- Conference Call Today at 5:00 p.m. Eastern Time - SOUTH SAN
FRANCISCO, Calif., Nov. 3 /PRNewswire-FirstCall/ -- Poniard
Pharmaceuticals, Inc. (NASDAQ:PARD), a biopharmaceutical company
focused on oncology, today reported financial results for the third
quarter ended September 30, 2009, and provided a corporate update.
"During the third quarter, we reached the 320th event target in our
pivotal Phase 3 SPEAR trial, which is evaluating picoplatin for the
treatment of small cell lung cancer. This event allowed us to
collect the data for overall survival analysis," said Jerry
McMahon, Ph.D., chairman and chief executive officer of Poniard.
"We expect to report top-line results from the SPEAR registration
trial this month and plan to present the data at international
medical conferences next year. If the top-line results are
positive, we plan to initiate a rolling submission of a New Drug
Application with the U.S. Food and Drug Administration by year-end,
targeting approval and commercial launch of picoplatin in 2010."
Recent Clinical and Corporate Developments Picoplatin Clinical
Update -- Announced in September that 320 evaluable events (patient
deaths) occurred in the pivotal Phase 3 SPEAR (Study of Picoplatin
Efficacy After Relapse) trial, evaluating picoplatin in the
treatment of small cell lung cancer (SCLC). The 320th event in the
registration SPEAR trial was defined in the Special Protocol
Assessment with the U.S. Food and Drug Administration (FDA), which
allowed the Company to collect the data for overall survival
analysis, which is the primary endpoint of the trial. This
randomized trial is comparing picoplatin with best supportive care
to best supportive care alone without systemic chemotherapy.
Corporate Update -- Secured a committed equity financing facility
in August under which Poniard may, over an 18-month period, sell up
to $60 million newly issued registered common stock to Azimuth
Opportunity Ltd. at a pre-negotiated discount to market price. The
Company will determine, at its sole discretion, the timing and
amount of any sales of its common stock, subject to certain
conditions. The Company is not obligated to utilize any of the $60
million facility and remains free to enter into other financing
transactions. Third Quarter 2009 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 quarter ended September 30, 2009, compared with a net loss of
$12.2 million ($0.36 diluted loss per share on a loss applicable to
common shares of $12.4 million) for the quarter ended September 30,
2008. The Company reported a net loss of $32.5 million ($0.95
diluted loss per share on a loss applicable to common shares of
$32.9 million) for the nine months ended September 30, 2009,
compared with a net loss of $34.6 million ($1.01 diluted loss per
share on a loss applicable to common shares of $35.0 million) for
the same period in 2008. Total operating expenses for the quarter
ended September 30, 2009, were $9.2 million compared with $12.4
million for the quarter ended September 30, 2008, and were $30.5
million for the nine months ended September 30, 2009, compared with
$35.8 million for the same period in 2008. Total operating expenses
for the nine months ended September 30, 2009, include a charge of
$1.1 million for the restructuring and related asset impairment
resulting from the Company's implementation of a 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
$5.4 million for the quarter ended September 30, 2009, compared
with $9.0 million for the quarter ended September 30, 2008.
Research and development expenses were $19.2 million for the nine
months ended September 30, 2009, compared with $24.5 million for
the same period in 2008. General and administrative expenses were
$3.8 million for the quarter ended September 30, 2009, compared
with $3.4 million for the quarter ended September 30, 2008. General
and administrative expenses were $10.3 million for the nine months
ended September 30, 2009, compared with $11.3 million for the same
period in 2008. Cash and investment securities as of September 30,
2009, were $40.1 million, compared with $72.8 million at December
31, 2008. The Company believes that its existing cash and
investment securities will provide adequate resources to fund the
Company's operations at least into the first quarter of 2010. Goals
and Objectives -- Report top-line results from the pivotal Phase 3
SPEAR trial in SCLC in November; -- Initiate submission of a
rolling NDA with the FDA for picoplatin as a treatment for
refractory or recurrent SCLC in 2009, targeting NDA approval and
commercialization in 2010; -- Continue to explore a potential
development and commercialization partnership for picoplatin to
maximize shareholder value; -- Present updated data from the Phase
2 trial in colorectal cancer and the final Phase 1 cardiac safety
trial results at the AACR - NCI - EORTC Symposium being held in
Boston, November 15-19; and -- Present data from the pivotal Phase
3 SPEAR trial in SCLC at international medical conferences next
year. 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 888-349-9587 from the U.S. or 719-457-2631 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/. Forward-Looking Statement
This release contains forward-looking statements, including
statements regarding the Company's financial position and results
of operations, business objectives and drug development plans; the
timing of the Company's announcement of top-line results of its
Phase 3 SPEAR trial and the initiation of submission of a rolling
NDA if the results are positive; the potential safety and efficacy
of the Company's picoplatin products in development; and the
Company's capital raising, commercialization and partnering goals
and strategies. 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 clinical testing, including the risk that the FDA may not
approve picoplatin for use in the treatment of SCLC; if regulatory
approval is received, the market's acceptance of picoplatin in the
treatment of SCLC or the occurrence of post-approval problems that
may require the withdrawal of picoplatin from the market; 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 and enter
into strategic collaborations on favorable terms; 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 September 30, 2009, which will be
filed with the SEC on or about November 6, 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 Nine Months
Ended September 30, September 30, ---------------
------------------- 2009 2008 2009 2008 ---- ---- ---- ----
Operating expenses: Research and development 5,396 9,024 19,153
24,511 General and administrative 3,802 3,383 10,321 11,289
Restructuring & asset impairment - - 1,056 - ----- ------
------ ------ Total operating expenses 9,198 12,407 30,530 35,800
----- ------ ------ ------ Loss from operations (9,198) (12,407)
(30,530) (35,800) ------ ------- ------- ------- Other income
(expense), net (679) 170 (2,017) 1,177 ---- --- ------ ----- Net
loss (9,877) (12,237) (32,547) (34,623) Preferred stock dividends
(125) (125) (375) (375) ---- ---- ---- ---- Loss applicable to
common shares $(10,002) $(12,362) $(32,922) $(34,998) ========
======== ======== ======== Loss per share: Basic and diluted
$(0.29) $(0.36) $(0.95) $(1.01) ====== ====== ====== ====== Shares
used in calculation of loss per share: Basic and diluted 34,769
34,688 34,723 34,685 ====== ====== ====== ====== Condensed
Consolidated Balance Sheets (In thousands) September 30, December
31, 2009 2008 -------------- ------------- (Unaudited) (Note 1)
ASSETS: Cash and investment securities $40,114 $72,755 Cash -
restricted 281 281 Facilities and equipment, net 277 1,123 Licensed
products, net 7,896 8,807 Other assets 1,072 1,266 ----- -----
Total assets $49,640 $84,232 ======= ======= LIABILITIES AND
SHAREHOLDERS' EQUITY: Current liabilities $17,574 $19,178 Long term
liabilities 11,848 17,407 Shareholders' equity 20,218 47,647 ------
------ Total liabilities and shareholders' equity $49,640 $84,232
======= ======= Note 1: Derived from audited financial statements
included in the Company's Annual Report on Form 10-K for the year
ended December 31, 2008. DATASOURCE: Poniard Pharmaceuticals, Inc.
CONTACT: Susan Neath (Investors), Burns McClellan, +1-212-213-0006,
; or Jani Bergan (Media), WeissComm Partners, +1-415-946-1064, Web
Site: http://www.poniard.com/
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