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* Cash and equivalents € 144 million on September 30, 2004 * Quarterly highlights include opening of clinical study to evaluate satraplatin plus radiation therapy in non-small cell lung cance GPC Biotech Reports Financial Results for Third Quarter and First Nine Months of 2004 Martinsried/Munich (Germany), and U.S. Research Facilities in Waltham/Boston, Mass. and Princeton, N.J., November 9, 2004 - GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30; NASDAQ: GPCB) today reported its financial results for the third quarter and first nine months of 2004. Revenues decreased 44% to € 9.1 million for the nine months ended September 30, 2004, compared to € 16.4 million for the same period in 2003. As reported in previous releases, GPC Biotech expects a reduction in revenues from technology alliances during 2004 since several of these alliances ended in 2003 and as the Company continues to focus its strategy on discovering and developing new anticancer drugs as opposed to new technology platform alliances. The 2004 revenues were generated from the Company’s ongoing alliance with ALTANA Pharma AG to build the ALTANA Research Institute in the U.S. Research and development (R&D) expenses remained relatively unchanged in the first nine months of 2004 at € 27.7 million compared to € 27.8 million for the same period in 2003. Despite increased drug development activities in 2004, especially related to the Company’s lead drug candidate satraplatin, R&D expenses were relatively unchanged compared to the same period in 2003 due to a higher R&D headcount and a milestone payment related to the initiation of the SPARC trial in 2003. In the first nine months of 2004, general and administrative (G&A) expenses increased 10% to € 9.3 million compared to € 8.4 million for the first nine months of 2003. Non-cash charges for stock options and convertible bonds, which are included in R&D and G&A expenses, were € 1.7 million in the first nine months of 2004 compared to € 2.2 million for the same period in 2003. The Company’s net loss increased 43% to € (26.1) million in the first nine months of 2004 compared to € (18.2) million for the same period in 2003. Basic and diluted loss per share was € (1.10) compared to € (0.88) for the same period in 2003. For the three months ended September 30, 2004, revenues were € 2.6 million, compared to € 5.2 million for the same period in 2003. R&D expenses were € 9.4 million in the third quarter of 2004 (third quarter of 2003: € 10.2 million). G&A expenses were € 3.7 million in the third quarter of 2004 (third quarter of 2003: € 3.0 million). Non-cash charges for stock options and convertible bonds, which are included in R&D and G&A expenses, were € 0.7 million in the third quarter of 2004 (third quarter of 2003: € 0.9 million). Net loss was € (9.8) million in the third quarter of 2004 (third quarter of 2003: € (7.7) million). Basic and diluted loss per share was € (0.34) in the third quarter of 2004, compared to € (0.37) for the same period in 2003. As of September 30, 2004, cash, cash equivalents, short-term investments and marketable securities totaled € 144.1 million (December 31, 2003: € 91.7 million), including € 2.6 million in restricted cash. The cash, cash equivalents, short-term investments and marketable securities figure for 2004 includes net proceeds of approximately € 78 million from the Company’s financing activities, which were booked in the third quarter. The net cash burn was € 28.9 million for the first nine months of 2004. Net cash burn is derived by adding net cash used in operating activities (€ 28.0 million) and purchases of property, equipment and licenses (€ 0.9 million). The figures used to calculate net cash burn are contained in the Company’s unaudited interim consolidated statements of cash flows for the nine months ended September 30, 2004. Net cash burn was € 10.5 million for the third quarter of 2004, € 9.6 million for the second quarter of 2004 and € 8.8 million for the first quarter of 2004. “Following the successful re-financing of our Company this summer, we have begun to use the new funds to build the Company’s long-term value by systematically investing in our oncology drug pipeline,” said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. “As part of our strategy to further enhance the commercial potential of our lead drug candidate, satraplatin, we recently opened for accrual a new clinical trial for satraplatin in combination with radiation therapy in patients with non-small cell lung cancer. We plan to conduct additional clinical trials for satraplatin in a variety of oncology indications and in combination with other anticancer treatments.” Dr. Seizinger continued, “We are also aggressively advancing our two other anticancer drug development programs – the monoclonal antibody 1D09C3 against lymphoid tumors and our novel broad-spectrum cell cycle inhibitor RGB-286199. We have recently completed pre-clinical testing with 1D09C3 and are preparing the necessary information for the regulatory authorities and ethics committees to begin human clinical studies in patients with non-Hodgkin’s lymphoma and other types of lymphoid tumors in the near future. The cell cycle inhibitor program is expected to enter human clinical studies in the second half of 2005. We are confident that our achievements for the year to date have put us in a strong position to elevate the Company to the next level in our corporate development.” Key achievements for the year to date Corporate * Company listed American Depositary Shares on NASDAQ U.S. stock exchange under symbol, GPCB. * Successful follow-on offering netting proceeds of approximately € 78 million (approximately $95 million). Lead anticancer drug candidate, satraplatin * Receipt of Scientific Advice letter from European central regulatory authority, European Agency for the Evaluation of Medicinal Products (EMEA). The same multicenter, multinational trial may be used as the basis for regulatory approval in both the U.S. and Europe. * Phase I combination study with radiation therapy in non-small cell lung cancer opened for accrual. * Pre-clinical data presented at key scientific conferences - Demonstrating in vitro efficacy of satraplatin in tumor cells resistant to both TAXOTERE® (docetaxel) and to TAXOL® (paclitaxel). The Company expects that many of the patients in the SPARC Phase 3 trial will have been pre-treated with and failed on a taxane-based therapy prior to entering the study. - Demonstrating potency in killing prostate cancer cells. Several androgen-independent (i.e., hormone-refractory) prostate cancer cell lines were particularly sensitive to satraplatin. Other development programs 1D09C3 monoclonal antibody – * Presentation of pre-clinical data demonstrating the efficacy of the antibody against a variety of hematological malignancies. * Completion of pre-clinical testing with the antibody and ongoing preparation of the necessary information to provide to regulatory authorities and ethics committees to begin human clinical studies. RGB-286199 cell cycle inhibitor – * U.S. patent issued with claims covering RGB-286199, including the composition of matter of a family of cell cycle inhibitors. Claims also include pharmaceutical compositions, as well as methods of treating certain diseases, including cancer. * Presentation of data showing RGB-286199 results in cell cycle arrest and apoptosis (programmed cell death) in a wide range of tumor cells in culture. - RGB-286199 shown to be a potent inhibitor of all known cyclin-dependent kinases involved in controlling various key events during the cell cycle. Compound also shown to selectively inhibit other distinct kinases associated with the development of cancer. - In vitro data showing RGB-286199 is active on quiescent tumor cells, in addition to tumor cells actively going through the cell cycle process, while not affecting normal resting cells under similar conditions. - Demonstration of in vivo efficacy, including tumor regressions, in various animal models. Press conference and investor meeting scheduled As previously announced, the Company has scheduled a press conference and an investor meeting today in Frankfurt, Germany. Dial-in numbers for the press conference (11:00-12:00 noon CET; in German) and investor meeting (14:00-15:00 CET/8:00-9:00 A.M. EST; in English) follow. Press conference: European participants: 0049 (0)69 2222 7111 U.S. participants: 1-866-850-2201 (toll-free) Investor meeting: European participants: 0049 (0)69 2222 3105 U.S. participants: 1-866-602-0258 (toll-free) Please dial in 10 minutes before the beginning of the conferences. Slides accompanying both presentations will be available for downloading from the Company’s Web site (www.gpc-biotech.com) shortly before the start of each meeting. Replays of both presentations also will be available via the Company Web site beginning approximately 3 hours after each meeting. GPC Biotech AG is a biotechnology company discovering and developing new anticancer drugs. The Company's lead product candidate - satraplatin - is currently in a Phase 3 registrational trial as a second-line chemotherapy treatment in hormone-refractory prostate cancer following successful completion of a Special Protocol Assessment by the U.S. FDA and receipt of a Scientific Advice letter from the European central regulatory authority, EMEA. The FDA has also granted fast track designation to satraplatin for this indication. Satraplatin was in-licensed from Spectrum Pharmaceuticals, Inc. Other anticancer programs in development include a monoclonal antibody and a cell cycle inhibitor. The Company is leveraging its drug discovery technologies to elucidate the mechanisms-of-action of drug candidates and to support the growth of its drug pipeline. The Company has formed successful alliances with a number of pharmaceutical and biotechnology firms. For example, the Company has a multi-year alliance with ALTANA Pharma AG to establish the ALTANA Research Institute in the U.S., which provides GPC Biotech with revenues until 2007. GPC Biotech AG is headquartered in Martinsried/Munich (Germany). The Company's wholly owned U.S. subsidiary has research sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit the Company's Web site at www.gpc-biotech.com. This press release may contain projections or estimates relating to plans and objectives relating to our future operations, products, or services; future financial results; or assumptions underlying or relating to any such statements; each of which constitutes a forward-looking statement subject to risks and uncertainties, many of which are beyond our control. Actual results could differ materially depending on a number of factors, including the timing and effects of regulatory actions, the results of clinical trials, the Company's relative success developing and gaining market acceptance for any new products, and the effectiveness of patent protection. TAXOL® is a registered trademark of Bristol-Myers Squibb Company. TAXOTERE® is a registered trademark of sanofi-aventis Group. Kontaktinformationen: GPC Biotech AG Fraunhoferstr. 20 82152 Martinsried/Munich, Germany Phone/Fax: +49 (0)89 8565-2600/-2610 info@gpc-biotech.com Martin Braendle (ext. 2693) Senior Manager, Investor Relations & Corporate Communications martin.braendle@gpc-biotech.com In the U.S.: Laurie Doyle Associate Director, Investor Relations & Corporate Communications Phone: +1 781 890 9007 (ext. 267) Fax: +1 781 890 9005 laurie.doyle@gpc-biotech.com Additional Media Contact: Euro RSCG Life NRP In NY: Mark Vincent, Vice President Phone: +1 212 845 4239 mark.vincent@eurorscg.com
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