-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, JrW1JSehIAMPHIo1aHWSF15cx87Pj83aa9XtYYueQYuJoc5GrRl3TPvbwcy80SD7 /EO6tEeIKj4kfa8AR4xvWw== 0001104659-10-012611.txt : 20100308 0001104659-10-012611.hdr.sgml : 20100308 20100308081542 ACCESSION NUMBER: 0001104659-10-012611 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20100305 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100308 DATE AS OF CHANGE: 20100308 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PONIARD PHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0000755806 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 911261311 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-16614 FILM NUMBER: 10662388 BUSINESS ADDRESS: STREET 1: 7000 SHORELINE COURT STREET 2: SUITE 270 CITY: SO. SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 2062862501 MAIL ADDRESS: STREET 1: 300 ELLIOTT AVENUE WEST STREET 2: SUITE 500 CITY: SEATTLE STATE: WA ZIP: 98119-4114 FORMER COMPANY: FORMER CONFORMED NAME: NEORX CORP DATE OF NAME CHANGE: 19920703 8-K 1 a10-5295_18k.htm 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

 

Date of Report (Date of earliest event reported) March 5, 2010

 

Poniard Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Washington

 

0-16614

 

91-1261311

(State or Other Jurisdiction

 

(Commission File No.)

 

(IRS Employer

of Incorporation)

 

 

 

Identification No.)

 

7000 Shoreline Court, Suite 270, South San Francisco, California

 

94080

(Address of principal executive offices)

 

(Zip Code)

 

(650) 583-3774

(Registrant’s telephone number, including area code)

 

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 March 8, 2010, announcing its financial results for the fourth quarter and year ended December 31, 2009.  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 March 5, 2010, the Company announced positive final data, including survival data, from its Phase 2 clinical trial of picoplatin as a first-line therapy in men with metastatic castration-resistant (hormone-refractory) prostate cancer.  The data were presented in the General Poster Session at the 2010 American Society of Clinical Oncology’s Genitourinary Cancers Symposium in San Francisco, CA.

 

See press release dated March 5, 2010, attached hereto as Exhibit 99.2 and incorporated herein by reference.  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.

 

Section 9 — Financial Statements and Exhibits

 

Item 9.01.              Financial Statements and Exhibits.

 

(d)           Exhibits.

 

99.1 — Press release dated March 8, 2010

 

99.2 — Press release dated March 5, 2010

 

2



 

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:  March 8, 2010

By:

/s/Gregory L. Weaver

 

 

Name: Gregory L. Weaver

 

 

Title: Chief Financial Officer

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press Release dated March 8, 2010

 

 

 

99.2

 

Press Release dated March 5, 2010

 

4


EX-99.1 2 a10-5295_1ex99d1.htm EX-99.1

EXHIBIT 99.1

 

GRAPHIC

 

Poniard Pharmaceuticals Reports Fourth Quarter and Year End 2009 Financial Results

 

 - Conference Call Today at 8:30 a.m. Eastern Time  -

 

South San Francisco, Calif. (March 8, 2010) — Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today reported financial results for the fourth quarter and year ended December 31, 2009.

 

“Picoplatin’s value proposition rests on establishing it as the preferred platinum,” said Ronald A. Martell, chief executive officer of Poniard.  “With nearly 1,100 patients treated in clinical trials to date, picoplatin has already demonstrated clinically meaningful safety and efficacy in a variety of solid tumor indications as a single agent or in combination.  We look forward to finalizing registration strategies in a number of these settings with our clinical advisors and the Food and Drug Administration, while simultaneously evaluating strategic opportunities, including potential partnerships, which we believe will enable us to unlock the full value of picoplatin.”

 

Recent Clinical and Corporate Developments

 

Picoplatin Clinical Update

 

·      Prostate Cancer:  On Friday, March 5, 2010, Poniard presented final data from the Company’s Phase 2 clinical trial of picoplatin in 32 men with metastatic castration-resistant (hormone-refractory) prostate cancer (CRPC) during the American Society of Clinical Oncology (ASCO) 2010 Genitourinary Cancers Symposium.  These data indicated that picoplatin, when added to the recommended first-line therapy of docetaxel and prednisone for CRPC, is active, as demonstrated by overall survival (21.4 months) in 29 evaluable patients, progression-free survival (PFS) (7.4 months), and prostate specific antigen (PSA) response rate (78 percent).  In contrast, data from published literature demonstrate an overall survival benefit of 18.9 months and a PSA response of 45 percent for patients who received recommended doses of docetaxel and prednisone alone.(1)  The Phase 2 trial evaluated the efficacy and safety of intravenous picoplatin (120 mg/meter squared) administered every three weeks in combination with full doses of docetaxel (75 mg/meter squared) with daily prednisone (5 mg) as a first-line treatment in chemotherapy näive patients with metastatic CRPC.  These results also showed that picoplatin can be safely administered with full doses of docetaxel and prednisone, without neurotoxicity being observed in these patients.

 

·      Colorectal Cancer (CRC): During the ASCO 2010 Gastrointestinal Cancers Symposium in January, Poniard presented final results from a randomized, controlled Phase 2 trial evaluating picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC.  The 101 patient study met its primary objective, as picoplatin in combination with 5-fluorouracil and leucovorin in the FOLPI regimen produced a statistically significant reduction in neurotoxicity, p <0.004, compared to oxaliplatin given in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen.  Neuropathy was 2.5 times more frequent for FOLFOX- treated patients compared to FOLPI-treated patients, and no Grade 3/4 neuropathy occurred in the FOLPI treated patients.  Results suggest that FOLPI had anti-tumor activity comparable to FOLFOX, as measured by disease control, PFS and overall survival.  Hematologic toxicity was the most frequent adverse event in the FOLPI regimen, but was manageable.

 



 

·      Small Cell Lung Cancer (SCLC): In November 2009, the Company reported results from the Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial, which enrolled 401 patients and evaluated intravenous picoplatin in patients who were refractory to or who progressed within six months following initial treatment with a platinum-based therapy.  While the data analysis showed that the study did not meet its primary endpoint of overall survival the data suggest a potential trend toward a survival advantage in SCLC patients treated with picoplatin and best supportive care compared to best supportive care alone.  An imbalance in the use of post-study chemotherapy was observed in favor of patients who received best supportive care alone compared to patients who received picoplatin plus best supportive care, and we believe that this may have been a significant factor contributing to the trial outcome. The intent-to-treat analysis was based on 321 patient deaths and showed a hazard ratio of 0.82 and a p value of 0.089.

 

Corporate Update

 

·      In February 2010, the Company secured a committed equity financing facility with Commerce Court Small Cap Value Fund Ltd, pursuant to which it may, subject to certain limitations, sell up to $20 million of its registered common stock to Commerce Court over an approximately 18-month period.  The Company believes that this facility offers a competitive cost of capital and a flexible structure to help finance its regulatory and partnering strategies to support the continued development of picoplatin.

 

·      In February 2010, Poniard announced management changes and a realignment of the Company’s workforce.  Ronald A. Martell was appointed chief executive officer, succeeding Jerry McMahon, Ph.D., who remains as non-executive chairman of the Board of Directors.  In addition, Michael S. Perry, DVM, Ph.D., has been named president and chief medical officer.  The Company also reduced its workforce by approximately 57 percent in order to focus its resources on the ongoing development of picoplatin in solid tumors.

 

·      In the fourth quarter of 2009, Poniard raised net proceeds of $13.8 million from the sale of common stock under the Company’s committed equity financing facility with Azimuth Opportunity Ltd.  That facility terminated by its terms on December 22, 2009.

 

2010 Goals and Objectives

 

The Company will focus on the following goals and objectives in 2010:

 

·      Pursue strategic opportunities, including a partnership to help advance the clinical development of picoplatin in multiple indications and two formulations;

·      Pursue a process with the Food and Drug Administration to identify a regulatory path forward for picoplatin in small cell lung cancer, and

·      Leverage insights gained from Phase 2 colorectal, prostate and ovarian cancer trials to develop registration strategies for these indications in collaboration with key opinion leaders and the FDA

 

Fourth Quarter 2009 Financial Results

 

The Company reported a net loss of $13.2 million ($0.36 diluted loss per share on a loss applicable to common shares of $13.3 million) for the quarter ended December 31, 2009, compared with a net loss of $13.9 million ($0.41 diluted loss per share on a loss applicable to common shares of $14.1 million) for the quarter ended December 31, 2008.  The Company reported a net loss of $45.7 million ($1.31 diluted loss per share on a loss applicable to common shares of $46.2 million) for the year ended December 31, 2009, compared with a net loss of $48.6 million ($1.41 diluted loss per share on a loss applicable to common shares of $49.1 million) for the same period in 2008.

 

Total operating expenses for the quarter ended December 31, 2009, were $12.4 million compared with $13.4 million for the quarter ended December 31, 2008, and were $43.0 million for the year ended December 31, 2009, compared with $49.2 million for the same period in 2008. Total operating expenses for the quarter and year ended December 31, 2009 include charges of $1.5 million and $2.5 million, respectively, for the $1.5 million

 



 

asset impairment loss on dedicated manufacturing equipment effective December 31, 2009, and for the $1.0 million 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 $7.2 million for the quarter ended December 31, 2009, compared with $10.0 million for the quarter ended December 31, 2008.  Research and development expenses were $25.7 million for the year ended December 31, 2009, compared with $33.7 million for the same period in 2008.

 

General and administrative expenses were $3.8 million for the quarter ended December 31, 2009, compared with $3.3 million for the quarter ended December 31, 2008.  General and administrative expenses were $14.7 million for the year ended December 31, 2009, compared with $15.4 million for the same period in 2008.

 

Cash and investment securities as of December 31, 2009, were $43.4 million, compared with $72.8 million at December 31, 2008.  The Company believes that its existing cash and investment securities, together with its projected operating and financing results, will provide adequate resources to fund the Company’s operations at least through the end of 2010.

 

Conference Call Details

 

Poniard’s management team will host a conference call and Webcast today at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time. To participate in the call by telephone, please dial 866-543-6403 (United States) or 617-213-8896 (International). The passcode for the conference call is 50673823. In addition, the call is being Webcast and 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. For additional information please visit http://www.poniard.com.

 

Forward-Looking Statements

 

This release contains forward-looking statements describing the Company’s results of operations and financial condition, the Company’s 2010 goals and objectives, including its regulatory and partnering strategies focused on optimizing the potential value of picoplatin, and the adequacy of the Company’s resources to successfully implement and pursue these strategies. Actual results and events may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties inherent in the Company’s business, including, but not limited to, the results and timing of the Company’s discussions with the FDA; the potential safety, efficacy and commercial viability of picoplatin; the risk that the Company’s additional analyses of data from clinical trials of picoplatin may produce negative or inconclusive results, or may be inconsistent with previously announced results or previously conducted trials; the Company’s anticipated future operating losses, need for future capital and ability to obtain future funding; the Company’s ability to retain key personnel and enter into strategic partnerships or other relationships to support the continued development of picoplatin on favorable terms, or at all; competition from third parties; the Company’s ability to preserve and protect its intellectual property rights; the Company’s dependence on third-party manufacturers, suppliers and other contractors; changes in technology, government regulation and general market conditions; the receipt and timing of any FDA and other required regulatory approvals, if any; 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. 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.

 

 

For Further Information:

 

Susan Neath (Investors & Media)

WCG

212-301-7182

sneath@wcgworld.com

 


(1)Tannock et al, NEJM 2004;351:1502-12.

 

# # #

 



 

Poniard Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

(Unaudited)

 

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

 

 

2009

 

2008

 

2009

 

2008

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development (Note 1)

 

7,194

 

10,011

 

25,739

 

33,732

 

General and administrative (Note 1)

 

3,769

 

3,346

 

14,698

 

15,425

 

Restructuring & asset impairment

 

1,485

 

 

2,541

 

 

Total operating expenses

 

12,448

 

13,357

 

42,978

 

49,157

 

Loss from operations

 

(12,448

)

(13,357

)

(42,978

)

(49,157

)

Other income (expense), net

 

(720

)

(585

)

(2,737

)

592

 

Net loss

 

(13,168

)

(13,942

)

(45,715

)

(48,565

)

 

 

 

 

 

 

 

 

 

 

Preferred stock dividends

 

(125

)

(125

)

(500

)

(500

)

Loss applicable to common shares

 

$

(13,293

)

$

(14,067

)

$

(46,215

)

$

(49,065

)

 

 

 

 

 

 

 

 

 

 

Loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.36

)

$

(0.41

)

$

(1.31

)

$

(1.41

)

Shares used in calculation of loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

36,899

 

34,688

 

35,272

 

34,686

 

 

Condensed Consolidated Balance Sheets

(In thousands)

 

 

 

December 31, 2009

 

December 31, 2008

 

 

 

 

 

 

 

(Unaudited)

 

(Note 2)

 

 

 

 

 

ASSETS:

 

 

 

 

 

 

 

 

 

Cash and investment securities

 

$

43,389

 

$

72,755

 

 

 

 

 

Cash - restricted

 

281

 

281

 

 

 

 

 

Facilities and equipment, net

 

219

 

1,123

 

 

 

 

 

Licensed products, net

 

7,592

 

8,807

 

 

 

 

 

Other assets

 

961

 

1,266

 

 

 

 

 

Total assets

 

$

52,442

 

$

84,232

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY:

 

 

 

 

 

 

 

 

 

Current liabilities

 

$

17,127

 

$

19,140

 

 

 

 

 

Long term liabilities

 

11,671

 

17,445

 

 

 

 

 

Shareholders’ equity

 

23,644

 

47,647

 

 

 

 

 

Total liabilities and shareholders’ equity

 

$

52,442

 

$

84,232

 

 

 

 

 

 

Note 1:  Patent related legal expenses are included in G&A expenses beginning in 2009.  These expenses, which have been reclassifed for 2008 to conform to the 2009 presentation, are $1.0 million for each of 2009 and 2008.

 

Note 2:  Derived from audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008.

 


EX-99.2 3 a10-5295_1ex99d2.htm EX-99.2

EXHIBIT 99.2

 

GRAPHIC

 

Poniard Pharmaceuticals Presents Positive Survival Data from a Phase 2 Clinical Study of Picoplatin in Metastatic Prostate Cancer at the 2010 American Society of Clinical Oncology Genitourinary Cancers Symposium

 

SOUTH SAN FRANCISCO, Calif. — March 5, 2010 — Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced the presentation of positive final data, including survival data, from the Company’s Phase 2 clinical trial of picoplatin as a first-line therapy in men with metastatic castration-resistant (hormone-refractory) prostate cancer (CRPC).  The results were presented in a General Poster Session today at the 2010 American Society of Clinical Oncology’s Genitourinary Cancers Symposium in San Francisco, CA.

 

The final data showed that picoplatin, in combination with docetaxel and prednisone, the current standard of care for CRPC, produced a clinically meaningful benefit in patients as measured by overall survival, progression-free survival (PFS) and prostate specific antigen (PSA) response rate.  These results also demonstrated that picoplatin can be safely administered with full doses of docetaxel and prednisone.  In addition, no neurotoxicity was observed in these patients.  Neutropenia was the most common hematologic adverse event, and was managed with supportive care.

 

“Safety and efficacy results from this study, particularly the overall survival data, are encouraging and suggest that picoplatin in this combination regimen has the potential to play a meaningful role in the treatment of metastatic prostate cancer,” said William K. Oh, M.D., professor of medicine and urology and chief, Division of Hematology and Medical Oncology, Tisch Cancer Institute at Mount Sinai School of Medicine.  “The results also support the study of picoplatin as a first-line treatment for advanced prostate cancer, a disease for which too few treatment options currently exist.”

 

“We believe these results reflect the promise of picoplatin as a safe and effective platinum chemotherapeutic agent in prostate cancer, and suggest picoplatin could play a significant role in the treatment of other tumor types where platinum and taxane chemotherapies are currently used, further supporting picoplatin’s value proposition to potential partners,” said Ronald Martell, chief executive officer of Poniard.  “We intend to consult with our clinical advisory board and the U.S. Food and Drug Administration to finalize registration strategies in prostate cancer while simultaneously exploring potential partnership opportunities to support the continued development of picoplatin in multiple solid tumor indications.”

 

Phase 2 Trial Design and Results

 

The Phase 2 trial enrolled 32 men.  The trial was designed to evaluate the efficacy and safety of intravenous picoplatin (120 mg/meter squared) administered every three weeks in combination with full doses of docetaxel (75 mg/meter squared) with twice daily prednisone (5 mg) as a first-line treatment in chemotherapy-näive patients with metastatic CRPC.  Treatment continued for up to 10 cycles of therapy, as specified in the protocol.  PSA response, defined as a reduction from baseline of at least 50 percent, was the primary endpoint.  Secondary endpoints include duration of PSA response, radiologic response, PFS, overall survival and safety.  Results from the study included:

 

·      Median overall survival was 21.4 months in 29 patients who received picoplatin in combination with docetaxel and prednisone.  Data from published literature report a median overall survival of 18.9 months for patients who received docetaxel 75 mg/meter squared and prednisone 5 mg alone.(1)

·      Progression free survival was 7.4 months.

 



 

·      PSA response was achieved in 78 percent of evaluable patients.  Data from published literature report a PSA response of 45 percent in patients who received docetaxel 75 mg/meter squared and prednisone 5 mg alone.(1)  In addition, 30 percent of these patients experienced PSA level normalization following treatment with the picoplatin, docetaxel and prednisone combination.

·      Picoplatin was safely administered with full-dose docetaxel and prednisone for up to 10 cycles of therapy.  Neuropathy was not observed in this study.  Data from published literature report evidence of neuropathy in 30 percent of patients, including severe neuropathy (Grade 3/4) in 1.8 percent of patients receiving 75 mg/meter squared docetaxel and prednisone alone every three weeks.(1)

·      Neutropenia was the most common hematologic adverse event, and was managed with supportive care.  In contrast to data from picoplatin monotherapy studies, thrombocytopenia was less severe and less frequent when picoplatin was administered in combination with docetaxel.

 

About Prostate Cancer

 

More than two million American men are currently living with prostate cancer, and it is the most common cancer, other than skin cancers, among men in the U.S.  In 2009, an estimated 192,280 new cases of prostate cancer were expected to be diagnosed.  Prostate cancer is the second leading cause of death in American men, behind only lung cancer, with an estimated 27,360 deaths in 2009.(2)  All patients with metastatic prostate cancer eventually become refractory to hormone treatment.  Docetaxel in combination with prednisone is the current standard of care in the United States.  According to IntrinsiQ, 88.5 percent of U.S. patients received a docetaxel-containing regimen for first-line treatment of CRPC in 2008.  To date, a docetaxel-containing regimen is the only FDA approved treatment regimen proven to prolong the lives of patients with CRPC.

 

About Picoplatin

 

Picoplatin is a new and differentiated platinum-based chemotherapeutic agent that is in clinical development for multiple cancer indications, treatment combinations and by two routes of administration.  It was designed to overcome platinum resistance associated with chemotherapy in solid tumors.  Study data to date suggest that picoplatin has an improved safety profile relative to existing platinum-based cancer therapies and can be easily combined and safely administered with other currently marketed oncology products.  Approximately 1,100 patients have received picoplatin in clinical trials.  Results obtained to date suggest that hematologic events are common, but manageable.  Kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) are less frequent and less severe than is commonly observed with other platinum chemotherapy drugs.

 

About Poniard Pharmaceuticals

 

Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products.  For additional information please visit http://www.poniard.com.

 

Forward-Looking Statement

 

This release contains forward-looking statements interpreting the results of the Company’s Phase 2 clinical trial of picoplatin in castration-resistant prostate cancer and describing the Company’s regulatory and partnering strategies with respect to picoplatin in that and other cancer indications. Actual results and events may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties inherent in the Company’s business, including, but not limited to, the results and timing of the Company’s discussions with the FDA; the potential safety, efficacy and commercial viability of picoplatin; the risk that the Company’s additional analyses of data from clinical trials of picoplatin may produce negative or inconclusive results, or may be inconsistent with previously announced results or previously conducted trials; the Company’s anticipated future operating losses, need for future capital and ability to obtain future funding; the Company’s ability to retain key personnel and enter into strategic partnerships or other relationships to support the continued development of picoplatin on favorable terms, or at all; competition from third parties; the Company’s ability to preserve and protect its intellectual property rights; the Company’s dependence on third-party manufacturers, suppliers and other contractors; changes in technology, government regulation and general market conditions; the receipt and timing of any FDA and other required regulatory approvals, if any; 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. 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.

 

 

For Further Information:

 

Susan Neath (Investors & Media)

WCG

212-301-7182

sneath@wcgglobal.com

 


(1)Tannock et al, NEJM 2004;351:1502-12.

(2)American Cancer Society, Cancer Facts and Figures 2009.

 

# # #

 


GRAPHIC 4 g52951mpi001.gif GRAPHIC begin 644 g52951mpi001.gif M1TE&.#EAQ0!0`/<``/___P!I3`YP51T='2(B(AD9&9^GI!45%?___O_]_/_^ M___^_A`0$/[^_0!D2`P,#/S\^RLK*^'AX=OJY`D)":6FICX^/BF!:3@X.#0T M-$5%1<7%Q0EM4_'Q\3&#;=/3TV1D9$U-3<'!P9&1D>7P[/;Z^.WM[1UY7Y>7 MER8F)N'NZJW.PK+1QK74R82$A&UM;>;FYG1T=*RLK(&!@=SKYWIZ>O7U]5U= M7:O,P+V]O1//X]J[0Q+S8SM;HX?S[^Q5T6[&QL MWOW]_6AH:+FYN4M+2^[U\SN*=>KS[U555;G6S(V-C?[^_O?[^5Z@CHB(B*&A MHULSAV(.VI`IK4`!@1J3(O$R4@?W^_OW__G:NG]_JYL_BVT.0?/S\_)?! MLJ'(NO?]^Y+`L+S9TI7`L>WS\9G$M15Q5\/=UHBYJ'*LG+#/Q)S#M8R[K)*_ MKZC,P_S^_66CD_[^_\?@VY&]KL[AV=-R<^?/;$%M.X M*\XYP=KS;,.Q?8>F@R"W\8:H)P3O+#QV\+.CX!R?OG#,6;1UL;-F+KNP(19Z MBE/_]\N#QI8BZ-.G_U*$T)NE3N/+E\J;\^_69Q^5&-_W"R6EL9P`B(`$#FC@ M(Q,DJ."""@[1@AQN7(#=`!!"D6:>21*:XH1R;;N598 M`$PT$=Z-."$`AQN7&8:8<$%ZD`!JJ#4@YIA@BIED"878YYD#@+Q!I4X^"##8 M+*P2,?#O;?8$RD<"C37"B MZ*RO.^CXW@M3 MC.H)*A@M>$MA(JEYGT'P".3G8R%6+%ER`&Z1"1)(``-?")D`!D*XV'!0!PO9 M8(+LN84YYNZ[`]:`"KM2Z&EA#HPBA>4?C#"#"\PS[X4(KQ>$0!4W6)!!!AAH M`448!<$0@P9*H%#0`D(H88$,1PS4@0L9@*#&07&XH,'\5)A@T`(=>+%\\RY0 MT4H>!D&#\O@W@Q'(P'X&48`.H."""F0%833H',.RA2Y:3<$,I@.`&BS`@`)X M\(,%&$`(=$`0&R"A``=`H0"Q!)#6A!`WO<(P5B,#(TM'(``X@` M%5"@`3VF4`@^!``(J"G)%"0AG9?TX@><"(01/(``#Q`EIHR0_\U(ZE$$Z10( M"3`00@)D3PL18&8W.,FZ_G)?(Z2(#+(Y`#V.``&>*$@)B#H'U'P M4PDX0:L'2`(`%O#0/$9`"(((@P@LX,H!]#*+,4A"$IQ@@2KX00O<.XDRE]F; MNB3F`FYX0PE6:CF!3+,`$8"!#_W@@D\>(`(;`,`+8HD!&_C0!B_X)`64<-6D M1E*2&9BG+1,*SJG:$Y_Z'&,-3JF!%/\LDH@$Z8!8"X`")RI`"#"5Y`B!J`68@$#_4``45J((,H)`#)Q3Q+R.%([$(8S>J3*$0/C"#%!C[*Y>" M$[)7!8`0:!A"$0#@K))T0CH3@()[,B`#+S1M)/,X@K5"U96#5$`"/`G;]'(R M!"G,`!0R,$,-I!=_NQ7?6O/`X)M*.`T*H8D$($_:B`/2NAC"G00T+!^L+<"^4`K)0GFXF*6(#>@ MY@&4D(6!"`'_"3.@`A+Z>Q+`D-0Y3^K!YNQHL%^>-[("48`7[!L!.W2@G)*, MP4`6D%6*'E>_X-0C.O\K50`(F,!6)8@0,HR$+-R``EVUX4"\_,>O6EH&P66` M$-9JYN,*Y`5Z+(`%U@@`$R1!!CI5R6!73!@B'$E,8.*9C4U0G`^8,@4/L(`$ MPD#7KM8@H$.FJ'N/'$D,5/D!,3@"5.7YY-=*>2`N8.\,%#`#T=8`B[KUX@B` M(`@[:$&/#XBL#UM-D!G$V@*2)8@"@EQG4:A`NS3"0:@@MA"7+1A"*`Z64W66N" M^O,!0=SJ`*`09'H/I`8_Y[?&[CPP'`3N(`:GY@`>T`4*&/X.*9"!0*"N1P9( MW-+1MKBE302064@52TB@`!L@ M201@`57F9)`5D:F`D=V$W?=X66V%5 MA'_D1Y&T0T`'`!@=P)A6K)F`GJ'-/7':V/A=Q1A7G]T M8ZWC8TQU@#I&`';0ASOG2UJ@9DI02S'_05*,,H.\%Q$VEF\'`03P=0`W,#("45]=A5\^Y(7-!P!& MP$%V>(34]VTH4%`I8`'SHP$6D$T40`5MEFX>!&8`D`0I8(CLEX@"06H%D'U< MT0`D(#`#XP,U2!`&EX8OJ&\Q4'$6$#W.%64.-GD9]F&6-@,/4(<4V'F9!@!( MH&,@0((VD`5FU7TWT`&"R%N$I(MJ)FHJ&`%&QFA%6`!0,!.I\0A\TQE!H`*3 M"!$VUHP$L8IU>%<;!$E=0$2A&&NCN(4I@&2HF(02@`""@&@'``6<*!`U<$\' MP%"".`"XF`,V=0"B9F8YT`$FH`-1MT=;%H9B*`6%H"C!X0!3L"IGB$?,_Y@0 M"Y`'(ZD!,I`$(`!),R1J2#6'EC:$V\A5F]1)545:JQ5+JS80](56`"6%$J9` M474`=)9C6&A-2@"!-W4#-&%G)P`VS)$)A``!1N<05QA31C!_!A$#,B1)0011 M=T!:8G2"DB26`U$%'N1/F]0'4-"4HW2%X!0!N38029!'*4`!*``$K)1AN'A) MNS1U3K0!2H1(%/``%1=O>>"2Y:(B/B`A9!$6)T"#%@%Z7=`%&$!K!R$!6A!$ M?<1"#$`!&3!M&KF9#U`#!"$!&G`'#/``*7!5"5`!7?``J8`$M*-R#Y!^0*!O M4`><=X`"1W!HA5<`4:D`7]<%!S!$E@9U79!(2O\TGE]T5V.)*S_`"4S@%$R0 M6$2RE@X!!E2`/3*0`*2P$!)@?AF0`BF`/2^@`_QF!$Z0`4Z`!OR6`R%P/5[P MG`(1!B^0`B%P7#!`JIE12)F#BIG(ZIW1:IW8Z$XOP0'AJ+TW``BN``YH@'5)0 M!"0``'%@"X4J$#30`FW_,!!TT`-_B@=%`0`3P*@E^@5K0!!I4`>.N`<^@`4K M<`8"L0=I@`5^2@,-``!I4*@E4`HT``!GL`(]X*>50P*$,!`D(`M(*HEP*P`T`0K\`>$U`*;,`$#\0>2 M(`8JP`5X```(0`BNH*TE\`E\$*QR8`ET(!!7T`(X0`<_0`;:&@`#(BL0;9`^4>"Q>,`%;!L*;UNB2]`"7,`%C2"FU%$&*T`#=(!,`%`"1/"J MCSH!5]`&B,`%+!`)._L#H2`%8["R`K$&6Z`)+=`#C?^P`C[T!YB``RM@"8%; M`IY0MWV`!P(+LMHZ1HAP&_8Z!`/1`VFPNK"Z`OQ:!#BP!P"@`BSPM!,0"3W0 M"9$0&6UKK0+1!(YPGU\`"AEI*"2['P,1K=K:!#V@K4.``Q*K`I@`P'\0M@"P M!C[`%VO`"DM0"$5P"5B@`)#0`ID*`"SP!'N``&O`!30P"&00N#R``RW0"&?0 M!(N@!VF@P[K`!4\K$#V@N@*Q!?P+`)>`"&LP`43P!"6P`%@`K`KP!"T``&-@ ML#^P!8$0"'RP!C2`!YW@B(8B!A-PMJ/Z![VJ-KW:K.F3`*=0%$OP!TZD`C2P MND`!`*C``R7PKVWP`TV0%21,L`7[2@MU,+F-(!"B<`8^L`9/0`,H-@EI4,.! M.Q`30`)>.P:[*P:4FP9N<02.(+'3NK9M4`:PZP-/2P<^T`*2>J=](;RVG,NZ &?* GRAPHIC 5 g52951mni001.gif GRAPHIC begin 644 g52951mni001.gif M1TE&.#EAQ0!0`/<``/___P!I3`YP51T='2(B(AD9&9^GI!45%?___O_]_/_^ M___^_A`0$/[^_0!D2`P,#/S\^RLK*^'AX=OJY`D)":6FICX^/BF!:3@X.#0T M-$5%1<7%Q0EM4_'Q\3&#;=/3TV1D9$U-3<'!P9&1D>7P[/;Z^.WM[1UY7Y>7 MER8F)N'NZJW.PK+1QK74R82$A&UM;>;FYG1T=*RLK(&!@=SKYWIZ>O7U]5U= M7:O,P+V]O1//X]J[0Q+S8SM;HX?S[^Q5T6[&QL MWOW]_6AH:+FYN4M+2^[U\SN*=>KS[U555;G6S(V-C?[^_O?[^5Z@CHB(B*&A MHULSAV(.VI`IK4`!@1J3(O$R4@?W^_OW__G:NG]_JYL_BVT.0?/S\_)?! MLJ'(NO?]^Y+`L+S9TI7`L>WS\9G$M15Q5\/=UHBYJ'*LG+#/Q)S#M8R[K)*_ MKZC,P_S^_66CD_[^_\?@VY&]KL[AV=-R<^?/;$%M.X M*\XYP=KS;,.Q?8>F@R"W\8:H)P3O+#QV\+.CX!R?OG#,6;1UL;-F+KNP(19Z MBE/_]\N#QI8BZ-.G_U*$T)NE3N/+E\J;\^_69Q^5&-_W"R6EL9P`B(`$#FC@ M(Q,DJ."""@[1@AQN7(#=`!!"D6:>21*:XH1R;;N598 M`$PT$=Z-."$`AQN7&8:8<$%ZD`!JJ#4@YIA@BIED"878YYD#@+Q!I4X^"##8 M+*P2,?#O;?8$RD<"C37"B MZ*RO.^CXW@M3 MC.H)*A@M>$MA(JEYGT'P".3G8R%6+%ER`&Z1"1)(``-?")D`!D*XV'!0!PO9 M8(+LN84YYNZ[`]:`"KM2Z&EA#HPBA>4?C#"#"\PS[X4(KQ>$0!4W6)!!!AAH M`448!<$0@P9*H%#0`D(H88$,1PS4@0L9@*#&07&XH,'\5)A@T`(=>+%\\RY0 MT4H>!D&#\O@W@Q'(P'X&48`.H."""F0%833H',.RA2Y:3<$,I@.`&BS`@`)X M\(,%&$`(=$`0&R"A``=`H0"Q!)#6A!`WO<(P5B,#(TM'(``X@` M%5"@`3VF4`@^!``(J"G)%"0AG9?TX@><"(01/(``#Q`EIHR0_\U(ZE$$Z10( M"3`00@)D3PL18&8W.,FZ_G)?(Z2(#+(Y`#V.``&>*$@)B#H'U'P M4PDX0:L'2`(`%O#0/$9`"(((@P@LX,H!]#*+,4A"$IQ@@2KX00O<.XDRE]F; MNB3F`FYX0PE6:CF!3+,`$8"!#_W@@D\>(`(;`,`+8HD!&_C0!B_X)`64<-6D M1E*2&9BG+1,*SJG:$Y_Z'&,-3JF!%/\LDH@$Z8!8"X`")RI`"#"5Y`B!J`68@$#_4``45J((,H)`#)Q3Q+R.%([$(8S>J3*$0/C"#%!C[*Y>" M$[)7!8`0:!A"$0#@K))T0CH3@()[,B`#+S1M)/,X@K5"U96#5$`"/`G;]'(R M!"G,`!0R,$,-I!=_NQ7?6O/`X)M*.`T*H8D$($_:B`/2NAC"G00T+!^L+<"^4`K)0GFXF*6(#>@ MY@&4D(6!"`'_"3.@`A+Z>Q+`D-0Y3^K!YNQHL%^>-[("48`7[!L!.W2@G)*, MP4`6D%6*'E>_X-0C.O\K50`(F,!6)8@0,HR$+-R``EVUX4"\_,>O6EH&P66` M$-9JYN,*Y`5Z+(`%U@@`$R1!!CI5R6!73!@B'$E,8.*9C4U0G`^8,@4/L(`$ MPD#7KM8@H$.FJ'N/'$D,5/D!,3@"5.7YY-=*>2`N8.\,%#`#T=8`B[KUX@B` M(`@[:$&/#XBL#UM-D!G$V@*2)8@"@EQG4:A`NS3"0:@@MA"7+1A"*`Z64W66N" M^O,!0=SJ`*`09'H/I`8_Y[?&[CPP'`3N(`:GY@`>T`4*&/X.*9"!0*"N1P9( MW-+1MKBE302064@52TB@`!L@ M201@`57F9)`5D:F`D=V$W?=X66V%5 MA'_D1Y&T0T`'`!@=P)A6K)F`GJ'-/7':V/A=Q1A7G]T M8ZWC8TQU@#I&`';0ASOG2UJ@9DI02S'_05*,,H.\%Q$VEF\'`03P=0`W,#("45]=A5\^Y(7-!P!& MP$%V>(34]VTH4%`I8`'SHP$6D$T40`5MEFX>!&8`D`0I8(CLEX@"06H%D'U< MT0`D(#`#XP,U2!`&EX8OJ&\Q4'$6$#W.%64.-GD9]F&6-@,/4(<4V'F9!@!( MH&,@0((VD`5FU7TWT`&"R%N$I(MJ)FHJ&`%&QFA%6`!0,!.I\0A\TQE!H`*3 M"!$VUHP$L8IU>%<;!$E=0$2A&&NCN(4I@&2HF(02@`""@&@'``6<*!`U<$\' MP%"".`"XF`,V=0"B9F8YT`$FH`-1MT=;%H9B*`6%H"C!X0!3L"IGB$?,_Y@0 M"Y`'(ZD!,I`$(`!),R1J2#6'EC:$V\A5F]1)545:JQ5+JS80](56`"6%$J9` M474`=)9C6&A-2@"!-W4#-&%G)P`VS)$)A``!1N<05QA31C!_!A$#,B1)0011 M=T!:8G2"DB26`U$%'N1/F]0'4-"4HW2%X!0!N38029!'*4`!*``$K)1AN'A) MNS1U3K0!2H1(%/``%1=O>>"2Y:(B/B`A9!$6)T"#%@%Z7=`%&$!K!R$!6A!$ M?<1"#$`!&3!M&KF9#U`#!"$!&G`'#/``*7!5"5`!7?``J8`$M*-R#Y!^0*!O M4`><=X`"1W!HA5<`4:D`7]<%!S!$E@9U79!(2O\TGE]T5V.)*S_`"4S@%$R0 M6$2RE@X!!E2`/3*0`*2P$!)@?AF0`BF`/2^@`_QF!$Z0`4Z`!OR6`R%P/5[P MG`(1!B^0`B%P7#!`JIE12)F#BIG(ZIW1:IW8Z$XOP0'AJ+TW``BN``YH@'5)0 M!"0``'%@"X4J$#30`FW_,!!TT`-_B@=%`0`3P*@E^@5K0!!I4`>.N`<^@`4K M<`8"L0=I@`5^2@,-``!I4*@E4`HT``!GL`(]X*>50P*$,!`D(`M(*HEP*P`T`0K\`>$U`*;,`$#\0>2 M(`8JP`5X```(0`BNH*TE\`E\$*QR8`ET(!!7T`(X0`<_0`;:&@`#(BL0;9`^4>"Q>,`%;!L*;UNB2]`"7,`%C2"FU%$&*T`#=(!,`%`"1/"J MCSH!5]`&B,`%+!`)._L#H2`%8["R`K$&6Z`)+=`#C?^P`C[T!YB``RM@"8%; M`IY0MWV`!P(+LMHZ1HAP&_8Z!`/1`VFPNK"Z`OQ:!#BP!P"@`BSPM!,0"3W0 M"9$0&6UKK0+1!(YPGU\`"AEI*"2['P,1K=K:!#V@K4.``Q*K`I@`P'\0M@"P M!C[`%VO`"DM0"$5P"5B@`)#0`ID*`"SP!'N``&O`!30P"&00N#R``RW0"&?0 M!(N@!VF@P[K`!4\K$#V@N@*Q!?P+`)>`"&LP`43P!"6P`%@`K`KP!"T``&-@ ML#^P!8$0"'RP!C2`!YW@B(8B!A-PMJ/Z![VJ-KW:K.F3`*=0%$OP!TZD`C2P MND`!`*C``R7PKVWP`TV0%21,L`7[2@MU,+F-(!"B<`8^L`9/0`,H-@EI4,.! M.Q`30`)>.P:[*P:4FP9N<02.(+'3NK9M4`:PZP-/2P<^T`*2>J=](;RVG,NZ &?*
-----END PRIVACY-ENHANCED MESSAGE-----