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

lexaria bioscience corp lxrp us lxx cse drug delivery
SMART_READER_LITE
LIVE PREVIEW

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

Lexaria Bioscience Corp. LXRP:US | LXX:CSE Drug Delivery Platform Innovator Corporate Presentation November 2019 LexariaBioscience.com 1 Disclaimer This presentation includes forward-looking statements within the meaning of Section 27A


slide-1
SLIDE 1

1

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

Corporate Presentation November 2019 LexariaBioscience.com

slide-2
SLIDE 2

2

Disclaimer

This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E

  • f 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

  • r services

for participation and/or financing, competitive positions, growth opportunities, plans and objectives of management for future

  • perations, 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

  • bligation, 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.

2

slide-3
SLIDE 3

3

Lexaria is initally focused on disrupting the $990B nicotine and $14B cannabis markets

Lexaria Bioscience – Corporate Highlights

▪ Lexaria out-licenses its disruptive patented technology platform for fast, flavorless & more effective oral drug delivery as a healthier alternative to common consumer product formats such as smoking/vaping: ▪

Nicotine, Cannabinoids, NSAIDs, Fat-Soluble Vitamins, PDE5 Inhibitors

▪ Introducing Lexaria’s patented DehydraTECH™:

▪ DehydraTECH’s dehydration processing reaction changes how the body detects and absorbs drugs; ▪ Faster onset/offset and higher bioavailability in capsules, foods, liquids, mixable powders, etc.; ▪ Also tested in topical product formats with faster/higher bioabsorption rates; and ▪ 16 patents granted (>60 pending) covering method-of-use, composition-of-matter and medical treatment claims

▪ Partnered with Altria Group to disrupt the $990 billion global nicotine market

▪ Up to $12 million Altria-funded R&D partnership & license to develop oral nicotine consumer products

▪ 8 existing cannabinoid (THC, CBD) licensees utilizing DehydraTECH ▪ Also applicable to fat-soluble vitamins, NSAIDs (Ibuprofen, Aspirin) and PDE5 Inhibitors (Viagra, Cialis)

slide-4
SLIDE 4

4

Simple and cost effective Increases bioavailability Improves speed of onset Masks unwanted taste

Eliminates the need for sugar- filled edibles. Competitive with less healthy methods like inhalation Effects are felt within 10-20 min (vs. 60-120 min). Easy to implement

DehydraTECH – Patented Technology Benefits

Patented technology changes how Active Pharmaceutical Ingredients (APIs) enter the body orally Increases brain absorption

Animal testing confirms up to 19x improvement

slide-5
SLIDE 5

5

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.: sorbitol, gum Arabic, etc.

3) Perform dehydration procedure

*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

e.g.: ∆9-THC Colloidal Complex ∆9-THC

11-OH-THC

4) Render as powder or liquid nanoemulsion suitable for use in desired final form factor

slide-6
SLIDE 6

6

6

Form Factor Flexibility

slide-7
SLIDE 7

7

Company Substance Territory Term Category Estimated Operations Launch Altria Ventures Inc. Nicotine USA Indefinite Oral Products TBD Nukas’ 1906-Brands CBD/Hemp USA 10-Year Beverages Q2/2020 Unamed CBD/Hemp USA 5-Year Beverages Q4/2019 Universal Hemp CBD/Hemp USA and Canada 5-Year Dry food ingredients Q1/2020 Nic’s Beverages CBD/Hemp USA 5-Year Beverages Q4/2019 Hill Street Beverage CBD/Hemp Global except Mexico 10-Year Beverages Q2/2000 Hill Street and Lexaria JV CBD/Hemp Global except Mexico 10-Year Multiple Q2/2020 Cannfections Cannabis Canada 7-Year Chocolates and Candies Q2/2020 Nuka’s 1906-Brands Cannabis OH, IL, MA, CO, MI 10-Yesr Candies, Chocolates, Beverages Q4/2019 Unamed Cannabis California 5 Year Beverages Q4/2019 Hill Street Beverages Cannabis Global except Mexico 10-Year Beverages Q1/2020 Hill Street and Lexaria Joint Venture Cannabis Global Except Mexico 10-Year Multiple Q2/2020

Nine Corporate Licensees and Counting…

slide-8
SLIDE 8

8

8

Cannabinoids | THC | CBD Oral Delivery

slide-9
SLIDE 9

9

9 Key Insights

  • 1. Trend away from cannabis smoking
  • 2. Trend to limit dosage in edibles
  • 3. Trend towards beverages and edibles

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

  • 1. DehydraTECH™ improves alternate delivery methods
  • 2. DehydraTECH™ improves cannabinoid absorption
  • 3. DehydraTECH™ spans foods, beverages, nutritional supplements

and more

Non-Flower Consumption Continues To Gain Market Share

slide-10
SLIDE 10

10

10

  • 90mg DehydraTECH dose vs. Competitor 100mg dose
  • Competitor delivers virtually zero CBD at 30 minutes
  • Lexaria quicker “on” and quicker “off”

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

  • 1. Inhalation
  • High bioavailability (~32%), harmful to Lungs
  • 2. Sub-lingual (under tongue)
  • Medium bioavailability (~16%), foul taste
  • 3. Oral – Gastrointestinal Tract
  • Low bioavailability (~3-5%), sugar filled to

mask taste DehydraTECHTM (Oral Technology) Transforms the way cannabinoids enter the bloodstream through the gastrointestinal tract

  • Fast Acting
  • Improved Taste
  • Increased Bioavailability
  • Improved Brain Barrier Penetration

Methods of Cannabinoid Consumption CASE STUDY: TurboCBD™ - Lexaria’s Oral CBD Product

DehydraTECHTM for Cannabinoids - Faster and More Effective Delivery

Faster onset and offset; higher peak concentration

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].

slide-11
SLIDE 11

11

Case Study: TurboCBD™ - Clinically Proven Blood/Body Response Benefits

  • 2018 European human

clinical study (n=12)

  • Double-blind, 90 mg CBD dose
  • 317% more CBD delivered

≤ 30 min (only TurboCBD 90 > placebo; p<0.05)

  • Higher CBD delivery

throughout entire study

  • Lower blood pressure

shown vs. baseline (p < 0.05)

  • Higher cerebral perfusion

shown vs. baseline (p < 0.001 )

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.

slide-12
SLIDE 12

12

TurboCBD™ BP and Cerebral Perfusion Effects

slide-13
SLIDE 13

14

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).

DehydraTECH™ Outperforms Typical MCT Formulations

475% more CBD Delivered @ 15 min. 334% higher Cmax

  • ver 60 min.

ng/mL

slide-14
SLIDE 14

15

Investor Presentation

10 male Sprague-Dawley rats were administered an identically sourced CBD at a rate of 25mg per kg of bodyweight. Delivery of CBD into the bloodstream was measured at 2; 4; 6; 8; 12; 15; 30; 45; and 60 minutes after dosing. Enhanced DehydraTECH delivered roughly twice as much CBD to animal blood at all measured time points in the study from the 15-minute mark onwards, compared to traditional DehydraTECH; and during the same time points from 717% to 1098% more CBD than the generic industry MCT coconut oil formulations. Enhanced DehydraTECH delivered more CBD to blood in just 12 minutes than the MCT coconut-oil formulation was able to achieve at any point during the 1- hour test duration. Enhanced DehydraTECH is even faster acting, reaching a maximum blood concentration level (“Tmax”) in just 45 minutes compared to traditional DehydraTECH at 50 minutes and the MCT coconut oil formulation at 57 minutes. Also of note, Enhanced DehydraTECH delivered 1,937% more CBD into animal brain tissue after 8 hours compared to generic industry MCT coconut oil formulations; and 487% more than traditional DehydraTECH.

“DehydraTECH™ 2.0” Formulation Development Underway

slide-15
SLIDE 15

16

Investor Presentation

“DehydraTECH™ 2.0” CBD Brain Absorption Data

Formulation Brain Tissue Concentration (ng/g) 8 hours 24 hours MCT Generic Formulation 13.5 ND Traditional DehydraTECH™ 46.8 2.49 Enhanced DehydraTECH™ 275 6.21

slide-16
SLIDE 16

17

Investor Presentation

17

Nicotine Oral Delivery Forms

LexariaNicotineCo.com

slide-17
SLIDE 17

18

Lexaria Nicotine LLC: Oral Nicotine Delivery

  • Press released January 15 2019: partnership to create

ingestible/oral nicotine products

  • Up to $12 million multi-year R&D milestones funded by

Altria Group ($1 million initial funding)

  • Altria is fully responsible for R&D; product development;

regulatory approval and product commercialization

  • Altria license: exclusive in U.S.; non-exclusive globally
  • Undisclosed royalty on oral nicotine product sales utilizing

DehydraTECH

Oral Nicotine (Non-Smoking Alternative)

  • 70% of U.S. smokers wish to quit; 50% attempt & fail each

year; 6% succeed

  • ~10% of global tobacco market (and increasing) is from

non-combustible products (~$99B)

  • An orally-ingestible nicotine product is an eloquent

solution

  • The FDA has authorized the marketing of oral nicotine

products through the Modified Risk Tobacco Product pathway, including product categories that could benefit from Lexaria’s technology

+

Altria Group Partnership

Majority Interest Minority Interest

Sources: FDA (www.fda.gov) World Health Organization (www.who.int); Foundation for a Smoke-Free World, Inc. (www.smokefreeworld.org); Partnership for Drug-Free Kids (www.drugfree.org)

slide-18
SLIDE 18

19

  • Market Cap: US$80B as of October 14 2019
  • Altria owns a portfolio of global tobacco brands including:

Phillip Morris (Marlboro, Virginia Slims, Benson & Hedges, etc.), John Middleton Inc. and Nat Sherman

  • Altria Group is the U.S. leader in authorized non-

combustible reduced risk products

  • Initial funding of $1M within $12M based upon milestone

achievements

  • Technology licensed to Altria Group in exchange for royalty

fees

  • Smokeless/non-combustible products represent the fastest

growing portion of Altria’s revenue

  • Of Altria’s $25.4B of revenue in 2018, $2.3B or ~9% comes

from smokeless products

Source: Altria Group 2018 Annual Report

Lexaria Nicotine – Commercial Strategy

royalty $2.3B smokeless revenue $25.4B total revenue

About Altria Group (NYSE: MO) Dominant U.S. Market Share

slide-19
SLIDE 19

20

DehydraTECH™ PK Studies with Nicotine To-Date

18LEXAP1 (08/18)

  • DehydraTECH™ nicotine polacrilex vs. positive control
  • 10 mg/Kg (oral gavage)
  • DehydraTECH™ formulation: Nicotine polacrilex + sunflower
  • il + infusion substrate
  • Control formulation: Nicotine polacrilex + infusion substrate
  • 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

50 100 150 200 250 300 350 400 450 0.033 0.067 0.1 0.13 0.17 0.2 0.25 0.5 0.75 1

Nicotine Absorption (ng/mL) in SD Rats @ 10 mg/Kg (n=20/group)

Nicotine Control DehydraTECH Nicotine

slide-20
SLIDE 20

21

18LEXAP1 Blood Absorption Data

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.

slide-21
SLIDE 21

22

Brain Tissue PK Data Highlighted

17LEXAP1 - Study of 12 lab rats with Brain Testing at 24 hours

April 17, 2018

Test Control Formulation (10 mg/Kg) Lexaria Formulation (10 mg/Kg) % Improvement

Maxiumum 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%

Test Control Formulation (10 mg/Kg) Lexaria Formulation (10 mg/Kg) % Improvement

Maxiumum Brain Concentration (Cmax; ng/g) 51.8 ± 30.4 290 ± 197 560%

18LEXAP1 - Study of 40 lab rats with Brain Testing at 1, 4, 8 and 24 hours

August 7, 2018

slide-22
SLIDE 22

23

NMR Molecular Characterization To-Date

Nicotine

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

Fatty acid oil signals

slide-23
SLIDE 23

24

Chris Bunka Chairman & CEO

  • 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

John Docherty, M.Sc. President

  • 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

Key Executives, Directors and Advisors

  • Dr. Edward Ergenzinger Chief Legal, SVP Innovation
  • U.S. licensed patent attorney
  • Doctorate in Neuroscience (Pharmacology and Physiology)
  • Over 15 years patent services from small start-ups to some of the world’s largest

biotechnology companies

  • Dr. Philip Ainslie Scientific & Medical Advisor
  • 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

Jamieson Bondarenko, CFA, CMT Capital Markets Advisor

  • Capital Markets Advisor to MustGrow Biologics
  • Chairman of BriaCell Therapeutics
  • Previous Equity Capital Markets roles with Eight Capital, Dundee Securities, HSBC

Brian Quigley Director

  • Co-Founder of cannabis consulting firm, Green Sky Strategy
  • 16 years at Altria Group; with seven of those years spent as president and CEO

for U.S. Smokeless Tobacco and Nu-Mark

Gregg Smith Strategic Advisor

  • Founder and Private Investor, Evolution VC Partners
  • Early JUUL Labs, Pax Labs, Beyond Meat investor
  • Member of Sand Hill Angels – active Silicon Valley angel investment group
  • Previous Investment Banking roles with Cowen and Company, BOA Merrill Lynch
slide-24
SLIDE 24

25

25

LXRP:OTCQX LXX:CSE

Shares outstanding 78M Fully diluted 86M Price (Oct 28 2019) US$0.67 Insider ownership 15M (20%) Market cap (Oct 28 2019) US$53M Last financing (Oct 2018) US$1.5M (@ US$1.60/unit)

Corporate and Financial Information

www.LexariaBioscience.com

Product & License Inquiries: info@LexariaBioscience.com Investor Relations: Alex Blanchard ablanchard@LexariaBioscience.com