-----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, TTEwYO5v6TgdyHcOUrE7Va4w2aZXFeYhCnjf3iAy1fKpc+1odixxgs6hcreZLQu0 WVWqzGO7aSQvLR9YltZ6Zw== 0001104659-10-016462.txt : 20100325 0001104659-10-016462.hdr.sgml : 20100325 20100325155415 ACCESSION NUMBER: 0001104659-10-016462 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20100322 ITEM INFORMATION: Cost Associated with Exit or Disposal Activities ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100325 DATE AS OF CHANGE: 20100325 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: 10704620 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 a10-7027_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

 

March 22, 2010

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

 

(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 2.05.              Costs Associated with Exit or Disposal Activities.

 

At its meeting on March 22, 2010, the Board of Directors (the “Board”) of the Company approved a restructuring plan in connection with the Company’s decision to suspend its efforts to pursue a New Drug Application (“NDA”) for  picoplatin in small cell lung cancer, as described in Item 8.01 below.  This reduction in personnel will decrease the number of employees by approximately 45 percent, to a total of 12, effective April 30, 2010.  The Company will continue to provide clinical and regulatory support activities for its current studies.  In connection with this plan, the Company currently estimates that it will incur a total restructuring charge of approximately $0.5 million, consisting of one-time employee termination benefits, which are subject to future change as further analysis is conducted.  The full amount of the estimated restructuring charge will result in future cash expenditures.

 

Section 8 – Other Events

 

Item 8.01.              Other Events.

 

On March 24, 2010, the Company announced that, following a detailed analysis of primary and updated data from the Phase 3 SPEAR study of picoplatin in small cell lung cancer (“SCLC”) and an evaluation of the ongoing NDA process with the U.S. Food and Drug Administration, the Company decided to suspend its efforts to obtain regulatory approval for picoplatin in SCLC at this time. The Company plans to focus its resources on developing pivotal clinical strategies for picoplatin in small cell lung cancer, as well as colorectal, prostate, and ovarian cancers.  Pursuant to this decision, the Company engaged Leerink Swann LLC to conduct a comprehensive review of the Company’s strategic alternatives, including capital raising alternatives, merger, sale or partnership. The Company does not plan to release additional information about the status of the review of alternatives until a definitive agreement is entered into or the process is otherwise completed.

 

See press release dated March 24, 2010, attached hereto as Exhibit 99.1 and incorporated herein by reference, specifically including the cautionary note regarding forward-looking statements contained in the press release.

 

Section 9 – Financial Statements and Exhibits

 

Item 9.01.              Financial Statements and Exhibits.

 

(d)           Exhibits.

 

99.1 - Press release dated March 24, 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 25, 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 24, 2010

 

4


EX-99.1 2 a10-7027_1ex99d1.htm EX-99.1

Exhibit 99.1

 

GRAPHIC

 

 

Poniard Pharmaceuticals Provides Strategic Update on Picoplatin Development Program

 

Engages Leerink Swann LLC to Explore Strategic Alternatives for the Company;
Announces Workforce Restructuring

 

South San Francisco, Calif. (March 24, 2010) — Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced a clinical and regulatory update on its lead product candidate, picoplatin.  Following a detailed analysis of primary and updated data from the Phase 3 SPEAR study of picoplatin in small cell lung cancer (SCLC) and an evaluation of the ongoing New Drug Application (NDA) process with the U.S. Food and Drug Administration (FDA), the Company has decided to suspend its efforts to obtain regulatory approval for picoplatin in SCLC at this time. The Company will focus its resources on developing pivotal clinical strategies for picoplatin in small cell lung cancer, as well as colorectal, prostate, and ovarian cancers.  Pursuant to this decision, the Company announced that it has engaged Leerink Swann LLC to conduct a comprehensive review of strategic alternatives aimed at enabling the execution of these strategies and optimizing shareholder value. These alternatives could include capital raising alternatives, merger, sale or partnership.

 

“Leveraging key insights from the SPEAR study, we plan to redirect our resources toward developing multiple registration strategies to advance picoplatin to market,” stated Ronald A. Martell, chief executive officer of Poniard.  “Picoplatin has demonstrated promising clinical activity, including favorable survival and safety data in small cell lung cancer, as well as in a variety of other solid tumors.  This versatility is at the core of the drug’s value proposition and what we believe makes it an attractive development candidate.  In the Company’s current position, we believe that a full review of strategic alternatives offers us the best opportunity to achieve our objectives for our shareholders.”

 

In connection with this action, Poniard announced a restructuring of its workforce, eliminating those positions focused on pursuing an NDA filing for SCLC, along with certain supporting functions. This reduction in personnel will decrease the number of employees by approximately 45 percent, to a total of 12, effective April 30, 2010. Poniard will continue to provide clinical and regulatory support activities for its current studies. Poniard expects the reduction in force to result in an approximately $2.2 million decrease in operating expenses in 2010, net of a charge in the second quarter of approximately $0.5 million related to the workforce reduction.

 



 

Mr. Martell concluded: “Internally, our efforts will now be focused on developing registration strategies and exploring strategic alternatives to support the continued development of picoplatin in colorectal, prostate, ovarian and small cell lung cancers.  We regret that this decision will affect those individuals charged with pursuing a regulatory application in SCLC, and we thank them for their service to the Company.”

 

The Company expects that efficacy and safety data from the SPEAR study will be presented at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting taking place June 4-8, 2010 in Chicago.

 

With respect to the review of strategic alternatives, there can be no assurances that any particular alternative will be pursued or that any transaction will occur, or on what terms. The Company does not plan to release additional information about the status of the review of alternatives until a definitive agreement is entered into or the process is otherwise completed.

 

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 is 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 safely administered in combination with multiple approved oncology products. Approximately 1,100 patients have received picoplatin. 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. Picoplatin has demonstrated anti-tumor activity in a variety of solid tumors.

 

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, including, without limitation, statements regarding the Company’s plan to refocus its resources on developing pivotal clinical strategies for picoplatin in a number of cancer indications, the Company’s plan to explore strategic alternatives, and the Company’s goal of optimizing shareholder value. 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, the Company’s anticipated future operating losses, need for future capital and ability to obtain future funding; the risk that strategic relationships may not be established on a timely basis, on terms that ultimately are favorable to the Company, or at all; the potential safety, efficacy and commercial viability of picoplatin; the risk that the

 

2



 

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 ability to retain key personnel; 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; 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, 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.

 

3


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