Author Archives: mmcdonald

  • Lexaria's DehydraTECH-nicotine pouch performance to be compared to existing leading brands ON! and Zyn

KELOWNA, BC / November 1, 2022 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that independent review board ("IRB") approval has now been received for human clinical nicotine study NIC-H22-1, and that human dosing will begin soon.

Study NIC-H22-1 is a 36-person human pharmacokinetic ("pk") randomized, double blinded, cross-over study conducted in current cigarette smokers, wherein each person will visit the laboratory to be dosed three times over a period of weeks. During each visit only one oral nicotine pouch will be administered and evaluated: either DehydraTECH-nicotine; On! brand manufactured by Altria; or Zyn brand manufactured by Swedish Match. Predetermined questionnaires for subjective evaluation will be used for each oral nicotine pouch, and blood samples will be taken a total of 8 times per visit to conduct objective evaluations related to quantity of nicotine in blood at various time points, and more. Vital signs such as temperature, blood pressure, heart rate and respiratory rate will also be collected. Subjective evaluations related to throat burn, user experience, gastrointestinal experience and more will be conducted. Lexaria hopes to evidence that processing purified nicotine with DehydraTECH leads to better oral-tissue absorption and reduced negative experiences compared to currently sold brands.

The study had earlier faced certain time extensions due to manufacturing and logistics, those issues since resolved. The study is fully funded from internal company resources. Lexaria will provide further updates and any relevant material findings in due course from this study as they become available.

As reported on October 5, 2021, Lexaria demonstrated in 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.

Lexaria Bioscience Corp., Tuesday, November 1, 2022, Press release picture

The oral nicotine pouch category is of intense interest to Lexaria and is one of the fastest growing segments of the nicotine industry due in part to its reduced risk health outcomes as noted by the Food and Drug Administration ("FDA"). This delivery method, in the white pouch format specifically, which avoids harmful lung outcomes experienced by smokers or vapers, involves absorption primarily through the buccal tissues of the mouth, of purified nicotine that has been separated from most other harmful compounds in the tobacco leaf. The global market for the oral nicotine pouch category was US$2.33 billion in 2020 and is growing at a rapid CAGR of 30.7% and is expected to reach $21.84 billion in 2027.

As reported on March 8, 2022, Lexaria recently received its first ever patent granted to use DehydraTECH to more efficiently deliver nicotine through buccal tissue absorption. Similar patent filings have been made in the USA and in the EU and Lexaria believes those potential patent awards could support significant competitive advantages in the nicotine white pouch category, as well as other oral nicotine product formats.

ABOUT LEXARIA BIOSCIENCE CORP.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 27 patents granted and roughly 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

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

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/723196/Lexaria-Receives-Independent-Review-Board-Approval-for-its-Upcoming-Human-Oral-Nicotine-Study

HYPER-H21-4 using DehydraTECH-CBD evidenced:

  • Exceptional safety and tolerability
  • Statistically significant lowering of 24-hour ambulatory blood pressure ("BP")
  • BP lowered for the entire 5-week study duration
  • BP lowered both for patients currently taking other antihypertensive drugs as well as patients not taking any other antihypertensive drugs

KELOWNA, BC / October 27, 2022 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that human clinical study HYPER-H21-4 may be the world's first study to evidence a sustained drop in BP in normally active hypertensive patients following multiple weeks of oral cannabidiol ("CBD") therapy, using Lexaria's patented DehydraTECHTM-CBD capsule formulation.

The primary safety and efficacy objectives of study HYPER-H21-4 were successfully achieved. BP was significantly reduced by 2.5 weeks and was sustained over the full 5-weeks of dosing. These reductions in BP were achieved with zero serious adverse events being reported. Also, there were no adverse changes observed in liver enzymes; an important clinical safety biomarker of oral CBD therapy. Of note, these significant decreases in BP were achieved using relatively low doses of DehydraTECH-CBD as a direct result of the well-established drug delivery efficiencies of Lexaria's DehydraTECH technology.

In general, patients receiving placebo doses trended toward increases in BP during the period of the study compared to baseline, while the average BP measured by each of mean arterial BP ("MAP"), systolic BP ("SBP") and diastolic BP ("DBP") significantly decreased from baseline when dosed with DehydraTECH-CBD; and those decreases were maintained during the full 5 weeks of dosing. In fact, as shown in the table below, as much as a 7.01 mmHg differential in SBP was evidenced comparing the average SBP reduction from baseline on DehydraTECH-CBD to the average SBP increase from baseline upon cross-over on placebo following the second 2.5 weeks of dosing. Furthermore, there appeared to be a trend toward greater BP reduction over time and at the higher doses employed in the second 2.5 weeks of dosing; an important factor to be explored in future studies.

24-Hour BP Monitoring

Change from Baseline

Dose Period 1

First 2.5 Weeks (mmHg)

Dose Period 2

Second 2.5 Weeks (mmHg)

DehydraTECH-CBD (225 mg - 300 mg daily)

Placebo

DehydraTECH-CBD (375 mg - 450 mg daily)

Placebo

MAP

-3.22 +/-0.90

P =0.002

+0.72 +/-0.78

P =1.000

-4.14 +/-0.69

P <0.001

-1.41 +/-0.91

P =0.387

SBP

-4.76 +/-1.24

P =0.001

+0.94 +/-0.99

P =0.993

-5.60 +/-0.81

P <0.001

+1.41 +/-1.16

P =0.688

DBP

-2.25 +/- 0.80

P =0.019

+0.67 +/-0.81

P =1.000

-3.25 +/-0.72

P <0.001

+1.30 +/-0.88

P =0.437

Lexaria Bioscience Corp., Thursday, October 27, 2022, Press release picture
Lexaria Bioscience Corp., Thursday, October 27, 2022, Press release picture
Lexaria Bioscience Corp., Thursday, October 27, 2022, Press release picture

Other published research has established that, in order to reduce the collective risk of cardiovascular events such as myocardial infarction, stroke and congestive heart failure, reductions in BP of ~4.6 mmHg for SBP and ~2.2 mmHg for DBP are required. Lexaria's DehydraTECH-CBD BP reductions exceed these crucial levels.

Lexaria is aware of only a handful of other published research studies, mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting BP is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this. DehydraTECH-CBD is currently unique in its evidenced superior power to reduce BP over other oral CBD formulations.

"That we were able to lower blood pressure in our patient population over multiple weeks using DehydraTECH-CBD is an exceptional discovery, given that previous studies by others using other oral CBD formulations have failed to evidence this sustained benefit," said Chris Bunka, CEO of Lexaria Bioscience Corp. "DehydraTECH also demonstrated excellent safety and tolerability results and no adverse changes in liver enzymes throughout the study. Indeed, of the handful of minor, non-serious adverse events reported, there were nearly as many reported by those patients receiving placebo as those who received DehydraTECH-CBD. Consistent with Lexaria's often-mentioned de-risking strategy, this exceptional safety profile should prove beneficial as we prepare for our planned upcoming Phase Ib Investigational New Drug clinical study to be registered with the U.S. Food and Drug Administration."

Another important discovery from study HYPER-H21-4 was that the decreases in BP were similar in persons currently being treated with standard of care BP medications as in persons who were not undergoing any current standard of care BP treatment. This observation is suggestive that Lexaria's DehydraTECH-CBD has the potential to offer additive BP reduction benefits on top of any degree of improvements the standard of care medications achieved for those patients before entry into the study. This additive improvement as an adjunct therapy, together with the exceptional safety profile of DehydraTECH-CBD, could become a significant value enhancer should it eventually enter the marketplace as an approved hypertension treatment.

Additional study endpoint analyses as described in the complete study protocol are still underway and any relevant material findings will be reported upon in due course as these findings become available, currently expected during the remainder of 2022. The current findings will be submitted to an appropriate peer-reviewed clinical hypertension journal for possible publication.

ABOUT THE STUDY.

Study HYPER-H21-4 was a randomized, double-blinded, placebo-controlled, cross-over study that consisted of male and female volunteers between the ages of 40-70. Sixty-six (66) people were ultimately dosed to completion of the study, and they had documented or measured:

  • elevated blood pressure (120/80 to 139/80 mmHg);
  • mild (stage 1) hypertension (140/90 to 159/99 mmHg); or
  • moderate (stage 2) hypertension (160/100 to 179/109 mmHg).

All study participants received DehydraTECH-CBD every day for a 5-week duration in the dose-escalating 2.5 week increments noted above. Upon cross-over and wash out, all 66 study participants also received the matching placebo for a 5-week duration following the study randomization schedule. Thirty-three (33) of these patients had been diagnosed with hypertension but were not being treated with any antihypertensive medications, while 33 patients had been diagnosed with hypertension and were receiving commonly used antihypertensive therapies including angiotensin-converting enzyme ("ACE") inhibitors with or without diuretics; or alternatively, ACE inhibitors with calcium channel blockers. The complete study protocol has already been published and is available at PubMed.

ABOUT LEXARIA BIOSCIENCE CORP.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 27 patents granted and roughly 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/722558/Lexarias-Human-Clinical-Hypertension-Study-a-Success

KELOWNA, BC / September 2, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that Catherine Turkel, PharmD, PhD has joined the board of directors of Lexaria Bioscience Corp.

"It is a pleasure to join the Lexaria Board of Directors at such an exciting time in the Company's evolution," said Dr. Turkel. "I look forward to working with the leadership team and the Board as they continue the development of DehydraTECH technology into a broad range of drug products for potential use in several important therapeutic areas."

Dr. Turkel has more than 20 years' experience as an executive in start-up and mid-size pharma/biotech companies. She was Founder and CEO of Nezee Therapeutics and served as President and R&D head at Novus Therapeutics (renamed Eledon Pharmaceuticals - Nasdaq: ELDN). She currently acts as an independent Board Director at Object Pharma (private) and Prostate Cancer Research (nonprofit; member of the Translational Scientific Advisory Committee) and is a Dean Advisor at Chapman University School of Pharmacy.

Dr. Turkel has formulated Food and Drug Administration registration & commercial strategic plans and has led global development programs for pharmaceutical and biologic treatments from phase 1 through phase 4 related to Neurosciences, Pain, Cardiovascular, Psychiatry, Rare Diseases, Ophthalmology, Aesthetics, Urology and Otology therapeutic areas. Dr. Turkel designed and led Allergan's (now AbbVie - NYSE: ABBV) pioneering BOTOX® Chronic Migraine registration program, generating revenue of more than a billion dollars.

"Lexaria is delighted to welcome Dr. Turkel as we continue to position the Company for advancement following our recent successful pre-IND meeting with the Food and Drug Administration," said Chris Bunka, Chairman of the Board of Lexaria. "Catherine's practical development and regulatory expertise will be of increasing value to Lexaria and we look forward to working with her."

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 27 patents granted and roughly 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/714439/Lexaria-Welcomes-Dr-Catherine-Turkel-to-its-Board-of-Directors

KELOWNA, BC / August 31, 2022 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq: LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce its continued accumulation of international patent recognition with the receipt of its 27th worldwide patent granted in Mexico under registration #390001.

This patent is from Lexaria's third patent family, "Stable Ready-to-Drink Beverage Compositions Comprising Lipophilic Active Agents" from which patents have already been issued in Australia, India and Japan. The patent is applicable to a range of active ingredients that includes but is not limited to non-psychoactive cannabinoids and NSAIDs. Types of products covered include certain pharmaceutical product formats as well as a wide variety of ready-to-drink consumer retail beverage products.

Given Lexaria's continued pursuit of regulatory approval of DehydraTECH-CBD for the treatment of hypertension in regulated pharmaceutical applications, certain claims allowed in this new Mexican patent to use DehydraTECH-processed non-psychoactive cannabinoids to treat cardiac and cardiometabolic disorders are of particular value to the Company.

Additional claims granted in Mexican patent #390001 include the treatment of neurological diseases such as Alzheimer's disease, Parkinson's disease, schizophrenia, and Human Immunodeficiency Virus (HIV) dementia; obesity; metabolic disorders such as insulin related deficiencies and lipid profiles, hepatic diseases, diabetes, and appetite disorders; cancer chemotherapy; benign prostatic hypertrophy; irritable bowel syndrome; biliary diseases; ovarian disorders; marijuana abuse; and alcohol, opioid, nicotine, or cocaine addiction.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 27 patents granted and roughly 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/714080/Lexaria-Receives-New-Patent-in-Mexico

Third Party Analysis for Biotech and Pharma Industries

KELOWNA, BC / August 11, 2022 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is providing the following information to its stakeholders as an aid to conveniently researching and understanding various non-affiliated third-party sources and their methodologies for valuing biotech and pharmaceutical companies.

"Biotech companies with little to no revenue can still be worth billions," says Raphael Rottgen, CFA, FRM. While valuations can be extremely low or extremely high, there is often underlying logic in identifying risks and arriving at those valuations. Developing new drugs can have significant costs of over $1 billion and can take as long as 10 to 15 years to reach the market.

According to the U.S. Food and Drug Administration ("FDA"), there are five steps to the drug development process:

  • Step 1: Discovery and Development
  • Step 2: Preclinical Research
  • Step 3: Clinical Research
  • Step 4: FDA Drug Review
  • Step 5: FDA Post-Market Drug Safety Monitoring

Lexaria's DehydraTECH-CBD for hypertension program is currently operating within Step 3 using the FDA descriptions - various human studies seeking to evidence both tolerability/safety as well as efficacy for intended purposes. Interestingly, of the 5,000 - 10,000 compounds examined and tested in the Discovery step above, not more than about 250 successfully complete the Preclinical Research step; DehydraTECH-CBD has already reached and surpassed this Preclinical Research stage.

Many investors and analysts use a discounted cash flow ("DCF") model as one method of trying to understand the present value ("PV") of a company. Understanding a defined sector's patient size, value of products, comprehensive opportunities, risks, and development timelines are just some of the many datapoints that contribute towards understanding potential valuations for that biotech or early-stage pharmaceutical company. Some have found this article sourced from Investopedia to be useful to contemplate biotech valuation potential.

In a study conducted by McKinsey that evaluated the 20 years from 1996 until 2016, total returns to shareholders from the biotech sector were 12% per annum, while the S&P 500 delivered 8% per annum during the same period. The Nasdaq biotech index is represented by the ETF; IBB. From the 2008 market lows, that index climbed nearly 1,000% to the all-time highs reached in August, 2021. It then declined by 41% to the recent low reached in June, 2022.

Bay Bridge Bio has made available an extensive valuation guide and set of online tools to help people understand potential valuation outcomes for different biotech companies or projects. Focusing on the above-referenced FDA drug development Steps 2 and 3 (Pre-Clinical and Clinical Research), Bay Bridge Bio looks in more detail at the widely utilized "Phase I, Phase II and Phase III" clinical trials often cited by the biotech industry within Step 3. Their valuation expectations PER DRUG MOLECULE are presented in the table below.

Start of Phase I

Start of Phase II

Start of Phase III

Valuation

$88,000,000

$248,000,000

$1,119,000,000

Probability of FDA Approval

12%

20%

56%

More sophisticated investors know that there are still finer-grained thresholds and opportunities within the FDA drug evaluation and registration process. Lexaria has commented many times that DehydraTECH processing of a molecule does NOT appear to create a new chemical entity ("NCE") or new molecular entity ("NME"). According to this article published at Pharma Tech Outlook, that distinction is important as it is favorable for Lexaria to pursue an abbreviated/accelerated drug evaluation and registration pathway known as 505(b)(2) where Lexaria would rely in part on already known data from previously FDA-approved CBD product(s). "The advantages of 505(b)(2) are significant…and… the clinical program is typically much less comprehensive due to the 505(b)(2) applicant's ability to reference the innovator's approved product."

Of note, Lexaria was pleased to report in its announcement of August 10, 2022, that the FDA deemed Lexaria's plans to pursue the 505(b)(2) regulatory pathway for DehydraTECH-CBD as appropriate, by way of its recent pre-Investigational New Drug ("pre-IND") meeting outcome. Analysis has shown that 505(b)(2) applications have roughly twice the FDA-approval rate of NME applications.

Valuation of equities is a complex task with innumerable risks and rewards that include far-reaching macro events as well as company-specific developments. It is nearly impossible to foresee all risks and rewards, but underlying logic-based evaluation is one way to provide a realistic framework of expectations that investors can use in their analysis.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 26 patents granted and roughly 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/711654/Lexaria-Discusses-Valuation-Metrics-for-Biotech-Industry

NEW YORK, Aug. 11, 2022 -- NetworkNewsAudio - Lexaria Bioscience Corp. (NASDAQ: LEXX) announces the availability of a broadcast titled, "The Power of Science to Stop a Killer."

To hear the AudioPressRelease, please visit: The NetworkNewsAudio News Podcast

To view the full editorial, please visit: https://nnw.fm/9kD5b

In its 2021 industry report, ReportLinker estimated the global anti-hypertensive drugs market at $24.17 billion in 2020 on its way to reach $27.81 billion in 2025. All told, hypertension costs the country on average $131 billion annually, and even more sobering, in 2020 alone, more than 670,000 deaths in the United States had hypertension as a primary or contributing cause.

A recognized global innovator in drug-delivery platforms, Lexaria Bioscience Corp. (NASDAQ: LEXX) is determined to fill the need for a safe, effective, tolerable treatment for hypertension and have a meaningful impact on comorbidity-related costs and deaths. Its patented flagship product, DehydraTECH(TM), improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting healthier oral ingestion methods and increasing the effectiveness of fat-soluble active molecules. DehydraTECH promotes fast-acting, less expensive, and more effective oral drug delivery and has been thoroughly evaluated through in vivo, in vitro and human clinical testing.

About Lexaria Bioscience Corp.

Lexaria's patented drug delivery technology, DehydraTECH(TM), 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 bioabsorption with cannabinoids and nicotine by up to five to ten times, reduce time of onset from one to two hours to minutes, and mask unwanted tastes; the innovative tech is also being evaluated for orally administered anti-viral drugs, nonsteroidal 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 25 patents granted and more than 50 patents pending worldwide.

For more information about the company, please visit www.LexariaBioscience.com.

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

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

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

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

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

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

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

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

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

About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 26 patents granted and roughly 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

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

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

SOURCE: Lexaria Bioscience Corp.



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

KELOWNA, BC / July 27, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that dosing with Lexaria's DehydraTECH™-processed cannabidiol ("DehydraTECH-CBD") has been completed in its multi-week human clinical hypertension study HYPER-H21-4, and that no serious adverse events have been reported as a result of the dosing.

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

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

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

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

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

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

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

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted, 1 patent allowed, and roughly 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

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

SOURCE: Lexaria Bioscience Corp.



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

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

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

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

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

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

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

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

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

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

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted plus a 26th patent allowed; and roughly 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.



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

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

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

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

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

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted plus the 26th patent allowed; and roughly 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

INVESTOR CONTACT:

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

SOURCE: Lexaria Bioscience Corp.



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