SOUTH SAN FRANCISCO, Calif., Aug. 3 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) announced today financial results for the
second quarter ended June 30, 2006. The company reported a net loss of
$27.9 million, or $0.60 per share, for the second quarter of 2006, compared
with a net loss of $27.4 million, or $0.60 per share, in the same quarter
of 2005.
Research and development expenses for the second quarter of 2006 were
$23.2 million which was unchanged from the same quarter in 2005 and
primarily due to ongoing Phase 3 clinical trials for the company's lead
product development program, GVAX(R) immunotherapy for prostate cancer.
These expenses included $1.2 million in non-cash stock-based compensation
expense recorded under Statement of Financial Accounting Standards No. 123
revised 2004 (FAS 123R), which offset decreased research and development
expenses in other areas. General and administrative expenses were $4.1
million, compared to $3.9 million in the second quarter of 2005, an
increase due to $0.3 million in non-cash expenses associated with FAS 123R.
As of June 30, 2006, Cell Genesys had approximately $166.1 million in
cash, cash equivalents and short-term investments compared to $129.6
million at December 31, 2005.
"We are pleased with our accomplishments in the first half of the year,
particularly with respect to multiple positive reports on our clinical
programs including two describing the results of trials for our lead
product, GVAX immunotherapy for prostate cancer," stated Stephen A.
Sherwin, M.D., chairman and chief executive officer of Cell Genesys. "We
look forward to continued progress in 2006 and advancing our ongoing Phase
3 program for our prostate cancer product."
Second Quarter 2006 and Other Recent Highlights:
-- Announced that the United States Food and Drug Administration (FDA) has
granted Fast Track designation for GVAX immunotherapy for prostate
cancer. Fast track designation, which was mandated by the FDA
Modernization Act of 1997, can potentially facilitate development and
expedite the review of Biologics License Applications (BLAs). Fast
track designation is reserved for products that demonstrate the
potential to treat a serious or life-threatening condition and
demonstrate the potential to address unmet medical needs for that
condition.
-- Announced encouraging interim data from a Phase 1 clinical trial of
GVAX immunotherapy for prostate cancer, administered in combination
with ipilimumab (MDX-010), a fully human antibody to CTLA-4 being
jointly developed by Medarex and Bristol-Myers Squibb. Twelve patients
with advanced prostate cancer have been treated to date, including six
patients who received the combination therapy at the therapeutic doses
currently being evaluated in both GVAX and ipilimumab Phase 3 clinical
trials. Antitumor activity was observed in five of these six patients,
including greater than 50% reductions in prostate-specific antigen
(PSA) levels that are ongoing at two months or longer with two patients
having greater than 95% reductions. Moreover, clinical evidence of
antitumor activity was observed in three of these five PSA responders.
All five patients with PSA partial responses have experienced
immune-mediated endocrine deficiencies which were similar in type to
those previously reported for ipilimumab and were successfully treated
with standard hormone replacement therapy.
-- Reported encouraging long-term follow-up data from a Phase 2 trial of
GVAX immunotherapy for chronic myelogenous leukemia (CML). A total of
19 CML patients with molecular evidence of persistent leukemia
following at least one year of Gleevec(R) (imatinib mesylate) therapy
were treated with GVAX immunotherapy while continuing to receive
Gleevec. Updated results showed that the addition of GVAX
immunotherapy to Gleevec therapy reduced persistent leukemic disease in
10 of 19 patients as demonstrated by a complete disappearance (five
patients) or a greater than one log (90%) reduction (five patients) in
bcr-abl, which is a validated genetic marker found on the leukemic
cells. The responses were ongoing in all but one of the ten
responders, with a median follow-up from treatment initiation of 14
months. Of the remaining nine patients, only one patient has developed
cytogenetic progression on therapy. Treatment with GVAX immunotherapy
for leukemia was well tolerated.
-- Announced that enrollment has been opened for an expanded multi-center
Phase 1 clinical trial of CG0070 to evaluate escalating multiple-dose
regimens of CG0070 and to include up to 45 additional patients who have
failed previous therapy with Bacillus Calmette-Guerin (BCG), the
current standard therapy for recurrent bladder cancer. The expansion
of the trial from single-dose to multiple-dose regimens was prompted by
data reported for the single-dose trial at the May 2006 meeting of the
American Urological Association including a complete anti-tumor
response at follow-up cystoscopy at approximately three months in three
of the nine patients evaluable to date. The duration of the complete
responses after just a single administration of CG0070 were 6, 9, and
3+ months respectively. Treatment was generally tolerable and the
majority of treatment-related side effects were local bladder
toxicities.
-- Announced that the results from an initial clinical trial of GVAX
immunotherapy for prostate cancer in patients with early-stage disease
have been published in a June issue of Clinical Cancer Research. The
Phase 1/2 trial enrolled 21 patients with rising PSA levels following
prostatectomy and who had not received any other treatment for their
prostate cancer, including hormone therapy. The results showed that 16
of 21 (76%) patients showed a statistically significant decrease in the
rate of rise of PSA (PSA slope) after only eight weeks of treatment
compared with the remaining five patients (p<0.001). One patient had a
partial PSA response (>50% reduction of PSA) of 7-month duration. GVAX
cancer immunotherapy was generally well tolerated and there were no
dose-limiting toxicities observed.
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
immunotherapies and oncolytic virus therapies. Ongoing clinical trials
include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2
trials of GVAX immunotherapy for pancreatic cancer and 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.
Cell Genesys will host its quarterly conference call to discuss events
that occurred during the second quarter of 2006 at 2:00 p.m. PDT on
Thursday, Aug. 3, 2006. 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 836221.
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, the
regulatory approval process for clinical trials, competitive technologies
and products, patents, continuation of corporate partnerships 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, 2005 filed on March 13, 2006 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 STATEMENTS OF OPERATIONS DATA
(unaudited, in thousands except
per share data) Three months ended Six months ended
June 30, June 30,
2006 2005 2006 2005
Revenue $1,046 $2,782 $1,222 $4,428
Operating expenses:
Research and development 23,203 23,199 48,517 48,042
General and administrative 4,114 3,945 9,159 7,708
Impairment of long-lived asset 194 -- 194 --
Restructuring charges (40) 853 (57) 853
Total operating expenses 27,471 27,997 57,813 56,603
Loss from operations (26,425) (25,215) (56,591) (52,175)
Other income (expense):
Gain on sale of Abgenix, Inc.
common stock -- -- 62,677 --
Interest and other income 1,765 804 3,325 1,532
Interest expense (2,622) (2,651) (5,244) (5,410)
Income (loss) before income taxes (27,282) (27,062) 4,167 (56,053)
Income tax provision (610) (354) (28,045) (674)
Net loss $(27,892) $(27,416) $(23,878) $(56,727)
Basic and diluted net loss per
common share $(0.60) $(0.60) $(0.52) $(1.25)
Weighted average shares of common
stock outstanding-basic and
diluted 46,629 45,411 46,127 45,342
CONSOLIDATED BALANCE SHEET DATA
(in thousands) June 30, December 31,
2006 2005
(unaudited) Note 1
Cash, cash equivalents and short-term
investments, including restricted cash $166,089 $129,598
Investment in Abgenix, Inc. common stock -- 63,824
Prepaid expenses and other current assets 3,243 2,104
Asset held for sale 137 --
Property and equipment, net 135,831 142,225
Noncurrent deferred tax assets -- 24,430
Unamortized debt issuance costs and
other assets 4,384 4,794
Total assets $309,684 $366,975
Other current liabilities $12,863 $12,343
Accrued income taxes 33,885 32,612
Deferred income tax liabilities -- 24,430
Other liabilities 2,522 2,174
Capital lease obligation, less current portion 49,225 49,919
Convertible senior note 145,000 145,000
Stockholders' equity 66,189 100,497
Total liabilities and stockholders' equity $309,684 $366,975
Note 1. Derived from audited financial statements.
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
|
