About Us
Cell Genesys (Nasdaq: CEGE) is a South San Francisco-based biotechnology company with manufacturing operations located in Hayward, California. Since its inception, the company focused primarily on the development and commercialization of novel biological therapies for patients with cancer. In August 2008 and October 2008, the company terminated its two Phase 3 clinical trials of GVAX immunotherapy for prostate cancer and subsequently placed on hold the further development of this program and implemented a substantial restructuring of business operations. GVAX immunotherapy for leukemia and GVAX immunotherapy for pancreatic cancer are currently being developed through investigator-sponsored trials being conducted by researchers at Johns Hopkins University. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders.
As of September 30, 2008, the company had approximately $151 million in cash.
Recent Highlights
- Announced in August 2008 the termination of the VITAL-2 Phase 3 trial which compared GVAX immunotherapy for prostate cancer in combination with Taxotere® (docetaxel) to Taxotere plus prednisone in patients with advanced-stage prostate cancer. The Company ended the trial as recommended by the study’s Independent Data Monitoring Committee (IDMC) which, in a routine safety review meeting of both the VITAL-1 and VITAL-2 trials, observed an imbalance in deaths between the two treatment arms of the VITAL-2 study, with a higher number of deaths in the GVAX immunotherapy in combination with Taxotere arm compared to the Taxotere plus prednisone arm. Cell Genesys conducted an initial analysis of the incomplete clinical trial data set that was reviewed by the IDMC in August. The analysis revealed no apparent imbalance in patient baseline characteristics with respect to both demographic and disease prognostic factors. In addition, no significant toxicities in the GVAX immunotherapy plus Taxotere combination therapy arm were observed that could explain the imbalance in deaths and in fact, the vast majority of deaths in both treatment arms were reported as due to progression of prostate cancer.
- Announced in September 2008 that the U.S. Food and Drug Administration (FDA) had, as expected, placed a partial clinical hold on the GVAX Phase 3 program for prostate cancer as a result of the Company’s announcement on August 27, 2008, regarding the termination of the VITAL-2 Phase 3 trial for this product. This communication from FDA had no impact on the previously announced action the Company took regarding the VITAL-2 trial.
- Announced in October 2008 a decision to terminate the VITAL-1 Phase 3 clinical trial of GVAX immunotherapy based on the results of a futility analysis conducted at the Company’s request by the study’s IDMC. In view of the termination of both the VITAL-1 and VITAL-2 trials, the Company placed on hold the further development of GVAX immunotherapy for prostate cancer and following approval by the board of directors, implemented a substantial restructuring plan.
- Announced in October 2008 the receipt of a Nasdaq Staff Deficiency Letter, or Nasdaq Letter, indicating that Cell Genesys had become non-compliant with the minimum $1.00 bid price requirement for continued listing on The Nasdaq Global Market. The Nasdaq Letter indicated that in light of extraordinary market conditions, Nasdaq has determined to suspend enforcement of the minimum bid price and market value of publicly held shares requirements through January 16, 2009. Accordingly, the Nasdaq Letter stated that the Company has 180 calendar days from January 20, 2009, or until July 20, 2009, to regain compliance. Compliance would be achieved if the bid price of the Company’s common stock closed at $1.00 per share or more for a minimum of 10 consecutive days during that period.
- Announced in October 2008 the repurchase of an aggregate of $26.3 million face value of the Company’s 3.125% Convertible Senior Notes due 2011, or Notes, at an overall discount of approximately 60 percent from face value in a series of privately negotiated transactions with institutional holders of the Notes, for aggregate consideration of $10.5 million in cash, plus accrued but unpaid interest. As a result of the retirement of the repurchased Notes, approximately $119 million remain outstanding. This early retirement of debt will result in a net gain of approximately $15.8 million in the fourth quarter of 2008 and a reduction of annualized interest expense by $0.8 million.