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Ted Ohashi, in response to comments about a possible 'sell-on-news event'.
"Just so you know. I am just concluding some research that indicates the LEXX rally may be less to do with the IND application and more to do with the GLP-1 potential for diabetes/obesity. This sector is white hot in the states. You know from what I've been saying in the Let's Toke Business newsletter that the IND application is very important to me and I have also been thinking about a "sell on history" response but it looks like there are a couple of drivers and from a US market point of view, the GLP-1 might be even more important. I'm just looking at a few more items to solidify my conclusion. In other words there may not be a "sell on history" correction."
Or ran into it. LOL
Wow! Just smashed through the 3 dollar level!
Viking jumped $47/share today on good results for their weight loss drug. Just goes to show you what could happen. Viking has 100 million O/S
https://finance.yahoo.com/news/viking-therapeutics-announces-positive-top-120300339.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuYmluZy5jb20v&guce_referrer_sig=AQAAALu4MpX6Qn2BSlj9waa7q14hC7Otmez8qlm-Fj9RkUHJ2bDhtAjVVg6KmYpQPs3dKxgN2E9fN1XO6HtL2h_uW0Q1ncqz0gS7tJ_R9CPcapIIcEBre6K2-rfs01odYyfL5wF3wRKnMbvZdyuQG3-n9PyKWu86rcGlyAysf7IEuOWb
Special Report: Lexaria announces and closes US$3.6 million equity offering…………….....…….....p 5
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_8b1ee2344c7449f7b0678bad1d9d6293.pdf
A new drug and a new procedure for hypertension.
https://www.msn.com/en-us/health/other/new-procedure-is-game-changing-for-patients-with-high-blood-pressure-doctors-say/ar-AA1m4PGv
https://www.healthline.com/health-news/single-injection-of-drug-zilebesiran-lowers-blood-pressure-for-6-months#:~:text=1%20A%20new%20drug%20called%20zilebesiran%20may%20help,day%2C%20and%20many%20people%20struggle%20with%20the%20regimen.
Thanks Abundance!
I think that with the strong volume recently some entity must be close to having to declare that they've acquired 10% of Lexaria's shares.
Lexaria is still buyable but do it now.
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_0a4b67e59fdc4856a1d634981e833d6f.pdf
And hormones!
I'm stubborn, I won't be happy with just getting my money back, I want a large profit! If they have the solution to making GLP-1 drugs orally feasible the sky is the limit.
I've had this for so long, over 10 years, that I don't remember how much exactly I need to break even, I'd have to go back through my records. I probably need about $30.
We're banging up against strong resistance at the $2.25 range that dates back all the way to May of 2023!
Bullish day, best high since May 2023
Accumulators are accumulating again! Nice volume with the bids building!
Lexaria Submits Investigational New Drug Application
Kelowna, British Columbia – TheNewswire -- January 30, 2024 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, announces that, on January 29, it submitted its much-anticipated Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for its planned U.S. phase 1b hypertension clinical trial HYPER-H23-1 of DehydraTECH-CBD.
This IND submission follows a successful pre-IND meeting with the FDA which provided Lexaria with guidance related to the development and filing of the IND. From 2018 through 2023, Lexaria sponsored five investigator-initiated human clinical studies of its DehydraTECH-CBD in an aggregate total of 134 people, without recording a single serious adverse event (the “Studies”). These Studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens alone and, in some cases, complementary to standard of care medications; suggesting that DehydraTECH-CBD has the potential to have broad therapeutic utility.
As indicated at the FDA website, “once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.”
Lexaria looks forward to commencing clinical trial HYPER-H23-1 as soon as possible following IND effectiveness, subject to certain conditions including funding. The IND review process when successfully concluded will be an important milestone achievement for Lexaria demonstrating that its DehydraTECH technology has met high level formal regulatory scrutiny towards prospective future pharmaceutical commercial registration.
About Planned Clinical Trial HYPER-H23-1
Clinical trial 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 trial will be to evaluate safety and tolerability in hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing.
All clinical, laboratory and analysis procedures for study HYPER-H23-1 are to be performed entirely by U.S.-based, third-party independent contract service providers.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria’s patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 38 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
https://ir.lexariabioscience.com/news-events/press-releases/detail/139/lexaria-completes-successful-antiviral-drug-molecular
"The NRC has successfully confirmed Lexaria's study objectives, demonstrating DehydraTECH™ processing and formulation technology does not create a covalently bonded new molecular entity ("NME") and that each drug tested remained stable and did not undergo change in chemical structure. The five drugs studied were remdesivir, ebastine, bepridil, rupintrivir and colchicine, which have antiviral effects through a variety of different modes of action."
GLP-1. Everyone wants a piece of this market and they're all trying for an oral application.
https://www.msn.com/en-ca/money/markets/the-weight-loss-drug-market-may-soon-get-more-crowded-here-are-the-companies-trying-to-enter-the-booming-space/ar-AA1n8L4O?ocid=msedgntp&pc=DCTS&cvid=2511223d8cbd440b87eab90fa48408c5&ei=199
I see some shares traded as high as 1.73 in after hours!
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_fda7c9d8647a468d856ddc51e5413803.pdf
“LEXX has shown many great results regarding the enhancements their technology can provide. Why do you think drug, tobacco and supplement companies aren't knocking each other
out of the way to get at this? Only one small supplement company has come knocking.”
DG
I think that up to now, it has been a question of size. I will use Altria (NYSE: MO) as an example since
most of us know it is one of the world’s largest producers and marketers of tobacco, cigarettes, and
related products. MO has a market cap of $73.1 billion. Lexaria (NASDAQ: LEXX), the company we all
know, has a market cap of $15.5 million. This means that if MO acquired LEXX and LEXX increased in
value tenfold that would be an outstanding return in most cases. Having said that, a tenfold increase in
the value of their investment in LEXX might translate into an increase in MO’s market cap of 0.2%.
Of course, LEXX’s DehydraTECH™ could improve the delivery of nicotine in MO’s product which would
boost their sales. That is why I was excited when Altria invested in Lexaria Nicotine. But that is yet to
develop into a business. I can only say, that sometimes multibillion corporations play defense. If they see
something with potential down the road, they will tie it up for a few million dollars to prevent anyone
else from getting at it.
I see the Investigational New Drug (IND) application for hypertension as completely different. Assuming
the application is accepted and approved by the U.S. Food and Drug Administration, it will be the most
advanced development of an application that LEXX has carried forward under their control. At this
point, I can see big pharma trying to acquire this interest. I look at GW Pharmaceuticals' development of Epidiolex® using a CBD base for the treatment of childhood seizures, a relatively small area of
medical treatment compared with hypertension. However, GW Pharma was acquired by Jazz PharmaCeuticals for $7.2 billion. That’s a number large enough to have an impact on any large-cap company
assuming the successful development of the IND into an FDA-approved drug. And the hypertension market
is exponentially larger than the childhood seizures market.
Conclusion: I alerted you to the fact that I thought LEXX was under accumulation starting last fall. The
LEXX market action has certainly borne this out in successive months as seen in the chart below. I suspect that there have been a lot of questionable trades
in LEXX, especially if you go back to the Robin Hood days
when LEXX traded multiple of its market cap in one session. I have also accepted that those trades will never be
properly sorted out. What I’m saying is I like the current pattern of trading much better: without spectacular price
changes in one session where prices move sharply higher,
then just as sharply lower and close unchanged on ridiculously high volume. I believe trading today is based on fundamentals where the recovery takes place
gradually over time. When news is announced such as submission of the IND application or approval
of the IND by the FDA, there will be strong jumps in the stock price in my opinion but off a stronger
base. I would continue to participate in the accumulation pattern with buy and hold being the key
"..he and his cronies sell shares and fill their coffers"
That's just outright bullshit and I think you know it!
https://www.networknewswire.com/exciting-new-cures-possible-from-glp-1-diabetes-weight-loss-drugs/
"The last time a drug-delivery technology achieved that, Novo Nordisk agreed to pay $1.8 billion to acquire Emisphere’s SNAC technology, which it placed into its Rybelsus tablets. That’s right: the $1.8 billion technology already embedded within every Rybelsus tablet was just bested by Lexaria’s DehydraTECH."
A could week for an announcement. A lot of deals have been announced lately.
"The JPMorgan healthcare conference is in San Francisco this week, and the marquee industry event typically brings a wave of deal announcements and merger talk."
https://www.msn.com/en-ca/money/companies/novartis-in-advanced-talks-to-buy-cytokinetics/ar-AA1mE9VJ?ocid=msedgntp&pc=DCTS&cvid=df02ca7f50664b7a9c58be902f4d59e4&ei=45
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_d1472a558c534d06bd9ff50fdb23487d.pdf
Lexaria Bioscience (NASDAQ: LEXX): If I look at the flow of information that lies ahead in the first quarter of 2024, I believe LEXX will be higher in price and perhaps much higher. Here is the schedule as I see it: (1) January 2024: this news was not on my original list but LEXX announced on January 4, 2024, that DehydraTECH™-powered semaglutide outperformed Rybelsus, an orally delivered drug for the treatment of Type 2 diabetes in sustaining higher levels of semaglutide in blood, improved blood glucose control, faster achievement of peak drug delivery and reduced side effects. This is a potentially positive precursor to (3) below. (2) January/February 2024: LEXX receives the remaining data needed to submit the Investigational New Drug (IND) application on hypertension to the Food and Drug Administration (FDA). (3) January 2024: LEXX will likely announce details on a new follow up study to the GLP-1 study relating to weight loss and diabetes. This will be the largest study LEXX has undertaken. (4) February 2024: LEXX reports submission of the IND application for hypertension to the FDA. (5) March/April 2024: receive a response from the FDA on the IND application for hypertension submitted in February and I anticipate a positive response. (6) March/April 2024: start receiving initial data from the new GLP-1 study started in January. Confirmation of initial results would be positive. An improvement is potentially spectacular. Conclusion: The expected news flow outlined above could result in explosive market action in the next quarter or more. I noted back in June 2023 that LEXX showed signs of being under accumulation. That pattern continues today. I believe we will see a major breakout in the stock during the next four months. Make sure you have it in your portfolio.
The struggle to cross the blood-brain barrier continues!
https://www.msn.com/en-ca/health/other/alzheimer-s-drugs-might-get-into-the-brain-faster-with-new-ultrasound-tool-study-shows/ar-AA1mqs7x?ocid=msedgntp&pc=DCTS&cvid=1b9842916885439894b3e5d66139a60e&ei=280
Also, Bunka never said Lexaria would be delivering Covid-19 vaccines.
I expect Novo is taking a long hard look at Lexaria's tech regarding GLP-1 drugs. LEXX has just finished their first small test, I wouldn't expect a deal to be made the same day. That being said, there are so many large multinational pharma companies racing to develop and improve these drugs that a deal would have to be concluded soon. Bidding wars are not always public, Bunka could be fielding calls from multiple drug companies as we speak.
There's an increased need for methods to deliver more effective lower doses with less side effects!
https://www.cnn.com/2024/01/03/health/glp1-agonist-side-effects-fda/index.html
I just can't see a product being advanced this far without Altria having locked up the underlying technology, so I doubt if DehyraTECH is being used. There could however be a confidential agreement between Lexaria and Altria where Altria would have the right of first refusal on any offer to buy the outstanding shares of Lexaria Nicotine or purchase worldwide rights to use DehydraTECH.
on! PLUS
Our New Tobacco-Derived Nicotine Wet Pouch Product▪ In September, our teams plan to begin an
international test of on! PLUS.
▪ The product will be available via e-commerce
in Sweden, where our teams plan to take a
disciplined approach to gain learnings that
can inform a future U.S. launch.
▪ We are on track to file a pre-market tobacco
product application for on! PLUS next year
https://www.altria.com/-/media/Project/Altria/Altria/Investors/events-and-presentations/2023/2023-Q2/Presentation.pdf
On!Plus is in a round can the old On! was in a rectangular container. According to the Q3 Presentation.
https://www.altria.com/-/media/Project/Altria/Altria/Investors/events-and-presentations/2023/2023-Q3/Presentation.pdf
I can't find On! Plus for sale in Sweden. Swenico.com would have it listed if it was available. Altria mentioned in their Investor Day presentation March 2023 that they had done a human study on their campus.
https://librariancapital.substack.com/p/altria-which-matters-most-h1s-10
"Altria continues to develop its on! PLUS new nicotine wet pouch product, and plans to launch it via e-commerce in Sweden in September as an international test. For the U.S. market, on! PLUS does not currently have marketing approval but Altria is on track to file a PMTA (Pre-Market Tobacco Product Application) in 2024."
September 2023 with the PMTA to be filed in 2024. I found the following while searching.
"On! Plus is a brand of tobacco-free nicotine pouches that is popular in Sweden. The company that manufactures On! Plus is called Burger Söhne AB, which is a subsidiary of Helix Sweden AB, a Swedish company owned by Altria. On! Plus pouches are small, white, and discreet, and come in several flavors. They contain a lower content of nicotine than many other products on the market"
Altria continues to develop its on! PLUS new nicotine wet pouch product, and plans to launch it via e-commerce in Sweden in September as an international test. For the U.S. market, on! PLUS does not currently have marketing approval but Altria is on track to file a PMTA (Pre-Market Tobacco Product Application) in 2024.
https://www.bing.com/search?q=on%21+plus+tobacco+pouches+Sweden&qs=n&form=QBRE&sp=-1&lq=0&pq=on%21+plus+tobacco+pouches+sweden&sc=11-31&sk=&cvid=471893CF0BBE49B29984EA4EB6F8AB31&ghsh=0&ghacc=0&ghpl=&showconv=1On! Plus is a brand of tobacco-free nicotine pouches that is popular in Sweden 1. The company that manufactures On! Plus is called Burger Söhne AB, which is a subsidiary of Helix Sweden AB, a Swedish company owned by Altria 2. On! Plus pouches are small, white, and discreet, and come in several flavors 3. They contain a lower content of nicotine than many other products on the market
Interview with Chris Bunka, CEO of Lexaria convinces me you have to buy this stock now...............p 6
https://letstoke.us19.list-manage.com/track/click?u=f2e0706764f99154e3a11feb5&id=9fc3debe46&e=9cbb5a4bc7