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Lexaria Updates Current GLP-1 Market

KELOWNA, BC / ACCESSWIRE / October 8, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery technology, provides an update on recent glucagon-like peptide-1 ("GLP-1") receptor agonist market sector advancements.

In 2020 the total market size for GLP-1 drugs was less than $4 billion . That same year, Novo Nordisk® paid $1.8 billion to purchase Emisphere's® SNAC drug delivery technology which was subsequently incorporated into Rybelsus® semaglutide oral tablets, resulting in the first and only Food and Drug Administration ("FDA") approved GLP-1 drug for use as an oral tablet.

Today, the GLP-1 market is growing faster than nearly all historic forecasts had predicted. Bay Bridge Bio has published a useful interactive chart which highlights that, while there are a number of GLP-1 drug brands available today, over 95% of the current market is served by only two drugs : semaglutide (Wegovy®, Ozempic®, Rybelsus®) manufactured by Novo Nordisk®; and the dual action GLP-1 plus glucose-dependent insulinotropic polypeptide ("GIP") receptor agonist tirzepatide (Mounjaro®, Zepbound®) manufactured by Eli Lilly®. Combined revenue of these two drugs during Q2, 2024, was $11.04 billion compared to $5.89 billion in Q2, 2023, and just $2.55 billion during Q2, 2022. As a stark comparison, these drugs generated less than $300 million during the entire year of 2018.

Despite this unprecedented growth, GLP-1/GIP drugs currently delivered by oral tablet comprise only roughly 10% of the entire market dominated by injectable delivery. The share of the market addressed with oral tablets is likely to grow aggressively as patients are expected to migrate away from injections as more available oral forms become available. Lexaria expects that its DehydraTECH drug delivery system could be a global leader in GLP-1/GIP drug delivery as oral delivery dominates in the years to come.

Analysts around the world have been trying to keep up with GLP-1 trends. Compounding the difficulty in doing so is projecting which major pharmaceutical firms will achieve approval for GLP-1/GIP and related drugs currently in the development pipeline. Tirzepatide, for example, was only approved by the FDA in May, 2022, but Eli Lilly is forecasting $15 billion in revenue from the drug during calendar 2024.

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Expanding Applications For GLP-1 Drugs
The effects of GLP-1 drugs for weight loss and diabetes control are well known, but additional benefits are appearing outside of those original areas of investigation. For example, on March 8, 2024, the FDA approved Wegovy ® (semaglutide) "to reduce the risk of cardiovascular death, heart attack and stroke". A large study of 17,600 people evidenced that weekly semaglutide injections reduced those cardiovascular risks by ~20%.

Heart disease remains the #1 leading cause of death in America, resulting in 702,880 deaths in 2022 . The World Health Organization estimates that cardiovascular diseases cause 17.9 million deaths , globally, each year.

A meta-analysis of 12 studies that included ~73,000 patients has shown reduced harm experienced from chronic kidney disease when GLP-1 drugs were administered. In a large analysis of over 165,000 patients , type-2 diabetic patients with acute kidney disease receiving GLP-1 drugs evidenced lower mortality rates and lower incidences of both major cardiovascular events and major adverse kidney events, than those patients not receiving GLP-1 drugs.

Approximately 35 million people in the US have chronic kidney disease , according to the Center for Disease Control, and it is estimated that 1.2 million people around the world die each year from the disease.

Some of the latest research seems to indicate a connection between GLP-1 drugs and the human brain, wherein inflammation models including heart disease, atherosclerosis, and liver and kidney inflammation may be mediated through the brain.

Given that heart disease and kidney disease are so widespread, and with the latest analytical study data showing that GLP-1 drugs are improving health outcomes for patients with these diseases, it seems likely that, over time, GLP-1 drugs may be approved for additional therapeutic uses in patient populations that far exceed today's regulator-approved disease indications.

GLP-1/GIP and related drugs are already one of the fastest growing sectors in the history of the pharmaceutical industry. Given that these drugs are evidencing an expansion of their therapeutic applications and are expected to be approved by national drug regulators for expanded use; and given that health insurers are increasing their coverage for these drugs, it seems possible that current growth expectations of most analysts are conservative.

Lexaria has already provided evidence that DehydraTECH seems to provide improved drug delivery kinetics and improved blood sugar control with the world's leading GLP-1 drug: semaglutide. Lexaria's interest and focus on the GLP-1/GIP and related drug sector will continue for the foreseeable future with additional studies and evaluation.

About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many 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 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

SOURCE: Lexaria Bioscience Corp.



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