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Poniard Pharmaceuticals Reports First Quarter 2008 Financial Results and Corporate Update

- Conference Call Today at 5:00 p.m. Eastern Time -

SOUTH SAN FRANCISCO, Calif., May 6 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today reported on its corporate progress and financial results for the first quarter ended March 31, 2008.

"During the first quarter, we made significant progress in moving our clinical trials forward and generating data to demonstrate the potential of picoplatin as a new generation platinum therapy," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "Our pivotal Phase 3 SPEAR trial in small cell lung cancer continues to enroll patients. Today, we are pleased to announce the completion of patient enrollment in our Phase 2 trial in metastatic colorectal cancer. The results of our Phase 1 trials in prostate cancer and colorectal cancer were presented earlier this year. Encouraging bioavailability data has been presented from our ongoing Phase 1 trial of oral picoplatin. We secured commercial manufacture and supply of picoplatin drug substance. A new chief medical officer was appointed to expedite the clinical development of picoplatin through product approval. Our accomplishments this quarter are consistent with the development of picoplatin as a platform product addressing multiple indications, combinations and formulations."

First Quarter and Recent Highlights

Picoplatin and Development Pipeline

* Small Cell Lung Cancer: Presented final data from our Phase 2 trial

of picoplatin in small cell lung cancer (SCLC) at the International

Association for the Study of Lung Cancer and the European Society

for Medical Oncology's 1st European Lung Cancer Conference. The

final efficacy results confirmed previously announced interim

results showing a survival benefit in patients with recurrent SCLC

who failed prior platinum-containing first-line chemotherapy or who

progressed within six months of first-line therapy. The median

overall survival in the picoplatin Phase 2 trial was 27 weeks for

refractory and resistant small cell lung cancer patients, a

population for which there is no approved therapy in the US. The

Pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse)

trial of intravenous picoplatin in SCLC is ongoing and compares

picoplatin with best supportive care to best supportive care alone.

The published median overall survival for best supportive care is 13

weeks for the platinum refractory and resistant patient group. Our

registrational trial is currently being conducted under a Special

Protocol Assessment from the U.S. Food and Drug Administration and

is evaluating overall survival as the primary endpoint. Top-line

Phase 3 data is targeted for mid-2009.

* Colorectal Cancer: In January, we presented preliminary safety data

from our 50-patient Phase 1 dose-escalation study of picoplatin in

patients with metastatic colorectal cancer at the ASCO

Gastrointestinal Cancers Symposium. Picoplatin was shown to have

manageable toxicity in combination with 5-fluorouracil and

leucovorin. Picoplatin did not cause severe neurotoxicity (Grade 3

or higher), as is commonly seen in metastatic CRC patients treated

with oxaliplatin as part of the FOLFOX regimen. Current National

Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in

Oncology for colon cancer encourage the discontinuation of FOLFOX

after three months of therapy or sooner if significant neurotoxicity

develops (Grade 3 or greater). Nephrotoxicities and ototoxicities

were rare and mild.

Based on this promising data, in November 2007 we initiated a

randomized, Phase 2 study comparing picoplatin to oxaliplatin, both

in combination with 5-fluorouracil and leucovorin. We announced

today that we completed the Phase 2 enrollment. This randomized,

controlled 100-patient trial is designed to compare the safety and

efficacy of picoplatin given once every four weeks in combination

with full-dose 5-fluorouracil and leucovorin dosing in the FOLPI

regimen to oxaliplatin in combination with 5-fluorouracil and

leucovorin in the modified FOLFOX-6 regimen.

We currently are on track to generate data from this trial

throughout 2008 and beyond, and will be presenting early Phase 2 and

updated Phase 1 data at ASCO in June this year.

* Prostate Cancer: At the February 2008 ASCO Genitourinary Cancers

Symposium, we reported encouraging safety and efficacy data from our

Phase 1 dose-escalation study of picoplatin in combination with

docetaxel and prednisone in patients with hormone refractory

prostate cancer (HRPC). Picoplatin was safely administered in

combination with full-dose docetaxel and prednisone, the current

standard of care for first-line HRPC patients. The follow-up Phase 2

study completed enrollment late 2007 and we plan to present data

from this study at ASCO this June and at other scientific meetings.

* Oral Picoplatin: In April this year, results were presented from the

ongoing Phase 1 clinical trial of oral picoplatin in patients with

advanced solid tumor malignancies at the Annual Meeting of the

American Association for Cancer Research. Data from this Phase 1

trial of oral picoplatin showed that picoplatin can achieve oral

bioavailability and supports further clinical development. These

results enable further clinical trials of oral picoplatin in new

combinations with radiation and oral chemotherapies as well as

targeted agents.

* Platinum Resistance: In April, we also announced preclinical

findings demonstrating that picoplatin retains its activity in SCLC

cell lines made resistant by treatment with cisplatin, carboplatin

or oxaliplatin. The data suggests that picoplatin may overcome

platinum resistance induced by currently available platinum agents.

We also announced 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.

* Picoplatin Drug Substance Manufacturing: We announced an agreement

with W. C. Heraeus GmbH for the manufacture and supply of picoplatin

drug substance to support our clinical trials and commercial product


Management Appointments

* Appointed Robert De Jager, M.D., as chief medical officer of the

Company who brings a depth of experience to our clinical development

programs to help the company position picoplatin for the global

oncology marketplace

First Quarter 2008 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 first quarter of 2008 compared to a net loss of $7.7 million ($0.34 diluted loss per share on a loss applicable to common shares of $7.9 million) for the first quarter of 2007.

There was no revenue in either of the first quarters of 2008 or 2007.

Total operating expenses for the first quarter of 2008 increased 33 percent to $10.5 million, from $7.9 million for the first quarter of 2007.

Research and development (R&D) expenses increased 15 percent to $6.3 million for the first quarter of 2008, from $5.5 million for the first quarter of 2007, primarily as the result of higher clinical costs associated with the Company's picoplatin trials and increased costs for other R&D efforts.

General and administrative (G&A) expenses increased 74 percent to $4.2 million for the first quarter of 2008, compared with $2.4 million for the first quarter of 2007, primarily due to the recording of stock option expense and increased personnel costs.

Cash and investment securities as of March 31, 2008 was $84.7 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.

During the remainder of 2008, we anticipate further important advancements of our picoplatin clinical development program. We intend to:

* Continue enrolling our Phase 3 SPEAR trial in small cell lung cancer

and advancing it towards NDA filing;

* Present emerging Phase 2 clinical data from both our metastatic

colorectal cancer and hormone-refractory prostate cancer trials at

ASCO in June and other scientific meetings;

* Present additional data from our Phase 1 oral picoplatin study at

scientific conferences;

* Evaluate opportunities to expand picoplatin development in

additional tumor types, settings and combinations and prepare

picoplatin for commercialization and partnering.

Conference Call Details

To participate in today's live 5 PM ET/2 PM PT call by telephone, please dial 877-440-5791 from the U.S. or +1-719-325-4909 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 A replay of the webcast will be available on the Company's website for 14 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 Phase 1 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

Poniard Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except per share data)


Three Months Ended March 31,

2008 2007

Revenues $- $-

Operating expenses:

Research and development 6,336 5,500

General and administrative 4,183 2,400

Total operating expenses 10,519 7,900

Loss from operations (10,519) (7,900)

Other income (expense), net 664 171

Net loss (9,855) (7,729)

Preferred stock dividends (125) (125)

Loss applicable to common shares $(9,980) $(7,854)

Loss per share:

Basic and diluted $(0.29) $(0.34)

Shares used in calculation of loss per share:

Basic and diluted 34,681 22,808

Condensed Consolidated Balance Sheets

(In thousands)


March 31, December 31,

2008 2007


Cash and investment securities $84,694 $92,621

Cash - restricted 281 281

Facilities and equipment, net 1,085 1,121

Licensed products, net 9,717 10,021

Other assets 1,341 1,096

Total assets $97,118 $105,140


Current liabilities $9,956 $9,474

Long term liabilities 5,606 6,561

Shareholders' equity 81,556 89,105

Total liabilities and shareholders' equity $97,118 $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 March 31, 2008, which will be filed with the SEC on or about May 8, 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.
Copyright©2008 PR Newswire.
All rights reserved

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