- Conference Call Today at 5:00 p.m. Eastern Time -
SOUTH SAN FRANCISCO, Calif., March 16 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today reported financial results for the fourth quarter and year ended December 31, 2008, and provided a corporate update.
"During the fourth quarter of 2008, we made significant progress toward our goal of developing picoplatin as an oncology platform compound by advancing our pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) clinical trial for the treatment of small cell lung cancer, presenting data from our ongoing Phase 2 picoplatin studies in colorectal and prostate cancers, and securing a commercial manufacturer of picoplatin as a finished drug product," said Jerry McMahon, PhD., chairman and chief executive officer of Poniard. "We anticipate completing patient enrollment in our ongoing SPEAR Phase 3 clinical trial and initiating our New Drug Application with the U.S. Food and Drug Administration this year. Throughout 2009, we expect to make continued progress in all of our picoplatin clinical trials and to generate additional key data to support use of picoplatin in multiple tumor indications."
Recent Corporate Highlights
Picoplatin Clinical Development
Corporate Developments
Fourth Quarter 2008 Financial Results
The Company reported a net loss of $13.9 million ($0.41 diluted loss per share on a loss applicable to common shares of $14.1 million) for the fourth quarter of 2008 compared with a net loss of $9.6 million ($0.28 diluted loss per share on a loss applicable to common shares of $9.7 million) for the fourth quarter of 2007. The Company reported a net loss of $48.6 million ($1.41 diluted loss per share on a loss applicable to common shares of $49.1 million) for the year ended December 31, 2008, compared with a net loss of $32.8 million ($1.08 diluted loss per share on a loss applicable to common shares of $33.3 million) for the year ended December 31, 2007.
Total operating expenses for the quarter ended December 31, 2008, were $13.4 million compared with $10.4 million for the quarter ended December 31, 2007. Total operating expenses were $49.2 million for the year ended December 31, 2008, compared with $35.4 million for the year ended December 31, 2007.
Research and development (R&D) expenses were $10.2 million for the quarter ended December 31, 2008, compared with $7.0 million for the quarter ended December 31, 2007. R&D expenses were $34.7 million for the year ended December 31, 2008, compared with $23.4 million for the year ended December 31, 2007.
General and administrative (G&A) expenses were $3.2 million for the quarter ended December 31, 2008, compared with $3.5 million for the quarter ended December 31, 2007. G&A expenses were $14.4 million for the year ended December 31, 2008, compared with $12.1 million for the year ended December 31, 2007.
Cash and investment securities as of December 31, 2008, were $72.8 million, compared with $92.6 million at December 31, 2007. Taking into account the $17.9 million minimum unrestricted cash that the Company is required to maintain under its loan facility with GE Healthcare Financial Services and Silicon Valley Bank and the Company's projected operating results, the Company believes that its existing cash and investment securities will provide adequate resources to fund the Company's operations at least into the first quarter of 2010. However, given the uncertainties of outcomes of the Company's ongoing clinical trials, there is no assurance that the Company can achieve its projected operating results. Accordingly, the report of the Company's independent registered public accounting firm on the Company's financial statements for the year ended December 31, 2008 expresses substantial doubt about the Company's ability to continue as a going concern.
2009 Goals and Objectives
The Company expects to make the following progress in picoplatin's clinical development and potential commercialization:
Conference Call Details
Poniard's management team will host a live conference call and Web cast today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. To participate by telephone, please dial 877-719-9791 from the U.S. or 719-325-4811 for international callers. The Web cast 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 Web cast 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 to impact the lives of people with cancer. Picoplatin, the Company's lead platform product candidate, is a new generation platinum chemotherapy. To date, clinical studies suggest that picoplatin has an improved safety profile relative to existing platinum-based cancer therapies. Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors, and is being studied in multiple cancer indications, combinations and formulations. Clinical trials of intravenous picoplatin include a Phase 3 trial in small cell lung cancer and Phase 2 trials in metastatic colorectal and castration-resistant (hormone-refractory) prostate cancers. The Company also is conducting a clinical trial of oral picoplatin in solid tumors. For additional information please visit http://www.poniard.com.
This release contains forward-looking statements, including statements regarding the Company's results of operations, liquidity and capital resources, financial prospects, business objectives and strategic goals, drug development plans, timing and results of clinical trials, the potential safety and efficacy of its products in development and commercialization strategy. The Company's actual results may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties associated with the current distressed economic and financial market, Company's research and development activities; the results of pre-clinical and clinical testing; the receipt and timing of FDA and other required regulatory approvals; the market's acceptance of the Company's proposed products; the Company's anticipated operating losses, need for future capital and ability to obtain future funding; competition from third parties; the Company's ability to preserve and protect intellectual property rights; the Company's dependence on third-party manufacturers and suppliers; the Company's lack of sales and marketing experience; the Company's ability to attract and retain key personnel; changes in technology, government regulation and general market conditions; and the risks and uncertainties described in the Company's current and periodic reports filed with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K for the year ended December 31, 2008. 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.
(C) 2009 Poniard Pharmaceuticals, Inc. All Rights Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
CONTACT: Brendan Doherty of Poniard Pharmaceuticals, +1-650-745-4425,
bdoherty@poniard.com; or Rebecca Der of Burns McClellan, +1-212-213-0006,
for Poniard Pharmaceuticals, Inc.
Web site: http://www.poniard.com/
