To discuss results from its pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in patients with small cell lung cancer

Poniard Pharmaceuticals, Inc. announced that its pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in the second-line treatment of small cell lung cancer (SCLC) did not meet its primary endpoint of overall survival. The analysis, based on 320 evaluable events (patient deaths), showed a hazard ratio of 0.82 with a p value of 0.089. The international, multi-center, randomized, controlled Phase 3 SPEAR trial was conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The trial evaluated the efficacy and safety of picoplatin as second-line therapy in 401 cancer patients with SCLC who were refractory to or who progressed within six months of first-line platinum-based therapy. Picoplatin administered as an intravenous infusion once every three weeks plus best supportive care (BSC) was compared to BSC alone. BSC was designed in accordance with the National Comprehensive Cancer Network's guidelines. The primary endpoint of the trial was overall survival. Other endpoints included overall response rate, progression-free survival, disease control rate and duration of response. The Statistical Analytical Plan of the trial, as agreed to in the SPA, was 90% powered to show a 33% reduction in risk in death for picoplatin treatment plus best supportive care (BSC) compared with BSC alone (hazard ratio of 0.67; p<0.05). Patient enrollment in the trial was completed in March 2009>

Poniard Pharmaceuticals, Inc. reported consolidated unaudited financial results for the third quarter and nine months ended September 30, 2009. For the quarter, the company reported a net loss of $9.9 million or $0.29 diluted loss per share, compared with a net loss of $12.2 million or $0.36 diluted loss per share for the quarter ended September 30, 2008. Loss from operations for the quarter was $9.2 million against $12.407 million for the same quarter last year. The company reported a net loss of $32.5 million or $0.95 diluted loss per share for the nine months ended September 30, 2009, compared with a net loss of $34.6 million or $1.01 diluted loss per share for the same period in 2008. Loss from operations for the nine months of 2009 was $30.53 million against $35.8 million for the same period last year.