SOUTH SAN FRANCISCO, Calif., Feb. 28 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today reported on its corporate progress and financial results for the fourth quarter and year ended December 31, 2007.
“Our 2007 fourth quarter accomplishments capped a productive year in which we made significant advancements in all aspects of our clinical development program for picoplatin, our lead product candidate,” said Jerry McMahon, Ph.D., chairman and CEO of Poniard. “We initiated a Phase 2 trial in metastatic colorectal cancer and completed patient enrollment in a Phase 2 trial in hormone-refractory prostate cancer -- two solid tumor malignancies for which there is significant medical need. We also continued to advance our pivotal SPEAR trial in small cell lung cancer and believe that we will have top-line data from this trial in mid-2009. Our progress and continued focus demonstrate our dedication to developing picoplatin as a new generation chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations.”
2007 Financial Results
The Company reported 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 compared to a net loss of $6.1 million ($0.27 diluted loss per share on a loss applicable to common shares of $6.2 million) for the same period in 2006. Net loss for the year ended December 31, 2007 was $32.8 million ($1.08 diluted loss per share on a loss applicable to common shares of $33.3 million) compared to a net loss of $23.3 million ($1.37 diluted loss per share on a loss applicable to common shares of $23.8 million) for the year ended December 31, 2006.
There was no revenue for the quarter and year ended December 31, 2007, nor was there revenue for the quarter and year ended December 31, 2006.
Total operating expenses for the fourth quarter of 2007 increased 61 percent to $10.4 million, from $6.5 million for the fourth quarter of 2006, due primarily to higher clinical costs associated with the Company’s picoplatin trials and the recognition of stock option expense. Total operating expenses increased 66 percent to $35.4 million for the year ended December 31, 2007, from $21.2 million for the same period in 2006.
Research and development (R&D) expenses increased 66 percent to $7.0 million for the fourth quarter of 2007, from $4.2 million for the fourth quarter of 2006, and increased 75 percent to $23.4 million for the year ended December 31, 2007, from $13.4 million for the same period in 2006. The increase in R&D expenses for the quarter and year ended December 31, 2007 resulted from higher clinical costs associated with the Company’s picoplatin trials and increased costs for other R&D efforts.
General and administrative (G&A) expenses increased 90 percent to $3.5 million for the fourth quarter of 2007, compared with $1.8 million for the fourth quarter of 2006 and increased 60 percent to $12.1 million for the year ended December 31, 2007, from $7.5 million for the same period in 2006. The increases in G&A costs for the quarter and year ended December 31, 2007 are primarily due to the recording of stock options expense and increased personnel costs.
Cash and investment securities as of December 31, 2007 was $92.6 million, compared with $53.7 million at December 31, 2006. Management currently believes the existing cash and investment securities will provide adequate resources to fund the Company’s operations at least through the second quarter of 2009.
Based on updated analysis and projections of the timelines for the Phase 3 SPEAR trial for SCLC, the Company currently expects that top-line data from this trial will be available in mid-2009.
Conference Call Details
To participate in today’s live call by telephone, please dial 877-604-9669 from the U.S. or +1-719-325-4913 for international callers. In addition, the live conference call is being webcast and can be accessed on the “Events” page of the “News & Events” section of the Company’s website at http://www.poniard.com. A replay will also be available online for 14 days following the live presentation.
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 therapy with an improved safety profile relative to existing platinum-based cancer therapies. Picoplatin is designed to overcome and prevent 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 hormone-refractory prostate cancer, as well as a clinical trial of oral picoplatin in solid tumors. Picoplatin has not been approved by regulatory authority for use in humans. For additional information please visit http:/www.poniard.com.
This release contains forward-looking statements, including statements regarding the Company’s financial condition and results of operations, business objectives and strategic goals, drug development plans, timing and results of clinical trials and the potential safety and efficacy of its products in development. 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 Company’s research and development activities; the results of pre-clinical and clinical testing; the receipt and timing of 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, 2006, as amended, and most current Quarterly Report on Form 10-Q, as well as the Company’s Annual Report on Form 10-K for the year ended December 31, 2007, which will be filed with the SEC on or before March 17, 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) 2008 Poniard Pharmaceuticals, Inc. All Rights Reserved. Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
CONTACT: Brendan Doherty, Corporate Communications of Poniard
Pharmaceuticals, +1-650-745-4425, bdoherty@poniard.com
Web site: http://www.poniard.com/
