Lexaria's Phase 1b GLP-1 Study Achieves Important "Last Patient Last Visit" Milestone

Lexaria's Phase 1b GLP-1 Study Achieves Important "Last Patient Last Visit" Milestone

(TheNewswire)

Kelowna, British Columbia TheNewswire - August 14, 2025 Lexaria Bioscience Corp. (Nasdaq: LEXX, LEXXW) (the " Company " or " Lexaria "), a global innovator in drug delivery platforms, is pleased to announce that its Contract Research Organization (" CRO ") has completed the important study milestone known as last patent last visit (" LPLV ") in Lexaria's Phase 1b glucagon-like peptide-1 (" GLP-1 ") study in Australia, GLP-1-H24-4 (the " Study ").

"We are delighted that this important milestone has been achieved on schedule, concluding all patient dosing and clinical testing in our Study," said John Docherty, Lexaria's President and CSO.  "Study work continues with full sample and data analyses currently underway in order to reach our late 2025 final reporting objective."

The Study CRO is actively managing the laboratory analysis phase of the work, where thousands of samples collected during the Study are being carefully processed, analysed, and recorded into an extensive database recording system. Lexaria is blinded to that data until the database work has been completed.

Lexaria previously released partial 8-week positive interim results from the Study with encouraging results aligned with its primary study endpoint. These interim results were tracking very nicely from a safety and tolerability perspective relative to the Rybelsus® control arm of the Study; most notably in terms of reductions in the incidence of gastrointestinal adverse events.

About The Study

The Study was conducted with 24-25 overweight, obese, pre- or type 2 diabetic patients in each of the 5 Study Arms (N=126), of which 4 arms evaluated various DehydraTECH formulations with the 5 th being the Study control arm.  All doses were administered daily by oral tablet or capsule – there were no drug injections involved in this Study as Lexaria is promoting a change in the standard of care, moving away from injections and instead embracing oral DehydraTECH delivery.

Arm 1 of the Study utilized a proprietary, patented DehydraTECH-CBD formulation. As a reminder, Lexaria has earlier received a Food and Drug Administration no-objection letter to proceed with a separately devised Phase 1b human clinical study to examine the utility of DehydraTECH-CBD in the pursuit of hypertension relief.

Arms 2 and 3 of the Study used DehydraTECH-processed pure semaglutide.  Arm 2 examined DehydraTECH-semaglutide on a stand-alone basis, while Arm 3 examined DehydraTECH-semaglutide in combination with DehydraTECH-CBD. These arms were compared to the Study control arm (Study Arm 4) which used Rybelsus® tablets (semaglutide) that contains Novo Nordisk's® proprietary salcaprozate sodium (" SNAC ") technology.

Study Arm 5 evaluated the performance of DehydraTECH-tirzepatide, pursuant to the positive findings previously achieved and released for Human Pilot Study #3 (GLP-1-H24-3).

In its first-ever GLP-1 study in humans reported in January 2024 , Lexaria discovered that DehydraTECH processing of Rybelsus®-branded semaglutide, after a single dose, improved blood sugar control and reached higher levels of semaglutide measured in blood, than did Rybelsus® alone. Also, in rodent study work reported in October 2024 , Lexaria was pleased to see comparable performance of DehydraTECH-semaglutide without SNAC to DehydraTECH-processed Rybelsus® formulations including SNAC; which Lexaria previously reported may be due to DehydraTECH preserving similar molecular properties in the gut for ingested semaglutide which has been shown to be integral to SNAC-enabled semaglutide gut absorption.

Lexaria has several important objectives for this Study:

  • Is DehydraTECH processed CBD, semaglutide, and/or tirzepatide safe over the 12-week Study duration in the Study population?

  • Does DehydraTECH-(pure) semaglutide match or outperform Rybelsus®-semaglutide with its proprietary SNAC technology in measures of blood sugar control, weight loss, and/or reduced side-effects?

  • Does DehydraTECH processing enhance real world outcomes such as weight loss, blood sugar control and/or reduction of side-effects over the Study duration?

  • Does DehydraTECH processing of pure semaglutide evidence reduced side effects during daily dosing for 12 weeks, as DehydraTECH processing of Rybelsus® seemed to achieve in a prior human study utilizing one single daily dose?

Lexaria expects to release the final results of the Study when available, which is currently projected to be during  the fourth quarter of 2025.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery.  DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 50 patents granted and additional patents pending worldwide. For more information, please visit www.lexariabioscience.com .

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements.  As such, you should not place undue reliance on these forward-looking statements.  Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA).  Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations

ir@lexariabioscience.com

Phone: 250-765-6424, ext 202

Copyright (c) 2025 TheNewswire - All rights reserved.

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Lexaria Bioscience

Lexaria Bioscience

Overview

Lexaria Bioscience Corp. (NASDAQ:LEXX) is a biotechnology company focused on its proprietary drug delivery technology DehydraTECH™. The company has been granted 18 patents internationally and submitted over 60 patent applications. Operating on an out-licensing and royalty business model, the company generates most of its revenue from very high profit-margin royalties by licensing its patented DehydraTECH™ technology to other companies.

Lexaria is exploring several verticals for its DehydraTECH™ technology:

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Cannabis companies continue to develop their offerings, and with potential catalysts ahead, some investors are interested in getting involved. Looking at the key players is often a good place to start, and this list of US and Canadian cannabis stocks covers the companies with the largest presence in two major cannabis exchange-traded funds (ETFs).

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Understanding trends in the cannabis industry is paramount for investors eyeing a market with steady growth potential, but the landscape is complex as products and regulations continue to evolve.

Consumption habits are changing as edibles, vaping and THC beverages gain traction, especially among younger users, and cannabis companies are adapting their offerings to meet shifting demand.

Meanwhile, regulatory uncertainty, particularly surrounding the future of the US Farm Bill and state-level restrictions on hemp-derived cannabinoids, continues to challenge the market.

Despite these headwinds, production data and long-term growth forecasts suggest the cannabis industry remains on a promising — albeit turbulent — path. Read on for more on key trends to watch in 2025.

Consumption methods evolving post-legalization

Shifts in consumer behavior are reshaping markets across the board, and the cannabis industry is no exception.

While smoking remains the dominant method of cannabis consumption, a recent report from the Centers for Disease Control and Prevention highlights the growing popularity of edibles, vaping and dabbing.

The report notes that vaping and dabbing are particularly pronounced among younger adults.

A separate study published by the American Medical Association and funded in part by the Canadian Institutes of Health Research also points to how product preferences have changed among Canadian users since legalization in 2018.


The study indicates that while the use of flower, cannabis concentrates, oil, tinctures and topicals has decreased during that time, the use of vape cartridges, edibles and beverages has increased.

Edibles and beverages were legalized in Canada in late 2019, and Truss Beverage was one of the first players to introduce cannabis-infused drinks. Truss was a joint venture formed by Molson Coors Canada (TSX:TPX.A,TSX:TPX.B) and HEXO, a cannabis company that has since been acquired by Tilray Brands (TSX:TLRY,NASDAQ:TLRY).

In early 2020, Tilray launched a lineup of confectionery, wellness products and beverages through its subsidiary, High Park; Canopy Growth (TSX:WEED,NASDAQ:CGC) made a similar move. These companies gradually brought their products to the US as more states legalized cannabis for medical and/or recreational use.

Today, established cannabis brands typically offer edibles and beverages alongside their other products. Organigram Global (TSX:OGI,NASDAQ:OGI) is one of the newest US entrants, with its April acquisition of Collective Project providing immediate access to the US hemp-derived THC beverage market.

Growing awareness of health and wellness, potentially amplified by the pandemic-led adoption of health trackers, appears to be making an impact on the alcoholic beverage market.

A 2023 Gallup poll reveals a two decade decline in alcohol consumption, particularly among younger adults, suggesting a shift towards more health-conscious lifestyles within this demographic.

Craft beer production declined by 4 percent year-on-year in 2024, according to data collected by the Brewers Association. This marked the largest drop in the industry's history, excluding the pandemic. For small, independent craft breweries, 2024 marked the third consecutive year of declining production. A drop in the number of operating small breweries last year provides further evidence of this trend, with 501 closures in 2024 versus 434 openings.

Challenges in the alcohol market extend beyond the brewing industry, with the New York Times recently reporting the closure of a handful of nightclubs facing decreased alcohol sales alongside rising insurance and rent costs.

Meanwhile, cannabis lounges have been popping up across the US for the last several years. As of early 2025, several states had legalized or were in the process of implementing regulations for cannabis consumption lounges.

Hemp market growth despite regulatory uncertainty

The burgeoning hemp industry is another segment of the expanding cannabis market.

The legalization of industrial hemp — defined as cannabis with a THC concentration of 0.3 percent or less — through the 2018 Farm Bill led to initial investment and optimistic projections for CBD wellness products and various industrial applications. The sector’s rapid evolution also brought the rise of hemp-derived intoxicating cannabinoids, creating a market that presented both opportunities and complexities for participants.

However, after an initial boom, a lack of infrastructure and clearly defined regulations for CBD, as well as state-level variations and market oversupply, ultimately contributed to a quick retraction.

2024 was a pivotal year for the US hemp industry, as the hemp-related provisions of the 2018 Farm Bill — originally set to expire in September 2023, but extended to December 31, 2024 — created an urgent need to address critical issues like THC limits and the regulation of novel hemp-derived cannabinoids. A major point of contention was the proposed shift from defining hemp based on Delta-9 THC concentration (0.3 percent or less) to “total THC,” which includes THCA.

This change had the potential to significantly impact farmers and processors, as many hemp varieties that are compliant under the Delta-9 THC rule could exceed the 0.3 percent limit when THCA is included.

Various bills and amendments were proposed in 2024 as part of the Farm Bill discussions, each with different approaches to regulating hemp. Separate regulatory frameworks for industrial hemp and hemp grown for cannabinoids were suggested, and many states took their own action, leading to a patchwork of regulations and even outright bans.

Despite challenges, data from the US Department of Agriculture suggests signs of recovery.

The department's annual National Hemp Report from 2024 points to an 18 percent increase in industrial hemp production value between 2022 and 2023, with output growth seen in specific sectors like floral (18 percent), fiber (133 percent) and seed hemp (414 percent). The 2025 report from the Department of Agriculture indicates further expansion, with notable increases observed in both acreage (up 64 percent from 2023) and value (46 percent).

The 2024 Farm Bill ultimately did not pass, and right now the hemp industry is operating under a temporary extension of the 2018 Farm Bill under the American Relief Act of 2025, signed into law on December 21, 2024.

The 2018 Farm Bill is now set to expire on September 30, 2025.

While analysts for Markets and Markets project that the North American hemp industry will grow at a CAGR of 22.4 percent and ultimately reach a valuation of US$30.24 billion by 2029, the future of the industry will be heavily influenced by the outcome of the ongoing Farm Bill discussions.

US cannabis legalization remains stalled

Although there is clear demand for cannabis products, the now-defunct rescheduling process in the US is likely to continue casting a shadow of uncertainty over the industry's long-term trajectory.

Legal and procedural delays, including allegations of improper conduct and bias within the US Drug Enforcement Administration (DEA), led to hearing cancellations, and the new administration of US President Donald Trump has brought leadership changes to key agencies like the DEA and the Department of Justice.

Terry Cole, who Trump nominated to be DEA administrator on February 11, has a history of opposing cannabis legalization in the country. Similarly, Pam Bondi, Trump’s pick to lead the justice department, staunchly opposed a movement to legalize medical cannabis during her tenure as Florida’s attorney general.

While there have been bipartisan efforts in Congress to end federal cannabis prohibition and establish regulations for eventual legalization, the DEA’s actions and statements indicate a potential stall or reversal of progress.

In addition to that, new research is adding complexity to the debate.

A study published in the American Journal of Psychiatry this past March highlights an association between the use of high-potency cannabis strains and increased risks of psychosis, a factor that may not have been fully considered by the Department of Health and Human Services. As stronger cannabis strains become more widely available, a reassessment of their potential health risks may be required.

Investor takeaway

While the cannabis industry holds promise for growth and innovation, investors must remain acutely aware of the regulatory uncertainties and market volatility that will undoubtedly shape its trajectory in the years to come.

Don’t forget to follow us @INN_Cannabis for real-time news updates!

Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.

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Medical cannabis was federally legalised in 2016, and the export of cannabis from Australia was legalised in 2018. As for recreational use, the only state to legalise recreational use and possession so far is the Australian Capital Territory, which did so in 2020, but it did not establish a regulated recreational cannabis market.

The country's medical cannabis market has been steadily expanding in size and scope. A Penington Institute report shows that Australians spent approximately AU$400 million on medicinal cannabis in the first half of 2024, 72 percent higher than the AU$234 million they spent over the entirety of 2022.

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