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Feels like something is brewing. Today could be a big day.
I stand corrected..
Not sure that is accurate
ActiPatch Store
Lexaria Announces $3.6 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules
Kelowna, British Columbia – February 15, 2024 – Lexaria Bioscience Corp. (Nasdaq: LEXX; LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, today announced that it has entered into definitive agreements for the purchase and sale of 1,558,443 shares of common stock (or common stock equivalents in lieu thereof) at a purchase price of $2.31 per share (or per common stock equivalent in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company will issue unregistered warrants to purchase up to 1,558,443 shares of common stock at an exercise price of $2.185 per share that will be immediately exercisable upon issuance and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about February 16, 2024, subject to the satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
The gross proceeds to the Company from the offering are expected to be approximately $3.6 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for research and development studies and the patent and legal costs associated thereto, and for general working capital purposes.
The common stock (or common stock equivalents) (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-262402) that was declared effective by the Securities and Exchange Commission (the “SEC”) on February 4, 2022. The offering of the shares of common stock (or common stock equivalents) is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.
The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
Here we go......!!!!
Form 4 - Statement of changes in beneficial ownership of securities
October 30 2023 - 12:47PM
Edgar (US Regulatory)
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SEC Form 4
FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP
Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934
or Section 30(h) of the Investment Company Act of 1940
OMB APPROVAL
OMB Number: 3235-0287
Estimated average burden
hours per response: 0.5
Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b).
Check this box to indicate that a transaction was made pursuant to a contract, instruction or written plan for the purchase or sale of equity securities of the issuer that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c). See Instruction 10.
1. Name and Address of Reporting Person*
DOCHERTY JOHN MARTIN
(Last) (First) (Middle)
23 MIKELEN DRIVE
(Street)
PORT PERRY A6 L9L 1V1
(City) (State) (Zip) 2. Issuer Name and Ticker or Trading Symbol
Lexaria Bioscience Corp. [ LEXX ] 5. Relationship of Reporting Person(s) to Issuer
(Check all applicable)
X Director 10% Owner
X Officer (give title below) Other (specify below)
President
3. Date of Earliest Transaction (Month/Day/Year)
10/26/2023
4. If Amendment, Date of Original Filed (Month/Day/Year)
6. Individual or Joint/Group Filing (Check Applicable Line)
X Form filed by One Reporting Person
Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1. Title of Security (Instr. 3) 2. Transaction Date (Month/Day/Year) 2A. Deemed Execution Date, if any (Month/Day/Year) 3. Transaction Code (Instr. 8) 4. Securities Acquired (A) or Disposed Of (D) (Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s) (Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V Amount (A) or (D) Price
common shares 54,075 I Private Holding Company
Table II - Derivative Securities Acquired, Disposed of, or Beneficially Owned
(e.g., puts, calls, warrants, options, convertible securities)
1. Title of Derivative Security (Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Transaction Date (Month/Day/Year) 3A. Deemed Execution Date, if any (Month/Day/Year) 4. Transaction Code (Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D) (Instr. 3, 4 and 5) 6. Date Exercisable and Expiration Date (Month/Day/Year) 7. Title and Amount of Securities Underlying Derivative Security (Instr. 3 and 4) 8. Price of Derivative Security (Instr. 5) 9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4) 10. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 11. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V (A) (D) Date Exercisable Expiration Date Title Amount or Number of Shares
Stock Options $3(1) 04/23/2020 04/23/2025 Common Shares 13,334 13,334 D
Stock Options $3(2) 04/26/2021 04/26/2026 Common Shares 18,000 31,334 D
Stock Options $3(3) 06/08/2021 06/08/2026 Common Shares 18,334 49,668 D
Stock Options $3(4) 09/01/2021 09/01/2026 Common Shares 15,000 64,668 D
Stock Options $2.91 08/29/2022 08/29/2027 Common Shares 30,000 94,668 D
Stock Options $1.15 10/26/2023 A 30,000 10/26/2023 10/26/2028 Common Shares 30,000 $0 124,668 D
Lexaria Enters New Global Exclusive Collaboration and License Agreement with SulfoSyn
Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has granted a new global, exclusive license to use DehydraTECH technology to SulfoSyn Limited ("SulfoSyn").
The exclusive license granted to SulfoSyn is for all non-pharmaceutical uses of sulforaphane world-wide, including SulfoSyn's ability to sub-license these rights. These non-pharmaceutical uses include but are not limited to supplements, additives, foods, dietary ingredients, and more. An up-front cash payment has already been received, minimum future payments have been agreed to, and ongoing royalty payments will be generated when they are in excess of the minimum payments.
As part of a broader agreement between the two companies, Lexaria is also being contracted to perform certain DehydraTECH-related manufacturing operations at its US partner facility on behalf of SulfoSyn for an initial term of 2 years. These manufacturing operations are expected to result in an increase in revenue to Lexaria, the amount of which cannot be forecasted at this time.
Beginning in late 2022, Lexaria and SulfoSyn began exploring the applicability of DehydraTECH upon sulforaphane. In extensive testing since, it has been determined that DehydraTECH confers certain superior qualities upon the sulforaphane molecule that are of commercial interest.
Sulforaphane is a sulphur-rich composite molecule commonly found in vegetables such as broccoli, cabbage and kale. According to this study published at the National Library of Medicine, sulforaphane has been shown to exhibit anti-inflammatory, antioxidant, antimicrobial and even antiaging qualities
Lexaria Institutional Holdings Update
Hello Lexaria Community,
Just a quick note directed mostly to our shareholders. We’ve had some pleasant developments unfolding lately that we wanted to ensure you were aware of.
Simply stated, our exposure to institutional analysts and investors is increasing. Notwithstanding the challenging market environment, our progress with human clinical trials and other applied R&D seems to be paying off with those people who are particularly familiar with the biotech industry.
Why do we say that? Because the fraction of our company owned by institutions is increasing. According to the latest data recently published at Nasdaq our institutional ownership is now 11.6% which is the highest it has been during 2022. As a reminder, we only have 5.95 million shares issued and outstanding, which is a very low number within our peer group of companies.
The table below shows our ten largest institutional shareholders according to their latest regulatory filings. Collectively, all our institutional shareholders own 690,344 shares according to their disclosures.
OWNER NAME SHARES HELD VALUE $ (IN 1,000S)
Invenomic Capital Management LP 473,103 1,017
Geode Capital Management, LLC 49,002 105
Susquehanna International Group, LLP 40,119 86
Vanguard Group Inc 33,164 71
Citadel Advisors LLC 24,874 53
Dimensional Fund Advisors LP 15,264 33
Centiva Capital, LP 13,259 29
Two Sigma Investments, LP 13,063 28
Renaissance Technologies LLC 11,900 26
UBS Group AG 6,398 14
In addition, I personally purchased an additional 38,500 shares of our common stock in October, in the open market, to hold a little more than 520,000 shares in total: I remain the largest shareholder of Lexaria and my conviction in the long-term prospects of this company is stronger than ever.
I’ve also been delighted to see a number of private shareholders greatly adding to their positions during recent weeks: you know who you are and we appreciate your support!
Thanksgiving is around the corner for all our US stakeholders: we wish you a safe and joyous holiday and prosperity to come!
Chris Bunka
CEO, Lexaria Bioscience Corp.
I think it was just a recap of what we already know??
Lexaria Bioscience: Taking Aim at the $28 Billion Hypertension Market; Human Clinical Study Yields 'Remarkable' Results
Lexaria Bioscience: Taking Aim at the $28 Billion Hypertension Market; Human Clinical Study Yields 'Remarkable' Results
New Drugs in Pipeline for Hypertension, the Silent Global Pandemic
8:30 am ET August 10, 2022 (PR Newswire) Print
NetworkNewsWire Editorial Coverage
In medicine, there is a term called "clinical inertia," or the case of what someone doesn't know -- or what they ignore -- could kill them. Simply put, it means failing to start or intensify a therapy when appropriate, which leads to advanced or chronic disease. It is particularly appropriate with a silent killer such as hypertension, a condition that all too often goes untreated, becoming a culprit in morbidity and mortality from cardiovascular, kidney and other serious diseases. Hypertension, or high blood pressure, stats continue to trend the wrong way, showing hundreds of thousands of people dying each year while costs of the disease are a major burden on already strained healthcare systems globally. Truth be told, hypertension is generally treatable with lifestyle changes and any number of prescription drugs, but most of the 1.28 billion people worldwide with high blood pressure go untreated. Because high blood pressure symptoms can be benign, patients would often rather go untreated than deal with unpleasant side effects of today's drugs. A new, safer option made available through Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile) may offer blockbuster potential. Lexaria, a global innovator in drug-delivery platforms, is working its way through the FDA pathway. Lexaria completed the pre-investigational new drug (IND) application meeting process for its newest DehydraTECH(TM) delivery system with the U.S. Food and Drug Administration (FDA) and is proceeding with plans to file an IND as soon as possible and begin clinical studies shortly thereafter. Quietly going about its business, Lexaria maintains a low market capitalization compared to bigger peers, such as Jazz Pharmaceuticals plc (NASDAQ: JAZZ), Johnson & Johnson (NYSE: JNJ), United Therapeutics Corporation (NASDAQ: UTHR) and Bristol-Myers Squibb (NASDAQ: BMY), a fact the company hopes to change by moving through the FDA process, where met milestones often equate to higher valuations.
-- The global market for drugs treating hypertension is forecast to climb from $24.17 billion in 2020 to $27.81 billion in 2025.
-- The economic burden of hypertension was $131 billion in 2020, while the disease was culpable in the death of more than 670,000 Americans.
-- Lexaria's patented DehydraTECH has been shown in laboratory, human studies to improve bioavailability of APIs to improve anti-hypertension therapy.
-- The most recent hypertension study hit a major milestone, while the company completed a highly constructive pre-IND application meeting with the FDA to plan the development of the company's DehydraTECH treatment of hypertension.
Click here to view the custom infographic of the Lexaria Bioscience Corp. editorial.
Nothing Slowing This Persistent Killer . . . Yet
Blood pressure (BP) is the measure of the force of blood pushing against artery walls as it courses throughout the body. While levels change throughout the day based on activity, normal BP is 120 over 80, meaning the pressure measurement is 120 mmHG when the heart beats and 80 mmHG in between heartbeats. Persistent high readings are considered hypertension and can result in increased chances of life-threatening complications such as heart disease, stroke, kidney and brain disease, among other things. A comprehensive study published in The Lancet shows hypertension cases in people aged 30 to 79 doubled worldwide from 1990 to 2019.
Today's approved drugs for hypertension are diverse, including alpha-blockers, beta-blockers, diuretics, ACE inhibitors, ARB inhibitors and other options for drug-resistant hypertension. Given the prevalence, it's no small market. ReportLinker last year estimated the global anti-hypertensive drugs market at $24.17 billion in 2020 with steady growth to $27.81 billion in 2025. The economic burden is staggering, averaging $131 billion annually according to the Centers for Disease Control and Prevention. Each year, more than 670,000 deaths in the United States are attributed to hypertension as a primary or contributing cause.
A recognized global innovator in drug-delivery platforms, Lexaria Bioscience Corp. (NASDAQ: LEXX) has its sights set on delivering a new, safe, effective and tolerable hypertension therapeutic that can slow the pervasive trend for the good of patients and healthcare systems alike. Lexaria's 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. The technology has been evaluated extensively across in vivo, in vitro and clinical research demonstrating that it promotes rapid absorption and improved effectiveness via oral delivery at a less-expensive cost point.
Moreover, implementation of DehydraTECH technology into production lines is relatively easy, achievable with the addition of only a few steps into the formulation and manufacturing of oral or topical products, albeit new or existing. During these new steps, the API is combined with suitable fatty acids with the mixture then infused into a substrate. From there, a controlled dehydration synthesis process associates the payload and fatty acids at a molecular level for integration into the final product at the specified form factor.
Lexaria has an extensive patent franchise covering the DehydraTECH intellectual property. There are 26 granted patents in the United States, the European Union, Australia, Japan, Mexico and India, with about four dozen more patents pending.
Strong Clinical Evidence
Lexaria is emerging as a pioneer of innovation with the DehydraTECH platform technology and its spate of potential applications with potential to improve pharmacokinetics in patient-friendly delivery methods. In doing so, the company is amassing a collection of evidence showcasing the prowess of DehydraTECH. For instance, a 12-patient study in 2018 resulted in a 317% improvement in substance delivery to the human bloodstream at 30 minutes after ingestion, followed by more studies this year specific to improved bioavailability specific to hypertension.
The most recent studies -- HYPER-H21-1, HYPER-H21-2 and HYPER-H21-3 -- speak volumes about the opportunity for DehydraTECH in hypertension. HYPER-H21-1 was a 24-person trial that evidenced rapid and sustained drop in blood pressure. The changes were especially notable in systolic pressure (the first number in BP readings, when the heart is beating) in stage 2 hypertensive patients. HYPER-H21-2 built on that data, adding info from a 16-patient study that exhibited a 23% average reduction in overnight blood pressure and reduced arterial stiffness, indicating a durable response. HYPER-H21-3, also a 16-person study, witnessed attenuated pulmonary artery systolic pressure by approximately 5 mmHG or 41% overall in male participants.
Importantly, all of the clinical work continued to build upon a robust safety and tolerability profile for DehydraTECH therapy.
Marching Towards an IND with FDA
Lexaria has just announced it has successfully completed its pre-IND meeting with the FDA -- a vital milestone. Now Lexaria is working to complete its planned IND-enabling program, and has early approval to pursue a coveted 505(b)(2) drug pathway for its DehydraTECH drug-delivery platform. In doing so, Lexaria is progressing smoothly through its most comprehensive hypertension study yet: HYPER-H21-4. On July 27, 2022, Lexaria reported that dosing in the study had been completed, adding that no serious drug-related adverse events had been reported.
The study was structured as a randomized, double-blinded, placebo-controlled, crossover study slated to enroll at least 60 patients. A total of 64 patients were enrolled and treated either with the experimental therapy or placebo. The highest dose of the Lexaria drug was ~5 mg/kg/day, a level substantially lower than maximum dose levels for similar drugs on the market today. The lower dosing level can have big implications for Lexaria, as lower doses are theorized to mitigate negative side effects of hypertension drugs, such as elevated levels of liver enzymes.
"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," said Lexaria CEO Chris Bunka.
The primary outcome of the study is the impact of the drug related to 24-hour ambulatory blood pressure, where blood pressures are recorded automatically multiple times during the day and night. Secondary outcomes abound, including a measure of effect on vascular health, electrocardiogram analysis, MRI examinations of brain structure and function, renal and hepatic analysis, readings of blood biomarkers, sleep quality, daytime sleepiness and sleep disorders, actigraphy, geriatric depression scale, perceived stress and Beck anxiety inventory.
While safety and efficacy as related to ambulatory blood pressure are top priorities, the abundance of secondary data should not be underappreciated. Lexaria wants to cull all this information as part of its broader strategy to develop DehydraTECH as a true platform technology. Understanding a full spectrum of effects could underpin other drug-development initiatives.
Each Step Adds Value (And It's Not Linear)
According to the FDA, there are five steps to developing a new drug. These include 1) discovery and development; 2) preclinical research; 3) clinical research; 4) FDA drug review; and 5) FDA post-market drug safety monitoring. In the eyes of the investment community, the third step, or clinical research, which is broken into Phase 1, 2 and 3 human trials, is crucial.
During this step, valuations can surge on the market being addressed. Take note that only a small percentage of drugs (fewer than 250 out of 5,000 to 10,000) exit the discovery stage to make it to preclinical research, and fewer yet make it to human trials. Thus, it is not uncommon for nonrevenue biotechs and pharmas to have market capitalizations in the hundreds of millions by phase 2 and billions of dollars in phase 3 trials.
Lexaria is on the cusp of the FDA's steps 2 and 3 with its mix of lab and clinical work in the DehydraTECH program generating a solid understanding of safety, tolerability and efficacy. The company's current market cap is about $17 million.
To provide a little backdrop as to what can happen with valuations for novel drugs, understand that Jazz Pharma paid $7.2 billion for GW Pharma after GW Pharma obtained marketing approval for its patented Epidiolex to treat two rare types of pediatric seizure disorders. In March, Pfizer shelled out $6.7 billion for Arena Pharmaceuticals to gain control of Arena's diverse portfolio of drugs. Big pharma is looking to reload pipelines with promising drugs and new revenue streams.
Follow the Trend to Value
At this moment, there is no real reason to think that the hypertension trend is going to change direction solely upon today's marketed drugs. The silent killer typically begins with unhealthy lifestyles and is frequently accompanied by obesity, a fellow killer in its own right with diagnoses running rampant as evidenced by 42% of American adults clinically obese. With that in mind, anti-hypertension drugs should continue to command high value for the foreseeable future.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is best known for its deep pipeline and approved drugs in the areas of neuroscience and oncology and an optimal example of building value by moving through the FDA process. For instance, shares were trading around $125 in December when Jazz and partner PharmaMar initiated a phase 3 trial of Zepzelca(R) (lurbinectedin) for the treatment of patients with relapsed small cell lung cancer. Two days later, Jazz said the first patient was enrolled in a global phase 2b trial evaluating the safety and efficacy of suvecaltamide for the potential treatment of moderate to severe essential tremor (ET). The stock has remained in an uptrend since.
The Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) are committed to developing a portfolio of pulmonary arterial hypertension (PAH) drug candidates; that development includes sponsoring the largest randomized, controlled trial ever conducted in PAH patients. PAH is a rare type of high blood pressure in the lungs that occurs when the organ's tiny arteries narrow, stiffen and block blood flow, ultimately leading to right-side heart failure.
United Therapeutics Corporation (NASDAQ: UTHR) is also in the PAH space. In May, United won FDA approval for Tyvaso DPI(TM) (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD.
Bristol-Myers Squibb (NASDAQ: BMY) is in the heart space in many areas, as exemplified by the company's April announcement of winning FDA approval for Camzyos(TM) (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms. Camzyos is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM.
The World Health Organization estimates that about 700 million people in the world between the ages 30 and 79 have untreated high blood pressure. A new drug that assumes the role as a standard of care aside, treating a portion of these people not already on medications is a massive market opportunity, especially if a drug can be differentiated from others. Safe to say that with that type of potential, companies of all sizes are on the lookout to be the company that brings a new, better drug to market.
For more information about Lexaria Bioscience Corp., please visit Lexaria Bioscience Corp.
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Lexaria Grants License to AnodGen Bioceuticals
Wed, June 8, 2022, 8:00 AM
In this article:
LEXX
+4.15%
DehydraTECH Pharmaceutical License Issued for the European, Australian and New Zealand markets
Lexaria to receive royalty revenue from DehydraTECH product sales
KELOWNA, BC / ACCESSWIRE / June 8, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce the awarding of a five-year, non-exclusive DehydraTECH license (the "License") from its wholly-owned subsidiary, Lexaria Pharmaceutical Corp. to AnodGen Bioceuticals ("AnodGen") of Ireland.
The awarded License is valid for the manufacturing and distribution of DehydraTECH processed cannabinoid active pharmaceutical ingredient ("API") powders within Europe including the UK, Australia and New Zealand; including pharmaceutical and medical product applications for psychoactive cannabinoids and medical product applications for non-psychoactive cannabinoids. Anodgen will pay royalty fees to Lexaria for all API powders sold that utilize the DehydraTECH technology. Anodgen has the right to manufacture and sell these API powders to third party companies for their own products that are designated by a national regulator as a medical product, drug, nutraceutical, pharmaceutical or biopharmaceutical, as applicable, under its cannabinoid product license rights.
"This strategic alliance with Lexaria Bioscience Corp. underscores the focus of Anodgen to ‘Bring Science to Life', in addition to our research and API's," said Dr Slimane Aboulkacem, Chairman and Founding Member of Anodgen Bioceuticals.
Dr Jeffrey Pruski, Anodgen's Chief Medical Officer and Founding Member mentioned that "the partnership with Lexaria will help bring research-based API's and technology to companies and people with superior bioavailability and enhanced absorption. This alliance will bring about change we will yet see in pharmacokinetics and formulation."
Consumer products purchased without physician or medical professional consultation are not permitted under the terms of this License. AnodGen is expected to have their new facility in Ireland fully operational later in 2022 and Lexaria recognizes the long-term potential for growth in the utilization of DehydraTECH across these pharmaceutical market opportunities.
About AndoGen Bioceuticals.
Anodgen Bioceuticals is a newly established contract manufacturing organization business that will manufacture and distribute active pharmaceutical ingredients for the pharmaceutical industry by focusing on world class research on pharmacognosy (plant-based medicine). Anodgen Bioceuticals mission is to "bring science to life" by developing a global, purpose-led, science-based company that specializes in pharmacognosy, active nutrition, health, and sustainable living. Anodgen Bioceuticals has global expertise and innovation to add value to science around plant derived medicine. More importantly, Anodgen specializes in sourcing and custom compound APIs of cannabinoids and other customized blends. The Company has recently signed two research MOUs with renowned U.S. universities to collaborate on research.
Lexaria Grants Exclusive License to Premier Wellness Science Co., Ltd. for Strategic and Long-Term Partnership in the Japanese Market
Minimum payments due to Lexaria of US$4,527,500 over the first five years to retain exclusivity
Lexaria to receive royalty revenue from DehydraTECH product sales
Kelowna, British Columbia – June 2, 2022 – Lexaria Bioscience Corp. (Nasdaq: LEXX) (Nasdaq: LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms is pleased to announce a significant exclusive* commercial licensing agreement (the “Agreement”) in Japan with Premier Wellness Science Co., Ltd., (“Premier”).
Under the terms of the Agreement, Premier is purchasing 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. Premier is a wholly-owned subsidiary of Premier Anti-Aging Co., Ltd. (“Parent”) which is listed on the Tokyo Stock Exchange Mothers division with securities code 4934.
“Premier conducted a global competition to evaluate the world’s most advanced molecule delivery technologies, and selected Lexaria’s DehydraTECH technology based on its superior performance and the extensive data available through Lexaria’s years of testing,” said Shinji Shosoyama, CEO of Premier.
“Lexaria is delighted to be working with Premier Wellness Science which we expect will dominate the newly opening Japanese market for CBD-based products,” said Chris Bunka, CEO of Lexaria. “Premier and Lexaria share similar philosophies, such as the provision of world-leading products created through scientific advantages and placing the consumer’s needs ahead of our own. We could not have found a better partner with which to introduce DehydraTECH-enabled products to the Japanese markets.”
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. Assuming that Premier continues to submit all required payments, the license for the Japanese market is perpetual.
In addition to the Payments, Lexaria will also receive royalty revenue from DehydraTECH licensed product sales, the terms of which have been agreed to. Total revenue is expected 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.
Premier’s Parent had revenues of approximately US$187,000,000 in the first three quarters of fiscal 2021 with year-over-year revenue growth of 63.1% and strong profit margins. Parent sells over 45 product SKU’s across four brands, and these products are sold in more than 16,000 retail stores as well as directly through mail/web order to over 2.6 million proprietary members. The overall Japanese cosmetics and personal products markets are estimated to be more than US$35 billion in annual sales.
As well, Lexaria and Premier have agreed to examine on a case-by-case basis the possibility of entering research and development collaborations related to advanced formulation science. Premier and Parent have long-established scientific relationships with some of the leading scientists in relevant fields in Japan.
This Agreement with Premier follows the awarding of two issued patents by the Japan Patent Office for DehydraTECH technology in Japan, strengthening Lexaria’s long-held beliefs that new patent protection is a vital component of entering commercial agreements.
*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 Premier Wellness Science Co., Ltd.
Premier Wellness Science Co., Ltd. is focused on the well-being of its customers that leads to good physical, mental and social health. The company seeks to achieve precision, individualized growth in health through a scientific approach to creating the highest performance products in the world.
About Premier Anti-Aging Co., Ltd.
Premier Anti-Aging Co., Ltd. engages in the planning, development, import/export, mail order, wholesale, and retail business of cosmetics and health foods. The company offers its cosmetic products under the DUO and CANADEL brands. It is also involved on the information provision and consulting services related to anti-aging, beauty, and health; research on management and beauty of beauty clinics, etc.; and marketing research and collection and analysis of various information. The company was founded in 2009 and is headquartered in Tokyo, Japan.
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 and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.
Lexaria Grants License to Valcon Medical for the European Market
Contract Manufacturing Organization first in Europe to License DehydraTECH
Lexaria will receive milestone fees and royalty payments from product sales
Kelowna, British Columbia - June 2, 2022 – Lexaria Bioscience Corp. (Nasdaq: LEXX) (Nasdaq: LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms is pleased to announce the awarding of a European and United Kingdom (“UK”) DehydraTECH license for medical cannabis applications from Lexaria Pharmaceutical Corp. to Valcon Medical A/S (“Valcon”).
Valcon Medical is a European contract manufacturing organization (“CMO”), specialized in the manufacturing of medical cannabis extracts for the European Union (“EU”) and the UK. Valcon is GMP certified and licensed under the Danish medical cannabis program to manufacture cannabis products that require physician-patient consultation.
Valcon products will span non-registered medical products through magistral programs, country-level market-authorized medical cannabis products through pilot programs, and country and/or EU Commission registered medical cannabis products. These products include bulk powders or solid oral dosage forms including, but not limited to, powder-filled capsules, compressed tablets, pills, oral melts, and topical creams and lotions with or without patch integration.
The non-exclusive license includes a combination of defined milestone fees payable to Lexaria upon completion of batch validation and marketing authorization application approvals for the first DehydraTECH-enabled products completed by Valcon for each of several product categories it shall pursue, together with defined royalties payable to Lexaria on revenues generated from Valcon’s product sales.
“We are very excited to have licensed Lexaria’s DehydraTECH technology for what we expect will be rapid growth across the European markets,” said Pete Patterson, CEO of Valcon Medical A/S. “As Valcon continues to build out its manufacturing capabilities we are developing new IP and partnering with industry leaders. Lexaria has developed and patented an incredible technology which will benefit medical cannabis patients with enhanced bioavailability with a quicker effect onset. Backed by substantial clinical efficacy studies, Valcon will bridge the extensive work that Lexaria has done in the US, over to Europe.”
Lexaria notes the potential for growth in utilization of DehydraTECH across these European markets given the advanced technical capabilities of Valcon, and their business focus on providing CMO services to a wide spectrum of companies active in the EU.
About Valcon Medical A/S
Founded in 2018, Valcon Medical is the most advanced medical cannabis manufacturer in its field in Europe and leads the cannabis industry in manufacturing capacity and production of the highest quality full spectrum extracts and API cannabinoid isolates. Valcon Medical is supported by a shareholder group comprised of some of the leading cannabis investment funds in the world, including Altitude Capital, Artemis Growth Partners, Enexis AB, Greenfield Global Opportunities, and Nimb Capital.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered antiviral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company’s ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company’s ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria’s postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Is CVS still stocking the KT Wave in stores?
Only seeing it available for shipping in my area and all the stores I check are out of stock on the website.
Some Target stores still show in store availability.
I believe the threshold is $1
How long can a stock stay below $1 on Nasdaq?
If a company trades for 30 consecutive business days below the $1.00 minimum closing bid price requirement, Nasdaq will send a deficiency notice to the company, advising that it has been afforded a "compliance period" of 180 calendar days to regain compliance with the applicable requirements.
Sree N Koneru is leaving BioElectronics Corporation
Sree N Koneru is leaving BioElectronics Corporation
Lexaria Biosciences Shares Spike To Session High, Up 2% Following Circulation Of Zacks Small Cap Research Note Showing $15 Valuation Target On Stock
Lexaria Biosciences Shares Spike To Session High, Up 2% Following Circulation Of Zacks Small Cap Research Note Showing $15 Valuation Target On Stock