Monthly Archives: May 2023

DehydraTECH-CBD offers distinctive mechanistic benefits related to its growing therapeutic utility

KELOWNA, BC / May 23, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce additional findings from last year's human clinical study HYPER-H21-4 ("the Study") demonstrating significant reductions in several pro-inflammatory biomarkers known to be linked to cardiovascular disease ("CVD") and a host of other conditions.

After five weeks of treatment with the patented DehydraTECH-processed cannabidiol ("CBD") capsule formulation, blood-plasma levels of interleukin ("IL") 8, 10, and 18 were reduced by ~19%, ~27%, and ~43%, respectively. Those persons receiving five weeks of placebo experienced no significant changes in their IL levels as shown with the black bars in the graph below. The differences evidenced relative to baseline and/or placebo with pro-inflammatory biomarkers IL 8, 10 and 18 were statistically significant (p<0.05).

Blood Plasma Levels (pg/mL) of Pro-Inflammatory Biomarkers IL-8, IL-10 and IL-18

"There is some pre-clinical evidence for the anti-inflammatory actions of CBD, but this is likely the most convincing evidence in humans that I have ever seen," said Dr. Philip Ainslie, Cardiovascular Advisor to Lexaria and Lead Investigator of Study HYPER-H21-4. "The bigger picture is that inflammation is the key basis of atherosclerosis, and several pro-inflammatory agents have been examined as potential mediators of the biochemical pathways of lesion formation. Other ‘common' diseases or disorders associated with chronic inflammation include fatty liver disease; Type 1 & 2 diabetes mellitus; inflammatory bowel disease; asthma; lung diseases chronic kidney disease; rheumatoid arthritis and obesity. Part of the reason why many of these diseases lead to cardiovascular disease is via chronic inflammation."

There is clear scientific evidence for the involvement of IL-8 in the establishment and preservation of the inflammatory microenvironment of the vascular wall in instances of CVD. In cardiovascular risk estimation, several reports have indicated that increased serum levels of IL-8 are correlated with an increased risk of CVD or acute cardiovascular events.

IL-10 and IL-18 are also considered anti-atherosclerotic cytokines with evidence for IL-8 and IL-18 perhaps being even stronger in CVD. In addition, IL-10 levels are known to increase along with the reduction of kidney function; and higher serum IL-10 levels have been associated with the risk of cardiovascular events during follow-up. Similarly, IL-18 is an independent predictor of cardiovascular events in patients with metabolic syndrome. In large population-based studies, circulating IL-18 is prospectively and independently associated with CVD risk.

Lexaria previously announced that the primary efficacy and safety objectives of the Study were successfully achieved, with resting blood pressure significantly reduced in hypertensive patients, and sustained over the full 5-weeks of dosing with zero serious adverse events being reported throughout the Study. Lexaria is aware of only a handful of other published research studies, mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this.

In addition, Lexaria also previously announced data from the Study revealing potentially a unique mechanistic benefit upon cardiovascular regulation via catestatin modulation with DehydraTECH-CBD treatment that has not previously been demonstrated with testing of CBD for blood pressure reduction to its knowledge. This finding together with today's announcement of improvements in pro-inflammatory biomarker levels related to cardiovascular and related disease states further strengthens the case for DehydraTECH-CBD offering distinctive mechanistic benefits related to its growing therapeutic utility. These reductions in inflammation also provide an mechanistic additional pathway by which DehydraTECH-CBD may act to lower blood pressure.

The Food and Drug Administration ("FDA") has laid out clear guidelines for sponsors who seek to develop new anti-hypertensive drugs, specifically defining the need for medications that offer complementary modes of action. Lexaria believes that its latest results, detailed below and already peer-reviewed and published in the respected journal, "Biomedicine and Pharmacotherapy", may support DehydraTECH-CBD qualification within these FDA guidelines.

DehydraTECH's Relationship to the Hypertension Market
Over 100 million adult Americans have high blood pressure, but only one in four of those have the condition under control. Many patients stop taking their medications because of troublesome side effects: some diuretics can cause excessive urination, beta blockers can cause erectile dysfunction, calcium-channel blockers can cause leg swelling, and ACE inhibitors can lead to persistent cough. Lexaria believes that its DehydraTECH-CBD may introduce a more tolerable anti-hypertensive treatment option that may be used alone or in combination with other medications, to reduce blood pressure with fewer discouraging and unwanted side effects.

There is a clear medical and market need for alternative anti-hypertensive therapies, especially in the case of patients with so-called resistant hypertension who fail to adequately control their high blood pressure with combinations of existing medications. Of note, the decreases in blood pressure evidenced in the Study were similar in both those hypertensive patients on standard of care blood pressure medications and those who were untreated for their hypertension upon Study entry. Therefore, Lexaria's findings indicate that Lexaria's DehydraTECH-CBD has the potential to offer complementary and additive blood pressure reduction benefits on top of any degree of improvements the standard of care medications provided. This additive improvement of DehydraTECH-CBD as an adjunct therapy, perhaps related to its pronounced effectiveness in modulating catestatin and pro-inflammatory cytokine levels, could become a significant value enhancer should it eventually enter the marketplace as an approved hypertension treatment.

Study HYPER-H21-4 together with four previous human clinical studies in hypertension Lexaria conducted from 2018 through 2022 are integral to successful filing and review of its upcoming Phase 1b investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for purposes of its planned U.S. study HYPER-H23-1. Lexaria's five foundational human clinical studies to-date in this area have been carried out in an aggregate total of 134 healthy and hypertensive persons and have evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens while producing zero serious adverse events.

Additional endpoint analyses from HYPER-H21-4 as described in the complete study protocol are still underway and any relevant material findings will be reported upon as these findings become available.

Study HYPER-H23-1 is entitled ‘A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension'. The primary objective of the study will be to evaluate safety and tolerability in hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing. Lexaria anticipates filing the IND this summer with hoped-for FDA authorization within 60 days thereafter.

About DehydraTECH-CBD
DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure. Lexaria has also developed DehydraTECH-CBD formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.

About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through 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 30 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.

900% and 2,000% improvements in peak bloodstream delivery using DehydraTECH

KELOWNA, BC / May 18, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that its animal study HOR-A22-1 has successfully completed, showing significant enhancement in the oral delivery of the estrogen hormone estradiol, an important component of therapeutic products in the women's health sector.

The DehydraTECH-estradiol formulation achieved an average peak concentration in the bloodstream (or "Cmax") of 5.65ng/mL that was roughly nine times (900%) higher than that achieved with the control formulation at only 0.63 ng/mL. As well, because estradiol is known to be quickly converted into the metabolite estrone by cells in the uterus, mammary glands and liver, estrone levels were also quantified in the study. This revealed that levels of the estrone metabolite were also significantly higher comparing an average Cmax of 6.49 ng/mL with the DehydraTECH formulation to only 0.302 ng/mL achieved with the control, representing greater than a twenty-fold (2,000%) improvement in delivery.

Also, the total estradiol and estrone recovery in the blood plasma over time or the Area Under the Curve ("AUC") was dramatically higher at 3.9 hr·ng/mL for estradiol and 32.6hr·ng/mL for the estrone with the DehydraTECH composition versus being non-detectable below the lower limit of quantitation of the assay (i.e., 0.25 ng/mL) with the control in both instances. This means that the AUC findings were at least fifteen times (1,500%) greater than the control for estradiol and over one hundred and twenty-five times (12,500%) greater for estrone.

Oral estradiol therapy is commonly used by women in birth control products, as well as to help reduce the symptoms of menopause and protect bone health. The hormone replacement market is estimated at $46.5 billion in 2027.

Oral estradiol formulations are known to have very low bioavailability, generally in the 5% range, necessitating relatively high dosages to achieve the desired beneficial effects. This, in turn, can lead to unwanted side effects ranging from gastrointestinal complications such as nausea, vomiting, diarrhea, stomach cramps and bloating, to other issues such as headache, dizziness, rash and more. Lexaria's DehydraTECH processing may offer a new approach to formulating estradiol and potentially other human hormone therapies for enhanced oral delivery toward improved safety and efficacy if pursued and proven ultimately clinically in humans.

According to a study just published in the Canadian Medical Association Journal, "menopause and perimenopause can be associated with distressing symptoms and reduced quality of life". As reported by CTV News, "more women suffering from debilitating symptoms of menopause should be presented with the option of hormonal therapy".

About Estrogen

There are three main types of Estrogen: They are Estrone (E1) which is the only estrogen that females continue to make after menopause and which males and females manufacture in the adrenal glands; Estradiol (E2) which is the most common form of estrogen in women of childbearing age and is primarily made in the ovaries, and in men, is manufactured in very small quantities in the testicles; and Estriol (E3) that is primarily made in the placenta of pregnant women.

About the Study

Study HOR-A22-1 was a pharmacokinetic ("PK") study performed in twenty female Sprague-Dawley rats in order to evaluate the ability of DehydraTECH™ to enhance the delivery characteristics of orally administered estradiol. Delivery was assessed comparing a DehydraTECH-estradiol composition to a concentration-matched generic estradiol preparation lacking the DehydraTECH formulation and processing enhancements. Formulations were administered orally at a dose of 10 mg/kg of estradiol. Following dosing, blood was collected up to 48 hours post-dose. The concentration of estradiol and estrone were then determined in plasma following dosing using a validated liquid chromatography tandem mass spectrometry "LC-MS/MS") method.

Study HOR-A22-1 was conducted at a U.S.-based, third-party independent laboratory. Lexaria will provide additional information of further developments or plans to pursue expanded investigation with DehydraTECH for human hormone therapies as they become available.

About DehydraTECH

DehydraTECH is a patented drug delivery formulation and processing platform technology Lexaria has developed and is investigating for a variety of beneficial molecules. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules into brain tissue, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria has also developed DehydraTECH formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through 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 30 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.

KELOWNA, BC / May 11, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, today announced the closing of its public offering of 2,106,000 units, with each unit consisting of one share of common stock and one warrant to purchase one share of common stock. Each unit was sold at a public offering price of $0.95. The warrants in the units are immediately exercisable at a price of $0.95 per share and expire five years from the date of issuance. The shares of common stock and accompanying warrants were only purchasable together in this offering, but were issued separately and were immediately separable upon issuance.

Gross proceeds, before deducting placement agent fees and other offering expenses, were approximately $2.0 million.

Maxim Group LLC acted as sole placement agent in connection with this offering.

The securities described above were offered pursuant to a registration statement on Form S-1, as amended (File No. 333-271096) (the "Registration Statement"), which was declared effective by the Securities and Exchange Commission (the "SEC") on May 8, 2023. The offering was made only by means of a prospectus which is a part of the Registration Statement. A copy of the final prospectus relating to the offering has been filed with the SEC and may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, at (212) 895-3745.

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

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through 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 30 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

Forward-Looking Safe Harbor Statement

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 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 / May 10, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the results of the 2023 Annual Meeting (the "Meeting").

On May 9, 2023 at 1:00 p.m. (Pacific Time), the Company held the Meeting whereby there were 3,372,024 shares of the Company represented in person or by proxy at the meeting, constituting 56.3% of the Company's issued share capital as at March 13, 2023, being the record date of the Meeting. The matters voted upon at the Meeting and the final voting results are set forth below:

¹ Percentage is calculated based on abstained votes being counted as a vote against the resolution

All of the proposals are described in detail in the Company's proxy statement filed with the Securities Exchange Commission via Edgar and with the BC Securities Commission and Ontario Securities Commission via SEDAR on March 22, 2023.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through 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 30 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.

KELOWNA, BC / May 8, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, today announced the pricing of its public offering of 2,106,000 units, with each unit consisting of one share of common stock (or one pre-funded warrant to purchase one share of common stock in lieu thereof), and one warrant to purchase one share of common stock. Each unit is being sold at a public offering price of $0.95. The warrants will be immediately exercisable at a price of $0.95 per share and will expire five years from the date of issuance. The shares of common stock (or pre-funded warrants in lieu thereof) and accompanying warrants can only be purchased together in this offering, but will be issued separately and will be immediately separable upon issuance.

Gross proceeds, before deducting placement agent fees and other offering expenses, are expected to be approximately $2.0 million. The offering is expected to close on May 11, 2023, subject to customary closing conditions.

Maxim Group LLC is acting as sole placement agent in connection with this offering.

The securities described above are being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-271096) (the "Registration Statement"), which was declared effective by the Securities and Exchange Commission (the "SEC") on May 8, 2023. The offering is being made only by means of a prospectus which is a part of the Registration Statement. A preliminary prospectus relating to the offering has been filed with the SEC. Copies of the final prospectus relating to this offering, when available, will be filed with the SEC and may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, at (212) 895-3745.

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

About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through 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 30 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

Forward-Looking Safe Harbor Statement
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 Company's ability to satisfy customary closing conditions related to the offering. 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 / May 8, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that dosing of the targeted 36 subjects in its human clinical oral nicotine study NIC-H22-1 has been completed.

Human study NIC-H22-1 represents the culmination of several years of work performed by Lexaria on oral nicotine formulations as an alternative to vaping or smoking and may entice the more rapid commercial adoption and distribution of Lexaria's patented DehydraTECH absorption technology in an industry sorely lacking in oral uptake and performance optimizing innovation for many years.

The dangers of cigarette smoking are well known and result in the death of 7 million people per year. Nicotine vaping was originally hoped to help wean people off cigarette use but has had mixed results in doing so, and vaping has also been associated with serious health risks. Nicotine vaping is becoming increasingly controversial and is severely limited in certain countries and was, for instance, just banned in Australia and is either banned or restricted in many other countries. By comparison, Lexaria's DehydraTECH-nicotine is already patent granted for oral nicotine delivery in Australia and pending in numerous other countries. The white pouch category, as tested in study NIC-H22-1, is one of the fastest growing, tobacco-free alternatives to smoking and vaping.

Lexaria's DehydraTECH-powered purified nicotine white pouch formulation contains no tobacco. DehydraTECH-nicotine has already shown in multiple sets of animal testing that it can be up to 10-times to 20-times faster and able to deliver up to 10-fold higher levels of nicotine into blood plasma from oral absorption than concentration matched controls. If the findings from study NIC-H22-1 also show similar improved performance, this could facilitate a more satisfying oral nicotine experience than any of the leading brands sold around the world today which all rely on outdated formulation technology. Speed of onset is of vital importance to nicotine users and Lexaria's DehydraTECH-nicotine has demonstrated superiority in this regard.

Nicotine Plasma Levels (ng/mL) - DehydraTECH vs. Control From Lexaria's Earlier Animal Study

The oral nicotine pouch category is of intense interest to Lexaria and the nicotine products industry, and its growth is 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 and sublingual 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.

About Study NIC-H22-1.

Study NIC-H22-1 is a human pharmacokinetic randomized, double blinded, cross-over study conducted in a minimum of 36 human volunteers that are current cigarette smokers, wherein each person visited the laboratory to be dosed three times over several weeks. During each visit only one oral nicotine pouch was administered and evaluated: either DehydraTECH-nicotine; On! brand manufactured by Altria; or Zyn brand manufactured by Swedish Match. While 36 people have to date completed their dosing, Lexaria expects a small number of additional person(s) who were over enrolled into the study to also complete dosing in the immediate future.

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

The study is fully funded from internal company resources. Sample and data analysis is already underway and will be reported upon as soon as possible and Lexaria will provide further updates and any relevant material findings in due course from this study as they become available.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through 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 30 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.