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  • Significant Milestone Achieved in Commercial Product Development Program
  • Abbreviated 505(b)(2) Strategy Confirmed as an Appropriate NDA Pathway

KELOWNA, BC / August 10, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that it has received a positive full written response from the Food and Drug Administration ("FDA") from its pre-Investigational New Drug ("Pre-IND") meeting regarding DehydraTECH-CBD for the treatment of hypertension.

The FDA confirmed that it agreed with Lexaria's proposal to pursue a 505(b)(2) new drug application ("NDA") regulatory pathway for its program which is advantageous because this abbreviated pathway, as it is often described, typically enables a faster route to commercial approval than the traditional 505(b)(1) NDA pathway.

Lexaria's proposed Phase Ib clinical protocol for DehydraTECH-CBD for treatment of a target of 100 patients with hypertension was received favorably by the FDA, with a view to opening the IND application to allow Lexaria to work towards full registration of DehydraTECH-CBD for treatment of hypertension.

"We are very pleased to have received comments from the FDA toward opening our IND program and we will be executing FDA-confirmed IND-enabling work immediately," said John Docherty, President of Lexaria Bioscience Corp. "We were delighted that our proposals were very well received by the FDA and the feedback received will be very helpful in compiling and filing our IND application as the next major regulatory step we are focused on moving forward."

Additionally, as part of the communication with FDA, it agreed that additional non-clinical studies are not required prior to initiation of the DehydraTECH-CBD IND program, given the compelling data already presented by Lexaria and others regarding the safety and tolerability of CBD. This supports Lexaria's long-held belief that its recent human clinical study program would be supportive of our eventual FDA registration pursuits.

As a result of the favorable FDA response, Lexaria expects to remain on track to file its full IND application with the FDA by late 2022 / early 2023 as previously announced. This is up to 6-9 months sooner than if the FDA had required modifications in Lexaria's current IND-enabling work plan, such as performance of additional non-clinical study work.

DehydraTECH-CBD is protected by multiple patents in the USA and internationally and has received specific patent protection in both the EU and Australia for use in the treatment of heart disease. Lexaria continues to investigate all opportunities within the heart disease sector, including hypertension, arterial stiffness, and more.

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 26 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. 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 contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/711505/Lexaria-Announces-Positive-Feedback-from-Pre-IND-Meeting-with-FDA-on-DehydraTECH-CBD-for-Hypertension

KELOWNA, BC / July 27, 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 with Lexaria's DehydraTECH™-processed cannabidiol ("DehydraTECH-CBD") has been completed in its multi-week human clinical hypertension study HYPER-H21-4, and that no serious adverse events have been reported as a result of the dosing.

HYPER-H21-4, is a randomized, double blinded, placebo-controlled, cross-over study that was designed to enrol a minimum of 60 patients. Dosing has now completed, meaning all patients at different times during the study have now received both the full DehydraTECH-CBD dose regimen as well as the placebo. A total of 64 patients were dosed in this study. Maximum dose levels were roughly 5 mg/kg/day which is significantly lower than maximum dose levels practiced for other regulator-approved pharmaceutical CBD applications, which Lexaria postulates may be beneficial in avoiding unwanted side effects such as clinically significant elevated liver enzymes sometimes reported in the published scientific literature at higher dose levels.

"We are extremely pleased that dosing has been completed on time in this multi-week clinical study without any serious adverse events having occurred," said Chris Bunka, CEO of Lexaria Bioscience Corp. "Demonstrating a noteworthy safety and tolerability profile relative to conventional anti-hypertensive medications is one of Lexaria's major goals with this program, and avoiding serious adverse events at clinically efficacious doses will be a primary requirement to achieve eventual regulatory marketing authorizations."

HYPER-H21-4 is designed to enhance Lexaria's probability of success toward an Investigational New Drug ("IND") application filing to seek U.S. Food and Drug Administration ("FDA") approval to commence registered clinical testing at the Phase I level or higher, to be determined in consultation with the FDA. This human study is also expected to enhance Lexaria's understanding of DehydraTECH-CBD for the treatment of cardiovascular and other disease states beyond hypertension related to increased arterial stiffness and blood biochemistry, pursuant to earlier promising findings in this area. HYPER-H21-4 follows Lexaria's previously announced successes in significantly reducing blood pressure in similarly hypertensive human volunteers in its 2021 studies HYPER-H21-1 and HYPER-H21-2.

HYPER-H21-4 consisted of male and female volunteers between the ages of 40-70 with documented or measured elevated blood pressure (120/80 to 139/80 mmHg), mild (stage 1) hypertension (140/90 to 159/99 mmHg) or moderate (stage 2) hypertension (160/100 to 179/109 mmHg) who received DehydraTECH-CBD every day for a 5-week duration. DehydraTECH-CBD doses escalated between 225 mg/day to 450 mg/day over the study duration adjusted relative to body weight. Some volunteers were already using leading standard of care hypertension drugs such as angiotensin-converting enzyme ("ACE") inhibitors with or without diuretics and/or calcium channel blockers, which will help evaluate the safety and efficacy of DehydraTECH-CBD with and without other hypertension treatments. The extended duration of the study allowed Lexaria to gather critical data monitoring the safety and efficacy of DehydraTECH-CBD over time and will evaluate the potential for longer term health benefits.

HYPER-H21-4 is more comprehensive than any clinical study previously undertaken by Lexaria and many types of analysis will be performed including 24-hour ambulatory blood pressure, which is the primary study outcome.

Secondary study outcomes include: vascular health including arterial stiffness and autonomic balance; electrocardiogram ("ECG") analysis; brain structure and function through MRI testing; blood biomarkers (including renal, hepatic inflammation, lipids such as cholesterol and more); sleep quality / daytime sleepiness / sleep disorders; actigraphy, geriatric depression scale, perceived stress, and Beck anxiety inventory. Large quantities of data have been gathered since the initiation of the study, and most data analyses will begin in September once results are available from ongoing bioanalyses work upon biological samples collected during the study.

Each of these sets of data may lead to additional applications for DehydraTECH-CBD. For example, the MRI data may assist one of the secondary outcome measurements in the study to evaluate possible positive effects upon brain structure and function; and the detailed psychometric testing may reveal new insights into the potential benefits for mental health. The wide range of data collection could provide additional insights into the long-term health benefits of DehydraTECH-CBD that might otherwise remain undetected.

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 25 patents granted, 1 patent allowed, 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. 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 contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/709884/Lexarias-DehydraTECH-CBD-Hypertension-Study-HYPER-H21-4-Dosing-Complete-with-No-Serious-Adverse-Events

KELOWNA, BC / July 26, 2022 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that its exclusive* Japanese Licensee, Premier Wellness Science Co., Ltd., ("Premier") officially launched its first generation of its new cannabidiol ("CBD") products under the brand "Ko", on July 21, 2022 for the Japanese consumer market.

Premier will create its own e-commerce infrastructure and digital marketing campaigns in collaboration with its parent company, Premier Anti-Aging Co., Ltd. ("Parent") which is listed on the Tokyo Stock Exchange (4934:JP).

For wholesale sales, Premier will work with a large third-party Japanese-based distribution company also listed on the Tokyo Stock Exchange to expand sales channels. Originally founded in 1898, it is a large distributor and logistics supplier for cosmetics, OTC pharmaceuticals and nutraceuticals to wholesalers, retailers and more; and, shipped more than 3.5 billion products in its most recent fiscal year, comprised of over 50,000 products and over 50,000 retail stores of distribution.

The "Ko" brand is focused on the endocannabinoid system and circadian rhythm to support the health and wellness of all people, highlighted by the concept of wellness for all and will contain CBD and other botanical extracts. Ko-branded products containing Lexaria's DehydraTECH™ delivery technology are expected to be introduced during Q2 2023, following rigorous product development and formula optimization.

Premier is working diligently to establish its new brand while also looking towards extensive distribution for the DehydraTECH-enabled products to be developed and sold. Lexaria notes the extensive capabilities of Premier, Parent, and PALTAC - all expected to contribute to the eventual widespread introduction of DehydraTECH-CBD products within the Japanese marketplace.

Under the terms of the license agreement with Lexaria as previously announced on June 3, 2022, Premier purchased the rights to DehydraTECH technology for the Japanese non-pharmaceutical market for use with CBD and hemp ingredients in oral liquid and non-liquid products, as well as for topical, hair-care, lip-care and cosmetics products.

In order to retain ongoing exclusivity, the negotiated minimum quarterly payments ("Payments") to Lexaria begin September 1, 2022 and, during the first five years of the Agreement, amount to US$4,527,500. Additional payments beyond five years are required to keep the license in good standing, in which case the license for the Japanese market is perpetual.

In addition to the Payments, Lexaria will also receive royalty revenue from DehydraTECH licensed product sales, which are anticipated to be significantly greater than the minimum Payments if Premier is capable of meeting its expected revenue targets. If Premier achieves even their worst-case projected penetration into the Japanese non-pharmaceutical CBD market, then based on their projections Lexaria could expect to receive annual payments of over $5 million by the fifth year of the contract.

*The exclusive rights are subject to two previously issued licenses for use of DehydraTECH in Japan, which remain valid. Lexaria will not be issuing any further licenses in Japan for non-pharmaceutical cannabinoid products.

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 25 patents granted plus a 26th patent allowed; 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. 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 contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/709713/Lexarias-Licensee-Premier-Wellness-Science-Co-Ltd-Launches-New-Brand-in-Preparation-to-Deploy-DehydraTECH-CBD-Products-in-Japan

KELOWNA, BC / July 14, 2022 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce the Company has been notified of the allowance of its 26th worldwide patent with a new patent to be granted in Japan.

This is Lexaria's third patent to be granted in Japan, entitled Lipophilic Active Agent Infused Compositions With Reduced Food Effect. This patent recognizes DehydraTECH's ability to deliver active pharmaceutical ingredients ("APIs") more efficiently regardless of the presence of foods within the gastrointestinal system - the so-called "food effect". Delivering drugs more consistently into the bloodstream regardless of the presence of food in the GI is an important achievement in the quest for more reliable drug dosing.

This is the first patent issued from Lexaria's seventh patent family and refers to tetrahydrocannabinol ("THC"). Lexaria has patents granted or patent applications progressing in countries around the world with aggregate populations of nearly 4 billion people and will report on further progress as information becomes available.

In additional news, Lexaria has submitted its briefing book to the US Food and Drug Administration ("FDA"). The Company has no further requirements or deliverables related to the pre-Investigational New Drug ("IND") meeting request announced on June 2, 2022. The FDA has provided a target date of July 30, 2022 for meeting or comments.

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 25 patents granted plus the 26th patent allowed; 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. 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 contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/708340/Lexaria-To-Receive-Third-Patent-Granted-in-Japan-Submits-FDA-Filing

Lexaria is targeting the oral nicotine pouch category, one of the fastest growing segments of the nicotine industry.

KELOWNA, BC / July 13, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the pending start of its upcoming human nicotine study NIC-H22-1. Lexaria expects to evidence that processing purified nicotine with its patented drug delivery technology, DehydraTECHTM, leads to enhanced oral-tissue absorption and reduced negative experiences.

Study NIC-H22-1 is a minimum 36-person human pharmacokinetic ("PK") randomized, double blinded, cross-over study to compare Lexaria's DehydraTECH-nicotine pouch performance to that of existing leading brands currently sold in the US such as ON! and Zyn. Objective data collection from blood samples that will evidence Tmax, Cmax, and AUC is the primary objective of the study. Secondary objectives include extensive subjective evaluations related to throat burn, user experience, and more.

The nicotine test article ingredient manufacturing and DehydraTECH processing have been completed and those processed materials have been received by the third-party pouch manufacturing company for filling and packaging. Independent Review Board approval and subsequent human dosing will be the next two major steps in this study.

As reported on March 8, 2022, Lexaria received its first ever patent granted to use DehydraTECH to more efficiently deliver nicotine through buccal tissue absorption, in Australia. A similar patent filing has been made in the USA and Lexaria believes that potential patent award could support significant competitive advantages in the nicotine white pouch category, as well as other oral nicotine product formats such as pills, tablets, lozenges, capsules, gums and sprays.

The oral nicotine pouch category 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.

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 25 patents granted and over 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. 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 contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/708333/Lexarias-Human-Nicotine-Study-Nearing-Start-Date

KELOWNA, BC / July 7, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that its DehydraTECH licensee Boldt Runners Corporation, owners of the Cannadips Brand, has expanded manufacturing agreements to include Europe, Japan, and South Africa.

"We are extremely grateful for our longstanding relationship with Lexaria and look forward to our continued expansion into new channels, geographies and product formats," said Pete Diatelevi, CEO of California-headquartered Boldt Runners Corporation.

Lexaria Bioscience Corp., Thursday, July 7, 2022, Press release picture

Cannadips CBD dip pouch, the leading CBD (cannabidiol) pouch brand in the United States ("USA"), is a tobacco-free, nicotine-free dip alternative providing an effective way to enjoy CBD and is sold in over 6,500 stores across the USA as well as through direct-to-consumer online sales. Lexaria's DehydraTECH enhancement technology is inside every tin, the result of longstanding collaboration and product design. The relationship between Lexaria and the Cannadips brand continues to flourish as international product sales have already begun, opening new channels for growth in Lexaria revenues.

"We are delighted with the expansion of the Cannadips brand outside of the USA," said Chris Bunka, CEO of Lexaria Bioscience Corp. "We continue to work with the Cannadips team on the infusion of exciting new formulations to meet the needs of adult consumers' changing preferences and will endeavour to always remain one step ahead of the competition."

About Cannadips

Our brand and story begin in Humboldt County, CA and we are exceedingly proud to be a part of this community. It means a lot to us. We manufacture each batch in the region that has made us famous. We found the right pouch material to make our pouches neat, comfortable, and to allow the CBD to move through the mesh. Our pouch material, the process we use with Lexaria, and our flavor systems make Cannadips CBD an experience that you can't find anywhere else. The result of our innovation journey is the next evolution of traditional dip - Cannadips CBD.

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 25 patents granted and over 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. 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 contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/707801/Cannadips-is-Expanding-Internationally-Leveraging-Lexarias-DehydraTECH

  • Expands DehydraTECH™ B2B manufacturing capabilities to support Lexaria's growing corporate customer base
  • Lexaria to also receive royalty revenue from DehydraTECH product sales through BevNology's commercial license rights

KELOWNA, BC / June 21, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce the signing of two agreements with Atlanta-based BevNology LLC ("BevNology").

The first agreement is a manufacturing operating agreement that expands production capabilities for Lexaria's own growing list of business-to-business ("B2B") clientele interested in purchasing DehydraTECH-powered active ingredients for consumer packaged-goods brands. A new, state-of-the-art processing facility custom-built by BevNology is operational that increases and broadens production capacity and is currently serving Lexaria's corporate clients. Lexaria has moved and installed all required commercial DehydraTECH manufacturing equipment into BevNology's new facility as it prepares for future growth in its B2B ingredient processing business.

The second agreement is a commercial license agreement that empowers BevNology to offer DehydraTECH products with active ingredients derived from hemp including cannabidiol ("CBD") under BevNology and partnered brands. For powdered DehydraTECH formulations this agreement is non-exclusive. For liquid DehydraTECH formulations, where BevNology has highly specialized skills and capabilities, the license is non-exclusive in most areas of the world but includes limited exclusivity rights in the United States only, that require certain minimum fee payments in order to maintain those rights. Lexaria will receive royalties from BevNology as a result of their utilization of this license. The only countries specifically excluded under this license are Japan, the Republic of Korea, and the People's Republic of China.

"We are very excited about this expanded partnership with Lexaria, which will further strengthen our longtime relationship as well as boost our development and manufacturing capabilities through the addition of our new facility. This will allow us to expand our product and service offerings," said Gonzalo de Aristegui, partner and co-founder of Bevnology.

Founded 10 years ago by Louis Heinsz and Gonzalo de Aristegui, Bevnology is the product development and manufacturing arm of IBC (InterContinental Beverage Capital). It operates a state of the art lab and manufacturing facility outside Atlanta, Georgia

"These agreements build on a long standing and very successful product development consulting relationship between Lexaria and the expert scientists and personnel at BevNology," said Chris Bunka, CEO of Lexaria. "BevNology's formulation and production capabilities are class leading and we are confident that our new relationship with our trusted partner will propel new and exciting growth opportunities for both companies."

Bevnology has advanced capabilities that support best-in-class beverage formulations and, together with Lexaria's superior technology, could make industry-leading beverage products a reality for many brands. Lexaria's DehydraTECHTM-CBD nanoemulsification formulation and processing techniques exhibited exceptional stability one year after production with less than 1% variability in CBD potency in fractions sampled from the top, middle and bottom of the beverage formulation without physical mixing or agitation; and, CBD content was verified at 93.4% of target potency and also evidenced excellent microbial purity after 12 months.

The latest stability testing occurred 25 months after originally bottling, with slightly higher variability but still retaining an average 78% of originally formulated CBD. As well, the microbiologic purity and cleanliness of the product exceeded all requirements 25 months after bottling.

Lexaria's DehydraTECH technology has been embraced by several consumer-packaged goods brands currently available in over 7,000 stores in the US and Japan, as well as through direct-to-consumer online retail portals.

About BevNology LLC

BevNology is a leading beverage development and advisory company with the focus on providing top-notch formulation and commercialization services of cutting-edge beverage products for both new and existing brands. BevNology's outside the box thinking as well as creative product development innovation has earned them the top position in the beverage industry. The team at BevNology each have over 30 years of beverage development and beverage design experience in the Beverage Industry.

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 25 patents granted and over 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. 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 contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/705874/Lexaria-Signs-Manufacturing-and-License-Agreements-with-BevNology

  • DehydraTECH Pharmaceutical License Issued for the European, Australian and New Zealand markets
  • Lexaria to receive royalty revenue from DehydraTECH product sales

KELOWNA, BC / June 8, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce the awarding of a five-year, non-exclusive DehydraTECH license (the "License") from its wholly-owned subsidiary, Lexaria Pharmaceutical Corp. to AnodGen Bioceuticals ("AnodGen") of Ireland.

The awarded License is valid for the manufacturing and distribution of DehydraTECH processed cannabinoid active pharmaceutical ingredient ("API") powders within Europe including the UK, Australia and New Zealand; including pharmaceutical and medical product applications for psychoactive cannabinoids and medical product applications for non-psychoactive cannabinoids. Anodgen will pay royalty fees to Lexaria for all API powders sold that utilize the DehydraTECH technology. Anodgen has the right to manufacture and sell these API powders to third party companies for their own products that are designated by a national regulator as a medical product, drug, nutraceutical, pharmaceutical or biopharmaceutical, as applicable, under its cannabinoid product license rights.

"This strategic alliance with Lexaria Bioscience Corp. underscores the focus of Anodgen to ‘Bring Science to Life', in addition to our research and API's," said Dr Slimane Aboulkacem, Chairman and Founding Member of Anodgen Bioceuticals.

Dr Jeffrey Pruski, Anodgen's Chief Medical Officer and Founding Member mentioned that "the partnership with Lexaria will help bring research-based API's and technology to companies and people with superior bioavailability and enhanced absorption. This alliance will bring about change we will yet see in pharmacokinetics and formulation."

Consumer products purchased without physician or medical professional consultation are not permitted under the terms of this License. AnodGen is expected to have their new facility in Ireland fully operational later in 2022 and Lexaria recognizes the long-term potential for growth in the utilization of DehydraTECH across these pharmaceutical market opportunities.

About AndoGen Bioceuticals.
Anodgen Bioceuticals is a newly established contract manufacturing organization business that will manufacture and distribute active pharmaceutical ingredients for the pharmaceutical industry by focusing on world class research on pharmacognosy (plant-based medicine). Anodgen Bioceuticals mission is to "bring science to life" by developing a global, purpose-led, science-based company that specializes in pharmacognosy, active nutrition, health, and sustainable living. Anodgen Bioceuticals has global expertise and innovation to add value to science around plant derived medicine. More importantly, Anodgen specializes in sourcing and custom compound APIs of cannabinoids and other customized blends. The Company has recently signed two research MOUs with renowned U.S. universities to collaborate on research.

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 25 patents granted and over 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. 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 contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/704285/Lexaria-Grants-License-to-AnodGen-Bioceuticals

KELOWNA, BC / June 6, 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 successfully filed a pre-Investigational New Drug ("IND") meeting request letter with the U.S. Food and Drug Administration ("FDA"). The FDA has already responded to and confirmed Lexaria's filing. A target date of July 30, 2022, has been provided to Lexaria, subject to certain conditions being met.

The request for a pre-IND meeting formally initiates communications with the FDA regarding development of Lexaria's DehydraTECH-CBD for the treatment of hypertension. The purpose of the pre-IND meeting will be to confirm the details and acceptability of Lexaria's ongoing IND-enabling development program to be completed thereafter prior to proceeding with its full IND application filing expected in late 2022 / early 2023.

"We are excited to take this important first regulatory step with the FDA for the development of our DehydraTECH-CBD for the treatment of hypertension," said John Docherty, President of Lexaria. "Submission of this request letter initiates formal communication with the FDA regarding our IND clinical trial plans, in order to help define the critical path for clinical development and marketing approval of our potentially very significant new hypertension therapeutic."

In pre-clinical and exploratory clinical studies conducted to-date, Lexaria has repeatedly evidenced efficacy in utilizing DehydraTECH-CBD to reduce blood pressure while avoiding negative serious adverse effects. Efficacy and lack of negative side effects are two major objectives of FDA-registered clinical studies.

Lexaria will update progress on its FDA program for DehydraTECH-CBD when there are material developments.

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.

Hypertension Markets

The hypertension market is valued at $28 billion per year and is expected to continue growing as one of the world's top health problems and as a subset of the larger heart disease market. Geographically, some of the highest rates of growth are expected in more recently industrialized nations such as China and India. Over 1.1 billion people worldwide suffer from hypertension.

Fewer than 1 person in 4 with hypertension have successfully controlled their blood pressure through medications, meaning the potential market for hypertension drugs is much larger than $28 billion per year if an affordable drug was available with few or no side effects. 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. Lexaria would seek to satisfy this currently unmet demand and in doing so could expand the overall hypertension market.

Among persons 50 years of age or older, isolated systolic hypertension is the most common form of hypertension, and systolic blood pressure becomes more important than diastolic blood pressure as an independent risk predictor for coronary events, stroke, heart failure, and end-stage renal disease (ESRD). The Global Burden of Disease Study identified elevated blood pressure as the leading risk factor, among 67 studied, for death and disability-adjusted life-years lost during 2010.

Drugs focused on blood pressure and related conditions are some of the highest selling drugs in the world. Lipitor, used to treat high cholesterol and reduce the risk of heart disease, has generated $94.7 billion in revenue from 1992 until 2017. Plavix, used to prevent heart attack and stroke, has sold $46.5 billion from 1992 until 2017. There are several hypertension drugs that each generate $1 billion per year or more in revenue.

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 25 patents granted and over 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. 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 contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/703931/Lexaria-Files-Pre-IND-Meeting-Request-Letter-with-US-FDA

  • Minimum payments due to Lexaria of US$4,527,500 over the first five years to retain exclusivity
  • Lexaria to receive royalty revenue from DehydraTECH product sales

KELOWNA, BC / June 2, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce a significant exclusive* commercial licensing agreement (the "Agreement") in Japan with Premier Wellness Science Co., Ltd., ("Premier").

Under the terms of the Agreement, Premier is purchasing the rights to DehydraTECH technology for the Japanese non-pharmaceutical market for use with CBD and hemp ingredients in oral liquid and non-liquid products, as well as for topical, hair-care, lip-care and cosmetics products. Premier is a wholly-owned subsidiary of Premier Anti-Aging Co., Ltd. ("Parent") which is listed on the Tokyo Stock Exchange Mothers division with securities code 4934.

"Premier conducted a global competition to evaluate the world's most advanced molecule delivery technologies, and selected Lexaria's DehydraTECH technology based on its superior performance and the extensive data available through Lexaria's years of testing," said Shinji Shosoyama, CEO of Premier.

"Lexaria is delighted to be working with Premier Wellness Science which we expect will dominate the newly opening Japanese market for CBD-based products," said Chris Bunka, CEO of Lexaria. "Premier and Lexaria share similar philosophies, such as the provision of world-leading products created through scientific advantages and placing the consumer's needs ahead of our own. We could not have found a better partner with which to introduce DehydraTECH-enabled products to the Japanese markets."

In order to retain ongoing exclusivity, the negotiated minimum quarterly payments ("Payments") to Lexaria begin September 1, 2022 and, during the first five years of the Agreement, amount to US$4,527,500. Assuming that Premier continues to submit all required payments, the license for the Japanese market is perpetual.

In addition to the Payments, Lexaria will also receive royalty revenue from DehydraTECH licensed product sales, the terms of which have been agreed to. Total revenue is expected to be significantly greater than the minimum Payments if Premier is capable of meeting its expected revenue targets. If Premier achieves even their worst-case projected penetration into the Japanese non-pharmaceutical CBD market, then based on their projections Lexaria could expect to receive annual payments of over $5 million by the fifth year of the contract.

Premier's Parent had revenues of approximately US$187,000,000 in the first three quarters of fiscal 2021 with year-over-year revenue growth of 63.1% and strong profit margins. Parent sells over 45 product SKU's across four brands, and these products are sold in more than 16,000 retail stores as well as directly through mail/web order to over 2.6 million proprietary members. The overall Japanese cosmetics and personal products markets are estimated to be more than US$35 billion in annual sales.

As well, Lexaria and Premier have agreed to examine on a case-by-case basis the possibility of entering research and development collaborations related to advanced formulation science. Premier and Parent have long-established scientific relationships with some of the leading scientists in relevant fields in Japan.

This Agreement with Premier follows the awarding of two issued patents by the Japan Patent Office for DehydraTECH technology in Japan, strengthening Lexaria's long-held beliefs that new patent protection is a vital component of entering commercial agreements.

*The exclusive rights are subject to two previously issued licenses for use of DehydraTECH in Japan, which remain valid. Lexaria will not be issuing any further licenses in Japan for non-pharmaceutical cannabinoid products.

About Premier Wellness Science Co., Ltd.

Premier Wellness Science Co., Ltd. is focused on the well-being of its customers that leads to good physical, mental and social health. The company seeks to achieve precision, individualized growth in health through a scientific approach to creating the highest performance products in the world.

About Premier Anti-Aging Co., Ltd.

Premier Anti-Aging Co., Ltd. engages in the planning, development, import/export, mail order, wholesale, and retail business of cosmetics and health foods. The company offers its cosmetic products under the DUO and CANADEL brands. It is also involved on the information provision and consulting services related to anti-aging, beauty, and health; research on management and beauty of beauty clinics, etc.; and marketing research and collection and analysis of various information. The company was founded in 2009 and is headquartered in Tokyo, Japan.

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 25 patents granted and over 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. 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 contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/703811/Lexaria-Grants-Exclusive-License-to-Premier-Wellness-Science-Co-Ltd-for-Strategic-and-Long-Term-Partnership-in-the-Japanese-Market