Geron Corporation Reports 2010 Third Quarter Financial Results and Events
MENLO PARK, Calif., Oct 28, 2010 (BUSINESS WIRE) -- Geron Corporation (GERN)
today reported financial results for the three and nine months ended September
30, 2010.
For the third quarter of 2010, the company reported net loss applicable to common
stockholders of $18.3 million, or $(0.19) per share, compared to $15.2 million,
or $(0.17) per share, for the comparable 2009 period. Net loss applicable to
common stockholders for the first nine months of 2010 was $52.0 million, or
$(0.54) per share, compared to $52.0 million, or $(0.59) per share, for the
comparable 2009 period.
Revenues for the third quarter of 2010 were $546,000, compared to $494,000 for
the comparable 2009 period. Revenues for the first nine months of 2010 were $2.5
million, compared to $1.1 million for the comparable 2009 period. Revenues for
the third quarter and year-to-date periods of 2010 and 2009 reflect funding under
collaboration agreements and royalty and license fee revenues.
Total operating expenses for the third quarter of 2010 were $18.7 million,
compared to $16.9 million for the comparable 2009 period. Research and
development expenses for the third quarter of 2010 were $13.7 million, compared
to $13.4 million for the comparable 2009 period. Research and development
expenses increased primarily as a net result of higher costs related to clinical
trials and preclinical toxicology studies, partially offset by reduced
manufacturing costs for GRNVAC1. In the 2010 third quarter, additional costs were
incurred for the start up of the Phase 2 clinical trial for imetelstat in
non-small cell lung cancer, start up of the Phase 1 clinical trial for GRNOPC1in
spinal cord injury and pre-IND enabling studies for GRNCM1. With the completion
of patient enrollment for the Phase 2 AML trial, production of GRNVAC1 has ceased
since January 2010. General and administrative expenses for the third quarter of
2010 were $5.0 million, compared to $3.5 million for the comparable 2009 period.
The increase in general and administrative expenses was primarily due to higher
non-cash compensation expense associated with stock-based awards and increased
legal and consulting costs.
Total operating expenses for the first nine months of 2010 were $54.0 million,
compared to $53.0 million for the comparable 2009 period. Research and
development expenses for the first nine months of 2010 were $40.7 million,
compared to $42.3 million for the comparable 2009 period. Overall research and
development expenses decreased in 2010 as a net result of reduced manufacturing
costs for GRNVAC1, partially offset by higher non-cash compensation expense
associated with stock-based awards. General and administrative expenses for the
first nine months of 2010 were $13.4 million, compared to $10.7 million for the
comparable 2009 period. The increase in general and administrative expenses was
primarily the result of higher non-cash compensation expense associated with
stock-based awards and increased legal and consulting costs.
Third Quarter 2010 Highlights:
The activities of TA Therapeutics, the joint venture with Hong Kong University of
Science and Technology (HKUST), are being fully consolidated into Geron.
Telomerase activator drug candidates have been advanced into early efficacy
studies, including animal models of idiopathic pulmonary fibrosis (IPF) and in
vitro studies employing immune cells from HIV patients. Geron plans to continue
both efficacy and safety studies in order to advance a compound to human trials.
The first patient was enrolled in a randomized Phase 2 clinical trial of the
telomerase inhibitor drug, imetelstat (GRN163L) for non-small cell lung cancer.
The multi-center trial tests the efficacy and safety of imetelstat in combination
with standard of care versus standard of care alone. The U.S. Food and Drug
Administration (FDA) lifted the clinical hold placed on Geron's Investigational
New Drug (IND) application for the Phase 1 clinical trial of GRNOPC1 in patients
with acute spinal cord injury. A collaboration was established with researchers
at University Campus Suffolk (UCS) in the U.K. to develop human embryonic stem
cell (hESC)-derived chondrocytes for the treatment of cartilage damage and joint
disease. This collaboration is being jointly funded by Geron and with U.K.
grants. Geron has exclusive rights to the technology for therapeutic
applications.
Events Subsequent to Q3 2010
GE Healthcare launched the first human cellular assay product, human
cardiomyocytes or heart muscle cells, for testing potential cardiac toxicity of
candidate drug compounds in development. The first commercial sale of this
product occurred in October 2010, triggering a milestone payment to Geron. The
first patient was enrolled in the Phase 1 clinical trial of hESC-derived
oligodendrocyte progenitor cells, GRNOPC1. The primary objective of this Phase 1
study is to assess the safety and tolerability of GRNOPC1 in patients with
"complete" American Spinal Injury Association (ASIA) Impairment Scale grade A
thoracic spinal cord injuries.
Conference Call
At 8:00 a.m. PDT / 11:00 a.m. EDT on Friday, October 29, 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 third
quarter and year-to-date results.
Participants can access the conference call via telephone by dialing 866-730-5770
(U.S.) or 857-350-1594 (international). The passcode is 14864744. A live
audio-only Webcast is also available through a link that is posted on the Events
page in the Investors section of Geron's Website at geron.com. The
audio Web broadcast of the conference call will be available for replay until
November 29, 2010.
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 in different
cancers. For more information, visit 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 statements in this press
release regarding potential applications of Geron's technologies and future
operating results 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 June 30, 2010.
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
THREE MONTHS ENDEDNINE MONTHS ENDED
SEPTEMBER 30,SEPTEMBER 30,
(In thousands, except share and2010200920102009
----------------------------------------
per share data)
Revenues from collaborative agreements$203$225$653$225
License fees and royalties3432691,812896
----------------------------------------
Total revenues5464942,4651,121
Operating expenses:
Research and development13,72813,39540,66242,278
General and administrative5,0213,49913,35910,705
----------------------------------------
Total operating expenses18,74916,89454,02152,983
----------------------------------------
Loss from operations(18,203)(16,400)(51,556)(51,862)
Unrealized gain (loss) on derivatives, net(97)966133(287)
Interest and other income2232406191,128
Losses recognized under equity method investment(243)--(1,135)(656)
Interest and other expense(24)(30)(76)(116)
---------- ------------ ------------ ------------ --
Net loss(18,344)(15,224)(52,015)(51,793)
Deemed dividend on derivatives------(190)
---------------------------------------- --
Net loss applicable to common stockholders$(18,344)$(15,224)$(52,015)$(51,983)
== ========== ==== ========== ==== ========== ==== ========== ==
Basic and diluted net loss per share applicable to common$(0.19)$(0.17)$(0.54)$(0.59)
stockholders
== ========== ==== ========== ==== ========== ==== ========== ==
Shares used in computing basic and diluted net loss per share97,476,66889,402,64296,400,27687,370,361
applicable to common stockholders
== ========== ==== ========== ==== ========== ==== ========== ==
CONDENSED CONSOLIDATED BALANCE SHEETS
SEPTEMBER 30,DECEMBER 31,
(In thousands)20102009
--------------------------
(Unaudited)(Note 1)
Current assets:
Cash, restricted cash and cash equivalents$35,282$35,392
Marketable securities91,05677,009
Other current assets11,1365,378
--------------
Total current assets137,474117,779
Noncurrent marketable securities19,85654,669
Property and equipment, net3,2173,938
Deposits and other assets1,7483,996
--------------
$162,295$ 180,382
====== ============= =======
Current liabilities$7,625$7,455
Noncurrent liabilities--350
Stockholders' equity154,670172,577
--------------
$162,295$ 180,382
====== ============= =======
Note 1: Derived from audited financial statements included in the company's
Annual Report on Form 10-K for the year ended December 31, 2009.
SOURCE: Geron Corporation
Geron Corporation
Anna Krassowska, Ph.D., 650-473-7765
Investor and Media Relations
info@geron.com |
