Investor FAQs
Q: What does StemCells do?
A: StemCells, Inc. is engaged in the discovery and development of cell-based therapeutics to treat damage to, or degeneration of, major organ systems. Our aim is to restore or support organ function, improve patients’ lives and reduce the substantial health care costs associated with these diseases and disorders by identifying and developing stem and progenitor cells as potential therapeutic agents. We currently have two product development programs at the Company: (i) our CNS Program, which is developing applications for our proprietary human neural stem cell and (ii) our Liver Program, which is developing applications for our proprietary human liver engrafting cells.
In our CNS Program, we are focused on developing applications for our HuCNS-SC® product candidate (purified human neural stem cells) for disorders of the central nervous system (CNS). Our HuCNS-SC product candidate is in clinical development for two indications. In January 2009, we completed a six patient Phase I clinical trial to evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for infantile and late infantile neuronal ceroid lipofuscinosis (NCL), two forms of a group of disorders often referred to as Batten disease. We expect to complete data analysis and to report the results of this trial in mid 2009. In December 2008, we received authorization from the US Food and Drug Administration (FDA) to initiate a Phase I clinical trial of our HuCNS-SC cells in a second indication, Pelizeaus-Merzbacher Disease (PMD), a fatal myelination disorder in the brain. We expect the PMD trial to begin in 2009 and that it will take 12-18 months to complete. In addition, our HuCNS-SC cells are in preclinical development for spinal cord injury and retinal disorders.
In our Liver Program, we are in preclinical development with our human liver engrafting cells (hLEC). We have settled on a process to isolate and purify hLEC, and we plan to seek the necessary approvals to initiate a clinical study to evaluate hLEC as a potential cellular therapy, with the initial indication likely to be liver-based metabolic disorders. We are also conducting research to see if hLEC can be made resistant to the hepatitis C virus.
ˆTop
Q: What is NCL (Batten disease)?
A: Neuronal ceroid lipofuscinosis (NCL), which is often referred to as Batten disease, is a neurodegenerative disease that affects infants and young children. Two forms of NCL — infantile and late infantile— are caused by the deficiency of a lysosomal enzyme. Infantile and late infantile NCL are brought on by inherited genetic mutations in the CLN1 gene, which codes for palmitoyl-protein thioesterase 1 (PPT1) and in the CLN2 gene, which codes for tripeptidyl peptidase I (TPP-I), respectively. As a result of these mutations, the relevant enzyme is either defective or missing, leading to the accumulation of cellular waste product in various cell types. This accumulation eventually interferes with normal cellular and tissue function, and leads to seizures and progressive loss of motor skills, sight and mental capacity. Today, NCL is always fatal.
ˆTop
Q:
What is the goal of StemCells' Phase I trial in NCL (Batten disease)?
A: The Phase I trial, which was conducted at Oregon Health & Science University Doernbecher Children's Hospital and completed in January 2009, was designed to evaluate the safety and preliminary efficacy of HuCNS-SC cells for the treatment of infantile and late-infantile NCL. In addition to measuring the safety of HuCNS-SC, the trial may provide initial data on HuCNS-SC's ability to affect the progression of the disease. Children enrolled in the study were evaluated with a number of standardized measures of development, cognition, behavior and language for one year following HuCNS-SC transplantation.
ˆTop
Q: How does the Company currently fund its research programs?
A: Our R&D programs, all of which concentrate on diseases of, or injury to, the central nervous system, the liver and the pancreas, have been funded primarily by StemCells’ shareholders, rather than by the public sector. As of December 31, 2008, the Company had $34.0 million in cash and cash equivalents
and marketable debt securities
.
ˆTop
Q: When was StemCells incorporated, and in which state?
A:The Company now known as StemCells was incorporated in Delaware in August 1988, under the name Cellular Transplants, Inc. In February, 1992 the Company was renamed CytoTherapeutics and in April of that year the Company had its initial public offering. In May 2000, the Company changed its name to StemCells, Inc., reflecting its decision to focus solely on stem cell therapies.
ˆTop
Q: How many people does StemCells employ?
A:As of December 31, 2008, we had 55 full-time employees, 16 of whom have Ph.D., M.D. or D.V.M. degrees. 43 full-time employees work in research and development and laboratory support services. No employees are covered by collective bargaining agreements.
ˆTop
Q: What is StemCells' fiscal year end?
A: December 31.
ˆTop
Q: On which exchange does StemCells trade and what is the symbol?
A: StemCells trades on the NASDAQ National Global Market. The ticker is STEM.
ˆTop
Q: When did StemCells become public?
A: The Company went public in 1992.
ˆTop
Q: How many shares are outstanding?
A: As of March 5, 2009, there were
95,543,083 shares of Common Stock issued and outstanding.
ˆTop
Q: Does StemCells issue dividends on its common stock?
A: No.
ˆTop
Q: Does StemCells have a direct stock purchase plan?
A: No.
ˆTop
Q: Who are StemCells' independent auditors?
A: Grant Thornton LLP is the Company's independent auditor.
ˆTop
Q: Who is StemCells' stock transfer agent?
A: Computer Share Investor Services
P.O. Box 43023
Providence, RI 02940-3023
Phone: 781.575.2879
Fax: 617.360.6900
www.computershare.com
ˆTop
Q: Who is StemCells' legal counsel?
A: Ken Stratton is StemCells' General Counsel. The Company's outside corporate counsel is Ropes and Gray of Boston and its patent counsel is Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, also of Boston.
ˆTop
Q: How do I contact StemCells' Investor Relations?
A: You can contact Investor Relations by calling 650.475.3100 extension 105 or via e-mail at ir-pr@stemcellsinc.com. Investor information can also be downloaded from our website at www.stemcellsinc.com.
ˆTop
Thank you for your interest in StemCells, Inc.
|
