Lexaria Bioscience Corp. Are Edible Nicotine Formats Finally - - PowerPoint PPT Presentation

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Lexaria Bioscience Corp. Are Edible Nicotine Formats Finally Possible?

April 24th 2018 www.LexariaBioscience.com LXX:CSE | LXRP:US

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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 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 objectives 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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Drug Delivery Platform Innovator

• Patented technology changes the way Active Pharmaceutical Ingredients

(“APIs”) enter the body orally:

• Masks unwanted tastes

– Eliminates the need for sugar-filled edibles.

• Reduces the time of onset

– Effects are felt within 15-20 min (vs. 60-120 min).

• Avoids first-pass liver metabolism

– Mitigating unwanted side effects.

• Increases bio-absorption (up to 5-10X)

– Equates absorption by inhalational delivery.

• DehydraTECH™ patents covers multiple APIs, e.g.:

– Cannabinoids – CBD, THC, etc. – Nicotine (and its analogs), – NSAIDs – Ibuprofen, ASA, etc.

• Business Model:

– Out-license (royalty) technology to third party partners, – Sales of Lexaria products. 3

Lexaria Bioscience has developed a new disruptive drug delivery platform: DehydraTECH™

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Tobacco Landscape is Shifting

July 28, 2017: FDA announces comprehensive regulatory plan to shift trajectory of tobacco- related disease, death

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September 28, 2017: Philip Morris shuffles management on its quest toward a smoke-free future March 15, 2018: FDA issues an advance notice

• f proposed rulemaking

seeking public comment through June 14, 2018 for consideration in developing a nicotine product standard to lower nicotine to non- addictive level. March 27, 2018: Health & medical groups sue FDA over e-cigarette rule delay that allows e- cigarettes to remain on the market for years without regulatory review. January 25, 2018: Reuters: U.S. panel rejects Philip Morris claim iQOS (e- cigarettes) reduces disease risk March 20, 2018: CNBC: The FDA considers banning or restricting menthol and other flavors from tobacco products. November 29, 2017: Reuters: FDA moves to speed up nicotine replacement product development

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Nicotine – Good Drug, Bad Delivery?

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Separating the Dependence from the Harm

• Nicotine is highly addictive, but not deadly.
• Addictiveness alone doesn't necessarily make a product dangerous.
• The burning or combustion of tobacco

and other substances inhaled through smoking causes cancer, heart disease and bronchitis.*

• 70% of U.S. smokers wish to quit; 50%

fail each year; 6% succeed.**

"The overwhelming amount of the death and disease attributable to tobacco is caused by addiction to cigarettes. Addiction causes long-term sustained use. But it’s exposure to the harmful chemicals [from combustion] that causes disease.” – FDA Commissioner Dr. Scott Gottlieb

*World Health Organization (http://www.who.int) ** Partnership for Drug-Free Kids (https://www.drugfree.org)

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Is Nicotine Harmful?

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* Survey conducted by Kantar Public, which was engaged by the Foundation for a Smoke-Free World, Inc.

FDA Commissioner Dr. Scott Gottlieb Weighs In…

• “The issue is not the nicotine, it's the combustion."
• “Nicotine's not a completely benign substance but it doesn't cause cancer.”
• “If we can get people who want access to nicotine on to medicinal products, for example, or products that don't

have all the risks associated with combustion, we can save a lot of lives.“

• "We must make it possible for current adult smokers who still seek nicotine to get it from alternative and less

harmful sources.”

More Education is Needed…

• 41% of U.S. smokers incorrectly believe nicotine in e-cigarettes causes lung cancer*
• 39% of U.S. smokers incorrectly believe nicotine in e-cigarettes causes throat cancer*
• 38% of U.S. smokers incorrectly believe nicotine in e-cigarettes causes heart disease*
• When asked whether moderate daily use of various substances was harmful, more U.S. smokers incorrectly

selected nicotine than: sugar, fat, caffeine, alcohol, and salt.*

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Smoking – A Bad Habit

Deeply Integrated

• Smoking isn’t just a physical addiction for smokers, it’s also a deeply engrained behavioral, emotional, and social

part of their lives.*

• People smoke a few minutes after waking up, after a meal, while drinking alcohol, while drinking coffee or tea,

and when people around are smoking.*

New Nicotine Delivery Solutions are Needed

• The FDA is moving to speed up nicotine replacement product development, including easing requirements for

approval of over-the-counter nicotine replacement therapies.

• “…the FDA intends to be open to innovation and it wants to talk about how to foster that innovation...” - Matthew

Myers, president of the Campaign for Tobacco-Free Kids An ingestible nicotine food/beverage product is an eloquent solution and would satiate not only the physical nicotine craving, but also the behavioral, emotional and social aspects. 7

* Survey conducted by Kantar Public, which was engaged by the Foundation for a Smoke-Free World, Inc.

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Existing Smoking Alternatives

Nicotine Replacement Therapies (NRTs)

• Patch: Ineffective; Overlooks behavioral, emotional, and social needs of smokers, 24-hour delivery interferes with

sleeping

• Oral & Chewing: Ineffective; Gum/mouth diseases; GI distress if swallowed
• Prescription Medication: Interferes with brain receptors; Reports of depression, nausea, headaches, difficulty sleeping

Vaporizer Devices, Liquid Nicotine, E-Cigarettes

• Inconclusive studies on risk & disease reduction and effectiveness in smoking cessation
• Some research shows that e-cigarettes are a gateway to regular smoking for adolescents, while other studies show that

the liquid vapor may contain harmful, even cancer-causing chemicals.

• Despite these concerns, use is on the rise among teens.
• "If these trends continue, the viability of the e-cigarettes and vaping products as an alternative for adult smokers could

be lost. It just won't be acceptable.” – FDA Commissioner Dr. Scott Gottlieb 8

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Lexaria’s Revolutionary Edible DehydraTECH™

Why don’t edible nicotine products already exist?

• GI: Gastro-intestinal tract (“GI”) rejects nicotine once identified, causing severe GI-distress
• Rapidity: First-pass liver metabolism could take 60-90 min; too long to satiate a craving
• Flavour: Nicotine’s bitter flavour would need to be covered with unhealthy sweeteners
• Bioavailability: Typically only 3-5% of ingested APIs are absorbed into the bloodstream

Lexaria’s patented DehydraTECHTM edible format:

• GI: The GI tract is not able to identify the co-localized nicotine & lipid (fatty-acid) molecules
• Rapidity: DehydraTECHTM is believed to bypass first-pass liver metabolism; 15 minute onset or less – up to 10x faster
• Flavour: DehydraTECHTM co-localized molecules shunt flavour receptors in the mouth that detect bitterness
• Bioavailability: Studies show up to 5-10x increase in absorption of ingestible APIs

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How does DehydraTECHTM 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

Nicotine Polacrilex LCFA: sunflower oil +

2) Apply to food/carrier particles

e.g.: mannitol, 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

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Breakthrough DehydraTECH™ Study

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• Absorption and tolerability study
• Nicotine Polacrilex formulated with and without DehydraTECH™

technology

• Four groups of Sprague-Dawley rats (n=12)
• 1 mg/Kg and 10 mg/Kg doses
• Comparative levels of nicotine and key nicotine liver metabolites

evaluated in blood, waste and select tissues.

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Major Topline Study Findings

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• 148% gain in peak Cmaxnicotine delivery to the

bloodstream relative to controls;

• 1,160% faster delivery of equivalent peak Cmax

quantities of nicotine to the bloodstream than achieved with controls (within 15 min vs. 2.9 hours);

• 560% higher brain levels of nicotine where nicotine

effects are focused, compared to controls;

Cmax = Peak blood plasma concentration

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

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Additional Study Findings…

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• Lower urine levels of nicotine excreted than controls (indicating enhanced

nicotine activity and bioavailability over the course of the study);

• Lower liver metabolite levels in the bloodstream than controls as hypothesized

(suggesting liver bypass);

• Treatment was generally well tolerated with no obvious signs of diarrhea or

vomiting in the animals.

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Conclusions and Next Steps

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• Lexaria’s DehydraTECH™ technology demonstrated rapid and substantial

ingestible nicotine absorption enhancement supporting further development and testing

• DehydraTECH™ showed promise both for use as an NRT and an alternative

delivery method for regular tobacco users.

• Expanded animal and human clinical trial planning underway.

>>> Drug Delivery Platform Innovation >>>

Company Information

Trading symbol: CSE:LXX, OTCQB:LXRP Shares o/s: 70 m Fully diluted: 80 m Recent price: US$1.10 Insider ownership: 15m (21%) Fiscal year-end: August 31 Cash on hand: US$ 2.3M (Feb 28) 15

Contact Information

Chris Bunka, CEO 250 765 6424 cbunka@lexariabioscience.com John Docherty, President 905 439 5423 jdocherty@lexariabioscience.com Alex Blanchard, Manager Corporate Communications & Investor Relations 778 796-1897 ablanchard@lexariabioscience.com

www.LexariaBioscience.com

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