StemCells, Inc. (Nasdaq:STEM), a leading stem cell company
developing and commercializing novel cell-based therapeutics and
tools for use in stem cell-based research and drug discovery, today
reported financial results for the second quarter ended June 30,
2011.
"The Company's management and Board of Directors remain keenly
focused on the successful execution of three key business
objectives, namely the timely generation of clinical data from our
groundbreaking clinical trials for HuCNS-SC in the brain, spinal
cord and the eye, significantly reducing our operating cash burn,
and the monetization of non-core, corporate real estate and
intellectual property assets," said Martin McGlynn, President and
CEO of StemCells, Inc. "Even with the continued uncertainties
in the capital markets, the difficult financing environment for
small-cap biotechs and the downward price pressure we've been
experiencing recently on our stock, we firmly believe our approach
of working towards meaningful clinical data in a thoughtful
cash-conscious way is the best pathway forward for the growth of
stockholder value. Already this year, we've taken a number of
steps to materially reduce our operating costs while at the same
time advancing our clinical development program. Given this,
it is difficult to explain the striking disconnect between our
current market value and what we believe is the significant
potential value inherent in the Company's technologies."
StemCells is currently conducting a Phase I/II clinical trial in
chronic spinal cord injury in Switzerland, and expects to enroll
and dose the first cohort of that trial this year. The Company
has completed patient enrollment in a Phase I trial in
Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in
children, and plans to initiate a Phase I/II clinical trial early
next year in Age-Related Macular Degeneration, the leading cause of
vision loss and blindness in people over the age of 55.
Second Quarter and Recent Business
Highlights
Therapeutic Product Development
- In April 2011, we entered into a research collaboration with
Frank LaFerla, Ph.D., a world renowned leader in Alzheimer's
disease research, to study the therapeutic potential of our
HuCNS-SC cells in Alzheimer's disease. Dr. LaFerla is director
of the University of California, Irvine (UCI) Institute for Memory
Impairments and Neurological Disorders (UCI MIND), and his
published research has shown that mouse neural stem cells enhance
memory in a mouse model of Alzheimer's disease. The goal of
this collaboration is to replicate these exciting results in the
mouse model using our human neural stem cells.
- In April 2011, we shelved a Phase Ib clinical trial of our
HuCNS-SC cells in neuronal ceroid lipofuscinosis (NCL, also
referred to as Batten disease) due to the lack of patient accrual.
NCL is a rare and fatal neurodegenerative disorder in
children, and this Phase Ib trial was designed to enroll patients
with less neuronal degeneration than patients in our Phase I NCL
trial.
- In June 2011, at the International Society for Stem Cell
Research (ISSCR) 9th Annual Meeting, we presented evidence of
engraftment, migration and the long-term survival of our HuCNS-SC
neural stem cells following transplantation into patients with
NCL. Importantly, the results show that the cells can persist
following the completion of the planned year-long immunosuppression
regimen. The data supports the Company's premise regarding the
viability and utility of neural stem cell therapy as a potential
treatment for a wide range of central nervous system (CNS)
disorders.
Tools and Technologies Programs
- We continued to experience strong demand for our SC Proven®
branded reagents and research tools. In the first half of
2011, revenues from product sales increased by 77% compared to the
first half of 2010. This growth is being driven by both higher
unit volumes, as well as sales of new products.
- In July 2011, we published a collaborative study which used
commercially available, SC Proven serum-free cell culture media for
the reproducible and robust production of large numbers of
genetically stable, self-renewing cells that retain true
multi-potent biological function over extended culture periods.
This work overcomes a key hurdle to the use of non-immortalized
cells for regenerative medicine, and demonstrates the utility of
human tissue-derived neural stem cells as a scalable platform for
cell-based drug discovery and drug screening applications.
The paper was published in a special edition of
Neurochemistry International dedicated to "The Potential of Stem
Cells for 21st Century Neuroscience."
Other Business Activities
- In July 2011, following the affirmative vote of our
stockholders at our Annual Meeting, we effected a one-for-ten
reverse stock split which reduced the number of shares outstanding
from approximately 137 million to approximately 13.7 million.
- Also in July 2011, we received notification from The NASDAQ
Stock Market that we have regained compliance with the minimum bid
price requirement needed to continue listing on the NASDAQ Global
Market. The NASDAQ Listing Rules require the Company's stock
to evidence a closing bid price of $1.00 per share or more for ten
consecutive days.
Second Quarter Financial Results
For the second quarter of 2011, the Company reported a net loss
of $4,035,000, or $(0.29) per share, compared with a net loss of
$4,610,000, or $(0.38) per share, for the second quarter of
2010. Loss from operations in the second quarter of 2011 was
$7,090,000, which was relatively flat when compared to the
$7,051,000 loss from operations in the second quarter of 2010.
Total revenue during the second quarter of 2011 was $234,000,
compared to $244,000 in the same period of 2010. Revenue from
product sales in the second quarter of 2011 was $185,000, which was
a 153% increase compared to the same period of 2010. This
growth was driven by both increased unit volumes and new products
in the Company's SC Proven media and reagents
business. Revenue from licensing agreements and grants was
$49,000, which was a 71% decrease compared to the previous year
primarily due to the completion and termination of several projects
funded by grants.
Total operating expenses in the second quarter of 2011 were
$7,272,000, compared to $7,271,000 in the same period of
2010. Operating expenses in the second quarter of 2011 include
$260,000 for severance and other expenses related to the
reduction-in-force effected by the Company in May. In the
second quarter of 2011, selling, general and administrative
expenses of $2,103,000 were 8% lower compared to the same period of
2010, while research and development expenses of $5,054,000 were 4%
higher in the second quarter of 2011 compared to the same quarter
of 2010 as the Company continued to prioritize its product
development efforts.
Other income in the second quarter of 2011 was $3,055,000,
compared to $2,441,000 in the second quarter of 2010. This
increase was primarily due to a decrease in the estimated fair
value of warrant liability.
Cash, cash equivalents and marketable securities at June 30,
2011 totaled $15,657,000, compared with $19,899,000 at December 31,
2010. For the six-month period ended June 30, 2011, net cash
used in operating activities was $13,131,000, which was 4% lower
than the same period in 2010.
Conference Call
StemCells, Inc. will host a live conference call and webcast
today, July 28, at 4:30 PM Eastern Time (1:30 PM Pacific Time) to
discuss its financial results and recent business
activities. Interested parties are invited to listen to the
call over the Internet via the Investors section of the Company's
website at
http://investor.stemcellsinc.com/phoenix.zhtml?c=86230&p=irol-irhome.
An archived version of the webcast will be available for replay on
the Company's website beginning approximately two hours following
the conclusion of the live call and continuing for a period of 30
days.
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development, and
commercialization of cell-based therapeutics and tools for use in
stem cell-based research and drug discovery. The Company's lead
therapeutic product candidate, HuCNS-SC® cells (purified human
neural stem cells), is currently in development as a potential
treatment for a broad range of central nervous system
disorders. Clinical trials are currently underway in spinal
cord injury and in Pelizaeus-Merzbacher disease (PMD), a fatal
myelination disorder in children. In addition, the Company
plans to initiate a Phase I/II clinical trial of HuCNS-SC
cells in age-related macular degeneration early next year, and is
also pursuing preclinical studies of its HuCNS-SC cells in
Alzheimer's disease and stroke. StemCells also markets stem
cell research products, including media and reagents, under the SC
Proven®brand, and is developing stem cell-based assay platforms for
use in pharmaceutical research, drug discovery and drug
development. Further information about StemCells is available at
http://www.stemcellsinc.com.
The StemCells, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7014
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 statements include, but are not limited to,
statements regarding the future business operations of StemCells,
Inc. (the "Company"); the timing and prospect associated with
beginning to detect potential clinical benefit from the use of the
Company's HuCNS-SC cells; the prospect for continued clinical
development of the Company's HuCNS-SC cells in CNS disorders; the
prospect for growth in the Company's product sales; the ability to
realize cost savings from the announced reduction in force; the
ability to realize the benefit of the Company's earlier investments
in process development and manufacturing; the adequacy of our
existing supply of HuCNS-SC cells to complete our ongoing and
planned clinical trials; and the timing and prospects associated
with filing an IND to initiate a clinical trial in age-related
macular degeneration. 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
uncertainties with respect to the fact that additional trials will
be required to confirm the safety and demonstrate the efficacy of
the Company's HuCNS-SC cells for the treatment of spinal cord
injury, PMD or any other condition; risks whether the FDA or other
applicable regulatory agencies will permit the Company to continue
clinical testing in spinal cord injury, PMD or in future clinical
trials of proposed therapies for other diseases or conditions such
as age-related macular degeneration; uncertainties about the design
of future clinical trials and whether the Company will receive the
necessary support of a clinical trial site and its institutional
review board to pursue future clinical trials in spinal cord
injury, PMD, age-related macular degeneration, or in proposed
therapies for other diseases or conditions; uncertainties regarding
the potential for the Company to grow its SC Proven business and to
advance the development and commercialization of stem cell-based
assays for drug discovery and development; uncertainties regarding
the Company's ability to obtain the increased capital resources
needed to continue its current and planned research and development
operations, including such operations of the Company for
non-therapeutic applications, and to conduct the research,
preclinical development and clinical trials necessary for
regulatory approvals; uncertainty as to whether HuCNS-SC cells and
any products that may be generated in the future in the Company's
cell-based programs will prove safe and clinically effective and
not cause tumors or other adverse side effects; uncertainties
regarding whether results in preclinical research in animals will
be indicative of future clinical results in humans; uncertainties
regarding the Company's manufacturing capabilities given its
increasing preclinical and clinical commitments; uncertainties
regarding the validity and enforceability of the Company's patents;
uncertainties as to whether the Company will become profitable; and
other factors that are described under the heading "Risk Factors"
disclosed in Part I, Item 1A in the Company's Annual Report on Form
10-K for the year ended December 31, 2010, and in its subsequent
reports on Form 10-Q and Form 8-K.
StemCells, Inc. |
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Unaudited Condensed
Consolidated Statements of Operations |
|
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|
(in thousands, except share and per share
amounts) |
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|
|
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|
|
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|
(unaudited) |
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Three months
ended |
|
Six months
ended |
|
June
30 |
|
June
30 |
|
2011 |
|
2010 |
|
2011 |
|
2010 |
Revenue: |
|
|
|
|
|
|
|
Revenue from licensing agreements and
grants |
$ 49 |
|
$ 171 |
|
$ 122 |
|
$ 285 |
Revenue from product sales |
185 |
|
73 |
|
334 |
|
189 |
Total revenue |
234 |
|
244 |
|
456 |
|
474 |
Cost of product sales |
52 |
|
24 |
|
107 |
|
68 |
Gross profit |
182 |
|
220 |
|
349 |
|
406 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
5,054 |
|
4,858 |
|
10,580 |
|
9,896 |
Selling, general and
administrative |
2,103 |
|
2,287 |
|
4,179 |
|
4,871 |
Wind-down expenses |
115 |
|
126 |
|
190 |
|
291 |
|
|
|
|
|
|
|
|
Total operating expenses |
7,272 |
|
7,271 |
|
14,949 |
|
15,058 |
|
|
|
|
|
|
|
|
Loss from operations |
(7,090) |
|
(7,051) |
|
(14,600) |
|
(14,652) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Realized gain on sale of marketable
securities |
84 |
|
-- |
|
84 |
|
-- |
Change in fair value of warrant
liability |
3,020 |
|
2,440 |
|
4,803 |
|
3,957 |
Interest income (expense), net |
(14) |
|
(11) |
|
(32) |
|
(37) |
Other income (expense), net |
(35) |
|
12 |
|
(37) |
|
(2) |
Total other income (expense), net |
3,055 |
|
2,441 |
|
4,818 |
|
3,918 |
|
|
|
|
|
|
|
|
Net loss |
$ (4,035) |
|
$ (4,610) |
|
$ (9,782) |
|
$ (10,734) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
$ (0.29) |
|
$ (0.38) |
|
$ (0.71) |
|
$ (0.90) |
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted loss
per share* |
13,802,372 |
|
11,990,573 |
|
13,741,481 |
|
11,943,505 |
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* Adjusted for 1 for 10 reverse stock split
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StemCells, Inc. |
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Unaudited Condensed Consolidated
Balance Sheets |
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(in thousands) |
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|
June 30, 2011 |
|
December 31,
2010 |
|
(unaudited) |
|
(unaudited) |
ASSETS: |
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Current Assets: |
|
|
|
Cash & cash equivalents |
$ 6,534 |
|
$ 19,708 |
Marketable securities |
9,123 |
|
191 |
Other current assets |
1,596 |
|
1,270 |
Total current assets |
17,253 |
|
21,169 |
|
|
|
|
Property, plant and equipment, net |
2,248 |
|
2,627 |
Goodwill and other intangible assets,
net |
4,890 |
|
4,874 |
Other assets, non-current |
1,930 |
|
1,932 |
Total assets |
$ 26,321 |
|
$ 30,602 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY: |
|
|
|
Current liabilities |
4,686 |
|
5,528 |
Fair value of warrant liability |
1,869 |
|
6,672 |
Other non-current liabilities |
2,904 |
|
2,921 |
Stockholders' equity |
16,862 |
|
15,481 |
Total liabilities and stockholders'
equity |
$ 26,321 |
|
$ 30,602 |
CONTACT: Rodney Young
Chief Financial Officer
(510) 456-4128
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