safe harbor statement - vitality biopharma · 15/02/2017  · partners, capital market conditions,...

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Page 1: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors
Page 2: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

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Safe Harbor Statement

This presentation and our commentary and responses to your questions may contain forward-looking statements, including

comments concerning drug development programs, evaluation of potential opportunities, the level of corporate expenditures,

the assessment of our technology by potential corporate partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning

factors that could cause actual results to differ materially from those set forth in our regulatory filings from time to time.

Page 3: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Company Background In 2015, we discovered that stevia UGT enzymes could

enable production of a new class of cannabinoid prodrugs

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Superpositioning of a steviol glycoside with cannabidiol

A drug development company, using cannabinoids to treat serious neurological and inflammatory disorders

Page 4: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Leadership entrepreneurial team focused on biotechnology and life sciences

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Anthony Maida, PhD, MBA, Director, Chair of Audit Committee

Senior Vice President, Clinical Research, Northwest Bio

MBA, MA in Toxicology, PhD in Immunology

Robert Brooke, CEO,Co-founder

Former hedge fund analyst at Bristol Capital for over 50 direct healthcare investments; Experienced biotech entrepreneur, Founder of Genesis, now Lion Biotech (NASDAQ:LBIO), Co-Founder of Intervene Immune

B.S. in Elec. Eng., Georgia Tech; M.S. in Biomedical /Neuroengineering, UCLA

Avtar Dhillon, MD, Chairman & Co-founder

Chairman, Inovio Pharmaceuticals, Oncosec Medical, and Arch Therapeutics

Raised $200M in public markets over last 10 years

Former venture capitalist and family physician for > 10 years

Richard McKilligan, JD, MBA, Controller & Counsel

Ex-Morgan, Lewis, & Bockius LLP, State Bars in CA and NY, CPA (inactive)

JD from Cornell, MBA from Univ of Chicago, BS in Accounting from Univ of Illinois

Brandon Zipp, PhD, Dir. of Research & Development, Scientific Co-founder

>10 years research experience with glucosyltransferase enzymes

Developer of UGT biosynthesis platform

Ph.D., Biochem & Molecular Biology, Univ. of California Davis

Page 5: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Cannabinoids in Medicine Initial skepticism has waned, and widespread acceptance within

medical community is leading to many new clinical trials

Independent Clinical Trials Inflammatory Bowel Disease

Opiate Dependence Epilepsy

Schizophrenia Neuropathic Pain Multiple Sclerosis

Huntington’s Disease

CBD is (a) not psychoactive and has (b) dramatic therapeutic effects when treating severe and drug-resistant seizure disorders in children.

Vitality Biopharma takes a similar approach with cannabosides for

treatment of IBD. Potential for dramatic benefits with no psychoactivity.

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Page 6: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Cannabinoid Drug

Companies There are surprisingly few drug development companies in the

U.S. capable of obtaining DEA licensing and FDA approvals

GW Pharmaceuticals Plc (NASDAQ:GWPH)

Pharma pioneer of cannabis drugs with decent

intellectual property position

Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE)

Topical or transdermal delivery, targeted effect

for localized muscle or joint pain relief

Vitality Biopharma, Inc. (OTCQB: VBIO)

Targeted delivery through glycosylation for

delivery to gut and brain, no psychoactivity

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Page 7: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Prodrug Background Cannabosides reduce or avoid entirely the psychoactive side

effects through targeted prodrug technology

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A prodrug is a medication or compound that, after administration, is converted within the body into a pharmacologically active drug. Prodrugs are typically designed to overcome well-known drawbacks of currently available therapies, i.e. cannabis drugs v1.0. Vitality’s prodrug technology enables the selective delivery to specific tissues or organs, including the gut or brain, enabling existing drugs to have a more targeted effect. As of 2015, there were approximately 15 prodrugs that had been classified as blockbusters, defined as having annual sales in excess of $1 billion.

Page 8: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Treatment of Inflammatory

Bowel Disease More than half of front-line therapies for induction of remission fail to have a sustained effect, and have severe side effects

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There is no cure for inflammatory bowel disease,

including either Crohn’s disease or ulcerative colitis.

Up to 75% of Crohn’s disease patients will require surgery,

including colectomies and colostomies.

Page 9: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

A teenager with Crohn’s disease failed all

therapies at the Mayo Clinic before his

family moved to Colorado to access

cannabis. He entered into remission and

was able to get his life back… and he’s

not the only one.

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IBD Case Study: “I’d rather be illegally alive than

legally dead.” Coltyn Turner, age 15

Page 10: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Treatment of Inflammatory

Bowel Disease Clinical data suggests Cannabis can induce remission, even in

patients resistant to steroids or biologic TNF-a inhibitors

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Naftali et al., Clinical Gastroenterology & Hepatology, 2013

In an independent and placebo-controlled trial, with only 8 weeks of Cannabis treatment, there

was a statistically significant change in Crohn’s Disease Activity Index

IBD

Symptoms

Improved

Patients

(%)

n=56

Abdominal

pain

83.9%

Abdominal

cramping

76.8%

Joint pain 48.2%

Diarrhea 28.6%

Storr et al., Inflammatory Bowel Diseases, 2014

Page 11: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

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Site-Specific Delivery of THC Enables More Potent Local Effects Current medications deliver psychoactive THC into the bloodstream/brain, so low doses are always required

Merrick, Cannabis & Cann. Research, April 2016

Higher local concentrations of cannabinoids could then

enable more potent cannabinoid treatments for

pain and inflammation within the gastrointestinal tract.

Figure 2, Wright, British Jo. of Pharmacology, 2008

“CB2 receptors represent a braking system for… the resolution of inflammation and many of its symptoms.”

Page 12: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

The U.S. Opiate Epidemic With 4.6% of the world’s population, we use 80% of the opiates

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The New England Journal of Medicine has written that the rising death toll has been rivaled in modern history only by that at the peak of the

AIDS epidemic in the early 1990s.

Since 2013, the rates of drug-overdose deaths have exceeded the number of deaths from car accidents.

Page 13: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Treatment of Narcotic

Bowel Syndrome Opiate-induced severe abdominal pain leads to

misdiagnosis, escalating dosages, and drug dependence

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Up to 81% of opiate users have have functional bowel

disorders, but they may hide opiate-induced severe

abdominal pain.

More than half (58%) report chronic abdominal pain in independently-conducted

clinical studies, and 6% develop NBS.

Drossman & Szigethy, Am J Gastroenterol Suppl, 2014

The vicious cycle of narcotic bowel syndrome

Reported quality-of-life for NBS patients is worse than quadriplegia, and opiates are associated with 61% of all drug overdose deaths.

Page 14: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

At age 57, Prince died of opiate

overdose, and was reported to have

struggled with abdominal pain and

was losing weight in his final months.

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NBS Case Study? “Prince suffered from stomach pains

and sore throats in final months” UK Independent, May 2016

Page 15: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Treatment of Narcotic

Bowel Syndrome Cannabinoids and opiates have synergistic effects, enabling

protocols to reduce pain and wean off or avoid opiate use

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THC (dronabinol) enhances pain relief in chronic users on stable

doses of opiates Narang, Journal of Pain, 2009

Even low-dose opiate use can lead to hypersensitivity, and may act by

neuroinflammation from glial cells Grunkemeier, Clin Gastroent, 2007

Page 16: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Clinical Development Pipeline Oral cannabosides - drug formulations including a novel class

of cannabinoid glycoside prodrugs (CBD, THC, CBDV, etc.)

Drug Clinical Indications Status

VB100 Inflammatory Bowel Disease,

Narcotic Bowel Syndrome

Phase 1/2 Studies to

initiate in 2017

VB210

Neuropathic Pain, Irritable Bowel Syndrome, Opiate-induced Bowel

Dysfunction, Muscle Spasticity in Multiple Sclerosis

Phase 1 Studies to initiate in 2017

Additional Drug Formulations

Epilepsy, Schizophrenia, Huntington’s, Guillain-Barré

Preclinical

Pursuing drug indications where cannabis has already proven useful Less regulatory burden and shorter trials through acute dosing regimens

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Page 17: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Clinical Development Strategy Low-cost data for initial drug approvals, and simultaneous

proof-of-concept in large market disease indications

Phase 1/2 Trial Designs for Inflammatory Bowel Disease & Narcotic Bowel Syndrome Trial of multiple agents for initial evaluation of pharmacokinetics and symptomatic relief of IBD & NBS (e.g. abdominal pain, cramping, etc.) Symptomatic relief will be pursued, along with secondary endpoints

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First-in-man clinical studies of proprietary cannabinoid glycosides “cannabosides”

Proprietary molecules and manufacturing process developed internally Use of enzyme biosynthesis process for biotransformation of cannabinoids for production of cannabinoid prodrugs of CBD, THC, CBDV, and more

Page 18: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Internal Drug Manufacturing Capacity Existing company facilities designed to enable large-scale production of small molecule drugs by enzymatic biosynthesis

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Page 19: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Platform Technology Enzymatic glycosylation breakthrough leads to novel

compositions of matter with improved drug properties

Cannabinoid Glycosides

(Cannaboside Prodrugs)

Cannabinoids (CBD, THC, etc.)

Steviol Glycosides

(Reb A, D, M, Next-gen Sweetener)

Steviol

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Page 20: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

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Cannabinoid Prodrugs Cannaboside prodrugs enable the site-specific delivery of

cannabinoids to the large intestine upon oral ingestion

Page 21: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Targeted Drug Delivery Glycoside prodrugs can selectively target different tissues,

including the through oral delivery, and also the (I.V.)

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Distribution of ibuprofen after intravenous injection of ibuprofen and glycoside prodrugs in rats (Chen et. al., 2009)

Independent studies have demonstrated reliable targeting to the colon upon oral delivery of glycoside prodrugs, as well as higher permeation of brain tissue upon IV or alternative routes of drug administration.

Page 22: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Cannabinoid Prodrugs Glycosylation has reliably led to improvements in drug

solubility and stability in novel class of cannabosides

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Patents pending for more than 20 novel

cannabinoid glycoside prodrugs,

known as “cannabosides”

Prodrugs of CBD, THC,

CBDV, TRPV1 agonists, vanilloids,

and many more compounds have also

been created…

Page 23: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Intellectual Property

New international patent filing with PCT covering compositions of matter for more than 20 cannabinoid prodrugs with modified solubility and stability, including glycoside prodrugs of THC, CBD, and CBDV, with protection that would extend to 2035 or longer with PTEs

Manufacturing system for glycosides, geared for low-cost efficient production of steviol and cannabinoid glycosides

Page 24: Safe Harbor Statement - Vitality Biopharma · 15/02/2017  · partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors

Company Highlights

Seeking DEA and FDA approval of cannabis pharmaceuticals using a low-cost, low-risk prodrug strategy

Intellectual property covering

more than 20 cannabinoid prodrugs including modifications of non-psychotropic CBD, THC, and CBDV, a new class of cannabosides

Proprietary glycosylation platform enables existing drugs to be tailored for selective delivery to the gut and brain