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Lexaria Bioscience Corp. LXRP:US | LXX:CSE Drug Delivery Platform Innovator
Corporate Presentation April 2020 LexariaBioscience.com
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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Corporate Presentation April 2020 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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▪ 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
powders, foods, liquid emulsions, tablets, capsules, etc.
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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
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].
absorption)
tolerability
Main Benefits
Additional Benefits
Human Case Study – DehydraTECH Cannabidiol Absorption 90 mg DehydraTECH (D 90mg) vs. 100 mg Comparator (PTL101)
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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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Antiviral Therapies for COVID-19 and other Infectious Diseases
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increase bioavailability for fat soluble drugs
university planned
therapeutic response and tolerability and to lower cost
efficacy testing in coronavirus and other infectious disease animal models
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COVID-19 HIV HSV Influenza EBV HEP CMV
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Antiviral therapies (COVID-19) and
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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BP = Blood Pressure (expressed in millimetres of mercury)
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▪ 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
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clinical study (n=12)
≤ 30 min (only TurboCBD 90 > placebo; p<0.05)
throughout entire study
shown vs. baseline (p < 0.05)
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
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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.
Source: Patrician A et al., 2019; Advances in Therapy.
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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
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Investor Presentation
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due to nicotine’s inability to securely pass through the GI tract without irritation.
pledges $1B to anti-smoking
smokers globally
deaths/year globally
deaths expected this century
lowering nicotine in cigarettes to non- addictive levels
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.”
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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▪ 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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DehydraTECH™ Formulation (ng/mL) Control Formulation (ng/mL) % Improvement p Value 2 minutes 56.68 105.57
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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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; hrng/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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Chris Bunka Chairman & CEO
private and public companies since the late 1980’s
markets, corporate governance, M&A and finance
pending patents
John Docherty, M.Sc. President
delivery technologies
BioPharma Corp. (TSX: HBP)
pending patents
toxicology from the University of Toronto
and Exercise Sciences, Faculty of Health and Social Development at the University of British Columbia
Jamieson Bondarenko, CFA, CMT Capital Markets Advisor
Brian Quigley Director
for U.S. Smokeless Tobacco and Nu-Mark
Gregg Smith Strategic Advisor
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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)
Product & License Inquiries: info@LexariaBioscience.com