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I don't think you realize how a investigational-new-drug-ind-application works and how quick drugs can be approved under this program.
Also, what makes you say they are not conducting "independent studies", the Lead investigator Dr. Phil Ainslie, Professor, School of Health and Exercise Sciences and Co-Director, Centre for Heart, Lung & Vascular Health, University of British Columbia Okanagan, and Canada Research Chair in Cerebrovascular Physiology, is certainly independent. The Canada Research Council which has conducted extensive safety studies, is certainly independent and the European facility where these clinical trials are being performed is also independent.
Looking Good!! Up over a dollar in pre-market!
Hill Street licensee signs two DehydraTECH partnerships
2021-09-01 13:00 ET - News Release
Mr. Craig Binkley reports
HILL STREET'S MICHIGAN LICENSEE DEHYDR8 SIGNS FIRST PARTNERSHIP AGREEMENTS FOR USE OF DEHYDRATECH TECHNOLOGY
Hill Street Beverage Company Inc.'s partner, DeHydr8, has recently signed agreements with two of Michigan's best-in-class licensed producers within weeks of DeHydr8 becoming a Hill Street licensee.
In a push to expand cutting-edge DehydraTECH technology into the US with B2B market scale, Hill Street announced a licensing partnership with DeHydr8 MI on July 27th, 2021. Since then, Dehydr8 has leveraged its deep relationships and years of experience in the Michigan cannabis market to create agreements with two LPs - Evolution Edibles, and For The Love of Charlie ("FTLOC"). These partners will be the first LPs in the State of Michigan to produce products powered by DehydraTECH.
Evolution Edibles is focused on creating the best edible flavor profiles in the industry. They offer a broad range of choices for consumers ranging from micro dosed products for the canna-curious to higher dosed products for more experienced users.
FTLOC is a best-in-class LP focused on the benefits of cannabis and cannabinoids in the Medical Use space. FTLOC creates cannabis products that address multiple indications including but not limited to pain relief, anxiety, sleeplessness, spectrum-related and dermal conditions.
The LPs are working on multiple form factors including edibles and topicals for both Medical and Adult use. Dehydr8 anticipates that the first products from these new partnerships will hit shelves in Michigan as soon as September 2021.
"The fact that Dehydr8 have come out of the gates quickly to sign agreements with top quality LPs is proof of their ability to gain traction in the Michigan market," said Craig Binkley, Co-CEO of Hill Street. "We're excited to see them expand the DehydraTECH ecosystem with these new like-minded partners who share our belief in the power of cannabis and best in class science to create superior product alternatives."
DeHydr8 was founded by Todd Webber, Jessica Webber, Craig Aronoff, and Marc Seyburn all from Michigan. The Dehydr8 Team is comprised of top legal counsel in the cannabis industry combined with premier marketing and sales professionals.
"Having The DehydraTECH technology behind us is a real competitive advantage," said Todd Webber, Founder of DeHydr8. "The research credibility that comes from a publicly traded drug and Bioscience company and the continuous scientific advancements that Lexaria Bioscience brings to the technology puts this product well ahead of any fast-acting competitors. Our DeHydr8 Team, working closely with the Hill Avenue Cannabis Team, are quickly bringing fast-acting, predictable and stable products to the Michigan market, and are actively changing the face of Cannabis consumption."
Findings from extensive scientific studies on the DehydraTECHTM technology performed by Lexaria Bioscience Corp. include:Increased bioavailability up to 5-10x - to equate to blood absorption by inhalational deliveryIncreased brain permeation up to 19x - as demonstrated in animal studiesAvoids first-pass liver metabolism - mitigating unwanted side effectsReduced time of onset - effects are felt within 15-20 min vs. 60-120 minMasks unwanted tastes - eliminating the need for sugar-filled edibles
Patented DehydraTECH technology improves the way active pharmaceutical ingredients (APIs) enter the bloodstream, delivering advantages including faster onset and more predictable cannabis experiences for consumers.
"We're delighted that these new partners will now be powered by DehydraTECH," said Lori Senecal, Co-CEO of Hill Street." Our mission is to partner with companies and brands that are driven to deliver premium quality, category leading performance. These Michigan partners align perfectly with these values as they constantly pursue the highest craft quality combined with the most advanced technology to ensure that consumers enjoy a superior experience."
About Hill Street Beverage Company Inc. (TSXV: BEER)
Hill Street Beverage Company is a progressive non-alcoholic beverage and cannabis solutions company. We are pioneering the space where craft consumer products meet bioscience by combining our deep CPG expertise and our rights to use Lexaria Bioscience's ground-breaking DehydraTECH patent portfolio for product development, licensing and B2B sales of Cannabis ingredients.
Hill Street Beverages brands include Hill Street Craft Brewed Lager, and Vin(Zero), and have won numerous medals and accolades around the world. Hill Avenue Cannabis Brands include (V)ia Regal Pink and White Grape Sparklers.
About DeHydr8
DeHydr8 is focused on delivering the premier fast-acting and most bioavailable technology, DehydraTECH, to our manufacturer partners in the US Market for application in Cannabis 2.0 products.
We seek Safe Harbor.
Lexaria has to pay for coverage. Sad.
They're not interested in oral formulations, they're going with inhalable products.
https://www.cnn.com/2021/08/09/business/philip-morris-vectura/index.html
Lexaria's revenue in the last quarter was USD$204,000. Chris predicted that they would have revenue on 56,000,000 units of cannabinoids in 2021, so in that quarter they should have done 14,000,000 units, so by my gross calculations they are making just 1.5 cents revenue on every unit sold by their licensees. This is more than enough to pay Chris' salary! LOL
Thanks Abundance. Here's a brief review of Cannadips.
https://cbdclinicals.com/cannadips-review/
Annnnd there goes the 200DMA support. We may see some support at $5.50.
https://www.accesswire.com/657567/Lexarias-DehydraTECH-CBD-Lowers-Blood-Pressure
Lexaria's DehydraTECH-CBD Lowers Blood Pressure
2021-07-29 07:06 ET - News Release
Human Clinical Study HYPER-H21-1 evidences a rapid and sustained drop in blood pressure with DehydraTECH-CBD and excellent tolerability
KELOWNA, BC / ACCESSWIRE / July 29, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is extremely pleased to issue partial results from human clinical study HYPER-H21-1 evaluating DehydraTECHTM-processed cannabidiol ("CBD") for potential application against hypertension. Partial results related to blood pressure ("BP") are being released today, while additional BP subset analyses and all other data analyses including pharmacokinetic ("PK") evaluations and detailed blood chemistry work is in progress and will be released when complete.
"We are very encouraged by these early results in our 2021 hypertension program," said Chris Bunka, CEO of Lexaria. "Lexaria's technology enabled a rapid and sustained drop in blood pressure, especially systolic pressure and particularly in Stage 2 hypertensive volunteers."
Lead investigator Dr. Phil Ainslie, Professor, School of Health and Exercise Sciences and Co-Director, Centre for Heart, Lung & Vascular Health University of British Columbia Okanagan, and Canada Research Chair in Cerebrovascular Physiology, commented that, "these early results are extremely promising in this at-risk hypertensive population and provide a fundamental support for expansion into more prolonged repeat dosing and future longer term clinical trials."
BP was reduced across both male and female volunteers and was most pronounced with DehydraTECH-CBD in the first 10-50 minutes of the study, reinforcing our pre-existing findings demonstrating that DehydraTECH delivers superior performance over generic CBD controls.
Blood pressure 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%."
There was also a tendency for a greater reduction in relative diastolic pressure from baseline with DehydraTECH-CBD than the concentration matched, generic CBD control (Fig 1). This was most notable in the initial 10-20 minute period post-dosing evidencing statistical significance at the 20-minute timepoint (p=0.025).
Fig 1. Changes in diastolic blood pressure between generic CBD control (dose A) and DehydraTECH-CBD (dose B). Data are grouped means (n=24) with linear regression.
As well, there was a tendency for relative Mean Arterial Pressure ("MAP") to be reduced greater from baseline with the DehydraTECH-CBD than the concentration matched, generic CBD control; again, most notably in the initial 20 minutes post-dosing (Fig 2.). By comparison, in Lexaria's 2018 human clinical study, 120 minutes were required to achieve the same level of MAP reduction, demonstrating superior rapidity of onset of the "DehydraTECH 2.0" CBD formulation used in the present study relatively speaking.
Fig 2. Changes in mean arterial blood pressure between generic CBD control (dose A) and DehydraTECH-CBD (dose B). Data are grouped means (n=24) with linear regression.
Lexaria was also pleased that its DehydraTECH-CBD was well tolerated by all subjects, with no serious adverse events or side effects observed or reported. Ingestion of the concentration-matched, generic CBD control, on the other hand, resulted in unwanted side effects in some of the volunteers, namely gastrointestinal distress including diarrhea. These findings corroborate what Lexaria has previously evidenced in other unrelated studies whereby human volunteers have also experienced reduced side effects with DehydraTECH-processed test articles compared to concentration-matched, generic controls.
Lexaria looks forward to completing its ongoing additional sample and data analyses work for this study and reporting upon those outcomes when complete. Lexaria's second human clinical hypertension study of 2021, study HYPER-H21-2, has completed dosing as previously reported and, in that study, three separate doses of DehydraTECH-CBD (150mg per dose) were used, administered evenly over the course of a 24-hour monitoring period. Based on the BP reducing trends witnessed in the present study, Lexaria is optimistic that repeat dosing such as this over a sustained period may further enhance efficacy. The results of these two studies will be carefully evaluated and considered before Lexaria's third planned human clinical hypertension study of 2021 begins, expected this Fall. Lexaria is evaluating study considerations for a fourth, expanded, randomized, controlled human clinical hypertension trial, with a view to building upon the results of current investigations in a larger population for enhanced statistical and clinical significance.
About Human Study HYPER-H21-1
Human Study HYPER-H21-1 was conducted at a European medical research hospital. Twenty-four human volunteers aged 45-65 with otherwise untreated pre- or mild-hypertension were given either a single 300mg dose of generic CBD, or a single 300mg dose of DehydraTECH-CBD and studied over a 3-hour duration. The weight of the average woman in the study was 178 lbs, and the weight of the average man in the study was 223 pounds. Blood pressure and heart rate analyses were taken every 10 minutes and speed and rate of absorption of the CBD and its main metabolites (PK assessments) were also assessed during the study. Secondary analyses that will be reported when complete include evaluation of inflammatory and oxidative markers associated with cardiovascular disease and gold-standard biomarkers of nitric oxide. This latter measure provides mechanistic insight into the reduction in blood pressure via vasodilation.
Inflammatory marker assessments may also be applicable to Lexaria's research initiatives in the antiviral therapeutics space whereby effective anti-inflammatory therapies are also useful in treating diseases like COVID-19 or other common pro-inflammatory conditions, where Lexaria has already successfully demonstrated DehydraTECH utility with one such anti-inflammatory drug, colchicine, used for COVID-19 treatment today as previously reported.
CBD in the Regulatory Environment.
CBD under the brand name Epidiolex was approved by the FDA in June 2018 for treating certain types of pediatric seizure disorders. Recommended dosing of Epidiolex CBD is 2.5mg per kilogram of bodyweight to begin treatment, taken twice per day, increasing to 5.0mg per kilogram of bodyweight, taken twice per day. An average 9 year-old child weighs about 28 kg, so the FDA recommended dose of Epidiolex would initially be 140mg, increasing to 280mg daily for long term use. The average adult man in the US weighs 199.6 lbs (90.7kg), so if he was using CBD at that same rate, he would require 900mg per day for a sustainable dose. The maximum FDA-approved dose of Epidiolex is 10.0mg per kilogram of bodyweight, taken twice daily.
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.
"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 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 proprietary drug delivery technology, DehydraTECH™, 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, thereby lowering overall dosing. The Company's technology can be applied to many different ingestible product formats, including foods, beverages, oral suspensions, tablets, and capsules. 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 planned to be further evaluated for orally administered bioactive molecules, including anti-viral drugs, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs) and more. Lexaria has licensed DehydraTECH to multiple companies including a world-leading tobacco producer for the development of smokeless, oral-based nicotine products and for use in industries that produce cannabinoid beverages, edibles, and oral products. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 21 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.
Nope, no witch hunt, just looking for the facts. My other question to lexaria would be why are you not giving us revenue projections for all these CBD sales in the US instead of unit sales numbers. It seems the industry standard would be to announce revenue projections. With projected sales of 56 million units the revenue this year seems dismal at best.
Whatever happened to Greg Smith. I can't find him mentioned anywhere on the website as a Senior Advisor, did he bail when the nicotine deals with Altria and BAT fell through?
https://ir.lexariabioscience.com/news-events/press-releases/detail/18/lexaria-bioscience-appoints-gregg-smith-as-senior-advisor
Whatever happened to our Scientific Advisory Board? It seems like they've all bailed as there's no mention on the website any longer!
https://ir.lexariabioscience.com/news-events/press-releases/detail/45/lexaria-bioscience-expands-advisory-board
This is the Blood Pressure study using DehydraTECH enhanced CBD!
HYPER-H21-1 (24-person) Human clinical 300mg PK study;
final results due in July
A Shooting Star and we're back on earth, quicker than Jeff Bezos. Ready for the next launch?
How to Trade Small-Cap Stocks & Volatility for Huge Profit, +23% LEXX - Learn, Trade & Profit LIVE! https://t.co/gIkxDM6J49
— Jason Spatafora (@WolfOfWeedST) July 21, 2021
Thanks FK!
Remdesivir neither prevents nor is a cure for Covid, however it is an effective treatment as it shortens the time to recovery in patients that have been hospitalized. Just the facts.
https://www.nejm.org/doi/full/10.1056/nejmoa2007764
Where's the income from the 56 million CBD doses they expected to sell in the US this year? Are they selling them at a loss?
http://www.stockwatch.com/News/Sedardoc/4884749.pdf
Revenue of $204,055. Loss $(2,566,552)
Only placebo controlled clinical trials by reputable medical scientists can prove the efficacy of a pharmaceutical drug, not supposed anecdotal evidence reported by someone who is not a medical doctor. Where do you get your medical news from? Tucker Carlson.
There's a real trial underway now, wait for the results.
I've read all the facts about ivermectin. Have you? Did you read the two links I just posted?
Your theory about ivermectin being buried because it's off-patent and there's no money in it makes no logical sense, the price of it has already shot up because of a fraudulent study and if it was really effective at treating Covid the demand would go through the roof and pharmaceutical companies would make a fortune, they would actually love for this to be true and also there's literally hundreds of drugs that are off-patent and are still produced at a profit.
Sure the old conspiracy theory about there not being any money to be made so they're trying to bury it. Of course big media is involved. Ha ha ha!
You should buy a Rife machine, it cures just about everything.
I took COLCHICINE once for gout. It made me violently ill, I didn't even have time to make it to the bathroom so I never tried it again. Vomiting is a common side affect of this orally administered drug so it seems that there's a potential need for a new delivery mechanism.
And then there's https://fertin.com/application_areas/ who have over 100 patents and can deliver Cannabinoids, nicotine and a whole range of APIs.
New patent granted in Japan adds to existing patents in the EU, the U.S.,
India and Australia
Kelowna, British Columbia, July 13, 2021 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, announces an additional expansion of its intellectual property portfolio with its first-ever patent granted in Japan.
The patent is titled “Stable ready-to-drink beverage compositions comprising lipophilic active agents”and becomes the 20th patent granted to Lexaria , continuing to add to the Company’s considerable intellectual property portfolio.
“With our 20th patent granted worldwide, Lexaria continues to demonstrate the versatility of our DehydraTECH drug delivery platform, encouraging innovation in the consumable liquid category around the world,” said Chris Bunka, CEO of Lexaria. “This new patent adds to our existing suite of granted patents spanning the EU, the U.S., India and Australia, and continues to build value for Lexaria shareholders and clients.”
This is the third patent granted from Lexaria’s third patent family. Lexaria’s patent application suite comprises a total of 13 patent families. Active ingredients that may be used under this new patent include non-psychoactive cannabinoids and NSAIDS (e.g., acetylsalicylic acid, ibuprofen, diclofenac, indomethacin, piroxicam).
Lexaria has 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.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s proprietary drug delivery technology, DehydraTECH™, 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, thereby lowering overall dosing. The Company’s technology can be applied to many different ingestible product formats, including foods, beverages, oral suspensions, tablets, and capsules. DehydraTECH has repeatedly demonstrated since 2016 with cannabinoids and nicotine the ability to increase bio-absorption by up to 5-10x, reduce time of onset from 1–2 hours to minutes, and mask unwanted tastes. DehydraTECH is planned to be further evaluated for orally administered bioactive molecules, including anti-virals, cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs), and nicotine. Lexaria has licensed DehydraTECH to multiple companies, including a world-leading tobacco producer for the development of smokeless, oral-based nicotine products, and for use in industries that produce cannabinoid beverages, edibles, and oral products. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 19 patents granted and approximately 60 patents pending worldwide. For more information, please visit www.lexariabioscience.com.
Yes, but one can assume that their technology can also be used for nicotine and other APIs just as Lexy claims.
So BAT is going with Trait and PMI is going with Fertin and so that means Lexaria is S.O.L. or as they say in the industry 'Up-in-smoke'!
https://www.prnewswire.com/news-releases/trait-biosciences-receives-strategic-investment-from-btomorrow-ventures-as-lead-investor-in-a-c31-million-series-a-financing-301313057.html
I would say it's bad news. They're delisting because of abysmally low volume due to a complete lack of interest. They've completely failed to execute in the cannabis market in Canada after nearly two years since legalization, zero products and Zero revenue. The nicotine business was a dream that has gone Up-In-Smoke!
They seem to have it all pouches, tablets, gums and lozenges. They also have a subsidiary that specializes in cannabinoids.
https://fertin.com/
It will soon be the one year anniversary of the 6 month research and development agreement with the British American Tobacco Company, so we can only assume that BAT, just like Altria has taken a look and walked away from DehydraTECH for use with nicotine. What's up Mr. Bunka?
https://ir.lexariabioscience.com/news-events/press-releases/detail/97/lexaria-bioscience-announces-rd-agreement-with-british
I thought that the resignation of a member of a BOD was a material fact that needed to be disclosed. I believe he had to leave Altria after leading them into their disastrous investment in JUUL. Perhaps he was the reason Altria has shied away from any further investment in Lexaria's technology.
Three Year Anniversary and Nothing to Show
https://ir.lexariabioscience.com/news-events/press-releases/detail/66/lexaria-bioscience-and-hill-street-beverage-company
Not Powered by Lexaria
Hill Street's (V)ia Regal™ Pink Grape Sparkler does not use DehydraTECH.
It is being bottled by Molecule using Vertosa technology. Hill Street is now looking to secure a licensed production partner to be able to produce DehydraTECH powder in Canada. Hill Street does not have a licensed facility to bottle cannabis drinks nor do they have a licensed facility to make the powder, what a joke!
It makes no sense to pay a dividend to shareholders from cash that you just raised from shareholders. Dividends are a long way off in the future, paid from free cash flow.
Chris Bunka Interview