Cougar Biotechnology Posts 2008 4Q and Year-End Financial Results

Mar 16, 2009 (Close-Up Media via COMTEX) -- CGRB | Quote | Chart | News | PowerRating -- Cougar Biotechnology, Inc., a biotechnology company engaged in the in-license and development of clinical stage cancer drug candidates, has reported its financial results for the fourth quarter and year ended December 31, 2008.

In a release, the company noted that for the quarter ended December 31, 2008, Cougar reported a net loss applicable to common stock of $21.5 million, or $1.04 per share, compared to a net loss applicable to common stock of $7.7 million, or $0.43 per share, for the quarter ended December 31, 2007. Net loss applicable to common stock for the year ended December 31, 2008, was $59.8 million, or $2.90 per share, compared to a net loss of $32.2 million, or $2.17 per share, for the year ended December 31, 2007.

Total operating expenses for the fourth quarter of 2008 were $21.9 million, an increase of $13.3 million compared to the fourth quarter of 2007. Included in the total operating expenses for the fourth quarters of 2008 and 2007 were non-cash stock-based compensation expenses of $1.5 million and $2.0 million, respectively. Total operating expenses for the year ended December 31, 2008, were $63.1 million, compared to $34.1 million in 2007, an increase of $29.0 million. Total operating expenses for the years ended December 31, 2008 and 2007, included non-cash stock-based compensation expenses of $5.4 million and $7.0 million, respectively. The increase in operating expenses in 2008 was primarily driven by clinical development expenses for CB7630 (abiraterone acetate) and increased headcount, principally related to growth in the company's clinical development and regulatory affairs departments.

Research and development expenses for the fourth quarter of 2008 were $18.4 million, compared to $6.7 million for the fourth quarter of 2007. Research and development expenses for the fourth quarters of 2008 and 2007 included non-cash stock-based compensation expenses of $0.6 million and $1.5 million, respectively. Total research and development expenses for the year ended December 31, 2008, were $52.9 million, compared to $27.3 million in 2007. The increase in research and development expenses in the fourth quarter of 2008 was primarily driven by the costs of our ongoing Phase III trial for our lead compound CB7630 in metastatic castration-resistant prostate cancer patients who have failed docetaxel-based chemotherapy (COU-AA-301), as well as the costs associated with preparing for our anticipated Phase III trial of CB7630 in metastatic castration-resistant prostate cancer patients who have not yet received chemotherapy (COU-AA-302). Research and development expenses for the years ended December 31, 2008 and 2007, included non-cash stock-based compensation expenses of $2.8 million and $5.9 million, respectively.

General and administrative expenses for the fourth quarter of 2008 were $3.4 million, compared to $1.8 million for the fourth quarter of 2007. General and administrative expenses for the fourth quarters of 2008 and 2007 included non-cash stock-based compensation expenses of $0.9 million and $0.5 million, respectively. Total general and administrative expenses for the year ended December 31, 2008, were $10.0 million, compared to $6.8 million in 2007. General and administrative expenses for the years ended December 31, 2008 and 2007, included non-cash stock-based compensation expenses of $2.6 million and $1.5 million, respectively.

Net cash used in operating activities for the year ended December 31, 2008, was $44.7 million, compared to $23.1 million in 2007. Net cash used in operating activities for the quarter ended December 31, 2008, was $15.4 million compared to $8.2 million in the corresponding period of 2007. The increased use of cash for both the quarter and year to date is primarily due to the ongoing costs of our COU-AA-301 Phase III trial, as well as the costs associated with preparation for our COU-AA-302 Phase III trial. As of December 31, 2008, cash, cash equivalents and investment securities available-for-sale totalled $91.0 million, compared to $135.3 million as of December 31, 2007. The decline from the December 31, 2007, balance largely reflects the expenditures required to advance our drug candidates through their various clinical trials and the additional infrastructure needed to support the advancement of our drug candidates.

"2008 brought many significant achievements and advancements for Cougar, as our lead drug candidate CB7630, abiraterone acetate, entered into Phase III clinical trials and we continued to report positive Phase I and Phase II data for CB7630 at various medical conferences throughout the year," said Alan H. Auerbach, Chief Executive Officer and President.

"We will continue to move forward aggressively with the clinical development of CB7630 during 2009. Our ongoing COU-AA-301 Phase III trial of CB7630 in patients with metastatic castration-resistant prostate cancer who have failed docetaxel-based chemotherapy has experienced rapid recruitment and we look forward to completing recruitment in this trial shortly. We were also very pleased to announce last month that we reached agreement with the U.S. Food and Drug Administration under a Special Protocol Assessment for our planned Phase III clinical trial of CB7630 in patients with chemotherapy naive castration-resistant prostate cancer and we look forward to initiating this Phase III trial (COU-AA-302) shortly. We also anticipate that we will present preliminary data from our Phase I/II trial of CB7630 in breast cancer during 2009 and further anticipate that we will report preliminary data from our Phase I/II trial of CB3304 (noscapine) in multiple myeloma during the year as well," added Auerbach.

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