27.02.2008 23:00:00
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Geron Corporation Reports Fourth Quarter and Annual 2007 Financial Results and Highlights
Geron Corporation (Nasdaq:GERN) today reported financial results for the
fourth quarter and year ended Dec. 31, 2007.
Fourth Quarter 2007 and Year End Results
Net loss applicable to common stockholders for the fourth quarter of
2007 was $16.5 million or $(0.22) per share, compared to $13.1 million
or $(0.20) per share for the comparable 2006 period. For fiscal 2007,
the company had net loss applicable to common stockholders of $45.8
million or $(0.62) per share, compared to a net loss of $31.4 million or
$(0.47) per share for the fiscal 2006 period.
In the fourth quarter of 2007, the company had revenues of $4.7 million
compared to $1.2 million for the comparable 2006 period. For fiscal
2007, the company had revenues of $7.6 million, compared to revenues of
$3.3 million in fiscal 2006. In 2007, the company received royalty and
license fee revenue and milestone payments under various license
agreements and collaborative agreements. Revenues in 2006 primarily
reflected royalty and license fee revenue under various license
agreements and collaborative agreements.
In the fourth quarter of 2007, the company had operating expenses of
$19.0 million, compared to $14.2 million for the comparable 2006 period.
Research and development expenses for the fourth quarter of 2007 were
$15.0 million compared to $11.8 million for the comparable 2006 period.
Research and development expenses increased due to increased clinical
trial costs and higher personnel-related costs, including increased
compensation expense for equity-based compensation pursuant to SFAS
123R. General and administrative expenses for the fourth quarter of 2007
were $4.0 million compared to $2.3 million for the comparable 2006
period. The increase in general and administrative expenses in the
fourth quarter of 2007 was primarily due to higher compensation expense
related to equity-based compensation pursuant to SFAS 123R.
For fiscal 2007, the company had operating expenses of $70.5 million,
compared to $50.6 million in fiscal 2006. Research and development
expenses for 2007 were $54.6 million compared to $41.2 million for 2006.
Overall research and development expenses increased in 2007 as a result
of higher personnel-related costs, including increased compensation
expense related to equity-based compensation pursuant to SFAS 123R,
increased clinical trial costs for GRN163L and GRNVAC1 and increased
manufacturing costs for GRN163L drug product. General and administrative
expenses for 2007 were $15.8 million compared to $9.4 million for 2006.
The overall increase in general administrative expense was due to
increased compensation expense related to equity-based compensation
pursuant to SFAS 123R, increased consulting expense and higher audit
fees.
2007 Highlights Clinical Development • Data presented on GRN163L from an ongoing
Phase I trial involving patients with chronic lymphocytic leukemia (CLL)
shows good pharmacokinetics and tolerability.
• Initiated clinical trial of GRN163L in
patients with advanced non-small cell lung cancer (NSCLC). The primary
objective of the Phase I study is to determine the safety and maximum
tolerated dose of GRN163L when administered intravenously in combination
with a standard paclitaxel/carboplatin regimen.
• Initiated clinical trial of GRNVAC1 in
patients with acute myelogenous leukemia (AML) in complete remission.
The primary objective of this new Phase II study is to evaluate the
safety and feasibility of a prime-boost vaccination regimen that extends
the duration of telomerase immunity.
• Initiated clinical trial of GRN163L in
patients with multiple myeloma. The primary objective of the Phase I
study is to determine the safety and maximum tolerated dose (MTD) of
GRN163L when administered intravenously in patients with multiple
myeloma who have failed at least two courses of standard chemotherapy.
In addition, researchers will perform correlative laboratory studies on
primary patient samples to characterize the effects of GRN163L on
myeloma cells and myeloma stem-cells.
Product Development • Published studies in Stem Cells and
Development that describe a newly discovered neurotrophic effect of
OPC-1 cells caused by their secretion of multiple nerve growth factors –
proteins that stimulate the survival and regeneration of neurons damaged
during spinal cord injury.
• Published studies in Cancer Research that
identify specific structural elements of GRN163L that contribute to its
unique anti-tumor and anti-metastatic activity.
• Published studies in Cloning and Stem
Cells that show hepatocytes produced from human embryonic stem cells
(hESCs) can model human hepatic drug metabolism. The hESC-derived
hepatocytes exhibit characteristic morphology and express several
markers, including albumin and HepPar1, and possess functional
activities, including p450 metabolism, albumin production, glycogen
storage and uptake and excretion of indocyanine green, that are
characteristic of normal human liver function.
• Published studies in Stem Cells that
describe how hESCs can be differentiated into islet-like clusters (ILCs)
that secrete insulin in response to elevated glucose levels. The studies
demonstrate the potential for producing therapeutic cells from hESCs for
the treatment of diabetes.
• Presented data at the International Society
of Stem Cell Research Annual Meeting that documents the scalable
production, survival following engraftment, and positive impact on
cardiac function in infarcted rats treated with GRNCM1. Other
presentations focused on the gene expression and neurotrophic protein
secretion patterns of hESC-derived oligodendroglial progenitor cells for
acute spinal cord injury, the functional characterization of
hESC-derived islets for diabetes, and hESC-derived chondrocytes for
arthritis and other orthopedic applications.
• Published studies in Nature Biotechnology
that document the potential clinical utility of regenerating damaged
heart muscle by injecting hESC-derived cardiomyocytes directly into the
site of the infarct. In addition, the research confirms the
effectiveness of a scalable production system that enables Geron to
manufacture the cardiomyocytes for use in ongoing large animal studies
and, ultimately, testing in humans.
• Presented data at the Neurosciences Annual
Meeting that shows GRNOPC1 survives and exhibits durable and robust
human remyelination in spinal cord-injured rats for at least nine months
following a single injection. The data also demonstrate that GRNOPC1
does not amplify neuropathic pain or the reaction to painful stimuli.
• Published studies in Journal of
Neuroimmunology that show GRNOPC1 evades direct attack by the human
immune system in vitro. Unlike whole organ transplants, cellular
therapeutics derived from hESCs may provoke only minimal immune
reactions and that rejection may be controlled or prevented by short
courses of low-dose immunosuppressive drugs. The results also support
the position that patient-specific hESC lines are not needed to prevent
immune rejection.
Business Development, Finance and
Intellectual Property • Warrants to purchase 1,875,000 shares of
common stock were exercised at $8.00 per share for gross proceeds of
$15.0 million. The exercised warrants were issued to institutional
investors in connection with a financing in Dec. 2006.
• Increased stake in joint venture entity, TA
Therapeutics Limited (TAT), from a 50% ownership to a 75% ownership
interest. TAT is a Hong Kong company that conducts research on
telomerase activator drugs to potentially restore the functional and
regenerative capacity of cells.
• The Technical Board of Appeal of the
European Patent Office (EPO) affirmed the decision to revoke the claims
of European Patent 1093381 as granted to Pharmexa in 2003.
• Received a milestone payment from Merck &
Co, Inc. as a result of Merck’s filing of an
Investigational New Drug application for a cancer vaccine that targets
telomerase.
Conference Call
At 8 a.m. PST/11 a.m. EST on Feb. 28, Thomas B. Okarma, Ph.D., M.D.,
Geron’s chief executive officer, and David L.
Greenwood, Geron’s chief financial officer,
will host a conference call to discuss the company’s
fourth quarter and year-end results.
Participants can access the conference call via telephone by dialing
866-578-5788 (U.S.); 617-213-8057 (international). The passcode is
64686356. A live audio-only Webcast is also available through a link
that is posted on the conferences page in the investor relations section
of Geron’s Web site at http://www.geron.com.
The audio Web broadcast of the conference call will be available for
replay through March 28.
Geron is developing first-in-class biopharmaceuticals for the treatment
of cancer and chronic degenerative diseases, including spinal cord
injury, heart failure and diabetes. The company is advancing an
anti-cancer drug and a cancer vaccine that target the enzyme telomerase
through multiple clinical trials. Geron is also the world leader in the
development of human embryonic stem cell-based therapeutics, with its
spinal cord injury treatment anticipated to be the first product to
enter clinical development. For more information, visit www.geron.com.
This news release may contain forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of
the Securities Exchange Act of 1934. Investors are cautioned that such
forward-looking statements in this press release regarding potential
applications of Geron’s technologies
constitute forward-looking statements that involve risks and
uncertainties, including, without limitation, risks inherent in the
development and commercialization of potential products, uncertainty of
clinical trial results or regulatory approvals or clearances, need for
future capital, dependence upon collaborators and maintenance of our
intellectual property rights. Actual results may differ materially from
the results anticipated in these forward-looking statements. Additional
information on potential factors that could affect our results and other
risks and uncertainties are detailed from time to time in Geron’s
periodic reports, including the quarterly report on Form 10-Q for the
quarter ended Sept. 30, 2007.
GERON CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED Three Months Ended December 31, Twelve Months Ended December 31, (In thousands, except shares and per share amounts)
2007
2006
2007
2006
Revenues from collaborative agreements
$
74
$
257
$
672
$
622
License fees and royalties
4,613
928
6,950
2,655
Total revenues
4,687
1,185
7,622
3,277
Operating expenses:
Research and development
15,011
11,842
54,624
41,234
General and administrative
4,012
2,339
15,837
9,403
Total operating expenses
19,023
14,181
70,461
50,637
Loss from operations
(14,336
)
(12,996
)
(62,839
)
(47,360
)
Unrealized gain (loss) on fair value of derivatives
931
(2,441
)
15,453
7,421
Interest and other income
2,384
2,340
10,791
8,704
Interest and other expense
(24 )
(26 )
(102 )
(130 )
Net loss
(11,045
)
(13,123
)
(36,697
)
(31,365
)
Deemed dividend on derivatives
(5,420 )
—
(9,081 )
—
Net loss applicable to common stockholders
$ (16,465 ) $ (13,123 ) $ (45,778 ) $ (31,365 )
Basic and diluted net loss per share:
Net loss per share applicable to common stockholders
$ (0.22 ) $ (0.20 ) $ (0.62 ) $ (0.47 )
Shares used in computing net loss per share applicable to common
stockholders
75,590,468
67,041,232
74,206,249
66,057,367
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31, December 31, (In thousands) 2007 2006
Current assets:
Cash, cash equivalents and restricted cash
$ 148,465
$ 136,412
Marketable securities
59,979
77,448
Other current assets
4,928 3,293
Total current assets
213,372
217,153
Property and equipment, net
4,075
2,482
Deposits and other assets
1,449 1,165 $ 218,896 $ 220,800
Current liabilities
12,717
46,776
Noncurrent liabilities
505
105
Stockholders’ equity
205,674 173,919 $ 218,896 $ 220,800
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