Monthly Archives: November 2022

KELOWNA, BC / November 29, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that its patented DehydraTECH-CBD™ has demonstrated performance enhancements compared to one of the world's leading anti-seizure medications, Epidiolex®.

Animal seizure study program EPIL-A21-1 was designed to determine whether DehydraTECH-CBD could provide similar seizure inhibiting efficacy, using an established, vehicle-controlled, acute animal seizure model induced by electrical stimulation ("MES"), at lower doses than were required with Epidiolex. Epidiolex is the world's only commercially approved, CBD-powered anti-seizure drug. Lexaria is always searching for the lowest possible efficacious dose levels of the drugs it formulates with DehydraTECH in order to minimize adverse side effects.

An initial MES pilot study in animals that examined three different doses revealed that, at the lower doses of 50 mg/kg and 75 mg/kg, DehydraTECH-CBD was more efficacious than Epidiolex in reducing or eliminating seizure activity. Epidiolex was more efficacious than DehydraTECH-CBD in eliminating seizure activity at the highest dose tested in the pilot study of 100 mg/kg. Only DehydraTECH-CBD demonstrated some reduction in seizure activity at the 50 mg/kg dose. At the 75 mg/kg dose DehydraTECH-CBD demonstrated full elimination of seizure activity in 66.6% of the animals compared to 50% of the Epidiolex treated animals. In this regard there was an apparent trend for DehydraTECH-CBD to be more efficacious at lower doses than Epidiolex.

Following the pilot experiment, a second MES animal seizure study was performed where time to peak efficacy was measured at various post-dosing time points. DehydraTECH-CBD also showed an apparent trend toward enhanced effectiveness, in this case based on rapidity of action. At the 30-minute timepoint, 50% of the animals dosed with DehydraTECH-CBD showed partial reduction or full elimination of seizure activity whereas 100% of the Epidiolex-dosed animals were exhibiting full seizure activity at 30 minutes. At the 60-minute timepoint 87.5% of the animals dosed with DehydraTECH-CBD showed partial reduction or full elimination of seizure activity compared to 62.5% of the Epidiolex-dosed animals showing partial reduction or full elimination of seizure activity. Epidiolex showed some enhanced seizure reduction capabilities at later time points in the study.

Lexaria is encouraged by these results from its first foray into the anti-seizure testing field. The results to-date demonstrate the performance of DehydraTECH-CBD to reduce or eliminate seizure activity in animals and to, in some cases, even surpass the performance of one of the world's leading anti-seizure medications, Epidiolex. Overall, DehydraTECH-CBD appeared to demonstrate effectiveness at lower doses and more rapidly than Epidiolex. Future work under consideration may include additional DehydraTECH-CBD formulation optimization to support more sustained activity for this therapeutic application, where numerous pharmaceutical strategies exist to achieve prolonged drug action when needed.

ABOUT THE STUDY PROGRAM

Additional work is underway in study program EPIL-A21-1 with a final MES study designed to establish an ED50 (i.e., the dose required to achieve seizure inhibition in 50% of the animals tested) for DehydraTECH-CBD in this animal model, where ED50 determination is a common performance metric in preclinical animal studies for developmental therapeutics. This ED50 study is designed to corroborate the MES experimental findings to-date, and Lexaria will provide further updates and any relevant material findings in due course from this study as they become available.

Study program EPIL-A21-1 was designed as a three-part series utilizing Sprague Dawley rats; 21 animals in the pilot study; 24 animals in time to peak efficacy study; and 24 animals in the ED50 study. In all three experiments, seizure activity was induced by the MES model methodology and treatment effect was judged by evaluation of acute clinical signs in the animals. Treatment timing relative to seizure induction following the MES model methodology was based upon published literature of the biological activity of the positive control, Epidiolex. Study program EPIL-A21-1 is being performed by a leading, US-based independent laboratory and is fully funded by Lexaria.

ABOUT THE SEIZURE MARKET OPPORTUNITY

Epidiolex/Epidyolex is one of the world's leading drugs used to combat certain forms of seizure disorders with other anti-seizure applications as well, generating revenue of $196.2 million in the most recent fiscal quarter for owner Jazz Pharmaceuticals. Cannabidiol is the active ingredient within Epidiolex. Epidiolex revenues grew by 22% from the same quarter last year, compared to roughly 2.5% to 4.5% growth for all epilepsy drugs as a whole.

The global epilepsy market size was estimated at US $16.5 billion in 2018. The broader anti-convulsant market, which includes epilepsy, is estimated at $19.2 billion in 2021. The American Journal of Managed Care has estimated the total annual costs per person with epilepsy to be US$15,414.

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, PDE5 inhibitors 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 27 patents granted and roughly 50 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. The Company only releases select, incomplete data from its study programs. 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 / November 10, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that study program DEM-A22-1 is expected to begin on November 15, 2022. This is Lexaria's first-ever study to investigate whether its patented DehydraTECH-processed cannabidiol ("CBD") may potentially have therapeutic utility against dementia.

Lexaria has previously evidenced the efficacy of DehydraTECH-CBD in human hypertension studies with no serious side effects. Clinical studies have established that there are connections between hypertension and dementia: individuals who have high blood pressure are more likely to develop vascular dementia, which is the second most common form of dementia following Alzheimer's disease. "Vascular dementia is caused by reduced blood flow to the brain, which starves brain cells of the oxygen and nutrients they need to function correctly". Others have conducted research evidencing therapeutic potential of cannabinoids including CBD in a variety of neurodegenerative diseases.

Lexaria has previously demonstrated in animal studies that DehydraTECH-CBD crosses the blood brain barrier ("BBB") much more effectively than originally thought possible. Given the propensity of DehydraTECH-CBD to cross the BBB; the established fact that DehydraTECH-CBD lowers human blood pressure; and the fact that CBD is known to act with vasodilation properties, Lexaria is excited to investigate whether DehydraTECH-CBD might have some positive effect on dementia.

ABOUT THE STUDY

Study DEM-A22-1 is a dose-ranging, two-month program in a total of 32 Long Evans rats that will be dosed with DehydraTECH-CBD. The study is a novel object recognition test which is widely used to assess memory in rodents, and is being utilized to investigate whether CBD enables cognitive performance enhancements in this model, potentially of utility in dementia treatment. Extensive use of cameras will be used to monitor and evaluate animal behaviour.

Study DEM-A22-1 will be undertaken by a leading, third-party testing laboratory located in Canada. The laboratory work is expected to complete in late January 2023 with data and reporting to follow thereafter. Depending on the outcomes, study DEM-A22-1 may be followed by additional investigations potentially including DehydraTECH-processed nicotine as another agent known to enhance cognitive performance when delivered effectively. Lexaria will provide further updates and any relevant material findings in due course from this study as they become available.

ABOUT THE DEMENTIA MARKET OPPORTUNITY

Dementia is a term describing loss of cognitive abilities related to memory, language, problem solving abilities and more. Alzheimer's disease is the most common type of dementia, followed by vascular dementia. According to the World Health Organization, 55 million people are currently suffering from dementia with roughly 10 million additional people being diagnosed each year.

Drugs used to treat dementia represented a $15.5 billion market in 2021, expected to double to a $32.3 billion annual market by 2030, in part due to the generally aging populations. Certain trials are underway to also investigate the use of nicotine for possible utility related to dementia, where some clinical success has already been reported.

Although Lexaria's current study DEM-A22-1 is utilizing only DehydraTECH-CBD in order to discover any effects that CBD might have on dementia, Lexaria is considering additional future studies that might utilize either nicotine alone, or nicotine in combination with CBD. Results from study DEM-A22-1 will be reported as soon as available, likely in April 2023.

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, PDE5 inhibitors 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 27 patents granted and roughly 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.

KELOWNA, BC / November 8, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that study program DIAB-A22-1 is expected to begin on schedule today. This is Lexaria's first-ever study to investigate whether its patented DehydraTECH-processed cannabidiol ("CBD") may potentially have therapeutic utility against diabetes.

Lexaria has previously evidenced the safety and efficacy of DehydraTECH-CBD in human hypertension studies. There are strong connections between heart disease, hypertension, and diabetes: hypertension is twice as frequent in diabetics and hypertensive patients are at greater risk of developing diabetes.

Diabetes prevents the body from making enough insulin, resulting in abnormal blood sugar levels. It is the 7^th largest cause of death in the US and there is currently no cure. Investigation of CBD related to diabetes is in early stages, though there are some areas of ongoing investigation. CBD has shown some ability to reduce the incidence of diabetes in mice.

ABOUT THE STUDY

Study DIAB-A22-1 is a dose-ranging, 56-day program in a total of 32 male Zucker rats, 24 obese and 8 lean, that will compare weight gain, blood glucose, cholesterol and trigyceride levels in animals that receive DehydraTECH-CBD to those that do not. The first 28 days of the study is a baseline validation and monitoring phase and the second 28 days of the study will include the daily DehydraTECH-CBD dosing and treatment phase. Blood will be drawn for analysis on days 0, 13, and 27 during the validation phase, and on days 7, 14 and 28 during the treatment phase.

Study DIAB-A22-1 will be undertaken by a leading, third-party testing laboratory located in Canada. The laboratory work is expected to complete in early January 2023 with data and reporting to follow thereafter. Lexaria will provide further updates and any relevant material findings in due course from this study as they become available.

ABOUT THE DIABETES MARKET OPPORTUNITY

Diabetes is a disease whereby the body does not produce sufficient insulin, leading to higher than normal levels of sugars in the blood. Risks of kidney disease, vision loss, heart and cardiovascular disease and more are greatly enhanced by sufferers of diabetes. Because diabetes is often closely connected to obesity, it is a chronic and growing problem around much of the world.

People with type-2 diabetes can often control the disease through lifestyle changes and/or taking certain diabetes medications, whereas those with type-1 diabetes are required to add insulin to their body through syringes, insulin pumps, or other similar devices. Thus the treatment of diabetes includes devices, drugs, and lifestyle alteration. The global diabetes devices market is estimated at $26.7 billion in 2021. The global diabetes drug market is estimated at $63.1 billion in 2021. Due to the pain and unpleasantness of injections, many diabetes sufferers prefer to treat their condition with drugs vs. devices, if they have the choice. More than 1.9 billion people were overweight in 2016, and due to the growth in obesity, which has nearly tripled from 1975 to 2016, the number of people experiencing diabetes continues to grow.

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, PDE5 inhibitors 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 27 patents granted and roughly 50 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's DehydraTECH-nicotine pouch performance to be compared to existing leading brands ON! and Zyn

KELOWNA, BC / November 1, 2022 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that independent review board ("IRB") approval has now been received for human clinical nicotine study NIC-H22-1, and that human dosing will begin soon.

Study NIC-H22-1 is a 36-person human pharmacokinetic ("pk") randomized, double blinded, cross-over study conducted in current cigarette smokers, wherein each person will visit the laboratory to be dosed three times over a period of weeks. During each visit only one oral nicotine pouch will be administered and evaluated: either DehydraTECH-nicotine; On! brand manufactured by Altria; or Zyn brand manufactured by Swedish Match. Predetermined questionnaires for subjective evaluation will be used for each oral nicotine pouch, and blood samples will be taken a total of 8 times per visit to conduct objective evaluations related to quantity of nicotine in blood at various time points, and more. Vital signs such as temperature, blood pressure, heart rate and respiratory rate will also be collected. Subjective evaluations related to throat burn, user experience, gastrointestinal experience and more will be conducted. Lexaria hopes to evidence that processing purified nicotine with DehydraTECH leads to better oral-tissue absorption and reduced negative experiences compared to currently sold brands.

The study had earlier faced certain time extensions due to manufacturing and logistics, those issues since resolved. The study is fully funded from internal company resources. Lexaria will provide further updates and any relevant material findings in due course from this study as they become available.

As reported on October 5, 2021, Lexaria demonstrated in animal study NIC-A21-1 that nicotine oral pouches using DehydraTECH technology were 10x to 20x faster in reaching peak delivery of nicotine to bloodstream than controls. Findings using a DehydraTECH nicotine benzoate formulation relative to a concentration-matched control from that study are shown in the figure below.

The oral nicotine pouch category is of intense interest to Lexaria and is one of the fastest growing segments of the nicotine industry due in part to its reduced risk health outcomes as noted by the Food and Drug Administration ("FDA"). This delivery method, in the white pouch format specifically, which avoids harmful lung outcomes experienced by smokers or vapers, involves absorption primarily through the buccal tissues of the mouth, of purified nicotine that has been separated from most other harmful compounds in the tobacco leaf. The global market for the oral nicotine pouch category was US$2.33 billion in 2020 and is growing at a rapid CAGR of 30.7% and is expected to reach $21.84 billion in 2027.

As reported on March 8, 2022, Lexaria recently received its first ever patent granted to use DehydraTECH to more efficiently deliver nicotine through buccal tissue absorption. Similar patent filings have been made in the USA and in the EU and Lexaria believes those potential patent awards could support significant competitive advantages in the nicotine white pouch category, as well as other oral nicotine product formats.

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, PDE5 inhibitors 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 27 patents granted and roughly 50 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.