Dendreon Reports First Quarter 2009 Financial Results
06 May 2009 - 9:30PM
PR Newswire (US)
SEATTLE, May 6 /PRNewswire-FirstCall/ -- Dendreon Corporation
(NASDAQ: DNDN) today reported results for the first quarter ended
March 31, 2009. Revenue for the first quarter of 2009 was $30,000
compared to $31,000 for the quarter ended March 31, 2008.
Dendreon's total operating expenses for the three months ended
March 31, 2009 were $17.0 million compared to $19.2 million for the
same period in 2008. The net loss for the quarter ended March 31,
2009 was $15.4 million, or $0.16 per share compared to a net loss
for the same quarter of 2008 of $19.5 million, or $0.23 per share.
Cash, cash equivalents, short-term, and long-term investments at
March 31, 2009 totaled $91.2 million compared to $108.5 million at
December 31, 2008. Recent Events: -- Reported final analysis of the
IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) Phase
3 trial for PROVENGE (sipuleucel-T) which demonstrated a
statistically significant increase in overall survival. Data were
presented at the American Urological Association (AUA) Annual
Meeting. Based on these data, the Company intends to amend its
Biologics License Application (BLA) with the U.S. Food and Drug
Administration (FDA) in the fourth quarter of this year. --
Presented preclinical data at the AUA meeting announcing that
D3263, a small molecule targeting TRPM8 (a transmembrane cation
channel protein), reduced the size of the prostate in an animal
model of benign prostatic hyperplasia (BPH) alone or in combination
with finasteride. -- Initiated a Phase 1 clinical trial of D3263 in
patients with advanced cancer. The trial is an open-label,
dose-escalation study evaluating the safety and pharmacokinetics of
orally-administered D3263 targeting TRPM8 in patients with solid
tumors that are refractory to standard therapies. -- Presented data
from the PROTECT (PROvenge Treatment and Early Cancer Treatment) or
P-11 Phase 3 study suggesting that PROVENGE induces long-term
memory immune responses that are durable and can be maintained
following boosting. The results of the study also indicate that
CD54 upregulation on Antigen Presenting Cells (APC), a measure of
product potency, is a correlate of immune activation. P-11 is an
ongoing Phase 3 clinical trial designed to evaluate the safety and
biologic activity of PROVENGE in patients with non-metastatic
androgen-dependent (hormone sensitive) prostate cancer who have had
a prostate-specific antigen (PSA) recurrence following surgical
removal of the prostate. "The significant increase in overall
survival demonstrated in our Phase 3 IMPACT trial for PROVENGE is a
major milestone for the company and puts us one step closer to
making PROVENGE available to patients with prostate cancer who
currently have few appealing treatment options," stated Mitchell H.
Gold, M.D., president and chief executive officer of Dendreon. "We
look forward to reviewing our commercialization plans for PROVENGE
in more detail during a webcast analyst day this summer." In lieu
of a conference call, the Company will present at several upcoming
investor conferences that will be webcast, three of which are later
this month and include: -- Bank of America / Merrill Lynch 2009
Health Care Conference on May 12, 2009 -- Deutsche Bank 34th Annual
Healthcare Conference on May 19, 2009 -- Leerink Swann Novel Cancer
Therapeutics: Roundtable Conference on May 20, 2009 About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to
target cancer and transform lives through the discovery,
development and commercialization of novel therapeutics. The
Company applies its expertise in antigen identification,
engineering and cell processing to produce active cellular
immunotherapy product candidates designed to stimulate an immune
response. Dendreon is also developing an orally-available small
molecule that targets TRPM8 that could be applicable to multiple
types of cancer as well as benign prostatic hyperplasia. The
Company has its headquarters in Seattle, Washington and is traded
on the Nasdaq Global Market under the symbol DNDN. For more
information about the Company and its programs, visit
http://www.dendreon.com/. Except for historical information
contained herein, this news release contains forward-looking
statements that are subject to risks and uncertainties surrounding
the efficacy of PROVENGE to treat men suffering from prostate
cancer, risks and uncertainties surrounding the presentation of
data to the FDA and approval of product applications by the FDA and
risks and uncertainties inherent in the process of discovering,
developing and commercializing drugs that are safe and effective
for use as human therapeutics. Factors that may cause such
differences include risks related to our limited operating history,
risks associated with completing our clinical trials, the risk that
the safety and/or efficacy results of existing clinical trials or
from additional clinical trials for PROVENGE will not support
approval for a biologics license, the risk that the FDA may
interpret data differently than we do or require more data or a
more rigorous analysis of data than expected, the risk that the FDA
will not approve a product for which a biologics license has been
applied, the risk that the results of a clinical trial for PROVENGE
or other product may not be indicative of results obtained in a
later clinical trial, risks that we may lack the financial
resources and access to capital to fund required clinical trials or
commercialization of PROVENGE, our dependence on the efforts of
third parties, and our dependence on intellectual property. Further
information on the factors and risks that could affect Dendreon's
business, financial condition and results of operations are
contained in Dendreon's public disclosure filings with the U.S.
Securities and Exchange Commission, which are available at
http://www.sec.gov/. DENDREON CORPORATION CONSOLIDATED STATEMENTS
OF OPERATIONS (in thousands, except per share amounts) Three months
ended March 31, ------------------ 2009 2008 ---- ---- (unaudited)
Revenue $30 $31 Operating expenses: Research and development 11,797
13,478 General and administrative 5,217 5,675 ----- ----- Total
operating expenses 17,014 19,153 ------ ------ Loss from operations
(16,984) (19,122) Interest income 333 1,137 Interest expense
(1,112) (1,531) Gain from valuation of warrant liability 2,379 -
----- --- Net loss $(15,384) $(19,516) ======== ======== Basic and
diluted net loss per share $(0.16) $(0.23) ====== ====== Shares
used in computation of basic and diluted net loss ------ ------ per
share 95,767 83,313 ====== ====== March 31, December 31, 2009 2008
---- ---- Balance Sheet Data: Cash and cash equivalents $59,699
$59,523 Short-term investments 29,981 45,638 Long-term investments
1,519 3,386 Total assets 130,074 147,204 Warrant liability 11,811
14,190 Convertible senior subordinated notes 85,250 85,250 Total
stockholders' equity 13,380 27,006 DATASOURCE: Dendreon Corporation
CONTACT: Jennifer Cook Williams, Investor Relations of Dendreon
Corporation, +1-206-829-1500 Web Site: http://www.dendreon.com/
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