Yearly Archives: 2024

Registered Phase-1b 12-week study will investigate safety, diabetes control, and weight loss

KELOWNA, BC / December 19, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has begun dosing in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study"). The Study is designed mainly to determine whether Lexaria's proprietary DehydraTECH technology improves the safety and effectiveness of existing GLP-1 drugs.

"Achieving the first patient, first dose Study milestone is a critical achievement," said John Docherty, President and Chief Scientific Officer of Lexaria Bioscience Corp. "The world's first 12-week human study evaluating DehydraTECH-processed GLP-1 drugs, in addition to DehydraTECH-CBD, in pre-diabetics or diabetic patients is underway. Potential benefits of reduced side-effects and improved efficacy could be evidenced."

The Study arms are as follows:

• Arm 1 - DehydraTECH-CBD capsules

• Arm 2 - DehydraTECH-semaglutide capsules

• Arm 3 - DehydraTECH-semaglutide combined with DehydraTECH-CBD capsules

• Arm 4 - Rybelsus® tablets (positive control)

• Arm 5 - DehydraTECH-tirzepatide capsules (potential additional arm with offset start date)

Quality control release testing of the clinical test articles has now been completed. The Study is planned to be conducted using seven clinical investigational sites in Australia as a registrational Phase 1b study within Australian clinical regulatory authority regulations. The Study, upon completion, is expected to be regarded as the equivalent of a Phase 1b registrational study by the U.S. Food and Drug Administration ("FDA").

About The Study

The Study is planned to commence with 20 overweight, obese, pre- or type 2 diabetic patients for each of Study arms 1-4, with the potential DehydraTECH-tirzepatide Study arm 5 to be added at a later date if supported by positive results from Lexaria's separate ongoing study GLP-1-H24-3. All drugs will be administered daily by oral tablet or capsule - there are no drug injections involved in this Study.

Arms 2 and 3 of the Study will use DehydraTECH-processed pure semaglutide and will be compared to Study Arm 4 which will use Rybelsus® tablets (semaglutide) that contains Novo Nordisk's proprietary salcoprozate sodium ("SNAC") technology. It is a world-first that pure semaglutide processed with DehydraTECH technology without SNAC will be compared directly to SNAC-enabled Rybelsus® in a multiple week human study.

Arm 1 of the Study will utilize a proprietary, patented DehydraTECH-CBD formulation. Our 2022 diabetes animal study DIAB-A22-1, utilizing DehydraTECH-CBD evidenced weight loss of 7% and reduced blood glucose levels of 19.9%+/-7% (p<0.05) during a multi-week rodent study without the addition of any GLP-1 drugs. Lexaria is looking forward to discovering whether DehydraTECH-CBD studied alone, or together with DehydraTECH-GLP-1, in humans might offer some benefit of improved weight loss and/or reduced side effects as compared to Rybelsus® alone.

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® itself. 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 and/or semaglutide safe over the Study duration in the Study population?

• Does DehydraTECH-(pure) semaglutide outperform Rybelsus®-semaglutide with its proprietary SNAC technology in measures of blood sugar control or weight loss?

• Does DehydraTECH processing enhance real world outcomes such as weight loss and blood sugar control 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?

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
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

North American drug delivery development experts added to help guide Lexaria's strategic plans

KELOWNA, BC / December 18, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces the creation of its new Scientific Advisory Board ("SAB") to assist in guiding Lexaria's rapid drug delivery platform technology and strategic development plans within the pharmaceutical industry.

The SAB will initially be comprised of four people and the Chairman of the SAB will be Lexaria's President and Chief Scientific Officer, John Docherty. Mr. Docherty joined Lexaria in 2015, at the time of its earliest foundational work in the drug delivery technology arena and has led the Company's scientific and intellectual property development programs since that time. Mr. Docherty has degrees in pharmacology and toxicology and is a senior operations and management executive with over 30 years of experience in the pharmaceutical and biopharmaceutical sectors. He has worked with large multinational pharmaceutical companies, as well as emerging private and publicly-traded biopharmaceutical start-ups, where the bulk of his career has been focused on drug delivery platform technology development and commercialization.

Lexaria's SAB has been carefully constituted with the following members to provide expertise in the key areas of pharmaceutical development spanning clinical and preclinical testing, as well as Chemistry Manufacturing and Controls ("CMC") characterization and validation; all of which are vital components of the highly regulated processes of advancing drug and delivery technology programs through to commercialization:

Dr. Michael Gibson M.S., M.D.

Dr. Gibson was recently announced by Lexaria as its new Chief Medical Advisor and will also participate on the SAB. Dr. Gibson is an interventional cardiologist, cardiovascular researcher & educator. He is the CEO of the combined non-profit Baim and PERFUSE research institutes at Harvard Medical School. Dr. Gibson founded PERFUSE in 1987 which served as the thrombolysis and myocardial infarction ("TIMI") Data Coordinating Center that coordinated data for the first 50 TIMI trials. The Baim institute was formerly known as Harvard Clinical Research Institute and was founded in 2000.

Dr. Karen Aust, Ph.D.

Dr. Aust has a Ph.D in Molecular Pharmacology from Stanford University and is deeply experienced in select therapeutic areas including cardiovascular, neuroscience, and more. Dr. Aust has, among other roles, served as a Director of Regulatory Strategy and is currently a Senior Director of Regulatory Affairs at G&L Healthcare Advisors. Her particular experience in US regulatory 505(b)(2) development programs is of exceptional value to Lexaria, pursuant to its objective to enable streamlined and rapid development of DehydraTECH-enabled drugs.

Prof. Philip Ainslie, Ph.D.

Phil Ainslie is a Professor, Research Chair and co-directs the Centre of Heart, Lung and Vascular Health at the University of British Columbia, Canada. Phil's research program aims to better understand the mechanisms regulating blood flow in health, disease and during environmental stress. His diverse expertise in assessing cardiometabolic and brain function during physiological scenarios ranging from sleep to exercise, the stresses of high altitude to deep-sea diving, and healthy aging to heart and lung disease, has made him a leading authority on vascular function. Of great interest to Lexaria, Phil's work on cerebrovascular function with DehydraTECH has revealed some evidence of a propensity to cross the blood-brain-barrier and improve cerebral blood flow. Phil has published >400 peer-reviewed full manuscripts (h-index: >80; i10 index: >250; >25,000 citations) and has recently co-authored two recent textbooks. Phil has won numerous national and international awards for his research and sits on various senior international scientific leadership and policy advisory groups. Prof. Ainslie has consulted to Lexaria for several years playing a lead role in the development and execution of Lexaria's clinical studies to-date in the therapeutic areas of cardiovascular and cardiometabolic disease.

"I am honoured to be joined by such an esteemed group of medical and pharmaceutical industry experts in directing the further growth and advancement of Lexaria's groundbreaking technology and product development programs," said Mr. Docherty, President and Chief Scientific Officer of Lexaria. "Our scientific advisory board will work together and provide invaluable guidance as Lexaria continues to progress toward expanded commercialization of its widely patented and clinically proven platform drug delivery technology, DehydraTECH."

Lexaria's SAB is expected to meet regularly and will provide assistance and recommendations to the Lexaria management team and board of directors.

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
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

Dr. Gibson joining Lexaria's new scientific advisor board

KELOWNA, BC / December 17, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces the appointment of Dr. Michael Gibson as its new Chief Medical Advisor. Dr. Gibson will collaborate directly with President John Docherty as Lexaria's patented DehydraTECH drug delivery platform continues to expand its applications in GLP-1 and hypertension.

C. Michael Gibson M.S., M.D., is an interventional cardiologist, cardiovascular researcher & educator. He is the CEO of the combined non-profit Baim and PERFUSE research institutes at Harvard Medical School. Gibson founded PERFUSE in 1987 which served as the TIMI Data coordinating center that coordinated data for the first 50 TIMI trials. The Baim institute was formerly known as Harvard Clinical Research Institute and was founded in 2000.

The combined institutes have led over 1,250 studies, published 5,500 manuscripts in peer review literature (including 144 in the New England Journal of Medicine) and have led 70 FDA submissions from their network of 7,000 sites in 57 countries worldwide. Since 2014, Gibson has consistently been ranked as one of the world's most highly cited authors in all of science by Thomson Reuters. In 2021, he was named one of the Fifty of the Most Influential Voices in Healthcare by Medika Life. His work has been cited over 170,000 times.

"Lexaria's drug delivery technology offers exciting new pathways towards improving pharmacokinetic drug performance that could unlock a new era of reduced drug waste and adverse side effects combined with enhanced efficacy," said Dr. Gibson. "I'm excited to pursue new and improved applications for this exciting technology."

"Dr. Gibson has a wealth of knowledge and experience that will benefit Lexaria, particularly in the area of hypertension which remains an area of intense interest for Lexaria," said John Docherty, President. "On behalf of everyone at Lexaria, I welcome Dr. Gibson's contributions as our new Chief Medial Advisor and member of our scientific advisory board."

As Chief Medical Advisor, Dr. Gibson will participate with other scientific and medical experts within Lexaria's newly-formed scientific advisory board in pursuing Lexaria's prioritized objectives in the fields of drug delivery optimization.

Dr. Gibson has led phase 1-4 clinical trials, and cardiology megatrials of over 34,000 patients which eventuate in international approval of drugs like prasugrel, rivaroxaban, betrixaban and andexanet as well as devices such as one that alarms to alert a patient to heart attack. He founded WikiDoc.org and WikiPatient.org and is Editor-In-Chief of over 2,200 active contributors who have edited the content of over 100,000 chapters millions of times over the past 15 years. Gibson also founded www.clinicaltrialresults.org. Gibson serves as Chief Medical Correspondent for the American College of Cardiology. Gibson has over 435,000 followers on social media where he is a leading influencer, second only to Sanjay Gupta in some polls

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
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

• Positive results in recent animal study strongly support first-ever human investigation for DehydraTECH-liraglutide

KELOWNA, BC / December 9, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce the engagement of a contract research organization ("CRO") to design and execute a human pilot study evaluating DehydraTECH-liraglutide against Saxenda® injectable liraglutide.

As reported on November 20^th in Lexaria's 12-week rodent study with unlimited food available, DehydraTECH-processed liraglutide - administered orally - demonstrated a 5.88% weight reduction and 11.54% blood sugar reduction compared to baseline. The Rybelsus® (semaglutide) control, which was expected to outperform liraglutide, instead produced a 5.65% increase in body weight and 0.41% blood sugar reduction compared to baseline during the same 12 weeks.

As a result of the stronger than expected performance of DehydraTECH-processed liraglutide, the Company has made the decision to investigate further with human study GLP-1-H25-5 expected to be conducted with 8-10 healthy volunteers (the "Study"). The goal of the Study will be to demonstrate safety and test pharmacokinetic performance in humans with an oral version of DehydraTECH-processed liraglutide. If positive, it could support a future decision to investigate DehydraTECH-liraglutide in a future Phase I registered trial.

Liraglutide is currently sold only in an injectable form under the brand names Saxenda® and Victoza®, both manufactured by Novo Nordisk. Despite the launch of a genericized version of liraglutide by Teva during 2024, liraglutide sold by Novo Nordisk under the brand name of Saxenda® still generated US$849 million in the first half of 2024; and under the brand name Victoza®, generated an additional US$1.6 billion in recent annual revenue.

"Liraglutide is a multi-billion dollar annual market-size opportunity," said Richard Christopher, CEO of Lexaria. "Several months ago, the US FDA authorized the first generic version of liraglutide, and Lexaria feels that if we are able to demonstrate similar, or superior, delivery of liraglutide via an oral capsule or tablet, we could provoke additional new revenue opportunities for this important GLP-1 drug."

Approved for use by diabetics to control blood sugar, liraglutide has also evidenced an ability to slow cognitive decline in a Phase 2b clinical trial, and reduce shrinkage of those areas of the brain that control memory, learning, and language by nearly 50% as compared to placebo.

Development of the Study protocol is underway and Lexaria and the CRO are evaluating options for selection of the clinical site and jurisdiction in which to perform this Study, which has not yet been determined. Further updates will be provided in due course when Lexaria has obtained the necessary ethics board approval before the Study can begin.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to 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 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 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
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

• Semaglutide being investigated for applications in heart disease, Alzheimer's, liver disease, and more

• GLP-1 drugs expected to generate multi-hundreds of billions of revenues in the years to come

KELOWNA, BC / November 26, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, provides the following strategic update.

Today's GLP-1 drug market consists primarily of semaglutide (Wegovy®, Ozempic®, and Rybelsus®), owned by Novo Nordisk®; and tirzepatide (Zepbound®, Mounjaro®), owned by Eli Lilly™. All five of those drug brands, with the exception of Rybelsus®, are administered by injection, whereas Rybelsus® is the only oral tablet currently approved by the FDA today. While these two drugs were originally approved by the FDA for diabetes management, weight-loss approvals soon followed and Wegovy® was also approved by the FDA in March 2024 to reduce the risk of cardiovascular death, heart attack and stroke.

Acceptance and use of these two drugs by the public has resulted in unprecedented demand, with estimates of 2024 revenue between them of ~$30 billion, compared to just $300 million in 2018, an increase of 100x or 10,000%.

"The GLP-1 market may be the most significant development in pharmaceutical achievements of our lifetimes," said Richard Christopher, CEO of Lexaria. "Given the relatively early stage of investigation and development of these drugs, we simply do not know how big of an impact they will have, but it is safe to say that nearly every person in Europe or North America could experience improvement in their own health, or the health of a loved one, from GLP-1 drugs."

Some are asking whether this trend is a temporary one-off event and whether the recent revenue growth is sustainable; whereas there is a growing realization that - not only is this NOT a temporary event - future revenue growth is likely to be even stronger than that seen in recent years.

There are two main reasons for the growing consensus that revenue in the GLP-1 drug sector will soon be over $100 billion per year: one is that the patient population for diabetes, weight loss, and heart disease is massive and growing, with these drugs demonstrating good overall safety and efficacy. The other reason is that it seems quite likely that the therapeutic benefits from using these drugs is poised for significant expansion based on the evidence that is continually being updated.

Cardiovascular Disease

Recently, Novo Nordisk® announced that Rybelsus® demonstrated a 14% reduction in risk of major adverse cardiovascular events in adults with type 2 diabetes, in a large Phase III trial of 9,650 people. With Wegovy® already FDA-approved for certain cardiovascular disease treatments, Novo Nordisk® will now be seeking FDA approval of Rybelsus® for similar use.

Liver Disease

There are currently no FDA-approved treatments for metabolic dysfunction-associated steatohepatitis ("MASH") liver disease, or for non-alcoholic fatty liver disease. GLP-1RAs have been reported to reduce liver fat content and liver enzymes, reduce oxidative stress and improve hepatic de novo lipogenesis and the histopathology of MASH. The MASH treatment market is forecasted to possibly reach $20 billion by 2032. Of the several leading pharmaceutical companies exploring treatment options for MASH, Pfizer is investigating its own GLP-1 molecule, danuglipron, as a potential daily tablet solution but is too early in its development to have received FDA approval at this time.

In 2020, Merck® agreed to pay up to $860 million in milestone payments to acquire the rights and licence to efinopegdutide, a GLP-1/GIP drug that was granted a Fast Track designation from the FDA in 2023 for the treatment of MASH.

Boehringer Ingelheim® has also been granted a Fast Track designation from the FDA for its molecule survodutide, yet another GLP-1 drug originally designed for application with obesity but now additionally being examined for certain liver diseases.

Sleep Apnea, Knee Pain

Following a Phase III study that showed an astonishing 63% reduction in apnea-hypopnea, Eli Lilly™ announced it would be seeking FDA approval for Zepbound® to be used for treating sleep apnea. Eli Lilly™ is also investigating its triple-agonist drug, retatrutide, for use in knee osteoarthritis as well as sleep apnea.

Not to be outdone, Novo Nordisk® has also reported that those who are overweight place additional stress on the knee and its protective cartilage and that in a study of 407 people diagnosed with knee arthritis, knee pain was reduced more thoroughly when those patients were treated with semaglutide than when they received a placebo.

Alzheimer's and Dementia

While GLP-1 drugs are known for triggering gastro-intestinal effects that create a sense of fullness, thus facilitating the treatment of obesity and diabetes, many investors have not yet realized that GLP-1 and related drugs have actions at main types of human brain receptors. Commercially available GLP-1 drugs have already shown an ability to bind with those receptors, but if and only if they are capable of crossing the blood-brain-barrier sufficiently upon administration. Lexaria has repeatedly shown, in previous studies with other drugs, that its DehydraTECH technology can at times improve the delivery of drugs into brain tissue. Lexaria's recently completed animal study WEIGHT-A24-1, is investigating for the brain absorption of DehydraTECH-processed GLP-1 drugs in study animals with data pending and expected to be released in either December, or in January, 2025.

Dulaglutide, owned by Eli Lilly™, is a GLP-1 drug that has shown a particular affinity to enter the brain, and, in a large human study of 8,828 participants, it has shown a significant benefit to cognition.

As well, liraglutide, owned by Novo Nordisk®, has also evidenced an ability to slow cognitive decline in a Phase 2b clinical trial, and reduce shrinkage of those areas of the brain that control memory, learning, and language by nearly 50% as compared to placebo. Semaglutide is also showing promising early-stage reduced risks against neurodegeneration and neuroinflammation.

Chronic Kidney Disease

Eli Lilly™ is conducting active research including a Phase II study expected to complete in early 2026, examining tirzepatide as a possible treatment for chronic kidney disease ("CKD"). If successful it is reasonable to expect Eli Lilly™ to progress to Phase III development and ultimately apply to the FDA for approval of the use of tirzepatide to treat this often life-threatening condition if successful.

Further, 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.

As well, Novo Nordisk® has earlier announced a successful outcome of a human trial of 3,533 people with CKD and type 2 diabetes using injected semaglutide. The study "demonstrated a statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney death of 24%."

Conclusion

The applications of GLP-1 and related drugs are still being identified. Given the widespread and rapid adoption of these drugs by tens of millions of people, data is being generated in real time at a scale never encountered before. The benefits of weight loss and diabetic control are obvious though not even close to being fully realized at this time, while the benefits in other areas of human health are still being discovered. Lexaria intends to continue research and development of its DehydraTECH drug delivery platform technology with as many GLP-1 and related drug molecules as it possibly can, in an attempt to identify broad areas of prospective commercial applicability for it to continue to participate in arguably the most exciting field of drug development in modern times.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to 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 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 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
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

DehydraTECH-processed tirzepatide from Zepbound® is being tested in an oral dose format

KELOWNA, BC / November 25, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that dosing has been completed for human pilot study #3 (the "Study") investigating a DehydraTECH-processed version of the dual action glucagon-like peptide-1 ("GLP-1") + glucose-dependent insulinotropic peptide ("GIP") receptor agonist tirzepatide (sold commercially as Zepbound®) in an oral dose format.

The Study has been dosed in nine (9) healthy volunteers. The final seven-day dosing phase, wherein all subjects received the opposite treatment condition from that which they received during the initial dosing phase, was completed on November 16^th. The initial dosing phase of either a seven-day regimen of oral DehydraTECH-processed tirzepatide capsules or a single injected tirzepatide dose was reported upon positively several weeks ago.

No serious adverse events have been observed thus far during both dosing visits, which serves as a point of interest given Lexaria's desire to create an effective oral version of Eli Lilly's™ tirzepatide products, which currently only exist in an injectable form.

The DehydraTECH composition for the Study was compound-formulated using the commercially available Zepbound® injectable formulation as the tirzepatide input material. Tolerability (side effects), blood absorption levels (pharmacokinetics or "PK"), and blood sugar control are being evaluated in the Study.

Tirzepatide is currently approved for use in the United States under the brand names Zepbound® and Mounjaro®, both owned by Eli Lilly™. These two brands combined are expected to generate approximately $15 billion in revenue in 2024. Eli Lilly™ recently announced that tirzepatide evidenced a 94% reduction in risk of progression to type 2 diabetes over a three-year study, and a reduction of 23% of bodyweight, on average, maintained for three years.

In two previous human pilot studies, Lexaria has evidenced that the oral administration of semaglutide (sold by Novo Nordisk® under the brands Rybelsus®, Ozempic®, and Wegovy®) processed with DehydraTECH yielded improvements in absorption rates and a reduction in both blood sugar and in adverse events, as compared to Rybelsus® tablets alone. The two drugs, semaglutide and tirzepatide, are believed to constitute over 90% of all revenue generated in the GLP-1 / GIP sector today.

Through the Study, Lexaria is attempting to evidence meaningful absorption rates of tirzepatide in an oral format, which is not available in the market today since it is currently administered only by injection. The Company expects that data analysis will occur in December with results available in January, 2025.

About the Study

Many design characteristics of the Study, also referred to as Study GLP-1-H24-3, are similar to Lexaria's initial GLP-1 human pilot study #1. The DehydraTECH-tirzepatide test articles were compound formulated using Zepbound®, strictly for research purposes, and dosed to the subjects under fasted conditions. The Study is designed to measure tolerability and side effects, blood levels of tirzepatide, and blood glucose levels. The DehydraTECH-tirzepatide composition was formulated at a strength of 20 mg tirzepatide administered orally daily for seven days. The Zepbound® formulation had a strength of 2.5 mg tirzepatide administered once via injection with the subject monitored over the same seven-day duration applicable with the oral DehydraTECH-tirzepatide condition. Blood samples were taken multiple times during the first 12 hours post dosing on the first day of each treatment phase, with a final blood draw taken 24 hours after dosing; and, a standardized meal was fed to the test subjects at a point in time after dosing. Single blood samples were also taken daily on each of the second through eighth days following commencement of each dosing visit. A total of 9 healthy subjects completed dosing with each test article following a randomized, cross over study design across two study phases.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to 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 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 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
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

• DehydraTECH-liraglutide and a select DehydraTECH-CBD formulation were the top performing groups in the Study outperforming the Rybelsus® control group in both body weight-loss, by 11.53% and 10.65% respectively, and in blood sugar, by 11.13% and 3.35% respectively.

• DehydraTECH-semaglutide compositions with and without SNAC technology outperformed Rybelsus® control in body weight

• Weight-control improvement demonstrated in ALL study groups during the final 4-weeks

• Outcomes are strongly supportive of pending Phase 1b Australian human study

KELOWNA, BC / November 20, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received final 12-week body weight and blood sugar results from all 12 study groups of the recently completed diabetes animal study WEIGHT-A24-1 (the "Study").

The Study results were highlighted by the fact that all groups utilizing Lexaria's proprietary DehydraTECH technology outperformed Rybelsus® in body weight-control, as well as experienced body weight-control improvement during the final 4-weeks of the Study.

Furthermore, in all but group A, by week 12, the degree of improvement over Rybelsus® in body weight-control was statistically significant, p<0.05. Also of note were the top performing DehydraTECH-liraglutide and DehydraTECH-CBD groups (H and B). These groups outperformed the Rybelsus® control group by week 12 in body weight-control by 11.53% (p<0.0001) and 10.65% (p=0.0002) respectively and in blood sugar control by 11.13% (p=0.0395) and 3.35% (p=0.3853) respectively.

This Study was specifically designed to perpetuate a diabetic condition throughout the 12-week duration by offering the animals unlimited food and water, 24-hours per day, in order to examine and compare the relative performance of each Study group. It was not designed to maximize weight loss or blood glucose reduction and, therefore, its results should not be compared to third-party weight loss studies specifically optimized for those purposes. Accordingly, weight gain would not be an unexpected outcome of the Study, especially with orally administered glucagon-like peptide-1 ("GLP-1") drugs that are specifically designed to be taken by humans on an empty stomach after overnight fasting.

Study group "K" was a placebo wherein the animals only received water in lieu of any drug (the "Placebo Group"). The animals in the Placebo Group experienced an average weight gain of 1.40%, and an average increase in blood sugar of 10.33% over the Study duration. These are the benchmarks used for comparative purposes.

Study group "L" was a positive control wherein the animals received unadulterated Rybelsus® as the only FDA-approved oral GLP-1 drug on the market today, to utilize as a so-called "standard of care" (the "SOC Group"). The animals in the SOC Group experienced an average weight gain of 5.65%, and an average reduction in blood sugar of -0.41% over the Study duration.

All three of the DehydraTECH-semaglutide groups (E, F, and G) achieved superior body weight-control results throughout the duration of the Study than both the Placebo Group and the SOC Group. Notably, the DehydraTECH-semaglutide groups included formulations created using Rybelsus® as the semaglutide input (E and F) and a formulation created using pure semaglutide drug substance as the semaglutide input (G) without the salcaprozate sodium ("SNAC") technology integral to Novo Nordisk's commercially available Rybelsus® product performance.

Those same three groups (E, F, and G) achieved mostly superior blood sugar control results as compared to the Placebo Group throughout the duration of the Study and mostly superior blood sugar control results as compared to the SOC Group at the 4^th and 8^th week durations, but inferior results compared to the SOC Group by the 12^th week duration.

Most of the DehydraTECH-CBD formulation groups (A, B, C, and D) achieved their best weight-control performance during the final 4 weeks of the Study, implying that a longer-term study may be required to determine the full extent of weight loss possible with DehydraTECH-CBD. Those same four formulation groups (A, B, C, and D) all achieved superior blood sugar control performance than the Placebo Group at the 8^th and 12^th week, and mostly superior blood sugar control performance to SOC Group at the 4^th and 8^th week periods. The SOC Group achieved its best blood sugar control in the final four weeks of the study.

Animal Weights (grams)

Notes

- Groups A through D were different DehydraTECH-CBD compositions
- Groups E and F were reformulated Rybelsus DehydraTECH compositions
- Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively) in DehydraTECH compositions
- Recalculations led to slight changes from earlier reported data
- Group K received only water as a placebo control versus the other groups that received water+drug at dosing
- Group L received unadulterated Rybelsus® with no DehydraTECH processing

Both of the combination drug groups (I and J) achieved superior body-weight control performance to both the Placebo Group and SOC Group at the 12^th week, but inferior blood sugar control across most time points.

Blood Sugar Levels (mmol/L)

The two groups of the Study (I and J), that combined doses of either DehydraTECH-semaglutide or DehydraTECH-liraglutide with DehydraTECH-CBD were generally worse performers than either of the drugs alone with respect to blood sugar control, although, regarding reduced body-weight control, they were nonetheless generally superior to both the Placebo Group and the SOC Group.

"Overall, the findings from our animal study showed benefits of DehydraTECH-processing with all drugs studied alone or in combination relative to the Rybelsus® control formulation," said John Docherty, President & CSO of Lexaria Bioscience Corp. "This Study is strongly supportive of our plans to advance to our upcoming Phase 1b chronic dosing clinical study in Australia through our Australian subsidiary, Lexaria (AU) Pty Ltd, which we have endeavoured to design to allow for maximum impacts upon blood glucose and body weight control while also evaluating safety and tolerability in humans."

All body weight and blood glucose findings from the Study, including from the SOC Group and Placebo Group, have now been received. Additional data processing and interpretation remains, including the analyses of brain and blood absorption pharmacokinetic results and more. Lexaria has not yet received this data from the third-party lab and will report upon same when results are available.

About the Study
The Study model selected - diabetic Zucker rates with unlimited food and water provided 24 hours per day - is a more stringent model design than that used in most studies primarily focused on weight loss. As such, it is expected that weight loss results within this Study would be less than other third-party weight loss studies and that weight gain would not be unexpected. The primary rational for conducting this Study was to perform a relative comparison of many different formulations and test for relative differences between them in a diabetic state purposefully perpetuated for the duration of the Study. Future animal work that is primarily focused on weight loss - already under design by Lexaria - will use a study model more typical of weight loss studies that do not provide 24-hour unlimited food and water.

Study WEIGHT-A24-1 was completed using diabetic, pre-conditioned Zucker rats. Each group of the Study was dosed for a 12-week period following the initial acclimation period. During the Study, over 1,500 blood plasma samples were collected from the total starting rat population of 72 animals for purposes of detailed PK drug delivery analyses. Because of the small animal population in each Study group, statistical significance was not necessarily expected - though achieved in some instances - and commentary on apparent trends has been noted. Body weight and blood glucose readings were taken prior to Study start continuing at regular intervals during and at conclusion of the dosing period. Brain tissue is also in the process of being analysed to help determine whether DehydraTECH processing results in higher brain absorption than non-DehydraTECH groups, as Lexaria has evidenced numerous times in previous animal studies. The Study also included a comprehensive battery of liver and kidney function testing and blood chemistry analyses that remain to be analysed and reported. LC-MS/MS and other techniques were used to analyse samples.

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
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

World's First-Ever Study Tracking Biodistribution of DehydraTECH GLP-1 Molecules

KELOWNA, BRITISH COLUMBIA / November 14, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has engaged a contract research organization to perform the world's first-ever fluorescently tagged DehydraTECH-semaglutide ("FTS") rodent biodistribution study (the "Study").

Distribution of a drug once it enters the body can provide vital clues as to the understanding of that drug's ability to bind with targeted receptor cells, avoid concentration at physical sites that might be prone to fostering adverse side effects, and increase the drug's ultimate efficacy. Lexaria hopes to discover whether the DehydraTECH processing of semaglutide improves its biodistribution in any significant way compared to conventional orally administered semaglutide formulation practices.

The FTS will be tracked via fluorescent imaging detection to evidence how and where the semaglutide distributes and localizes following oral ingestion in Sprague-Dawley rats. Later in the Study, the animals will be euthanized and various key tissues will be examined including the brain, pancreas, lung, kidney, liver and heart for more detailed fluorescent imaging detection showing very specific tissue localization patterns and concentrations.

Lexaria has already begun the early-stage collaboration with the third-party laboratory that will synthesize the FTS that will then be used to create the DehydraTECH-semaglutide test articles. There will be two different test articles manufactured and tested:

• FTS will be combined with ingredients in the proportions used within the Rybelsus® orally-administered product sold today designed to mimic Rybelsus® performance, without DehydraTECH processing.

• FTS will be combined with patented DehydraTECH ingredients and processes to evidence potential biodistribution differences when DehydraTECH is used compared to the Rybelsus®-mimicking control FTS formulation.

The Study will also include use of certain glucagon-like peptide-1 ("GLP-1") receptor specific antibodies detectable through an immunofluorescence methodology to allow the analytical laboratory to confirm the extent of GLP-1 receptor binding of the two FTS formulations in the tissue samples taken from the animals, providing an additional detailed measure of the FTS distribution and localization patterns.

Results from the Study will enhance any future communications between Lexaria and prospective industry partners. Study work has already begun with completion and final reporting expected in May, 2025.

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
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

DehydraTECH clinical test article manufacturing has been completed

KELOWNA, BC / November 13, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX, LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has received lead clinical site human research ethics committee ("HREC") approval that was required before dosing can begin in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study").

The Company is also announcing that clinical test article manufacturing for all planned Study arms has already been completed. This includes production for the four planned DehydraTECH formulation Study arms and clinical repackaging of the commercially available Rybelsus® comparator tablets for the Study control arm as follows:

Arm 1 - DehydraTECH-CBD capsules

Arm 2 - DehydraTECH-semaglutide capsules

Arm 3 - DehydraTECH-semaglutide combined with DehydraTECH-CBD capsules

Arm 4 - Rybelsus® tablets (positive control)

Arm 5 - DehydraTECH-tirzepatide capsules (optional arm with offset start date)

It is possible that the First Patient, First Dose ("FPFD") Study milestone could be achieved in late December, and failing that, in January, 2025.

"We are delighted by the work of our project team in completing study documentation preparation and primary ethics board submission so quickly and efficiently," said John Docherty, President of Lexaria Bioscience Corp. "Their nearly round-the-clock work has resulted in a rapid ethics board approval so that the study can start dosing as soon as possible. Together with our expedited manufacturing processes recently completed, we have potentially saved months of time."

The Study is planned to be conducted using seven clinical investigational sites in Australia as a registrational Phase 1b study within Australian clinical regulatory authority regulations. HREC approval has been received for the primary clinical site, while clinical trial notification acknowledgement by the Australian Therapeutic Goods Administration and HREC approvals for the remaining clinical sites remain to be completed; but expected shortly now that primary site HREC approval is in hand. Quality control release testing of the clinical test articles also remains to be completed. The Study, upon completion, is expected to be equally regarded as a Phase 1b registrational study by the U.S. Food and Drug Administration ("FDA").

About The Study

The Study is planned to commence with 20 overweight, obese, pre- or type 2 diabetic patients for each of Study arms 1-4, with the DehydraTECH-tirzepatide Study arm 5 to be added at a later date if supported by positive results from Lexaria's separate ongoing study GLP-1-H24-3. All drugs will be administered daily by oral tablet or capsule - there are no drug injections involved in this Study.

Arms 2 and 3 of the Study will use DehydraTECH-processed pure semaglutide and will be compared to Study Arm 4 which will use Rybelsus® tablets (semaglutide) that contains Novo Nordisk's proprietary salcoprozate sodium ("SNAC") technology. It is a world-first that pure semaglutide processed with DehydraTECH technology without SNAC will be compared directly to SNAC-enabled Rybelsus® in a multiple week human study.

Arm 1 of the Study will utilize a proprietary, patented DehydraTECH-CBD formulation. Our 2022 diabetes animal study DIAB-A22-1, utilizing DehydraTECH-CBD evidenced weight loss of 7% and reduced blood glucose levels of 19.9%+/-7% (p<0.05) during a multi-week rodent study without the addition of any GLP-1 drugs. Lexaria is looking forward to discovering whether DehydraTECH-CBD studied alone, or together with DehydraTECH-GLP-1, in humans might offer some benefit of improved weight loss and/or reduced side effects as compared to Rybelsus® alone.

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® itself. Also, in rodent study work Lexaria has undertaken with updates 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 as have been shown to be integral to SNAC-enabled semaglutide gut absorption.

Lexaria has several important objectives for this Study:

• Is DehydraTECH processed CBD and/or semaglutide safe over the Study duration in the Study population?

• Does DehydraTECH-(pure)semaglutide outperform Rybelsus®-semaglutide with its proprietary SNAC technology in measures of blood sugar control or weight loss?

• Does DehydraTECH processing enhance real world outcomes such as weight loss and blood sugar control 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?

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
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

DehydraTECH™ for GLP-1 being optimized for global pharmaceutical use

KELOWNA, BC / November 7, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms provides the following glucagon-like peptide-1 ("GLP-1") industry update.

It is no surprise that Novo Nordisk's ("Novo") blockbuster drug, semaglutide, which is sold under the brand names Ozempic®, Wegovy®, and Rybelsus®, is the bestselling diabetes and weight loss drug in the world today. Novo has, for one hundred years, been the world's leading diabetes drug and research company, after receiving the extraction and purification techniques from the Canadian doctor who discovered insulin in 1921. They owned six of the world's top-15 bestselling diabetes drugs, for combined sales in 2022 of US$16.87 billion for diabetes applications alone, and in just the first half of 2024 generated $8.3 billion from sales of the blockbuster drug, Ozempic®.

Lexaria's strategy is to continue developing and optimizing our wholly-owned DehydraTECH™ drug delivery platform for application in the GLP-1 space, positioning it as a "must-have" technology for larger companies seeking to develop, defend or increase their cash flows from existing drugs as well as to be utilized in early stages of drug development for next-gen GLP-1 drugs due to hit the market in 2026, 2027, and beyond.

An 'arm's race' of sorts has begun amongst the world's pharmaceutical companies once it became apparent that the GLP-1 drugs responsible for life-changing outcomes in diabetes management were also responsible for impressive weight-loss benefits. Close behind Novo is Eli Lilly with its own drug, tirzepatide, which is branded as both Mounjaro® and Zepbound®. Because of its dual action properties, working on both GLP-1 receptors and also glucose-dependant insulinotropic polypeptide pathways ("GIP"), tirzepatide is even more effective at weight loss and is expected by some analysts to reach $50 billion in global total annual revenue.

Global pharmaceutical companies are competing against each other in the GLP-1 space utilizing three main strategies:

1. Developing or acquiring their own new GLP-1 and related molecules under traditional drug development techniques;

2. Developing or acquiring technologies and intellectual property ("IP") that improves the delivery pharmacokinetics of GLP-1 in attempts to increase drug absorption and decrease drug side effects; and,

3. Developing or acquiring related technologies and IP that can act as platforms for improved drug performance and patient outcomes.

On November 4, 2024, Ascendis Pharma announced it had granted an exclusive worldwide license to its technology platform to Novo for Novo products in metabolic disease - obesity and type 2 diabetes. In return, Ascendis will be eligible to receive total payments of US$285 million from Novo for this initial program, as well as payments up to an additional $77.5 million for each additional disease product candidate.

On September 18, 2024, it was reported that Novo was agreeing to pay NanoVation Therapeutics up to $600 million, plus research funding in addition to tiered royalties to collaborate on up to seven programs for technology utilizing NanoVation's lipid nanoparticle technology.

On September 16, 2024, Korro Bio announced a collaboration wherein it could receive up to $530 million in aggregate payments from Novo to apply Korro's patented platform to develop RNA editing product candidates focused initially on cardiometabolic diseases.

In September 2024, Eli Lilly began working with Haya Therapeutics by way of up to a $1 billion investment, to use a proprietary RNA-guided genome platform to target obesity and other metabolic conditions.

In August, 2024, Canadian-based Inversago Pharma announced its pending acquisition by Novo for up to $1.08 billion if certain milestones are achieved. Inversago has its own weight loss drug, INV-202, that showed weight loss of 3.3% in a small human study of 37 people.

In February, 2024 Viking Therapeutics announced positive Phase II weight-loss results from its GLP-1/GIP drug and watched its company valuation sore from less than $2 billion to more than $8 billion as a result. Viking is considered by some to be a leading takeover candidate for more-established pharmaceutical companies looking to stake their ground in the GLP-1 sector.

In February, Novo paid $16.5 billion to acquire its contract manufacturer Catalent, and their three manufacturing plants working diligently to churn out Ozempic® and Wegovy®, vertically integrating the semaglutide franchise.

In December, 2023, Eli Lilly agreed to pay up to $494 million to Fauna Partnership, to utilize its artificial intelligence platform to search for new molecules focused on weight loss.

The GLP-1 and related drug sector has generated tens of billions of dollars in corporate M&A and licensing activity even as it is on its way to becoming one of the largest drug sectors in history with estimates widely ranging from $100 billion per year to as much as $471 billion per year in revenue.

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
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.