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Lexaria Bioscience Corp. LXX:CSE | LXRP:US
Drug Delivery Platform Innovator
Investor PresentationMay 2019
LexariaBioscience.com
2Investor Presentation
DisclaimerThis presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, andSection 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 andobjectives 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 that are forward-looking statements. Suchforward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number ofrisks and uncertainties, and there can be no assurance that other factors will not affect the accuracy of such forward-looking statementsincluding, without limitation, foreign exchange and other financial markets; changes of the interest rates on borrowings; whether or not theCompany will be successful in executing its business plan in whole or in part; hedging activities; changes in commodity prices; changes inthe marketing or capital project expenditure levels; litigation; legislation; environmental, judicial, regulatory, political and competitivedevelopments in areas in which Lexaria Corp. operates. These and other risks and uncertainties are more fully described in our periodicreports and other disclosure documents filed by Lexaria Corp. from time to time with regulatory authorities available on SEDAR atwww.sedar.com and on EDGAR at www.sec.gov, and the reader is encouraged to review these documents. Planned dates stated herein areestimates only, based on best information available. Dates are not assured and are subject to revision without notice. The Companyassumes no obligation, except as required by law, to update any forward-looking statement, whether as a result of new information, futureevents 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 ashort 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.
2
3Investor Presentation
Simple and cost effective
Increases bioavailability
Improves speed of onset
Masks unwanted taste
Drug Delivery Platform Innovator
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.
4Investor Presentation
Method of use &Composition of matter claims• Cannabinoids (CBD, THC)• Nicotine (and its analogs)• NSAIDs• Fat soluble vitamins
Multiple dosage forms - foods, liquid emulsions, tablets, capsules
50+ Patent Applications
10Patent Families
11Patents Granted
6 USA5 Australia
DehydraTECH™ Patent Portfolio
5Investor Presentation
NicotineNSAIDsVitaminsCannabis
Commercial Applications
5
• Ingestible product formats of all types,•Enhanced palatability, speed of effectiveness and potency,•Viable and healthier alternative to smoking/vaping.
•Existing and new ingestible product formats,•Enhanced absorption performance for synthetics as well as natural fat soluble vitamins (A, D, K & E).
•Alternate means to formulate NSAIDs,•Higher bioavailability,•Lower input requirements,•Less burden on liver and kidneys (lower toxicity).
•World’s first ingestible nicotine products,•Alternative to smoking/vaping, gums and patches,•High bioavailability without first pass liver metabolism.
Estimated Global Market Sizes
Sources: ArcView Research & EuroMonitor
$13B $31B $60B $990B
6Investor Presentation
6
Cannabinoids | THC | CBD
Oral Delivery
7Investor Presentation
Cannabinoids: Entering the Blood Stream
7
3 prominent ways cannabinoids enter the blood stream:
Inhalation High bioavailability (est. 30%)Harmful to Lungs
Sub-lingual (under tongue) Medium bioavailability (est. 16%)Foul taste
Oral – Gastrointestinal TractLow bioavailability (est. 3-5%)Sugar filled, to mask taste
DehydraTECHTM
transforms the way cannabinoids enter the
bloodstream through the Gastrointestinal Tract:
Fast ActingImproved Taste
Increased Bioavailability
8Investor Presentation
Consumer Shift Away From Flower
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
37344406 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
9Investor Presentation
Cannabis Consumption Trends
Trend to limit dosage in
edibles
Trend away from smoking
Trend toward beverages &
edibles
DehydraTECH™Improves
cannabinoid absorption
DehydraTECH™Improves alternate
delivery methods
DehydraTECH™spans foods, beverages, nutritional supplements and more
10Investor Presentation
How Does DehydraTECH™ Work?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 IngredientLCFA = Long Chain Fatty Acid; MCFA = Medium Chain Fatty Acid
Colloidal Complex
Cannabidiol
11Investor Presentation
Clinically Proven PK/PD Performance Gains - TurboCBD™
• 2018 European human clinical study (n=12)
• Double-blind, 90 mg CBD dose
• 317% more CBD delivered ≤ 30 min (95% CI, p=0.051).
• Higher CBD delivery throughout entire study
• Lower blood pressureshown vs. placebo(95% CI, p=0.027)
• Higher cerebral perfusionshown vs. placebo and positive control (95% CI, p=0.002 and 0.017)
0
10
20
30
40
50
60
70
80
0 30 60 90 120 150 180 210 240 270 300 330 360
Ven
ou
s p
lasm
a c
on
cen
trati
on
(n
g/m
L)
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.
.
ΨΨ
317% more CBD delivered≤ 30 min.
12Investor Presentation
DehydraTECH™ Outperforms Conventional MCT Formulations
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 CBDDelivered @ 15 min.
334% higher Cmaxover 60 min.
13Investor Presentation
TurboCBD™ Absorption - Market Comparator
0
10
20
30
40
50
60
0 30 60 90 120 150 180 210 240 300 360 420 480
Pla
sma c
on
cen
trati
on
(μ
g/m
L)
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.
• Faster onset and offset• Higher peak concentration
14Investor Presentation
TurboCBD™ Liver Metabolite Analyses
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
15Investor Presentation
Out-license to third-party partners High margin royalty modelExample licensees:Demonstration products
TurboCBD™ capsules ViPova™ teas
Distribution partnerships
Innovation & ResearchNew product development
Patent applicationsClinical trials
Business Model: Royalties & Sales
1906 New Highs (Colorado)
Hill Street Beverages(TSX.V:BEER )
Cannfections Group(Canada)
16Investor Presentation
Nuka/1906 Deal Expansion – May 21, 2019
• Lexaria’s oldest client
• Deal expansion announced 05/21
• Expanding operations into 6 additional states
• 10-fold increase in product volumes expected over next 18 months
17Investor Presentation
17
Lexaria Nicotine
Oral Nicotine Delivery Forms
LexariaNicotineCo.com
18Investor Presentation
Nicotine: a smoke-free future?
NoNicotine edibles
due to nicotine’s inability to securely pass through the GI
tract without irritation.
Phillip Morris
pledges $1B to anti-smoking
1.1 billion smokers globally
7 million deaths/year globally
1 billion deaths expected this century
lowering nicotine in
cigarettes to non-
addictive levels
FDA 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.”-- André Calantzopoulos,
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”
19Investor Presentation
Altria Group Inc.Funding Partner, DehydraTECH Licensee
Leading nicotine industry
participant
Patentedoral-based
delivery technique
Altria GroupLeader in authorized,
non-combustible, reduced-risk products.
Lexaria NicotineLeader in unique alternate gastro-intestinal delivery methods for orally-administered products.
Product development
for orally-administered
nicotine formats
Lexaria Nicotine• Majority-owned subsidiary of
Lexaria Bioscience,• Holds DehydraTECH license
rights for nicotine related use.
Altria Group• DehydraTECH licensee for oral &
non-combustible nicotine formats,• Ownership investment in Lexaria
Nicotine to fund further research.
Definitive Agreement signed January 15, 2019
20Investor Presentation
Completing the puzzle for Oral Nicotine Forms
Market needFDA – comprehensive plan to reduce smoking
Collaborative ResearchAltria Group & Lexaria Nicotine
to conduct animal & human studies
Altria Group - Strategic Funding Partner
Initial Funding: US$1 millionMilestone based: up to US$12 million
DehydraTECHTM
• Altria Group has licensed DehydraTECH to commercialize oral, non-combustible nicotine products,
• Exclusive license in the United States,• Non-exclusive globally,• Royalty-based payment structure.
21Investor Presentation
DehydraTECH™ PK Studies with Nicotine To-Date
17LEXAP1 (04/18)
- DehydraTECH™ nicotine polacrilex vs. positive control- 1 mg/Kg and 10 mg/Kg (oral gavage)- 12 male Sprague Dawley rats (4 groups of 3)- Jugular vein cannulation for blood collection- Blood sampling T=0, 15, 30, 45, 60, 120, 240 and 480 min- Urine and feces collection T=0, 0-8 hrs and 8-24 hrs- Brain, liver and kidney tissue collection T=24 hrs
18LEXAP1 (08/18)
- DehydraTECH™ nicotine polacrilex vs. positive control- 10 mg/Kg (oral gavage)- 40 male Sprague Dawley rats (2 groups of 20)- Jugular vein cannulation for blood collection- Blood sampling T=0, 2, 4, 6, 8, 12, 15, 30, 45 and 60 min- Urine and feces collection T=0, 0-8 hrs and 8-24 hrs- Brain, liver and kidney tissue collection T=1, 4, 8 and 24 hrs
22Investor Presentation
17LEXAP1 Nicotine PK Results
560% higher brain levelsof nicotine where nicotine effects are focused, compared to controls.
0
100
200
300
400
Control DehydraTECH
Gain in Nictone Cmax
TM
ng/
mL
0
100
200
300
400
Control DehydraTECH
Brain Levels of Nicotine
ng/
g
TM
≤15 min
ng/
mL
TM
Time to reach Nicotine Control Cmax
0
1
2
3
4
Control DehydraTECH
2.9hrs
48% improvement in peak Cmax nicotine delivery to the bloodstream relative to controls.
1,160% faster deliveryof equivalent peak Cmax
quantities of nicotine to the bloodstream than achieved with controls (within 15 min vs. 2.9 hours).
Cmax = Peak blood plasma concentration
23Investor Presentation
17LEXAP1 Additional Findings of Interest
• Lower urine levels of nicotine excreted than controls (indicating enhanced nicotine activity and bioavailability over the course of the study);
• Lower liver metabolite levels (hydroxycotinine, nicotine N’-oxide and cotinine) in the bloodstream than controls as hypothesized (suggesting liver bypass);
• Treatment was generally well tolerated with no SAEs or obvious signs of diarrhea or vomiting in the animals reported.
24Investor Presentation
70% more
nicotine delivered overall
within first 15
min of study
(p=0.0004)
90%more
nicotine delivered at 10
minute mark
(p=0.044)
94%more
nicotine delivered over the
60 min study period(p=0.0086)
18LEXAP1 Nicotine PK Results
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) 203 120 70 0.0004
Peak Nicotine Blood Level 0-60
min (ng/mL) 394 220 79 0.0257
Total Nicotine Absorption (i.e.,
AUC) 0-60 min (hr∙ng/mL) 266 137 94 0.0086
25Investor Presentation
18LEXAP1 Nicotine PK Results (cont’d)
DehydraTECH™ Formulation
(ng/mL)
Control Formulation
(ng/mL) % Improvement pValue
2 minutes 56.68 105.57 -46.32 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 0.008632357NOTE: No AEs reported.
26Investor Presentation
Control DehydraTECH™ % Improvement(10 mg/Kg) (10 mg/Kg)
Nicotine: Blood-Brain-Barrier Results SummarySignificant nicotine absorption increase across the Blood-Brain Barrier into brain tissue:
40 lab rat testAug 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%
04Total Quantity in Brain Tissue (AUC; hr·ng/g)
5,881 ± 538 12,999 ± 1252 221%
27Investor Presentation
NMR Molecular Characterization To-Date
Nicotine Polacrilex infused mannitol (0 day)
Fatty acid oil
Polacrilex standard
Fatty acid oil signals
28Investor Presentation
Key Executives & Advisors
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.
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
Dr. Edward Ergenzinger
Chief Legal, SVP Innovation
Dr. Philip AinslieAdvisor
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.
Dr. Dwayne GodwinAdvisor
Dr. Terry BlumenthalAdvisor
Dr. Matthew FraserAdvisor
Dr. Carla Lema TomeAdvisor
29Investor Presentation
Corporate Information
29
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
[email protected] [email protected] [email protected]
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