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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

Superpositioning of a steviol
glycoside with cannabidiol

A drug development company, using cannabinoids to treat

serious neurological and inflammatory disorders


entrepreneurial team focused on biotechnology and life sciences

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 & Cofounder

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

Brandon Zipp, PhD, Dir. of Research &

Development, Scientific Co-founder

Richard McKilligan, JD, MBA,


Anthony Maida, PhD, MBA, Director,

Chair of Audit Committee

>10 years research experience with

glucosyltransferase enzymes
Developer of UGT biosynthesis platform
Ph.D., Biochem & Molecular Biology, Univ.
of California Davis

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

Senior Vice President, Clinical Research,

Northwest Bio
MBA, MA in Toxicology, PhD in

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
Neuropathic Pain
Multiple Sclerosis
Huntingtons 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.

Cannabinoid Drug

There are surprisingly few drug development companies in the

U.S. capable of obtaining DEA and FDA approvals


Pharmaceuticals Plc (NASDAQ:GWPH)

Pharma pioneer of cannabis drugs with decent
intellectual property position


Pharmaceuticals, Inc. (NASDAQ:ZYNE)

Topical or transdermal delivery, targeted effect
for localized muscle or joint pain relief


Biopharma, Inc. (OTCQB: VBIO)

Targeted delivery through glycosylation for
delivery to gut and brain, no psychoactivity

Prodrug Background

Cannabosides reduce or avoid entirely the psychoactive side

effects through targeted prodrug technology

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.
Vitalitys 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

There is no cure for

inflammatory bowel disease,
including either Crohns
disease or ulcerative colitis.
Up to 75% of Crohns disease
patients will require surgery,
including colectomies and

IBD Case Study:

Id rather be illegally alive than
legally dead.
Coltyn Turner, age 15
A teenager with Crohns 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 hes
not the only one.


Treatment of Inflammatory
Bowel Disease

Clinical data suggests Cannabis can induce remission, even in

patients resistant to steroids or biologic TNF-a inhibitors






Joint pain




Storr et al., Inflammatory

Bowel Diseases, 2014

In an independent and placebo-controlled trial,

with only 8 weeks of Cannabis treatment, there
was a statistically significant change in
Crohns Disease Activity Index

Naftali et al., Clinical Gastroenterology &

Hepatology, 2013


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 worlds population, we use 80% of the opiates

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

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.


Treatment of Narcotic
Bowel Syndrome

Opiate-induced severe abdominal pain leads to

misdiagnosis, escalating dosages, and drug dependence
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
clinical studies, and 6%
develop NBS.

The vicious cycle of

narcotic bowel syndrome

Drossman & Szigethy, Am J

Gastroenterol Suppl, 2014

Reported quality-of-life for NBS patients is worse than quadriplegia,

and opiates are associated with 61% of all drug overdose deaths.


NBS Case Study?

Prince suffered from stomach pains
and sore throats in final months
UK Independent, May 2016
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.


Treatment of Narcotic
Bowel Syndrome

Cannabinoids and opiates have synergistic effects, enabling

protocols to reduce pain and wean off or avoid opiate use

Even low-dose opiate use can lead to

hypersensitivity, and may act by
neuroinflammation from glial cells
Grunkemeier, Clin Gastroent, 2007
THC (dronabinol) enhances pain
relief in chronic users on stable
doses of opiates
Narang, Journal of Pain, 2009


Clinical Development Pipeline

Oral cannabosides - drug formulations including a novel class

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

Clinical Indications



Inflammatory Bowel Disease,

Narcotic Bowel Syndrome

Phase 1/2 Studies to

initiate in 2017


Neuropathic Pain, Irritable Bowel

Syndrome, Opiate-induced Bowel
Dysfunction, Muscle Spasticity in Multiple

Phase 1 Studies to
initiate in 2017

Additional Drug

Epilepsy, Schizophrenia, Huntingtons,



Pursuing drug indications where cannabis has already proven useful

Less regulatory burden and shorter trials through acute dosing regimens


Clinical Development Strategy

Low-cost data for initial drug approvals, and simultaneous

proof-of-concept in large market disease indications
First-in-man clinical studies of proprietary cannabinoid glycosides
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

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


Platform Technology

Enzymatic glycosylation breakthrough leads to novel

compositions of matter with improved drug properties





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

(CBD, THC, etc.)

(Cannaboside Prodrugs)


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
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
Patents pending for
more than 20 novel
glycoside prodrugs,
known as
Prodrugs of CBD, THC,
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 lowcost efficient production of
steviol and cannabinoid

Company Highlights

Seeking DEA and FDA approval

of cannabis pharmaceuticals
using a low-cost, low-risk prodrug

Intellectual property covering

more than 20 cannabinoid

prodrugs including modifications
of non-psychotropic CBD, THC,
and CBDV, a new class of

Proprietary glycosylation

platform enables existing drugs

to be tailored for selective
delivery to the gut and brain