• Lexaria, a global innovator in drug delivery platforms, has, since 2016, proven its patented DehydraTECH(TM) technology, asserting its superiority in improving drug bioavailability
• This has earned it 39 granted patents, with many pending globally
• DehydraTECH has a number of potential pharmaceutical applications with successful early stage results in hypertension, diabetes and weight loss and many others With its focus on GLP-1 clinical studies for 2024, Lexaria looks to carve out greater market share to make 2024 its biggest year

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, has been pushing the envelope and redefining drug delivery technology. Its patented DehydraTECH(TM) technology has proven itself in numerous studies since 2016, highlighting its ability to increase bio-absorption compared to standard industry formulations while also reducing time of onset, as well as delivering drugs more effectively across the blood brain barrier (https://cnw.fm/iZZZR).

The technology’s effectiveness and uniqueness have earned it 39 granted patents, with many patents pending globally. DehydraTECH has a number of potential pharmaceutical applications, a testament to its versatility and overall effectiveness. The key factor that has played a role in its adoption is its unique ability to improve drug bioavailability, a critical marker and determinant in overall drug effectiveness.

Bioavailability can be described as the extent to which a substance or drug becomes entirely available for its intended biological destination (https://cnw.fm/uH82n). It may also be referred to as a measure of the rate and fraction of the initial drug dose that ultimately gets to the targeted part of the body (https://cnw.fm/bsUUT). Usually, the higher the bioavailability, the more effective the drug, and since time immemorial, scientists have been exploring various ways to improve it.

Studies have highlighted several factors that have shown to affect drug bioavailability, particularly for orally administered drugs. These include decomposition of the medication in the lumen, hepatic fist-pass impact, surface and time accessible for retention, as well as pH and perfusion of the small digestive system.

Lexaria, through its DehydraTECH technology, enhances the performance of several categories of fat-soluble active molecules and drugs, ultimately improving their bioavailability and efficiency. This is achieved by mixing the active ingredients as a delivery “payload” with specific fatty acids, infusing the mixture into a substrate material, and then using controlled dehydration synthesis processing to associate the payload and fatty acids together at a molecular level. This is followed by integrating the newly combined molecules into end-product production across various dosage form factors (https://cnw.fm/iAUAI).

With this technology, Lexaria looks to tap into various growing markets, among them the cardiovascular drugs market and the diabetes markets, both projected to be valued at $115.8 billion and $134.1 billion by 2028 and 2030, respectively. It also hopes to make drugs more effective, possibly reducing the cost of treatment and the patients’ overall quality of life. The company is also aggressively pushing for its patent applications and approvals globally, a show of commitment to creating shareholder value. In addition to its focus on GLP-1 clinical studies for the 2024 calendar year, Lexaria is confident that it will carve out a decent market share for itself, ultimately making 2024 its biggest year yet.

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

About CannabisNewsWire

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• Lexaria, a global innovator in drug delivery platforms, just announced $3.6 million in gross proceeds from its registered direct offering priced at the market
• The proceeds will go to critical R&D studies, patent, and legal costs, as well as general working capital purposes
• This is timely, given Lexaria’s resolve to double down on GLP-1 investigations for the 2024 calendar year

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, recently announced that the registered direct offering for the purchase and sale of 1,558,443 shares of common stock at a purchase price of $2.31 – at the market under Nasdaq rules – per share yielded approximately $3.6 million in gross proceeds. This was offered by the company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-262402), and it opens Lexaria to important new opportunities for the 2024 calendar year (https://cnw.fm/9CHup).

Most notably, Lexaria intends to use the net proceeds from this offering for research and development (“R&D”) studies, and the associated patent and legal costs. It also intends to use the funds for general working capital purposes, important for its current focus on GLP-1 clinical studies for the 2024 calendar year.

“Our R&D plans for 2024 are very tightly focused and will be concentrated mainly on GLP-1 investigations,” noted Chris Bunka, Lexaria’s CEO (https://cnw.fm/RIBhV).

In 2023, Lexaria laid down the groundwork for its GLP-1 clinical studies. The company achieved positive interim and final human pilot study results using a single semaglutide dose of a Rybelsus(R) tablet to a matching dose of Rybelsus that had been processed with DehydraTECH (TM) processing technology enhancements.

“Frankly, the results surprised us with their level of positivity,” noted Mr. Bunka.

“It was found that DehydraTECH processing: delivered a statistically-significant higher proportion of the semaglutide, and did so more quickly (very typical of results for our technology); reduced the quantity and severity of unwanted side effects; and had a statistically-significant impact on blood sugar in general and much more effectively after eating a meal, than did Rybelsus,” he added.

These results inspired the confidence of Lexaria’s team. In addition, the FDA’s recognition of GLP-1 drugs, having offered approvals as recently as 2021 and 2022 due to its health benefits, incentivized Lexaria to double down on this specific study. Consequently, the $3.6 million could not have come at a better time. Mr. Bunka and the rest of Lexaria’s management are optimistic that with this focus, the team’s hard work will prove its worth this year.

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

About CannabisNewsWire

CannabisNewsWire (“CNW”) is a specialized communications platform with a focus on cannabis news and the cannabis sector. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled recognition and brand awareness. CNW is where breaking news, insightful content and actionable information converge.

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• Lexaria, a global innovator in drug delivery platforms to enhance bioavailability, announced recently that it will focus on GLP-1 applications for diabetes and weight loss for the 2024 calendar year
• Chris Bunka, Lexaria’s CEO, has expressed his confidence in the company’s direction, reiterating the intention to demonstrate the superior performance of GLP-1 drugs processed with its patented DehydraTECH(TM) technology
• The company looks to build on the success of the early-stage results achieved in 2023, and looks to embark on two human pilot studies, a multi-arm 12-week animal chronic study, a human chronic weight-loss and diabetes study, as well as a multi-month stability testing of DehydraTECH GLP-1

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, recently announced its 2024 R&D plans, with emphasis on GLP-1 investigations. GLP-1 agonists (glucagon-like peptide 1) is a class of drugs used for diabetes and weight loss.

This comes hot on the heels of a successful, active year of R&D in 2023, a year that saw significant strides in developing its patented DehydraTECH(TM) technology including its new foray into GLP-1 drugs. Chris Bunka, Lexaria’s CEO, expressed his confidence and overall optimism in the company’s new direction, reiterating the company’s intention to demonstrate the superior pharmacokinetics and safety/efficacy performance of GLP-1 drugs when formulated and processed with DehydraTECH (https://cnw.fm/5pVk5).

In 2023, DehydraTECH showed positive results in its 8-week study that involved 32 diabetic rodents. The study showed that DehydraTECH-CBD lowered triglyceride levels and body weight differential over the eight weeks, positive results that would also be replicated in its other studies including, but not limited to, hypertension, human hormones, and the overall reduced risk of oral nicotine. This laid the groundwork for Lexaria to explore a new class of molecules it had never worked on before, ultimately quietly launching its top-priority and unpublicized early-stage work program – GLP-1- for weight loss and diabetes control.

In the words of Mr. Bunka, this was a “high-risk program,” mainly because this class of drugs is considered “large molecules,” yet all of Lexaria’s previous investigations were concentrated on “small molecules.” However, by the end of November and early January 2024, the company reported positive interim and final human pilot study results using a single semaglutide dose of a Rybelsus(R) tablet to a matching dose from Rybelsus(R) that had been compound formulated in capsule form using DehydraTECH processing technology enhancements. This was a massive milestone for Lexaria, with Bunka describing the results as “surprising.” Of note was that DehydraTECH processing delivered a statistically-significant higher proportion of the semaglutide and did so more quickly, ultimately having a statistically-significant impact on blood sugar.

GLP-1 drugs have been receiving rising interest recently. Having received FDA approvals as recently as 2021 and 2022, mainly given its health benefits and potential market size, Lexaria understands that this could be the next best thing, hence its focus on this drug class.

“Our R&D plans for 2024 are very tightly focused and will be concentrated mainly on GLP-1 investigations,” noted Mr. Bunka.

“Given the overwhelming interest in the GLP-1 sector, this will be a main focus. We are not at this time planning additional 2024 research in the antiviral, nicotine, or PDE5 sectors. We have solid early-stage data in each of those areas that will allow us to build upon those at the right time,” he added.

Mr. Bunka has reiterated that 2024 will be the year that Lexaria’s hard work will prove its worth. He looks to follow up on the positive early-stage results achieved in 2023, even as it embarks on two human pilot studies, a multi-arm 12-week animal chronic study, a human chronic weight-loss and diabetes study, as well as a multi-month stability testing of DehydraTECH GLP-1. Mr. Bunka is confident that its focus on GLP-1 drugs will yield this outcome.

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

About CannabisNewsWire

CannabisNewsWire (“CNW”) is a specialized communications platform with a focus on cannabis news and the cannabis sector. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled recognition and brand awareness. CNW is where breaking news, insightful content and actionable information converge.

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• Lexaria, a global innovator in drug delivery platforms, just announced the submission of its IND application with the FDA for its HYPER-H23-1 phase 1b hypertension clinical trial
• This study will seek to evaluate the safety and tolerability of Lexaria’s patented DehydraTECH(TM) technology, specifically DehydraTECH-CBD, in hypertensive patients
• Lexaria expects to build on success of its previous studies, which showed positive results and DehydraTECH-CBD’s potential to have broad therapeutic utility

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, just announced the submission of its much-anticipated Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for its HYPER-H23-1 phase 1b hypertension clinical trial. The submission follows a successful pre-IND meeting with the FDA, an integral step in the IND’s development and filing (https://cnw.fm/exwpC).

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,” this study will seek to evaluate the safety and tolerability of Lexaria’s patented DehydraTECH(TM) and specifically DehydraTECH-CBD in hypertensive patients. Secondary objectives will also include efficacy evaluation in reducing blood pressure and detailed pharmacokinetic testing.

The IND submission was initially set for the end of August 2023 but was delayed by the overdue delivery of required analytical and stability information from one of Lexaria’s core ingredient suppliers. However, the company has since made tremendous progress and looks to commence with its HYPER-H23-1 clinical trial as soon as possible following IND effectiveness, subject to certain conditions, including funding.

Lexaria is optimistic about the study and looks to build on the success of its previous studies that date back to 2018. So far, the company has sponsored five investigator-initiated human clinical studies of its DehydraTECH-CBD in an aggregate total of 134 people and has not recorded a single adverse event. Positive results from these studies included significant reductions in resting blood pressure over both acute and multi-week dosing regimens alone and, in some cases, complementary to standard-of-care medications. These results suggested that DehydraTECH-CBD has the potential to have broad therapeutic utility, and that is something Lexaria is looking to explore more in its HYPER-H23-1 clinical study.

This submission affirms Lexaria’s commitment to creating shareholder value. It also points to its goal to fulfill the promises made to its shareholders, as detailed in its roadmap for the 2024 calendar year. For Chris Bunka, Lexaria’s CEO, this marks a significant milestone in line with his pledge to do all he can to “turn 2024 into the year that Lexaria leaps forward.”

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

About CannabisNewsWire

CannabisNewsWire (“CNW”) is a specialized communications platform with a focus on cannabis news and the cannabis sector. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled recognition and brand awareness. CNW is where breaking news, insightful content and actionable information converge.

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• Lexaria, a global innovator in drug delivery platforms, has laid down its GLP-1 human and animal studies roadmap for the 2024 calendar year
• This builds on the success of its human pilot study, which marked a successful undertaking for exploring its patented DehydraTECH(TM) technology for the improved delivery of the GLP-1 drug semaglutide, available commercially in the branded product Rybelsus(R)
• The company’s chronic dosing animal study and its second human pilot study will commence in Spring and run for 12 weeks. The third human pilot study will start in May or June
• These studies will evaluate DehydraTECH for the improved delivery of GLP-1 drugs, designed to support prospective commercial partnering with global pharmaceutical companies

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, has announced five additional studies that aim to support commercial partnering for glucagon-like peptide-1 (“GLP-1”) agonists with its patented DehydraTECH(TM) technology. This follows the update on the final results from its human pilot study in what marked a successful undertaking for exploring DehydraTECH for the improved delivery of the GLP-1 drug Rybelsus(R), reduced side effects, enhanced weight loss, and improved health outcomes, per recent Zacks report (https://cnw.fm/auy9e).

Of note from the human pilot study was the sustained higher levels of semaglutide in blood using DehydraTECH technology, even 24 hours after a single dose.  DehydraTECH processing technology enhancements also achieved better blood glucose control, faster peak drug delivery and reduced side effects.

The 2024 GLP-1 study program will aim to characterize the pharmacokinetics of DehydraTECH processing technology enhancements while also exploring the commercial applicability of DehydraTECH-formulated versions of semaglutide, liraglutide, and tirzepatide. Lexaria plans to embark on one animal, three human studies, and long-term stability testing on DehydraTECH compositions of GLP-1 agonists. All of these proposed studies will depend upon sufficient funding, and all human studies will be investigator initiated non-registrational studies, and will require certain approvals before they commence.

Lexaria’s chronic dosing animal study will advance 12 arms with 8-10 obese rats per arm. It is scheduled to commence in Spring 2024. It will run for 12 weeks, with the primary objective of evaluating weight loss, pharmacokinetics, and blood sugar control over the duration of the study. Once completed, a full analysis will be performed, and results will be shared with stakeholders. This study will use DehydraTECH formulations of semaglutide and liraglutide alone and with DehydraTECH-CBD.

A second human pilot study will begin in Spring 2024, with the third starting in May or June 2024. The latter will enroll up to eight healthy human volunteers and evaluate DehydraTECH’s effectiveness in combination with a dual-action GLP-1 agonist and a glucose-dependent insulintropic peptide (“GIP”) drug absent in the SNAC formulation. It will build on the second human clinical study, whose primary objective would be to evaluate tolerability, side effects, pharmacokinetics, and blood sugar control.

For the 2024 calendar year, Lexaria also plans to evaluate the chemical and microbiological purity and stability of select DehydraTECH compositions over 6-12 months. This long term stability testing is crucial if oral variants of GLP-1 drugs are to be seriously considered as replacements for currently injectable versions of these drugs. All the studies lined up for the year will support this objective, and the company’s management is optimistic that it will be realized.

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

About CannabisNewsWire

CannabisNewsWire (“CNW”) is a specialized communications platform with a focus on cannabis news and the cannabis sector. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled recognition and brand awareness. CNW is where breaking news, insightful content and actionable information converge.

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• Lexaria, a global innovator in drug delivery platforms, has announced its GLP-1 research plans for the 2024 calendar year
• The company will kick off its chronic dosing animal study in March/April, followed by the human pilot study #2, kicking off at around the same time
• The third human pilot study will start in May/June followed by a chronic dosing human study that will involve 70-90 pre-diabetic and type-2 diabetic human patients
• These studies will evaluate DehydraTECH for the improved delivery of GLP-1 drugs, designed to support prospective commercial partnering with global pharmaceutical companies

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, has announced its research plans for the evaluation of its patented DehydraTECH(TM) technology for the improved delivery of GLP-1 drugs designed to support prospective commercial partnering with global pharmaceutical companies.. This builds on the success achieved from a recent human pilot study, which yielded impressive results, demonstrating superior pharmacokinetic (“PK”) oral delivery performance of the DehydraTECH-enhanced GLP-1 drug, semaglutide, which is currently available commercially as Rybelsus(R) (https://cnw.fm/Z5F9w).

Kicking off at the end of Q1 or the beginning of Q2 is Lexaria’s chronic dosing animal study – an obese rat diabetic-conditioned study that will run for 12 weeks. The study will involve approximately 12 study arms and 6-10 animals per arm. It will also explore varied DehydraTECH formulations of semaglutide and liraglutide, alone and together with DehydraTECH-CBD, to evaluate overall efficiency.

Lexaria will also kick off human pilot study #2 in March/April. This study will involve up to 8 healthy volunteers and seek to explore the effectiveness of a single dose of oral ingested DehydraTECH-semaglutide capsules. It will seek to determine whether GLP-1 drug absorption via this route is effective and well tolerated as an alternative to the conventional oral ingestible route. It will evaluate blood sugar control, tolerability, and PK, with the DehydraTECH compositions compound-formulated using commercially available Rybelsus tablets as the semaglutide input material.

The third human pilot study will be in May/June, studying a single dose of orally ingested DehydraTECH-tirzepatide capsules to evaluate tolerability, PK, and blood sugar. The capsules will be compound-formulated using Zepbound(R). This product is currently administered by injection only but will be used as an input material to produce the capsules used for the study. This will set Lexaria up for its chronic dosing human study, which will involve 70-90 pre-diabetic and type-2 diabetic human patients, dosing daily using oral DehydraTECH capsules for 12 weeks. The study will also evaluate tolerability, PK, weight loss, blood sugar levels, and more.

The chronic dosing human study’s primary goal will be to compare DehydraTECH-processed semaglutide capsules to DehydraTECH-CBD capsules alone and together in combination, relative to a placebo control over an extended period. Insights from this study will also inform the company’s long-term stability testing, which will seek to explore the chemical and microbiological purity and stability of select DehydraTECH compositions that it prepares for this and future animal and human studies.

These studies highlight what is set to be a significant year for Lexaria. The ambitious goals show confidence in its DehydraTECH technology and its viability in the market.

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

About CannabisNewsWire

CannabisNewsWire (“CNW”) is a specialized communications platform with a focus on cannabis news and the cannabis sector. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled recognition and brand awareness. CNW is where breaking news, insightful content and actionable information converge.

To receive SMS alerts from CNW, text CANNABIS to 888-902-4192 (U.S. Mobile Phones Only)

For more information, please visit https://www.CannabisNewsWire.com

Please see full terms of use and disclaimers on the CannabisNewsWire website applicable to all content provided by CNW, wherever published or re-published: https://www.CannabisNewsWire.com/Disclaimer

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