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

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

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

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

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

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

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

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

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

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

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

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

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

Animal Weights (grams)

Study Groups

End of
Acclimation Period

Day
28

% Change
to Day 28

Day
56

% Change
to Day 56

Day
84

% Change
to Day 84

A: DHT-CBD1

427.9

432.6

+1.10%

438.0

+2.36%

432.3

+1.05%

B: DHT-CBD2

394.6

393.3

-0.33%

386.1

-2.15%

374.9

-5.00%

C: DHT-CBD3

416.0

408.8

-1.72%

407.3

-2.08%

402.5

-3.24%

D: DHT-CBD4

431.2

431.7

+0.11%

434.2

+0.69%

419.0

-2.83%

E: DHT-Rybelsus1
w/SNAC

394.9

394.6

-0.06%

401.4

+1.65%

393.6

-0.32%

F: DHT-Rybelsus2
w/SNAC

406.2

409.1

+0.70%

406.7

+0.11%

403.1

-0.78%

G: DHT-Semaglutide
No SNAC

394.2

394.8

+0.15%

399.0

+1.21%

394.1

-0.02%

H: DHT-Liraglutide
No SNAC

392.2

385.7

-1.65%

373.6

-4.74%

369.1

-5.88%

I: DHT-Combo
CBD3©+Semaglutide(G)
No SNAC

440.8

453.3

+2.84%

448.6

+1.77%

444.1

+0.75%

J: DHT-Combo
CBD3©+Liraglutide(H)
No SNAC

446.7

468.7

+4.93%

463.4

+3.74%

451.4

+1.05%

K: Vehicle Control
(Placebo)

427.7

442.5

+3.46%

440.1

+2.90%

433.7

+1.40%

L: Rybelsus Control
(SOC)
w/SNAC (No DehydraTECH)

430.2

446.7

+3.84%

459.2

+6.74%

454.5

+5.65%

Notes

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

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

Blood Sugar Levels (mmol/L)

Study Groups

End of Acclimation Period

Day
28

% Change
to Day 28

Day
56

% Change
to Day 56

Day
84

% Change
to Day 84

A: DHT-CBD1

27.4

26.2

-4.31%

26.9

-1.90%

27.7

1.09%

B: DHT-CBD2

28.4

29.2

2.73%

26.6

-6.22%

27.3

-3.76%

C: DHT-CBD3

26.4

24.9

-5.99%

27.1

2.46%

27.5

3.85%

D: DHT-CBD4

24.6

27.9

13.16%

26.8

8.94%

27.0

9.75%

E: DHT-Rybelsus1
w/SNAC

26.4

25.5

-3.60%

26.8

1.33%

26.8

1.59%

F: DHT-Rybelsus2
w/SNAC

24.9

26.8

7.70%

26.4

5.96%

27.3

9.58%

G: DHT-Semaglutide
No SNAC

26.3

25.9

-1.52%

27.8

5.54%

26.9

2.13%

H: DHT-Liraglutide
No SNAC

26.4

25.8

-2.08%

25.2

-4.56%

23.3

-11.54%

I: DHT-Combo
CBD3©+Semaglutide(G)
No SNAC

25.1

27.2

8.37%

28.2

12.35%

26.8

6.77%

J: DHT-Combo
CBD3©+Liraglutide(H)
No SNAC

23.5

27.0

14.89%

27.0

14.89%

26.4

12.34%

K: Vehicle Control (Placebo)

24.2

25.7

6.2%

27.7

14.46%

26.7

10.33%

L: Rybelsus Control
(SOC)
w/SNAC (No DehydraTECH)

24.3

25.1

3.29%

26.1

7.41%

24.2

-0.41%

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

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

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

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

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

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

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

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

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

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

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

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

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

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

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

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

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

About Lexaria Bioscience Corp. & DehydraTECH

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

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

DehydraTECH clinical test article manufacturing has been completed

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

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

Arm 1 - DehydraTECH-CBD capsules

Arm 2 - DehydraTECH-semaglutide capsules

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

Arm 4 - Rybelsus® tablets (positive control)

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

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

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

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

About The Study

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

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

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

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

Lexaria has several important objectives for this Study:

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

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

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

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

About Lexaria Bioscience Corp. & DehydraTECH

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

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

  • DehydraTECH-liraglutide and select DehydraTECH-CBD formulations were the top performing blood sugar groups

KELOWNA, BC / October 24, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received partial 12-week (final) blood sugar results from the recently completed animal study WEIGHT-A24-1 (the "Study").

Blood Sugar Levels (mmol/L)

DehydraTECH
Groups

Day 7
Baseline

Day
28

%
Change
to Day 28

Day 56

%
Change
to Day 56

Day 84

%
Change
to Day 84

A: CBD1

27.4

26.2

-4.31%

26.9

-1.90%

27.7

1.09%

B: CBD2

28.4

29.2

2.73%

26.6

-6.22%

27.3

-3.76%

C: CBD3

26.4

24.9

-5.99%

27.1

2.46%

27.5

3.85%

D: CBD4

24.6

27.9

13.16%

26.8

8.94%

27.0

9.75%

E: Rybelsus1

26.4

25.5

-3.60%

26.8

1.33%

26.8

1.59%

w/SNAC

F: Rybelsus2

24.9

26.8

7.70%

26.4

5.96%

27.3

9.58%

w/SNAC

G: Semaglutide

26.3

25.9

-1.52%

27.8

5.54%

26.9

2.13%

No SNAC

H: Liraglutide

26.4

25.8

-2.08%

25.2

-4.56%

23.3

-11.54%

No SNAC

Notes

- Groups A through D were different DehydraTECH-CBD compositions

- Groups E and F were reformulated Rybelsus DehydraTECH compositions

- Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively) in DehydraTECH compositions

- Recalculations led to slight changes from earlier reported data

Lexaria is strongly encouraged that the DehydraTECH-liraglutide and DehydraTECH-CBD groups A and B outperformed all three of the Rybelsus® and pure semaglutide DehydraTECH composition groups regardless of whether the semaglutide had or had not been processed with the salcaprozate sodium technology known as "SNAC". Rybelsus®, which utilizes Novo Nordisk's proprietary SNAC technology, is the world's only orally administered GLP-1 drug brand.

Study data for four additional animal groups (I, J, K, and L), including a positive control group of Rybelsus® that has not been processed with DehydraTECH, will be available soon. Of the eight Study groups reported on today, DehydraTECH-CBD group B and the sole DehydraTECH-liraglutide group H were both successful in reducing blood sugar levels, while the other six groups, including all three of the Rybelsus® and pure semaglutide DehydraTECH composition groups, were not.

This Study is the world's first to evaluate the relative performance of liraglutide processed with DehydraTECH. Thus, the outperformance of DehydraTECH-liraglutide compared to the other groups is of notable interest and was unexpected. In this Study, the processed liraglutide in Study group H was administered orally even though it is injected when used by patients under the brand names Saxenda® or Victoza®.

Usually, injected versions of drugs have greater efficacy than orally administered versions of the same drug because of superior pharmacokinetics ("PK"). Lexaria's DehydraTECH drug delivery technology has historically enhanced the PK of orally administered drugs, opening a potential for viability in commercial markets.

Additional data from this Study is pending, including body weight and blood glucose findings from the second Study cohort that included positive and vehicle (placebo) control arms. Analyses of brain and blood absorption pharmacokinetic results is also underway, although unforeseen delays at the third-party laboratories involved is affecting timing of completion of this work. Lexaria is working with these laboratories to minimize further delays and will report on these data as soon as possible.

About the Study

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

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.



View the original press release on accesswire.com

  • DehydraTECH-liraglutide and select DehydraTECH-CBD formulations were the top performing weight loss groups

  • Accelerated rates of weight loss were experienced during the final 4 weeks of the study in all DehydraTECH groups

KELOWNA, BC / October 22, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received partial 12-week (final) body weight results from the recently completed animal study WEIGHT-A24-1 (the "Study").

Animal Weights (grams)

DehydraTECH
Groups

End of
Acclimation
Period

Day
28

%
Change
to Day
28

Day
56

%
Change
to Day
56

Day
84

%
Change
to Day
84

A: CBD1

427.9

432.6

+1.10%

438.0

+2.36%

432.3

+1.046%

B: CBD2

394.6

393.3

-0.33%

386.1

-2.15%

374.9

-4.996%

C: CBD3

416.0

408.8

-1.72%

407.3

-2.08%

402.5

-3.237%

D: CBD4

431.2

431.7

+0.11%

434.2

+0.69%

419.0

-2.829%

E: Rybelsus1
w/SNAC

394.9

394.6

-0.06%

401.4

+1.65%

393.6

-0.321%

F: Rybelsus2
w/SNAC

406.2

409.1

+0.70%

406.7

+0.11%

403.1

-0.780%

G: Semaglutide
No SNAC

394.2

394.8

+0.15%

399.0

+1.21%

394.1

-0.017%

H: Liraglutide
No SNAC

392.2

385.7

-1.65%

373.6

-4.74%

369.1

-5.880%

Average

407.1

406.3

-0.21%

405.8

-0.37%

398.6

-2.127%

Notes

  • Groups A through D were different DehydraTECH-CBD compositions

  • Groups E and F were reformulated Rybelsus® DehydraTECH compositions

  • Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively) in DehydraTECH compositions

  • Recalculations led to slight changes from earlier reported data

Lexaria is strongly encouraged that the DehydraTECH-liraglutide and select DehydraTECH-CBD groups B, C, and D outperformed all three of the Rybelsus® and semaglutide DehydraTECH composition groups regardless of whether the semaglutide had or had not been processed with the salcaprozate sodium technology known as "SNAC". Rybelsus®, which utilizes Novo Nordisk's proprietary SNAC technology, is the world's only orally administered GLP-1 drug brand.

This Study is the world's first to evaluate the relative performance of liraglutide processed with DehydraTECH. In humans, semaglutide has been shown in other studies to be more than twice as effective at promoting weight loss as liraglutide . Thus, the outperformance of DehydraTECH-liraglutide compared to DehydraTECH-semaglutide is of notable interest. In this Study, the processed liraglutide in Study group H was administered orally even though it is injected when used by patients under the brand names Saxenda® or Victoza®.

Teva Pharmaceuticals (NYSE:TEVA) on June 24, 2024, announced the authorized launch of a generic version of Novo Nordisk's Victoza® as injected liraglutide and noted that Victoza had annual sales of $1.656 billion as of April, 2024.

Lexaria notes that it has already filed patent applications to recognize the unique outperformance of liraglutide once processed with DehydraTECH delivery technology.

Readers are cautioned to not compare results of this animal study to human weight loss studies , primarily because unlimited food and water has been provided to the animals for the entire duration of this Study. Offered unlimited food, many rats will reach morbid obesity.

The primary value in this Study is the relative performance of the different Study groups, which has provided directional evidence for additional future work. For context, in an older Lexaria diabetic animal study DIAB-A22-1 reported on March 2, 2023 , the obese control group of animals that received no drug treatment , experienced 3.04% weight gain during the first 28 days of that study.

During the initial acclimation phase of 34 days before the beginning of dosing in this Study, the animals gained 10.9% body weight on average. Actual weight decreases or slower rates of weight gain have since been achieved in the 12 weeks of dosing in all Study groups receiving DehydraTECH drug therapies. Importantly, accelerated rates of weight loss were experienced in all DehydraTECH groups during the final 4 weeks of the study.

Additional data from this Study is pending including blood glucose findings from the animals reported herein, as well as body weight and blood glucose findings from the second study cohort that included positive and vehicle (placebo) control arms. Analyses of brain and blood absorption pharmacokinetic results is also underway, although unforeseen delays at the third-party laboratories involved is affecting timing of completion of this work. Lexaria is working with these laboratories to minimize further delays and will report on these data as soon as possible.

About the Study

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

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.



View the original press release on accesswire.com

KELOWNA, BC / October 16, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX; LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, today announced that it has closed its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 1,633,987 shares of common stock at a purchase price of $3.06 per share. In a concurrent private placement, the Company issued unregistered warrants to purchase up to 4,551,019 shares of common stock at an exercise price of $3.06 per share. The warrants will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the warrants (the "Stockholder Approval Date") and will expire five years from the Stockholder Approval Date.

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

The gross proceeds to the Company from the offering were approximately $5 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 shares of common stock (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-262402) that was declared effective by the Securities and Exchange Commission (the "SEC") on February 4, 2022. The offering of the shares of common stock 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 were 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 or 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].

The unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

In addition, effective on the closing of the offering certain outstanding warrants to purchase 2,917,032 shares of the Company's common stock issued in April 2024 will be cancelled.

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.

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, the intended use of proceeds from the offering, receipt of Stockholder Approval and 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.



View the original press release on accesswire.com

KELOWNA, BC / October 15, 2024 / 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 for the purchase and sale of 1,633,987 shares of common stock at a purchase price of $3.06 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company will issue unregistered warrants to purchase up to 4,551,019 shares of common stock at an exercise price of $3.06 per share. The warrants will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the warrants (the "Stockholder Approval Date") and will expire five years from the Stockholder Approval Date. The closing of the offering is expected to occur on or about October 16, 2024, 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 approximately $5 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 (but not the unregistered warrants and the shares of common stock underlying the warrants) described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-262402) that was declared effective by the Securities and Exchange Commission (the "SEC") on February 4, 2022. 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].

The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

In addition, effective on the closing of the offering certain outstanding warrants to purchase 2,917,032 shares of the Company's common stock issued in April 2024 will be cancelled.

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.
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 completion of the offering, the satisfaction of customary closing conditions related to the offering, the intended use of proceeds from the offering, receipt of Stockholder Approval and 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.



View the original press release on accesswire.com

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

KELOWNA, BC / October 9, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that dosing has begun, for human pilot study #3 (the "Study"), investigating a DehydraTECH-processed version of the dual action GLP-1 (glucagon-like peptide) + GIP (glucose-dependent insulinotropic peptide) Zepbound® (tirzepatide) in an oral dose format.

The Study is being conducted in up to 10 healthy volunteers. The initial seven day dosing phase of either an oral DehydraTECH-processed tirzepatide capsule or a single injected tirzepatide dose is scheduled to be completed on October 13th. After a multi-week washout period, the second (final) seven day dosing phase will be administered in mid-November where subjects will receive the alternate treatment condition than what was received during the initial dosing phase. No serious adverse events have been observed thus far during this initial dosing phase.

Tolerability (side effects), blood absorption levels (pharmacokinetics or "PK"), and blood sugar control will all be evaluated in this Study. The DehydraTECH compositions for this Study were compound-formulated using commercially available Zepbound® injectable formulation as the tirzepatide input material.

Tirzepatide is currently approved for use in the USA under the brand names Zepbound® and Mounjaro®, owned by Eli Lilly™. These two brands combined are expected to generate approximately $15 billion in revenue in 2024.

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

In pilot Study #3 referred to today, Lexaria is hopeful of evidencing meaningful absorption rates of tirzepatide in a swallowed oral format, which is not available in the market today since it is currently administered only by injection.

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

About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

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

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

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

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

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

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

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

Analyst Firm
Link to Report

2023
Billions
$USD

2024
Billions
$USD

2030
Billions
$USD

2031
Billions
$USD

2032
Billions
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2033+
Billions
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ResearchAndMarkets

$

28.1

$

133.4

InsightAce Analytic

$

44.5

$

95.4

BMO Capital Markets

$

150.0

J.P. Morgan

$

100.0

Roots Analysis

$

49.3

$

157.5

Global Data

$

125.0

UBS

$

126.0

Goldman Sachs

$

130.0

MarketsAndMarkets

$

47.4

$

471.1

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

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

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

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

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

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

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

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

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

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

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com