8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

November 1, 2007

Date of Report (Date of earliest event reported)

Poniard Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

Washington	0-16614	91-1261311
(State or Other Jurisdiction of Incorporation)	(Commission File No.)	(IRS Employer Identification No.)

7000 Shoreline Court, Suite 270, South San Francisco, California	94080
(Address of principal executive offices)	(Zip Code)
(Registrant’s telephone number, including area code) (650) 583-3774

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o  Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Section 2 - Financial Information

Item 2.02.Results of Operations and Financial Condition.

The Company issued a press release dated November 1, 2007, announcing its financial results for the quarter ended September 30, 2007.  The full text of the press release is set forth in Exhibit 99.1 attached hereto.  The press release should be read in conjunction with the note regarding forward-looking statements, which is included in the text of the press release.

The information in this Item 2.02 and attached as Exhibit 99.1 to this Report will not be treated as “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section. This information will not be incorporated by reference into any filing under the Securities Act of 1933, or into another filing under the Exchange Act, unless that filing expressly incorporates this information by reference.

Section 8 - Other Events

Item 8.01.Other Events.

On November 1, 2007, the Company announced the initiation of a randomized Phase 2 clinical trial to evaluate intravenous picoplatin for the first-line treatment of metastatic colorectal cancer.  The objective of this trial is to generate proof-of-concept data to evaluate the efficacy and safety, including neuropathy, of picoplatin in combination with 5- FU and leucovorin, FOLPI versus FOLFOX, and to provide support for a Phase 3 trial.  See press release dated November 1, 2007 attached hereto as Exhibit 99.2 and incorporated herein by reference.

Section 9 - Financial Statements and Exhibits

Item 9.01.Financial Statements and Exhibits.

(d)     Exhibits.

99.1 - Press release dated November 1, 2007

99.2 - Press release dated November 1, 2007

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Poniard Pharmaceuticals, Inc.
Dated: November 2, 2007	By:	/s/Anna Lewak Wight
		Name: Anna Lewak Wight
		Title: Vice President, Legal

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EXHIBIT INDEX

Exhibit No.	Description
99.1	Press Release dated November 1, 2007
99.2	Press Release dated November 1, 2007

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EX-99.1

Exhibit 99.1

Poniard Pharmaceuticals Reports Third Quarter 2007

Financial Results and Corporate Update

South San Francisco, Calif. (November 1, 2007) - Poniard Pharmaceuticals, Inc. (NASDAQ: PARD), a biopharmaceutical company focused on oncology, today reported on its corporate progress and financial results for the quarter ended September 30, 2007.  The Company will host a conference call today at 5:00 p.m. Eastern time to provide a corporate update.

“Over the last several months, Poniard has continued to execute on its strategy of developing picoplatin as a platform product and studying it in multiple indications, combinations and formulations.  We have achieved several significant clinical milestones in our picoplatin development program with the initiation of our pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial in small cell lung cancer under a Special Protocol Assessment and the initiation of two Phase 2 trials — in metastatic colorectal and hormone-refractory prostate cancer,” said Jerry McMahon, Ph.D., chairman and CEO of Poniard.  “We also achieved two regulatory milestones with the receipt of fast track designation in the U.S. and a positive recommendation for orphan medicinal product designation in the E.U. by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) for picoplatin for the treatment of small cell lung cancer.  We have made important progress in getting a majority of our clinical sites up and running for the SPEAR trial.  Our Phase 1 trial of oral picoplatin is progressing and we anticipate announcing initial results this quarter.”

Third Quarter and Recent Highlights

•Initiated a randomized Phase 2 clinical trial of intravenous picoplatin for the first-line treatment of metastatic colorectal cancer.  The trial is evaluating whether picoplatin given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen demonstrates equivalent or better efficacy than oxaliplatin in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen without the substantial neurotoxicity associated with oxaliplatin.

•Received a positive recommendation for orphan medicinal product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) for picoplatin for the treatment of small cell lung cancer (SCLC).

•Initiated a Phase 2 clinical trial of intravenous picoplatin in combination with docetaxel (Taxotere®) and prednisone in patients with metastatic hormone-refractory prostate cancer.  This multi-center, open-label, single-arm trial 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 and to enable a Phase 3 trial.

•Presented updated results from an on-going Phase 2 clinical trial of picoplatin in patients with recurrent SCLC who relapsed within six months of first-line therapy during a poster discussion session at the International Association for the Study of Lung Cancer’s 12th World Conference on Lung Cancer in Seoul, Korea.  The results confirmed and extended a median overall survival of 27 weeks.

•Received fast track designation from the U.S. Food and Drug Administration for picoplatin for the second-line treatment of refractory or resistant SCLC.

•Announced an upgrade of the Company’s common stock listing to the NASDAQ Global Market.

Third Quarter 2007 Unaudited Financial Results

The Company reported a net loss of $7.0 million ($0.20 diluted loss per share on a loss applicable to common shares of $7.1 million) for the third quarter of 2007, compared to a net loss of $4.9 million ($0.22 diluted loss per share on a loss applicable to common shares of $5.0 million) for the same period in 2006.  The Company reported a net loss of $23.2 million ($0.80 diluted loss per share on a loss applicable to common shares of $23.6 million) for the nine months ended September 30, 2007, compared to a net loss of $17.2 million ($1.13 diluted loss per share on a loss applicable to common shares of $17.5 million) for the nine months ended September 30, 2006.  There was no revenue for the three and nine months ended September 30, 2007 and 2006.

Total operating expenses for the third quarter of 2007 increased 41 percent to $7.9 million, from $5.6 million for the third quarter of 2006 and increased 69 percent to $24.9 million for the nine months ended September 30, 2007, from $14.8 million for the same period in 2006.

Research and development (R&D) expenses increased 50 percent to $5.1 million for the third quarter of 2007, from $3.4 million for the third quarter of 2006 and increased 79 percent to $16.3 million for the nine months ended September 30, 2007, from $9.1 million for the same period in 2006.  The increase in R&D expenses for both the quarter and nine months ended September 30, 2007, resulted primarily from increased clinical costs associated with the Phase 3 trial of picoplatin in SCLC, the Phase 1 trial of the oral formulation of picoplatin, and increased costs of picoplatin active ingredient and finished drug product in support of all of the Company’s clinical programs.

General and administrative (G&A) expenses increased 28 percent to $2.8 million for the third quarter of 2007, compared with $2.2 million for the third quarter of 2006, and increased 51 percent to $8.6 million for the nine months ended September 30, 2007, from $5.7 million for the same period in 2006.  The increase in G&A costs for the quarter and nine months ended September 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 September 30, 2007, were $97.1 million, compared with $53.7 million at December 31, 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.

Conference Call Details

To participate in the live call by telephone, please dial 877-419-6600 from the U.S. or 1-719-325-4873 internationally.  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 www.poniard.com.  A replay will also be available online for seven days following the live presentation.

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 anew generation platinum therapy with an improved safety profile.  Picoplatin is designed to overcome and prevent

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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 cancer, as well as a clinical trial of oral picoplatin in solid tumors.  For additional information please visit www.poniard.com.

This release contains forward-looking statements, including statements regarding the Company’s operations and financial condition, business objectives and strategic goals, drug development plans, and the 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, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2006, as amended, and most current Quarterly Report on Form 10-Q.  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.

© 2007 Poniard Pharmaceuticals, Inc.  All Rights Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.

For Further Information:

Brendan Doherty

Poniard Pharmaceuticals

Corporate Communications

7000 Shoreline Court, Suite 270

South San Francisco, CA  94080

650-745-4425

bdoherty@poniard.com

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Poniard Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

(Unaudited)

	Three Months Ended September 30,							Nine Months Ended September 30,
	2007				2006			2007			2006
Revenues	$		—		$	—		$	—		$	—
Operating expenses:
Research and development	5,050				3,369			16,362			9,135
General and administrative	2,806				2,186			8,584			5,703
Realized gain on equipment disposal	—				—			—			(73		)
Total operating expenses	7,856				5,555			24,946			14,765
Loss from operations	(7,856			)	(5,555		)	(24,946		)	(14,765		)
Other income (expense), net	897				669			1,730			(2,408		)
Net loss	(6,959			)	(4,886		)	(23,216		)	(17,173		)
Preferred stock dividends	(125			)	(125		)	(375		)	(375		)
Loss applicable to common shares	$	(7,084		)	$	(5,011	)	$	(23,591	)	$	(17,548	)
Loss per share:
Basic and diluted	$	(0.20		)	$	(0.22	)	$	(0.80	)	$	(1.13	)
Shares used in calculation of loss per share:
Basic and diluted	34,657				22,805			29,449			15,546

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)

	September 30, 2007			December 31, 2006
ASSETS:
Cash and investment securities	$		97,096	$	53,710
Cash - restricted	281			136
Facilities and equipment, net	1,174			525
Assets held for sale	2,624			2,624
Licensed products, net	10,325			11,236
Other assets	1,467			836
Total assets	$	112,967		$	69,067
LIABILITIES AND SHAREHOLDERS' EQUITY:
Current liabilities	$	8,650		$	12,201
Long term liabilities	7,483			9,975
Shareholders' equity	96,834			46,891
Total liabilities and shareholders' equity	$	112,967		$	69,067

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EX-99.2

Exhibit 99.2

Poniard Pharmaceuticals Initiates Randomized Phase 2 Trial of Picoplatin for
First-Line Treatment of Metastatic Colorectal Cancer

— Phase 1 CRC Data Support Picoplatin’s Lack of Neuropathy and Use in Combination Therapy

South San Francisco, Calif. (November 1, 2007) - Poniard Pharmaceuticals, Inc. (NASDAQ: PARD), a biopharmaceutical company focused on oncology, today announced initiation of a randomized Phase 2 trial to evaluate intravenous picoplatin for first-line treatment of metastatic colorectal cancer (CRC). The objective of this trial is to generate proof-of-concept data to evaluate the efficacy and safety, including neuropathy, of picoplatin in combination with 5- FU and leucovorin, FOLPI versus FOLFOX, and to provide support for a Phase 3 trial.  Picoplatin, the Company’s lead product candidate, is a new generation platinum chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations.

“This Phase 2 trial supports our strategy to broadly develop picoplatin for a variety of solid tumor indications,” said Jerry McMahon, Ph.D., chairman and CEO of Poniard. “Based on the encouraging safety data we have seen in our Phase 1 trial in colorectal cancer to date, we are initiating this Phase 2 trial to evaluate the efficacy of picoplatin as a first-line chemotherapeutic agent with a potentially more favorable toxicity profile than currently marketed platinums. If the Phase 2 results are positive, we expect to explore advancement to a Phase 3 registrational trial for CRC.”

Interim safety results from Poniard’s Phase 1 trial in CRC, which was designed to identify the maximum tolerated dose of picoplatin administered every two or four weeks with 5-fluorouracil and leucovorin (the FOLPI regimen), confirmed that this combination can be administered safely in this patient population. In the trial, no neuropathy greater than grade 1 has been observed in all patients treated, including four patients who received a cumulative picoplatin dose of greater than 900 mg/m2. The Company plans to present data from the Phase 1 trial at scientific meetings in 2008.

The platinum therapy oxaliplatin is an integral component of chemotherapy regimens which have become a standard treatment for metastatic CRC. The associated side effects, most notably, neuropathy, can significantly impair the quality of life of patients and limits the optimal use of oxaliplatin. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology, discontinuation of oxaliplatin from the FOLFOX regimen (in which oxaliplatin is given in combination with 5-fluorouracil and leucovorin) should be strongly considered after three months of therapy, or sooner if significant neurotoxicity develops.

Phase 2 Colorectal Cancer Trial Design

The Phase 2 trial will include approximately 100 patients with metastatic CRC randomized to either picoplatin (150 mg/m²) given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen or oxaliplatin in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen.  The trial will evaluate whether FOLPI demonstrates equivalent or better efficacy than FOLFOX without the substantial neurotoxicity associated with oxaliplatin.

Efficacy and safety assessment will include objective tumor response, duration of response, progression-free survival, overall survival and assessment of peripheral neuropathy.  The trial will be conducted at approximately 25 clinical sites and is expected to complete enrollment in the first half of 2008. The Company currently expects to have early tumor response data and long-term safety data in the first half of 2008 and intends to submit the data for presentation at scientific conferences in 2008.

Poniard is continuing to evaluate picoplatin administered once every two weeks in the FOLPI regimen in its ongoing Phase 1 trial and has not yet reached the maximum tolerated dose for this dosing regimen.

About Picoplatin

Picoplatin has an improved safety profile compared to existing platinum-based chemotherapeutics and was designed to overcome platinum resistance.  Poniard’s strategy is to develop picoplatin as a platform product that can be used second-line in patients who are resistant or refractory to currently available platinums, such as small cell lung cancer (SCLC) patients, and first-line in patients, such as CRC patients, who cannot tolerate the toxicity profile of currently marketed platinums. We also plan to advance the use of picoplatin in new combination regimens in which platinums are not currently used, such as in the treatment of hormone-refractory prostate cancer (HRPC) patients, in order to improve efficacy.  In addition to the Phase 2 trial in metastatic CRC, Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in SCLC. This registrational trial is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) and is evaluating overall survival as the primary endpoint.

The Company is also evaluating intravenous picoplatin in an ongoing Phase 2 trial in combination with docetaxel (Taxotere®) and prednisone in patients with metastatic HRPC. Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors.

Picoplatin has been tested in more than 600 patients in Phase 1 and 2 safety and efficacy studies.

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. Picoplatin is designed to overcome and prevent 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 cancer, as well as a Phase 1 clinical trial of oral picoplatin in solid tumors. For additional information please visit www.poniard.com.

This release contains forward-looking statements, including statements regarding the Company’s business objectives and strategic goals, drug development plans, and the 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

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 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, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2006, as amended, and most current Quarterly Report on Form 10-Q.  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.

© 2007 Poniard Pharmaceuticals, Inc. All Rights Reserved.

Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.

For Further Information:

Brendan Doherty

Poniard Pharmaceuticals Corporate Communications

7000 Shoreline Court, Suite 270

South San Francisco, CA 94080

650-745-4425 bdoherty@poniard.com

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