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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.
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
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
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
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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Cannabinoid Drug
Companies There are surprisingly few drug development companies in the
U.S. capable of obtaining DEA 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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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.
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.
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
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
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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.”
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.
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.
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
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
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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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
Internal Drug Manufacturing Capacity Existing company facilities designed to enable large-scale production of small molecule drugs by enzymatic biosynthesis
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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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Cannabinoid Prodrugs Cannaboside prodrugs enable the site-specific delivery of
cannabinoids to the large intestine upon oral ingestion
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.
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…
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
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