Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical
company focused on oncology, has reported on its corporate progress and
financial results for the quarter ended June 30, 2007.
"Poniard achieved significant milestones during the last
quarter, including the initiation of our pivotal Phase 3 SPEAR trial of
picoplatin in small cell lung cancer, presentation at ASCO of results
from our Phase 2 trial in small cell lung cancer and our Phase 1
combination trials in first-line colorectal and hormone refractory
prostate cancers, and completion of a $75 million financing," said
Jerry McMahon, Ph.D., chairman and CEO of Poniard. "We continue to
advance our picoplatin clinical development programs and recently began
enrollment in our Phase 2 trial in metastatic hormone-refractory
prostate cancer. We expect to start the Phase 2 component of our trial
in metastatic colorectal cancer later this year."
Second Quarter and Recent Highlights
Picoplatin and Development Pipeline -- Initiated the pivotal Phase
3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin
for the second-line treatment of small cell lung cancer (SCLC) under the
Special Protocol Assessment (SPA) agreement previously reached with the
U.S. Food and Drug Administration. -- Presented new picoplatin clinical
results at the 2007 American Society of Clinical Oncology (ASCO) Annual
Meeting that confirmed and extended the previously announced interim
data analysis from the company's Phase 2 clinical trial, which
demonstrated a survival benefit in patients with recurrent SCLC. --
Announced promising results from interim safety analyses of two Phase 1
dose-escalating trials of picoplatin for the potential first-line
treatment of metastatic colorectal cancer (CRC) and metastatic
hormone-refractory prostate cancer (HRPC). The abstracts were published
in the 2007 ASCO Annual Meeting Proceedings. -- Initiated a Phase 2
clinical trial of intravenous picoplatin in metastatic HRPC. This
multi-center, open-label, single-arm trial of approximately 30 patients
is designed to generate proof-of-concept data demonstrating that
picoplatin has improved efficacy when combined with docetaxel and
prednisone compared to that seen with docetaxel and prednisone alone. --
Initiated a Phase 1 clinical trial of oral picoplatin in solid tumors.
Financing -- Completed a public offering of 11,848,341 shares of
the company's common stock at a purchase price of $6.33 per share,
raising net proceeds of approximately $70 million.
Management/Board Appointments -- Appointed Ronald A. Martell as
president and chief operating officer of the company and Robert S. Basso
to the company's board of directors.
Second Quarter 2007 Unaudited Financial Results
The company reported a net loss of $8.5 million ($0.28 diluted loss
per share on a loss applicable to common shares of $8.7 million) for the
second quarter of 2007, compared to a net loss of $6.5 million ($0.37
diluted loss per share on a loss applicable to common shares of $6.6
million) for the same period in 2006. The company reported a net loss of
$16.3 million ($0.62 diluted loss per share on a loss applicable to
common shares of $16.5 million) for the six months ended June 30, 2007,
compared to a net loss of $12.3 million ($1.06 diluted loss per share on
a loss applicable to common shares of $12.5 million) for the six months
ended June 30, 2006. There was no revenue for the three and six months
ended June 30, 2007 and 2006.
Total operating expenses for the second quarter of 2007 increased
76 percent to $9.2 million, from $5.2 million for the second quarter of
2006 and increased 86 percent to $17.1 million for the six months ended
June 30, 2007, from $9.2 million for the same period in 2006.
Research and development (R&D) expenses increased 79 percent to
$5.8 million for the second quarter of 2007, from $3.2 million for the
second quarter of 2006 and increased 96 percent to $11.3 million for the
six months ended June 30, 2007, from $5.8 million for the same period in
2006. The increase in R&D expenses for both the quarter and six
months ended June 30, 2007, resulted primarily from increased clinical
costs associated with our Phase 3 small cell lung cancer picoplatin
trial, our Phase 1 oral formulation picoplatin trial and from increased
costs of picoplatin active ingredient and finished drug product in
support of all of our clinical programs.
General and administrative (G&A) expenses increased 69 percent
to $3.4 million for the second quarter of 2007, compared with $2.0
million for the second quarter of 2006, and increased 64 percent to $5.8
million for the six months ended June 30, 2007, from $3.5 million for
the same period in 2006. The increase in G&A costs for the quarter
and six months ended June 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 June 30, 2007, were $103.2
million, compared with $53.7 million at June 30, 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.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the discovery, development and commercialization of
innovative oncology products to impact the lives of people with cancer.
Picoplatin, the company's lead 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. Intravenous picoplatin is currently being
studied in clinical trials for the treatment of small cell lung,
colorectal and hormone-refractory prostate cancer, and oral picoplatin
is in a clinical trial in solid tumors. As part of the company's
strategic goal of building a diverse oncology pipeline, the company is
collaborating with The Scripps Research Institute on the discovery of
novel, small-molecule, multi-targeted protein kinase inhibitors.
For more information, visit http://www.poniard.com or call
206/286-2517.
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