Newest granted patent expands worldwide patent portfolio to 24
KELOWNA, BC / March 8, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has been granted a new patent entitled "Compositions Infused with Nicotine Compounds and Methods of Use Thereof".
The new Australian patent expands upon Lexaria's international intellectual property rights to apply DehydraTECH enhancement technology to most oral forms of nicotine, including pills, tablets, lozenges, capsules, pouches, gums and sprays. The patent covers many different forms of nicotine including free base nicotine, nicotine salts, polymer resins of nicotine and other forms of nicotine complexes.
Given the rapid progress Lexaria is making towards development of world-leading oral nicotine products, the intellectual property protection afforded by this patent and other similar patent applications, could be meaningful towards building value.
In news announced on October 5, 2021, Lexaria demonstrated in its animal study NIC-A21-1 that nicotine oral pouches using DehydraTECH technology were 10x to 20x faster in reaching peak delivery of nicotine to bloodstream than controls. Findings using a DehydraTECH nicotine benzoate formulation relative to a concentration-matched control from that study are shown in the figure below.
This is Lexaria's 24th overall granted patent receipt and is noteworthy for a number of reasons including it is the first patent awarded from Lexaria's 8th patent family. At times in Lexaria's history, the granting of a first patent in a new patent family has led to additional subsequent patents from within that same family. Corresponding patent applications are pending within this patent family elsewhere in the world including in the United States. A total of 9 claims have been awarded within this patent granted by the government of Australia that has an expiration date of April 9, 2039.
In other news, Lexaria announces that it has issued an aggregate 36,700 stock options to a total of six employees, consultants and independent directors bearing an exercise price of US$3.39 for a period of five years ending March 8, 2027 (collectively the "Options"). The Options were issued pursuant to the Company's registered Incentive Equity Plan and any common shares issued upon the exercise of the Options will be unrestricted securities.
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 and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered antiviral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), 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 24 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
DehydraTECHTM sildenafil delivered 74% more drug at 4 minutes, than the control
KELOWNA, BC / February 2, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces positive findings in an animal study evaluating DehydraTECHTM processing of the phosphodiesterase inhibitor ("PDE5 inhibitor") sildenafil, for potential application in the management of erectile dysfunction.
A clear trend toward faster and higher overall delivery of sildenafil into the bloodstream was evidenced over the course of the study. In as little as four minutes after dosing, the DehydraTECH formulation delivered 74% more sildenafil into the bloodstream on average than the concentration-matched, generic control formulation. Seven minutes after dosing, the DehydraTECH-sildenafil formulation achieved an average blood level higher than the generic sildenafil control formulation reached at any point during the study.
The DehydraTECH-sildenafil formulation achieved a maximum concentration in the bloodstream (or "Cmax") that was roughly 70% higher than that achieved with the generic sildenafil control formulation (i.e., DehydraTECH-sildenafil Cmax = 5.93 ± 6.53 ng·kg/mL/mg versus Control-sildenafil Cmax = 3.48 ± 1,83 ng·kg/mL/mg).
The time at which the Cmax was reached on average across all of the animals in the study ("Tmax") was roughly 25% faster at 15.1 ± 5.9 minutes with the DehydraTECH-sildenafil versus 21 ± 7.74 minutes with the Control-sildenafil. Also, the total sildenafil delivery over time or the Area Under the Curve ("AUC") was higher with roughly a 37% improvement evident over the control formulation (i.e., DehydraTECH-sildenafil AUC = 6.35 ± 3.04 hr·kg·ng/mL/mg versus Control-sildenafil AUC = 4.62 ± 2.04 hr·kg·ng/mL/mg).
The most well-known sildenafil product for sale in the world today is Viagra®. Sildenafil is moderately bioavailable orally at roughly 40%, but many people find it slow to act. Lexaria's study findings could pave the way for development of faster and better acting sildenafil oral formulations, whether for the Viagra® branded product or its generic pharmaceutical competitors.
Study PDE5-A21-1 was an animal study conducted at a US-based, third-party independent laboratory, in which twenty male Sprague-Dawley rats (two groups of 10 rats each) were treated with a single dose of the DehydraTECH-sildenafil and Control-sildenafil formulations described herein. Of note, the reported improvements in delivery rate including the Cmax, Tmax and AUC evidenced in the study did not achieve statistical significance, therefore, supporting further investigation in a larger number of animals.
Lexaria will provide additional information of further developments or plans to pursue expanded investigation with DehydraTECH for PDE5 inhibitors as they materialize.
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 and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered antiviral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), 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 23 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
KELOWNA, BC / January 27, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to provide an annual letter from CEO, Chris Bunka and a thorough strategic update to all stakeholders.
Dear Shareholders,
Will anyone ever forget 2021? If a global pandemic and unprecedented weather events don't resonate, then perhaps the tectonic changes in politics or social involvement in investing epitomized with GameStop might register. Against this constantly shifting backdrop, Lexaria faced challenges and delivered impressive results in many areas.
First, it may be useful to state Lexaria's key area of focus: improving our understanding of the capabilities of the ground-breaking DehydraTECHTM drug-delivery technology to enhance our abilities to commercialize and profit from this technology platform. Our applied R&D programs are designed to reduce future risks of both commercial and regulatory failure by identifying weaknesses as early as possible; and to enhance the likelihood of future commercial and regulatory success by thoroughly understanding strengths and capabilities, also as early as possible. As our data sets expand, they provide answers to many of the questions we expect to face from potential commercial partners, or from regulators, as we seek to advance those commercial pursuits.
DehydraTECH is not an EVOLUTION of existing technology - it is a REVOLUTIONARY new drug delivery platform. Expecting entire industries to change overnight to adopt a revolutionary new process is not realistic: it takes time, evidence, and a lot of positive results to overcome industry inertia. We have long been hopeful that, before the end of 2022, we will have built sufficient data to effect meaningful industry and/or regulatory progress and sustainable increases in valuation. Is 2022 the year that Lexaria begins to soar?
Shareholder/Market Achievements
As has been true for many years, I continue to be the largest shareholder of Lexaria - although just barely! We have a number of individual and institutional shareholders who have bought sizeable positions since our Nasdaq debut and we welcome you all.
In the following discussion and details about shareholders, some supportive explanation is required. NOBO shareholders are "Non Objecting Beneficial Owners": these are those of you who have permitted your identity to be known to us. OBO shareholders are "Objecting Beneficial Owners" and we, as a company, do not have access to your identity through the normal data suppliers. For OBO shareholders, we only have summary data of how many shareholders object to having their identity known, and collectively, how many shares they own together.
Our NOBO shareholder list currently covers 9,773 shareholders collectively owning 4.39 million shares and we have updates to much of that data, every day. We can and do follow trends and try to ensure that we are satisfying your needs.
Since listing on Nasdaq, we have witnessed an unusual phenomenon, namely the substantial increase in new shareholders who hold very small securities positions. We currently have over 600 shareholders who own 1 single share each; over 3,300 shareholders who own 10 shares or less; and an amazing 7,200 shareholders who own 100 shares or less.
At the other end of the scale, we have relatively few shareholders with large positions. We only have about 50 shareholders who own 10,000 shares or more; over 100 shareholders who own 5,000 shares or more; and about 650 shareholders who own 1,000 shares or more. Because of the small numbers of shareholders with large positions, it is easy for us to track changes even on large volume days.
In January of 2021, each of our 8,352 NOBO shareholders owned an average of 142 shares. By July of 2021, our 9,594 NOBO shareholders owned an average of 389 shares each. And in December 2021, our 9,773 NOBO shareholders owned an average of 449 shares each.
As 2021 progressed, our number of shareholders has increased, and the average number of shares owned per shareholder has increased by 216%. These are positive trends showing accumulation and general approval of Lexaria's business plans.
The institutional shareholders who participated in our January 2021 financing have, as expected, mostly sold their positions: their business is in the provision of capital, not in long term strategic investing. That said, we have simultaneously dramatically increased our long-term institutional ownership which fluctuates between about 9% and 16% of the Company. The vast majority of the reported institutional positions are NOT included within our NOBO lists. We welcome these forward-looking institutional shareholders who we suspect are investing for the long-term potential.
Another interesting trend we've noticed that seems to fly in the face of logic, is that during those several days of the year when we've had manic trading - days when we have traded more than 10 million to over 50 million shares in a single day - the actual turnover in our NOBO list is generally not more than a fraction of what you might expect. In other words, on those days when we've traded over 40 million shares in a day, we might only witness a couple hundred thousand shares actually changing hands in our NOBO list. It has always made us wonder "where are all those shares coming from?" And to this day, we have been unable to answer that question.
I want to say to all of our Lexaria shareholders, old and new, that the management team at Lexaria truly appreciates your support; that we will always work our hardest to try to achieve positive developments and increase the value of your company. No senior executive with Lexaria has sold LEXX stock and we remain absolutely committed to the success of this great company. Sometimes, we cannot explain our market activity which simply defies logic. But that won't stop us from remaining focused on our strategy, and on creating value for you over the longer term.
Judging from the increased number of shareholders as well as the increased quantity of shares owned, on average, more of you would agree with our plans and progress than disagree. Currently, we estimate that about 12,000 shareholders collectively own all of our 5.9 million shares.
Capital Markets
2021 began for Lexaria with a new listing on the Nasdaq Capital Markets which was the culmination of year-earlier plans to seek out stronger sources of capital and provide more liquidity for our shareholders. Nasdaq-reported volume for LEXX during 2021 is over 168,000,000 shares - an astonishing number given the fact that the Company only has about 5,900,000 shares issued and outstanding. Notwithstanding the seemingly "impossibly high" volume, one of our objectives for 2021 was to offer shareholders increased liquidity: given the fact that our split-adjusted volume for 2020 was only 1,320,660 shares, this 127-fold increase in volume certainly achieved that goal.
Another goal for 2021 was to escape what had earlier been a perpetual "hamster wheel" of corporate finance activities. In previous times the Company had generally struggled in locating sufficient working capital to pursue its objectives as rapidly and effectively as it wanted to. That era ended in January 2021 when we raised US$11 million in gross proceeds associated with our Nasdaq up-listing. That financing was budgeted to provide two years of working capital to aggressively accelerate our R&D plans, representing the highest R&D spend Lexaria had ever achieved.
We also raised approximately $4 million in July when some of the existing warrants that had been issued in January were exercised. That additional capital added to our working capital runway, giving us more time to advance our business plans. We are happy to report that our corporate spending for 2021 was on target and on budget in all material respects - we have carefully balanced our objectives with our abilities. Without raising another penny in capital we expect our existing resources to be sufficient until mid-year of 2023. Lexaria's management has long demonstrated financial prudence and clever methods to extract the most value possible from each dollar raised and we will continue to do so.
As we look towards 2022 and 2023, Lexaria is also taking steps to ensure we have multiple choices in how we fund the Company. Some details must remain undisclosed for now and will be revealed at the appropriate times, but in other respects we clearly are trying to position the Company for non-dilutive injections of capital through strategic partners and other commercial relationships.
Stock Performance
One area where Lexaria management is not at all satisfied, is with the Company's valuation and thus our stock price. During a year of exciting scientific progress and undisputed applied R&D advancement bringing us, we believe, closer than ever before to commercial relationships and success, the value of our company did not increase during the year. Indeed, during the early winter of 2021/22, our valuation declined to the lowest of the year which seems to defy logic considering our significant R&D progress.
We experienced inexplicably manic trading days in May, July and December when a quantity of shares equal to many times more than 100% of all our outstanding shares traded in a single trading day and, despite intraday price spikes reaching 52-week highs, there was little net change in value by the end of the day. While we cannot explain what seems at times as manipulative trading activity, rest assured that Lexaria and certain key shareholders have filed formal investigatory requests with the SEC, the Nasdaq, and FINRA; asking these regulators to step in and protect Lexaria shareholders. We will continue to monitor our market and seek every path and recourse available to us to protect your interests which are closely aligned with the Company's interests.
That said, it was a very difficult year across the broad biotech sectors, with most biotech companies losing value during the year. The SPDR biotech ETF, XBI, started the year at $139 and finished 2021 at $112: a decline of 19.5%. Genomic biotech ETF ARKG declined even more, from $91 to $62, dropping nearly 32%. And the Nasdaq biotech ETF, IBB, managed only a small gain of 2% on the year, after a year-end rally brought it out of the red. Regardless, it was a difficult year to earn a positive return in the biotech industry.
LEXX opened for trading on the Nasdaq near $4.25 and closed it's first day of trading near $4.50 before spending most of the year between $5.00 and $7.00. But we experienced a slide in valuation during the final six weeks of the year, along with an increase in reporting stock shorting, to end the year at a disappointing $4.03.
In part to address this, we recently approved the largest marketing plan in the Company's history, designed to ensure the public is aware of Lexaria's achievements in 2022; and, we have three major applied R&D studies that will launch and complete this year as well as many smaller programs. We expect that, if we have positive results, these study results could be enough to bring important industry relationships that could see us one big step closer to commercialization and revenues - obviously, this is tightly connected to our capital markets strategy in that we hope to take important steps towards commercial relationships in the year to come.
We will also be pursuing a pre- Investigational New Drug ("IND") meeting with the Food and Drug Administration ("FDA") for our most advanced drug product candidate, DehydraTECH-Cannabidiol ("CBD") for the treatment of hypertension and heart disease, in early 2022, and hope to complete our subsequent IND filing and obtain FDA approval to commence registered clinical testing during the year. That is only the start of our FDA-related plans; we will have more to discuss as time goes by. Our R&D plans are detailed in other areas of this letter, but they are an important ingredient within our plans for capital markets and value creation.
Research & Development
The results from our R&D can never be known in advance, but the initiation and progression of our R&D programs are within our control, and this is the aspect of 2021 of which we are most proud. Remember, our R&D efforts to date have largely been conducted to reduce or remove risks and to establish whether DehydraTECH is capable of being applied in broad use within the pharmaceutical industry. Meaningful national or international implementation of DehydraTECH is unrealistic prior to full knowledge and understanding of its limitations and capabilities. Lexaria has been very brazen and transparent conducting these studies in full public view compared to many pharmaceutical companies that keep these sorts of investigations hidden within their walls and undisclosed. Every positive result we generate is one more step towards removing risks associated with regulation and commercialization; eventually, with enough positive data, that formula will tilt in our direction.
Our R&D focus for 2021 was to investigate DehydraTECH CBD for possible hypertension and heart disease applications; to further our knowledge of DehydraTECH nicotine as a replacement for damaging and deadly lung-based absorption methods; and to learn whether DehydraTECH would be compatible with antiviral drugs. We were successful in each of these primary areas of investigation.
Hypertension and Heart Disease.
Our biggest area of investigation in 2021 was CBD for hypertension and heart disease, and we enjoyed a very successful year in this regard. Our first human study of the year, HYPER-H21-1, confirmed and built upon results we obtained in our 2018 human clinical study. This year we evidenced that human blood pressure ("BP") dropped within minutes of swallowing DehydraTECH-CBD capsules, after just a single dose.
In our HYPER-H21-2 follow-up study which administered 3 doses of DehydraTECH-CBD and monitored the volunteers over a 24-hour period, we witnessed even more impressive results. At selected times during the 24-hour study, volunteers with mild to moderate hypertension averaged as much as a 20 mmHg (i.e., 23%) decrease in BP relative to placebo. This is a large response after a single day of dosing and we were very encouraged by these results. For many existing prescribed blood pressure medications, similar decreases in BP are only apparent after many days or even weeks of dosing. Over the 24-hour ambulatory monitoring period, volunteers averaged a significant reduction of 7.0% in systolic pressure with DehydraTECH-CBD relative to placebo (p < 0.001).
In this same study, we also demonstrated with statistical significance for the first time that DehydraTECH-CBD reduced arterial stiffness in our human volunteers. Arterial stiffness is a strong predictor of many aspects of human diseaseand reducing it could lead to additional FDA regulatory findings as well as assist Lexaria in its goals of attracting a corporate pharmaceutical partner. Arterial stiffness is measured through pulse wave velocity ("PWV") evaluation, and it has been estimated that a 1.0 m/s increase in PWV accounts for a 15% increase in cardiovascular and all-case mortality.
This was one of our most important achievements of the year, which we feel evidences sufficient improvement in BP reduction to justify our ambitions within the regulated drug markets. In large part because our de-risking studies have been so positive, we formally announced our intention to pursue an IND filing with the FDA specifically for the purpose of developing DehydraTECH-CBD as a prospective registered treatment for hypertension and heart disease. That process is underway and will commence with a pre-IND meeting with the FDA in order to define our path to IND filing thereafter, and we expect to have an update within the next several months.
Beginning in April 2022 or possibly sooner, we expect to begin dosing in our largest ever hypertension study that will evaluate our DehydraTECH-CBD in 60 volunteers over a six-week study duration. This should be a large enough group to obtain reliable, statistically significant data and a long enough study duration to witness the true power of DehydraTECH-CBD in modulating BP, while observing if there are any serious adverse effects over a chronic dosing regimen period. If this study is successful, we feel strongly that it will be highly supportive of our IND filing plan, and we will have a clear path towards designs of Phase I and even potentially Phase II FDA-registered clinical studies thereunder. Assuming there are no major delays either in study execution or evaluation, we expect full results from this study sometime in Q3, 2022.
Nicotine.
In November 2021 we issued study results that demonstrated yet another first for Lexaria: in an animal study we evidenced that DehydraTECH was effective in promoting superior nicotine drug delivery characteristics in sublingual/buccal (oral) tissue.
DehydraTECH was originally developed to promote more efficient delivery of fat-soluble drugs across the intestinal wall, so our findings demonstrating its effectiveness also in enhancing sublingual/buccal (oral) absorption greatly enhances the value proposition for our technology for the oral nicotine products sector. This nicotine study was noteworthy not just because we delivered much higher levels of nicotine, more quickly; but also because we made this breakthrough utilizing buccal tissues of the mouth, gums and throat instead of through our traditional delivery through the intestines.
This was yet another opportunity demonstrating the versatility of DehydraTECH to work effectively in different parts of the body and opens doors to drug delivery through products such as lozenges, sub-lingual tablets, and other forms of non-swallowed oral products.
Because of this important new discovery for DehydraTECH, we are launching a very similar study in humans expected to start soon. If we can demonstrate similar performance of nicotine absorption through the sublingual/buccal tissue in humans, we feel that DehydraTECH will have advanced another big step in the direction of commercial applicability.
Antiviral.
Another area of significant advancement in 2021 was with antiviral drugs. We successfully demonstrated, for the first time ever, that DehydraTECH enhances delivery characteristics of certain antiviral drugs. This opens an entirely new class of drugs for investigation of applicability with DehydraTECH and helps to open long term business strategies that go beyond our core competencies with cannabinoids and nicotine. To date we have evidenced that DehydraTECH improves the delivery of each of the following drugs into animal bloodstreams: darunavir, efavirenz, remdesivir, ebastine, and colchicine; all of which are known to possess various antiviral properties.
We commissioned a study to evaluate DehydraTECH with the live SARS-CoV-2 virus. This study was performed using a primate cell line, VERO-E6, and conducted by a leading independent, US biosafety level 3 testing laboratory that delivers critical services to government and commercial customers. We learned that both remdesivir and ebastine (known to have poor aqueous solubility and compromised intestinal absorption and bioavailability when administered orally) processed with DehydraTECH were effective at inhibiting the COVID-19 SARS-CoV-2 virus using an in vitro screening assay in infected cells in Lexaria study VIRAL-C21-3.
We haven't confirmed much additional antiviral work in 2022 - this is not due to a lack of interest but instead simply because we are maximizing our financial and human resources towards other pursuits in 2022 that we feel are closer to commerciality. We are very encouraged by our antiviral progress in 2021, however, and we feel that it has demonstrated the tremendous flexibility of DehydraTECH to be applicable across a breadth of drug classes worthy of further investigation.
Seizure Disorders.
Beyond our key advancements described above, we also indicated in 2021 our intention to pursue expanded development opportunities for our DehydraTECH-CBD program. Lexaria is a global leader in conducting CBD research and we have completed more work in this field than many companies 20 times our size. Before the Spring of 2022 we expect to launch a complex animal study evaluating DehydraTECH-CBD as a potential treatment to inhibit seizure activity in animals. This, of course, is the same field where the former GW Pharmaceuticals had so much success and was able to achieve FDA certification for its version of CBD medication (Epidiolex®) in treating certain pediatric seizure disorders. Epidiolex® is thought to be currently generating about $160 million in quarterly revenue and continues to grow rapidly.
Although Epidiolex® enjoys regulatory exclusivity for its noted medical conditions, some of its exclusivity provisions are nearing expiration. We believe, therefore, that studies like those Lexaria is pursuing can help Lexaria attract commercial relationships and represent opportunities for DehydraTECH to enter commercial markets far more quickly than is generally thought. Accordingly, we have also announced our intention to pursue efficacy modelling through 2022 with our DehydraTECH-CBD in animals for other possible therapeutic indications of interest including dementia, rheumatoid diseases and diabetes.
Other R&D Advancements.
Throughout 2021, Lexaria also increasingly worked with DehydraTECH 2.0 formulations that we anticipate utilizing mostly within the FDA-regulated drug industry and that demonstrate our growing ability to optimize the "engine" that makes our drug delivery so fast and abundant. During 2021 we reached new heights of performance, delivering 2,178% and even 2,708% more CBD into animal blood than standard CBD industry formulations, in independent testing. Not only does this showcase the performance capabilities of DehydraTECH, it also casts a harsh eye on the woefully poor performance of many standard CBD industry practices that actually deliver as little as 2% of the labelled CBD into the bloodstream. That's abysmal and Lexaria challenges the industry to do better.
We also learned that DehydraTECH was remarkably stable in consumer beverages and that one year after production, bottled consumer beverages contained a remarkable 93.4% potency of CBD. We also showed less than 1% variability of CBD potency within the beverage, a concept of critical importance when delivering drugs in an aqueous solution. Beverages containing cannabinoids often need to be shaken prior to use and tend to degrade over time, sometimes dramatically. There have been reports of beverages sold that contain only a tiny fraction of the cannabinoids listed on the product label, whether due to inadequate manufacturing techniques or time decay. Lexaria's data demonstrate exceptional effectiveness in integrating CBD into Ready-to-Drink ("RTD") beverages in a stable and homogenously distributed manner over time without the need for physical mixing or agitation before consumption.
In 2018 we hired a third-party lab that evidenced that DehydraTECH was also capable of enhancing the delivery of cannabinoids across human epithelium ("skin"). While we have not yet pursued skin-based delivery markets, we have good early evidence of effectiveness. This is yet another area we are actively working on as it could open additional commercial pathways both in the regulated drug industry as well as with consumer goods. We have several prospective commercial clients that are indicating their desire to introduce their new skin-based products utilizing DehydraTECH to the market in Q2 or Q3 this year.
In a tetrahydrocannabinol THC pharmacokinetic ("PK") study we also demonstrated that DehydraTECH-processed THC was three times faster (15 minutes vs. 45 minutes) to deliver the same amount of THC into the bloodstream than generic THC. The DehydraTECH-processed THC also reached maximum blood saturation levels 2.5 times higher than the generic THC. Rapidity of action is particularly desired by customers of psychotropic drugs.
R&D Summary.
January 2021 really marked the birth of our modern version of Lexaria. During 2021, we completed R&D and validating work equal to or greater than all the combined amount previously completed since 2018! We have conducted studies across broad areas of interest, but also concentrated in specific areas where we have had supportive data. This is leading to substantial data sets that are increasingly supportive of discussions with potential commercial partners, as well as supporting our formal regulatory pathways.
During 2022 we are planning to enter the FDA IND pathway for DehydraTECH-CBD for hypertension as our first drug application. Lexaria has generated a lot of positive data both in animals and humans evidencing no significant adverse effects with DehydraTECH-CBD, and we do not expect that to change whether the health indication we are pursuing is hypertension, arterial stiffness, seizure disorders, or any other CBD-related application. If we continue to evidence safety with DehydraTECH-CBD, then our ability to pursue other health indications utilizing DehydraTECH-CBD might increase significantly if we provide evidence of effectiveness in any of those other areas of investigation.
We are launching three major studies in the March-April period: the 6-week human hypertension study (CBD); the animal seizure study (CBD); and the human sublingual/buccal tissue study (nicotine). Results from these studies are expected by early Summer to Fall. We will also be conducting a number of smaller studies throughout the year and will announce those when appropriate. All of our 2022 work is funded through existing resources, so we have no need to raise capital to complete this work.
Please make note: the COVID-19 pandemic is not over, and we hope you will grant us a little patience if any of our R&D investigations experience any delays in volunteer recruitment, or study execution. We do our best, but delays are possible.
The goal of our three major studies is to generate sufficient data to support either regulated IND-type applications; or to stimulate corporate partnering within their appropriate market sectors. We are optimistic of positive results - noting that science can be unpredictable - and, if so, expect 2022 to be our most exciting year ever!
Multiple Shots on Net in Huge Markets
Lexaria is a drug delivery technology company. Lexaria is not a CBD company, nor a nicotine company, nor an antiviral drug company. We do not define ourselves by any single molecule that seems to work with our DehydraTECH process, even though that molecule might represent years of opportunities and growth for the Company. CBD is obviously our "lead candidate" at this time and it has several possible routes towards success for us.
We are currently pursuing or investigating several large market opportunities, the smallest of which is currently generating over $10 billion in annual revenue. In many of these markets, growth is expected to be significant over the next several years. The Lexaria management team is trying to ensure that we have multiple paths to success: if any one single area of investigation were to fail, we want to ensure we still have other opportunities to exploit.
I'm often asked about well understood "normal" business metrics such as revenues, numbers of clients, and other similar aspects of our business. We had our highest ever revenues in 2021 of over $720,000 which is more than double that from one year earlier; and we generated a gross profit of $547,000 on this revenue, demonstrating the high quality of our revenue streams which are mostly associated with licensing of DehydraTECH. That said, we reported a big decline in revenues in our quarter ended November 30, 2021 due to some clients postponing additional orders.
Notwithstanding, we don't place a lot of relevance, yet, on our revenue numbers. That might seem counterintuitive, but upon reflection most people agree that is a reasonable comment. For the most part, our revenues to date are "proof of concept" or early-stage revenues: they show that we are able to gain and retain commercial clients willing to pay to use our technology, and that our DehydraTECH technology is available in the marketplace. But, given the early-stage nature of many of our clients, it is nearly impossible to build any type of reliable revenue model. Their revenues are expected to fluctuate widely, and as a result ours likely will too.
Lexaria's current clients are small companies anxious to establish themselves. They have worked hard - and we are delighted for them and their successful distribution in over 7,000 stores across America, including many well-recognized chains such as Hudson News, Albertson's, Safeway, and more. We expect our revenues will generally grow within these business segments, but they will not grow every quarter as challenges of various sorts are encountered.
And while important, these current revenue streams are not Lexaria's main area of business focus. We are focused on larger national and international applications for DehydraTECH, primarily but not entirely in the pharmaceutical sector. These are our areas of interest that we expect will provide significant revenue streams over time; but they have not yet begun.
The reason we spend so much time and resources on validating R&D programs, is to make our technology more attractive for large national and international consumer products companies and pharmaceutical companies. We know we have to provide copious amounts of data to satisfy the needs of the largest companies in their industries, and that these companies are naturally risk averse. We also expect that, if we do have success with these larger organizations, the commercial ramifications for Lexaria will be profound.
For example, many national or international corporations do not participate in new business segments unless they can be assured of multi-billion revenue potential. For large companies with sales of $10 billion or $30 billion per year, this makes sense. And given that Lexaria's business model is to out-license our technology in exchange for royalties, you can see very quickly how every single percentage point of royalty on each $1 billion in revenue, amounts to $10,000,000 per year in highly profitable revenue to Lexaria. For example, a 3% royalty rate on $4 billion would be $120,000,000 in revenue; or an 8% royalty on $2 billion would be $160,000,000 in revenue.
Furthermore, any out-licensing transactions Lexaria achieves with pharmaceutical companies may also be accompanied by significant, potentially large multi-million dollar staged development milestone fees that are customary in pharmaceutical licensing deals. These fees can at times be received years before a product ever reaches the market, or even regardless of whether a product ever reaches the market. Lexaria expects licensing fees to significantly complement its royalty revenue generation and also allow it to realize commercial revenue generation well in advance of when royalty revenues start to flow from actual product sales under these licensing transactions.
Thus, while we are grateful for our smaller clients and will continue to support those we have and work to gather more of them, a single larger client would quickly eclipse many years of growth of our smallest clients. Given that there are many regulated drugs that each enjoy annual revenue of more than $1 billion, you intuitively understand why we are positioning Lexaria for larger revenue streams with these longer-term plans.
Intellectual Property
Lexaria was awarded five new patents granted during 2021, bringing our total to 23 granted worldwide. New patents were awarded for the first time in India, Japan, and Mexico, continuing our efforts to receive intellectual property protection across wider areas of the world. With existing patents also granted in the USA, the European Union and Australia, our IP portfolio has never been stronger.
Within the vast market in India, our technology was patented in 2021 for use withnon-carbonated beverages, carbonated beverages, colas, root beers, fruit-flavoured beverages, citrus-flavored beverages, fruit juices, fruit-containing beverages, vegetable juices, vegetable-containing beverages, teas, coffees, dairy beverages, protein-containing beverages, shakes, sports drinks, energy drinks, and flavored waters. A similar patent was granted to Lexaria this year in Japan.
We expect additional patents to be awarded in 2022 although we acknowledge that the biggest growth in DehydraTECH-related IP is likely already achieved and solidified behind our patent portfolio.
Summary
Management of Lexaria feels we are on track, on schedule, and on budget to deliver what we hope and expect will be great results in 2022. If we generate sufficient positive data in ANY of our three major studies this year, we feel that positivity could be sufficient to enable our "graduation" to either the next logical regulatory step, or to a commercial relationship with one or more major industry partners.
We will continue working to advance our shorter-term business interests and meaningfully increase the modest revenue streams currently being generated. But we caution against applying undue reliance on those operations at this early stage in the Company's life. If we do not deliver higher revenue numbers, that is not particularly relevant to our primary business focus. If we do deliver higher revenue numbers, let's celebrate!
Before 2022 ends, we expect to have at least one major regulatory advancement such as an IND program approval, or one major new industry partner. We believe either of those will support what could be significantly higher valuations. If we are able to achieve more than one of these advancements…..so much the better.
Hundreds of you know me. You know I can't tell the future or forecast things outside of my control. But you also know that I and the Lexaria team are dedicated, and we believe in the Company and in the potential we have to make the world a better place. Your support has been so helpful in assisting us to achieve our mutually beneficial goals. We continue down this path, together.
Chris Bunka
The Company is not making any express or implied claims that it has the ability to eliminate, cure or contain COVID-19 (or the SARS-CoV-2) virus.
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 and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered antiviral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), 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 23 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 which are not historical facts are forward-looking statements. The Company makes forward-looking public statements including but not limited to: its expected future financial position, results of operations, cash flows, financing plans, research and development, business strategy, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, including statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions that are forward-looking statements. 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 other factors will not affect the accuracy of such 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, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval or rejection process and other factors which may be identified from time to time in the Company's public announcements and filings. There is no assurance that existing capital is sufficient for the Company's needs or that it will be able to raise additional capital. There is no assurance the Company will be capable of developing, marketing, licensing, or selling products containing cannabinoids, nicotine or any other active ingredient or drug. There is no assurance that any planned corporate activity, scientific research or study, business venture, technology licensing pursuit, patent application or allowance, consumer or scientific study, or any initiative will be pursued, or if pursued, will be successful. 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. The Company is not obligated to update this article in whole or in part, and every reader should rely only on the Company's official filings with the Securities and Exchange Commission for more up to date information. 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; only the FDA can grant approval for registered drugs within the US.
INVESTOR CONTACT: George Jurcic - Head of Investor Relations [email protected] Phone: 250-765-6424, ext 202
KELOWNA, BC / January 18, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, comments on an independent January 10 study, available here, that discovered that "Cannabinoids Block Cellular Entry of SARS-CoV-2 and the Emerging Variants".
In an interview granted to vice.com, lead research scientist Dr. Richard van Breeman commented on how smoking or vaping of cannabis was likely not effective, while oral delivery was effective. "If these hemp products containing these compounds are smoked or vaped, the heat exposure could cause the chemical decomposition or conversion… So, we would recommend in favor of an oral administration of these compounds instead of smoking them, inhaling them from vaping."
"Lexaria has led the conversation for years related to oral delivery of cannabinoids and is a world-leader through its pioneering drug delivery technology, DehydraTECHTM, in more effective delivery of cannabinoids to the human bloodstream through oral means," said Chris Bunka, CEO of Lexaria Bioscience.
In the peer-reviewed study, the researchers concluded that "Cannabinoid acids from hemp (Cannabis sativa) were found to be allosteric as well as orthosteric ligands with micromolar affinity for the spike protein. In follow-up virus neutralization assays, cannabigerolic acid and cannabidiolic acid prevented infection of human epithelial cells by a pseudovirus expressing the SARS-CoV-2 spike protein and prevented entry of live SARS-CoV-2 alpha variant B.1.1.7 and the beta variant B.1.351."
Lexaria is actively engaged in research with DehydraTECH-powered cannabinoid formulations across a range of potential therapeutic applications, including an advanced oral DehydraTECH-CBD formulation that it is preparing for registered clinical trials as a prospective new pharmaceutical product. Moreover, the patented DehydraTECH process does not involve processing temperatures remotely as high as those encountered in smoking or vaping processes, and in previous studies has been found to leave the cannabinoid molecules undamaged.
In other work previously conducted by Lexaria and announced on June 3, 2021, we discovered that Lexaria's DehydraTECH-enabled remdesivir and ebastine effectively inhibit the COVID-19 SARS-CoV-2 Virus. Remdesivir is a well-known nucleotide reverse transcriptase inhibitor, available under the trade name Veklury® from Gilead Sciences Inc., that interferes with the SARS-CoV-2 viral replication life cycle and has received emergency use authorization in many regions of the world for treatment of COVID-19. Ebastine is an antihistamine drug that has potent effects in inhibiting the SARS-CoV-2 main protease (Mpro, also called the 3CL protease) blocking viral entry into human cells, together with effects to reduce COVID-19 inflammatory reactions. Mpro inhibitors are gaining attention in the fight against COVID-19, as announced by Pfizer with their novel compound PF-07304814.
The Company is not making any express or implied claims that it has the ability to eliminate, cure or contain COVID-19 (or the SARS-CoV-2) virus.
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 and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), 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 23 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
KELOWNA, BC / December 29, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to report that Independent Review Board ("IRB") approval has been received ahead of schedule for its upcoming DehydraTECH-CBD human hypertension study HYPER-H21-4.
This study should "de-risk" outcomes prior to Lexaria's planned entry into regulatory pathways for the use of DehydraTECH-CBD to treat hypertension and perhaps other forms of cardiovascular disease. This study is entirely funded through the Company's existing cash resources and is not subject to any financing requirement. Dosing is tentatively scheduled to begin by April, 2022.
HYPER-H21-4 is expected to consist of 60 volunteers between the ages of 45-70 using three 150 mg doses of DehydraTECH-CBD, every day for the 6-week duration of the study. The study will use a double blinded, randomized cross-over design, and a placebo control. Some volunteers will already be using leading standard of care hypertension drugs such as ACE inhibitors with or without diuretics which will help evaluate the efficacy of DehydraTECH-CBD with and without other hypertension treatments. The extended duration of the study will allow Lexaria to gather critical data monitoring of DehydraTECH-CBD over time and will evaluate the potential for longer term health benefits.
HYPER-H21-4 is more comprehensive than any work previously undertaken by Lexaria and many types of analysis will be performed including 24-hour ambulatory blood pressure (the primary outcome); arterial stiffness and autonomic balance; brain structure and function through brain magnetic resonance imaging ("MRI"); blood biomarkers (including lipids such as cholesterol and more); renal, hepatic, sleep quality / daytime sleepiness / sleep disorders; actigraphy, geriatric depression scale, perceived stress, and Beck anxiety inventory. The wide range of data collection could provide additional insights into the long-term health benefits of DehydraTECH-CBD that might otherwise remain undetected.
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 BP 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 and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), 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 23 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
KELOWNA, BC / December 16, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has entered into an advertising and media agreement (the "Contract") for media buys and digital marketing with SRAX, Inc. ("SRAX").
"Lexaria is pleased to be working with SRAX to inform and engage a broad investor community in this significant, year-long media outreach campaign," said Chris Bunka, CEO of Lexaria Bioscience. "Lexaria has made tremendous progress during 2021 and we expect even more significant advancement in 2022 and are pursuing the broadest possible investor involvement to ensure that Lexaria's achievements are communicated to all investors."
Lexaria is planning for 2022 to be its busiest year ever, with major studies and events already announced that include:
a six-week human clinical hypertension study to evaluate DehydraTECH-CBD for possible relief of hypertension;
an industry-leading oral nicotine human study including both subjective evaluation and objective blood measurements expected to demonstrate the superiority of DehydraTECH-nicotine compared to leading industry products;
a program of animal studies designed to evaluate DehydraTECH-CBD for seizure relief and comparison against the only existing FDA-approved CBD medication currently in use for treatment of certain seizure disorders; and
our expectation of completing a pre-IND meeting with the FDA, and subsequently filing an IND application, for registered clinical trial testing of DehydraTECH-CBD for hypertension.
Along with those major studies Lexaria will also be conducting a number of pharmacokinetic studies designed to provide potential early-stage indications of enhancing delivery characteristics of various drugs for potential future use. In aggregate, the quantity of work to be performed demands the maximum visibility possible to the investor community and therefore should be maximized with a sustained and intelligent marketing campaign.
Pursuant to the Contract, SRAX will act as the agent for Lexaria and will engage and manage media companies to create advertising materials and distribute them on internet platforms and manage the flow of such media distributions (the "Services"). SRAX will employ leading-edge analytical algorithms to maximize engagement. As consideration for the Services, Lexaria will issue SRAX an aggregate 224,299 restricted common shares from its authorized share capital (the "Shares") at a deemed price of $5.35 per share for an aggregate value of $1,200,000.
The Shares have not been registered under the Securities Act of 1933, as amended (the "Securities Act") or any state securities laws. The issuance of the Shares will be in reliance on the exemptions from registration provided by Section 4(a)(2) under the Securities Act.
About SRAX
SRAX (SRAX) is a financial technology company that unlocks data and insights for publicly traded companies. Through its premier investor intelligence and communications platform, Sequire, companies can track their investors' behaviors and trends and use those insights to engage current and potential investors across marketing channels. For more information on SRAX, visit srax.com and mysequire.com.
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 and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), 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 23 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
KELOWNA, BC / December 14, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that its human clinical study HYPER-H21-3 is expected to complete all dosing and sample collection this week.
Formal hospital and ethics board approvals for human clinical study HYPER-H21-3 had been received in March. Study HYPER-H21-3 used a placebo-controlled and blinded design, with administration of a single 300mg dose of a specific DehydraTECH 2.0 CBD formulation compared to placebo in a target group of sixteen enrolled volunteers. This "Stress Test" study was undertaken to examine the effects of DehydraTECH-CBD upon acute pulmonary hypertension. Blood samples collected from this study will be subjected to analysis and the blood pressure results are expected to be reported soon.
Exposure to acute reductions in oxygen tension (i.e., hypoxia) causes rapid hypoxic pulmonary vasoconstriction (HPV) and, as a consequence of this HPV response, pulmonary arterial pressure increases. If this increase in pressure becomes too high, as is the case in many cardiac pathologies, an excess of fluid in the lungs can occur that causes difficulty with breathing.
The extent to which CBD may act as a novel treatment for HPV, and potentially as an alternative treatment for pulmonary hypertension, is unknown. Thus, the primary objective of this study is to evaluate the effect of DehydraTECH-CBD on pulmonary vascular function in normotensive individuals exposed to hypoxia. The magnitude of HPV, blood pressure, heart rate, blood samples and pulmonary gas exchange data is being collected and analysis is ongoing.
Results from study HYPER-H21-3 are expected to add to Lexaria's growing body of evidence for the effectiveness of DehydraTECH-CBD against hypertension, and will be submitted to regulators such as the FDA, as the Company pursues its planned investigational new drug research program. Lexaria offers its gratitude to the teams of experts conducting its series of three human clinical studies through 2021 overwhelmingly on schedule and on budget particularly during the past year when challenges from the COVID-19 epidemic were pronounced.
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 and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), 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 23 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
Results suggest broader applications for DehydraTECH-CBD beyond hypertension
KELOWNA, BC / December 8, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to issue follow-up results from human clinical study HYPER-H21-2 confirming that DehydraTECHTM-processed cannabidiol ("CBD") reduces arterial stiffness, potentially broadening its application to treatment of cardiovascular and other disease states beyond hypertension where it has already shown tremendous promise.
"Reducing arterial stiffness in Lexaria's recent hypertension study after only a single day of dosing with our DehydraTECH-CBD is a major discovery," said John Docherty, President of Lexaria. "We know that increased arterial stiffness is correlated with many serious and life-threatening diseases affecting people worldwide, and we are optimistic that our latest findings could have future widespread implications for promotion of improved human health and wellness."
Arterial stiffness is a strong predictor of many aspects of human disease. The impacts of increased arterial stiffness are not limited only to coronary heart disease such as hypertension, but also include other disease states such as diabetes mellitus, renal disease and more. It can also be a prognostic marker for cardiovascular events and all-cause mortality, even in asymptomatic individuals without overt cardiovascular disease.
The efficacy of blood pressure treatment and differences in efficacy between different types of antihypertensive agents is strongly correlated with measuring arterial stiffness, whereby the significant blood pressure reduction effects as previously reported with DehydraTECH-CBD from study HYPER-H21-2 appear to have been at least partially due to these improvements in arterial stiffness.
The arterial stiffness findings from study HYPER-H21-2 are summarized in the table below. Arterial stiffness was measured through pulse wave velocity ("PWV") evaluation, together with assessments of augmentation index and pressure. All comparisons between DehydraTECH-CBD and placebo were statistically significant (p < 0.01).
DehydraTECH-CBD
Placebo
Pulse Wave Velocity (PWV)
8.1 ± 0.3 m/s
8.3 ± 0.3 m/s
Augmentation Index (Alx)
28.4 ± 1.4%
32.3 ± 1.3%
Augmentation Index corrected to heart rate of 75 BPM (Alx.75)
To have decreased arterial stiffness to the degree demonstrated in our present study after only a single day of dosing with DehydraTECH-CBD is quite remarkable and will be more thoroughly investigated in Lexaria's upcoming 6-week hypertension study HYPER-H21-4, where multiple doses over this period are expected to demonstrate additional benefits against hypertension and arterial stiffness.
As first reported on September 7, 2021, at selected times during study HYPER-H21-2, some volunteers with mild to moderate hypertension had reductions of as much as a 20 mmHg (i.e., 23%) drop in blood pressure relative to placebo. When averaged over the 24-hour duration of the study, reductions in diastolic, systolic and mean arterial pressure were all significantly evidenced with DehydraTECH-CBD when compared to the placebo condition. All secondary objectives of human clinical study HYPER-H21-2 have now been successfully completed
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.
About Human Study HYPER-H21-2
Human Study HYPER-H21-2 was conducted at a European medical research hospital. Sixteen human volunteers (8 male; 8 female) aged 45-65 with otherwise untreated pre- or mild-hypertension were given either a placebo, or three separate doses of 150 mg each of DehydraTECH-CBD over a 14-hour period and studied over a 24-hour duration. The average weight and height were 91 ± 13 kg and 173 ± 9 cm. Ambulatory blood pressure was recorded for 24 hours.
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. 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 - elevated blood pressure. Hypertension is a major risk factor for cardiovascular and cerebrovascular disease, and accounts for approximately 45% of cardiovascular disease mortality and morbidity worldwide.
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 and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), 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 23 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.
KELOWNA, BC / November 10, 2021 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces its plans for several new and ongoing DehydraTECHTM applied R&D programs for 2022. The studies mentioned herein are only a fraction of Lexaria's 2022 work programs.
"Calendar 2022 will continue to see significant milestones in utilizing DehydraTECH-CBD for investigation of heart disease and hypertension; and separately, for oral nicotine delivery as an alternative to smoking", said Chris Bunka, CEO of Lexaria Bioscience Corp. "We are delighted to announce that DehydraTECH as an enhanced drug delivery platform will also be evaluated for characteristics and potential treatment options for hormone replacement, dementia, rheumatoid disease and diabetes."
Heart disease is the #1 killer in the US, responsible for the deaths of 659,000 Americans each year; and cigarette smoking is the #3 killer in the US, responsible for the deaths of 480,000 Americans per year. Lexaria continues its unwavering commitment to lessening the loss of life in these areas and will detail these advanced work programs in the heart disease and nicotine sectors in separate communications.
During 2022, Lexaria will also be conducting pharmacokinetic ("PK") and efficacy modelling studies in animals to evaluate DehydraTECH's ability to improve the delivery characteristics of many other drugs or active pharmaceutical ingredients ("APIs") and determine whether there might be commercial benefit to continue with further pursuit within different market sectors. The following studies are part of approximately 12 applied R&D programs planned for 2022 (tentative start dates are included):
HOR-A22-1: April, 2022. This PK study will evaluate the ability of DehydraTECH to enhance the delivery characteristics of estrogen. Estrogen helps to control the menstrual cycle but also controls cholesterol and protects bone health. The hormone replacement market is estimated at $46.5 billion in 2027.
DEM-A22-1: July, 2022. This efficacy study will evaluate DehydraTECH-CBD with and without nicotine for the potential treatment of dementia. Alzheimer's disease is the most common form of dementia and accounts for at least 60% of all cases, and nicotine is already showing promising results related to Alzheimer's treatment. An estimated 55 million people worldwide are currently affected by dementia, with 78 million expected to be living with some form of dementia by 2030. The dementia drug treatment market is estimated at $19.6 billion in 2026.
RHEUM-A22-1: October, 2022. This efficacy study will focus on the ability of DehydraTECH-CBD to potentially affect treatment of rheumatoid disease. Given CBD's postulated efficacy related to inflammation, Lexaria will explore a possible role for CBD in this area of investigation. Rheumatic diseases are autoimmune and inflammatory diseases that cause the immune system to attack joints, bones, muscles and organs. There are over 100 rheumatic diseases including Fibromyalgia, Lupus, Osteoarthritis, Rheumatoid Arthritis and more. The Rheumatoid Arthritis therapeutics market alone is expected to be over $30 billion per year by 2025.
DIAB-A22-1: November, 2022. This efficacy study will explore the ability of DehydraTECH-CBD to potentially affect treatment of diabetes. Diabetes prevents the body from making enough insulin, resulting in abnormal blood sugar levels. Diabetes is the 7th largest cause of death in the US and there is currently no cure. Investigation of CBD related to diabetes is in early stages, though there are some areas of ongoing investigation. CBD has shown some ability to reduce the incidence of diabetes in mice. The prescription drug market used to treat diabetes is expected to be a $77.9 billion global market in 2024.
Lexaria raised approximately USD$15 million in funding during 2021 which has enabled the active work programs of 2021 and supported significant advances in the fields of heart disease, oral nicotine, and antiviral research. Lexaria's budget for applied R&D during 2022 is fully funded and includes each of the R&D programs noted within this press release. Lexaria's objective for its R&D programs is to build significant value for all Lexaria stakeholders while pursuing policies for significant improvements to human health.
Lexaria is debt free and expects its current cash reserves to meet all its needs until at least Q2, 2023. Lexaria plans to seek strategic corporate business partners for many of its specific drug investigations after sufficient data has been generated which, if successful, could generate any combination of up-front, milestone, and/or royalty payments to Lexaria.
In other news, Lexaria has engaged Barretto Pacific Corporation to provide various investor relations related services for compensation of USD$56,000 for the first four months, and USD$12,000 per month thereafter for the remainder of the 1-year term. Lexaria has also retained the consulting services of Mei Kuo for a 3-month period ending January 08, 2022, for public relations, marketing and similar related services in return for payment of USD$15,000 per month. No stock or options have or will be issued in relation to either contract.
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 and nicotine by up to 5-10x, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), 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 23 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, alterations or cancellations of planned R&D that could occur related to pandemics or for other reasons including changed priorities or lack of funding, 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
DehydraTECH-CBD also being evaluated in three other human clinical studies
Positive studies would support Lexaria's regulatory approval plans
KELOWNA, BC / November 3, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces a significant new study to expand its hypertension clinical program and provides updates on three ongoing human clinical studies evaluating its proprietary DehydraTECH-CBD for potentially treating hypertension and heart disease.
"HYPER-H21-4 is the most ambitious study Lexaria has ever undertaken and is enabled from the successful outcomes from our other 2021 human hypertension studies," said Chris Bunka, CEO of Lexaria Bioscience Corp. "Outcomes from this study could support Lexaria's goals related to pursuit of regulatory approvals for DehydraTECH-CBD for potential use as a treatment for high blood pressure."
HYPER-H21-4
HYPER-H21-4 is expected to consist of 60 volunteers between the ages of 45-70 using three 150 mg doses of DehydraTECH-CBD, every day for the 6-week duration of the study. The study will use a double blinded, randomized cross-over design, and utilize a placebo control. Some volunteers will already be using leading standard of care hypertension drugs such as ACE inhibitors with or without diuretics to help evaluate the efficacy of DehydraTECH CBD with and without other hypertension treatments. The extended duration of the study will allow Lexaria to gather critical data monitoring extended use of DehydraTECH-CBD and will evaluate the potential for longer term health benefits. Study protocols are being readied for submission to the Independent Review Board ("IRB") and approval is anticipated by January, 2022.
HYPER-H21-4 is more comprehensive than any work previously undertaken by Lexaria and many types of analysis will be performed including 24-hour ambulatory blood pressure (which is the primary outcome); arterial stiffness and autonomic balance; brain structure and function through brain magnetic resonance imaging ("MRI"); blood biomarkers (including lipids such as cholesterol and more); renal, hepatic, sleep quality / daytime sleepiness / sleep disorders; actigraphy, geriatric depression scale, perceived stress, and Beck anxiety inventory. The wide range of data collection could provide additional insights into the benefits of DehydraTECH-CBD that might otherwise remain hidden from view.
HYPER-H21-4 is expected to produce an enormous amount of data that, if positive, should be supportive of Lexaria's plans to enter regulatory pathways anticipated to result in eventual regulatory approval to use DehydraTECH-CBD to treat hypertension and perhaps other forms of cardiovascular disease. This study is entirely funded through the Company's existing cash resources and is not subject to any financing requirement.
Updates on Other Hypertension Studies
HYPER-H21-1
Partial results, related only to BP readings, were released on July 29, 2021, as summarized below. This study was conducted in 24 adult volunteers, used a single dose of 300 mg of DehydraTECH-CBD, and measured results over a number of hours. Pending analyses and results include speed and rate of absorption of the CBD and its main metabolites, as well as evaluation of inflammatory markers associated with cardiovascular disease and gold-standard biomarkers of nitric oxide. This latter measure is expected to provide mechanistic insight into the witnessed reduction in blood pressure via vasodilation. Those results were originally expected to be released by October, but are now due by early December due to certain supply chain challenges.
BP reduction from baseline was greatest when measured via systolic pressure. In the subset of volunteers who were Stage 2 hypertensive, peak systolic BP reductions from baseline were observed of as much as approximately 13 mmHg by the 50-minute time point with DehydraTECH-CBD, and systolic BP remained depressed throughout almost the entire 3-hour duration of the study. For reference, other studies of coronary heart disease ("CHD") have concluded that "lowering systolic pressure by 10 mm Hg or diastolic pressure by 5 mm Hg using any of the main classes of drugs reduced CHD events (fatal and nonfatal) by about a quarter and stroke by about a third, regardless of the presence or absence of vascular disease and of pretreatment BP. Heart failure is also reduced by about 25%."
HYPER-H21-2
Partial results were released on September 7, 2021 as summarized below. This study was conducted in 16 adult volunteers, used three doses of 150 mg each of DehydraTECH-CBD, and measured results over a 24-hour ambulatory time-period. Pending analyses and results to be concluded include additional blood pressure subset analyses, sleep quality and other data analyses that are in progress and final results are expected in early December.
At selected times during the 24-hour study, volunteers with mild to moderate hypertension averaged as much as a 20 mmHg (i.e., 23%) decrease in BP relative to placebo. Over the 24-hour ambulatory monitoring period, volunteers averaged a significant reduction of 7.0% (p < 0.001) in systolic pressure with DehydraTECH-CBD relative to placebo.
HYPER-H21-3
DehydraTECH-CBD manufacturing for this study is complete and the clinical test articles have been delivered to the study location where dosing is expected to begin in mid-November or thereabouts, and dosing is expected to be complete by mid-December. Thereafter, the BP findings are expected to be reportable by the end of January, 2022.
HYPER-H21-3 will be conducted in 16 adult volunteers and will utilize a single dose of 300mg of DehydraTECH-CBD. This study is designed to evaluate acute pulmonary hypertension and cardiovascular effects under severe stress. Exposure to acute reductions in oxygen tension (i.e., hypoxia) causes rapid hypoxic pulmonary vasoconstriction ("HPV") and, as a consequence of this HPV response, pulmonary arterial pressure increases. If this increase in pressure becomes too high, as is the case in many cardiac pathologies, an excess of fluid in the lungs can occur that causes difficulty with breathing. The extent to which DehydraTECH-CBD may act as a novel treatment for HPV, and potentially as an alternative treatment for pulmonary hypertension, is unknown. Thus, the primary objective of this study is to evaluate the effect of DehydraTECH-CBD on pulmonary vascular function in normotensive individuals exposed to hypoxia. The magnitude of HPV, blood pressure, heart rate, blood samples, and pulmonary gas exchange data will be collected and analyzed.
Hypertension and Cardiovascular Disease Markets
About 1.28 billion people worldwide suffer from hypertension - elevated blood pressure-in a market valued at $28 billion per year and is recognized as one of the world's top health problems. Only 21% of people with hypertension have it under control which demonstrates enormous unmet need. Hypertension is one subset of the broader cardiovascular disease category, which is expected to be a $146 billion market in 2022.
"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 best 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 is 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 and nicotine by up to 5-10x, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), 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 23 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.
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
