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Total costs and expenses in FY 2008 increased to $30,233,000 from$25,618,000 in FY 2007. Increased costs of contract manufacturing directlyrelated to the increase in Avid's revenues accounted for almost one-third ofthe increase in total expenses. Most of the remainder of the increase was dueto the company's increased investment in research and development associatedwith the advancement of its three clinical programs for bavituximab andCotara(R) for the treatment of solid tumors and hepatitis C virus (HCV)infection. These programs include seven clinical trials: Three bavituximabPhase II studies in combination with chemotherapy for the treatment ofadvanced breast cancer and non-small cell lung cancer (NSCLC), a bavituximabPhase I cancer study, a bavituximab Phase I study in HCV patients co-infectedwith HIV, and two Cotara studies for the treatment of glioblastoma multiforme(GBM), a deadly form of brain cancer.
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The company reported a consolidated net loss of $23,176,000, or $0.10 perbasic and diluted share in FY 2008, compared to a consolidated net loss of$20,796,000, or $0.11 per basic and diluted share for FY 2007.
"This past year has been marked by major progress in all areas of ourbusiness," said Steven W. King, president and CEO of Peregrine. "The mostsignificant developments included initiating, completing enrollment in andreporting positive data for the first set of patients in our first bavituximabPhase II oncology study, entering into a five-year contract potentially worthup to $44.4 million with the Defense Threat Reduction Agency (DTRA) toexpedite evaluation of bavituximab for the prevention or treatment of viralhemorrhagic fever infections and achieving significantly increased revenuesand an expanded client base at our manufacturing subsidiary Avid. We expectto continue building on these accomplishments during FY 2009 and we areoptimistic that the company will achieve even more significant advances duringthe coming year."
Mr. King continued, "Our most significant product advancements this yearwere in the bavituximab clinical program. In the anti-cancer program, we wereable to start and complete patient enrollment in the planned first set of15 patients in a Phase II breast cancer trial combining bavituximab and thechemotherapy drug docetaxel. The trial has already met the pre-establishedprimary endpoint with none of the patients having any tumor growth to date andhalf of the patients achieving an objective tumor response by the firsteight-week evaluation point. These are encouraging results and open the doorto expanding the trial to an additional planned 31 patients. We alsoinitiated patient enrollment in a second Phase II study combining bavituximabwith carboplatin and paclitaxel in patients with advanced lung cancer. Athird Phase II study is set to begin shortly testing this same combination inadvanced breast cancer patients. In addition, the bavituximab cancer programreceived significant attention when positive data from an earlier Phase lstudy was presented at the 2008 ASCO Annual Meeting. These developments haveset the stage for what we expect to be additional significant clinicaladvancements during the coming year. In the bavituximab anti-viral program,we recently received a significant external validation of this program whenthe DTRA awarded Peregrine a multi-year contract worth up to $44.4 million todevelop bavituximab for the treatment and prevention of viral hemorrhagicfevers. We expect this contract will help advance all of our bavituximabanti-viral programs."
Mr. King added
