Poniard Pharmaceuticals Reports First Quarter 2009 Financial Results and Provides a Corporate Update
- Conference Call Today at
“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
Partnering Strategy
“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
Recent Clinical and Corporate Developments
- Small Cell Lung Cancer
- In March, Poniard reached its enrollment target and a total of 401 patients were enrolled in the SPEAR (Study of Picoplatin Efficacy After Relapse) trial. The global, pivotal Phase 3 SPEAR trial is evaluating the efficacy and safety of picoplatin in patients with refractory or progressive small cell lung cancer (SCLC) who have failed prior platinum-containing first-line chemotherapy regiments or who have progressed within six months of first-line therapy. Patients were enrolled at more than 100 clinical trial sites in 16 countries in
Europe ,South America andAsia . - In May, the Company announced that the independent Data Monitoring Committee, after review of available information regarding the efficacy, safety and quality of trial conduct, recommends that the SPEAR trial continue.
- In March, Poniard reached its enrollment target and a total of 401 patients were enrolled in the SPEAR (Study of Picoplatin Efficacy After Relapse) trial. The global, pivotal Phase 3 SPEAR trial is evaluating the efficacy and safety of picoplatin in patients with refractory or progressive small cell lung cancer (SCLC) who have failed prior platinum-containing first-line chemotherapy regiments or who have progressed within six months of first-line therapy. Patients were enrolled at more than 100 clinical trial sites in 16 countries in
- Colorectal Cancer
- In April, final data from a Phase 1 dose-escalation study of picoplatin in patients with metastatic colorectal cancer (CRC) was presented at the American Association for Cancer Research’s (AACR) 100th Annual Meeting 2009. Results demonstrated that picoplatin can be safely administered in combination with 5-fluorouracil and leucovorin in the FOLPI regimen as a first-line treatment for CRC. Based on the clinical activity and promising safety data observed in the Phase 1 study, Poniard initiated a randomized, controlled, proof-of-concept Phase 2 trial in
November 2007 to evaluate picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC. Patient enrollment was completed inMay 2008 .
- In April, final data from a Phase 1 dose-escalation study of picoplatin in patients with metastatic colorectal cancer (CRC) was presented at the American Association for Cancer Research’s (AACR) 100th Annual Meeting 2009. Results demonstrated that picoplatin can be safely administered in combination with 5-fluorouracil and leucovorin in the FOLPI regimen as a first-line treatment for CRC. Based on the clinical activity and promising safety data observed in the Phase 1 study, Poniard initiated a randomized, controlled, proof-of-concept Phase 2 trial in
- Oral Picoplatin
- In April, final data from a Phase 1 clinical study of an oral formulation of picoplatin in patients with solid tumors was also presented at the AACR Annual Meeting. Results showed that the bioavailability of oral picoplatin is nearly 100 percent at doses of 50 mg and 100 mg, indicating sufficient bioavailability to support further clinical development of this formulation.
- Strategic Focus of Cash Resources
- In March, Poniard announced that it would concentrate its cash resources on the clinical and commercial development of picoplatin. As a result, on
March 31, 2009 , the Company discontinued its in-house preclinical research operations and reduced its workforce by approximately 12 percent, or eight employees. The Company continues to evaluate strategic alternatives for its preclinical research programs and related assets.
- In March, Poniard announced that it would concentrate its cash resources on the clinical and commercial development of picoplatin. As a result, on
First Quarter 2009 Unaudited Financial Results
The Company reported a net loss of
Total operating expenses for the quarter ended
Research and development expenses were
General and administrative expenses were
Cash and investment securities as of
Goals and Objectives
During the remainder of 2009 Poniard expects to:
- Present progression-free survival data and safety data from two ongoing Phase 2 trials of picoplatin as first-line treatment for metastatic colorectal and castration-resistant prostate cancers (CRPC) at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO); the Company plans to hold an investor event featuring oncology experts at ASCO on
Sunday, May 31 ; - Report top-line results from the pivotal Phase 3 SPEAR trial in SCLC in the second half 2009; and
- Initiate submission of a New Drug Application with the U.S. Food and Drug Administration for picoplatin as a second-line treatment for SCLC, targeting approval and commercialization in 2010.
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.
About Picoplatin
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
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
(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,
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2009 2008
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Revenues $- $-
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Operating expenses:
Research and development 8,104 6,336
General and administrative 3,084 4,183
Restructuring & asset impairment 1,056 -
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Total operating expenses 12,244 10,519
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Loss from operations (12,244) (10,519)
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Other income (expense), net (706) 664
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Net loss (12,950) (9,855)
Preferred stock dividends (125) (125)
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Loss applicable to common shares $(13,075) $(9,980)
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Loss per share:
Basic and diluted $(0.38) $(0.29)
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Shares used in calculation of loss per share:
Basic and diluted 34,688 34,681
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Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
March 31, 2009 December 31, 2008
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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
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Total assets $70,118 $84,232
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LIABILITIES AND SHAREHOLDERS' EQUITY:
Current liabilities $19,170 $19,178
Long term liabilities 15,128 17,407
Shareholders' equity 35,820 47,647
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Total liabilities and shareholders'
equity $70,118 $84,232
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SOURCE Poniard Pharmaceuticals, Inc.