- Conference Call Today at 5:00 p.m. Eastern Time -
SOUTH SAN FRANCISCO, Calif., May 5 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today reported financial results for the first quarter ended March 31, 2009, and provided a corporate update.
"The completion of enrollment of our pivotal Phase 3 SPEAR trial of picoplatin for the second-line treatment of small cell lung cancer, along with the independent Data Monitoring Committee's support of the continuation of SPEAR, are significant accomplishments that bring us closer to our goal of building a U.S.-based oncology business," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "Upon positive SPEAR data, we plan to initiate a rolling New Drug Application to the U.S. Food and Drug Administration this year."
"Given the Phase 2 proof-of-concept data in our colorectal and prostate cancer clinical trials that will be presented at the American Society of Clinical Oncology Annual Meeting, and the completion of patient enrollment of the Phase 3 SPEAR trial, we are now in a position to formalize our strategic partnering process," said Ronald Martell, president and chief operating officer of Poniard. "We are seeking a global partner that shares our vision that picoplatin represents a pipeline in a product. Such partner would provide Poniard co-development and co-promotion rights in the U.S. and would commit to follow-on development of picoplatin to support its broad worldwide market potential for multiple indications beyond small cell lung cancer."
Recent Clinical and Corporate Developments
First Quarter 2009 Unaudited Financial Results
The Company reported 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 compared with 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 quarter ended March 31, 2008.
Total operating expenses for the quarter ended March 31, 2009, were $12.2 million compared with $10.5 million for the quarter ended March 31, 2008. Total operating expenses for the first quarter of 2009 include a charge of $1.1 million for the restructuring and related asset impairment resulting from the Company's strategic restructuring plan to discontinue its in-house preclinical research operations and reduce its workforce by approximately 12 percent effective March 31, 2009.
Research and development expenses were $8.1 million for the quarter ended March 31, 2009, compared with $6.3 million for the quarter ended March 31, 2008.
General and administrative expenses were $3.1 million for the quarter ended March 31, 2009, compared with $4.2 million for the quarter ended March 31, 2008.
Cash and investment securities as of March 31, 2009, were $59.6 million, compared with $72.8 million at December 31, 2008. Management currently believes the existing cash and investment securities will provide adequate resources to fund the Company's operations into the first quarter of 2010.
Goals and Objectives
During the remainder of 2009 Poniard expects to:
About Small Cell Lung Cancer
SCLC is the most aggressive form of lung cancer and tends to be widespread by the time of diagnosis. According to the American Cancer Society, in the U.S. in 2008 an estimated 32,000 new cases of SCLC were expected to be diagnosed and 52,000 SCLC patients were treated with therapy (American Cancer Society, Cancer Facts and Figures 2009). Patients with SCLC have few treatment options and a poor prognosis. Effective second-line treatment for SCLC is a major unmet medical need.
About Colorectal Cancer
CRC is the third most common cancer in both American men and women, and the third leading cause of cancer death in the U.S. In 2008, an estimated 148,810 new cases of colon and rectal cancer were expected to be diagnosed in the U.S., with an estimated 49,960 deaths (American Cancer Society, Cancer Facts and Figures 2009). The current standard of care is associated with significant side effects including neuropathy, which can limit its use and result in its discontinuation. Effective first-line, neuropathy sparing treatment for CRC is a major unmet medical need.
About Prostate Cancer
More than 1 million American men are currently living with prostate cancer and it is the second leading cause of death among men in the U.S. In 2008, an estimated 186,320 new cases of prostate cancer were expected to be diagnosed in the U.S., with an estimated 28,660 deaths (American Cancer Society, Cancer Facts and Figures 2009). CRPC is prostate cancer that continues to grow despite current standard of care hormonal (anti-androgen) therapies. CRPC is more invasive and more likely to spread to other organs than androgen dependent prostate cancers. Patients with CRPC have few treatment options and a poor prognosis.
Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Study data to date suggest that it has an improved safety profile relative to existing platinum-based cancer therapies. More than 1,100 patients have received picoplatin. Results obtained to date suggest manageable hematologic adverse events with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy drugs. Picoplatin has demonstrated anti-tumor activity in a variety of solid tumors. It is being studied in multiple cancer indications, treatment combinations and by two routes of administration.
Conference Call Details
Poniard's management team will host a live conference call and Webcast today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. To participate by telephone, please dial 877-741-4240 from the U.S. or 719-325-4751 for international callers. The Webcast 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 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 and commercialization strategy, the timing and results of clinical trials and the potential safety and efficacy of the Company's 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 current distressed economic and financial market; the Company's research and development activities; the results of preclinical 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 and its Quarterly Report on Form 10-Q for the period ended March 31, 2009, which will be filed with the SEC on or about May 11, 2009. 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.
Poniard Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (In thousands, except per share data) (Unaudited) Three Months Ended March 31, ------------- 2009 2008 ---- ---- Revenues $- $- -- -- Operating expenses: Research and development 8,104 6,336 General and administrative 3,084 4,183 Restructuring & asset impairment 1,056 - ----- - Total operating expenses 12,244 10,519 ------ ------ Loss from operations (12,244) (10,519) ------- ------- Other income (expense), net (706) 664 ---- --- Net loss (12,950) (9,855) Preferred stock dividends (125) (125) ---- ---- Loss applicable to common shares $(13,075) $(9,980) ======== ======= Loss per share: Basic and diluted $(0.38) $(0.29) ====== ====== Shares used in calculation of loss per share: Basic and diluted 34,688 34,681 ====== ====== Condensed Consolidated Balance Sheets (In thousands) (Unaudited) March 31, 2009 December 31, 2008 -------------- ----------------- ASSETS: Cash and investment securities $59,636 $72,755 Cash - restricted 281 281 Facilities and equipment, net 387 1,123 Licensed products, net 8,503 8,807 Other assets 1,311 1,266 ----- ----- Total assets $70,118 $84,232 ======= ======= LIABILITIES AND SHAREHOLDERS' EQUITY: Current liabilities $19,170 $19,178 Long term liabilities 15,128 17,407 Shareholders' equity 35,820 47,647 ------ ------ Total liabilities and shareholders' equity $70,118 $84,232 ======= =======
|SOURCE Poniard Pharmaceuticals, Inc.|
Copyright©2009 PR Newswire.
All rights reserved