SOUTH SAN FRANCISCO, Calif., Nov. 1 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today reported financial results for the third
quarter ended September 30, 2007. The company reported a net loss of $34.5
million, or $0.46 per fully diluted share, for the third quarter of 2007,
compared with a net loss of $28.8 million, or $0.57 per fully diluted
share, in the corresponding period of 2006.
The company's research and development costs were $28.6 million for the
third quarter of 2007 compared to $23.2 million for the corresponding
period in 2006. The increase is primarily due to expenses related to the
ongoing Phase 3 clinical trials of GVAX immunotherapy for prostate cancer,
the company's lead product development program. General and administrative
expenses were $5.1 million for the third quarter of 2007 compared to $4.3
million for the corresponding period in 2006. This increase is primarily
attributed to an increase in infrastructure costs associated with product
development and other business activities.
As of September 30, 2007, Cell Genesys had $161.9 million in cash, cash
equivalents and short-term investments compared to $154.1 million at
December 31, 2006. The ending third quarter balance reflects gross proceeds
raised since the beginning of 2007, including $29.2 million raised from the
company's Committed Equity Financing Facilities (CEFF) with Kingsbridge
Capital Limited, and $60.0 million raised from a registered direct offering
in the second quarter.
"During the third quarter we continued to make progress in our GVAX
immunotherapy for prostate cancer program both with respect to preparing
for the interim analysis of our now fully enrolled VITAL-1 Phase 3 clinical
trial and our continuing recruitment into our ongoing VITAL-2 Phase 3
clinical trial," stated Stephen A. Sherwin, M.D., chairman and chief
executive officer of Cell Genesys. "At the same time we continue to
maintain balance sheet strength to allow us to advance our product
development programs."
Third Quarter and Other Recent Highlights
-- Announced completion of the recruitment of over 600 patients into
VITAL-1, the first of two ongoing clinical trials of GVAX immunotherapy
for prostate cancer. The multi-center, randomized, controlled Phase 3
study in advanced prostate cancer will compare GVAX(TM) cancer
immunotherapy to Taxotere(R) (docetaxel) chemotherapy plus prednisone
in hormone refractory prostate cancer (HRPC) patients with metastatic
disease. The primary endpoint of the trial is an improvement in
survival. The company estimates the timing of the pre-planned interim
analysis from the VITAL-1 trial to be in 2008, probably in the first
half of the year, and that there will be a sufficient number of events
required for the final analysis to follow sometime later in 2009.
-- Published in the July 1, 2007 issue of Clinical Cancer Research final
clinical data for GVAX immunotherapy for prostate cancer from the first
of two independent, multi-center Phase 2 clinical trials, which
combined involved approximately 115 patients. Data from these two
trials showed a median survival of 34.9 months and 35.0 months,
respectively, for the patients who received doses comparable to the
Phase 3 dose. These results exceeded the predicted survival of 22.5
months and 22.0 months, respectively, as determined by a seven point
patient disease characteristic nomogram. Moreover, as previously
reported, the safety profile of GVAX immunotherapy for prostate cancer
in Phase 2 clinical trials to date compares favorably with that
reported for chemotherapy. Results from both studies also compare
favorably to the previously published median survival of 18.9 months
for metastatic HRPC patients treated with Taxotere chemotherapy plus
prednisone, the current standard of care. The ongoing Phase 3 program
is designed to confirm a potential survival benefit and safety profile
for GVAX immunotherapy for prostate cancer.
-- Received net proceeds of $16.7 million from the sale of 4.9 million
shares of Cell Genesys common stock under the 2007 CEFF, during the
three months ended September 30, 2007.
Please visit the investor section of the Cell Genesys website for a
list of upcoming investor conferences.
Cell Genesys will host its quarterly conference call at 2:00 p.m. PT on
Thursday, November 1, to discuss events that occurred during the third
quarter of 2007. Investors may listen to the webcast of the conference call
live on Cell Genesys' website. Alternatively, investors may listen to a
replay of the call by dialing 800-475-6701 from locations in the U.S. and
320-365-3844 from outside the U.S. The call-in replay will be available for
at least 72 hours following the call. Please refer to reservation number
883863.
About Cell Genesys
Cell Genesys is focused on the development and commercialization of
novel biological therapies for patients with cancer. The company is
currently pursuing two clinical stage product platforms -- GVAX(TM) cancer
immunotherapies and oncolytic virus therapies. Ongoing clinical trials
include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2
trials of GVAX immunotherapies for pancreatic cancer and for leukemia, and
a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell
Genesys continues to hold an equity interest in its former subsidiary,
Ceregene, Inc., which is developing gene therapies for neurodegenerative
disorders. Cell Genesys is headquartered in South San Francisco, CA and has
its principal manufacturing operation in Hayward, CA. For additional
information, please visit the company's website at
http://www.cellgenesys.com.
Statements made herein about the company, other than statements of
historical fact, including statements about the company's progress, results
and timing of clinical trials and preclinical programs and the nature of
product pipelines are forward-looking statements and are subject to a
number of uncertainties that could cause actual results to differ
materially from the statements made, including risks associated with the
success of clinical trials and research and development programs,
regulatory requirements and the regulatory approval process for clinical
trials, manufacture and commercialization of the company's products,
competitive technologies and products, patents, the need for and reliance
on partnerships with third parties, and the need for additional financings.
For information about these and other risks which may affect Cell Genesys,
please see the company's Annual Report on Form 10-K for the year ended
December 31, 2006 filed on March 1, 2007 as well as Cell Genesys' reports
on Form 10-Q and 8-K and other reports filed from time to time with the
Securities and Exchange Commission. The company assumes no obligation to
update the forward-looking information in this press release.
SELECTED CONSOLIDATED FINANCIAL INFORMATION
CONSOLIDATED STATEMENTS OF OPERATIONS DATA
(unaudited, in thousands, except per share data)
Three months Nine months
ended ended
September 30, September 30,
2007 2006 2007 2006
Revenue $ 2 $ 52 $ 1,278 $ 1,274
Operating expenses:
Research and development 28,629 23,196 77,674 71,713
General and administrative 5,114 4,335 15,141 13,631
Total operating expenses 33,743 27,531 92,815 85,344
Loss from operations (33,741) (27,479) (91,537) (84,070)
Other income (expense):
Gain on sale of Abgenix, Inc.
common stock - - - 62,677
Gain (loss) on sale of property
and equipment (75) - 1,309 -
Interest and other income 1,982 2,082 6,102 5,407
Interest expense (2,580) (2,614) (7,761) (7,858)
Income (loss) before
income taxes (34,414) (28,011) (91,887) (23,844)
Income tax benefit (provision) (124) (790) 26,009 (28,835)
Net loss $(34,538) $(28,801) $(65,878) $(52,679)
Basic and diluted net loss per
common share $ (0.46) $ (0.57) $ (0.96) $ (1.10)
Weighted average shares of
common stock outstanding -
basic and diluted 74,673 50,782 68,882 47,695
CONSOLIDATED BALANCE SHEET DATA
(in thousands) September 30, December 31,
2007 2006
(unaudited) Note 1
Cash, cash equivalents and
short-term investments,
including restricted cash $161,881 $154,074
Prepaid expenses and other
current assets 3,563 3,481
Property and equipment, net 120,746 129,643
Unamortized debt issuance costs
and other assets 3,346 3,969
Total assets $289,536 $291,167
Other current liabilities $ 20,230 $ 15,904
Current portion of accrued income
taxes - 35,410
Other liabilities 3,304 2,851
Non-current portion of accrued
income taxes 6,068 -
Non-current portion of capital
lease obligation 47,118 48,475
Convertible senior notes 145,000 145,000
Stockholders' equity 67,816 43,527
Total liabilities and
stockholders' equity $289,536 $291,167
Note 1. Derived from audited financial statements.
Contact:
Susan Ferris
Investor Relations
650-266-3200
SOURCE Cell Genesys, Inc.
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Related links:
http://www.cellgenesys.com
CONTACT:
Susan Ferris, Investor Relations of Cell
Genesys, Inc., +1-650-266-3200
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