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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
3
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
4
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.
5
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
6
Prodrug Background
Cannabosides reduce or avoid entirely the psychoactive side
effects through targeted prodrug technology
7
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
8
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.
9
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
10
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
11
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
12
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
13
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.
14
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
15
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
16
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
17
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
18
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
19
20
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.)
21
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
22
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

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Vitality bio-ppt-v15-december-2016

  • 1.
  • 2. 2 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.
  • 3. Company Background In 2015, we discovered that stevia UGT enzymes could enable production of a new class of cannabinoid prodrugs 3 Superpositioning of a steviol glycoside with cannabidiol A drug development company, using cannabinoids to treat serious neurological and inflammatory disorders
  • 4. Leadership entrepreneurial team focused on biotechnology and life sciences 4 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
  • 5. 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. 5
  • 6. 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 6
  • 7. Prodrug Background Cannabosides reduce or avoid entirely the psychoactive side effects through targeted prodrug technology 7 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.
  • 8. 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 8 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.
  • 9. 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. 9 IBD Case Study: “I’d rather be illegally alive than legally dead.” Coltyn Turner, age 15
  • 10. Treatment of Inflammatory Bowel Disease Clinical data suggests Cannabis can induce remission, even in patients resistant to steroids or biologic TNF-a inhibitors 10 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
  • 11. 11 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.”
  • 12. The U.S. Opiate Epidemic With 4.6% of the world’s population, we use 80% of the opiates 12 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.
  • 13. Treatment of Narcotic Bowel Syndrome Opiate-induced severe abdominal pain leads to misdiagnosis, escalating dosages, and drug dependence 13 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.
  • 14. 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. 14 NBS Case Study? “Prince suffered from stomach pains and sore throats in final months” UK Independent, May 2016
  • 15. Treatment of Narcotic Bowel Syndrome Cannabinoids and opiates have synergistic effects, enabling protocols to reduce pain and wean off or avoid opiate use 15 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
  • 16. 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 16
  • 17. 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 17 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
  • 18. Internal Drug Manufacturing Capacity Existing company facilities designed to enable large-scale production of small molecule drugs by enzymatic biosynthesis 18
  • 19. 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 19
  • 20. 20 Cannabinoid Prodrugs Cannaboside prodrugs enable the site-specific delivery of cannabinoids to the large intestine upon oral ingestion
  • 21. Targeted Drug Delivery Glycoside prodrugs can selectively target different tissues, including the through oral delivery, and also the (I.V.) 21 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.
  • 22. Cannabinoid Prodrugs Glycosylation has reliably led to improvements in drug solubility and stability in novel class of cannabosides 22 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…
  • 23. 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
  • 24. 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