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|StemCells, Inc. Posts Letter to Shareholders|
Dear Fellow Shareholders:
Over the past year,
While our stock price in 2014 was disappointing, we are making undeniable progress. We will continue to focus intently on what we can control: progressing our clinical studies, managing our costs, and executing our strategy in a capital-efficient manner. In this letter, I will share some of my thoughts regarding the real value of STEM and why I believe it is a sound investment; I will recap our recent actions and achievements, and I will update you on our future plans.
Why Invest in STEM: The Long and Short of It
Vaccines against diphtheria, tetanus, anthrax, cholera, plague, typhoid and tuberculosis were not developed until the 1930s – nearly 200 years after
Our journey began in 2000, when scientists at
Just a few years later, in 2006, our HuCNS-SC cells were surgically transplanted into the brain of a six-year-old child with neuronal ceroid lipofuscinosis (NCL), a rare, fatal disorder of the central nervous system. Since then we have gone on to achieve other significant "firsts" including completion of a very successful trial in Pelizaeus-Merzbacher disease (PMD), another incurable pediatric disorder, and our recent completion of enrollment and dosing in the world's first neural stem cell transplant trials in not just one, but two indications with large patient populations awaiting viable treatments: spinal cord injury (SCI) and dry age-related macular degeneration (AMD).
Now, with Phase II clinical trials commencing in both SCI and AMD, we are closing in on achieving our goal of clinical proof-of-concept in both indications by 2017, making relatively rapid progress in the realm of clinical development. The successes we have already achieved and those anticipated are quite encouraging for investors who take the longer-term view. Even those who may seek a more rapid return have reason to hold fast, for now, as well. We expect that as in the historic progress of most pharmaceutical and therapeutic products, our stock should gain value with each advancing stage of clinical development, moreover driven by the news flow of data over the next three years resulting from our clinical trials in SCI and AMD:
It is also important to note that we have been manufacturing our HuCNS-SC cells for clinical trials since 2006, in compliance with current Good Manufacturing Practices (cGMP). We currently have enough product banked and cryopreserved to fulfill the needs of our Phase II clinical trials. We are prepared to scale our processes as needed to meet the requirements of future clinical trials and commercialization.
Investors and Analysts are Taking Notice
The Company's first "Investor and Analyst Day," held in
Recent Actions: Streamlining Our Business
We are now able to fully concentrate our corporate resources on SCI and AMD, our two lead clinical programs, as a result of two actions completed toward the end of 2014:
The Company is now fully focused on two clinical targets with significant unmet need: chronic spinal cord injury, which is the second leading cause of paralysis in the U.S., and geographic atrophy of age related macular degeneration, the most advanced form of dry AMD, and the leading cause of vision loss in developed countries. There are currently no curative treatments for either of these indications. Our mission is clear: to demonstrate, in well controlled Phase II clinical trials, that our HuCNS-SC cells can restore lost motor function in patients with chronic spinal cord injuries and lead to preservation of visual function in patients who are progressively losing eyesight.
Recent Achievements: Progressing Our Clinical Studies in Two Major Indications
The Company continues to make significant progress toward its twin goals of demonstrating the safety and efficacy of HuCNS-SC cells in spinal cord injury (SCI) and dry age-related macular degeneration (dry AMD).
Spinal Cord Injury: Earlier this month, we announced that we had successfully dosed the first patient in our groundbreaking Pathway Study. This Phase II controlled proof-of-concept study is designed to evaluate the safety and efficacy of our HuCNS-SC cells in cervical spinal cord injury patients.
In 2014, we completed enrollment in our Phase I/II clinical trial in thoracic spinal cord injury and reported encouraging safety and preliminary efficacy data:
Dry AMD: We recently announced plans to initiate a multi-center Phase II proof-of-concept study in geographic atrophy (GA) of dry age-related macular degeneration.
In 2014, we completed enrollment in our Phase I/II clinical trial in dry AMD and reported encouraging safety and preliminary efficacy data:
An Eye on the Future
Ultimately, we will be judged by our success in achieving our goal of translating our "Groundbreaking Science" into "Breakthrough Medicine." The progress we have seen in our clinical programs, to date, signifies that we are en route to fulfilling the therapeutic promise of human neural stem cells — as a one-time intervention yielding a long-term benefit for millions of patients suffering from the devastating effects of intractable diseases and disorders of the central nervous system. We are confident that our Company's value will come through because our mission, and therein the opportunity, is to realize the potential of stem cell therapy to create new, life-altering treatment paradigms. There is simply too much at stake for the patients and their families who are counting on us to succeed for us to waiver in our commitment to finish what we started in 2006.
On behalf of our employees, as well as the patients and families whose hopes we hold dear, I want to thank you for your continuing support and your faith in our ability to prove our value.
A copy of the shareholder letter may be found on the
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the U.S. securities laws, and is subject to the safe harbors created therein. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including those described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended