Lexaria Bioscience Corp. LXX:CSE | LXRP:US Drug Delivery - - PowerPoint PPT Presentation

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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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Lexaria Bioscience Corp. LXX:CSE | LXRP:US Drug Delivery Platform Innovator

Investor Presentation May 2019 LexariaBioscience.com

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Investor Presentation

Disclaimer

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

  • bjectives 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. 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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Investor Presentation

Simple and cost effective Increases bioavailability Improves speed

  • f 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.

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Investor 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

10

Patent Families

11

Patents Granted 6 USA 5 Australia

DehydraTECH™ Patent Portfolio

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Investor Presentation

Nicotine NSAIDs Vitamins Cannabis

Commercial Applications

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  • 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

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Cannabinoids | THC | CBD Oral Delivery

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Cannabinoids: Entering the Blood Stream

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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 Tract

Low bioavailability (est. 3-5%) Sugar filled, to mask taste

DehydraTECHTM

transforms the way cannabinoids enter the bloodstream through the Gastrointestinal Tract:

Fast Acting Improved Taste Increased Bioavailability

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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 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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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

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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 Ingredient LCFA = Long Chain Fatty Acid; MCFA = Medium Chain Fatty Acid

Colloidal Complex Cannabidiol

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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 pressure

shown vs. placebo (95% CI, p=0.027)

  • Higher cerebral perfusion

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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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 CBD Delivered @ 15 min. 334% higher Cmax

  • ver 60 min.
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TurboCBD™ Absorption - Market Comparator

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.

  • Faster onset and offset
  • Higher peak concentration
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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

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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

Business Model: Royalties & Sales

1906 New Highs

(Colorado)

Hill Street Beverages

(TSX.V:BEER )

Cannfections Group

(Canada)

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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

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Lexaria Nicotine Oral Nicotine Delivery Forms

LexariaNicotineCo.com

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Nicotine: a smoke-free future?

No Nicotine 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”

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Altria Group Inc.

Funding Partner, DehydraTECH Licensee

Leading nicotine industry participant Patented

  • ral-based

delivery technique

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

  • 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

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Completing the puzzle for Oral Nicotine Forms

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

  • 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.
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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
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17LEXAP1 Nicotine PK Results

560% higher brain levels

  • f nicotine where

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

  • f 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

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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
  • r vomiting in the animals reported.
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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

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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 0.008632357 NOTE: No AEs reported.

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Control DehydraTECH™ % Improvement

(10 mg/Kg) (10 mg/Kg)

Nicotine: Blood-Brain-Barrier Results Summary

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%

04

Total Quantity in Brain Tissue

(AUC; hr·ng/g)

5,881 ± 538 12,999 ± 1252 221%

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NMR Molecular Characterization To-Date

Nicotine

Polacrilex infused mannitol (0 day) Fatty acid oil Polacrilex standard

Fatty acid oil signals

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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

  • f 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 Ainslie

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.

  • Dr. Dwayne Godwin

Advisor

  • Dr. Terry Blumenthal

Advisor

  • Dr. Matthew Fraser

Advisor

  • Dr. Carla Lema Tome

Advisor

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Investor Presentation

Corporate Information

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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