Geron Corporation Reports Fourth Quarter and Annual 2010 Financial Results
Summary of 2010 Highlights
MENLO PARK, Calif., Feb 24, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN)
today reported financial results for the fourth quarter and year ended December
31, 2010.
Fourth Quarter 2010 Results
Net loss applicable to common stockholders for the fourth quarter of 2010 was
$59.4 million or $(0.59) per share, which included a charge of $35.0 million in
connection with the Angiochem in-license, compared to $18.4 million or $(0.20)
per share for the comparable 2009 period. In the fourth quarter of 2010, the
company had revenues of $1.1 million, compared to $605,000 for the comparable
2009 period. Revenues for the fourth quarter of 2010 and 2009 reflect funding
under collaboration agreements and royalty and license fee revenues.
Interest and other income for the fourth quarter of 2010 was $1.4 million,
compared to $246,000 for the comparable 2009 period. In November 2010, the
company received $1.2 million in total grants under the Qualifying Therapeutic
Discovery Project (QTDP) program.
In the fourth quarter of 2010, the company had operating expenses of $60.7
million, which included a charge of $35.0 million in connection with the
Angiochem in-license, compared to $19.0 million for the comparable 2009 period.
Research and development expenses for the fourth quarter of 2010 were $21.0
million, compared to $15.3 million for the comparable 2009 period. Research and
development expenses increased due to higher drug purchases and increased
clinical trial costs related to four Phase 2 trials with imetelstat and
re-initiation of our Phase 1 trial with GRNOPC1. General and administrative
expenses for the fourth quarter of 2010 were $4.7 million, compared to $3.6
million for the comparable 2009 period. The increase was primarily due to higher
non-cash compensation expense for stock-based awards and legal and consulting
costs.
Year End 2010 Results
For 2010, the company had net loss applicable to common stockholders of $111.4
million or $(1.14) per share, which included a charge of $35.0 million in
connection with the Angiochem in-license, compared to $70.4 million or $(0.80)
per share for 2009. The company ended the year with $221.3 million in cash and
investments.
For 2010, the company had revenues of $3.6 million, compared to $1.7 million for
2009. Revenues for 2010 and 2009 reflect funding under collaboration agreements
and royalty and license fee revenues.
For 2010, interest and other income was $2.0 million, compared to $1.4 million
for 2009. The company has not incurred any impairment charges on its marketable
securities portfolio.
For 2010, the company had operating expenses of $114.7 million, which included a
charge of $35.0 million in connection with the Angiochem in-license, compared to
$72.0 million for 2009. Research and development expenses for 2010 were $61.7
million, compared to $57.6 million for 2009. Overall research and development
expenses increased in 2010 as a result of higher drug purchases, clinical trial
costs and non-cash compensation expense for stock-based awards, partially offset
by reduced manufacturing costs for GRNVAC1 with the completion of the Phase 2 AML
trial. General and administrative expenses for 2010 were $18.0 million, compared
to $14.3 million for 2009. The increase was the result of higher non-cash
compensation expense and legal and consulting costs.
2010 Highlights
Clinical Development
* The Phase 2 clinical program of Geron's telomerase inhibitor drug, imetelstat,
was launched. Two large randomized Phase 2 clinical trials were initiated testing
imetelstat in addition to standard of care against standard of care alone in
non-small cell lung cancer and metastatic breast cancer. Primary endpoints are
progression-free survival. Two single arm Phase 2 clinical trials of imetelstat
as a single agent were opened for patient enrollment in multiple myeloma and
essential thrombocythemia. The Phase 2 clinical trials focus on malignancies in
which cancer stem cells are believed to play an important role in disease
progression and relapse after standard therapy.
* Final data from the Phase 2 clinical trial of GRNVAC1, an autologous dendritic
cell vaccine targeting telomerase, in patients with acute myelogenous leukemia
(AML), showed prolonged remission duration in some patients with high-risk AML,
providing the first evidence that targeting telomerase may be associated with a
clinically significant outcome. The data were presented at the Annual Meeting of
the American Society of Hematology.
* The Phase 1 clinical trial of GRNOPC1, Geron's cell therapy product containing
oligodendrocyte progenitor cells derived from human embryonic stem cells (hESCs),
was initiated in patients with spinal cord injury.
Product Development
* Developed under a license and alliance agreement with Geron, GE Healthcare
launched the first cellular assay product for use in drug discovery and toxicity
screening. The hESC-derived cardiomyocytes are for testing potential cardiac
toxicity of candidate drug compounds, an important and universal step in drug
development.
* Developed under a collaboration and license agreement with Geron, Corning
Incorporated launched the Synthemax(TM) surface, a new synthetic matrix for
growth and differentiation of hESCs. The companies have been working together to
develop synthetic surface matrices to enhance the scalability of hESC-derived
product manufacturing.
* Preclinical study data showed that GRNCM1 does not cause cardiac arrhythmias
after transplantation into a small animal model of chronic heart damage designed
to test this potential safety concern. GRNCM1 is being developed for the
treatment of congestive heart failure and myocardial infarction. The data were
presented at the 31st Annual Scientific Sessions of the Heart Rhythm Society by
Geron's collaborator, Dr. Michael Laflamme from the University of Washington.
* Preclinical data provided the first demonstration that a telomerase activator
can affect fibrotic disease progression in a model system. Geron's small molecule
telomerase activator, GRN510 (formerly TAT153), increased telomerase activity in
the lung tissue, reduced inflammation, preserved functional lung tissue, slowed
disease progression and attenuated loss of pulmonary function in an animal model
of idiopathic pulmonary fibrosis (IPF). The data were presented at the American
Thoracic Society International Conference by Geron collaborator, Dr. Claude
Jourdan Le Saux from the University of Texas at San Antonio.
Business Development and Finance
* A worldwide exclusive license was signed with Angiochem, Inc. for proprietary
peptide technology to facilitate the transfer of anti-cancer compounds across the
blood-brain barrier for the treatment of primary brain cancers and cancers that
have metastasized to the brain, both significant unmet medical needs. The license
includes a novel taxane derivative, GRN1005 (formerly ANG1005) that has completed
two Phase 1 clinical trials. The companies also entered into a research and
collaboration agreement to utilize these receptor-targeting peptides to transport
telomerase inhibitors into the central nervous system.
* Geron maintained a strong balance sheet by raising $103.7 million in net
proceeds from a public offering of common stock and sale of common stock to
institutional investors.
* Thomas Hofstaetter, Ph.D., Hoyoung Huh, M.D., Ph.D., and Robert Spiegel, M.D.,
FACP, joined Geron's board of directors. Each member brings extensive
pharmaceutical industry and medical experience to contribute in the development
of clinical and corporate strategies.
Event Subsequent to 2010
* A new leadership structure was implemented with the appointment of David L.
Greenwood to president, interim chief executive officer and a member of the board
of directors; Hoyoung Huh, M.D., Ph.D., to executive chairman; and Alexander E.
Barkas, Ph.D., to lead independent director. The transition reflects the
company's progression into mid-stage clinical development of multiple therapeutic
product candidates.
Conference Call
At 8 a.m. PT/11 a.m. ET on February 25, David L. Greenwood, Geron's president,
interim chief executive officer and 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 800-322-5044
(U.S.); 617-614-4927 (international). The passcode is 46409714. A live audio-only
webcast is also available at
phx.corporate-ir.net. The audio
webcast of the conference call will be available for replay approximately one
hour following the live broadcast through March 25, 2011.
Geron is developing first-in-class biopharmaceuticals for the treatment of cancer
and chronic degenerative diseases. The company is advancing anti-cancer therapies
through multiple Phase 2 clinical trials in different cancers by targeting the
enzyme telomerase and with a compound designed to penetrate the blood-brain
barrier (BBB). The company is developing cell therapy products from
differentiated human embryonic stem cells for multiple indications, including
central nervous system (CNS) disorders, heart failure, diabetes and
osteoarthritis, and has initiated a Phase 1 clinical trial in spinal cord injury.
For more information, visit geron.com.
This news release may contain forward-looking statements made pursuant to the
"safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.
Investors are cautioned that statements in this press release regarding potential
applications of Geron's telomerase, oncology, and human embryonic stem cell
technologies, including plans for future clinical development, constitute
forward-looking statements that involve risks and uncertainties, including,
without limitation, risks inherent in the development and commercialization of
potential products, the uncertainty and preliminary nature of clinical trial
results or regulatory approvals or clearances, need to raise additional capital,
dependence upon collaborators and protection 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 September 30, 2010 and the annual report on Form 10-K for
the year ended December 31, 2009.
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED
Three Months EndedYear Ended
December 31,December 31,
---------------------------------------------------------
(In thousands, except share and per share data)2010200920102009
---------------------------------------------------------
Revenues from collaborative agreements$272$225$925$450
License fees and royalties8263802,6381,276
-----------------------------------------
Total revenues1,0986053,5631,726
Operating expenses:
Research and development21,02515,33961,68757,617
Acquired in-process research and development35,000--35,000--
General and administrative4,6843,63818,04314,343
-----------------------------------------
Total operating expenses60,70918,977114,73071,960
-----------------------------------------
Loss from operations(59,611)(18,372)(111,167)(70,234)
Unrealized gain on fair value of derivatives57444190157
Interest and other income1,4262462,0451,374
Losses recognized under equity method investment(1,212)(682)(2,347)(1,338)
Interest and other expense(22)(27)(98)(143)
----------- ------------ ------------ ------------ --
Net loss(59,362)(18,391)(111,377)(70,184)
Deemed dividend on derivatives------(190)
----------------------------------------- --
Net loss applicable to common stockholders$(59,362)$(18,391)$(111,377)$(70,374)
== =========== ==== ========== ==== ========== ==== ========== ==
Basic and diluted net loss per share:
Net loss per share applicable to common stockholders$(0.59)$(0.20)$(1.14)$(0.80)
== =========== ==== ========== ==== ========== ==== ========== ==
Shares used in computing net loss per share applicable to common101,205,25290,203,14597,601,52088,078,557
stockholders
== =========== ==== ========== ==== ========== ==== ========== ==
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31,December 31,
(In thousands)20102009
--------------------------
Current assets:
Cash, cash equivalents and restricted cash$46,764$35,392
Current marketable securities140,59977,009
Other current assets7,6545,378
--------------
Total current assets195,017117,779
Noncurrent marketable securities33,91154,669
Property and equipment, net3,0883,938
Deposits and other assets1,5683,996
--------------
$ 233,584$ 180,382
====== ============= =======
Current liabilities$40,849$7,455
Noncurrent liabilities--350
Stockholders' equity192,735172,577
--------------
$ 233,584$ 180,382
====== ============= =======
SOURCE: Geron Corporation
Geron Corporation
Anna Krassowska, Ph.D., 650-473-7765
Investor and Media Relations
info@geron.com
===========
OPC1..'initiated in patients with' ....rather than 'initiated FOR patients with'....hmmm, more than one? |
