Drug Delivery Platform Innovator Corporate Presentation April 2020 - - PowerPoint PPT Presentation

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Drug Delivery Platform Innovator Corporate Presentation April 2020 - - PowerPoint PPT Presentation

Lexaria Bioscience Corp. LXRP:US | LXX:CSE Drug Delivery Platform Innovator Corporate Presentation April 2020 LexariaBioscience.com 1 Disclaimer This presentation includes forward-looking statements within the meaning of Section 27A of


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

Corporate Presentation April 2020 LexariaBioscience.com

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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.

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Lexaria Bioscience – Corporate Highlights

▪ Introducing Lexaria’s disruptive, patented DehydraTECH™:

▪ DehydraTECH changes how the body detects and absorbs lipophilic (i.e. fat soluble) beneficial compounds; ▪ Faster onset/offset and higher bioavailability in capsules, pills, foods, liquids, 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

▪ Lexaria is focused on commercializing its DehydraTECH technology mainly through strategic partners and licensees in the pharmaceutical and consumer products industries ▪ In-use in CPG products sold in the USA ▪ Human studies beginning for DehydraTECH application to antivirals (COVID-19 and other conditions) ▪ Applied R&D ongoing for new CPG/pharma offerings for Nicotine, NSAIDs (Ibuprofen, Aspirin) PDE5 Inhibitors (Viagra, Cialis) and other compounds

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Method of Use, Composition of Matter and Medical Treatment Claims

  • Multiple active ingredients
  • Multiple dosage forms – oral

powders, foods, liquid emulsions, tablets, capsules, etc.

~60

Patent Applications

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Patent Families

16

Patents Granted 8 USA 8 Australia

DehydraTECH™ Patent Portfolio

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DehydraTECH – Patented Technology Benefits

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

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].

  • Increases speed of bioabsorption
  • Increases bioavailability (peak and total quantity of

absorption)

  • Reduces financial costs of drug treatments
  • Improves potency at a given drug dose for greater

tolerability

  • Increases brain absorption for CNS-targeted molecules

Main Benefits

  • Improves palatability for oral drugs
  • Inexpensive to implement

Additional Benefits

Human Case Study – DehydraTECH Cannabidiol Absorption 90 mg DehydraTECH (D 90mg) vs. 100 mg Comparator (PTL101)

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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.: 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.: Cannabidiol Colloidal Complex

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

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Investor Presentation

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Pharma Programs

Antiviral Therapies for COVID-19 and other Infectious Diseases

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COVID-19 Pandemic

  • Global pandemic spreading uncontrollably
  • No available preventative vaccine
  • Researchers world-wide are investigating

antiviral and other therapies to potentially fight infection

  • Oral therapies needed for mass distribution
  • Many oral antiviral drugs are fat soluble

and poorly absorbed orally, compromising potency and are exceptionally expensive, limiting access if hundreds of millions of doses are required.

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Symptoms of COVID-19

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DehydraTECH Antiviral Research Beginning

  • DehydraTECH is clinically proven to significantly

increase bioavailability for fat soluble drugs

  • Initial study testing three antiviral medications
  • Pilot human study at a leading Canadian

university planned

  • Objective is to increase potency for greater

therapeutic response and tolerability and to lower cost

  • Research expected to lead to expanded safety and

efficacy testing in coronavirus and other infectious disease animal models

  • Significant strategic partnering potential
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Broad Drug Classes – COVID-19 & other Infectious Diseases

COVID-19 HIV HSV Influenza EBV HEP CMV

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Pharma Pipeline - DehydraTECH

Antiviral therapies (COVID-19) and

  • ther infectious

diseases Drug Selection In vivo PK/PD/ Tox Phase I/II/III Clinicals CBD therapeutics

(potential utility against hypertension; seizure disorders and other indications)

Research Expansion

(Nicotine Replacement Therapies, NSAIDs, PDE5 inhibitors and other molecules)

Nicotine NRT NSAIDs and PDE5 Inhibitors

Future Directions Underway

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Possible Pharma Expansion – DehydraTECH CBD for BP Reduction

BP = Blood Pressure (expressed in millimetres of mercury)

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Cannabinoid Products CPG Industry

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Cannabinoid Products CPG Industry

▪ DehydraTECH is proven to cost-effectively enhance bioavailability, performance and palatability of cannabinoids such as CBD and THC in oral and topical product formats ▪ Lexaria has out-licensed DehydraTECH to companies in the sector for their product offerings ▪ Lexaria has additionally developed its own formulations for and the ability to service the growing CBD CPG products industry specifically ▪ The Food and Drug Administration has begun to engage Congress (announced March 2020) on rulemaking for CBD dietary supplement commercialization in the US ▪ Lexaria plans to grow revenues in the CBD CPG products industry through white label distribution and

  • ut-licensing of its DehydraTECH technology with strategic partners where regulations allow
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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.

Source: Patrician A et al., 2019; Advances in Therapy.

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CBD CPG Market Growth Projections

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CONFIDENTIAL

Company Substance Territory Term Category Estimated Operations Launch Cannadips CBD/Cannabis USA 10-Year Oral Pouch and Dip Q2/2020 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 Confectionary Q2/2020 Nuka’s 1906-Brands Cannabis OH, IL, MA, CO, MI 10-Year Confectionary, 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

Growing Universe of DehydraTECH Licensees

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Investor Presentation

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Nicotine Oral CPG Applications

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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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Nicotine Oral CPG Products Opportunity

▪ DehydraTECH oral nicotine formulations have been developed and shown to enable enhanced bioavailability and brain tissue permeability in in vivo animal testing ▪ Lexaria received $1M in funding from the Altria Group to support expanded oral nicotine formulation development and testing through 2019 in exchange for license rights ▪ Lexaria intends to pursue development of its oral nicotine product innovations through to commercial launch pending further strategic partner funding and support

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Example Blood Absorption Data

DehydraTECH™ Formulation (ng/mL) Control Formulation (ng/mL) % Improvement p Value 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. p Value < 0.05 signifies statistical significance

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Brain Tissue PK Data Highlighted

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

April 2018

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

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%

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

Maximum 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 2018

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SUMMARY

▪ Clinically proven DehydraTECH technology for enhancing bioavailability of fat soluble compounds for increased potency, tolerability and cost effectiveness ▪ Focused on pharmaceutical applications to improve therapeutics for COVID-19 and

  • ther infectious diseases

▪ Opportunities to expand into additional pharmaceutical therapeutic applications including prospective CBD therapies for hypertension and seizure disorders, Nicotine Replacement Therapies to help quit smoking and improved NSAID and PDE5 inhibitor product offerings ▪ Also pursuing revenue growth in the cannabinoid and nicotine CPG products sectors

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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

  • Named inventor on multiple issued and

pending patents

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. 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
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LXRP:OTCQX LXX:CSE

Shares outstanding 81M Fully diluted 85M Insider ownership Over 18M (22%) Market cap (March 2020) US$25M Last financing (Nov, 2019) US$1.5M (@ US$0.45/unit)

Corporate and Financial Information

www.LexariaBioscience.com

Product & License Inquiries: info@LexariaBioscience.com