Nov. 3, 2009 (PR Newswire) -- SOUTH SAN FRANCISCO, Calif., Nov. 3 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today reported financial results for the third quarter ended September 30, 2009, and provided a corporate update.

"During the third quarter, we reached the 320th event target in our pivotal Phase 3 SPEAR trial, which is evaluating picoplatin for the treatment of small cell lung cancer. This event allowed us to collect the data for overall survival analysis," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "We expect to report top-line results from the SPEAR registration trial this month and plan to present the data at international medical conferences next year. If the top-line results are positive, we plan to initiate a rolling submission of a New Drug Application with the U.S. Food and Drug Administration by year-end, targeting approval and commercial launch of picoplatin in 2010."

Recent Clinical and Corporate Developments

Picoplatin Clinical Update

    --  Announced in September that 320 evaluable events (patient deaths)
occurred in the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy
After Relapse) trial, evaluating picoplatin in the treatment of small
cell lung cancer (SCLC).  The 320th event in the registration SPEAR
trial was defined in the Special Protocol Assessment with the U.S. Food
and Drug Administration (FDA), which allowed the Company to collect the
data for overall survival analysis, which is the primary endpoint of the
trial.  This randomized trial is comparing picoplatin with best
supportive care to best supportive care alone without systemic
chemotherapy.

Corporate Update

    --  Secured a committed equity financing facility in August under which
Poniard may, over an 18-month period, sell up to $60 million newly
issued registered common stock to Azimuth Opportunity Ltd. at a
pre-negotiated discount to market price. The Company will determine, at
its sole discretion, the timing and amount of any sales of its common
stock, subject to certain conditions. The Company is not obligated to
utilize any of the $60 million facility and remains free to enter into
other financing transactions.

Third Quarter 2009 Unaudited Financial Results

The Company reported a net loss of $9.9 million ($0.29 diluted loss per share on a loss applicable to common shares of $10.0 million) for the quarter ended September 30, 2009, compared with a net loss of $12.2 million ($0.36 diluted loss per share on a loss applicable to common shares of $12.4 million) for the quarter ended September 30, 2008. The Company reported a net loss of $32.5 million ($0.95 diluted loss per share on a loss applicable to common shares of $32.9 million) for the nine months ended September 30, 2009, compared with a net loss of $34.6 million ($1.01 diluted loss per share on a loss applicable to common shares of $35.0 million) for the same period in 2008.

Total operating expenses for the quarter ended September 30, 2009, were $9.2 million compared with $12.4 million for the quarter ended September 30, 2008, and were $30.5 million for the nine months ended September 30, 2009, compared with $35.8 million for the same period in 2008. Total operating expenses for the nine months ended September 30, 2009, include a charge of $1.1 million for the restructuring and related asset impairment resulting from the Company's implementation of a strategic restructuring plan to discontinue its in-house preclinical research operations and reduce its workforce by approximately 12 percent effective March 31, 2009.

Research and development expenses were $5.4 million for the quarter ended September 30, 2009, compared with $9.0 million for the quarter ended September 30, 2008.