developed since 2015, aims to enhance drug delivery kinetics, with a focus on cardio-metabolic, diabetes, weight loss, and hypertension sectors.

Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) has entered into a Material Transfer Agreement with a pharmaceutical company, referred to as 'PharmaCo'. The agreement aims to evaluate Lexaria's DehydraTECH technology in a pre-clinical setting. Under the terms:

1. Lexaria will formulate and supply specific DehydraTECH compositions.
2. PharmaCo will conduct animal studies to evaluate the pharmacokinetics of these compositions.
3. PharmaCo has been granted a temporary exclusive license option for specific DehydraTECH concepts and formulations under examination.

The evaluation process is expected to be completed within approximately 6 months or less. This agreement represents a significant step for Lexaria in advancing its drug delivery platform technology.

Lexaria Bioscience Corp. (NASDAQ:LEXX) has announced positive results from its second GLP-1 human pilot study (GLP-1-H24-2) on DehydraTECH-processed Rybelsus® oral capsules. Key findings include:

1. Superior tolerability: None of the 9 participants taking DehydraTECH-processed Rybelsus® capsules experienced adverse events, compared to 6 out of 9 taking standard Rybelsus® tablets.

2. Improved absorption: DehydraTECH-processed Rybelsus® capsules showed 106.9% blood concentration levels compared to standard Rybelsus® tablets.

3. Novel delivery method: A DehydraTECH-processed Rybelsus® mouth-melt format showed promising results, delivering about one-third of the drug concentration of standard tablets.

These findings suggest that Lexaria's DehydraTECH technology could potentially enhance the oral delivery and tolerability of GLP-1 drugs like semaglutide, which may lead to increased use of oral GLP-1 products in the future.

Lexaria Bioscience Corp. (NASDAQ:LEXX) has announced initial results from its second GLP-1 human pilot study, GLP-1-H24-2. The study compared DehydraTECH-processed Rybelsus to standard Rybelsus under fed conditions. Key findings include:

1. DehydraTECH-processed Rybelsus showed 18.8% higher average semaglutide levels over 24 hours.

2. Higher semaglutide levels were observed in 17 out of 19 blood draws.

3. The study used 7 mg semaglutide doses in both arms.

4. Results were not statistically significant due to small sample size.

These findings complement an earlier study showing a 43% peak blood level improvement under fasted conditions. Lexaria plans to continue its 2024 GLP-1 program with ongoing animal studies and a planned 12-week chronic human study.