SEC Connect
Exhibit 99.1
A Letter from the ChromaDex Chief Executive Officer
IRVINE,
Calif., Feb. 23, 2017 (GLOBE NEWSWIRE) - The following is issued on
behalf of ChromaDex:
Dear
Fellow Shareholders:
In
January 2016, I issued a shareholder
letter wherein I described in some detail my enthusiasm
surrounding the enormous commercial opportunity we have with our
patented
NIAGEN®
nicotinamide riboside
(NR), a next-generation form of
Vitamin B3 with what I believe has blockbuster potential in the
emerging category of NAD+ (nicotinamide adenine dinucleotide)
precursors.
What makes NR unique is its scientifically proven ability to
increase production of the co-enzyme, NAD+. As we age, NAD+ levels
decline. Such declines have been implicated in mitochondrial
dysfunction and poor cellular energy metabolism, whereas increases
in NAD+ levels are consistently being linked to improved
mitochondrial function. Recent publications have reported the
beneficial impact of NAD+ on conditions as far ranging as glaucoma
to chemotherapy-induced neuropathy. This
ever growing body of evidence demonstrating the importance of NAD+
is key to keep in mind when considering the potential
value of
NIAGEN®.
2016
saw continued growth in the number of published research studies,
as well as subsequent media attention regarding NR and NAD+ and
their importance in healthy aging. In fact, since the
launch of NIAGEN®, there have
been more than 60 published studies involving NR. During the
same time, there were nearly 500 studies that have published
referencing NAD+ and aging. To support the
education of the general public on these new, but growing areas of
interest, we are helping to develop and curate an educational
website,
www.aboutnr.com,
which is devoted
entirely to education on the topics of NR and NAD+. With the help
of many of the world’s foremost research authorities on these
topics, we believe this site will become the
scientifically-validated,
information hub for NR and NAD+ education.
We believe NIAGEN® will
eventually become part of an important nutrient deficiency story
similar to vitamin C, vitamin D, folic acid, Co-Enzyme Q-10,
and omega-3
fatty acids (DHA and EPA). Ingredients that
address nutrient deficiencies are among the largest in the
ingredient market, and are currently estimated to have a value
between $2 billion and $2.5 billion as reported by Nutritional
Business Journal.
These
blockbuster vitamins and ingredients are commonly found in many
mainstream consumer products including food, beverage, supplements,
multi-vitamins, early-life nutrition, medical food, skin care,
sports nutrition, and even pharmaceutical products. We believe
NIAGEN®
is on track to become the next blockbuster ingredient, and as such,
we expect it will eventually be incorporated in all of these types
of products.
Many
blockbuster vitamins and ingredients that have a high level of
customer awareness also have a substantial number of published
research and clinical studies validating their safety and health
benefits. In fact, there is a strong correlation showing that the
higher the number of published studies on an ingredient, the higher
the amount of revenue the ingredient ultimately
generates.
Over
the past three years, we have established over 100 collaborative
agreements with leading universities and research institutions to
study the safety and efficacy of NIAGEN®.
To put this into perspective, a typical new ingredient is fortunate
to have five or six collaborative studies in
the first three years. I am not aware of any other
vitamin or ingredient in recent history that has been the subject
of such tremendous interest at the research level at such an early
stage in its lifecycle. Simply put, I believe this level of
scientific interest in NIAGEN®
may be an enormous early validation of its blockbuster potential.
It is also important to
note that ChromaDex is not bearing the cost of these studies, which
we estimate could surpass $40 million. Moreover, we expect the
number of collaborative research studies for
NIAGEN®
will continue to
increase.
The number of studies
of NIAGEN®
showing positive effects
are approaching an inflection point where peer-reviewed published
clinical data are likely to result in additional commercial
opportunities for NIAGEN®.
All
indications point to 2017 being a pivotal year for ChromaDex in
both continued published research and business development
activity. We believe positive data from both human and animal
studies will deepen the validation of NIAGEN®
safety, function, applications and efficacy, and become a primary
driver in ChromaDex’s striking business development deals and
substantial revenue opportunities with large consumer product
companies.
There
are currently twelve human clinical studies on nicotinamide riboside
(NR) that are in various phases that can be found on
clinicaltrials.gov.
While NIAGEN®
is used in
all of these studies, two are fully sponsored by
ChromaDex:
●
Results from ChromaDex’s (KGK Synergize)
first
completed human clinical trial of NIAGEN® along
with an animal study component, were published in
Nature Communications in
October 2016. The studies confirmed that NIAGEN® is
safe and can significantly elevate NAD+ more efficiently than other
forms of Vitamin B3.
●
ChromaDex’s (KGK Synergize)
second
study is a 140 participant
trial that will evaluate the effect of repeated doses of
NIAGEN®
on NAD+ metabolite concentrations in blood, urine and muscle in
healthy adults. This study will evaluate the impacts of 3 dose
levels of NIAGEN®
compared to a placebo. One quarter of subjects will receive the low
dose of NIAGEN®
(100 mg), one quarter will receive the moderate dose of
NIAGEN®
(300 mg), one quarter will receive the higher dose of NIAGEN®
(1000 mg) and one quarter will receive the placebo. The recruitment
and dosing portions of the trial are currently in the final stages
as the last participant is currently on study.
Four
studies have been completed and are awaiting
publication:
●
University of Washington - to assess the
pharmacokinetics (PK) of NR at a maximum dose of 1,000 mg as well
as the safety and tolerability of NR. Also to determine if NR
significantly raises NAD levels.
●
University of Colorado, Boulder - to
assess the efficacy of supplementation with the NAD+ precursor
compound, NR, for improving physiological function (vascular,
motor, and cognitive) in healthy middle-aged and older
adults.
●
Aarhus University Hospital/University of
Copenhagen - to assess the pharmacokinetics (PK) of
NR.
●
Elysium Health/KGK Synergize - to assess
the safety, tolerability and potential health benefits of the
dietary supplement, Basis. There will be two doses of Basis
compared to a placebo. One third of subjects will receive the low
dose Basis, one third will receive the higher dose Basis and one
third will receive placebo.
Five
studies are in the recruiting process:
●
Mayo Clinic / Thorne Research - to asses
if NR (750 mg/day for 12 weeks) affects the levels of NAD+ in the
brain as measured by 31P MRS in collegiate football
linemen.
●
Maastricht University Medical Center
Netherlands - to assess the effects of 6 week NR
supplementation (1000 mg/day) on metabolic health in healthy
(pre)obese humans. The primary objective will be hepatic and whole
body insulin sensitivity. Secondary objectives, to provide
information about the underlying mechanism, will be muscle
mitochondrial function, brown fat activity, ectopic lipid
accumulation, energy metabolism, cardiovascular risk parameters,
body composition and acetylcarnitine levels.
●
NIH-NHLBI - to assess if taking NR will
have the same healthy immune system effects as fasting. To further
assess if these good effects continue even after resumed
eating.
●
University of Birmingham (UK) - to
assess the physiological consequences of elevating NAD+
availability using NR supplementation in skeletal muscle tissue,
and examine its effect upon muscle metabolic
phenotype.
●
Aarhus University Hospital/University of
Copenhagen - to assess the effect of NIAGEN®
NR on substrate metabolism,
insulin sensitivity, and body composition in obese
men.
One
study is in the development stage and has yet to beginning
recruiting subjects:
●
University of Texas San Antonio –
to assess the effects of NR on NAD levels and brain function,
including cognition and blood flow in people diagnosed with mild
cognitive impairment (MCI).
It should be noted that these last 10 studies each have a varying
degree of ChromaDex involvement and we will not be in full control
of recruiting, executing, reporting and publication of the study
data.
ChromaDex is one step
closer to the Pharmaceutical opportunity of NIAGEN®.
In
addition to an abundance of markets in consumer product
applications for NIAGEN®,
there may also be significant opportunity in pharmaceutical
applications. Numerous pre-clinical studies have been published by
distinguished researchers which speak to the potential of NR as a
therapy for a various age-related diseases such as cancer,
neuro-degenerative diseases, mitochondrial dysfunction, obesity,
and cardio vascular disease.
We have
been working closely with
the NIH under a collaborative agreement on a
therapeutic indication for NR as a treatment of a rare pediatric
orphan disease, Cockayne
Syndrome. We
completed a pre-IND meeting with the U.S. Food and Drug
Administration (FDA) last November and we expect to file an IND
application with the FDA in 2017.
Yesterday,
we announced that University of Iowa researchers have published an
animal study on NR in the prestigious Journal of the International Association for
the Study of Pain (PAIN) revealing NR as an effective tool
in relieving chemotherapy induced peripheral neuropathy (CIPN)
pre-, during, and post-treatment with a common anticancer agent
– paclitaxel. As the American Society of Clinical Oncology
has issued a position paper that there is an unmet need for
treatments that can alleviate CIPN, I believe this has potential to
be a very significant business opportunity for NIAGEN®.
Revenue growth is always
important, but our focus is on the significant untapped markets
for NIAGEN®.
We
completed 2016 with momentum, recently announcing preliminary
revenue in Q4 2016 of approximately $5.6 million, an
increase of approximately 29% as compared to $4.4 million in Q4
2015. Importantly, no
single customer accounted for more than 11% of total expected
revenue in Q4 2016.
Full-year
2016 revenue is expected to be approximately $26.8 million, an
increase of approximately 22% as compared to $22 million for
full-year 2015.
While
we have experienced significant revenue growth, I want to stress
that we are in the early
stage of commercial development for NIAGEN®.
As we anticipated, thus far we have only penetrated the
early-adopting product
companies strictly within the dietary supplement
market.
While
pre-clinical [animal] studies, such as the ones mentioned above,
may drive media attention and build consumer awareness, I believe
peer-reviewed published human studies will be the key for a
natural transition of our customer base from the early adopters to
large mainstream consumer product companies. This transition has
played out many times before with other well-known blockbuster
vitamins and ingredients.
We have
been actively engaged with numerous large multi-national consumer
product companies with
respect to commercial opportunities for NIAGEN® being
included and featured in a number of branded consumer products
within extremely large product categories.
Following
the playbook of other well-known blockbuster vitamins and
ingredients, we are progressing through the safety, clinical and
regulatory hurdles that would allow NIAGEN® to be included
in consumer products within the following segments:
●
Dietary Supplements
(Complete)
●
Sports Nutrition
(Complete)
●
Functional Food
& Beverage
Additionally,
as studies generate more published human data, we are developing
regulatory dossiers for NR registration in key international
markets. We are in varying stages of the respective registration
processes in Canada, Australia and the EU.
I will end this letter with the same conclusion I reached in the
January 2016 shareholder letter:
I am convinced more than ever that ChromaDex has an extraordinary
opportunity to create substantial shareholder value with our
patented NIAGEN® nicotinamide
riboside. I believe a new vitamin or ingredient of this
magnitude is the type of opportunity that does not come along very
often. All of the important pieces of the puzzle are
systematically falling into place, creating a perfect storm that
may allow NIAGEN® to
become the next blockbuster ingredient.
On behalf of ChromaDex's management, Board of Directors,
and employees, I want to personally thank you for your continued
support.
Sincerely,
Frank
Jaksch
Founder
& CEO
Forward-Looking Statements:
This letter contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as
amended, including statements related to future commercial
opportunities for NIAGEN®,
whether
www.aboutnr.com will become the
scientifically-validated, information hub for NR and NAD+
education, the ability of NR to increase production of NAD+,
whether NIAGEN®
will
become the next blockbuster ingredient, whether the number of
collaborative research studies for NIAGEN®
will
increase, the timing and results of future studies, whether
positive data from clinical studies will result in business
development deals and revenue opportunities, the potential for
NIAGEN®
to be used
in pharmaceutical applications, the timing and results of future
regulatory filings in the U.S. and other countries, unaudited
financial results, whether human studies will grow the customer
base to include large mainstream consumer product companies, and
whether NIAGEN®
will be
included in consumer products in certain consumer segments.
Statements that are not a description of historical facts
constitute forward-looking statements and may often, but not
always, be identified by the use of such words as "expects",
"anticipates", "intends", "estimates", "plans", "potential",
"possible", "probable", "believes", "seeks", "may", "will",
"should", "could" or the negative of such terms or other similar
expressions. More detailed information
about ChromaDex and the risk
factors that may affect the realization of forward-looking
statements is set forth in ChromaDex's Annual Report on
Form 10-K for the fiscal year ended January 2, 2016, ChromaDex's Quarterly
Reports on Form 10-Q and other filings submitted
by ChromaDex to
the SEC,
copies of which may be obtained from the SEC's website
at www.sec.gov.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof,
and actual results may differ materially from those suggested by
these forward-looking statements. All forward-looking statements
are qualified in their entirety by this cautionary statement
and ChromaDex undertakes no
obligation to revise or update this letter to reflect events or
circumstances after the date hereof.