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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-K

Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

for the fiscal year ended December 31, 2003

Commission File No. 000-30681

DENDREON CORPORATION

(Exact name of registrant as specified in its charter)

3005 FIRST AVENUE SEATTLE, WASHINGTON 98121

(206) 256-4545

(Address, including zip code, of Registrant’s principal executive offices and telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

NONE

Securities registered pursuant to Section 12(g) of the Act:

COMMON STOCK, $0.001 PAR VALUE

Indicate by check mark whether the Registrant (1) has filed all reports required by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  þ            No    ¨        

Indicate by a check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of Registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.    þ

Indicate by check mark whether the Registrant is an accelerated filer (as defined in Rule 12b-2 of the Act).     Yes  þ            No    ¨        

The aggregate market value of the common stock held by non-affiliates of the Registrant based on the closing sale price of the Registrant’s common stock on June 30, 2003, as reported on the National Association of Securities Dealers Automated Market, was $105,497,233*.

As of March 5, 2004, the Registrant had outstanding 57,724,704 shares of common stock.

DOCUMENTS INCORPORATED BY REFERENCE

The Registrant’s definitive Proxy Statement, which will be filed on or before April 29, 2004 with the Securities and Exchange Commission in connection with the Registrant’s annual meeting of stockholders is incorporated by reference into Part III of this Report.

INDEX

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SPECIAL NOTE ON FORWARD-LOOKING STATEMENTS

This annual report on Form 10-K contains forward-looking statements concerning matters that involve risk and uncertainties. The statements contained in this report that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These forward-looking statements concern matters that involve risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. Words such as believe, expects, likely, may and plans are intended to identify forward-looking statements, although not all forward-looking statements contain these words.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We are under no duty to update any of the forward-looking statements after the date hereof to conform such statements to actual results or to changes in our expectations.

Readers are urged to carefully review and consider the various disclosures made by us in this report which attempt to advise interested parties of the factors which affect our business, including without limitation the disclosures made under the caption “Factors That May Affect Results of Operations and Financial Condition” in Management’s Discussion and Analysis of Financial Condition and Results of Operations set forth herein.

Dendreon^®, the Dendreon logo, DACS^®, Provenge^®, Simplesep Enrichment System^®, Mylovenge^™, Myezenium^™, Neuvenge^™, Neuzenium^™, Provenge^™, Prozenium^™ and the Antigen Delivery Cassette^™ are our trademarks. All other trademarks appearing or incorporated by reference into this report are the property of their owners.

AVAILABLE INFORMATION

We file annual, quarterly and current reports, proxy statements and other information with the SEC. You may read and copy any reports, statements and other information filed by us at the SEC’s Public Reference Room at 450 Fifth Street, N.W., Washington, D.C. 20549. Please call (800) SEC-0330 for further information on the Public Reference Room. The SEC maintains an Internet web site that contains reports, proxy and information statements and other information regarding issuers, including us, that file electronically with the SEC. The address for the SEC’s web site is http://www.sec.gov.

We make available, free of charge, through our investor relations web site our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, statements of changes in beneficial ownership of securities, and amendments to those reports and statements as soon as reasonably practicable after they are filed with the SEC. The address for our investor relations web site is http://investor.dendreon.com/edgar.cfm.

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PART I

ITEM 1.

BUSINESS

BUSINESS OVERVIEW

We are a biotechnology company focused on the discovery, development and commercialization of targeted therapies for cancer. Our portfolio includes product candidates to treat a wide range of cancers using therapeutic vaccines, monoclonal antibodies, small molecules and pro-drugs.

Our most advanced product candidate is Provenge, a therapeutic vaccine for the treatment of prostate cancer. We are currently conducting a pivotal Phase 3 clinical trial of Provenge, D9902B, in men with androgen independent prostate cancer whose cancer has a Gleason score of 7 and less. This trial is designed to confirm the results of our first Phase 3 clinical trial of Provenge, D9901. D9901 was a double-blind, placebo-controlled clinical trial in men with androgen independent prostate cancer. The results of that trial did not achieve statistical significance for the trial population as a whole. Analysis of the results of D9901 in Provenge treated men with Gleason scores of 7 and less, however, demonstrated a significant clinical benefit in delaying time to disease progression and delaying the onset of disease related pain. On January 12, 2004, we announced survival data from D9901 that also indicated that men whose cancer has a Gleason score of 7 and less receiving Provenge had a significant survival advantage. The design of our pivotal D9902B trial was agreed to by the Food and Drug Administration under its Special Protocol Assessment program, and Provenge also has been granted Fast Track designation by the FDA. We own commercialization rights for Provenge worldwide.

In addition, we are completing Phase 1 clinical trials of APC8024, our second product candidate. APC8024 is a therapeutic vaccine being developed for the treatment of HER-2/neu over-expressing solid tumors. Our preclinical programs include monoclonal antibodies, therapies targeting the trp-p8 pathway, and serine protease and pro-drug product candidates for the treatment of cancer.

CANCER IMMUNOTHERAPIES

Cancer is characterized by abnormal cells that proliferate uncontrollably and metastasize or spread, throughout the body, producing deposits of tumor cells, called metastases. These proliferating cells form masses called tumors. As the tumors grow, they cause tissue and organ failure and, ultimately, death.

To be effective, cancer therapies must eliminate or control the growth of the cancer both at its site of origin and at sites of metastases. Current therapies, such as surgery, radiation, chemotherapy and hormone treatments may not have the desired therapeutic effect and may result in severe side effects.

Treatments known as immunotherapies stimulate the immune system, the body’s natural mechanism for fighting disease, and may overcome many of the limitations of current cancer therapies. Immunotherapy may be particularly useful for the treatment of less advanced or residual disease.

The Immune System

The immune system is composed of a variety of specialized cells. These cells recognize specific chemical structures, called antigens. Foreign antigens trigger an immune response that results in the eventual removal of disease causing agents from the body.

The immune system recognizes and generates a strong response to hundreds of thousands of different foreign antigens. Tumors, however, frequently display antigens that are also found on normal cells. Thus, the immune system may not distinguish between tumors and normal cells and, therefore, may be unable to mount a strong anti-cancer response. Tumors may also actively prevent the immune system from fully activating. We believe one key to directing the immune system to fight cancers is to modify, or engineer, tumor antigens so that they are recognized by the immune system and to manipulate immune system cells to stimulate a vigorous response.

An immune response is started by a specialized class of immune system cells called antigen-presenting cells. Antigen-presenting cells take up antigen from their surroundings and process the antigen into fragments that are recognized by specific classes of immune cells called lymphocytes. One category of lymphocytes, T-lymphocytes or T-cells, combat disease by killing

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antigen-bearing cells directly. In this way, T-cells may eliminate cancers and virally infected tissue. T-cell immunity is also known as cell-mediated immunity and is commonly thought to be a key defense against tumors and cells chronically infected by viruses. Our therapeutic vaccines are designed to stimulate a T-cell response to cancer cells.

A second category of lymphocytes, B-lymphocyte or B-cells, produce specific antibodies when activated. The antibodies are secreted by B-cells and are extremely specific. Each antibody binds to and attacks one particular type of antigen expressed on a cell, interfering with that cell’s activity or causing cell death. Our monoclonal antibody product candidates are manufactured antibodies that share characteristics of naturally occurring antibodies. They may be created to recognize a specific antigen present on tumor cells, but not on healthy cells, and to bind to that antigen and cause the death of the tumor cell. Because each monoclonal antibody targets only cells expressing a specific antigen, healthy cells may be unaffected, and many of the harsh side effects of conventional cancer therapies avoided. Monoclonal antibodies may be used alone or coupled with drugs or radioisotopes in combination therapies that attack cancer cells in several ways.

OUR THERAPEUTIC CANCER VACCINE APPROACH

We combine our experience in antigen identification, antigen engineering and antigen-presenting cell processing to produce therapeutic cancer vaccines designed to stimulate a robust T-cell immune response. Our approach to therapeutic cancer vaccines is to:

Antigen Identification

Our internal antigen discovery programs begin by identifying novel antigens expressed in specific tissues or in malignant cells. We consider the antigens that we find localized in diseased tissue as candidates for antigen engineering. We also consider antigens from external sources that meet these criteria. Our lead product candidate, Provenge, targets the prostate cancer antigen, prostatic acid phosphatase, or PAP. PAP is found in approximately 95% of all prostate cancers. The antigen target for APC8024, our therapeutic vaccine for breast, ovarian and other solid tumors, is HER-2/neu. Through licenses, we have also acquired the opportunity to work with the tumor antigens designated carcinoembryonic antigen, carbonic anhydrase IX, NY-ESO, and telomerase.

Antigen Engineering

We engineer antigens to produce proprietary therapeutic vaccines. Our antigen engineering is designed to trigger and maximize cell-mediated immunity by augmenting the uptake and processing of the target antigen by antigen-presenting cells. We can affect the quality and quantity of the immune response that is generated by adding, deleting or modifying selected sequences of the antigen gene, together with inserting the modified antigen into our Antigen Delivery Cassette.

Our Antigen Delivery Cassette is a protein that enhances antigen binding and entry into antigen-presenting cells. The Antigen Delivery Cassette targets each engineered antigen to a receptor on antigen-presenting cells and provides a common key to unlock the potential of these cells to process antigen. The antigen-presenting cells process antigen along pathways that stimulate cell-mediated immunity. The antigen region of the Antigen Delivery Cassette thus gains access to processing by the antigen-presenting cell that would otherwise be denied to non-engineered antigen. We believe this process results in a potent cell-mediated immune response. Our Antigen Delivery Cassette technology also provides us with a foundation on which new proprietary antigens are built.

Provenge Vaccine Production

Our vaccine manufacturing process for Provenge incorporates two elements: the Antigen Delivery Cassette and antigen-presenting cells. To obtain antigen-presenting cells, we first remove white blood cells from a patient’s blood through a standard

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blood collection process called leukapheresis. Antigen-presenting cells are then separated from other white blood cells using our proprietary cell separation technology. We perform our process outside of the body, away from the immunosuppressive environment of the prostate cancer cells. We believe that this allows the antigen-presenting cells to become fully mature and activated, leading to a more robust immune response.

The antigen-presenting cells are then incubated with the required concentration of Antigen Delivery Cassette under controlled conditions. After about 40 hours, the antigen-presenting cells are ready to be used as Provenge. We subject each dose of Provenge to quality control testing, including identity, purity, potency, sterility and other safety testing. Our process requires less than three days from white blood cell collection to the administration of Provenge.

By performing this process using our proprietary technology, we are able to create a highly concentrated and potent product. A dose of Provenge contains, on average, over 900 million activated antigen-presenting cells. We believe that our proprietary technology is applicable to many antigens of interest and therefore may be developed to target a variety of solid tumor and blood-borne malignancies.

Vaccine Delivery

A vaccine dose is delivered as an intravenous infusion lasting about 30 to 60 minutes given as an outpatient procedure. Our clinical trials of Provenge indicate that maximum stimulation requires three infusions given at two-week intervals. Patients in our Provenge trials typically complete a course of therapy in one month.

OUR THERAPEUTIC VACCINES

Provenge

Provenge is our therapeutic vaccine being developed for the treatment of prostate cancer. Prostate cancer is the most common solid tumor malignancy in men in the United States, with over one million men currently diagnosed with the disease. The American Cancer Society estimates that there will be approximately 230,000 new cases of prostate cancer diagnosed in the U.S. and approximately 29,900 deaths due to the disease in 2004.

We are currently conducting a pivotal, randomized, double blind, placebo-controlled Phase 3 clinical trial of Provenge, D9902B, at more than 60 centers in the United States. This trial is designed to test Provenge in men with asymptomatic, metastatic, androgen independent prostate cancer whose cancer has a Gleason score of 7 and less and to confirm results of our first Phase 3 clinical trial of Provenge that indicated significant clinical benefit in delaying time to disease progression and delaying the onset of disease-related pain in this patient population.

Androgen independent prostate cancer, or AIPC, is an advanced stage of prostate cancer in which the tumor growth is no longer regulated by androgens, or male hormones. Currently, there are no Food and Drug Administration, or FDA, approved therapeutic treatment options for patients with AIPC. The Gleason score is the most commonly used prostate cancer scoring system and is considered one of the most important prognostic indicators for prostate cancer. The Gleason score is a measure of the aggressiveness of a patient’s tumor and ranges in score from 2 to 10. It is widely accepted within the medical community that Gleason scores of 7 and less suggest a better prognosis than Gleason scores of 8 and higher. Approximately 75% of androgen independent, and approximately 95% of androgen dependent, prostate cancer patients have a Gleason score of 7 and less.

Provenge Clinical Trial Results

The results from our first Phase 3 placebo-controlled clinical trial of Provenge, D9901, in men with metastatic, asymptomatic AIPC were first announced in August 2002. Comparison of the Provenge treated group to the placebo treated group in the overall population showed a 43% benefit in delaying time to disease progression, the primary endpoint of the trial. Although the results of the D9901 trial did not achieve statistical significance for the overall population, p-value = 0.05, the results closely approached statistical significance at p-value = 0.061. For Provenge treated men with Gleason scores of 7 and less, however, the results demonstrated a statistically significant benefit in delaying time to disease progression, p-value = 0.001. For these men, the probability of remaining progression-free while on the study was over two times higher than for men treated with placebo. In addition, six months after randomization, these men had a greater than eight-fold advantage in progression-free survival compared to men who received placebo (35.9% of Provenge men versus 4% of placebo patients).

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In December 2002, we announced additional results from D9901 indicating that, in addition to delaying the time to progression of disease, Provenge treatment also delayed the onset of disease-related pain in men with Gleason scores of 7 and less. Delay in the onset of disease-related pain was the secondary endpoint of D9901, which enrolled patients who did not have cancer-related pain at the time of entry into the study. In men with Gleason scores of 7 and less, those receiving treatment with Provenge remained pain free significantly longer than those receiving placebo, p-value = 0.016. In addition, for these men, the probability of remaining free of cancer-related pain while on the study was over two-and-one-half times higher than for patients who received placebo. Provenge treatment was generally well tolerated, with most side effects resolving within 24 to 48 hours.

On January 12, 2004, we announced interim survival data from D9901 for men with Gleason scores of 7 and less. Based on data accumulated as of December 2003, men with Gleason scores of 7 and less receiving Provenge had a significant survival advantage, having on average an 89% overall increase in their survival time as compared to placebo (log rank p = 0.047, hazard ratio = 1.89). This benefit is reflected by a prolongation in the median survival time in these men receiving Provenge by 8.4 months (30.7 months versus 22.3 months). At 30 months from randomization, the survival rate for Provenge treated men in this population is 3.7 times higher than for men receiving placebo (53% versus 14%, p-value = 0.001).

In June 2003 at the American Society of Clinical Oncology meeting, D9901 trial data was presented confirming that the Provenge mechanism of action, a T-cell based immune response, correlates with the clinical benefit seen in men with Gleason scores of 7 and less (p-value = 0.0065).

Pivotal Clinical Trial—D9902B

In June 2003, we received an agreement under a Special Protocol Assessment, or SPA, from the FDA for D9902B. The SPA provides a binding written agreement with the FDA that the design and planned analysis of D9902B will form a basis for a Biologics License Application, if the trial is successful in meeting its pre-determined objectives.

We have also received Fast Track designation from the FDA for Provenge for metastatic, asymptomatic, AIPC for tumors with Gleason scores of 7 and less. Fast Track designation allows for a rolling submission of a potential Biologics License Application with the FDA, and ordinarily provides for a priority review. Priority review is defined by the FDA as a six-month review cycle. If D9902B is completed as currently planned, the results meet the trial endpoints, and we are successful in completing other necessary tasks, we would expect to submit a Biologics License Application for Provenge in 2005.

Other Provenge Clinical Trials

We are currently conducting a Phase 3 clinical trial called PROTECT (PROvenge Trial of Early Prostate Cancer Treatment), or P-11, to evaluate the safety and potential effectiveness of Provenge in treating men with early stage, androgen dependent prostate cancer. Men whose prostate cancer is responsive to hormone treatment are considered androgen dependent. The prevalence of androgen dependent prostate cancer in the U.S. and Europe is approximately 600,000 men, which is approximately four times greater than the prevalence of androgen independent prostate cancer. This trial is being conducted at a number of sites throughout the United States, and we currently expect to complete enrollment in 2004.

In addition, we supply the National Cancer Institute with Provenge for use in a Phase 2 clinical trial, P-16, testing Provenge together with Genentech, Inc.’s Bevacizumab (Avastin) to treat patients with androgen dependent prostate cancer. Early results of this trial indicate that Provenge plus Avastin is able to generate a robust immune response and provide an improvement in the median PSA doubling time (from 8.2 months pre-treatment to 21.4 months post-treatment). PSA doubling time is a well-accepted prognostic tool in the medical community for men with androgen dependent prostate cancer. If the results of either P-11 or P-16 are successful, we believe the results will facilitate pivotal trials to obtain FDA approval for market expansion of Provenge into androgen dependent prostate cancer.

We own commercialization rights for Provenge worldwide. We are currently engaged in discussions with pharmaceutical and biotechnology companies regarding potential collaboration arrangements for the commercialization of Provenge.

APC8024

Our second product candidate, APC8024, is a therapeutic vaccine for the treatment of breast, ovarian and other solid tumors directed against the antigen, HER-2/neu. The vaccine is manufactured in a similar fashion to Provenge, and uses a recombinant

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version of the HER-2/neu antigen. Increased levels of HER-2/neu are found in approximately 25% of metastatic breast, ovarian and colon cancers.

We are currently conducting Phase 1 trials to evaluate APC8024 for the treatment of patients with tumors that over-express HER-2/neu. The trials examine different doses, schedules and formulations of APC8024 for safety and ability to stimulate immunity. In June 2003, we announced results from a Phase 1 study of APC8024 indicating that APC8024 stimulated an immune response and may provide clinical benefit in patients with advanced, metastatic HER-2/neu positive breast cancer. We are currently designing Phase 2 studies for APC8024, and we plan to commence a Phase 2 study in 2004. We also will be presenting additional data from our Phase 1 studies of APC8024 at scientific meetings in 2004. We own commercialization rights to APC8024 worldwide.

OTHER VACCINE TARGETS

Trp-p8

Trp-p8, the protein encoded by the trp-p8 gene, is a voltage gated calcium ion channel. It is the first gene generated from our internal antigen discovery program. A patent on the gene encoding trp-p8 was issued to us in 2001. Trp-p8 displays numerous characteristics that make it an attractive target for immunotherapy, as well as for small molecule drug therapy. In normal human tissues, trp-p8 is expressed predominantly in the prostate and is over-expressed in hyperplastic prostate. It is present in 100% of prostate cancers and approximately 71% of breast cancers, 93% of colon cancers and 90% of lung cancers. We plan to incorporate the trp-p8 antigen into our vaccine technology.

NY-ESO

NY-ESO is a protein that is present on many cancers, including melanoma, breast, prostate, lung, ovarian/uterine and bladder cancers. We licensed the NY-ESO antigen from the Ludwig Cancer Institute, where scientists performed a series of preclinical studies that demonstrated that NY-ESO is an appropriate immunotherapy target. We engineered the NY-ESO antigen into our Antigen Delivery Cassette.

Carcinoembryonic Antigen (CEA)

The carcinoembryonic antigen, or CEA, is present on 70% of lung cancers, virtually all cases of colon cancers and approximately 65% of breast cancers. We licensed the CEA antigen from Bayer Corporation, Business Group Diagnostics. We plan to incorporate the CEA antigen into our vaccine technology.

Carbonic Anhydrase IX Antigen (MN)

MN antigen is a protein also known as the carbonic anhydrase IX antigen. It is present on approximately 75% of cervical and colon cancers and 95% of renal cancers. We licensed the MN antigen from Bayer Corporation, Business Group Diagnostics. We plan to incorporate the MN antigen into our vaccine technology.

Telomerase

The human telomerase antigen, or hTERT, is present on approximately 80% of tumor samples. We licensed the hTERT antigen from Geron Corporation and plan to incorporate it into our vaccine technology.

MONOCLONAL ANTIBODIES

DN1924 and DN1921

We have therapeutic monoclonal antibodies for the treatment of cancer and autoimmune diseases in preclinical development. DN1924, our monoclonal antibody against HLA-DR positive cancers, is in preclinical development for the treatment of leukemias and lymphomas such as Non-Hodgkin’s lymphoma, Hodgkin’s lymphoma, and B-cell leukemia. Current treatments for these cancers include chemotherapy, radiation, and high dose chemotherapy with stem cell transplantation, all of which are

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highly toxic. More recently, a monoclonal antibody, rituximab, has been approved for use in some of these patients. It is directed to a different antigen than the antigen to which DN1924 binds. Preclinical studies suggest that DN1924 can kill human cancer cells without apparent toxicity or immune suppressive side effects. Furthermore, these preclinical studies suggest that cancer cells may not develop resistance to this treatment over time.

DN1921 is our monoclonal antibody that suppresses activities of the immune system. Autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, myasthenia gravis and pemphigus vulgaris, result from unwanted activities of the immune system. Current therapies include non-specific immune suppression by corticosteroids, methotrexate and other drugs. Although these treatments may reduce tissue damage in some patients, they are not curative.

DN1921 is specific for a well-known target for immunosuppression, HLA-DR. Previously, other companies have attempted to develop drugs that target HLA-DR. Although those drugs usually suppressed immune response, they failed in preclinical studies due to unacceptable toxicity. We have observed that suppression of immune response and toxicity are mediated by two separate parts of the antibody molecule. We are developing DN1921 to take advantage of this observation. DN1921 has shown encouraging immunosuppressive abilities in our preclinical studies without producing unacceptable levels of toxicity.

Trp-p8 Monoclonal Antibody

In collaboration with Genentech, Inc., we are working to develop a monoclonal antibody to trp-p8, a protein encoded by a gene discovered in our internal discovery program, that is a potential treatment for solid tumor malignancies such as prostate, breast and colon cancer.

Serine Protease Monoclonal Antibodies

Proteases are proteins that act as molecular scissors to cleave other proteins to activate or inactivate them, and are responsible for regulating normal cellular function. Maintaining normal health requires that the activity of proteases be tightly controlled. Excessive or deficient protease activity underlies many serious diseases in humans, including cancer.

The growth and progression of human tumors involve different proteases at multiple stages during these processes. Serine proteases are thought to be important for tumor cell growth directly and through the modulation of growth factors required for tumor growth. In addition, serine proteases have been shown to indirectly support tumor cell growth through their effects on the network of blood vessels that is essential for tumor survival, a process known as angiogenesis.

Our serine proteases program is focused on the development of monoclonal antibodies that suppress the growth of primary and secondary solid tumors by inhibiting known and novel key serine proteases involved in cancer processes.

Matriptase

Our collaboration agreement with Abgenix, Inc., which we obtained through our acquisition of Corvas International, Inc., or Corvas, in mid-2003, focuses on the discovery, development and commercialization of fully-human monoclonal antibodies against the membrane-bound serine protease, matriptase. This protease is implicated in several solid tumors including breast and prostate cancer. Under the terms of the collaboration, Abgenix agreed to use its human antibody technologies to generate and select antibodies against matriptase. We and Abgenix have the right to co-develop and commercialize antibody product candidates discovered during the collaboration. Our agreement with Abgenix provides for both companies to share equally in the product development costs and any profits from sales of product candidates successfully commercialized from any co-development efforts.

We also have a research and exclusive license agreement with Georgetown University, which we obtained through our acquisition of Corvas, related to Georgetown’s intellectual property for matriptase. In the event that we develop and commercialize any products covered by Georgetown’s intellectual property, we would be required to make milestone payments and pay royalties.

Endotheliase

We have a collaboration with Dyax Corp., which we obtained through our acquisition of Corvas, to discover, develop and commercialize monoclonal antibody and other products against endotheliase 1 and endotheliase 2, proteases that are over-expressed

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in certain cancers. Under the terms of this agreement, both companies will jointly develop any inhibitory agents that may be identified and will share commercialization rights and profits, if any, from any marketed products.

OTHER PRODUCT DEVELOPMENT PROGRAMS

Trp-p8 Small Molecule

Small molecules are a diverse group of natural and synthetic substances that generally have a low molecular weight. They are either isolated from natural sources such as plants, fungi or microbes, or they are synthesized by organic chemistry. Most conventional pharmaceuticals, such as aspirin, penicillin, and chemotherapeutics, are small molecules. Ion channels like trp-p8 that transport calcium through the cell membrane may be an attractive target for manipulation by small molecule drug therapy.

We are currently engaged in discovering, evaluating and developing small molecule therapeutics that modify trp-p8 function. Through screening and drug design efforts, we have discovered several classes of small molecule drugs that manipulate the trp-p8 channel and selectively kill trp-p8 expressing cancer cells by modifying the movement of calcium ions through the cell membrane. We are evaluating these compounds in preclinical studies and working to expand the number of candidate compounds through additional screening and synthesis efforts.

Protease Activated Therapy (PACT) Pro-Drugs

Our PACT program, obtained through our acquisition of Corvas, focuses on exploiting the activity of proteases that are present on the surface of tumor cells. The goal of this pro-drug approach is to deliver a potent cytotoxic, or cell-killing, drug directly to the tumor cells, thereby sparing healthy tissue from the toxic treatment. This program, called PACT, involves the design of synthetic molecules composed of a sequence of amino acids recognized by a targeted serine protease. This sequence of amino acids is chemically attached to a known cancer chemotherapeutic or cytotoxic drug such as doxorubicin, yielding a hybrid or conjugate molecule. This approach may reduce damage to normal, non-tumor cells because the sequence of attached amino acids will prevent the cytotoxic drug from entering the normal cells where it could cause lethal effects. In addition, with the PACT approach, a solid tumor should be more susceptible to the cytotoxic drug because the serine proteases in the tumor cells should free the cytotoxic drug in the vicinity of the tumor cell. Once free, the cytotoxic drug can enter into the tumor cell and kill it. We believe that this strategy of using the conjugate molecules may result in fewer side effects compared to cytotoxic drugs alone.

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PRODUCTS

The following table summarizes the target indications and status of our product candidates in development.

Status shown above is as of March 5, 2004. Preclinical means that a potential product is undergoing study and evaluation, including study in cell and animal disease models in preparation for potential human clinical trials. We continue to undertake preclinical development work with respect to potential products that are in clinical trials.

Phase 1-3 clinical trials denote safety and efficacy tests in humans as follows:

Phase 1: Evaluation of safety and dosing.

Phase 2: Evaluation of safety and efficacy.

Phase 3: Definitive evaluation of safety and efficacy.

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COLLABORATIONS

Genentech, Inc.

In August 2002, we entered into an agreement with Genentech, Inc. to collaborate in the preclinical research, clinical development, and commercialization of monoclonal antibody and potentially other products derived from our trp-p8 gene platform. We will be jointly responsible with Genentech for conducting preclinical and clinical work. Genentech will fund a majority of these expenses for products that reach Phase 3 clinical trials. Genentech will also be responsible for all manufacturing of resulting products. The agreement provides for profit-sharing and co-promotion in the United States. Genentech will be responsible for the commercialization of trp-p8 products in the rest of the world except Asia and Oceania, where we retain all development and commercialization rights.

Abgenix

Our collaboration agreement with Abgenix focuses on the discovery, development and commercialization of fully-human monoclonal antibodies against the membrane-bound serine protease, matriptase. Under the terms of the collaboration, Abgenix agreed to use its human antibody technologies to generate and select antibodies against matriptase. We and Abgenix have the right to co-develop and commercialize antibody products discovered during the collaboration. Our agreement with Abgenix provides for both companies to share equally in the product development costs and any profits from sales of product candidates successfully commercialized from any co-development efforts.

Dyax

We have a collaboration with Dyax to discover, develop and commercialize monoclonal antibody and other products against endotheliase 1 and endotheliase 2, enzymes that are over-expressed in certain cancers. Under the terms of this agreement, both companies will jointly develop any inhibitory agents that may be identified and will share commercialization rights and profits, if any, from any marketed products.

OUR STRATEGY

Our goal is to become a leading biotechnology company focused on discovering, developing and commercializing a variety of drugs and therapeutic vaccines to treat cancer. Key elements of our strategy are to:

Develop and Commercialize Provenge

We are seeking to develop and commercialize Provenge for the treatment of prostate cancer. Provenge is in late-stage clinical trials, and we are currently engaged in discussions with pharmaceutical and biotechnology companies regarding potential collaboration arrangements for the commercialization of Provenge.

Continue to Build a Portfolio of Medically Important Oncology Product Candidates

We are developing a pipeline of oncology product candidates in various stages of clinical and preclinical development in a variety of therapeutic areas using multiple technologies. We believe this strategy increases the likelihood of successful product commercialization.

Leverage Our Core Competencies

We believe that we have significant expertise in the development of novel immunotherapeutics, which we have used to establish a strong platform for the development of product candidates to treat a variety of cancers. We intend to leverage our core competencies to develop high-value products in oncology markets with large unmet medical needs. When strategically advantageous, we may seek licensing or collaborative arrangements for our product candidates.

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Seek to License or Acquire Complementary Products and Technologies

We intend to supplement our internal drug discovery efforts through the acquisition of products and technologies that complement our general product development strategy. We continue to identify, evaluate and pursue the acquisition or licensing of strategically valuable organizations or product opportunities.

RECENT DEVELOPMENTS

Corvas Acquisition

On July 30, 2003, we announced the completion of our acquisition of Corvas, with a value of approximately $69.6 million, through the issuance of approximately 12.4 million shares of our common stock. This acquisition expanded our product pipeline and strengthened our balance sheet. On December 17, 2003, we announced the closure of the San Diego operations we acquired through the acquisition of Corvas. The closure is intended to allow us to focus our resources on optimizing the value of key assets and to obtain future operating efficiencies. To efficiently manage the ongoing programs located in San Diego, we are re-locating essential activities to our headquarters in Seattle.

Kirin

On November 14, 2003, we announced that we had licensed to Kirin Brewery Co., Ltd, or Kirin, of Tokyo, Japan, patent rights relating to the use of certain HLA-DR antibodies for which Kirin will pay $20 million and relinquished rights to Provenge and other therapeutic vaccines in countries in Asia and the Pacific Rim. HLA-DR antibodies have potential applications in the treatment of cancer and autoimmune diseases such as multiple sclerosis and rheumatoid arthritis. We believe the return of Provenge rights to us will facilitate our ongoing discussions with potential collaborators for Provenge. In addition, this agreement will allow Kirin to continue to develop its monoclonal antibodies, without potentially infringing our patent rights in HLA-DR. Kirin agreed to pay us the $20 million in four installments, of which $2 million was paid in December 2003, and $6 million is to be paid annually for three years thereafter.

Nuvelo

On February 4, 2004, we announced a worldwide licensing agreement with Nuvelo, Inc. for our novel anticoagulant, recombinant nematode anticoagulant protein c2 (rNapc2), and all other rNAPc proteins. Under the terms of the agreement, Nuvelo paid us an upfront payment of $4.6 million, consisting of $500,000 in cash and the balance in Nuvelo common stock. In addition to the upfront payment, the agreement provides for milestone payments for development and royalties upon the commercialization of rNAPc product candidates. Under the terms of the agreement, Nuvelo owns worldwide rights for all indications for rNapc2 products. Since February 4, 2004, we have sold the common stock we acquired from Nuvelo.

MANUFACTURING AND COMMERCIAL INFRASTRUCTURE

Our vaccine manufacturing process incorporates two elements: the Antigen Delivery Cassette and antigen-presenting cells. We manufacture the Antigen Delivery Cassettes for our preclinical studies and clinical trials as recombinant proteins using production methods in compliance with current good manufacturing practices, or cGMP. Preclinical and clinical studies require relatively small amounts of our Antigen Delivery Cassette. To produce commercial quantities of the Antigen Delivery Cassette for Provenge requires that we develop manufacturing processes to permit the production of much larger quantities of that protein. To assist us to scale-up to commercial levels of production of the Antigen Delivery Cassette used in Provenge, we contracted with Diosynth RPT, Inc., or Diosynth, in March 2001. We and Diosynth have since agreed to modifications to the original work plan to allow us to progressively designate work to be done in discrete blocks that are negotiated with Diosynth at a specified price. A separate cancellation fee applies in the event that we cancel any such block of work.

Certain blocks of work have been agreed upon and are being performed pursuant to the modified agreement and we are discussing additional blocks of work with Diosynth. The modification of the agreement allows us greater flexibility in scheduling the availability of Diosynth’s facilities and personnel. In light of the results from our first Phase 3 clinical trial of Provenge, D9901, and our ongoing Phase 3 pivotal clinical trial of Provenge, D9902B, we presently intend to continue the work for scale-up to commercial level production.

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Cell-processing for the manufacture of Provenge and APC8024 for our clinical trials of those product candidates is conducted at a cell processing center we operate in Seattle, Washington, and through third-party contracts with the Mayo Clinic in Rochester, Minnesota, the American Red Cross in Philadelphia, Pennsylvania, and Progenitor Cell Therapy in Hackensack, New Jersey and Mountain View, California. For the manufacture of Provenge on a commercial scale, assuming that product candidate is approved for sale, we plan to construct two or more cell processing centers in the United States. These centers will be strategically located for maximum market coverage. We intend to begin initial development work for these centers in 2004.

The cell separation devices and related media that isolate the cells for our therapeutic vaccines from a patient’s blood and other bodily fluids are manufactured by third-party contractors in compliance with cGMP. We plan to use third-party contractors to produce commercial quantities of these devices and media for Provenge, assuming Provenge is approved for sale.

The manufacture of a dose of Provenge or our other therapeutic vaccines begins with a standard cell collection process called leukapheresis. The resulting cells are then transported to a cell processing center, processed, and returned to a health care provider for infusion into the patient. We rely upon health care providers, including Gambro Healthcare, Inc., or Gambro, to perform leukapheresis for our clinical trials. We have an agreement with Gambro to provide leukapheresis services nationwide through its network of kidney dialysis centers if Provenge is approved for sale.

For our clinical trials, we use a variety of carriers to transport the patient cells derived from leukapheresis to and from the cell processing center. If Provenge is approved for sale, we intend to consolidate a substantial portion of our transportation needs with one or more third-party carriers or transportation systems managers. We are presently engaged in the analysis and planning for our commercial transportation needs.

We intend to link our transportation network, cell processing centers, leukapheresis providers, patients and physicians through an information technology system that allows for the timely, efficient, and cost effective production of Provenge on a commercial basis, if it is approved for sale. We are currently in the process of identifying our information technology needs, and we may rely on one or more third-party contractors to assist us in the development of these systems.

INTELLECTUAL PROPERTY

We protect our technology through numerous United States and foreign patent filings, trademarks and trade secrets that we own or license. We have issued patents or patent applications that are directed to the solutions and devices by which cells can be isolated and manipulated, our Antigen Delivery Cassette, antigen-presenting cell processing, and our monoclonal antibody and small molecule product candidates. We have filed foreign counterparts to these issued patents and patent applications in a number of countries.

We also have issued patents or patent applications acquired in our acquisition of Corvas that are directed to potential pharmaceutical compounds such as rNIF and protease inhibitors and modulators, to methods of making the compounds and for treating specific diseases using the compounds. For many of these issued patents or applications, foreign counterparts are filed in a number of countries.

We intend to continue using our scientific experience to pursue and patent new developments with respect to uses, compositions and factors to enhance our position in the field of cancer. Patents, if issued, may be challenged, invalidated or circumvented. Thus, any patent that we own or license from third-parties may not provide adequate protection against competitors. Our pending patent applications, those we may file in the future, or those we may license from third-parties may not result in issued patents. Also, patents may not provide us with adequate proprietary protection or advantages against competitors with similar or competing technologies. We are also subject to the risk of claims, whether meritorious or not, that our therapeutic vaccines or other potential products or processes use proprietary technology of others for which we do not have a valid license. There are patents owned by third-parties, and such a third-party could assert a claim that our therapeutic vaccines infringe a patent owned by that party. If a lawsuit making any such claims were brought against us, we would assert that the patent at issue is either invalid or not infringed. However, we may not be able to establish non-infringement, and we may not be able to establish invalidity through clear and convincing evidence sufficient to overcome the presumption that issued patents are valid. If we are found to infringe a valid patent, we could be required to seek a license or discontinue or delay commercialization of the affected products, and we could be required to pay substantial damages, which could materially harm our business.

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We also rely on trade secrets and unpatentable know-how that we seek to protect, in part, by confidentiality agreements. Our policy is to require our officers, employees, consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers and other advisors to execute confidentiality agreements. These agreements provide that all confidential information developed or made known to the individual during the course of the individual’s relationship with us be kept confidential and not disclosed to third-parties except in specific limited circumstances. We also require signed confidentiality agreements from companies that are to receive our confidential data. In the case of employees, consultants and contractors, confidentiality agreements with them generally provide that all inventions conceived by the individual while rendering services to us shall be assigned to us as our exclusive property. However, it is possible that these parties may breach those agreements, and we may not have adequate remedies for any breach. It is also possible that our trade secrets or unpatentable know-how will otherwise become known to or be independently developed by competitors.

COMPETITION

The biotechnology and biopharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. Many entities, including pharmaceutical and biotechnology companies, academic institutions and other research organizations are actively engaged in the discovery, research and development of products that could compete directly with our therapeutic vaccine product candidates, including Provenge, and our other products under development. For example, we understand that companies, including Cell Genesys, Inc. and Therion Biologics Corporation, are developing cancer vaccines for the United States market that could potentially compete with Provenge, if Provenge is successfully developed. These competitors may succeed in developing and marketing cancer vaccines that are more effective than or marketed before Provenge. Other products such as chemotherapeutics, antisense compounds, angiogenesis inhibitors and gene therapies are also under development and could potentially compete with Provenge, our therapeutic vaccines for other cancer types, or with other products we develop.

Many companies, including major pharmaceutical companies, are also developing therapies that may compete with our other potential products in the field of cancer. Many of these companies have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing. Others collaborate with large established companies to obtain access to these resources. Smaller companies may also prove to be significant competitors, particularly through the establishment of collaborative arrangements with large, established companies.

Our ability to commercialize Provenge and our other potential products and compete effectively will depend, in large part, on:

Competition among products approved for sale will be based, among other things, upon efficacy, reliability, product safety, price and patent position. Our competitiveness will also depend on our ability to advance our product candidates, license additional technology, maintain a proprietary position in our technologies and products, obtain required government and other public and private approvals on a timely basis, attract and retain key personnel and enter into corporate relationships that enable us and our collaborators to develop effective products that can be manufactured cost-effectively and marketed successfully.

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EMPLOYEES

As of March 5, 2004, we had 146 employees. None of our employees is subject to a collective bargaining agreement, and we believe that our relations with our employees are good.

ITEM 2.

PROPERTIES

We lease approximately 70,650 square feet of laboratory, manufacturing and office space in Seattle, Washington under a lease expiring in December 2008. We sublease to a subtenant approximately 4,475 square feet of this leased space under a sub-lease that expires on March 15, 2005. We also lease approximately 5,256 square feet of office space in another Seattle, Washington location, under a lease expiring on December 31, 2008. Both leases may be extended at our option for two consecutive five-year periods. We lease approximately 25,000 square feet of laboratory, manufacturing and office space in Mountain View, California under a lease expiring June 2006. We sublease to a subtenant approximately 9,166 square feet of this leased space under a sublease agreement that expires in June 2006. We have engaged a real estate broker to sublease the balance of the space. This lease may be extended at our option for one five-year period. We lease approximately 42,300 square feet of laboratory and office space in San Diego, California under a lease expiring in September 2006. With the closure of our San Diego facility, we have engaged a real estate broker to sublease this space.

ITEM 3.

LEGAL PROCEEDINGS

On October 20, 2003, Dr. George P. Vlasuk, a former Corvas employee, commenced an action against us in the San Diego, California Superior Court. Dr. Vlasuk is a named beneficiary of Corvas’s 2002 Change in Control Executive Severance Benefit Plan, which provides for the payment of severance benefits upon a change of control of Corvas, subject to certain terms and conditions. Our wholly-owned subsidiary, Dendreon San Diego LLC, as successor by merger to the obligations of Corvas under the Change in Control Plan, withheld payment of Dr. Vlasuk’s claimed severance benefits, pending a determination whether Dr. Vlasuk engaged in certain disqualifying conduct. In his lawsuit, Dr. Vlasuk alleges breach of the Change in Control Plan, violation of the California Labor Code and other claims, and seeks damages, and attorneys’ fees and costs. On February 24, 2004, we reached an agreement to resolve Dr. Vlasuk’s claims and we presently expect to complete a settlement agreement with Dr. Vlasuk by March 30, 2004. If the settlement is not completed, we intend to vigorously defend the action.

ITEM 4.

SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

None.

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PART II

ITEM 5.

MARKET FOR REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS

Our common stock commenced trading publicly on the Nasdaq National Market on June 16, 2000 under the symbol “DNDN.” The following table sets forth, for the periods indicated, the high and low reported sale prices of our common stock as reported on the Nasdaq National Market: