11/3/2014
Dear Shareholders,
Thank you for your continuing support of International Stem Cell
Corporation. I want to update you
on some important matters including how we intend to increase the Company’s
visibility, recognition and market capitalization and outline our most significant
near term objectives, most notably the initiation of our first clinical study, the
first-ever using neural stem cells derived from pluripotent stem cells for the
treatment of Parkinson’s disease.
As a company our goals are to be a recognized
leader in human stem cell transplantation and to use our scientific expertise to
develop commercial products that address unmet medical needs for patients
around the world. To achieve these
goals, we must advance our research from the preclinical to the clinical stage
and demonstrate safety and efficacy of our therapy in humans. Based on the safety and efficacy data
reported to date and new data we will report at this month’s annual meeting of
the Society for Neuroscience, the world’s largest organization of scientists
and physicians devoted to understanding the brain and nervous system. We have a strong preclinical evidence to
support our planned clinical trial in Parkinson’s disease. The Phase I trial in patients with
Parkinson’s disease will examine the safety of our approach, as well as some
efficacy endpoints, and if successful, a larger Phase II study will follow, to evaluate
the effectiveness of our approach in treating the symptoms and halting or even
reversing the progress of the disease.
We know from previous cell therapy trials in other indications that, because
of patient enrollment rate limitations, safety studies in the United States can
often take several years to complete.
For this reason it is relatively common to carry out Phase I in countries
where early-stage trials can be completed faster and more economically, maintaining
clinical quality while saving the company time and money. Countries such as the UK, Australia and
Sweden all have excellent Parkinson’s disease specialists, have successful track
records of running movement disorder clinical trials and, most importantly, permit
studies to enroll patients relatively quickly. We believe that filing a regulatory submission before the
end of this year and beginning our clinical trial as early as 1Q 2015 in one of
these countries may significantly accelerate the overall clinical program. The human safety data we obtain from
the foreign trial will strengthen our US IND, which we continue to plan for,
and may allow us to transition directly to a Phase II study as part of our
collaboration with Duke Clinical Research Institute.
We are already experiencing growing levels of interest in our core stem
cell platform and our therapeutic products from pharmaceutical companies and
with human data this interest will only increase. In addition, when we receive the definitive and final ruling
on our patent filings from the Court of Justice for the European Union, which
we expect before year-end, this new intellectual property will give us
significant licensing advantages in Europe over embryonic stem cell-based
technologies.
Concurrent to our lead target indication of Parkinson’s disease, we are also
researching the use of human neural stem cells in other indications. In 1Q 2015 we anticipate reporting data
from our collaboration with Tulane University on the use of these cells in stroke.
To ensure the Company’s achievements are
optimally recognized by the investment community, it’s important that we increase
our visibility and position our stock to be more accessible to institutional
investors and brokerage firms, which should also help make potential future
financings more accretive. The first move is to transition our stock listing to
a national securities exchange such as NASDAQ. A national exchange listing and the associated higher stock
price should generate greater interest among investors and analysts. If we are successful in generating this interest,
I anticipate that the Company’s common stock would have greater liquidity and a
stronger long-term investor base.
However, to qualify for listing on a national exchange the stock price
needs to be over $3 and ideally closer to $5, which is why the ratio of the
reverse split we are proposing at the December 4 stockholders meeting is
between 50 and 150. Waiting for the
share price to grow organically simply delays our ability to grow the business
and bring these important treatments to patients.
Future Milestones
We believe that the timing is optimal to elevate our investor and public
visibility given that we’re in the midst of transforming from a preclinical to
a clinical stage company. The several milestones we see ahead of us should all
add significant value to our business and should facilitate our bringing innovative treatments to patients. These milestones include:
- Initiate the Phase I clinical trial
in Parkinson’s disease in 1Q 2015.
- Report interim data from the Phase I
clinical trial at a medical conference in 2015.
- Transition to trading on a national
exchange such as NASDAQ.
- Execute a definitive license
agreement with Rohto Pharmaceutical Co. Ltd following the conclusion of their
evaluation of our cells.
- Publish preclinical data from the
Stroke study using our human neural stem cells.
I think you can see that we have a
tremendously exciting time ahead of us. I
look forward to your support at the stockholders meeting on December 4, 2014
Sincerely,
Andrey
Semechkin, PhD
Co-Chairman and CEO
About International Stem Cell Corporation
International
Stem Cell Corporation is focused on the therapeutic applications of human
parthenogenetic stem cells (hpSCs) and the development and commercialization of
cell-based research and cosmetic products. ISCO's core technology,
parthenogenesis, results in the creation of pluripotent human stem cells from
unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use
or destruction of viable human embryos. ISCO scientists have created the first
parthenogenetic, homozygous stem cell line that can be a source of therapeutic
cells for hundreds of millions of individuals of differing genders, ages and
racial background with minimal immune rejection after transplantation. hpSCs
offer the potential to create the first true stem cell bank, UniStemCell™. ISCO
also produces and markets specialized cells and growth media for therapeutic
research worldwide through its subsidiary Lifeline Cell Technology
(www.lifelinecelltech.com), and stem cell-based skin care products through its
subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is
available at www.internationalstemcell.com and companyblog.intlstemcell.com.
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Forward-looking
Statements
Statements pertaining to anticipated
developments, the expected timing and results of preclinical studies and
subsequent regulatory filings, the potential benefits of research programs and
products, and other opportunities for the company and its subsidiaries, along
with other statements about the future expectations, beliefs, goals, plans, or
prospects expressed by management constitute forward-looking statements. Any
statements that are not historical fact (including, but not limited to
statements that contain words such as "will," "believes,"
"plans," "anticipates," "expects,"
"estimates,") should also be considered to be forward-looking
statements. Forward-looking statements involve risks and uncertainties,
including, without limitation, risks inherent in the development and/or
commercialization of potential products, regulatory approvals, need and ability
to obtain future capital, application of capital resources among competing
uses, and maintenance of intellectual property rights. Actual results may differ
materially from the results anticipated in these forward-looking statements and
as such should be evaluated together with the many uncertainties that affect
the company's business, particularly those mentioned in the cautionary
statements found in the company's Securities and Exchange Commission filings.
The company disclaims any intent or obligation to update forward-looking
statements.