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Lexaria Bioscience Corp. LXX:CSE | LXRP:US Drug Delivery Platform Innovator
Investor Presentation May 2019 LexariaBioscience.com
Lexaria Bioscience Corp. LXX:CSE | LXRP:US Drug Delivery - - PowerPoint PPT Presentation
Lexaria Bioscience Corp. LXX:CSE | LXRP:US Drug Delivery Platform Innovator Investor Presentation May 2019 LexariaBioscience.com 1 Disclaimer This presentation includes forward-looking statements within the meaning of Section 27A of the
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Investor Presentation May 2019 LexariaBioscience.com
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Investor Presentation
This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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, evaluation of medical marijuana projects, alternative health projects or products, and cannabidiol-fortified products or services for participation and/or financing, competitive positions, growth opportunities, plans and
"estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions that are forward-looking statements. 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 including, without limitation, foreign exchange and other financial markets; changes of the interest rates on borrowings; whether or not the Company will be successful in executing its business plan in whole or in part; hedging activities; changes in commodity prices; changes in the marketing or capital project expenditure levels; litigation; legislation; environmental, judicial, regulatory, political and competitive developments in areas in which Lexaria Corp. operates. These and other risks and uncertainties are more fully described in our periodic reports and other disclosure documents filed by Lexaria Corp. from time to time with regulatory authorities available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov, and the reader is encouraged to review these documents. Planned dates stated herein are estimates only, based on best information available. Dates are not assured and are subject to revision without notice. The Company assumes no obligation, except as required by law, to update any forward-looking statement, whether as a result of new information, future events or otherwise. This presentation is not an offer to sell or a solicitation of an offer to buy securities of Lexaria Bioscience Corp. It is a short summary of certain information for introductory purposes only and is not to be relied upon for investment purposes. No statement within has been evaluated by the Food and Drug Administration, and no product or service is intended to diagnose, treat, cure or prevent any disease.
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Eliminates the need for sugar- filled edibles. Equates that of less healthy administration methods like inhalation Effects are felt within 10-20 min (vs. 60-120 min). Easy to implement
DehydraTECHTM - Patented technology, Changing the way Active Pharmaceutical Ingredients (“APIs”) enter the body orally
Eliminates the need for sugar- filled edibles.
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Multiple dosage forms - foods, liquid emulsions, tablets, capsules
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Nicotine NSAIDs Vitamins Cannabis
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formats of all types,
speed of effectiveness and potency,
alternative to smoking/vaping.
ingestible product formats,
performance for synthetics as well as natural fat soluble vitamins (A, D, K & E).
formulate NSAIDs,
requirements,
and kidneys (lower toxicity).
nicotine products,
smoking/vaping, gums and patches,
without first pass liver metabolism.
Estimated Global Market Sizes
Sources: ArcView Research & EuroMonitor
$13B $31B $60B $990B
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High bioavailability (est. 30%) Harmful to Lungs
Medium bioavailability (est. 16%) Foul taste
Low bioavailability (est. 3-5%) Sugar filled, to mask taste
transforms the way cannabinoids enter the bloodstream through the Gastrointestinal Tract:
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Market share for flower is eroding – even though the market is growing and prices are dropping.
66 62 59 54 44 34 38 41 46 56 2014 2015 2016 2017 Q1 2018
Colorado
54 44 46 56 Q1 '17 Q1 '18
Oregon
43 40 57 60 Jan '18 April '18
California
$372M $4.94/g Q1 2014 (Colorado) Q1 2018 Non-flower Market share % Flower Source: colorado.gov bdsanalytics.com $7.12/g $150M
Apr May Jun Jul Aug Sept Cannabis Oil 3734 4406 4124 4310 4391 4455 Dried Cannabis 2354 2310 2103 2151 2069 1755 3734 4406 4124 4310 4391 4455
Canada:
Cannabis sold to clients during 2018 (kg)
In Canada’s tightly regulated market (with limited product formats), consumers are moving away from smoking.
Source: canada.ca
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DehydraTECH™ Improves cannabinoid absorption DehydraTECH™ Improves alternate delivery methods DehydraTECH™ spans foods, beverages, nutritional supplements and more
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Process: Results:
Fatty acids are believed to block and shunt bound APIs away from bitter taste receptors*
1) Combine API and Fatty Acid Oil
LCFA: sunflower oil +
2) Apply to food/carrier particles
e.g.: mannitol, gum Arabic, etc.
3) Dehydration processing step
*Coupland & Hayes (2014). Pharm Res. Nov 31(11); 2921-2939 **Soehngen et al., (1998). Arthritis & Rheumatism. Vol 31, No. 3. ***Iqbal & Hussain (2009). Am J Physiol Endocrinol Metab. Jun;296(6);E1184-94.
Small intestine quickly absorbs LCFAs into lymphatics (bypassing first pass liver effect) and MCFAs via the liver*** Lipids enable gastric protection and rapid passage**
API = Active Pharmaceutical Ingredient LCFA = Long Chain Fatty Acid; MCFA = Medium Chain Fatty Acid
Colloidal Complex Cannabidiol
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clinical study (n=12)
≤ 30 min (95% CI, p=0.051).
throughout entire study
shown vs. placebo (95% CI, p=0.027)
shown vs. placebo and positive control (95% CI, p=0.002 and 0.017)
10 20 30 40 50 60 70 80 30 60 90 120 150 180 210 240 270 300 330 360 Venous plasma concentration (ng/mL) Time (min) Turbo 90mg 90mg placebo
** **
Plasma cannabidiol (CBD) concentration in venous blood over 6 hours following consumption of generic 90mg (dashed black open circles) CBD doses compared to DehydraTECHTM 90mg (solid grey solid circles) CBD doses. Standard error included for clarity. **p<0.01 TurboCBDTM 90mg > all others; Ψp<0.05 only TurboCBD 90mg > placebo. Note both generic and DehydraTECHTM are otherwise significantly greater when compared to placebo. .
Ψ Ψ
317% more CBD delivered ≤ 30 min.
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Plasma cannabidiol (CBD) concentration in 10 male Sprague-Dawley rats administered at 25mg per kg of bodyweight. Delivery of CBD into the bloodstream was monitored over a 60-minute duration. At 15 minutes DehydraTECH’s LCFA formulation achieved a CBD blood concentration level that was 475% more than the MCT oil formulation. Over the entire 60-minute study, the animals that received the standard DehydraTECH long chain fatty acid (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).
475% more CBD Delivered @ 15 min. 334% higher Cmax
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10 20 30 40 50 60 30 60 90 120 150 180 210 240 300 360 420 480 Plasma concentration (μg/mL) Time (min)
D 90mg PTL101 - 100mg
Pharmacokinetic comparison of the ingestion of DehydraTECHTM 90mg (solid black solid circles) and PhytoTech Therapeutics’ PTL101- 100mg gelatin matrix capsules (dashed grey open squares) [Atsmon et al., Clinical Pharmacology in Drug Development 2018, 7(7) 751– 758]. Only mean data are shown for clarity.
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TurboCBD 90 mg CBD 90 mg positive control Comparative Levels of CBD Liver Metabolites Following TurboCBD 90 mg and Positive CBD 90 mg Control
Lower apparent levels initially supporting first pass liver metabolism mode of action
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Out-license to third-party partners
High margin royalty model Example licensees:
Demonstration products
TurboCBD™ capsules ViPova™ teas Distribution partnerships
Innovation & Research
New product development Patent applications Clinical trials
1906 New Highs
(Colorado)
Hill Street Beverages
(TSX.V:BEER )
Cannfections Group
(Canada)
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LexariaNicotineCo.com
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due to nicotine’s inability to securely pass through the GI tract without irritation.
pledges $1B to anti-smoking
smokers globally
deaths/year globally
deaths expected this century
lowering nicotine in cigarettes to non- addictive levels
Comprehensive regulatory plan to shift trajectory of tobacco-related disease, death Smoking is the world's leading cause of preventable death
“Ultimately, we want to be in a position to stop
selling cigarettes entirely.”
Phillip Morris CEO, May 30, 2018.
World Health Organization (www.who.int) Foundation for a Smoke-Free World, Inc. (www.smokefreeworld.org)
British American Tobacco
to rapidly expand “next-gen products”
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Altria Group
Leader in authorized, non-combustible, reduced-risk products.
Lexaria Nicotine
Leader in unique alternate gastro-intestinal delivery methods for orally- administered products.
Product development for orally- administered nicotine formats Lexaria Nicotine
Lexaria Bioscience,
rights for nicotine related use.
Altria Group
non-combustible nicotine formats,
Nicotine to fund further research.
Definitive Agreement signed January 15, 2019
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Market need
FDA – comprehensive plan to reduce smoking
Collaborative Research
Altria Group & Lexaria Nicotine to conduct animal & human studies
Altria Group - Strategic Funding Partner
Initial Funding: US$1 million Milestone based: up to US$12 million
DehydraTECHTM
to commercialize oral, non-combustible nicotine products,
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560% higher brain levels
nicotine effects are focused, compared to controls.
100 200 300 400 Control DehydraTECH
Gain in Nictone Cmax
TM
ng/mL
100 200 300 400 Control DehydraTECH
Brain Levels of Nicotine ng/g
TM
≤15 min
ng/mL
TM
Time to reach Nicotine Control Cmax
1 2 3 4 Control DehydraTECH
2.9 hrs 48% improvement in peak Cmax nicotine delivery to the bloodstream relative to controls. 1,160% faster delivery
quantities of nicotine to the bloodstream than achieved with controls
(within 15 min vs. 2.9 hours).
Cmax = Peak blood plasma concentration
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more nicotine
delivered overall within first 15 min of study (p=0.0004)
more nicotine
delivered at 10 minute mark (p=0.044)
more nicotine
delivered over the 60 min study period (p=0.0086)
DehydraTECH™ Formulation (nicotine polacrilex 10 mg/Kg) Control Formulation (nicotine polacrilex 10 mg/Kg) % Improvement pValue
Average Nicotine Blood Level 0- 15 min (ng/mL)
Peak Nicotine Blood Level 0-60 min (ng/mL)
Total Nicotine Absorption (i.e., AUC) 0-60 min (hr∙ng/mL)
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DehydraTECH™ Formulation (ng/mL) Control Formulation (ng/mL) % Improvement pValue 2 minutes 56.68 105.57
0.260114297 4 minutes 124.55 74.63 66.88 0.171769198 6 minutes 124.04 92.12 34.64 0.241171951 8 minutes 230.02 119.22 92.94 0.102332181 10 minutes 254.64 133.89 90.19 0.043918813 12 minutes 278.99 147.94 88.58 0.029947174 15 minutes 307.68 150.09 105.00 0.006564706 30 minutes 303.13 148.68 103.88 0.002363596 45 minutes 300.43 155.54 93.15 0.003034948 60 minutes 394.23 220.16 79.07 0.025735488 Peak Nicotine Blood Level 0-60 min (ng/mL) 394.23 220.16 79.07 0.025735488 Total Nicotine Absorption (i.e., AUC) 0-60 min (hr∙ng/mL) 266.48 136.75 94.87 0.008632357 NOTE: No AEs reported.
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Control DehydraTECH™ % Improvement
(10 mg/Kg) (10 mg/Kg)
Significant nicotine absorption increase across the Blood-Brain Barrier into brain tissue:
40 lab rat test
Aug 7, 2018
Testing at
1, 4, 8, 24 hrs.
12 lab rat test
Apr 17, 2018 Maximum Brain Concentration
(Cmax; ng/ g)
427 ± 66.5 1,260 ± 200 295% Maximum Brain Concentration
(Cmax; ng /g)
51.8 ± 30.4 290 ± 197 560%
Time to Cmax 4 hours 1 hour 400%
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Total Quantity in Brain Tissue
(AUC; hr·ng/g)
5,881 ± 538 12,999 ± 1252 221%
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Nicotine
Polacrilex infused mannitol (0 day) Fatty acid oil Polacrilex standard
Fatty acid oil signals
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Serial entrepreneur involved in several private and public companies since the late 1980’s. Extensive experience in the capital markets, corporate governance, M&A and finance.
Specialist in development of drug delivery technologies. Former President and COO of Helix BioPharma Corp. (TSX: HBP). Named inventor on multiple issued and pending
pharmacology and B.Sc. in toxicology from the University of Toronto.
U.S. licensed patent attorney, Doctorate in Neuroscience (with concentrations in Pharmacology and Physiology), Over 15 years patent services from small start-ups to some
biotechnology companies.
Co-Director for the Centre for Heart, Lung and Vascular Health, Canada, Research Chair in Cerebrovascular Physiology and Professor, School of Health and Exercise Sciences, Faculty of Health and Social Development at the University of British Columbia.
Chris Bunka Chairman & CEO John Docherty, M.Sc. Director & President
Chief Legal, SVP Innovation
Advisor
Dean of the Graduate School and Professor in the Departments of Neurobiology and Anatomy and the Institute for Regenerative Medicine at Wake Forest University. Professor, Psychology and Neuroscience, at Wake Forest University, and is past president of the Society for Psychophysiological Research Associate Professor and Director of Basic Science Research in the Department of Surgery, Division of Urology, at Duke University Medical Center. Adjunct Assistant Professor of Neurobiology and Anatomy at Wake Forest University School of Medicine.
Advisor
Advisor
Advisor
Advisor
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One year stock chart – OTCQX:LXRP
Chris Bunka John Docherty Alex Blanchard
CEO President Manager Corp. Comm & IR 250 765 6424 905 439 5423 778 796-1897 Cbunka@lexariabioscience.com Jdocherty@lexariabioscience.com Ablanchard@lexariabioscience.com
Trading symbol: LXX:CSE, LXRP:OTCQX Shares o/s: 77 m Fully diluted: 86 m Recent price: C$1.33 / US$0.96 Insider ownership: 15m (20%) Fiscal year-end: August 31 Cash on hand (Feb ‘19) US$ 3.1M Recent financing (Oct ‘18) US$1.5M (@ US$1.60/unit) Lexaria Bioscience Corp. 100-740 McCurdy Road, Kelowna, BC, V1X 2P7