Author Archives: mmcdonald

KELOWNA, BC / ACCESS Newswire / May 12, 2025 / Lexaria Bioscience Corp. (Nasdaq:LEXX, LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, provides this update on corporate developments.

Lexaria previously announced, on September 3, 2024, that it had entered into a Material Transfer Agreement ("MTA") with a pharmaceutical company ("PharmaCO") to evaluate Lexaria's DehydraTECH^TM technology in a pre-clinical setting.

Lexaria today announces that the initial pre-clinical studies covered by the MTA, which examined pharmacokinetics in animals, have been performed. Results of that work will not be made public. In addition, Lexaria reports being informed by PharmaCO that they wish to review the pending safety (adverse events) and efficacy data from Lexaria's ongoing independent human study GLP-1-H24-4 currently underway in Australia. We expect that data to become available beginning in Q3, 2025.

Lexaria is preparing for strategic planning discussions with PharmaCO's human clinical development team soon given the possibility that potential additional collaborative work may include human clinical studies.

The parties have agreed to continue their relationship under the MTA and to keep the temporary exclusive license active and in force until such time as the data from the Australian study becomes available and final decisions have been made, at which time further information will be provided.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 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 to use of proceeds from the offering and 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, market and other conditions, 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 / April 28, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, today announced the closing of its previously announced registered direct offering with a single institutional investor for the purchase and sale of 2,000,000 shares of common stock (or pre-funded warrants in lieu thereof) at a purchase price of $1.00 per share (or per pre-funded warrant in lieu thereof) Other than the pre-funded warrants, no other warrants were issued to the institutional investor in the registered direct offering.

"We are pleased to have raised funds in what is an extremely difficult market," stated Richard Christopher, CEO of Lexaria. "Despite the related market challenges, we were able to successfully complete a transaction, during a particularly uncertain market period, which consciencely minimized the dilutive impact on our existing shareholders by avoiding the issuance of any new warrants in the deal, other than the pre-funded warrants."

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering were $2.0 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The securities described above were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-284407) that was declared effective by the Securities and Exchange Commission (the "SEC") on January 30, 2025. The offering of the securities in the registered direct offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering have been filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC's website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 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 to use of proceeds from the offering and 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, market and other conditions, 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 / April 25, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, today announced that it has entered into a definitive agreement with a single institutional investor for the purchase and sale of 2,000,000 shares of common stock at a purchase price of $1.00 per share in a registered direct offering. The closing of the offering is expected to occur on or about April 28, 2025, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be $2.0 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The common stock described above is being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-284407) that was declared effective by the Securities and Exchange Commission (the "SEC") on January 30, 2025. The offering of the shares of common stock in the registered direct offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov and may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 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 to the completion of the offering, the satisfaction of customary closing conditions related to the offering, the intended use of proceeds from the offering and 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, market and other conditions, 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.

• Pfizer and Eli Lilly reporting significant - and opposing - news in the GLP-1 industry

• Lexaria's technology could enhance performance and lower side effects

KELOWNA, BC / ACCESS Newswire / April 23, 2025 / 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") strategic update following important industry developments reported both by Pfizer® Inc. and by Eli Lilly and Company®.

Nearly all of the world's top pharmaceutical companies are racing to develop new oral GLP-1 drugs, including: Amgen®, AstraZenca, Eli Lilly, Merck®, Novo Nordisk®, Pfizer®, and Roche®.

By enhancing the performance of oral dosing choices as a replacement for disliked injections; and by reducing adverse events - often the #1 reason that patients stop using GLP-1 drugs - Lexaria's proprietary DehydraTECH technology could be of vital importance to any of these companies in their pursuit of the next oral GLP-1 drug(s).

As previously announced, Lexaria has already demonstrated in human testing, enhanced delivery performance to the world's ONLY existing orally dosed GLP-1 drug: Rybelsus® (semaglutide), owned by Novo Nordisk®.

On April 14, 2025, Pfizer® announced that it would scrap development of danuglipron as a once-daily oral GLP-1 treatment after a patient in a trial experienced a liver injury possibly related to the drug. This was doubly disappointing since, in December 2023, Pfizer® had discontinued a twice-daily trial dose of danuglipron after unwanted side effects derailed an earlier study.

Similarly, Pfizer® experienced earlier setbacks in 2023 with a different GLP-1 drug, lotiglipron, when it too resulted in elevated liver enzymes in patients who took the drug in earlier clinical studies. Development of safe and effective orally-dosed GLP-1 drugs is extremely challenging even for the largest pharmaceutical companies in the world, and Pfizer® and others still need to rise to the challenge of developing effective oral GLP-1 drugs with minimal side effects.

On April 17, 2025, Eli Lilly reported that their experimental, orally-dosed GLP-1 drug (orfoglipron) resulted in lower blood sugar and lower body weight after 40 weeks in a phase 3 clinical trial. As a result of this news, Eli Lilly's market valuation increased by nearly $100 billion in a single day.

Eli Lilly plans to apply for approval to launch the drug for both weight loss and diabetes treatment in 2026 - and that rapid path to market, combined with the fact that it might be only the 2^nd oral GLP-1 drug to potentially be approved by the Food and Drug Administration ("FDA"), is likely responsible for the dramatic market response to the news.

Although clearly a positive step forward for the weight loss and diabetes treatment sectors, it should still be noted that 13% to 18% of patients receiving the drug experienced nausea; 19% to 26% experienced diarrhea; and 5% to 14% experienced vomiting. Lexaria's experience with other GLP-1 drugs to date in humans, has shown a trend towards reducing these types of side effects.

Side Effects a Known Challenge.
In the studies just reported (above), and in earlier studies, unwanted side effects remain one of the largest challenges still faced by the industry, seemingly without a solution in sight. The results of another study showed that between 47% and 64% of GLP-1 users with type 2 diabetes discontinued use of their GLP-1 drug within 1 or 2 years, respectively. "Gastrointestinal adverse events were linked to the discontinuation rates."

Obviously, side effects serious enough to persuade patients to discontinue use of an otherwise effective drug, are a major problem for the industry. For companies like Pfizer®, those side effects have been serious enough to stop drug development in its tracks.

As Lexaria reported on August 28, 2024 and January 14, 2025, DehydraTECH-GLP-1 processing has repeatedly shown its propensity to reduce side effects, including but not limited to gastrointestinal adverse events, in both of the major GLP-1 drugs currently available in the world today, being Eli Lilly's tirzepatide, and Novo Nordisk's® semaglutide. One of the only other GLP-1 drugs on the market today, liraglutide, is currently in pilot testing by Lexaria in humans utilizing DehydraTECH processing.

Lexaria is rapidly executing its multi-faceted strategy centered around its proprietary DehydraTECH processing technology. Our main goal is to attract pharmaceutical companies seeking the benefits of adopting Lexaria's technology for use with their own existing drug products. This first prong of our strategy has been evidenced and validated by the Company's entry in a material transfer agreement with a pharmaceutical company ("PharmaCO") which was announced in September of 2024. Lexaria continues to collaborate with PharmaCO on evaluating DehydraTECH compositions.

As we noted on November 26, 2024, GLP-1 drugs are either approved for use, or are being investigated for use, in all of the following healthcare sectors:

• Cardiovascular disease

• Chronic Kidney disease

• Liver disease

• Obesity

• Diabetes

• Sleep apnea

• Alzheimer's and dementia

• Addiction including cocaine addiction

Most recently, the FDA approved Ozempic® (semaglutide) owned by Novo Nordisk®, to "reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease ("CKD"). This has the potential to literally be a life-saver for some of the 37 million adults in America struggling with CKD, which, until now, often had NO CURE.

As we noted on November 7, 2024, growth expectations for the GLP-1 industry - prior to the FDA's approval of semaglutide for treatment of CKD - supported a growing consensus that revenue in the GLP-1 drug sector will soon be over $100 billion per year.

About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 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 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.

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

KELOWNA, BC / ACCESS Newswire / April 3, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to provide this progress update on its Phase 1b, 12-week chronic study GLP-1-H24-4 (the "Study") underway in Australia.

Enrollment of patients for all 5 Study arms has now been completed on schedule. Participation interest in the Study was extremely high, so the Study overenrolled entering a total of 24 patients per Study arm versus the original target of 20. Completion of enrollment signifies the important "last patient in" ("LPI") clinical study milestone, meaning that treatment of all patients is expected to be completed roughly twelve weeks from now, to be followed by the series of patient sample analyses, data compilation, analysis and reporting.

"Lexaria is pleased to have reached LPI enrollment completion," said John Docherty, President and Chief Scientific Officer of Lexaria Bioscience Corp. "Dosing is progressing nicely and, at this point, we are expecting the Study to complete on schedule."

About The Study

The Study is underway with 24 overweight, obese, pre- or type 2 diabetic patients for each of the 5 Study Arms, four of which are evaluating DehydraTECH-semaglutide, DehydraTECH-tirzepatide, and DehydraTECH-cannabidiol ("CBD"), with Study Arm 4 being the control arm. All drugs are being 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, moving 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 salcaprozate 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.

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

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

Lexaria has several important objectives for this Study:

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

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

About Lexaria Bioscience Corp. & DehydraTECH

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

• Head-to-head human study comparing traditional injected liraglutide to first-ever oral DehydraTECH-liraglutide

• Study will investigate Pharmacokinetics and Safety

KELOWNA, BC / ACCESS Newswire / April 2, 2025 / 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 begun as scheduled in its human study GLP-1-H25-5 (the "Study") that is comparing oral DehydraTECH-liraglutide to injected Saxenda®-branded liraglutide.

On November 20, 2024, Lexaria reported on an earlier 12-week study in rodents which showed that with unlimited food available, oral DehydraTECH-liraglutide demonstrated a 5.88% weight reduction and an 11.54% blood sugar reduction as compared to baseline.

The current Study is designed to test pharmacokinetics ("PK") (absorption into bloodstream) and adverse events in humans. Lexaria has previously shown in other GLP-1 PK studies in humans, that certain oral DehydraTECH formulations demonstrated superior bloodstream delivery, as well as reduced adverse events as compared to the oral semaglutide and injectable tirzepatide products on the market today.

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 Pharmaceutical Industries, Ltd. in June of 2024, Novo Nordisk generated US$1.0 billion in Saxenda® revenue, as well as an additional US$0.8 billion in Victoza® revenue during 2024.

Results of the Study will be released once available.

About Lexaria Bioscience Corp. & DehydraTECH

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

• More consistent accumulation demonstrated in bloodstream over a one-week duration with once-daily DehydraTECH-tirzepatide oral capsules as compared to once-weekly injection of Zepbound®

• As previously announced, oral DehydraTECH-tirzepatide also reduced adverse events by 47% compared to injected Zepbound®

• Lexaria's oral capsules worthy of expanded investigation as a viable alternative to injected tirzepatide.

KELOWNA, BC / ACCESS Newswire / March 18, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce positive pharmacokinetic ("PK") results from Human Study #3 or GLP-1-H24-3 (the "Study"), comparing an oral version of DehydraTECH-processed Zepbound® ("DehydraTECH-tirzepatide") to conventional injected Zepbound®.

Zepbound® is currently only available as a once-weekly injection for weight loss. It is not sold by Eli Lilly in any oral format. Lexaria's Study was designed to discover whether the active drug within Zepbound® - tirzepatide - could be administered using Lexaria's patented DehydraTECH drug delivery technology via simple oral capsules in order to deliver a useful quantity of tirzepatide into the human bloodstream, as well as provide a viable alternative to disliked injections. The results were unexpectedly positive, showing that orally delivered DehydraTECH-tirzepatide reached roughly equal end of Study blood-concentration levels as the injected drug.

During the 8-day Study, data was successfully collected from 10 people who were dosed with a single weekly injection of Zepbound®, and from 9 people who were dosed daily over the same one-week duration with DehydraTECH-tirzepatide capsules.

In general, the peak levels of blood delivery of the injected Zepbound® were, for the most part, higher than that of the DehydraTECH-tirzepatide, but not in all cases. The injected Zepbound® typically reached a peak level within blood on the 2^nd day of the Study and subsequently declined. Conversely, the DehydraTECH-tirzepatide blood levels increased steadily and more consistently each day of the Study, avoided any abrupt peaks or declines, and were generally still rising on Day 8, the final day of the Study. Of those receiving the Zepbound® injection, 8 of 10 people (80%) experienced peak levels on Day 2 of the Study and subsequently experienced declining levels, whereas of those receiving the DehydraTECH-tirzepatide, 4 of 8 people (50%) experienced their peak levels on the final day of the Study, indicating that their levels were still rising at the conclusion of the Study.

As announced on January 14, 2025, during the Study DehydraTECH-tirzepatide also evidenced reduced side effects, while achieving comparable concluding glycemic performance indicators. The injected Zepbound® produced a total of 38 adverse events during the Study, whereas the oral DehydraTECH-tirzepatide produced only 20, or 47% fewer, adverse events along with a 54% reduction in gastrointestinal side effects as compared to the Zepbound®. Furthermore, the DehydraTECH-tirzepatide capsules produced a comparable reduction in blood glucose together with a similar increase in blood insulin from baseline to Day 8 of the Study.

"Lexaria's first-ever study of oral DehydraTECH-tirzepatide has far exceeded our expectations," said Richard Christopher, CEO of Lexaria. "We have succeeded in demonstrating all 3 of our main objectives; reduced side effects with similar efficacy and similar blood-delivery levels as compared to injected tirzepatide by the end of the Study. Our ongoing 12-week study in Australia is well positioned to further evaluate the effectiveness of DehydraTECH over an extended dosing duration and potentially establish Lexaria as a global player in oral delivery within the fast-growing GLP-1 weight loss and diabetes control markets."

All the results of this study - reduced side effects, comparable end of Study blood sugar control and measured drug in bloodstream - are extremely encouraging and support our decision to further evaluate DehydraTECH-tirzepatide in our ongoing Australian Phase 1b registrational study (GLP-1-H24-4). In that 12-week study, DehydraTECH-tirzepatide will be dosed at the same 20mg/day level utilized in Human Study #3 for the initial 4 weeks of treatment, escalating further to 40mg/day over the last 8 weeks of treatment, thereby allowing Lexaria to potentially demonstrate further increased delivery and efficacy relative to the present Study.

Lexaria looks forward to the opportunity to assess the very important steady-state blood levels which DehydraTECH-tirzepatide administered via its oral capsules will achieve over an extended dosing duration in study GLP-1-H24-4 as they relate to published figures for sustained injectable tirzepatide dosing, given the fact that blood levels from DehydraTECH-tirzepatide witnessed in the present Study were continuing to ascend at Day 8.

There is no oral version of tirzepatide sold in the world today, as it is administered only by injection (Zepbound® and Mounjaro®). Lexaria has previously completed other research with oral DehydraTECH-processed semaglutide, sold by Novo Nordisk®, which is the only GLP-1 drug that is currently available as both an oral (Rybelsus®) and an injectable (Ozempic® and Wegovy®). This research yielded similar findings wherein Lexaria's DehydraTECH-processed semaglutide 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.

As noted, Rybelsus® is the only orally delivered GLP-1 drug on the market today. Rybelsus® uses a proprietary drug delivery technology called salcaprozate sodium ("SNAC"), that Novo Nordisk paid US$1.8 billion to acquire, to enable efficacy in an oral delivery format. Lexaria notes that, of course, there was no SNAC present in either the Zepbound® or in Lexaria's DehydraTECH-tirzepatide in the present Study, showcasing that Lexaria's wholly owned DehydraTECH technology has now demonstrated its ability to successfully deliver 3 of the world's best-selling weight-loss and diabetes control drugs: tirzepatide, liraglutide, and semaglutide across its animal and human GLP-1 studies conducted to-date.

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. Subjects were dosed 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 a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 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.

• Lexaria executing a triple-pronged strategy in obesity and diabetes

• Semaglutide recently approved to treat chronic kidney disease

KELOWNA, BC / ACCESS Newswire / February 27, 2025 / 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") strategic update.

Lexaria is rapidly executing its multi-faceted strategy centered around its proprietary DehydraTECH processing technology. Our main goal is to attract pharmaceutical companies seeking the benefits of adopting Lexaria's technology for use with their own existing drug products. This first prong of our strategy has been evidenced and validated by the Company's entry in a material transfer agreement with a pharmaceutical company which was announced in September of 2024. Lexaria continues to collaborate with its pharmaceutical partner on examining the impact of DehydraTECH processing.

In the second prong of our strategy, the Company is examining the potential to develop and launch a patented DehydraTECH-CBD product within GLP-1. This could come in the form of a partnership with an existing player or Lexaria could potentially launch its own internally developed product(s). Lastly, in the third prong of our strategy, the Company is investigating the possibility of developing and selling the world's first oral version of a leading injectable GLP-1 drug, liraglutide, using DehydraTECH. As such, GLP-1 industry developments have the potential to dramatically affect Lexaria's strategy and future.

The GLP-1 industry is experiencing revolutionary advancements across multiple healthcare sectors. If there has ever been a class of drugs that could change the world - or is perhaps already changing the world - it would be GLP-1. As tens of millions of people around the world utilize these drugs in their pursuit of better health outcomes, there will of course be unwanted side effects and even negative health outcomes in some fraction of GLP-1 drug users. With that said, the benefits of these drugs overwhelmingly outweigh all of the currently known negative outcomes.

As we noted on November 26, 2024, GLP-1 drugs are either approved for use, or are being investigated for use, in all of the following healthcare sectors:

• Cardiovascular disease

• Chronic Kidney disease

• Liver disease

• Obesity

• Diabetes

• Sleep apnea

• Alzheimer's and dementia

• Addiction including cocaine addiction

Most recently, the Food and Drug Administration ("FDA") approved Ozempic® (semaglutide) owned by Novo Nordisk®, to "reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease ("CKD"). This has the potential to literally be a life-saver for some of the 37 million adults in America struggling with CKD, which, until now, often had NO CURE.

As we noted on November 7, 2024, growth expectations for the GLP-1 industry - prior to the FDA's approval of semaglutide for treatment of CKD - supported a growing consensus that revenue in the GLP-1 drug sector will soon be over $100 billion per year, with one sector revenue forecast at an astounding $471 billion per year.

Initial skepticism related to the sector's staying power has dissipated as positive healthcare results continue to build, and the industry continues its unprecedented expansion into additional use categories. With all this positivity, it seems that "nothing could go wrong". And yet, there are two inescapable challenges that continues to plague the industry: disliked injections and gastrointestinal adverse events.

Lexaria's DehydraTECH technology is designed to allow for effective oral dosing as opposed to the intensely disliked injected administration: 63% of participants in one study reported experiencing trypanophobia or needle phobia. As reported on August 27, 2024, Lexaria has already demonstrated in human testing, delivery superiority to the world's ONLY existing orally dosed GLP-1 drug, Rybelsus® (semaglutide), owned by Novo Nordisk®.

In addition, between 47% and 64% of GLP-1 users with type 2 diabetes, discontinue use of their GLP-1 drug within 1 or 2 years, respectively. "Gastrointestinal adverse events were linked to the discontinuation rates."

As we reported on August 28, 2024 and January 14, 2025, DehydraTECH-GLP-1 processing has repeatedly shown its propensity to reduce side effects, including but not limited to gastrointestinal adverse events, in both of the major GLP-1 drugs currently available in the world today, being Eli Lilly's tirzepatide, and Novo Nordisk's® semaglutide. One of the only other GLP-1 drugs on the market today, liraglutide, will soon also be tested by Lexaria in humans utilizing DehydraTECH processing.

By enabling oral dosing choices to replace injections; and by reducing adverse events that seem to the be #1 reason that patients stop using GLP-1 drugs, Lexaria's DehydraTECH technology could be of vital importance to the future health of this burgeoning healthcare sector.

"Lexaria is the only company in the world that has demonstrated an ability to improve the drug delivery characteristics of the dominant GLP-1 drugs prescribed today, which are expected to generate over $30 billion in revenue in 2025," said Richard Christopher, CEO of Lexaria. "We continue to work at the fastest pace possible and make every attempt to assist the pharmaceutical industry in its investigations of our unique drug delivery platform technology, DehydraTECH, and encourage its adaptation into what is surely the most exciting healthcare sector of our time."

About Lexaria Bioscience Corp. & DehydraTECH

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

5^th study arm in 12-week Phase 1b Study receives lead clinical site approval

KELOWNA, BC / ACCESS Newswire / February 24, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ: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 5^th study arm of the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study") in Australia.

This news complements similar news issued on November 13, 2024, when initial lead clinical site HREC approval was received for the first 4 arms of the Study. The Company is pleased to have received all of the necessary lead clinical site approvals so quickly. Additional HREC approval is still pending for the other clinical sites, which is expected soon.

The Study is progressing with both patient recruitment and dosing. The milestone of First Patient First Dose occurred in December 2024 as planned. As a reminder, the 5 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 (with the newly received HREC approval)

"The ability to study two GLP-1 drugs - semaglutide and tirzepatide - in a single study that together comprise well over 90% of the global GLP-1 market is truly a remarkable achievement for a company of our size," said Richard Christopher, CEO of Lexaria Bioscience Corp. "Lexaria's ability to utilize our patented DehydraTECH delivery technology to potentially enhance performance characteristics of these drugs, along with our very own DehydraTECH-CBD, all the while utilizing oral dosing as opposed to injections, is a unique opportunity."

Further Study updates will be provided as and 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 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.

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.