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Hope Springs Eternal!
Once again.
“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.” LOL
Ted Ohashi-Let's Toke Business
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_3016755b45d446ce80c41c2926478a86.pdf
Is the decline in Lexaria Bio justified
Pretty much. It's going to be a long time before this stock comes back.
Thanks for sneaking that one through Bunka.
SEC Form S-1 #333-271096 $12 million units filed Friday (April 28, 2023)
Lexaria Awards CRO Contract for Upcoming U.S. Phase 1b Hypertension Study
2023-04-24 09:03 ET - News Release
(via TheNewswire)
Lexaria Bioscience Corp.
Clinical study will evaluate safety and tolerability of Lexaria’s patented DehydraTECH-CBD as a potential treatment for hypertension
California-based InClin to provide CRO services to manage and expedite the study
Lexaria is working with its regulatory and clinical advisors toward upcoming IND submission
Kelowna, British Columbia – TheNewswire - April 24, 2023 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms announces it has awarded the contract for clinical research organization (“CRO”) services for its expected upcoming Food and Drug Administration (“FDA”)-registered, U.S. Phase 1b Investigational New Drug (“IND”) hypertension study HYPER-H23-1 with its patented DehydraTECH-powered cannabidiol (“DehydraTECH-CBD”) to California-based InClin, Inc .
Study HYPER-H23-1 is entitled ‘ A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension’ . The primary objective of the study will be to evaluate safety and tolerability in 120 hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing.
InClin is about to begin study start-up and preparatory activities to enable Lexaria to “hit the ground running” with patient dosing as soon as possible after the expected FDA IND filing and review is completed. Lexaria anticipates filing the IND this summer with hoped-for FDA authorization within about 60 days, resulting in the Phase 1(b) trial aggressively targeting commencement of patient dosing as early as October 2023.
The study start-up services to be provided by InClin include but are not limited to: clinical site evaluation and selection, personnel and site training, project management, clinical database design and management, quality assurance support, medical writing, study documentation creation, biostatistics and programming, support vendor coordination, Independent Review Board (“IRB”) submissions and more.
Lexaria had a successful outcome following its FDA pre-IND meeting as announced on August 10, 2022 . Since then, the Company has been working tirelessly with its regulatory and clinical advisors on refining the study plan and preparing for the IND submission pursuant to the pre-IND guidance it received from the FDA. The Company is in the process of performing the drug product manufacturing and stability testing required as part of the upcoming IND submission, compliant with current Good Manufacturing Practice (“cGMP”) regulations. Assembling the stability data from its cGMP-manufactured batch production work is one of the last requirements prior to Lexaria submitting its formal IND application to the FDA this summer.
Lexaria’s five previous human clinical studies conducted from 2018 through 2022, which were not conducted under FDA-registration but are expected to be integral to successful filing and review of its upcoming IND submission, were carried out in an aggregate total of 134 healthy and hypertensive persons. These foundational studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens, and also produced zero serious adverse events; suggesting that DehydraTECH-CBD has the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics.
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 blood pressure 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 blood pressure over other oral CBD formulations.
Findings from Lexaria’s latest study HYPER-H21-4 demonstrated a potentially novel mechanism of action of DehydraTECH-CBD in reducing blood pressure which may be explained, at least in part, by its interaction with the human sympatho-chromaffin system via catestatin modulation as detailed in the peer-reviewed and published respected journal, " Biomedicine and Pharmacotherapy ". This is of significance because the FDA has previously laid out clear guidelines for sponsors who seek to develop new anti-hypertensive drugs, specifically defining the need for medications that offer novel and complementary modes of action. Data gathered from study HYPER-H21-4 suggested that DehydraTECH-CBD had the potential to offer additive blood pressure reduction benefits on top of any degree of improvements that standard of care medications achieved for patients prior to DehydraTECH-CBD dosing.
About DehydraTECH-CBD
DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure. Lexaria has also developed DehydraTECH-CBD formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.
About InClin, Inc.
InClin is a full-service Contract Research Organization (CRO) with offices in the San Francisco Bay Area and Sydney, Australia. They are a single source provider of an integrated full suite of clinical development services from Phase 1 to Phase 4, including project management, clinical monitoring, site and contract management, vendor management, data management, biostatistics, programming, drug safety, medical monitoring, medical writing, QA inspection readiness, and strategic consulting services. InClin has assembled a team of seasoned professionals and vendor service providers who will support study HYPER-H23-1 for Lexaria, with extensive expertise and experience in the core areas relevant for this program including cardiac safety and efficacy monitoring and pharmacokinetic testing. For more information visit www.InClin.com .
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through 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 30 patents granted and many 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.
Here's annual letter which contains the list of institutional investors as of Jan.13. https://ir.lexariabioscience.com/news-events/press-releases/detail/201/lexaria-releases-annual-letter-from-the-ceo
Lexaria is Receiving Four New Patents
Kelowna, British Columbia – April 20, 2023 – Lexaria Bioscience Corp. (Nasdaq: LEXX) (Nasdaq: LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms announces that it has received notifications of four new patents either awarded or allowed.
In Japan, Lexaria has received a new patent under its Patent Family #3: Stable Ready-to-Drink Beverage Compositions Comprising Lipophilic Active Agents. This is Lexaria’s 5th awarded patent in Japan, providing strength to our growing Japanese patent portfolio. Lexaria has existing patents under this Patent Family in Australia, India, Japan, and Mexico.
In Australia, Lexaria has received a new patent under its Patent Family #18: Compositions and Methods for Enhanced Delivery of Antiviral Agents. This is Lexaria’s 10th patent in Australia and only our second patent in this Patent Family, following a similar patent award in 2022 in the USA.
In Canada, Lexaria has been advised that a new patent under our Patent Family #8: Compositions Infused With Nicotine Compounds and Methods of Use Thereof has been allowed. This is Lexaria’s second patent in this Patent Family and follows a similar patent issuance in Australia in 2022.
In the USA, Lexaria has been advised that a new patent under our Patent Family #21: Compositions and Methods for Treating Hypertension has been allowed. Lexaria believes this patent could be of particular importance related to the Company’s pursuit of utilizing DehydraTECH-CBD in relation to its expected upcoming FDA Investigational New Drug application. The outcomes of our series of hypertension studies already completed were instrumental in achieving this patent. This will be Lexaria’s first patent in this Patent Family.
The global cardiovascular drugs market was worth US$146.5 billion in 2022 and expected to reach $173.5 billion in 2026 and by geography, North America is the biggest market in the world making US patent protection a necessity in the pursuit of commercial markets.
When a patent is “allowed”, it means we have been notified by the patent office that they have determined they will soon grant the patent, often subject to some administrative tasks and/or fees. Lexaria is continuously pursuing additional patent protection for its innovative DehydraTECH drug delivery technology. After the awarding of these patents, Lexaria’s total patent portfolio will have grown to 32 granted patents worldwide.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through 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 28 patents granted and many 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
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
“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.”
"Lexaria is also in discussions with a number of larger companies in Europe and North America regarding licensed use of our DehydraTECH technology both for consumer sectors as well as – for the first time ever - within the pharmaceutical industry."
Lexaria is still waiting on at least 2 more reports on the secondary aims of the hypertension study HYPER-H21-4. Clinicians are writing peer reviewed papers, which would be published, so one can assume that the results were positive. Secondary aims were arterial stiffness, vascular health biomarkers, inflammation, heart rate variability, and the psychological well-being of patients. Take your pick. A deal with a pharmaceutical company could come after all the data is published.
We've already surpassed the daily highest share volume since august of 2022 and there's still 2.5 hours to go!
There's still more data to come from the Hypertension study, I'm particularly interested in seeing the data on Arterial Stiffness. I believe the delay is caused by the need to have the data 'peer reviewed' and published in an appropriate medical journal.
"Additional study endpoint analyses as described in the complete study protocol are still underway and any relevant material findings will be reported upon as these findings become available."
On a positive note, this morning's volume is strong with the share price rising above the 6 month high. Up 8.6% on volume of 66,000.
Ted Ohashi-Let's Toke Business
/https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_d6a00860938245228995fb017fae007d.pdf
Ted Ohashi Let's Toke Business Pg. 11
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_87f74e0b9c6c4d7492b0afaf509e4dbd.pdf
Ted Ohashi-Let's Toke Business.
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_3ec4ed316d5740b0ac4c38141587efb8.pdf
Yes, the silence is deafening. I just asked them if there will be more data from the HYPER-H21-4 study. They said there was more data but couldn't say when it would be released as the team was still analyzing the data. Are they late because they're still being peer reviewed? I don't know, it's been almost 4 months since the first results though, WTF.
Here's a quote from their news release dated Oct 27 2022
"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."
Who better to negotiate with Jazz Phama than someone who's been there already?
I wonder what he sees? Is it greater efficacy with lower side effects for DehydraTECH CBD than Epidiolex?
Here's why a lower effective dose is important.
'The most common side effects for Epidiolex include: sleepiness, decreased appetite, diarrhea, increase in liver enzymes, feeling very tired or weak, rash, sleep problems, fever, vomiting and infections.'
When I said 'Nice to see such big name players involved.' I clearly meant as a group, here are some of the Assets under management.
Geode Capital Management 799 billion USD
Susquehanna International Group $293M USD
Vanguard Group Inc $8.1 trillion USD
UBS Group AG $2.124 trillion USD
Invenomic Capital Management LP $477.7 MM USD
Citadel Advisors LLC $253.4 BB USD
Two Sigma Investments, LP $60B+ USD
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.
Looks like Invenomic Capital Management has 8.01% of the outstanding shares, just behind Chris Bunka. Nice to see such big name players involved.
https://www.newsfilecorp.com/release/145019
Lexaria Bioscience Turns Focus to Dementia and Diabetes with New Studies
Premier Wellness just announced the launch of their new products using DehydraTECH at the end of July, so there's been barely a quarter of sales so far, so I don't know how you can say that they are not 'generating a lot of revenue and profits from their products made with DehydraTECH ...' Also Lexaria can only report sales and revenue on a quarterly basis.
Also, in regards to exclusivity, Premier is paying for that market advantage so obviously LEXX would not be even trying to negotiate deals with competitors in Japan.
It's also interesting how he was conveniently wrong about the epilepsy study. First of all it may be 'insanely expensive' to commercialize a drug, but Lexaria has repeatedly said that it's not their intention to commercialize it on their own. It's their intention to partner with a pharma company. Secondly DehydraTECH has more benefits than just the speed of absorption, it has also proven to greatly assist APIs to cross the blood brain barrier which would have obvious benefits in treating many neurological conditions including epilepsy. It's expected that CBD DehydraTECH would have greater efficacy at a lower dose and help protect the liver at the same time reducing the cost of the API.
More pressure for alternative methods of nicotine ingestion.
https://www.cnn.com/2022/10/18/health/e-cigarette-manufacturers-fda-justice-department/index.html