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| Stem Cell Companies: Burning
Cash on Research with Hopes of New Drugs and Therapies |
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Michael Wijaranakula
Staff Researcher, Infotix
Systems, Inc. - September
09, 2005
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StemCells Inc.'s patent portfolio in the stem cell therapy area includes 43 U.S. patents issued. Their proprietary human neural stem cells,
HuCNS-SC, had its IND application filed in December 2004 for the treatment of Batten disease, a genetic disease causing neurological cell loss. The
Investigational New Drug (IND) application is currently on clinical hold to
respond to the Food & Drug Administration’s (FDA) questions and concerns. In late August 2005, the State of California granted
StemCells, Inc. a manufacturing license for its cell processing facility for
HuCNS-SC. “Acquiring this license is another milestone in our progress toward beginning our first human clinical trial,” said Martin
McGlynn, President and CEO of StemCells.
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StemCells posted widening losses of $3.9 million for Q2 2005 versus a loss
of $3.3 in the same period last year. Revenues grew from $6,000 for the
period last year to $36,000 for the quarter in 2005, primarily from
grants and licensing. R&D spending for the quarter was $2.1 million,
compared with $1.9 million for the same period in 2004, primarily due to
an increase in the number of full-time employees, now 30 compared to 24
in 2004, working in R&D and lab support.
Aastrom Biosciences,
(NASDAQ:ASTM)
based in Ann Arbor, MI with a current market cap of $280 million,
develops products for the repair or regeneration of human tissues
utilizing its proprietary adult stem cell technology to focus on Tissue
Repair Cells (TRCs), a mix of bone marrow-derived adult stem and
progenitor cells. Aastrom is enrolling participants for Phase I/II level
clinical trials in developing TRCs for the treatment of severe bone
fractures, ischemic vascular disease, jaw reconstruction, and spine
fusion. Aastrom's total annual revenues for 2004 were $1.3 million. Although
StemCells' and Aastrom Biosciences' shares are among best performers of
the stem cell-related group in the past 12 months with a return of over 200 percent, compared
to the 30 percent return of the AMEX Biotechnology Index
(AMEX:$BTK.X),
investors should be aware that the average daily trading volume of
StemCells, 3.1 million shares, and Aastrom Bioscience, 3.4 million
shares, are extremely high for companies with a market cap
of just under $350 million. Heavy trading days for stem
cell companies such as STEM and ASTM are activities most likely driven by
day-trading and short-selling. |
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ViaCell Inc., (NASDAQ: VIAC) based in Cambridge, MA, with Q2-2005 revenues of $11 million, is a biotech company currently working with umbilical cord blood and stem cell therapy. Their Viacord
unit, which provides almost all of their revenue, is a leading private cord blood bank that collects and cryopreserves umbilical cord blood for customers. Thus far, Viacord stores over 63,000 cord blood units and reports that cord blood retains viability and function for 15 years or more when stored under
cryopreservation.
ViaCell hopes to enable applications of hematopoietic (blood) stem cells from umbilical cord blood with their lead cellular therapy product candidate, CB001, for use in bone marrow transplants. CB001 is currently in Phase
I clinical trials with reports indicating Phase II studies are to begin in mid-2006.
ViaCell recently announced an expansion of its collaboration and license agreement with Amgen (NASDAQ:
AMGN) and new license from Johns Hopkins for the use of growth factors for use in developing and manufacturing cellular therapy products. "Amgen's
r-metHuG-CSF is an important growth factor with demonstrated utility in cellular therapies.
By applying r-metHuG-CSF to the Johns
Hopkins co-culturing technology, we believe we will be able to extend our current cell expansion platform for the manufacture of next-generation hematopoietic stem cell products," said Marc Beer, president and CEO of
ViaCell. "We believe that this is further indication of ViaCell's ability to identify the technologies that could ultimately help realize the therapeutic value of cord blood stem cells."
Financial results for ViaCell for Q2 2005 report that total revenues were
$11.4 million compared with $9.7 million for the same period in 2004
with Q2 2005 net losses widening to $3.1 million, compared to a net loss
of $2.3 million in the same period in 2004. R&D expenses are $3.0
million for the latest quarter, compared with $3.9 million for the
second quarter in 2004, attributed to the closure of their German
laboratory but offset in the increase in clinical development expenses
related to the Phase I trial of CB001.
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VIAC
share prices have been virtually flat since its Initial Public Offering
(IPO) in late January this year.
Although VIAC shares has dropped as much as 35% from its IPO pricing of
$7.00/ share, Wall Street analysts are expecting VIAC's revenue to grow as
much as 22% next year and set a price target as high as $15.00.
Less
Risky Investment. Companies providing specialized biotech R&D products,
equipment and services, such as Invitrogen Corporation (NASDAQ: IVGN),
may be less risky than the stem cell companies themselves with customers
including corporate, academic and government research facilities. Invitrogen
Corporation,
with annual revenues of over $1 billion, is a Carlsbad, CA-based global provider of products and services
for the life science research market with its BioDiscovery and BioProduction
segments. The segments cover functional genomics, cell biology, and drug discovery product
lines, software to analyze and interpret genomic, proteomic, and other
biomolecular data
as well as various cell culture products and biological testing
services.
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About NMS
Research Analysis:
NMS Research Analysis is a private independent research entity of
Infotix Systems, since 1999, bridging the gap between cutting-edge
scientific research and the investment community. We offer in-depth
research analysis of companies and emerging technology in sectors
ranging from semiconductors, biotech, nanotechnology, novel
materials for aerospace and energy industries. Mr. Wijaranakula's portfolio holds long positions
or controls in GERN and IVGN.
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