Author Archives: mmcdonald

Pursuing the world's first-ever orally-dosed liraglutide

KELOWNA, BC / ACCESS Newswire / February 20, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces that it has made a strategic business decision to further investigate the commercial opportunities and applications for a unique new GLP-1 solution: orally taken liraglutide processed with our wholly-owned DehydraTECH™ enhancement technology.

"Our ability to work with liraglutide, which went off-patent last year, is an opportunity that does not often present itself," said Rich Christopher, CEO of Lexaria. "Lexaria has already demonstrated that our unique DehydraTECH technology seems to deliver potent oral delivery performance characteristics to liraglutide. This opens the door to the possibility of Lexaria developing and selling the world's first oral capsule or tablet version of liraglutide."

As part of that strategic business decision, Lexaria has already filed certain patent applications related to DehydraTECH-enhanced oral liraglutide which, if granted, will further support Lexaria's ability to commercialize oral DehydraTECH-liraglutide. Presently, there is no oral version of liraglutide available commercially anywhere in the world and Lexaria is hopeful that potential new patent awards in this sector could be of strategic value to the Company.

Lexaria's patent applications are reinforced by the successful animal study results announced on November 20, 2024 that evidenced superior pharmacodynamic ("PD") performance. In that study, DehydraTECH-liraglutide outperformed the Rybelsus® control group by week 12 both in terms of blood sugar and body weight control, by 11.53% (p<0.0001) and 11.13% (p=0.0395) respectively.

Those positive study results reinforced Lexaria's diversified strategy to conduct work, all at the same time, on all three of the world's leading GLP-1/GIP weight-loss/diabetes drugs: liraglutide, semaglutide, and tirzepatide. Estimated global 2024 revenue of these three drugs is~$30 billion, compared to just $300 million in 2018, an increase of 100x or 10,000%.

To support the broader strategy of entering the GLP-1 weight loss and diabetes control market as quickly as possible, Lexaria is also preparing to commence pilot clinical testing of DehydraTECH-liraglutide in humans, as announced on January 15, 2025, when we received the necessary independent ethics board approval that allowed our contract research organization to begin to implement and execute human pilot study GLP-1-H25-5 (the "Study"). That Study will compare an oral version of liraglutide, formulated from the DehydraTECH-processing of Saxenda® to the conventional injected liraglutide (Saxenda®).

If that Study is successful, Lexaria intends to begin additional registrational clinical testing to demonstrate wider safety and PD performance utilizing orally-dosed DehydraTECH-liraglutide. Positive results could then be used as part of a potentially accelerated regulatory approval pathway with the Food and Drug Administration to seek approval to launch the world's first orally-dosed liraglutide, ideally with the approval of liraglutide's developer, Novo Nordisk®.

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 injected version of liraglutide by Teva® during 2024, liraglutide sold by Novo Nordisk® under the brand names of Saxenda® still generated US$849 million in the first half of 2024; and generated an additional US$1.6 billion in recent annual revenue under the brand name Victoza®.

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

About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients enter the bloodstream through oral delivery. Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral 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. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 48 patents granted and additional patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating 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.

Additions broaden DehydraTECH patent suite for Epilepsy

KELOWNA, BC / ACCESS Newswire / February 11, 2025 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce that we have been granted two new patents from the United States Patent and Trademark Office for the use of DehydraTECH™ enhanced processing technology related to the treatment of epilepsy.

"We are thrilled to have received broadened claims related to our proprietary DehydraTECH™ technology for the treatment of epilepsy," said Rich Christopher, CEO of Lexaria. "Each of our patent awards enhances our ability to reach commercial criticality while providing enhanced value to our potential pharmaceutical partners and, ultimately, to patients."

Lexaria has received its 5^th and 6^th US patents granted in its patent family #24, Compositions and Methods for Treating Epilepsy. These patents complement earlier research which indicated that DehydraTECH-CBD was capable of mitigating epileptic seizures in rodents, and was also absorbed into the bloodstream more effectively than the commercially available cannabinoid-based anti-seizure medication, Epidiolex®. The new patents expire in 2043, if not extended, and increase Lexaria's granted patent total to 48.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients enter the bloodstream through oral delivery. Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral 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. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 48 patents granted and additional patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating 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, BC / ACCESS Newswire / February 6, 2025 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces that dosing has begun in its 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 the conventional orally administered semaglutide formulation practice.

The FTS will be tracked via fluorescent imaging detection to evidence how and where semaglutide distributes and localizes following oral ingestion by 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. These tissues will be subject to more detailed fluorescent imaging detection exams which should show very specific tissue localization patterns and concentrations.

Two different test articles were manufactured for evaluation:

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

• FTS 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 includes use of a certain glucagon-like peptide-1 ("GLP-1") receptor that makes specific antibodies detectable through an immunofluorescence methodology. This will 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, and additional information will be released when available.

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.

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

KELOWNA, BC / ACCESS Newswire / February 5, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to provide progress updates on its Phase 1b, 12-week chronic study GLP-1-H24-4 (the "Study") underway in Australia.

Lexaria has completed its submission to the human research ethics committee ("HREC") for its planned addition of Study Arm 5 to evaluate performance of its DehydraTECH-tirzepatide formulation, pursuant to the positive findings it previously achieved and released for Human Pilot Study #3 (GLP-1-H24-3).

In addition, the Company is pleased to report that it has received HREC approval for all 4 of the original arms for all clinical sites participating in the Study. Lexaria had previously reported it had received HREC approval for the lead clinical site, and that it also had completed all clinical test article manufacturing.

"Lexaria thanks its regulatory and clinical team for their efforts to complete these milestones," said John Docherty, President and Chief Scientific Officer of Lexaria Bioscience Corp. "We are especially excited about the prospect of adding the 5^th Arm to this Study following the results of our Human Pilot Study #3 which not only showed comparability in terms of both blood glucose reduction and increased levels of insulin but also a significant reduction in adverse events related to the oral administration of Eli Lilly's Zepbound®, once processed with our proprietary DehydraTECH™ technology."

About The Study
The Study is underway with 20 overweight, obese, pre- or type 2 diabetic patients for each of Study Arms 1-4, with Study Arm 5 to test DehydraTECH-processed pure tirzepatide. The 5^th Arm is in the process of being added because of the previously announced positive results from Lexaria's separate study Human Pilot Study #3. All drugs will be administered daily by oral tablet or capsule - there are no drug injections involved in this Study as Lexaria is promoting a change in the standard of care away from injections and instead embracing oral DehydraTECH delivery.

Arm 1 of the Study is utilizing 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 in humans whether DehydraTECH-CBD studied alone, or together with DehydraTECH-semaglutide as is being explored in Arm 2, might offer some benefit of improved weight loss and/or reduced side effects as compared to Rybelsus® alone.

Arms 2 and 3 of the Study are using 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.

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

Lexaria has several important objectives for this Study:

• Is DehydraTECH processed: CBD, semaglutide, and/or tirzepatide safe over the 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.

KELOWNA, BC / ACCESS Newswire / January 30, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW), (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to provide this annual letter from its Chief Executive Officer ("CEO") Richard Christopher as a strategic update to all stakeholders.

CEO Letter to Stakeholders

Dear Fellow Stakeholders,

It is with great pleasure that I continue the long-standing tradition, established by my predecessor Chris Bunka, of delivering Lexaria's annual letter from the CEO.

In 2024, Lexaria made the course changing commitment to becoming an oral based drug delivery enabling technology company focused on one of the largest and fastest growing drug sectors in the world today - GLP-1. To that end, we conducted a series of human and animal studies which produced extremely encouraging pharmacokinetic, weight, blood glucose, insulin, and safety results. The success of these studies is a true testament to the effectiveness, versatility, and promise of our proprietary DehydraTECH^TM technology platform within, and outside of, GLP-1.

I welcome this opportunity to summarize last year's results and achievements, as well as to present you with a look into the year ahead.

(Please note: all dates within this letter refer to calendar periods versus fiscal periods)

2024 Highlights

• The Company successfully raised $13.4M (net) during 2024 through a combination of equity raises and warrant exercises. The proceeds were used to fund operations in 2024, as well as allow us to execute on our development plans for 2025.

• Our DehydraTECH technology demonstrated positive results in each and every study we conducted in 2024. These studies included: Human Pilot Study #2 (GLP-1-H24-2), GLP-1 Diabetes Animal Study (WEIGHT-A24-1), and Human Pilot Study #3 (GLP-1-H24-3).

• The Company launched its first Phase 1b registrational study (GLP-1-H24-4 Human Study #4) in Australia.

• We received FDA clearance to proceed with our Phase 1b hypertension study utilizing DehydraTECH-CBD.

• The Company initiated a fluorescently tagged DehydraTECH-semaglutide biodistribution study in rodents.

• 8 additional patents were issued in 2024, increasing the Lexaria portfolio to 46 patents worldwide.

• We entered into a Material Transfer Agreement ("MTA") with a pharmaceutical company to evaluate our DehydraTECH technology in a pre-clinical setting with use of their drug.

• In an extremely challenging 2024 biotech market, Lexaria's share price rose by 68% throughout the year. In comparison, the S&P Biotech Select Industry Index (XBI) increased by only ~1% over the same period.

2024 R&D Results
In 2024, Lexaria spent virtually all of its time and efforts on conducting a series of human and animal studies which utilized our DehydraTECH technology with the three most widely used GLP-1 drugs on the market today: semaglutide, tirzepatide, and liraglutide. Of these three drugs, only one - semaglutide - is currently approved and offered in an oral format. It is sold by Novo Nordisk under the brand name Rybelsus® and it constitutes less than 10% of the overall GLP-1 market. This is truly our opportunity - the GLP-1 market is in desperate need of the addition, improvement, and advancement of oral solutions.

To that end, our goal is to produce evidence that DehydraTECH improves the ways in which active pharmaceutical ingredients enter the bloodstream, allowing for greater effectiveness and reduced side effects, in an effort to attract pharmaceutical partners and enable the expansion of the use of the oral delivery of drugs within the GLP-1 market and beyond.

Human Pilot Study #2:
Human Pilot Study #2 (GLP-1-H24-2) was designed to examine the administration of the oral version of the GLP-1 drug semaglutide. It was a 9 patient - 3 arm - single dose - cross-over - fed-state study which accessed Rybelsus® with and without Lexaria's propriety DehydraTECH processing technology. The 3 arms in the study included a Rybelsus® tablet control arm, a crushed Rybelsus® tablet-DehydraTECH capsule arm - similar to the one that we evaluated in Human Pilot Study #1 (GLP-1-H24-1), as well as a DehydraTECH-semaglutide mouth-melt arm. The study was dosed over the period May through July with results published in late August.

The results of the study were significant both in terms of absorption and Adverse Events ("AEs"). As for absorption, the DehydraTECH-semaglutide capsule arm yielded 18.8% higher semaglutide levels over the course of the study as compared to the Ryblesus® tablet control arm. This further validates the absorption properties that DehydraTECH illustrated in Human Pilot Study #1 (GLP-1-H24-1), where 43% peak blood level improvement was achieved with DehydraTECH-semaglutide capsules under fasted conditions. In terms of AEs, there were 10 AEs recorded in the Rybelsus® tablet control arm, as compared to zero AEs in the DehydraTECH-semaglutide capsule arm. This also further validates the patient tolerability results from Human Pilot Study #1 (GLP-1-H24-1) where 28 AEs were experienced in the Rybelsus® tablet control arm as compared to just 15 AEs experienced in the DehydraTECH-semaglutide capsule arm. The combined results of the two studies show an impressive 60% reduction in the total number of AEs when using DehydraTECH-semaglutide as compared to using Rybelsus® alone.

In summary, the results of Human Pilot Study #2 (GLP-1-H24-2) serve as further endorsement of the results seen in Human Pilot Study #1 (GLP-1-H24-1). Together they are extremely encouraging and support our decision to conduct a much larger Phase 1b registrational study (GLP-1-H24-4 Human Study #4) in Australia.

Animal Study #1:
Our GLP-1 Diabetes Animal Study (WEIGHT-A24-1) investigated the effects of various DehydraTECH formulations containing: CBD; semaglutide; and liraglutide, on diabetes and obesity in rats. This is the first study in which Lexaria worked with the drug liraglutide, which is sold by Novo Nordisk under the brand names Victoza® and Saxenda®. This drug recently went off patent and is now also marketed by Teva Pharmaceuticals. It is important to note that this drug is currently only available in an injectable form.

WEIGHT-A24-1 was a 72 subject - 12 week - 12 arm study, which included both a placebo and a Rybelsus® control arm. It was dosed over the period May through mid-October with 12-week results published in late October.

The results of the study were meaningful both in terms of weight control and blood sugar reduction levels. As for weight control, the results were highlighted by the fact that all study arms using DehydraTECH processing outperformed the Rybelsus® control arm. In addition, the top two performing weight loss arms in the study - DehydraTECH-liraglutide and a select DehydraTECH-CBD formulation - outperformed the Rybelsus® control arm by 11.53% and 10.65%, respectively. The weight loss results are both promising and somewhat surprising as other studies have shown semaglutide to be more than twice as effective at promoting weight loss than liraglutide. As for blood sugar reduction, the top two performing arms in the study - DehydraTECH-liraglutide and a select DehydraTECH-CBD formulation - outperformed the Rybelsus® control arm by 11.13% and 3.35%, respectively.

The results of this study are not only very promising but also are supportive of our Phase 1b registrational study in Australia (GLP-1-H24-4) and our planned Human Study #5 (GLP-1-H25-5) which will be focused on oral DehydraTECH-liraglutide.

Human Pilot Study #3:
Human Pilot Study #3 (GLP-1-H24-3) was designed to investigate the safety, tolerability, and pharmacokinetics of the injectable drug tirzepatide versus an oral DehydraTECH-tirzepatide capsule formulation. This represents the first time that Lexaria worked with the drug tirzepatide, which is sold by Eli Lilly under the brand names Zepbound® and Mounjaro®. Much like liraglutide, tirzepatide is also currently only available in an injectable form.

GLP-1-H24-3 was an 8 patient - 2 arm - single dose - cross-over study. The 2 arms included an injectable tirzepatide control arm and a DehydraTECH-tirzepatide capsule arm. The study was dosed over the period October through November.

The initial results of this study were released earlier this month and were notable in terms of improvements in AEs, blood glucose reduction, and insulin secretion. As for AEs, there were 38 AEs recorded in the injectable tirzepatide control arm as compared to just 20 AEs in the DehydraTECH-tirzepatide capsule arm. This represents an impressive 47% overall reduction in the number of AEs. In terms of blood glucose levels, the DehydraTECH-tirzepatide capsule arm evidenced a comparable reduction in blood glucose levels over the 8-day duration period as the injectable tirzepatide control arm. And lastly, both arms in the study produced similarly increased levels of insulin from baseline to the end of the 8-day duration period.

It is fair to say that the initial results of this study have exceeded our expectations and have resulted in our decision to add an oral DehydraTECH-tirzepatide arm to our Phase 1b registrational study (GLP-1-H24-4 Human Study #4) in Australia.

Phase 1 Studies:
We were thrilled to announce in December 2024, that we had begun dosing in our registered Phase 1b DehydraTECH GLP-1 diabetes and weight loss study (GLP-1-H24-4 Human Study #4) in Australia. This is designed to be a 100 patient - 12 week - 5 arm study. 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)

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

The decision to add the 5^th arm to the study was fueled by the promising results of Lexaria's Human Pilot Study #3 (GLP-1-H24-3). Again, these results impressively showed that oral DehydraTECH-tirzepatide capsules yielded significantly lower (47%) AEs, a comparable reduction in blood glucose levels and similar increases in the production of insulin as compared to the injectable tirzepatide control arm.

We have begun the process of amending Human Study #4 (GLP-1-H24-4) to include the 5^th oral DehydraTECH-tirzepatide arm. The Company plans to announce regulatory authorization of this addition when it becomes available. Pending the timing associated with the addition of the 5^th arm, we expect study results in the Q425/Q126 timeframe.

In addition, the Company received clearance from the FDA in March of 2024 for its Phase 1b hypertension study utilizing DehydraTECH-CBD. Since then, we have been fulfilling on-going requests from the FDA, as well as fine tuning and re-quoting the study for which we are seeking considerable cost savings. It should be noted that additional funding will be required in order for Lexaria to conduct this study.

While our primary focus currently remains in the area of GLP-1, it is entirely possible that with additional funding the Company could be executing on two Phase 1 studies in 2025. One focused on GLP-1 and another focused on hypertension.

2025 R&D Plans
Our R&D plans for 2025 will remain concentrated on GLP-1 investigations. We will continue to utilize a "follow the data" approach to our development program, as such our go-forward plans are continuously evolving and are subject to change. With that said, we expect that our plans for 2025 will minimally include the following:

• Finalizing the results of Human Pilot Study #3 (GLP-1-H24-3) focused on oral DehydraTECH-tirzepatide,

• Executing on our Phase 1b study (GLP-1-H24-4 Human Study #4) in Australia,

• Completing Human Pilot Study #5 (GLP-1-H25-5) focused on oral DehydraTECH-liraglutide,

• Conducting our fluorescent biodistribution study, as well as,

• Running additional animal studies.

Collaboration Agreement
In September of 2024, the Company announced that it had entered into an MTA, with an unnamed pharmaceutical company. The purpose of the agreement is to evaluate the use of Lexaria's DehydraTECH technology in a pre-clinical setting with use of the partner's drug.

Under the terms of the agreement, Lexaria is responsible for the formulation and supply of certain DehydraTECH compositions that are to be evaluated in two animal studies performed by the partner. These materials were processed by Lexaria and delivered to the partner in November. The studies are currently underway. We expect the studies to conclude sometime in the late Q125 - early Q225 timeframe.

This is tremendous news for the Company and we are hopeful that positive results from the studies will potentially result in a much larger collaboration.

Summary
While we are extremely pleased with what Lexaria has accomplished to date, we are also excited and energized by the extent of the R&D opportunities that the GLP-1 drug sector presents for DehydraTECH advancement. We plan to build upon the momentum created in 2024 by continuing to produce evidence that our DehydraTECH technology improves the ways in which active pharmaceutical ingredients enter the bloodstream, allowing for greater effectiveness and reduced side effects. This is all being done with the ultimate goal of attracting pharmaceutical partners who have an interest in utilizing our technology as a means to improve and expand upon the use of orally delivered drugs within the GLP-1 market and beyond.

Throughout all of this, we remain truly grateful to our shareholders for your continued support, patience, and trust. We are unwaveringly committed to acting in your best interests. We will continue to thoughtfully develop and execute on our strategies in an effort to drive long-term shareholder value.

In closing, I want to leave you with this extremely powerful message. As it stands right now, Lexaria is likely the only biotechnology company in existence that has demonstrated success utilizing all three of the top GLP-1 drugs in the world today. This speaks volumes to the value, flexibility, and promise of our DehydraTECH technology platform.

I am genuinely excited about the Company's future and look forward to an extremely successful 2025!

Sincerely,

Richard Christopher
CEO & Director
Lexaria Bioscience Corp.

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 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.

• Positive results in a recent animal study strongly supports first-ever human investigation for DehydraTECH-liraglutide in an oral capsule format

KELOWNA, BC / January 15, 2025 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce that it has received the necessary independent ethics board approval required for its contract research organization ("CRO") to begin to implement and execute human pilot study GLP-1-H25-5 (the "Study"). The Study will compare an oral version of liraglutide, formulated from the DehydraTECH-processing of Saxenda® ("DehydraTECH-liraglutide") to the conventional injected liraglutide (Saxenda®).

Lexaria has already demonstrated success in DehydraTECH processing for superior human oral delivery performance of the world's two most widely used GLP-1 drugs; semaglutide (Novo Nordisk®) and tirzepatide (Eli Lilly). Liraglutide, also owned by Novo Nordisk®, is the world's 3^rd most popular glucagon-like peptide-1 ("GLP-1") or glucose-dependent insulinotropic ("GIP") weight loss/diabetes drug on the market today. Lexaria has previously investigated liraglutide in a 12-week rodent study, as reported on November 20, 2024, in which DehydraTECH- liraglutide - administered orally - demonstrated a 5.88% weight reduction and 11.54% blood sugar reduction compared to baseline, outperforming the comparably dosed positive control semaglutide product, Rybelsus®, also tested in that study.

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 injected 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.

The Study is expected to be conducted with 8-10 healthy volunteers with the goals of demonstrating safety and pharmacokinetic performance in humans utilizing orally dosed DehydraTECH-liraglutide. If the Study results are positive, it could support a decision to investigate oral DehydraTECH-liraglutide in a future Phase I registered trial.

"All three of the GLP-1 and GIP drugs that Lexaria has tested during the last fifteen months have delivered successful results," said Richard Christopher, CEO of Lexaria. "We are establishing our technology as perhaps the most effective drug delivery technology in the world to date, for weight loss drugs such as GLP-1."

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.

The Study protocol design is complete and a clinical test site has been determined. Further updates will be provided when the first dosing begins.

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.

• Oral DehydraTECH-tirzepatide evidenced reduced adverse events of 47% compared to injected Zepbound®

• Blood glucose reduction and insulin secretion levels from the oral DehydraTECH-tirzepatide were comparable to injected Zepbound®

KELOWNA, BC / January 14, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces partial final results showcasing the tolerability and glycemic control efficacy findings from human study GLP-1-H24-3 (the "Study"), comparing an oral version of DehydraTECH-processed Zepbound® ("DehydraTECH-tirzepatide") to conventional injected Zepbound®.

The injected Zepbound® produced a total of 38 adverse events across the study group of 9 persons, whereas the oral DehydraTECH-tirzepatide only produced 20 adverse events, a reduction of 47%. Likewise, the injected Zepbound® resulted in 22 gastrointestinal ("GI")-related adverse events, whereas the oral DehydraTECH-tirzepatide resulted in only 10 GI-related adverse events, a reduction of 54%. This latter finding is particularly noteworthy as unwanted GI impacts are generally the most commonly cited side effects of today's leading glucagon-like peptide-1 / glucose-dependent insulinotropic (GLP-1/GIP) drugs.

Furthermore, the oral DehydraTECH-tirzepatide evidenced a comparable overall reduction in blood glucose from baseline to the end of the 8-day total duration of observation in the Study that was statistically significant (p0.05). The mean baseline blood glucose levels (expressed in mg/dL) were 88.2±9.0 for oral DehydraTECH-tirzepatide and 87.8±11.3 for injected Zepbound®, compared to the Study-ending levels of 83.2±5.7 and 81.7±4.0 respectively.

Also, both the oral DehydraTECH- tirzepatide and the injected Zepbound® produced similarly increased levels of insulin from baseline to the end of the 8-day duration period in the Study, albeit only statistically significant (p<0.05) in the case of the injected Zepbound®. One objective of diabetes drugs is to assist the body in producing more insulin to better control blood glucose levels. The mean baseline blood insulin levels (expressed in µU/mL) were 11.2±4.1 for injected Zepbound® and 12.0±6.1 for oral DehydraTECH- tirzepatide, compared to the ending levels of 16.2±6.2 and 14.9±3.5 respectively. Of note, however, at peak times, the oral DehydraTECH-tirzepatide-induced insulin levels were as much as approximately 100% higher than those from the Zepbound® injection.

"Lexaria is delighted, in our first-ever attempt to render a competitive version of an orally deliverable tirzepatide formulation, to have already achieved approximate parity in effectiveness with apparent superiority in tolerability to the advanced commercial, injected version of Zepbound® already on the market," said Richard Christopher, CEO of Lexaria. "We plan to continue to optimize dosing and other proprietary DehydraTECH aspects for future work, as we seek to investigate the potential for even greater performance enhancement."

There is no oral version of tirzepatide sold in the world today, as it is administered only by injection (Zepbound® and Mounjaro®). Lexaria has completed other research with oral DehydraTECH-processed semaglutide, sold by Novo Nordisk®, which is the only GLP-1 drug available today both in an oral form (Rybelsus®) and as an injectable (Ozempic® and Wegovy®), wherein Lexaria's DehydraTECH-processed semaglutide also evidenced certain improvements in oral delivery compared to Rybelsus®. Lexaria believes that an effective oral version of tirzepatide with fewer adverse events than the current injectable versions, could be highly valued.

Oral delivery of drugs requires far higher quantities of active pharmaceutical ingredients than injectable versions, because of relatively poor bioavailability of many drugs through the GI tract when taken orally. In the case of semaglutide, 98-196 times more semaglutide is administered as an oral dose of Rybelsus® over an equivalent period of time as compared to an injected dose of Ozempic®. In the current Lexaria Study, the oral DehydraTECH-tirzepatide was conservatively dosed at only 56 times more tirzepatide than what is administered via an injected Zepbound® dose, meaning that a stronger, more equivalent oral dose of tirzepatide, based on conventional oral versus injectable semaglutide dosing, has still unknown potential to be investigated relative to injected Zepbound®.

Armed with this new safety and efficacy data from the current Study that has exceeded expectations, Lexaria intends to add a 5^th study arm - using DehydraTECH-tirzepatide in an oral capsule - to its 12-week human study already underway in Australia (study GLP-1-H24-4). In that study arm, oral DehydraTECH-tirzepatide will be dosed initially at the same dose as in the current Study, but will also escalate to a dose roughly twice as high, in order to more aggressively investigate oral DehydraTECH-tirzepatide performance through metrics such as blood sugar control and overall weight loss. Steps have been initiated to amend human study GLP-1-H24-4 accordingly, pending regulatory authorization which will be reported upon when available.

Additional results from the current Study are still being analysed at a third-party laboratory, including full blood pharmacokinetic information, and will be reported upon as they become available.

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, investigating the dual agonist GLP-1/GIP drug tirzepatide in this Study instead of the GLP-1 agonist semaglutide from human pilot study #1. The DehydraTECH-tirzepatide test articles were compound formulated using Zepbound®, strictly for research purposes, and dosed orally to the subjects under fasted conditions. The Study was designed to measure tolerability and side effects, blood levels of tirzepatide, and blood glucose and insulin levels. The DehydraTECH-tirzepatide composition was formulated at a strength of 20 mg tirzepatide administered orally daily for seven days followed through to the end of the eighth day post-dosing. The Zepbound® formulation had a strength of 2.5 mg tirzepatide administered once via injection with the subject monitored over the same eight-day total duration. Blood samples were taken multiple times during the first 12 hours post dosing on the first day of each treatment phase, with single blood samples taken daily thereafter through to a final blood draw taken 24 hours after the end of dosing (i.e., on the eighth day of the Study); and, all subjects were dosed under fasted conditions with a standardized meal fed to the test subjects at a point in time after dosing. A total of 9 healthy subjects completed dosing with each test article following a randomized, cross over study design across two study phases, separated by a 4-6 week washout duration.

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.

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.