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Dendreon Reports Third Quarter 2008 Financial Results Nov 7, 2008 7:30:00 AM SEATTLE, Nov. 7 /PRNewswire-FirstCall/ -- Dendreon's total operating expenses for the third quarter of 2008 were $17.3 million compared to $19.8 million in 2007. Dendreon's total operating expenses for the nine months ended September 30, 2008 were $55.1 million compared to $75.2 million for the same period in 2007.
The net loss for the quarter ended September 30, 2008 was $26.8 million, or $0.29 per share, compared to a net loss of $19.2 million, or $0.23 per share, for the quarter ended September 30, 2007. The net loss for the nine months ended September 30, 2008 was $62.8 million, or $0.71 per share, compared to $72.3 million, or $0.88 per share for the nine months ended September 30, 2007. Included in our net loss for the three and nine months ended September 30, 2008 was a non-cash charge of $9.1 million and $6.8 million, respectively, to other expense. This represents an increase in the fair value of the warrants issued in connection with our April 3, 2008 common stock offering, which has been recorded as a liability. Cash, cash equivalents and short-term and long-term investments at September 30, 2008 totaled $106.6 million compared to $120.6 million at December 31, 2007. Additionally, subsequent to September 30, 2008, the Company received net proceeds of $19.8 million relating to a draw down on the Company's equity line of credit with
Recent Highlights:
* Completed the planned interim analysis of the Phase 3, randomized,
double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate
AdenoCarcinoma Treatment, also known as D9902B) clinical trial
designed to assess the safety and efficacy of the investigational
active cellular immunotherapy PROVENGE(R) (sipuleucel-T) in men with
metastatic androgen-independent prostate cancer. While Dendreon
remains blinded to the data, the independent data monitoring
committee (IDMC) reported to Dendreon a 20 percent reduction in the
risk of death in the PROVENGE arm relative to placebo (Hazard
Ratio= 0.80; 95% Confidence Interval [0.610-1.051]). The IDMC
observed no safety concerns and recommended that the study continue
to its final analysis, which is expected to be completed in mid-2009.
* Presented preclinical data on the Company's lead small molecule
candidate, D-3263, which targets Trp-p8 (a transmembrane cation
channel protein also known as Trp-M8), supporting Trp-p8 as a
therapeutic cancer target. Dendreon plans to file an Investigational
New Drug (IND) application later this year with the "The interim analysis of our Phase 3 IMPACT trial was an important milestone for us. We were encouraged to see a 20 percent reduction in the risk of death in the PROVENGE arm versus placebo at the time of this analysis in a patient population that currently has few appealing treatment options available," stated Mitchell H. Gold, M.D., president and chief executive officer of About Dendreon 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
DENDREON CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended Nine months ended
September 30, September 30,
2008 2007 2008 2007
Revenue $26 $112 $83 $715
Operating expenses:
Research and development 12,660 13,449 39,331 54,780
General and administrative 4,625 6,364 15,720 20,458
Total operating expenses 17,285 19,813 55,051 75,238
Loss from operations (17,259) (19,701) (54,968) (74,523)
Interest income 819 2,022 2,907 4,744
Interest expense (1,218) (1,551) (3,995) (2,534)
Loss from valuation of warrant
liability (9,119) - (6,751) -
Net loss $(26,777) $(19,230) $(62,807) $(72,313)
Basic and diluted net loss per
share $(0.29) $(0.23) $(0.71) $(0.88)
Shares used in computation of basic
and diluted net loss per share 91,723 82,965 88,762 82,356
September 30, December 31,
2008 2007
Balance Sheet Data:
Cash and cash equivalents $61,839 $75,721
Short-term investments 35,654 27,115
Long-term investments 9,077 17,739
Total assets 145,144 161,662
Warrant liability 21,313 -
Convertible senior subordinated
notes 85,250 85,250
Total stockholders' equity 13,579 40,377
SOURCE
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