GenStar Therapeutics Reports Financial Results and Operating Highlights for the Fourth Quarter and Year Ended December 31, 2001
BUSINESS WIRE - April 04, 2002 07:31
SAN DIEGO, Apr 4, 2002 (BW HealthWire) -- GenStar Therapeutics (AMEX:GNT), a biotechnology company developing gene therapy products for the treatment of hemophilia A, prostate cancer and HIV/AIDS, today reported financial results for the fourth quarter and year ended December 31, 2001.
For the year ended December 31, 2001 GenStar reported a net loss of $11.1 million, or $0.48 per share, as compared with a net loss of $9.6 million, or $0.46 per share, for the year ended December 31, 2000. Research and development costs totaled $8.5 million in 2001 compared with $6.4 million in 2000. The increase is attributable in large part to the Company's expanding development efforts for each of its product programs. Revenues for the year ended December 31, 2001 were $301,000, compared with $162,000 in 2000. Revenues were derived from research grants. For the three months ended December 31, 2001 GenStar reported a net loss of $2.6 million, or $0.11 per share, on revenues of $139,000, compared with a net loss of $3.0 million, or $0.13 per share, on revenues of $48,000 for the same period of 2000.
GenStar ended 2001 with approximately $16.4 million in cash, cash equivalents and short-term investments, down from $21.4 million as of December 31, 2000.
"This past year we achieved significant accomplishments," stated Robert E. Sobol, M.D., chief executive officer. Dr. Sobol continued, "We have advanced our gene therapy product development programs for hemophilia, cancer and HIV/AIDS, using GenStar's advanced gene delivery systems. With our innovative technology platforms, Baxter partnership, current cash position and experienced management and scientific teams, we are well-positioned to move our existing product programs forward."
Among the highlights for the year, Dr. Sobol noted the following achievements:
- In the Company's Phase I clinical trial for severe Hemophilia A, the data show that eight months following treatment with MAX AD Factor VIII, the first patient has sustained an expression level of Factor VIII at approximately the 1% level. Factor VIII levels of less than 1% are characteristic of severe disease while higher levels are associated with a more moderate condition. - Accrual to the study has continued and additional eligible candidates have been identified. - A Phase I clinical trial for hemophilia A will also be initiated in Europe by the second half of 2002. - GenStar reported a successful pre-IND meeting with the FDA, positioning the Company to initiate Phase I clinical trials for its prostate cancer DUAL AD product in late 2002. - The Company also generated pre-clinical data on an HIV vaccine candidate demonstrating induction of HIV immunity in vivo.
Dr. Sobol added, "This year will be an important one for the company as we move our lead product forward for the treatment of hemophilia A. We are very encouraged that our first patient continues to express Factor VIII, demonstrating the potential of GenStar's technology to sustain gene expression that will be required for successful therapy. Our prostate cancer and HIV/AIDS programs are anticipated to make significant progress as we move toward clinical trials for these indications. Concurrently, we are actively pursuing corporate partnering opportunities for the Company's DUAL AD prostate cancer and vaccine programs."
Hemophilia A is a potentially life threatening hereditary disease that affects over 50,000 people in the United States and Europe. The disease results from a defect in the Factor VIII gene, which produces the Factor VIII protein essential for blood clotting. Current therapies for Hemophilia A are based upon intermittent injections of the Factor VIII protein that do not provide the sustained levels of Factor VIII needed to prevent bleeding episodes characteristic of the disorder. GenStar's product carries the entire human Factor VIII gene sequence and uses a molecular switch with a genetic sequence designed for increasing Factor VIII expression in the liver, one of its normal biological sites of production. GenStar's clinical study is open for accrual and will be evaluating additional patients. Transient liver and hematologic laboratory abnormalities observed in the first patient have returned to normal values and the trial has resumed at a lower dose with a dose escalation design. MAX AD, the Company's core technology is a gutted adenoviral vector that can be applied broadly across gene-based applications.
GenStar Therapeutics www.genstar-rx.com is a biopharmaceutical company developing innovative gene therapy products for the treatment of serious medical disorders. The Company's research and development efforts, utilizing advanced gene delivery technologies, are focused on hemophilia, cancer, and vaccines. The Company's MAX AD Factor VIII program is being developed in collaboration with Baxter Healthcare and its hemophilia, prostate cancer and HIV/AIDS product development programs are supported, in part, by grants from the National Cancer Institute and the National Institute of Health. |
