StemCells, Inc. (NASDAQ: STEM) today reported financial results for the
second quarter ended June 30, 2009.
Results for the quarter reflect the Company’s acquisition of the
operations of Stem Cell Sciences Plc (SCS), a UK-based company focused
on cell-based technologies for drug discovery and screening. This
acquisition, which closed on April 1, 2009, solidifies StemCells’
leadership position in human neural stem cell technology, broadens its
proprietary cell-based technologies, adds expertise and infrastructure
for providing cell-based assays for drug discovery and screening, adds a
revenue-generating cell culture media business, and establishes a
European presence for the Company with operations in Cambridge, U.K. As
consideration for the acquired operations, StemCells issued to SCS
2,650,000 shares of common stock and waived certain commitments of SCS
to repay $709,000 in principal and accrued interest owed to the Company.
The Company reported a net loss of $7,366,000, or $0.07 per share, for
the second quarter ended June 30, 2009, compared with a net loss of
$6,715,000, or $0.08 per share, in the second quarter of 2008. Total
revenue for the second quarter of 2009 was $265,000, compared to $30,000
for the second quarter of 2008. This significant increase in revenue
reflects the consolidation of the acquired SCS operations, and includes
$121,000 in product sales from the Company’s SC Proven®
portfolio of cell culture media products.
Total operating expenses for the quarter were $7,597,000, a 10% increase
compared to the same period in 2008. Operating expenses in the second
quarter of 2009 include two non-recurring items: (i) a charge of
$310,000 to set up a reserve for costs and expenses associated with the
Company’s exit from its Melbourne, Australia site, and (ii) transaction
expenses of $172,000 related to the acquisition of the SCS operations.
Research and development expenses were 14% higher in the second quarter
of 2009 compared with the same period in 2008, primarily due to the
consolidation of the SCS operations, while general and administrative
expenses were 6% lower in the second quarter compared with the same
period in 2008, primarily due to lower external services fees.
Cash, cash equivalents and short-term marketable debt securities totaled
$36,760,000 at June 30, 2009. In the second quarter of 2009, the Company
raised $8,655,000 in gross proceeds through the sale of 4,937,400 shares
of common stock. For the first six months of 2009, the Company’s cash
used in operations totaled $12,383,000, which was 1% higher than the
same period in 2008. This modest increase reflects the Company’s
continuing efforts to control expenses and manage working capital
requirements.
Significant recent events include:
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In April 2009, StemCells announced that a major international
pharmaceutical company acquired a non-exclusive license to the
Company’s Internal Ribosome Entry Site (IRES) technology, which was
acquired as part of the SCS operations. The IRES technology enables
researchers to genetically modify any mammalian cell and to monitor
the activity of a particular gene of interest without blocking the
normal function of the gene. The IRES technology is particularly
important for evaluating the success of gene knock-outs or knock-ins
in stem cells, as well as for the successful creation of transgenic
mouse and rat disease models.
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In May 2009, the U.S. Patent and Trademark Office (PTO) upheld the
validity of StemCells’ two remaining neural stem cell patents, which
were subjected to reexamination proceedings commenced by Neuralstem,
Inc. The PTO’s decision to uphold the two patents is final and cannot
be appealed. The upheld patents are the subject of litigation
initiated by the Company against Neuralstem alleging infringement of a
total of six patents. These six patents collectively claim the
manufacture and use of human neural stem and progenitor cells as tools
for drug discovery and as therapeutic agents. In August 2009, the
court approved a scheduling order for discovery and trial.
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In May 2009, the Company’s collaborators at Oregon Health & Science
University Casey Eye Institute presented data at the Association for
Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting
showing that StemCells’ human central nervous system stem cells, when
transplanted into an animal model of retinal degeneration, engraft
long-term and can protect the retina from progressive degeneration.
Retinal degeneration leads to loss of vision in diseases such as
age-related macular degeneration.
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In June 2009, StemCells announced positive results from a Phase I
clinical trial of its HuCNS-SC product candidate (purified human
neural stem cells) in infantile and late infantile neuronal ceroid
lipofuscinosis (NCL), often referred to as Batten disease. This first
Phase I trial was designed primarily to assess the safety of HuCNS-SC
cells as a potential cell-based therapeutic. Overall, the trial data
demonstrated that the HuCNS-SC cells, the transplantation procedure
and the immunosuppression regimen were well tolerated by all six
patients enrolled in the trial, and the patients’ medical,
neurological and neuropsychological conditions, following
transplantation, appeared consistent with the normal course of the
disease. In addition to this favorable safety profile, the Company
reported evidence of engraftment and long-term survival of the
HuCNS-SC cells.
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In June 2009, StemCells was added to the Russell 3000®
Index, a broad market index that measures the performance of the 3000
largest companies in the United States. As part of membership in the
Russell 3000, StemCells is also included in the Russell 2000®
Index, which is a subset of the Russell 3000 representing the small
capitalization segment of the U.S. equity market.
“This was a notable quarter for StemCells as we announced positive
results from our first clinical trial and, for the first time, we are
reporting revenue from product sales,” said Martin McGlynn, President
and CEO of StemCells, Inc. “Our Phase I clinical trial in Batten disease
was a landmark achievement, and we are encouraged by the favorable
safety profile of our HuCNS-SC product and the evidence that our cells
engrafted and survived after transplantation. We are working diligently
to initiate a second clinical trial of our HuCNS-SC cells in
Pelizaeus-Merzbacher Disease (PMD) before year-end, and we are pursuing
a clinical study with our liver cell. With respect to product sales, we
are experiencing strong demand for our SC Proven media, and are focused
on growing this business.
“We continue to be mindful of the difficult economic environment and
remain committed to proactively managing our expenses and cash balance,”
continued Mr. McGlynn. “During the past six months, we have taken
advantage of the liquidity of our shares to opportunistically raise $15
million. Our ability to access the capital markets in these trying
conditions has enabled us to maintain a strong balance sheet and given
us the resources and flexibility to execute on our strategic agenda,
which is to build a sustainable business focused on cell-based
technologies.”
About StemCells, Inc.
StemCells, Inc. is a clinical-stage biotechnology company focused on the
research, development and commercialization of cell-based technologies.
In its therapeutic product development programs, StemCells is focused on
developing cell-based therapeutics to treat diseases of the central
nervous system and liver. StemCells’ lead product candidate, HuCNS-SC®
cells, are highly purified human neural stem cells which can be expanded
and banked until they are delivered as patient doses. StemCells has
completed a Phase I clinical trial of HuCNS-SC cells in neuronal ceroid
lipofuscinosis (NCL), a fatal neurodegenerative disease that affects
infants and young children. The trial data demonstrated that the
HuCNS-SC cells were well tolerated by the trial participants. StemCells
has also received approval from the U.S. Food and Drug Administration to
initiate a Phase I clinical trial of HuCNS-SC cells in
Pelizaeus-Merzbacher Disease (PMD), a fatal brain disorder that
primarily affects young children. StemCells also operates a specialty
cell culture media business, which is marketing a portfolio of products
under the brand SC Proven®, and is developing its cell-based
technologies for use in drug discovery and screening. StemCells has
exclusive rights to approximately 55 issued or allowed U.S. patents and
approximately 200 granted or allowed non-U.S. patents. Further
information about StemCells is available on its web site at: www.stemcellsinc.com.
Apart from statements of historical fact, the text of this press
release constitutes forward-looking statements regarding, among other
things, the future business operations of StemCells, Inc. and its
wholly-owned subsidiaries (together, the “Company”). 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 about, and the costs associated with, the integration of
the acquired SCS operations; uncertainties about the effects of the
integration with respect to maintaining relationships with employees,
licensees, other business partners or governmental entities;
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 NCL or any other disease;
risks whether the FDA or other applicable regulatory agencies will
permit the Company to continue clinical testing in NCL, PMD or in future
clinical trials of proposed therapies for other diseases or conditions
despite the novel and unproven nature of the Company’s technologies;
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 NCL,
PMD or in proposed therapies for other diseases or conditions;
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; and other factors
that are described under the heading “Risk Factors” in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2008 and in
its subsequent reports on Form 10-Q and Form 8-K.
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StemCells, Inc.
Unaudited Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
(unaudited)
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Three Months Ended June 30,
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Six Months Ended June 30,
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2009
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2008
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2009
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2008
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|
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Revenue:
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|
|
|
|
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|
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Revenue from licensing agreements and grants
|
|
$
|
144
|
|
|
$
|
30
|
|
|
|
|
$
|
201
|
|
|
$
|
47
|
|
|
Revenue from product sales
|
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121
|
|
|
|
-
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121
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
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265
|
|
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|
30
|
|
|
|
|
|
322
|
|
|
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47
|
|
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Cost of product sales
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(59
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)
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|
-
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(59
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)
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|
|
-
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|
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Gross profit
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|
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206
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|
30
|
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263
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47
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|
|
|
|
|
|
|
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|
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Operating expenses:
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Research and development
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5,055
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4,416
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|
|
|
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9,290
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|
|
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8,915
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|
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General and administrative
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|
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2,202
|
|
|
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2,346
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|
|
|
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4,741
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|
|
|
4,600
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|
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Wind-down expenses
|
|
|
340
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|
|
|
167
|
|
|
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|
|
546
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|
|
|
328
|
|
|
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|
|
|
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Total operating expenses
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7,597
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6,929
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14,577
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13,843
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|
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|
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Loss from operations
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|
|
(7,391
|
)
|
|
|
(6,899
|
)
|
|
|
|
|
14,314
|
|
|
|
(13,796
|
)
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|
|
|
|
|
|
|
|
|
|
|
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Other income (expense):
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|
|
|
|
|
|
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|
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Realized gain on sale of marketable securities
|
|
|
-
|
|
|
|
-
|
|
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|
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|
398
|
|
|
|
-
|
|
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Change in fair value of warrant liability
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|
|
103
|
|
|
|
-
|
|
|
|
|
|
(2,653
|
)
|
|
|
-
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|
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Other income (expense), net
|
|
|
(78
|
)
|
|
|
184
|
|
|
|
|
|
(79
|
)
|
|
|
535
|
|
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Total other income (expense), net
|
|
|
25
|
|
|
|
184
|
|
|
|
|
|
(2,334
|
)
|
|
|
535
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(7,366
|
)
|
|
$
|
(6,715
|
)
|
|
|
|
$
|
(16,648
|
)
|
|
$
|
(13,261
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
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Basic and diluted net loss per share
|
|
$
|
(0.07
|
)
|
|
$
|
(0.08
|
)
|
|
|
|
$
|
(0.17
|
)
|
|
$
|
(0.16
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
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Shares used to compute basic and diluted loss per share
|
|
|
104,776,073
|
|
|
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80,814,838
|
|
|
|
|
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100,436,291
|
|
|
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80,759,400
|
|
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StemCells, Inc.
Unaudited Condensed Consolidated Balance Sheets
(in thousands)
|
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June 30, 2009
|
|
December 31, 2008 (a)
|
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(unaudited)
|
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(unaudited)
|
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ASSETS:
|
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Current Assets:
|
|
|
|
|
|
|
|
Cash & cash equivalents
|
|
|
|
$
|
36,760
|
|
$
|
30,043
|
|
Marketable securities
|
|
|
|
|
200
|
|
|
4,182
|
|
Other current assets
|
|
|
|
|
1,099
|
|
|
1,107
|
|
Total current assets
|
|
|
|
|
38,059
|
|
|
35,332
|
|
|
|
|
|
|
|
|
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Property, plant and equipment, net
|
|
|
|
|
3,294
|
|
|
3,173
|
|
Goodwill and other intangible assets, net
|
|
|
|
|
5,624
|
|
|
646
|
|
Other assets
|
|
|
|
|
2,095
|
|
|
2,079
|
|
Total assets
|
|
|
|
$
|
49,072
|
|
$
|
41,230
|
|
|
|
|
|
|
|
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LIABILITIES AND STOCKHOLDERS’ EQUITY:
|
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|
|
|
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Current liabilities
|
|
|
|
$
|
6,163
|
|
$
|
5,318
|
|
Warrant liability
|
|
|
|
|
11,093
|
|
|
8,440
|
|
Other non-current liabilities
|
|
|
|
|
5,168
|
|
|
5,663
|
|
Stockholders' equity
|
|
|
|
|
26,648
|
|
|
21,809
|
|
Total liabilities and stockholders’ equity
|
|
|
|
$
|
49,072
|
|
$
|
41,230
|
|
|
|
|
|
|
|
|
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(a) Derived from audited financial statements included in
StemCells’ annual report on form 10-K filed with the SEC.
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StemCells, Inc.
Megan Meloni, 650-475-3100, ext. 105
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