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.
VIP Call Girls Hyderabad Megha 9907093804 Independent Escort Service Hyderabad
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
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