Monthly Archives: December 2022

KELOWNA, BC / December 29, 2022 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce its continued accumulation of international patent recognition with the receipt of its first granted patent in Canada, which is its 28^th granted patent worldwide.

Canadian Patent #3,093,414 is the first granted patent from Lexaria's sixth patent family and is entitled "Transdermal And/Or Dermal Delivery Of Lipophilic Active Agents". The patent is for improved compositions and methods for transdermal and dermal delivery of cannabinoids, including cannabidiol ("CBD") and tetrahydrocannabinol ("THC"). Similar patent applications for skin-based delivery of DehydraTECH formulations remain pending in many other countries.

Effective skin-based administration opens up new possibilities for pharmaceutical and medical applications of CBD and other cannabinoids for peripherally focused disease conditions in the body, or for those people who have difficulty with oral dosage forms. In countries where CBD is legal for non-pharmaceutical use, superior skin-penetrating advantages could prove to be commercially valuable.

In a 2018 study, Lexaria's DehydraTECH-CBD demonstrated almost a 1,900% increase in CBD permeability through human skin compared to a control formulation that was devoid of any commercial penetration enhancers. When compared to the highest performing commercial penetration enhancer that was evaluated in that study, DehydraTECH-CBD still offered a 225% increase in CBD permeability through the skin. Lexaria's DehydraTECH-CBD was also the fastest acting for absorption into the epidermis, dermis and through the skin into the representative systemic circulation.

Since 2018 Lexaria has developed significantly more powerful versions of DehydraTECH-CBD tested orally that have not yet been tested in skin penetration studies, but that may offer even further enhanced CBD delivery topically compared to its compositions tested to-date. Lexaria's DehydraTECH-CBD formulated topically also exhibits nearly zero unwanted odor often associated with cannabinoid extracts, without using any masking perfumes or other artificial agents to mask odor.

Delivery of drugs through the skin has been both an attractive and challenging area for research, as one of the principle functions of skin is to provide a barrier to the transportation of water and substances potentially harmful to normal homeostasis. The skin helps to prevent the entry of harmful substances into the body but can also be used to administer beneficial substances. The global skin-care market is estimated to be over $121 billion in annual sales, not including pharmaceutical applications.

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 28 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 / December 21, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce it has demonstrated superior cannabidiol ("CBD") blood absorption levels from its patented DehydraTECH-CBD™ relative to those of published, pharmaceutical-grade CBD industry comparators in its recently completed, multi-week human clinical hypertension study HYPER-H21-4.

In a 2017 randomized clinical trial that evaluated a non-Lexaria, pharmaceutical-grade, plant-derived CBD formulation published by Devinski et. al., an average blood plasma CBD level of 23.0 ng/mL was evidenced after 22 days (so-called, "steady state"¹) of daily dosing at a 5 mg/kg CBD dose level. By comparison, in Lexaria's 2022 HYPER-H21-4 hypertension study, a 45.8% higher average blood plasma level (33.3 mg/mL) was reached at DehydraTECH-CBD's lowest dose level tested of just 3.38 mg/kg, climbing to a blood plasma level that was 133.4% higher (53.7 ng/mL) at its highest dose level tested of 4.46 mg/kg.

The Devinsky publication also examined higher CBD dosing at a level of 10 mg/kg, evidencing a blood level of 62.1 ng/mL. Although Lexaria's HYPER-H12-4 study did not see the need to dose as high as 10 mg/kg, the data trend observed at its 3.38 and 4.46 mg/kg dose levels extrapolated linearly to 10 mg/kg would be expected to reach a level of 149.5 ng/mL; a 141% improvement over the Devinsky CBD formulation.

Similarly, a 2019 study published by Wheless et. al., also evaluated average CBD levels in blood following dosing to steady-state¹ over a multi-day period, using a different pharmaceutical-grade, synthetic CBD formulation. At a 10 mg/kg dose level in the Wheless study, the non-Lexaria synthetic CBD reached a level within blood plasma of 91 ng/mL.; DehydraTECH-CBD absorption outperformed this synthetic CBD by 64% improvement upon linear extrapolation.

"DehydraTECH-CBD has repeatedly shown that it can be administered at much lower dose levels than other CBD formulations to achieve effective levels within the blood stream, as supported by this pharmaceutical-industry peer comparison," said Chris Bunka, CEO of Lexaria Bioscience Corp. "This is extremely important to patients hoping to achieve positive health outcomes while using lower levels of medication with no serious side effects and also important to Lexaria as we pursue FDA registration of DehydraTECH-CBD."

Additional study endpoint analyses as described in the complete study protocol are still underway and any relevant material findings will be reported upon in due course as these findings become available. It is highly likely that multiple additional datasets will be released in January through March of 2023.

Lexaria's HYPER-H21-4 study was a randomized, double-blinded, placebo-controlled, cross-over study of a total of 66 male and female volunteers between the ages of 40-70. All study participants received DehydraTECH-CBD every day for a total of 5 weeks. Blood CBD levels reported herein from DehydraTECH-CBD administration were measured prior to dosing, as was the case reported in the Devinsky article, whereas the Wheless article did not specify blood sampling timing relative to dosing. The complete HYPER-H21-4 study protocol has been published and is available at PubMed.

¹Steady State

In Pharmacology, "steady-state" refers to the amount of time required before a consistent dose of drug achieves a stable blood plasma level. While the Devinsky and Wheless study references examined CBD levels in the blood at different points in time compared to Lexaria's study, all three studies would have been expected to have reached steady-state pharmacokinetics after sustained dose administration by the points in time at which sampling was performed. CBD is generally thought to reach steady-state dose levels within several days of consistent dosing.

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.

• Lexaria's DehydraTECH-nicotine pouch performance to be compared to existing leading brands ON! and Zyn

KELOWNA, BC / December 20, 2022 / 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 now begun in its human clinical nicotine study NIC-H22-1.

Study NIC-H22-1 is a 36-person human pharmacokinetic randomized, double blinded, cross-over study conducted in current cigarette smokers, wherein each person will visit the laboratory to be dosed three times over the weeks to come. 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.

The primary study objectives are to determine the quantity of nicotine in blood at various time points and vital-sign data collection of temperature, blood pressure, heart rate and respiratory rate. Subjective evaluations related to throat burn, user experience, gastrointestinal experience and more will be conducted.

Nicotine study NIC-H22-1 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.

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.

Separately and as previously disclosed under Item 4.01 of the Company's Form 8-K as filed with the US Securities and Exchange Commission on November 28, 2022, the Company has appointed MaloneBailey LLP as its new independent auditor. There was no disagreement with the Company's former auditors, Davidson & Company LLP, related to this change in auditors.

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.