SOUTH SAN FRANCISCO, Calif., Nov. 1 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today reported on its corporate progress and financial results for the quarter ended September 30, 2007. The Company will host a conference call today at 5:00 p.m. Eastern time to provide a corporate update.
“Over the last several months, Poniard has continued to execute on its strategy of developing picoplatin as a platform product and studying it in multiple indications, combinations and formulations. We have achieved several significant clinical milestones in our picoplatin development program with the initiation of our pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial in small cell lung cancer under a Special Protocol Assessment and the initiation of two Phase 2 trials -- in metastatic colorectal and hormone-refractory prostate cancer,” said Jerry McMahon, Ph.D., chairman and CEO of Poniard. “We also achieved two regulatory milestones with the receipt of fast track designation in the U.S. and a positive recommendation for orphan medicinal product designation in the E.U. for picoplatin for the treatment of small cell lung cancer. We have made important progress in getting a majority of our clinical sites up and running for the SPEAR trial. Our Phase 1 trial of oral picoplatin is progressing and we anticipate announcing initial results this quarter.”
Third Quarter 2007 Unaudited Financial Results
The Company reported a net loss of $7.0 million ($0.20 diluted loss per share on a loss applicable to common shares of $7.1 million) for the third quarter of 2007, compared to a net loss of $4.9 million ($0.22 diluted loss per share on a loss applicable to common shares of $5.0 million) for the same period in 2006. The Company reported a net loss of $23.2 million ($0.80 diluted loss per share on a loss applicable to common shares of $23.6 million) for the nine months ended September 30, 2007, compared to a net loss of $17.2 million ($1.13 diluted loss per share on a loss applicable to common shares of $17.5 million) for the nine months ended September 30, 2006. There was no revenue for the three and nine months ended September 30, 2007 and 2006.
Total operating expenses for the third quarter of 2007 increased 41 percent to $7.9 million, from $5.6 million for the third quarter of 2006 and increased 69 percent to $24.9 million for the nine months ended September 30, 2007, from $14.8 million for the same period in 2006.
Research and development (R&D) expenses increased 50 percent to $5.1 million for the third quarter of 2007, from $3.4 million for the third quarter of 2006 and increased 79 percent to $16.3 million for the nine months ended September 30, 2007, from $9.1 million for the same period in 2006. The increase in R&D expenses for both the quarter and nine months ended September 30, 2007, resulted primarily from increased clinical costs associated with the Phase 3 trial of picoplatin in SCLC, the Phase 1 trial of the oral formulation of picoplatin, and increased costs of picoplatin active ingredient and finished drug product in support of all of the Company’s clinical programs.
General and administrative (G&A) expenses increased 28 percent to $2.8 million for the third quarter of 2007, compared with $2.2 million for the third quarter of 2006, and increased 51 percent to $8.6 million for the nine months ended September 30, 2007, from $5.7 million for the same period in 2006. The increase in G&A costs for the quarter and nine months ended September 30, 2007, was due primarily to increased stock-based compensation expense, increased personnel costs and increased G&A portion of shared facilities expense.
Cash and investment securities as of September 30, 2007, were $97.1 million, compared with $53.7 million at December 31, 2006. Management believes that existing cash and investment securities will provide adequate resources to fund the Company’s operations at least through the second quarter of 2009.
Conference Call Details
To participate in the live call by telephone, please dial 877-419-6600 from the U.S. or 1-719-325-4873 internationally. 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 seven 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. 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. For additional information please visit http://www.poniard.com.
This release contains forward-looking statements, including statements regarding the Company’s operations and financial condition, business objectives and strategic goals, drug development plans, and the 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, 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. 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.
CONTACT: Brendan Doherty of Poniard Pharmaceuticals Corporate
Communications, +1-650-745-4425, bdoherty@poniard.com
Web site: http://www.poniard.com/
