SOUTH SAN FRANCISCO, Calif., July 25 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) reported a net loss of $27.4 million, or $0.60
per share, for the quarter ended June 30, 2005. This compares with a net loss
of $26.0 million, or $0.58 per share, for the quarter ended June 30, 2004.
The slight increase in net loss quarter to quarter is due primarily to the
absence of gains from the sale of marketable securities. Cell Genesys ended
the quarter with approximately $120.6 million in cash, cash equivalents and
short-term investments, and in addition, held approximately 6.6 million shares
of its former subsidiary, Abgenix, Inc., which as of June 30, 2005 had a
market value of approximately $56.8 million.
The company's research and development costs for the quarter were $23.2
million, compared with $24.1 million for the second quarter of 2004. The
decrease in research and development costs is due primarily to the absence of
consolidated expenses from Ceregene, Inc., the company's former subsidiary,
whose expenses were incurred in 2004 prior to the closing of Ceregene's Series
B equity financing. General and administrative expenses decreased to $3.9
million in the second quarter of 2005 from $5.1 million in the second quarter
of 2004 due to the accrual of certain facility-related costs in 2004.
"We are pleased with our recent business progress particularly with
respect to the Phase 3 clinical trials for our lead product development
program, GVAX(R) vaccine for prostate cancer," stated Stephen A. Sherwin,
M.D., chairman and chief executive officer of Cell Genesys. "During the
second quarter, we reported encouraging median survival data from our second
Phase 2 clinical trial in advanced prostate cancer at this year's American
Society of Clinical Oncology (ASCO) meeting and initiated our second Phase 3
clinical trial. We have the resources we need to advance our product
development programs and a seasoned and accomplished executive team ready to
lead our business forward."
Second Quarter 2005 and Other Recent Highlights:
-- Reported additional promising results at the ASCO Meeting from a second
Phase 2 trial of GVAX(R) vaccine for prostate cancer in patients with
metastatic hormone-refractory prostate cancer. The results for the 22
patients who received the highest dose -- a dose comparable to that employed
in the company's ongoing Phase 3 program -- indicate that the median survival
has not been reached and the final median survival will be no less than 24.1
months based on the current median follow-up time for these patients.
Previously reported findings from the company's first Phase 2 trial of GVAX(R)
vaccine for prostate cancer indicated an overall median survival of 26.2
months. The median survival results from both Phase 2 trials compare
favorably to the recently reported median survival of 18.9 months for
metastatic hormone-refractory prostate cancer patients treated with
Taxotere(R) plus prednisone, the current standard of care.
-- Initiated a second multicenter Phase 3 clinical trial of GVAX(R)
vaccine for prostate cancer in patients with metastatic hormone-refractory
prostate cancer. The VITAL-2 trial will compare GVAX(R) vaccine for prostate
cancer plus Taxotere(R) (docetaxel) chemotherapy to Taxotere(R) plus
prednisone with respect to survival benefit and is expected to enroll
approximately 600 patients at approximately 100 medical centers across North
America and Europe. In May 2005, Cell Genesys received a Special Protocol
Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for this
trial, which provided FDA confirmation that the trial design would adequately
support a product registration application. The company's first Phase 3 trial,
VITAL-1, is also being conducted under an SPA.
-- Reported encouraging follow-up clinical data at the ASCO Meeting from
an ongoing Phase 2 trial of GVAX(R) vaccine for acute myelogenous leukemia
(AML). The ongoing findings of this trial indicate that vaccine therapy is
generally well tolerated and may reduce residual leukemic cells that persist
after chemotherapy, as indicated by decreased levels of WT-1, a leukemia-
associated genetic marker which is detectable in over 95 percent of patients
with active AML. In addition, there was an observed correlation between two-
year relapse-free survival, decreased WT-1 and the vaccine-associated immune
response.
-- Announced that Sharon E. Tetlow has joined the company as senior vice
president and chief financial officer. Ms. Tetlow, who was a venture partner
at Apax Partners, a private equity firm, brings over 18 years of financial
management experience in the life science industry, including over five years
as chief financial officer for diaDexus, a pharmacogenomics company.
-- Announced a strategic restructuring to focus resources on the company's
most advanced and most promising product development programs. Based on the
encouraging data reported at this year's ASCO Meeting, Cell Genesys intends to
deploy the majority of its resources going forward to advance GVAX(R) vaccine
for prostate cancer currently in Phase 3 development, as well as GVAX(R)
vaccine for leukemia and GVAX(R) vaccine for pancreatic cancer, both of which
are in Phase 2 development. In the oncolytic virus therapy program, the
company will focus on CG0070, which is in a Phase 1 trial in recurrent bladder
cancer, and CG5757, which is in preclinical development, both of which can
potentially target multiple types of cancer.
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 second quarter of 2005 at 8:30 a.m. PDT on Tuesday,
July 26, 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
at least 48 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
48 hours following the call. Please refer to access number 787711.
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.
Contact: Ina Cu
Investor Relations
650-266-3200
SELECTED CONSOLIDATED FINANCIAL INFORMATION
CONSOLIDATED STATEMENT OF OPERATIONS DATA
(unaudited, in thousands Three months ended Six months ended
except per share data) June 30, June 30,
2005 2004 2005 2004
Revenue $2,782 $2,462 $4,428 $5,046
Operating expenses:
Research and development 23,199 24,097 48,042 46,741
General and administrative 3,945 5,115 7,708 10,664
Restructuring charges 853 -- 853 --
Total operating expenses 27,997 29,212 56,603 57,405
Loss from operations (25,215) (26,750) (52,175) (52,359)
Gain on sale of Abgenix, Inc.
common stock -- 6,474 -- 11,980
Interest and other income 804 309 1,532 1,550
Interest expense (2,651) (2,213) (5,410) (4,451)
Loss before income taxes (27,062) (22,180) (56,053) (43,280)
Income tax provision (354) (3,839) (674) (3,658)
Net loss $(27,416) $(26,019) $(56,727) $(46,938)
Basic and diluted net loss per
common share $(0.60) $(0.58) $(1.25) $(1.11)
Weighted average shares of
common stock outstanding -
basic and diluted 45,411 44,667 45,342 42,469
CONSOLIDATED BALANCE SHEET DATA
(in thousands) June 30, December 31,
2005 2004
(unaudited) (note 1)
Cash, cash equivalents and short-term
investments, including restricted cash
and investments $120,573 $174,971
Investment in Abgenix, Inc. common stock 56,843 68,503
Other current assets 2,064 1,184
Property and equipment, net 152,189 159,663
Noncurrent deferred tax assets 20,513 25,177
Other assets 5,163 5,641
Total assets $357,345 $435,139
Deferred revenue $-- $2,031
Deferred tax liabilities 20,513 25,177
Other current liabilities 47,326 50,715
Noncurrent portion of facility lease
obligation 50,489 51,013
Convertible senior note 145,000 145,000
Redeemable convertible preferred stock -- 1,897
Stockholders' equity 94,017 159,306
Total liabilities and stockholders' equity $357,345 $435,139
Note 1. Derived from audited financial statements.
SOURCE Cell Genesys, Inc.
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Related links:
http://www.cellgenesys.com
CONTACT:
Ina Cu, Investor Relations of Cell Genesys,
Inc., +1-650-266-3200
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