Dendreon Corporation Reports Second Quarter 2003 Financial Results & Highlights Recent Company Milestones.Business Editors/Health/Medical Writers BIOWIRE2K SEATTLE--(BUSINESS WIRE)--Aug. 4, 2003 Significant Achievements Include Acquisition, Financing and Key Data Presentations Dendreon Corporation (Nasdaq:DNDN) today reported results for the quarter ended June 30, 2003 and provided an overview of recent company achievements. Revenues for the second quarter of 2003 were $1.8 million compared to $3.1 million for the quarter ended June 30, 2002. Revenues for the six months ended June 30, 2003 were $3.6 million compared to $6.1 million for the six months ended June 30, 2002. Most of the revenues for the second quarter of 2003 were from Dendreon's research collaboration with Kirin Brewery Co., Ltd. The decrease in revenue for the quarter ended June 30, 2003 was attributable to the conclusion of a collaborative research contract in January 2003. The net loss for the quarter ended June 30, 2003 was $8.3 million, or $0.30 per share, compared to a net loss of $6.3 million, or $0.25 per share, for the quarter ended June 30, 2002. The net loss for the six months ended June 30, 2003 was $16.0 million, or $0.59 per share, compared to a net loss of $13.6 million, or $0.54 per share, for the six months ended June 30, 2002. Research and development expenses were $7.5 million for the second quarter of 2003 compared to $7.4 million for the same period in 2002. Research and development expenses were $14.5 million for the six months ended June 30, 2003 compared to $15.8 million for the six months ended June 30, 2002. Cash, cash equivalents and short-term and long-term investments as of June 30, 2003 totaled $68.2 million compared to $46.9 million as of December 31, 2002. The increase in cash reflects the June 2003 financing of $30.7 million "The company is in a strong financial position. Our recent financing and our July 30, 2003 acquisition of Corvas International has strengthened our cash position to more than $130 million," said Martin Simonetti, senior vice president of finance and chief financial officer of Dendreon. "We have significant resources to fuel the development of Provenge." "The first half of 2003 has been one of the most significant periods of achievement for Dendreon," said Mitchell H. Gold, M.D., chief executive officer of Dendreon. "We are in the strongest financial position in the history of the company, have a Phase 3 product with proven mechanism of action and a Special Protocol Assessment from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , and have expanded our expertise in oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. to four key therapeutic platforms. This momentum will continue as we work to partner Provenge and to bring our first immunotherapy Immunotherapy The treatment of cancer by improving the ability of a tumor-bearing individual (the host) to reject the tumor immunologically. There are molecules on the surface of tumor cells, and perhaps in their interior, that are recognized as different from to market." Recent company highlights include: -- The acquisition on July 30, 2003 of Corvas International in a stock-for-stock transaction valued at $80.3 million. The acquisition provides Dendreon with an enhanced product pipeline that now includes four platforms in oncology: therapeutic vaccines therapeutic vaccine Immunology A vaccine–eg, Salk's Remune™ intended to treat a viral infection by stimulating the immune system. See Vaccine therapy. , monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). , small molecules and prodrugs. -- The presentation of new data from the completed Phase 3 trial, D9901, of Provenge(R) at the American Society of Clinical Oncology Annual Meeting confirming that the underlying mechanism of action, a T-cell immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. , is consistent with the positive clinical response seen in patients with advanced, metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . -- The presentation of updated results from Dendreon's ongoing Phase 1 trial of its therapeutic vaccine APC (1) (American Power Conversion Corporation, West Kingston, RI, www.apcc.com) The leading manufacturer of UPS systems and surge suppressors, founded in 1981 by Rodger Dowdell, Neil Rasmussen and Emanual Landsman, three electronic power engineers who had worked at MIT. 8024 in patients with advanced, metastatic, Her-2 positive breast cancer at the 94th Annual Meeting of the American Association American Association refers to one of the following professional baseball leagues:
Research in Washington, D.C. Results indicated APC8024 is showing continued clinical benefit in 25 percent of patients evaluated. Results were also presented demonstrating that a durable immune response could be boosted by re-treatment with APC8024. -- The receipt of a binding agreement, known as a Special Protocol Assessment, from the U.S. Food and Drug Administration that allows for Dendreon's pivotal Phase 3 trial (D9902B) to serve as basis for a Biologics License Application for Provenge(R) for the treatment of androgen androgen (ăn`drəjən): see testosterone. androgen Any of a group of hormones that mainly influence the development of the male reproductive system. independent prostate cancer. -- The raising of $30.7 million through the sale of Dendreon common stock. -- The addition of Dendreon Corporation to the Russell 3000(R) and Russell 2000(R) stock indexes on July 1, 2003. The indexes are widely used as benchmarks for investment strategies. -- The presentation of preliminary results from a Phase 2 trial, P-16, indicating that a combination therapy of Provenge(R) and Bevacizumab (Avastin(TM)) has demonstrated evidence of increasing PSA (Professional Services Automation) An information system designed to organize, track and manage all opportunities, work, resources, costs, revenues and invoices to improve the productivity and efficiency of the workforce. doubling time doubling time Oncology A parameter used to determine tumor aggressiveness, which serves to prognosticate, measure therapeutic success, and quantify tumor kinetics and growth rate. Cf Gompertzian growth curve. in men with androgen dependent prostate cancer. The results of the National Cancer Institute-sponsored trial from the University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). , San Francisco San Francisco (săn frănsĭs`kō), city (1990 pop. 723,959), coextensive with San Francisco co., W Calif., on the tip of a peninsula between the Pacific Ocean and San Francisco Bay, which are connected by the strait known as the Golden were presented at the American Society of Clinical Oncology 2003 Annual Meeting. -- The presentation of data relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc a new antigen engineering method, alternative reading frame technology, allowing for the selection of specific genes as a target for cancer immunotherapy. In preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. animal testing Animal testing or animal research refers to the use of animals in experiments. It is estimated that 50 to 100 million vertebrate animals worldwide [4][5][6] to date, this approach has provided up to 100 percent protection from developing cancer. The proprietary alternative reading frame (ARF) technology uses, as a target for cancer vaccines Cancer vaccines A treatment that uses the patient's immune system to attack cancer cells. Mentioned in: Pancreatic Cancer, Exocrine , abnormal peptides produced by cells as they translate genes into proteins. Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. The company's lead investigational product candidate, Provenge, is a cancer immunotherapy Cancer immunotherapy is the use of the immune system to reject cancer. The main premise is stimulating the patient's immune system to attack the malignant tumor cells that are responsible for the disease. undergoing a pivotal Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. for the potential treatment of androgen independent prostate cancer. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing , small molecule and prodrug prodrug /pro·drug/ (-drug) a compound that, on administration, must undergo chemical conversion by metabolic processes before becoming an active pharmacological agent; a precursor of a drug. product candidates. Dendreon has research and development alliances with industry leaders Genentech, Inc., Kirin Brewery Co., Ltd., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com. Except for historical information contained herein, this news release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. . Factors that may cause such a difference include risks and uncertainties, inherent in an acquisition transaction, including those relating to the inability to achieve planned synergies or execute integration plans and establish management and organizational structure  This article has no lead section.To comply with Wikipedia's lead section guidelines, one should be written. . Other risk factors include the risk that the safety and/or efficacy results of a clinical trial for Provenge will not support an application for a biologics license; the risk that the FDA will not be satisfied with the data we provide for Provenge or 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 for Provenge; the failure by Dendreon to secure and maintain relationships with collaborators, including a collaborator for the development and commercialization of Provenge; risks associated with completing Dendreon's clinical trials; reliance on key employees, especially senior management; risks related to Dendreon's limited operating history; dependence on the efforts of third parties; and 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 (SEC), which are available at www.sec.gov.
DENDREON CORPORATION
STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three months ended Six months ended
June 30, June 30,
------------------ -------------------
2003 2002 2003 2002
--------- -------- --------- ---------
Total revenue $ 1,823 $ 3,114 $ 3,599 $ 6,142
Operating expenses:
Research and development 7,547 7,421 14,487 15,797
General and administrative 2,462 2,127 5,033 4,444
Marketing 154 217 240 478
--------- -------- --------- ---------
Total operating expenses 10,163 9,765 19,760 20,719
--------- -------- --------- ---------
Loss from operations (8,340) (6,651) (16,161) (14,577)
Interest income 164 483 379 1,115
Interest expense (84) (82) (185) (171)
--------- -------- --------- ---------
Interest income, net 80 401 194 944
--------- -------- --------- ---------
Net loss $ (8,260) $(6,250) $(15,967) $(13,633)
========= ======== ========= =========
Basic and diluted net loss per
share $ (0.30) $ (0.25) $ (0.59) $ (0.54)
========= ======== ========= =========
Shares used in computation of
basic and diluted net loss per
share 27,682 25,111 27,206 25,047
========= ======== ========= =========
DENDREON CORPORATION
BALANCE SHEET DATA
(In thousands)
June 30, December 31,
2003 2002
(Unaudited)
------------ ------------
Cash and cash equivalents $ 9,555 $ 11,263
Short-term investments 58,596 35,614
Long-term investments - 8,102
Total assets 76,396 63,724
Total stockholders' equity 59,990 44,743
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