SOUTH SAN FRANCISCO, Calif., Nov. 2 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) reported a net loss of $27.3 million, or $0.60
per share for the quarter ended September 30, 2005. This compares with a net
loss of $24.0 million, or $0.54 per share, for the same quarter in 2004. The
increase in net loss in the current quarter compared to the third quarter of
2004 can be attributed to increased operating losses, resulting in part from
greater expenditures on our GVAX(R) vaccine for prostate cancer program. Cell
Genesys ended the quarter with approximately $102.4 million in cash, cash
equivalents and short-term investments. In addition, Cell Genesys held
approximately 6.0 million shares of its former subsidiary, Abgenix, Inc.,
which had a market value of approximately $76.1 million as of September 30,
2005.
Revenues for the quarter ended September 30, 2005 were less than $0.1
million compared with revenues of $3.2 million for the comparable period in
2004. The timing of revenue payments from licensing arrangements vary from
quarter to quarter. The company's research and development costs for the
quarter ended September 30, 2005 were $23.3 million compared with $21.7
million for the comparable period in 2004. The increase in 2005 compared to
2004 is primarily attributed to the company's expanding clinical trials and
other product development activities in both its GVAX(R) cancer vaccines and
oncolytic virus therapy programs.
"The third quarter was highlighted by the initiation of our second Phase 3
trial of GVAX(R) vaccine for prostate cancer, the company's lead product
development program," stated Stephen A. Sherwin, M.D., chairman and chief
executive officer of Cell Genesys. "We are pleased to have achieved the major
milestones we have set for our business thus far in 2005, and look forward to
continued progress in our key product development programs in the months
ahead."
Third Quarter 2005 and Other Recent Highlights:
-- Initiated a second multicenter Phase 3 clinical trial of GVAX(R)
vaccine for prostate cancer in patients with metastatic hormone-refractory
prostate cancer. This trial, referred to as VITAL-2, will compare GVAX(R)
vaccine for prostate cancer plus Taxotere(R) (docetaxel) chemotherapy to
Taxotere(R) plus prednisone with respect to survival benefit in patients who
have symptomatic metastatic hormone-refractory prostate cancer. The trial is
expected to enroll approximately 600 patients at approximately 100 medical
centers across North America and Europe and is being conducted under a Special
Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA).
The company's first Phase 3 trial, VITAL-1, was initiated in July 2004 and is
also being conducted under an SPA. The VITAL-1 trial is expected to enroll
approximately 600 patients who have asymptomatic metastatic hormone-refractory
prostate cancer and will compare GVAX(R) vaccine for prostate cancer to
Taxotere(R) plus prednisone with respect to survival benefit.
-- Confirmed that new clinical data from both its GVAX(R) vaccine for
pancreatic cancer and GVAX(R) vaccine for leukemia programs will be presented
at two upcoming medical conferences later this year. Initial results from a
Phase 2 trial of GVAX(R) vaccine for pancreatic cancer will be presented at
the AACR-NCI-EORTC meeting in Philadelphia, PA on November 17, 2005. In
addition, initial results from a Phase 2 trial of GVAX(R) vaccine for leukemia
in patients with chronic myelogenous leukemia (CML) will be presented at the
American Society of Hematology (ASH) meeting in Atlanta, GA on December 12,
2005.
-- Confirmed that the company's former subsidiary, Ceregene, initiated a
Phase 1 clinical trial for CERE-120 to treat Parkinson's disease, its second
product candidate for neurodegenerative disorders to enter clinical
development. CERE-120 is a novel gene therapy product that delivers
neurturin, a protein that maintains survival of dopamine-producing nerve cells
which degenerate in Parkinson's disease patients. Ceregene also announced
that it had completed enrollment in a Phase 1 study of CERE-110, a gene
therapy product that delivers nerve growth factor to treat patients with
Alzheimer's disease.
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(R) cancer vaccines and
oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of
GVAX(R) vaccine for prostate cancer, Phase 2 trials of GVAX(R) vaccines for
leukemia and pancreatic cancer, and a Phase 1 trial of CG0070 oncolytic virus
therapy for bladder cancer and potentially other types of cancer. Cell
Genesys continues to hold equity interests in its two former subsidiaries
-- Abgenix, Inc., an antibody products company, and 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.
Cell Genesys will host its quarterly conference call to discuss events
that occurred during the third quarter of 2005 at 8:30 a.m. PST on November 3,
2005. Investors may listen to the webcast of the conference call live on Cell
Genesys' website. A replay of the webcast will be available for approximately
72 hours following the call. 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
72 hours following the call. Please refer to access number 798445.
Statements made herein about the company, other than statements of
historical fact, including statements about the company's progress, financial
results, timing and results 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, the
regulatory approval process for clinical trials, competitive technologies and
products, patents, continuation of corporate partnerships and the need for
additional funding. 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, 2004 filed on March 14, 2005 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 STATEMENT OF OPERATIONS DATA
(unaudited, in thousands Three months ended Nine months ended
except per share data) September 30, September 30,
2005 2004 2005 2004
Revenue $71 $3,228 $4,499 $8,274
Operating expenses:
Research and development 23,333 21,686 71,375 68,427
General and administrative 3,648 3,772 11,356 14,436
Restructuring charges 744 -- 1,597 --
Total operating expenses 27,725 25,458 84,328 82,863
Loss from operations (27,654) (22,230) (79,829) (74,589)
Gain on sale of Abgenix, Inc.
common stock 6,293 180 6,293 12,160
Interest and other income 778 341 2,310 1,891
Interest expense (2,634) (2,253) (8,044) (6,704)
Loss before income taxes (23,217) (23,962) (79,270) (67,242)
Income tax provision (4,051) (87) (4,725) (3,745)
Net loss $(27,268) $(24,049) $(83,995) $(70,987)
Basic and diluted net loss per
common share $(0.60) $(0.54) $(1.85) $(1.64)
Weighted average shares of
common stock
outstanding - basic and
diluted 45,499 44,805 45,395 43,253
CONSOLIDATED BALANCE SHEET DATA
(in thousands) September 30, December 31,
2005 2004
(unaudited) (note 1)
Cash, cash equivalents and short-term
investments,
including restricted cash $102,361 $174,971
Investment in Abgenix, Inc. common
stock 76,143 68,503
Prepaid expenses and other current
assets 2,868 1,184
Assets held for sale 3,200 --
Property and equipment, net 145,639 159,663
Noncurrent deferred tax assets 28,463 25,177
Deposits and other assets 5,000 5,641
Total assets $363,674 $435,139
Deferred revenue $-- $2,031
Other current liabilities 15,889 20,761
Accrued income taxes 31,878 29,954
Deferred tax liabilities 28,463 25,177
Other long-term liabilities 1,963 --
Noncurrent portion of facility lease
obligation 50,207 51,013
Convertible senior notes 145,000 145,000
Redeemable convertible preferred stock -- 1,897
Stockholders' equity 90,274 159,306
Total liabilities and stockholders'
equity $363,674 $435,139
Note 1. Derived from audited financial statements.
Contact: Ina Cu
Investor Relations
650-266-3200
SOURCE Cell Genesys, Inc.
 back to top
Related links:
http://www.cellgenesys.com
CONTACT:
Ina Cu, Investor Relations of Cell Genesys,
Inc., +1-650-266-3200
|
