Lexaria Bioscience Corp. (NASDAQ: LEXX) Is Building a Robust and Growing International Patent Portfolio for DehydraTECH(TM) in Support of Commercial Opportunities

Lexaria is a global innovator in drug delivery platforms with an expanding portfolio of patents that currently stands at 34 granted patents and many patents pending worldwide
These patents pertain to the company’s method of improving bioavailability and taste as well as the use of DehydraTECH(TM) as a delivery platform for a wide variety of active pharmaceutical ingredients (“APIs”)
The company has, since June 2015, simultaneously filed the US utility patent application and an international patent application under the Patent Cooperation Treaty (“PCT”) procedure, both through the USPTO
The PCT procedure has made the process of initiating international patent applications a bit easier by eliminating the need to file multiple applications directly to each target country
Lexaria is looking to leverage the protection its portfolio confers to pursue commercial out-licensing opportunities

“Patenting is one way for a company to differentiate itself. Patents can protect innovation, create licensing value, advance a brand, and reward innovators – all of which contributes to a larger corporate identity,” Alan Fisch of Fisch Sigler, a patent litigation firm in Washington, DC., told WIRED (https://cnw.fm/VvgFi). According to WIRED, patenting can be a process that takes years, ending in success for only about half of patents submitted. So it’s a significant accomplishment and, according to Fisch, “patenting is one way for a company to differentiate itself. Patents can protect innovation, create licensing value, advance a brand, and reward innovators—all of which contributes to a larger corporate identity.”

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, recently hit a milestone, announcing it had received notification of four newly granted patents that grew its intellectual property (“IP”) portfolio to 34 granted patents worldwide as of July 13, 2023 (https://cnw.fm/J8Bmu), with many more pending worldwide. Lexaria now has patents issued in the United States, Canada, Mexico, Australia, Europe, India, the European Union and Japan, pertaining to its method of improving bioavailability and taste, as well as the use of DehydraTECH(TM) as a delivery platform for a range of active pharmaceutical ingredients (“APIs”).

Formative Years

“Lexaria began filing for DehydraTECH in [June] 2014 with two initial US provisional patent application filings by the original inventors Poppy’s Teas LLC. (“PoViva”), which Lexaria acquired by way of exclusive, worldwide license rights and controlling interest in the founding company,” the company explains in its annual report for FY 2021 (https://cnw.fm/fTIHK). But the provisional applications, which have a 12-month pendency period that cannot be extended, would be pointless if the company did not act within the specified timeline. So, to enjoy the benefit from the earlier filing of the provisional application, the company, on June 2015, filed a nonprovisional utility patent, following which the USPTO issued a patent granted in October 2016. The company’s first in the US, this patent was titled Cannabinoid Infused Food and Beverage Compositions and Methods of Use Thereof (https://cnw.fm/ma13B) under its Patent Family #1.

The company’s decision to first file a provisional application followed by a nonprovisional application has benefits, according to the USPTO. “A provisional application provides the means to establish an early effective filing date in a later-filed nonprovisional patent application filed under 35 USC §111(a). It also allows the term ‘Patent Pending’ to be applied in connection with the description of the invention,” explains USPTO’s website (https://cnw.fm/LM44l). And for a company that was still growing, it provided an effective and fast avenue to gain protection for 12 months before filing the nonprovisional patent.

US Patent Application Process

In its subsequent patent applications, at least in the United States, Lexaria has largely prepared and submitted nonprovisional patent applications, a process that has several steps. Before submitting an application, the applicant must decide on whether to file the application on their own or with the assistance of a registered patent attorney or agent, pay for and conduct a search to establish if the invention has already been publicly disclosed by another party, and create and validate a USPTO.gov account, just to mention a few crucial initial steps.

They then submit the application, whereupon they obtain a filing date. This application should contain the following elements: Utility Patent Application Transmittal Form or Transmittal Letter; appropriate fees (captured in a Fee Transmittal Form); bibliographic data (captured in an Application Data Sheet); specifications, including the description of the patent, at least one claim, and an abstract; drawings (when necessary); executed oath or declaration; nucleotide and amino acid sequence listing (when necessary); and large tables or computer listings (when necessary).

The USPTO then examines the patent application and sends a Notice of Allowance if it meets all legal patent requirements. The applicant must then pay the issue fee within three months from the date of mailing of the Notice of Allowance, at which point the patent becomes granted (https://cnw.fm/EDzDQ). Patent maintenance fees may apply thereafter.

International Patent Application Under PCT Procedure

A patent granted in the US does not, of course, guarantee international protection for companies like Lexaria targeting the international market. For them, the international patent application is the only recourse. And while it may sound daunting, the Patent Cooperation Treaty (“PCT”), administered by the World Intellectual Property Organizations (“WIPO”) (https://cnw.fm/Mu9vU), has made the process a tad easier.

Under the PCT, applicants can file a single international patent application that they then use as the foundation to file national filings. (National filings are necessary because legal patent requirements vary from country to country, but the steps are largely more or less the same.) Because applicants do not need to file multiple applications directly to each target country, the PCT can save time and money.

It is this route that Lexaria has continually used, starting June 2015 when the company first initiated the simultaneous filing of the US utility patent application and an international patent application under the PCT procedure, both through the USPTO. Lexaria has used the PCT procedure to seek the protection of its IP for multiple patent families, with some applications successful and many more pending worldwide. These granted patents include:

Benefits of Lexaria’s Growing Patent Portfolio

Patent Family #1: Food and Beverage Compositions Infused with Lipophilic Active Agents and Methods of Use Thereof, granted in the United States, Australia, Japan, Canada, and Europe
Patent Family #2: Methods for Formulating Orally Ingestible Compositions Comprising Lipophilic Active Agents, granted in Australia, Japan, and Mexico
Patent Family #3: Stable Ready-to-Drink Beverage Compositions Comprising Lipophilic Active Agents, granted in Australia, India, Japan, and Mexico
Patent Family #6: Transdermal and/or Dermal Delivery of Lipophilic Active Agents, granted in Canada
Patent Family #7: Lipophilic Active Agent Infused Compositions with Reduced Food Effect, granted in Japan
Patent Family #8: Compositions Infused with Nicotine Compounds and Methods of Use Thereof, granted in Canada and Australia
Patent Family #18: Compositions and Methods for Enhanced Delivery of Antiviral Agents, granted in the United States and Australia
Patent Family #21: Compositions and Methods for Treating Hypertension, granted in the United States

Lexaria’s approach to seeking protection for its IP has been nothing short of strategic. The company not only pursues international patent protection through filings under the PCT, to which 157 countries are current signatories, but it also follows that up with national filings in jurisdictions with the highest commercial potential. The company also understands the commercial opportunities that a robust patent portfolio confers.

In his latest annual letter to shareholders (https://cnw.fm/IYgr8), CEO Chris Bunka emphasized that “Lexaria’s business model is to out-license our technology in exchange for royalties” and that “any out-licensing transactions Lexaria achieves with pharmaceutical companies may also be accompanied by significant, potentially multi-million dollar staged development milestone fees payable to Lexaria.”

Last summer, the company signed commercial licensing agreements with Japan’s Premier Wellness Science Co. Ltd. (https://cnw.fm/7kKHg), Atlanta-based BevNology (https://cnw.fm/1l4Ao), Denmark’s Valcon Medical A/S (https://cnw.fm/tumiX) and Ireland’s AnodGen Bioceuticals (https://cnw.fm/1P5we). Lexaria is also in discussions with a number of larger companies in Europe and North America regarding the licensed use of DehydraTECH technology for the consumer sectors and within the pharmaceutical industry, according to Bunka. In addition, if and when the company’s remaining patent applications become granted patents, its ability to generate additional license revenues from its IP may increase from multiple other jurisdictions.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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Lexaria Bioscience Corp. (NASDAQ: LEXX) Patented DehydraTECH(TM) Technology Increases Bioavailability in Lipophilic Drugs for Potential Hypertension, Epilepsy Treatments

The bioavailability enhancement technologies and services market is expected to reach $10 billion by 2035, growing at a CAGR of approximately 11%
Drug developers are shifting focus to the development of lipophilic drug compounds, which increases bioavailability
DehydraTECH-enabled drugs improve the speed of onset, increase bioavailability, increases brain absorption, and reduces drug administration costs
Lexaria’s DehydraTECH has 34 patents granted worldwide and many more pending across several categories of fat-soluble active molecules and drugs
The company operates through four separate subsidiaries to explore the potential and options for the use of DehydraTECH in respective industries

Bioavailability is the ability of a drug or other substance to be absorbed and used by the body – and in recent years, it has become an integral part of drug pharmacokinetics. The bioavailability enhancement technologies and services market is expected to reach $10 billion by 2035, growing at a CAGR of approximately 11%. Drug developers have shifted focus to developing lipophilic drug compounds, undertaking new efforts to identify enhancement techniques that mitigate the challenge of low bioavailability and stability (https://cnw.fm/6uTZv).

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, has developed its patented DehydraTECH(TM) technology to improve how active pharmaceutical ingredients (“APIs”) enter the bloodstream, promoting healthier oral digestion, increasing the effectiveness of lipophilic molecules, and increasing the bioavailability of targeted substances. DehydraTECH promotes fast-acting, less expensive, and more effective oral drug delivery, and it has been thoroughly evaluated through in vivo, in vitro, and human clinical testing.

DehydraTECH is suitable for use with a wide range of product formats, including pharmaceuticals, nutraceuticals, and over-the-counter capsules, pills, tablets, oral suspensions and more. The benefits of DehydraTECH include the following:

Improves the speed of onset, with effects felt in minutes
Increases bioavailability by more effectively delivering the drug into the bloodstream
Increases brain absorption, with testing suggesting up to 10x improvement
Reduces drug administration costs with a higher ratio of drug delivery

To date, Lexaria has been granted 34 patents, with several more pending worldwide, including DehydraTECH-CBD for the potential treatment of hypertension, epilepsy, and more. Lexaria is also exploring food and beverage compositions infused with lipophilic active agents – improving bioavailability through food and drink. Through animal studies, DehydraTECH has shown the ability to elevate the quantity of the drug delivered across the blood-brain barrier by as much as 1,700 percent, which has initiated additional new patent applications and has opened possibilities for improved drug delivery.

Lexaria operates four subsidiary companies to focus on different commercial opportunities in their respective industries: Lexaria Pharma Corp. investigating new products for hypertension, anti-viral treatments, and other drug classes; Lexaria Nicotine Corp. (16.67% owned by Altria Ventures Inc.), investigating oral non-combusted tobacco-derived nicotine formats; Lexaria Hemp Corp. pursuing business-to-business opportunities with cannabinoids such as cannabidiol from hemp; and Lexaria Canpharm Corp. operating a state-of-the-art Health Canada licensed laboratory capable of developing novel psychotropic cannabinoid formulations for potential commercialization in sectors where it is federally legal to do so.

Lexaria’s DehydraTECH is a revolutionary technology that makes it possible to deliver bioactive substances topically or by oral ingestion without the need for unhealthy practices of inhalational dosing where applicable and without the need for co-administration with unhealthy sugars or sweeteners commonly used to mask bitter tastes. It provides power acceleration of intestinal absorption and requires fewer quantities of drugs to achieve desired results.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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Lexaria Bioscience Corp. (NASDAQ: LEXX) – A Zacks Update

Lexaria just released its mid-year update, highlighting its key milestones so far and its objectives going forward, summarized in a recent Zacks update
Of note was the company’s most ambitious clinical study yet, HYPER-H21-4, along with its growing patent portfolio that now sees six additional patents awarded across Australia, Japan, the U.S., and Canada so far in 2023
The company also noted its $2 million capital raise back in May, a strong indicator of shareholders’ confidence in the brand, and its efforts to grow its operations
Lexaria looks to build on the momentum gathered so far, and its management is optimistic that it will achieve its objectives for the 2023 calendar year

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, just released its mid-year update, marking significant strides both in its research and in creating value for its shareholders. In a report by Zacks Small Cap Research, the company’s critical milestones for the current calendar year were highlighted, from recent publications to awarded patents and capital raised thus far.

Of note was Lexaria’s most ambitious clinical study yet, HYPER-H21-4, a clinical study exploring the potential of the company’s patented DehydraTECH(TM)-processed cannabidiol (“CBD”) for the treatment of hypertension. Enrollments for the study kicked off in April 2022, with dosing beginning ahead of schedule and completed on July 27th (https://cnw.fm/1HQdu). With the success of this study so far, Lexaria is on track to file an Investigational New Drug application with the U.S. Food and Drug Administration, for DehydraTECH-processed CBD later this year, in addition to tapping into the hypertension treatment market that is estimated to hit $39.5 billion in value by 2030 (https://cnw.fm/zNTt1).

Lexaria has also made significant strides in growing its patent portfolio, with its 28th patent worldwide being awarded in late December 2022. Two additional announcements were made in April and June highlighting several global grants, in addition to six patents awarded across Australia, Japan, the United States, and Canada so far in 2023. This goes a long way in strengthening the Lexaria brand, as evidenced by the $2 million capital raise on May 8th.

This capital raise in a public offering saw 2,106,000 units sold at $0.95 per unit, consisting of one share of stock and a warrant with an exercise price of $0.95 per share, offering a five-year term. It showed shareholders’ confidence in the company and its efforts to grow its operations and fulfill its mandate. It was also a show of the company’s growth and future ambitions.

Lexaria also noted significant progress on its nicotine operations, particularly given its receipt of Independent Review Board (“IRB”) approval for its human nicotine study designated NIC-H22-1. Similar progress was made on its Estradiol hormone study, with the recently-concluded animal study HOR-A22-1 demonstrating successful delivery of estradiol and its metabolite estrone using DehydraTECH. These, and more efforts from Lexaria, were recognized in research circles, with eight research paper publications playing a massive role in it.

In a June 22nd press release, Lexaria acknowledged its most recent publication in the International Journal of Molecular Sciences, titled Differences in Plasma Cannabidiol Concentrations in Women and Men: A Randomized, Placebo-Controlled, Crossover Study. The publication noted that CBD concentrations were higher in women than men and correlated with the proportion of adipose tissue. The difference in sexes, it noted, was attributed to higher levels of fat tissue in women than men.

Lexaria looks to build on its momentum so far and achieve its objectives for the 2023 calendar year. Its management is optimistic that these goals, and more, will be achieved in the year and that the company will continue to create value for its shareholders while at it.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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Lexaria Bioscience Corp. (NASDAQ: LEXX) Grows Robust Intellectual Property Portfolio to 34 Worldwide Patents with Receipt of 4 New Granted in Canada, US

Lexaria Bioscience recently received four new patents granted in Canada and the United States
In the U.S., the company received two new hypertension-related patents expected to be of particular importance as the company pursues FDA approval for a Phase 1b study evaluating DehydraTECH(TM)-processed CBD
So far, the company has a robust intellectual property portfolio comprising 34 patents granted worldwide
The strong portfolio gives the company the necessary impetus and peace of mind to pursue multiple large markets, starting with the multi-billion dollar cardiovascular drugs market
The company has conducted five human clinical studies that have provided insights into the potential of DehydraTECH-CBD to reduce blood pressure

Lexaria Bioscience’s (NASDAQ: LEXX) intellectual property (“IP”) rests on a strong foundation of granted patents worldwide, a foundation that was recently strengthened by new patents granted in North America. The company, which is developing its patented DehydraTECH(TM) technology platform with the intention of availing it to the masses as an additional step in the manufacturing or processing of active pharmaceutical ingredients (“APIs”) with better bioavailability and bioabsorption properties, celebrated the receipt of four new patents granted in Canada and the United States (https://cnw.fm/ZYNTt).

In Canada, the company has been granted two new patents, the first for Patent Family #1: Food and Beverage Compositions Infused with Lipophilic Active Agents and Methods of Use Thereof. According to the company, this is the first patent for this Patent Family issued in Canada, but the 18th patent in this family worldwide. The second patent granted falls under the company’s Patent Family #8: Compositions Infused with Nicotine Compounds and Methods of Use Thereof and is the company’s second patent in this Patent Family, following a similar issuance in Australia.

Across the border in the United States, Lexaria received two new hypertension-related patents, both under its Patent Family #21. The first covers Pharmaceutical Compositions and Methods for Treating Hypertension, while the second is for non-pharmaceutical Compositions and Methods for Treating Hypertension. The company expects these two patents to reinforce its commercial opportunities in both pharmaceutical and consumer markets.

The two new hypertension-related patents come at a time when the company is looking to file its Investigational New Drug (“IND”) application seeking approval from the Food and Drug Administration (“FDA”) to commence the formal and registered study HYPER-H23-1, a Phase 1b evaluation of DehydraTECH-CBD for hypertension, later this year. In fact, Lexaria believes these patents “could be of particular importance related to the company’s pursuit of utilizing DehydraTECH-CBD in relation to our expected upcoming FDA IND application.”

Once approved, the FDA-registered IND program will build on positive data from five hypertension-focused human clinical trials, which evidenced lower blood pressure among participants who received DehydraTECH-processed CBD.

The company’s first human study of 2021, HYPER-H21-1, evidenced a reduction in BP across both male and female volunteers, with the drop most pronounced within the first 10-50 minutes after dosing (https://cnw.fm/980Ou). HYPER-H21-2, a 16-person study, evidenced up to a 23% average drop in overnight blood pressure and reduced arterial stiffness (https://cnw.fm/s3CmC), while HYPER-H21-3, also a 16-person study, showed that DehydraTECH-CBD’s use reduced pulmonary artery systolic pressure by about 5 mmHg or 41% overall among male participants (https://cnw.fm/YQxZV).

The company then conducted the HYPER-H21-4 study, its most comprehensive study yet, involving 66 participants. This fifth study evidenced the exceptional safety and tolerability profile of DehydraTECH-CBD, with the formulation resulting in a statistically significant lowering of 24-hour ambulatory blood pressure. The company also observed that the formulation lowered patients’ BP throughout the entire study duration (5 weeks) and that it was effective at lowering the BP among patients who were taking other antihypertensive drugs as well as those who were not taking any such drugs (https://cnw.fm/0tbue). The company has also released additional findings from this study, adding to its list of successes announced in 2023.

So far, on the IP front, for example, the company has received seven new granted patents in the current financial year (2023), which commenced September 1, 2022, six of which have been awarded in calendar 2023. As a result, Lexaria now holds 34 granted patents worldwide. The company has achieved considerable intellectual property protection through this existing patent portfolio, giving it the necessary impetus and peace of mind to pursue multiple large markets, including the cardiovascular drugs market, which is projected to grow at a 3.1% CAGR from $153.6 billion in 2022 to $173.48 billion by 2026 (https://cnw.fm/TcVIq).

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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CannabisNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Reports on Promising Results from Diabetes Animal Study

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug-delivery platforms, is releasing additional findings from its DIAB-A22-1 study, a diabetes animal study designed to evaluate the company’s proprietary DehydraTECH-CBD. DehydraTECH is a patented drug-delivery formulation and processing platform technology developed by Lexaria. The company noted that in addition to the three positive outcomes reported earlier — weight loss in obese diabetic-conditioned animals and improved triglyceride and cholesterol levels — the study has indicated a reduction in blood glucose levels and improvements in kidney function. These results were gathered after the company undertook a further round of analysis to explore additional study outcomes; the additional analysis included using an alternate blood glucose assay detection system with higher detection sensitivity. The company also reported updates on two of its applied R&D programs:DEM-A22-1 and EPIL-A21-1. Lexaria’s DEM-A22-1 is a study designed to investigate whether DehydraTECH-CBD enables any procognitive performance enhancements with potential use in dementia treatment.

The company noted that the findings from this study were “generally unremarkable and several unexpected study complications may have muted efficacy distinction ability.” The EPIL-A21-1 was designed to evaluate the effectiveness of LEXX’s DehydraTECH-CBD compared to one of the world’s leading anti-seizure medications, Epidiolex(R), in reducing seizure activity. Initial findings from the study seemed to demonstrate that DehydraTECH-CBD had effectiveness at lower doses and with greater rapidity than Epidiolex. In the past few months, Lexaria has also completed a final study under its EPIL-A21-1 program that looked at establishing dosage amounts. “This ED50 study was designed with an objective to hopefully corroborate Lexaria’s prior MES experimental findings,” the company states in the press release. “Lexaria is pleased to confirm that the outcome demonstrated that DehydraTECH-CBD was most effective at a dose of 75 mg/Kg, also as previously reported from the initial round of work in this animal model, which compared favorably to Epidiolex that generally required a higher dose of 100 mg/Kg to achieve comparable findings.”

To view the full press release, visit https://cnw.fm/aUBBj

About Lexaria Bioscience Corp.

Lexaria Bioscience’s patented drug-delivery technology, DehydraTECH(TM), improves the way active pharmaceutical ingredients (“APIs”) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bioabsorption 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 about the company, please visit www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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Lexaria Bioscience Corp.’s (NASDAQ: LEXX) May Announcements Show Resolve to Continue Supporting R&D ‘Lifeblood’

In May, Lexaria made a number of positive announcements related to its R&D initiatives
In addition to holding its 2023 Annual Meeting, the company completed dosing for its human clinical nicotine study, NIC-H22-1
Lexaria also reported 900% improvements in delivery of DehydraTECH(TM) processed estrogen into blood plasma in an animal study
In a human hypertension study, the company announced that its DehydraTECH-CBD formulation resulted in significant reductions in the blood plasma levels of pro-inflammatory biomarkers (IL 8, 10, and 18)
These biomarkers are linked to cardiovascular disease (“CVD”) and many other conditions, such as asthma, lung diseases, chronic kidney disease, fatty liver disease, Type 1 and 2 diabetes, obesity, and rheumatoid arthritis

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, held its 2023 Annual Meeting on the 9th of May, with shareholders voting on several agenda items, including the election of directors, appointment of auditors, approval of the stock option pricing, approval of the amendment to the maxim number of shares issuable pursuant to the Incentive Equity Plan, and approval of the addition of an evergreen formula to the Incentive Equity Plan. All items put to the vote were approved by the majority, setting the stage for what would become a month of even more positives, particularly around the company’s research and development (“R&D”) initiatives.

“If you’ve been following Lexaria for any period of time, you know that applied R&D is our lifeblood. It helps us establish areas of investigation for commercial pursuits, reduces risks of the unknown for both commercial and regulatory goals, and more,” wrote Lexaria CEO Chris Bunka in the January 2023 annual letter (https://cnw.fm/o1Ypu).

A look at the company’s announcements throughout May shows its unwavering resolve to support its lifeblood and, in the process, gain additional knowledge and understanding of the limitations and capabilities of its patented DehydraTECH(TM) technology. The company started the month off with the announcement that it had completed dosing in its human clinical nicotine study, NIC-H22-1.

With data showing that cigarette smoking claims the lives of more than 7 million people per year globally, Lexaria conducted the study as part of its efforts to validate its reduced-risk technology, which is poised to potentially provide tobacco smokers with a safer and faster-acting source of purified nicotine that delivers nicotine into blood plasma faster, potentially satisfying cravings more quickly. The study evaluated the capabilities of the company’s DehydraTECH-processed oral nicotine formulation by comparing it with the performance of other commercially available oral nicotine pouches sold under the On! and Zyn brands. Lexaria will provide further updates and any relevant material findings as they become available (https://cnw.fm/5YIKF).

Lexaria also reported the completion of its animal study HOR-A22-1, demonstrating its DehydraTECH(TM) platform technology significantly enhanced the oral delivery of estradiol, a type of estrogen hormone that is used in therapeutic products in women’s health sector (https://cnw.fm/wwDVX). Performed in 20 female Sprague-Dawley rats, the study compared a DehydraTECH-estradiol formulation to a generic estradiol composition.

The study aimed to evaluate the ability of DehydraTECH to enhance the delivery properties of the orally administered hormone using parameters such as Cmax, the maximum concentration in the bloodstream, and area under the curve (“AUC”), a measure that gives insight into the total delivery of estradiol over time and the extent of exposure to estrone. (Estrone is a second type of estrogen that is reversibly manufactured from estradiol in tissues found in the mammary gland, uterus, and liver.)

The animal study HOR-A22-1 found that the DehydraTECH-estradiol formulation resulted in a Cmax about 900% higher than the control formulation’s. Additionally, the AUC readings for estradiol and estrone when the DehydraTECH-processed composition was used were 1,500% and 12,500% higher, respectively, than when the control was used.

In other R&D, Lexaria announced additional findings from its human clinical study HYPER-H21-4, completed last year. The hypertension study sought to evaluate DehydraTECH-processed cannabidiol (“CBD”) as a potential antihypertensive medication and already achieved primary efficacy and safety objectives. According to the company, the study also demonstrated significant reductions in several pro-inflammatory biomarkers – interleukin (“IL”) 8, 10, and 18 – known to be linked to cardiovascular disease (“CVD”) and many other conditions such as asthma, lung diseases, chronic kidney disease, fatty liver disease, type 1 and 2 diabetes, obesity, and rheumatoid arthritis.

More specifically, after five weeks of treatment, the DehydraTECH-CBD formulation resulted in a 19%, 27%, and 43% reduction in the blood plasma levels of IL 8, 10, and 18, respectively. “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,” Dr. Philip Ainslie, Cardiovascular Advisor to Lexaria and Lead Investigator of the study, said of the results.

In non-R&D-related news, the company reported the closing of its public offering, which generated approximately $2.0 million in gross proceeds (https://cnw.fm/1EL5N).

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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Lexaria Bioscience Corp. (NASDAQ: LEXX) Yields Most Convincing Evidence for Anti-Inflammatory Actions of CBD with its DehydraTECH(TM)-CBD

Lexaria just announced additional findings from its HYPER-H21-4 human clinical study, highlighting significant reductions in several pro-inflammatory biomarkers associated with cardiovascular disease
This has been termed as “the most convincing evidence in humans,” ultimately showcasing the potential of the company’s patented DehydraTECH(TM)-processed CBD
Other third-party research studies have failed to demonstrate a sustained decrease in resting blood pressure with oral CBD dosing. More so, none have yielded evidence of the anti-inflammatory actions of CBD until Lexaria’s HYPER-H21-4 human clinical study

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, recently announced additional findings from its HYPER-H21-4 human clinical study that sought to explore the potential of its patented DehydraTECH(TM)-processed cannabidiol (“CBD”) in reducing blood pressure (“BP”). Of note was the demonstration of significant reductions in several pro-inflammatory biomarkers associated with cardiovascular disease (“CVD”) in what was described as “the most convincing evidence in humans” of the anti-inflammatory actions of CBD.

“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,” noted Dr. Philip Ainslie, Cardiovascular Advisor to Lexaria and Lead Investigator of Study HYPER-H21-4 (https://cnw.fm/UQFIv).

This finding adds to the success of the ambitious HYPER-H21-4, which successfully met all primary efficacy and safety objectives, with resting BP showing a significant reduction among hypertensive patients. Furthermore, this reduction in BP was sustained over a full 5-weeks of dosing, with no serious adverse events reported. This built on the findings from the four previous human clinical studies conducted from 2018 to 2022, all of which have paved the way for Lexaria’s anticipated U.S. Food and Drug Administration (“FDA”) HYPER-H23-1 clinical study, its most ambitious yet.

Titled “A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension,” HYPER-H23-1 looks to build on all previous studies conducted by Lexaria thus far. It also plays an integral role as a lead-up to IND filing this summer, with hopes for FDA authorization within 60 days after that.

So far, only a handful of other research studies have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing. However, none have been successful at achieving it. More so, none have yielded evidence of the anti-inflammatory actions of CBD, which shows the potential of Lexaria’s DehydraTECH-CBD.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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Lexaria Bioscience Corp. (NASDAQ: LEXX) Completes Animal Study Showing Its Patented DehydraTECH(TM) Technology Significantly Enhances Oral Delivery of Estradiol; Raises $2 Million in Gross Proceeds from Public Offering

Lexaria recently completed its animal study HOR-A22-1 showing its patented DehydraTECH(TM) technology dramatically enhanced the oral delivery of estradiol, a type of estrogen hormone
The use of DehydraTECH resulted in ~900% higher peak concentration of estradiol in the bloodstream compared to the control, as well as a 2,000% increase in the levels of estrone
Estrone is a type of estrogen that can be reversibly made from estradiol in certain tissues within the female body
The study HOR-A22-1 also revealed that DehydraTECH resulted in 1,500% and 12,500% higher exposure to estradiol and estrone over time, respectively, compared to the control
Lexaria also announced the closing of a public offering that raised approximately $2 million in gross proceeds

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, recently reported that it had completed its animal study HOR-A22-1, which showed that the company’s patented DehydraTECH(TM) technology platform significantly enhanced the oral delivery of the estrogen hormone estradiol (https://cnw.fm/7InvU).

Performed in 20 female Sprague-Dawley rats, the pharmacokinetic study compared a DehydraTECH-estradiol formulation to a generic estradiol composition, both containing 10 mg/kg of estradiol, to evaluate the ability of DehydraTECH to enhance the delivery properties of the orally administered hormone. Once dosing was completed, blood was collected up to 48 hours post-dosing, with the concentration of estradiol and estrone determined thereafter.

Estradiol is a major female sex hormone and the most common form of estrogen in women of childbearing age. It is normally made in the ovaries (although it is also manufactured in the testicles in men, albeit in small quantities) but can be administered as an oral tablet, topical gel or patch, cream, or injection to reduce the symptoms of menopause and protect bone health. It is also found in birth control products. Put simply, estradiol is an important element of therapeutic products in the women’s health sector. On the other hand, Estrone is the only type of estrogen that females continue to manufacture after menopause. It is primarily made in the adrenal glands (in both males and females), although it is also reversibly manufactured from estradiol in tissues found in the mammary gland, uterus, and liver, a factor that informed the study’s measurement of estrone levels.

The study found that the DehydraTECH-estradiol composition resulted in a maximum concentration in the bloodstream (“Cmax”) of 5.65 ng/mL, which was approximately 900% higher than the control formulation’s Cmax (0.63 ng/mL). Additionally, the use of the DehydraTECH-formulation resulted in a 2,000% increase in the levels of the estrone metabolite, also measured using the Cmax parameter: DehydraTECH-estradiol resulted in a Cmax of 6.49 ng/mL compared to the control’s 0.302 ng/mL.

Additionally, the study evaluated the area under the curve (“AUC”), a parameter that gave insight into the total delivery of estradiol over time as well as the extent of exposure to estrone. The AUC was 3.9 hr.ng/mL for estradiol and 32.6 hr.ng/mL for estrone when the DehydraTECH-processed composition was used. In comparison, the AUC after administering the control was non-detectable for both estradiol and estrone, as it was below 0.25 ng/mL, the lower limit of quantitation of the assay. This means the AUC findings were 1,500% and 12,500% greater than the control for estradiol and estrone, respectively.

Considered an additional step that is readily incorporated into the formulation and manufacturing process of existing or new orally ingestible and topical products, DehydraTECH has been shown to improve the proportion of the drug delivered into the bloodstream (bioavailability) and the absorption of drugs into the brain tissue. Among the drugs that can benefit from these improvements is oral estradiol, which has minimal bioavailability (2% to 10%) due to gut and liver metabolism (https://cnw.fm/AWDP1). This, according to Lexaria, often necessitates high dosages to achieve the desired beneficial effect; but this can, in turn, lead to unwanted side effects. Thus, incorporating DehydraTECH into the manufacturing process of oral estradiol and potentially other human hormone therapies may enhance their oral delivery.

The animal study HOR-A22-1, which is part of Lexaria’s efforts to pursue multiple paths to success by investigating several large market opportunities, represents a foray into the hormone replacement market estimated to grow from $31.06 billion in 2019 to an estimated $46.50 billion by 2027, a 5.1% CAGR (https://cnw.fm/wKiCZ).

Meanwhile, Lexaria also announced the closing of its public offering of 2,106,000 units, each consisting of one share of common stock and one warrant to purchase one share of common stock. The offering generated approximately $2.0 million in gross proceeds.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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Lexaria Bioscience Corp. (NASDAQ: LEXX) Finalizes DehydraTECH(TM)-CBD Batch Manufacturing for IND Filing This Summer and FDA Phase 1b Trial Commencement in October 2023

Lexaria just announced the completion of batch manufacturing of its patented DehydraTECH(TM)-processed CBD and placebo materials for its FDA Phase 1b HYPER-H23-1 human clinical study
This is in line with the company’s IND filing with the FDA, which it looks to complete this summer, with potential authorization within 60 days
FDA authorization will mark the commencement of Phase 1b trial patient dosing, with the study evaluating the safety and tolerability of DehydraTECH-CBD in hypertensive patients
Filling into capsules of the manufactured DehydraTECH-CBD is expected to be completed before the end of this month, after which analytical release and stability testing will be conducted

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, announced an ambitious plan to embark on its Food and Drug Administration (“FDA”)-registered, U.S. Phase 1b Investigational New Drug (“IND”) hypertension study, HYER-H23-1. Earlier in May, the company announced the awarding of the contract for clinical research organization (“CRO”) services to California-based InClin, Inc. Since this announcement, it has completed batch manufacturing of its patented DehydraTECH(TM)-processed cannabidiol (“CBD”) and placebo materials for the study (https://cnw.fm/MR9kR).

Lexaria retained the services of a U.S. contract manufacturing organization to produce these study materials, in line with current Good Manufacturing Practice (“cGMP”) regulations as directed by the FDA. With everything on track, the company looks to file the IND this summer, with potential authorization by the FDA within 60 days in what will mark the commencement of Phase 1b trial patient dosing, possibly in October 2023.

Titled “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,” Hyper-H23-1 will explore the safety and tolerability of its DehydraTECH-CBD in hypertensive patients. It will also monitor the efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing, building on the five previous human clinical studies which evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens with zero serious adverse events.

The filling into capsules of the manufactured DehydraTECH-CBD is expected to be completed before the end of this month, after which analytical release and stability testing will be conducted to gather essential quality control data essential for the IND filing. So far, DehydraTECH-CBD has shown the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics. In addition, none of the other published studies thus far have shown a sustained decrease in resting blood pressure following multiple weeks of oral CBD dosing, demonstrating DehydraTECH-CBD’s superior power to reduce blood pressure over other oral CBD formulations.

Finalized DehydraTECH-CBD batch manufacturing marks a significant step towards IND filing and subsequent FDA approval for Lexaria. It also marks a notable achievement for the company, especially given the multiple human clinical studies conducted since 2018 and the over 130 healthy and hypertensive persons that have taken part in the studies so far. Its management is optimistic about the HYPER-H23-1 clinical study and is confident that results from the company’s previous efforts will be replicated, if not exceeded.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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Lexaria Bioscience Corp. (NASDAQ: LEXX) Shareholders Approve Board Appointments Amid Push for Diversity; Vote to Endorse 6 Agenda Items in 2023 Annual Shareholder Meeting

Lexaria held its virtual 2023 Annual Shareholders meeting on May 9, 2023
On the agenda were the election of six director nominees, the ratification of the appointment of the company’s independent registered public accounting firm, and the approval of a one-time repricing of specific issued stock options, among others
All items presented received approval, with the highest approval percentage standing at 97.6% and the lowest at 63.1%
The meeting presented an opportunity for Lexaria to evaluate areas of expertise that would provide additional benefits to the company and its shareholders while also adding diversity to its board

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, on May 9 held its 2023 Annual Shareholder Meeting, in which 3,372,024 shares, constituting 56.3% of the company’s issued share capital, were represented.

Carrying on with the theme of the previous year’s Annual Meeting, the virtual 2023 Annual Shareholder Meeting adhered to COVID-19 protocols, with provisions for shareholders to vote via proxy. Among the meeting’s agenda items included the election of Chris Bunka, John Docherty, Nicholas Baxter, Ted McKechnie, Albert Reese Jr., and Dr. Catherine Turkel as directors. Shareholders also voted on the appointment of Malone Bailey LLP as auditors, the approval of the stock option pricing, and the approval of the amendment to the maxim number of shares issuable according to the incentive Equity Plan (https://cnw.fm/T5kov).

All items put to the vote were selected in favor of, with the highest approval percentage standing at 97.6% for the election of Dr. Catherine Turkel as director and the lowest standing at 63.1% for the approval of the addition of an evergreen formula to the Incentive Equity Plan. Percentages were calculated based on abstained votes being counted as a vote against the resolution.

Lexaria and its management expressed their support of recent initiatives the SEC and the Nasdaq Group took to encourage diversity within the board of directors of reporting companies. With the company reviewing its board composition annually, this meeting presented an opportunity to not only evaluate areas of expertise that would provide additional benefits to the company and its shareholders but also add to the diversity of its board. Lexaria hopes that with these appointments, it will further pursue its goal of leveraging technology in pharmaceutical applications. More so, it looks to make its patented DehydraTECH(TM) technology and offerings even more accessible to the masses (https://cnw.fm/LbIuk).

For more details, please visit Lexaria’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.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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