UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) May 15, 2019
LEXARIA BIOSCIENCE CORP. |
(Exact name of registrant as specified in its charter) |
Nevada |
| 000-52138 |
| 20-2000871 |
(State or other jurisdiction of incorporation) |
| (Commission File Number) |
| (IRS Employer Identification No.) |
100 – 740 McCurdy Road, Kelowna, BC Canada |
| V1X 2P7 |
(Address of principal executive offices) |
| (Zip Code) |
Registrant’s telephone number, including area code (250) 765-6424
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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Item 1.01 Entry into a Material Definitive Agreement
On May 15, 2019 Lexaria Bioscience Corp. (“Lexaria”), Lexaria CanPharm ULC (“CanPharm”) and Nuka Enterprises, LLC (“Nuka”), maker of 1906 brand cannabis chocolates and other edible products, entered into an amending agreement, effective May 15, 2019, which amends the terms of an original Intellectual Property License Agreement entered into between Lexaria and Nuka on April 24, 2018 (the “Original Agreement”). The material amendments to the Original Agreement include the following:
| 1. | The rights, responsibilities and obligations of the Licensor in the Original Agreement have been assigned by Lexaria to CanPharm; |
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| 2. | The license to Lexaria’s patented DehydraTech™ technology on products that contain 0.3% or more of tetrahydrocannabinol (“THC”), has extended to the following States for the following products: |
| a. | Michigan for chocolates, candies and beverages; |
| b. | Massachusetts for chocolates, candies and beverages; |
| c. | Illinois for chocolates and candies; |
| d. | Ohio for chocolates and candies; and |
| e. | Colorado (the original territory) for beverages. |
Nuka shall pay to CanPharm an additional annual territory fee for each of Michigan, Massachusetts and Ohio and shall pay usage fees for products sold using the DehydraTech™ technology in all of the new territories.
On May 15, 2019, Nuka entered into a definitive intellectual property license agreement (the “Definitive Agreement”) with Lexaria Hemp Corp. (“Hempco”), a wholly owned subsidiary of Lexaria whereby Hempco is licensing the patented DehydraTECHTM technology, on a non-exclusive basis, in connection with the production of beverages containing 0.3% or less of THC, for sale in the United States. The Agreement shall have an initial 10 year term and Nuka shall pay to Hempco a Territory License fee and usage fees pertaining to the sale of the products.
Item 8.01 Other Events
On May 15, 2019 the Company announced that its animal study has produced results evidencing that its DehydraTech™ technology produces faster delivery of cannabinoids in the bloodstream with higher rates of absorption via edible products than current conventional industry formulations, namely using coconut oil and MCT oil. The studies specifically showed that:
| · | CBD was measurable in the rats’ blood within 2 minutes for edibles using DehydraTech™ compared no measurable CBD in rats’ blood for edibles using an MCT formulation; |
| · | At 15 minutes of ingestion, the CBD blood concentration level for rats that consumed edibles using the DehydraTech™ technology was 475% more than those of rats who consumed edibles using an MCT oil formulation; |
| · | At 60 minutes of ingestion, the CBD blood concentration level for rats that consumed edibles using the DehydraTech™ technology was 319% more than those of rats who consumed edibles using an MCT oil formulation; |
| · | Over the entire 60 minute study it was found that edibles prepared with the DehydraTech™ technology resulted in an average maximum CBD blood concentration that was 334% more than the average maximum CBD blood concentration found in subjects that consumed edibles that used the MCT oil formulation and that the total quantity of CBD delivered using the DehydraTech™ technology was 389% more than those using the MCT oil formulation |
| · | The results also reconfirmed the Company’s previous observations that its DehydraTech™ technology facilitates greater delivery of CBD across the blood-brain-barrier, with this study reflecting the DehydraTech™ technology outperforming the MCT oil formulation by 246% |
Item 9.01 |
| Financial Statements and Exhibits |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
LEXARIA BIOSCIENCE CORP. | ||
/s/ Chris Bunka | ||
Chris Bunka | ||
CEO, Principal Executive Officer | ||
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Date: | May 21, 2019 |
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EXHIBIT 99.1
Lexaria’s DehydraTECHTM Formulation Delivers 475% More CBD to Bloodstream after 15
Minutes than Conventional Industry Formulations
| · | The DehydraTECH formulation delivered measurable quantities of cannabidiol (“CBD”) into blood in as little as 2 minutes; |
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| · | Lexaria’s technology delivered more CBD to bloodstream in 15 minutes than conventional medium chain triglyceride (“MCT”) oil based control formulation achieved in 60 minutes; |
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| · | The area under the curve (“AUC”) for Lexaria’s patented DehydraTECH formulation was 389% more than the MCT oil control formulation; |
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| · | Lexaria’s DehydraTECH formulation delivers cannabinoids at industry-leading volumes and speed while effectively masking bitter flavor and aroma profiles. |
Kelowna, British Columbia – May 15, 2019 – Lexaria Bioscience Corp. (OTCQX: LXRP) (CSE: LXX) (the “Company” or “Lexaria”), a drug delivery platform innovator, has proven in animal testing that Lexaria’s DehydraTECHTM technology delivers cannabinoids to the bloodstream much more quickly and effectively than conventional industry cannabinoid edible formulation designs that often combine cannabinoids with MCT oils such as coconut oil.
BACKGROUND
On March 20, 2019, Lexaria announced it had commenced a series of animal studies with multiple objectives, including gaining a better understanding of how edible forms of cannabinoids enter the bloodstream. Initial results from these studies are now available and Lexaria expects to make a series of announcements disclosing results as they are processed.
In the first animal study results announced today, Lexaria compared its standard DehydraTECH formulation that combines cannabinoids with long-chain fatty acids (“LCFA”) using Lexaria’s patented dehydration processing technique to a concentration-matched formulation utilizing coconut oil which is a commonly used medium chain triglyceride (“MCT”) oil in the cannabis edibles industry.
MCT oils are commonly used by many firms making and selling cannabis edibles throughout North America. Lexaria has consistently postulated that the use of MCT oil in edibles is less effective for purposes of cannabinoid delivery optimization than its patented DehydraTECH LCFA formulations. Although these studies tested only for CBD delivery, Lexaria has every reason to believe that virtually identical results would have been achieved if THC was instead the cannabinoid under examination, consistent with subjective human clinical studies Lexaria’s partners have conducted with edible THC products.
TEST RESULTS
In each arm of the Lexaria animal studies, 10 male Sprague-Dawley rats were administered CBD at 25mg per kg of bodyweight. Delivery of CBD into the bloodstream was monitored over a 60-minute duration. Certain data are not being disclosed at this time for reasons of intellectual property protection.
\s
Above: Lexaria LCFA Formulation vs. MCT Formulation
| · | At 2 minutes DehydraTECH’s LCFA formulation delivered measurable CBD in blood, compared to no measurable CBD in blood until 6 minutes and onwards for the MCT oil formulation. |
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| · | At 15 minutes DehydraTECH’s LCFA formulation achieved a CBD blood concentration level that was 475% more than the MCT oil formulation; and, the DehydraTECH LCFA formulation CBD blood levels reached at 15 minutes were greater than the CBD blood levels reached by the MCT oil formulation at any time point during the 60-minute evaluation. |
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| · | At 60 minutes DehydraTECH’s LCFA formulation achieved a CBD blood concentration level of 319% more than the MCT oil formulation. |
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| · | Over the entire 60-minute study, the animals that received the standard DehydraTECH LCFA formulation achieved an average maximum CBD blood concentration level that was 334% more than the average maximum blood concentration level of the animals that received the MCT oil formulation (p<0.0021). |
| · | Over the entire 60-minute study, the area under the curve (AUC) (total quantity of CBD delivered) for the Lexaria DehydraTECH LCFA formulation was 389% more than the MCT oil formulation (p<0.0011). |
Lexaria also tested for brain tissue concentrations to quantify 8-hour CBD delivery from the DehydraTECH-enabled LCFA formulation compared to the MCT oil formulation and DehydraTECH’s LCFA formulation outperformed the MCT oil formulation by 246%. As was previously demonstrated through two series of animal tests delivering nicotine in 2018, Lexaria’s DehydraTECH continues to deliver a drug both to the bloodstream and across the blood-brain-barrier (“BBB”) more effectively than industry standards. More efficient delivery into bloodstream and across the BBB can lead to increased consumer satisfaction and results utilizing lower drug dosage quantities.
CONCLUSION
The cannabis edibles industry has partially embraced the use of MCT oils such as coconut oils as a co-ingredient in edible products, mostly because of the luxurious taste and mouth-feel of coconut oil. Lexaria’s head-to-head animal absorption study has proven that coconut oil formulations deliver cannabinoids into animal bloodstreams very poorly at only about one-quarter the rate of the patented Lexaria LCFA formulation. Lexaria’s DehydraTECH technology was also shown to deliver CBD considerably more quickly than MCT oil formulations.
Lexaria’s patented DehydraTECH technology has been used by licensees in the cannabis industry for three years and has been proven to effectively mask the bitter flavors and aromas of cannabis without the use of MCT oils, artificial chemical masking agents, or additional flavoring agents or sweeteners. DehydraTECH’s LCFA formulation is capable of delivering cannabinoids at industry-leading volumes and speed and simultaneously offering the most advanced flavor and aroma profile masking techniques in the industry.
About Lexaria
Lexaria Bioscience Corp. has developed and out-licenses its disruptive delivery technology that promotes healthier ingestion methods, lower overall dosing and higher effectiveness of lipophilic active molecules. Lexaria has multiple patents pending in over 40 countries around the world and has patents granted in the USA and in Australia for utilization of its DehydraTECH™ delivery technology. Lexaria’s technology provides increases in intestinal absorption rates; more rapid delivery to the bloodstream; and important taste-masking benefits, for orally administered bioactive molecules including cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs), nicotine and other molecules.
www.lexariabioscience.com
For regular updates, connect with Lexaria on Twitter http://twitter.com/lexariacorp
and on Facebook http://www.facebook.com/lexariabioscience/
FOR FURTHER INFORMATION PLEASE CONTACT:
Lexaria Bioscience Corp.
Alex Blanchard, Communications Manager
(250)765-6424 Ext 202
Or
NetworkNewsWire (NNW)
www.NetworkNewsWire.com
FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements. Statements which are not historical facts are forward-looking statements. The Company makes forward-looking public statements concerning its expected future financial position, results of operations, cash flows, financing plans, business strategy, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, including statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements, including but not limited to: that any additional stock warrants or stock options will be exercised. 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 other factors will not affect the accuracy of such 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, managing and maintaining growth, the effect of adverse publicity, litigation, competition, the patent application and approval process and other factors which may be identified from time to time in the Company's public announcements and filings. There is no assurance that existing capital is sufficient for the Company's needs or that it will be able to raise additional capital. There is no assurance that Lexaria will successfully complete any other contemplated or existing technology license agreements; or that results from any studies will be favorable or in any way support future business activities of any kind. Scientific R&D is often unpredictable and unanticipated results could emerge from any study and have a material impact. There is no assurance that positive results from animal testing will be reproduced nor that similar positive results will be apparent in human tests of a similar nature. There is no assurance that any planned corporate activity, scientific study, R&D, business venture, or initiative will be pursued, or if pursued, will be successful. 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). TurboCBDTM, DehydraTECHTM technology and ViPovaTM products are not intended to diagnose, treat, cure or prevent any disease.
The CSE has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.
EXHIBIT 99.2
Lexaria Bioscience and Nuka Enterprises’ 1906 Expand Cannabis Product Relationship
1906 fast-acting edibles products, powered by Lexaria’s DehydraTECH technology, will expand across the US in 2019 and 2020
Kelowna, British Columbia – May 21, 2019 – Lexaria Bioscience Corp. (OTCQX: LXRP) (CSE: LXX), an innovator in drug delivery platforms, today announced the most reliable fast acting edibles on the market will now be available across the country through a major expansion in operations by Nuka Enterprises LLC, (“Nuka”) maker of 1906 cannabis edibles for high functioning adults.
Last year, Nuka acquired contractual options to expand its use of DehydraTECHTM technology. Exercising some of those options, Nuka plans to expand operations for cannabis chocolates and edibles in six additional states and cannabis beverages in three states in 2019 and 2020.
“As the fastest growing edibles brand in Colorado, we believe a huge part of our consumer appeal is because of this fast-acting technology,” said Peter Barsoom, Nuka Enterprises CEO and Co-Founder. “We look forward to continuing to innovate alongside Lexaria, whose technology is the best in the industry.”
Currently, 1906 offers six distinct formulations that combine low-dose cannabis with targeted plant medicines. Over the next two years, 1906 is expanding their product offerings to other legal markets including: Illinois, Ohio, Massachusetts, Michigan and others. Overall, roughly a ten-fold increase in product volumes manufactured by Nuka utilizing DehydraTECH is expected over the next eighteen months.
As part of its mission to bring cannabis back to its pre-prohibition status as a mainstream, widely used medicine for the greater good, Nuka will also begin using DehydraTECH to create consumer products containing CBD. Lexaria recently announced that its technology was able to deliver 475% more CBD after just 15 minutes than conventional industry formulations.
Nuka has utilized Lexaria’s technology within its award-winning 1906 chocolates for roughly three years. Since its founding in 2016, 1906 has advanced from a start-up to Colorado’s fastest growing edibles company, now available in more than 200 dispensaries. Praise for 1906 products can be seen in Vogue, Penthouse, Cosmo, Eater, The Huffington Post, VICE and many more nationally-recognized publications.
The comprehensive semi-exclusive agreement provides Nuka and 1906 with competitive technological advantages until 2028, as well as growing revenue streams for Lexaria. A second license provides Nuka and 1906 with the immediate ability to utilize DehydraTECH technology for CBD across the US marketplace.
“Nuka’s astonishing growth since launch is impressive and we can’t wait to see what innovative products they design next using DehydraTECH technology,” said Chris Bunka, Chief Executive Officer of Lexaria Bioscience Corp. “Together, we have a market advantage that will significantly change public perception of how and when to consume cannabis and plant medicine because consumers don’t have to wait an hour or longer for their edibles to kick in with 1906 brand.”
On April 30, 2018, Lexaria announced that Nuka had also acquired an option to expand its products and brand to Canada and across the US and that Nuka and 1906 planned to leverage the competitive advantages of DehydraTECH across multiple product lines. They also strategically acquired new rights in product categories in addition to the original chocolate formats, which include candies, beverages, capsules and pills, and topical creams. In doing so, Nuka and 1906 have the opportunity to create America’s first national DehydraTECH-powered cannabis brand for edible and topical products that offer the superior experiential profiles 1906 consumers desire, together with the exceptional flavor and speed of onset benefits.
About Nuka Enterprises and 1906
Nuka Enterprises develops processes, IP and services focused on disrupting the nascent and fast-emerging cannabis industry. Nuka’s 1906 brand is creating a new category of premium edibles that marry the benefits of cannabis and plant medicines, designed to appeal to responsible, informed, health conscious adults. 1906 products deliver distinct highs with functional benefits in fast-acting edible of artisanal chocolate and other high quality ingredients. 1906’s product lineup delivers six unique experiences that promote sleep, energy, arousal, relaxation, cognitive focus, and a happy mood, all in a safe and predictable formulation. For more information, please visit 1906newhighs.com.
About Lexaria
Lexaria Bioscience Corp. has developed and out-licenses its disruptive delivery technology that promotes healthier ingestion methods, lower overall dosing and higher effectiveness of lipophilic active molecules. Lexaria has multiple patents pending in over 40 countries around the world and has patents granted in the USA and in Australia for utilization of its DehydraTECHTM delivery technology. Lexaria’s technology provides increases in intestinal absorption rates; more rapid delivery to the bloodstream; and important taste-masking benefits, for orally administered bioactive molecules including cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs), nicotine and other molecules.
www.lexariabioscience.com
For regular updates, connect with Lexaria on Twitter (http://twitter.com/lexariacorp)
and on Facebook http://www.facebook.com/lexariabioscience
FOR FURTHER INFORMATION PLEASE CONTACT:
Lexaria Bioscience Corp.
Alex Blanchard, Communications Manager
(778) 796-1897
Or
NetworkNewsWire (NNW)
www.NetworkNewsWire.com
FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements. Statements which are not historical facts are forward-looking statements. The Company makes forward-looking public statements concerning its expected future financial position, results of operations, cash flows, financing plans, business strategy, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, including statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements, including but not limited to: that any additional patent protection will be realized or that patent achievements will deliver material results. 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 other factors will not affect the accuracy of such 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 and other factors which may be identified from time to time in the Company's public announcements and filings. There is no assurance that existing capital is sufficient for the Company's needs or that it will be able to raise additional capital. There is no assurance the Company will be capable of developing, marketing, licensing, or selling edible products containing cannabinoids, nicotine or any other active ingredient. There is no assurance that Nuka Enterprises or any customer, client or licensee will execute their business plans or expansion plans as communicated. There is no assurance that any planned corporate activity, scientific research or study, business venture, letter of intent, technology licensing pursuit, patent application or allowance, consumer study, or any initiative will be pursued, or if pursued, will be successful. 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.
The CSE has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.
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