SOUTH SAN FRANCISCO, Calif., May 6 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today reported on its corporate progress and financial results for the first quarter ended March 31, 2008.
“During the first quarter, we made significant progress in moving our clinical trials forward and generating data to demonstrate the potential of picoplatin as a new generation platinum therapy,” said Jerry McMahon, Ph.D., chairman and CEO of Poniard. “Our pivotal Phase 3 SPEAR trial in small cell lung cancer continues to enroll patients. Today, we are pleased to announce the completion of patient enrollment in our Phase 2 trial in metastatic colorectal cancer. The results of our Phase 1 trials in prostate cancer and colorectal cancer were presented earlier this year. Encouraging bioavailability data has been presented from our ongoing Phase 1 trial of oral picoplatin. We secured commercial manufacture and supply of picoplatin drug substance. A new chief medical officer was appointed to expedite the clinical development of picoplatin through product approval. Our accomplishments this quarter are consistent with the development of picoplatin as a platform product addressing multiple indications, combinations and formulations.”
First Quarter 2008 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 first quarter of 2008 compared to a net loss of $7.7 million ($0.34 diluted loss per share on a loss applicable to common shares of $7.9 million) for the first quarter of 2007.
There was no revenue in either of the first quarters of 2008 or 2007.
Total operating expenses for the first quarter of 2008 increased 33 percent to $10.5 million, from $7.9 million for the first quarter of 2007.
Research and development (R&D) expenses increased 15 percent to $6.3 million for the first quarter of 2008, from $5.5 million for the first quarter of 2007, primarily as the result of 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 74 percent to $4.2 million for the first quarter of 2008, compared with $2.4 million for the first quarter of 2007, primarily due to the recording of stock option expense and increased personnel costs.
Cash and investment securities as of March 31, 2008 was $84.7 million, compared with $92.6 million at December 31, 2007. 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.
During the remainder of 2008, we anticipate further important advancements of our picoplatin clinical development program. We intend to:
Conference Call Details
To participate in today’s live 5 PM ET/2 PM PT call by telephone, please dial 877-440-5791 from the U.S. or +1-719-325-4909 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 of the webcast will be available on the Company’s website for 14 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 therapy with 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 hormone-refractory prostate cancers, as well as a Phase 1 clinical trial of oral picoplatin in solid tumors. Picoplatin has not been approved by any regulatory authority for use in humans. For additional information please visit 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, 2007 and its Quarterly Report on Form 10-Q for the period ended March 31, 2008, which will be filed with the SEC on or about May 8, 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, Inc., +1-650-745-4425, bdoherty@poniard.com
Web site: http://www.poniard.com/
