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The Company reported a net loss of $11.9 million ($0.29 diluted loss per share on a loss applicable to common shares of $12.5 million) for the quarter ended March 31, 2010. As of March 31, 2010, cash and investment securities totaled $38.3 million. Management currently believes the existing cash and investment securities will provide adequate resources to fund the Company's operations at least through the end of 2010.
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"In recent months, we have taken action to strengthen our financial position and focus our resources on identifying an effective path for the continued development of picoplatin in multiple indications," said Ronald A. Martell, chief executive officer of Poniard. "The data generated to date underscore picoplatin's potential efficacy and safety in a variety of solid tumors, and we are currently developing registration strategies for picoplatin in lung, colorectal, prostate and ovarian cancers. Concurrent with this effort, we are continuing to explore strategic alternatives to support and optimize the value of the picoplatin program for our shareholders."
Recent Clinical and Corporate Developments
Picoplatin Clinical Update
Results from this trial highlight the potential of picoplatin as a safe and effective platinum chemotherapeutic agent for the first-line treatment of prostate cancer, and suggest that picoplatin could play a role in the treatment of other tumor types where platinum and taxane chemotherapies are currently used.
Corporate Update
First Quarter 2010 Unaudited Financial Results
The Company reported a net loss of $11.9 million ($0.29 diluted loss per share on a loss applicable to common shares of $12.5 million) for the quarter ended March 31, 2010 compared with a net loss of $13.0 million ($0.38 diluted loss per share on a loss applicable to common shares of $13.1 million) for the quarter ended March 31, 2009.
Total operating expenses for the quarter ended March 31, 2010 were $11.3 million compared with $12.2 million for the quarter ended March 31, 2009. Total operating expenses for the first quarter of 2010 included a charge of $1.6 million related to two workforce reductions.
Research and development expenses were $4.9 million for the quarter ended March 31, 2010 compared with $8.2 million for the quarter ended March 31, 2009.
General and administrative expenses were $4.8 million for the quarter ended March 31, 2010 compared with $3.0 million for the quarter ended March 31, 2009. The increase was primarily attributable to an increase in share-based compensation expenses.
Cash and investment securities as of March 31, 2010, were $38.3 million, compared to $43.4 million at December 31, 2009.
Conference Call Details
Poniard's management team will host a conference call and Webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time. To participate in the call by telephone, please dial 866-700-0133 (United States) or 617-213-8831 (International). The passcode for the conference call is 65089280. In addition, the call is being Webcast and can be accessed on the "Events" page of the "News & Events" section of the Company's Web site at http://www.poniard.com. A replay of the Webcast will be available on the Company's Web site for 10 days.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products. For additional information please visit http://www.poniard.com.
Forward-Looking Statements
This release contains forward-looking statements describing, among other things, the Company's projected financial position and future operations, the adequacy of its cash resources, the Company's plan to focus its resources on developing registration strategies for picoplatin in multiple cancer indications, the Company's plan to explore strategic alternatives to support the continued development of picoplatin, and the Company's goal of optimizing shareholder value. Actual results and events may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties inherent in the Company's business, including the Company's anticipated future operating losses, need for future capital and ability to obtain future funding; the risk that strategic relationships may not be established on a timely basis, on terms that are ultimately favorable to the Company, or at all; the potential safety, efficacy and commercial viability of picoplatin; the risk that the Company's additional analyses of data from clinical trials of picoplatin may produce negative or inconclusive results, or may be inconsistent with previously announced results or previously conducted trials; the Company's ability to retain key personnel; competition from third parties; the Company's ability to preserve and protect its intellectual property rights; the Company's dependence on third-party manufacturers, suppliers and other contractors; changes in technology, government regulation and general market conditions; the receipt and timing of FDA and other required regulatory approvals, if at all; and the risks and uncertainties described in the Company's current and periodic reports filed with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2009 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2010. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.
(1) Tannock et al, NEJM 2004;351:1502-12.
-- Presented Final Data from Picoplatin Prostate Cancer Trial: In March, Poniard presented final data during the American Society of Clinical Oncology (ASCO) 2010 Genitourinary Cancers Symposium from the Company's Phase 2 clinical trial evaluating the efficacy and safety of intravenous picoplatin (120 mg/meter squared) administered every three weeks in combination with full doses of docetaxel (75 mg/meter squared) with twice daily prednisone (5 mg) as a first-line treatment in 32 chemotherapy naive patients with metastatic castration resistant prostate cancer (CRPC). Data from 29 evaluable patients indicated that picoplatin, when added to the recommended first-line therapy of docetaxel and prednisone for CRPC, is active, as demonstrated by median overall survival (21.4 months), median progression-free survival (PFS) (7.4 months), and prostate specific antigen (PSA) response rate (78 percent). In contrast, data from published literature report a median overall survival benefit of 18.9 months and a PSA response of 45 percent for patients who received recommended doses of docetaxel and prednisone alone.(1)( )Picoplatin was safely administered with full-dose docetaxel and prednisone for up to 10 cycles of therapy as specified by the protocol. No neuropathy was observed in this study.
SOURCE Poniard Pharmaceuticals, Inc.
