Poniard Pharmaceuticals Reports Second Quarter 2008 Financial Results and Corporate...

Poniard Pharmaceuticals Reports Second Quarter 2008 Financial Results and
Corporate Update
- Conference Call Today at 5:00 p.m. Eastern Time -

SOUTH SAN FRANCISCO, Calif., July 31 /PRNewswire-FirstCall/ -- Poniard
Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on
oncology, today reported on its corporate progress and financial results for
the second quarter ended June 30, 2008.
"Our strategy and focus are to develop picoplatin as an oncology platform
compound addressing multiple indications, combinations and formulations. Our
accomplishments during the second quarter are consistent with this objective,"
said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "We are on track to
commercialize picoplatin for the treatment of small cell lung cancer (SCLC) in
2010. We presented data at the American Society of Clinical Oncology (ASCO)
Annual Meeting in June, illustrating the platform potential of picoplatin in
multiple solid tumor indications, including metastatic colorectal cancer
(CRC), hormone refractory prostate cancer (HRPC) and ovarian cancer. Data
from these trials could support future trials and may be of significant
interest to potential partners. We are building a comprehensive strategy to
direct our clinical development plan for further development of picoplatin in
a wide range of tumor types."
Second Quarter and Recent Highlights

Picoplatin Clinical Development Program

-- Small Cell Lung Cancer: Presented final data in April from our Phase 2
trial of picoplatin in SCLC at the International Association for the Study of
Lung Cancer and the European Society for Medical Oncology's 1st European Lung
Cancer Conference. Final efficacy results confirmed previously announced
interim results showing median overall survival in the picoplatin Phase 2
trial was 27 weeks for platinum-refractory and -resistant SCLC patients, a
population for which there are very few treatment options.
-- Colorectal Cancer: Completed enrollment in our randomized, controlled
Phase 2 trial in patients with CRC and presented positive preliminary results
from this study at ASCO. Preliminary data suggested that picoplatin given
once every four weeks in combination with 5-fluorouracil and leucovorin in the
FOLPI regimen may have similar anti-tumor activity to oxaliplatin in
combination with 5-fluorouracil and leucovorin in the FOLFOX regimen, which is
the current standard of care in the first-line treatment of CRC.
We also presented expanded and updated results from our Phase 1
dose-escalation study in patients with CRC treated with FOLPI treatment
administered every two or four weeks. None of the patients treated with
picoplatin at doses of up to a cumulative dose of 1,350 mg/m2 exhibited severe
neuropathy (Grade 3 or 4) in 62 evaluable patients. Current use of FOLFOX in
CRC patients is associated with substantial neurotoxicity related to
increasing cumulative doses of oxaliplatin at greater than 800 mg/m2. In
addition, nephrotoxicities and ototoxicities were rare and mild with the FOLPI
regimen.
-- Prostate Cancer: Presented preliminary safety and efficacy at ASCO data
from our ongoing Phase 2 clinical trial of picoplatin in combination with
docetaxel and prednisone, the standard of care for the first-line treatment of
HRPC. Results to date demonstrated that picoplatin can be safely administered
at full-dose docetaxel. Prostate specific antigen levels, or PSA normalized
in 23 percent of patients. The data also demonstrated that reductions in PSA
of at least 50 percent were achieved in 69 percent of evaluable patients.
This compares favorably to published docetaxel treatment PSA response rates of
approximately 45 percent.
-- Ovarian and Other Advanced Solid Tumors: Announced positive safety and
efficacy data at ASCO from a Phase 1 clinical trial of picoplatin combined
with liposomal doxorubicin in patients with advanced solid tumors, including
ovarian cancer. Results demonstrated robust signals of clinical efficacy in
ovarian cancer patients and acceptable toxicity with this combination.
-- Oral Picoplatin: Presented results at the Annual Meeting of the
American Association for Cancer Research (AACR) in April, from our ongoing
Phase 1 clinical trial of oral picoplatin in patients with advanced solid
tumors. Data from this trial showed that picoplatin can achieve oral
bioavailability at levels that support further clinical development of this
dosage form.
-- Platinum Resistance: Announced at the AACR Annual Meeting expanded
preclinical data indicating that picoplatin retained its anti-tumor activity
in SCLC cells resistant to previous treatment with cisplatin, carboplatin or
oxaliplatin. These data support the property of picoplatin to overcome
platinum resistance induced by currently available platinum agents.
In additional, we announced in April an agreement with AltheaDx to use its
Express Pathway platform to identify molecular signatures that may be
correlated with platinum resistance. The identification of molecular
signatures of platinum resistance may lead to the development of biomarkers
for platinum resistance.
Pipeline Development
-- Executed an agreement with The Scripps Research Institute licensing
classes of protein kinase inhibitors for the treatment of human diseases,
including cancer. The research collaboration was initiated in 2005 at Scripps
Florida, a division of the Institute located in Palm Beach County, and later
broadened to include The Scripps Research Institute, La Jolla, Calif. The
license includes compounds that were discovered by Scripps Research in
collaboration with Poniard.
Clinical Advisory Board
-- Appointed four additional members to the Clinical Advisory Board to
help guide the expanding clinical development strategy for picoplatin,
including Howard A. Burris, III, M.D., of The Sarah Cannon Research Institute
in Nashville; E. David Crawford, M.D., of the University of Colorado
Comprehensive Cancer Center; Robert F. Ozols, M.D., Ph.D., of the Fox Chase
Cancer Center in Philadelphia; and Everett E. Vokes, M.D., of the University
of Chicago Pritzker School of Medicine.
Management Appointment
-- Appointed Janet R. Rea, MSPH, RAC, as vice president, regulatory
affairs and quality, to execute regulatory and quality activities with the FDA
and other regulatory authorities in support of our targeted commercial launch
of picoplatin.
Second Quarter 2008 Unaudited Financial Results
The Company reported a net loss of $12.5 million ($0.36 diluted loss per
share on a loss applicable to common shares of $12.7 million) for the second
quarter of 2008 compared to 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.
There was no revenue in either of the second quarters of 2008 or 2007.
Total operating expenses for the second quarter of 2008 increased 40
percent to $12.9 million, from $9.2 million for the second quarter of 2007,
and increased 37 percent to $23.4 million for the six months ended June 30,
2008, from $17.1 million for the same period in 2007.
Research and development (R&D) expenses increased 57 percent to $9.2
million for the second quarter of 2008, from $5.8 million for the second
quarter of 2007. R&D expenses increased 37 percent to $15.5 million for the
six months ended June 30, 2008, from $11.3 million for the same period in
2007. The increase in R&D expenses for the three and six months ended June 30,
2008 resulted primarily from increased costs associated with our picoplatin
trials and pre-clinical programs.
General and administrative (G&A) expenses increased 10 percent to $3.7
million for the second quarter of 2008, from $3.4 million for the second
quarter of 2007. G&A expenses increased 37 percent to $7.9 million for the
six months ended June 30, 2008, from $5.8 million for the same period in 2007.
The increases in G&A expenses for the three months ended June 30, 2008 are due
primarily to higher personnel costs and increased costs for the use of
consultants. The increases in G&A expenses for the six months ended June 30,
2008 are due primarily to higher stock-based compensation expense and
increased personnel costs.
Cash and investment securities as of June 30, 2008 were $75.1 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.
2008 Goals and Objectives
During the remainder of 2008, we anticipate further important advancements
in our picoplatin clinical development program. We intend to:
-- Continue enrolling our pivotal Phase 3 SPEAR (Study of Picoplatin
Efficacy After Relapse) trial in SCLC and advance it towards our commercial
launch, targeted in 2010. This registrational trial of intravenous picoplatin
is comparing picoplatin with best supportive care to best supportive care
alone and is evaluating overall survival as the primary endpoint. It is being
conducted under a Special Protocol Assessment from the U.S. Food and Drug
Administration in SCLC patients who are refractory or resistant to platinum-
based therapy;
-- Present emerging Phase 2 clinical data from both our CRC and HRPC
trials at scientific meetings;
-- Present additional data from our Phase 1 oral picoplatin study at
scientific conferences; and
-- Evaluate opportunities to expand picoplatin development in additional
tumor types, settings and combinations and prepare picoplatin for
commercialization.
Conference Call Details
To participate in today's live 5 PM ET/2 PM PT call by telephone, please
dial 877-419-6591 from the U.S. or +1-719-325-4901 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 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 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 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 http://www.poniard.com.

Poniard Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
(Unaudited)

Three Months Ended Six Months Ended
June 30, June 30,
2008 2007 2008 2007

Revenues $- $- $- $-
Operating expenses:
Research and development 9,151 5,812 15,487 11,312
General and administrative 3,723 3,378 7,906 5,778
Total operating expenses 12,874 9,190 23,393 17,090
Loss from operations (12,874) (9,190) (23,393) (17,090)
Other income (expense), net 343 662 1,007 833
Net loss (12,531) (8,528) (22,386) (16,257)
Preferred stock dividends (125) (125) (250) (250)
Loss applicable to common shares $(12,656) $(8,653) $(22,636) $(16,507)
Loss per share:
Basic and diluted $(0.36) $(0.28) $(0.65) $(0.62)
Shares used in calculation of loss
per share:
Basic and diluted 34,688 30,751 34,684 26,801

Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)

June 30, December 31,
2008 2007
ASSETS:
Cash and investment securities $75,106 $92,621
Cash - restricted 281 281
Facilities and equipment, net 1,150 1,121
Licensed products, net 9,414 10,021
Other assets 1,528 1,096
Total assets $87,479 $105,140

LIABILITIES AND SHAREHOLDERS' EQUITY:
Current liabilities $12,414 $9,474
Long term liabilities 4,621 6,561
Shareholders' equity 70,444 89,105
Total liabilities and shareholders'
equity $87,479 $105,140

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 June 30, 2008, which
will be filed with the SEC on or about August 7, 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.
SOURCE Poniard Pharmaceuticals, Inc.

Brendan Doherty of Poniard Pharmaceuticals, +1-650-745-4425,
bdoherty@poniard.com