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Lexaria Bioscience Corp. LXX:CSE | LXRP:US Drug Delivery Platform Innovator
Investor Presentation July 2019 LexariaBioscience.com
Drug Delivery Platform Innovator Investor Presentation July 2019 - - PowerPoint PPT Presentation
Lexaria Bioscience Corp. LXX:CSE | LXRP:US Drug Delivery Platform Innovator Investor Presentation July 2019 LexariaBioscience.com 1 Disclaimer This presentation includes forward-looking statements within the meaning of Section 27A of
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Investor Presentation July 2019 LexariaBioscience.com
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This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E
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
for participation and/or financing, competitive positions, growth opportunities, plans and objectives of management for future
"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
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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Lexaria’s initial focuses are the $990B ingestible Nicotine and $14B Cannabis markets
and patch nicotine based products
mechanism
NSAIDs, Vitamins, Hormones, and more
toxicity)
Over $1 Trillion Combined Market Size
Cannabis/Hemp Pharma Nicotine
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Over $1 Trillion Combined Market Size
Cannabis/Hemp Pharma Nicotine
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more effective than ingesting generic cannabinoids
shifts from flower to non-flower products → current market size is $14B
brands, such as Hill Street Beverages and 1906
revenue
product
Regulations favorable to nicotine alternatives → current market size is $990B
including commercial licensing agreement
development; regulatory approval and product introduction
undisclosed royalty; license rights remain available in rest of world
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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
DehydraTECH™ - Patented technology changing how Active Pharmaceutical Ingredients (APIs) enter the body orally
Animal testing confirms up to 19x improvement
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Multiple dosage forms - foods, liquid emulsions, tablets, capsules
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9 Key Insights
Sources: colorado.gov, bdsanalytics.com and canada.ca 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 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
Non- flower Market share % Flower
US FLOWER VS. NON-FLOWER CONSUMPTION CANADA: CANNABIS SOLD TO CLIENTS IN 2018 (kgs) KEY INSIGHTS AND LEXARIA’S SOLUTION Lexaria’s Solution
and more
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10 20 30 40 50 60 30 60 90 120 150 180 210 240 300 360 420 480 Plasma concentration (ng/mL) Time (min)
D 90mg PTL101 - 100mg
mask taste DehydraTECHTM (Oral Technology) Transforms the way cannabinoids enter the bloodstream through the gastrointestinal tract
Methods of Cannabinoid Consumption CASE STUDY: TurboCBD™ - Lexaria’s Oral CBD Product
Faster onset and offset; higher peak concentration
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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
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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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12 Innovation & research
Demonstration products
Out-license to third-party partners
geography (per state)
cannabinoid product manufacturers
components:
Business ModelStrategy and Execution
Hill Street Beverages (TSXV: BEER) Cannfections Group (Canada) 1906 New Highs (Colorado)
Our Progress
Lexaria’s technology is highly scalable and is demonstrating commercial traction
Based on $10,000,000 in product sales, each license can represent $500,000 in annual revenue to Lexaria at a ~99% margin
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Investor Presentation
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LexariaNicotineCo.com
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deaths/year globally
deaths expected this century
Sources: World Health Organization (www.who.int) and Foundation for a Smoke-Free World, Inc. (www.smokefreeworld.org)
the world’s first ingestible nicotine product in a $990B global market
(and increasing) is from non- combustible products (~$99B)
preventable death
shift the trajectory of tobacco-related disease and death
“next-gen products”
“Ultimately, we want to be in a position to stop selling cigarettes entirely.”
due to nicotine’s inability to securely pass through the GI tract without irritation.
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brands including: Phillip Morris (Marlboro, Virginia Slims, Benson & Hedges, etc.), John Middleton Inc. and Nat Sherman
non-combustible reduced risk products
within $12M based upon milestone achievement
in exchange for royalty fees
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growing portion of Altria’s revenue
from smokeless products
Source: Altria Group 2018 Annual Report
About Altria Group (NYSE: MO) Altria #1 Dominant Market Share
Lexaria royalty generation $2.3B of smokeless product revenue $25.4B of total revenue
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nicotine to date:
nicotine delivery to the bloodstream relative to controls
peak Cmax quantities of nicotine to the bloodstream than achieved with controls (within 15 min vs. 2.9 hours)
where nicotine effects are focused, compared to controls
minute mark
within first 15 mins of study
60 min study period
40 animal test Aug 7, 2018 Testing at 1, 4, 8, 24 hrs. 12 animal test Apr 17, 2018
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Maximum Brain Concentration
(Cmax; ng /g) 51.8 ± 30.4
290 ± 197 560% Maximum Brain Concentration
(Cmax; ng /g)
427 ± 66.5 1,260 ± 200 295%
Time to Cmax
4 hours 1 hour 400% Total Quantity in Brain Tissue
(AUC; hr·ng/g)
5,881 ± 538 12,999 ± 1252 221%
Control
(10 mg/Kg) DehydraTECH™
(10 mg/Kg)
% Improvement
Nicotine Studies Nicotine Blood-Brain-Barrier Results Summary
Lexraria’s product offers significant improvements over combustible product and continues to be developed
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Lexaria’s technology outperforms in taste, rapidity, peak concentration, versatility and more
Lexaria DehydraTECHTM VESIsorb Caliper SC / Ripple OLEOTM
Generic Industry
Taste
Sugar/additives not required Flavouring added Flavouring added Flavouring added Sugars and artificial flavors required
Rapid Absorption
Measurable blood levels in 2 minutes; Tmax 45-120 minutes Tmax 4 hours 15 minute onset N/A 40-75 minute
hours
Enhances Potency
2x – 8x gain in blood levels; 475% at 15 minutes 4x – 6x gain in blood levels N/A 2x gain in bioaccessibility No
Enhances Brain Uptake
Up to 19x gain N/A N/A N/A No
Testing and Validation
Human clinical study; over 15 animal studies; In vivo In vivo In vivo Unknown No
CBD, THC, NSAID, Nicotine
YES No No No No
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Trading symbol: LXX:CSE, LXRP:OTCQX Shares O/S: 78M Fully Diluted: 86M Price (07/10/19): C$1.09 Insider ownership: 15M (20%) Market cap (07/10/19): C$86.1M Cash on hand (02/28/19) US$ 3.1M Recent financing (Oct ‘18) US$1.5M (@ US$1.60/unit)
500,000 1,000,000 1,500,000 2,000,000 2,500,000 3,000,000 $0.0 $0.5 $1.0 $1.5 $2.0 $2.5 Jul-2018 Aug-2018 Sep-2018 Oct-2018 Nov-2018 Dec-2018 Jan-2019 Feb-2019 Mar-2019 Apr-2019 May-2019 Jun-2019 VOLUME SHARE PRICE (USD)
1 Year Stock Chart – OTCQX:LXRP
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Investor Presentation
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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Investor Presentation
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
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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. .
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317% more CBD delivered ≤ 30 min.
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Investor Presentation
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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Investor Presentation
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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Investor Presentation
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Investor Presentation
delivered overall within first 15 min of study (p=0.0004)
delivered at 10 minute mark (p=0.044)
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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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 patents. M.Sc. in 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 of the world’s largest biotechnology companies. Chris Bunka Chairman & CEO John Docherty, M.Sc. Director & President
Chief Legal, SVP Innovation
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Investor Presentation
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.
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
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