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Originator-Name: webmaster@www.sec.gov
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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
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0-16614
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91-1261311
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(State or Other
Jurisdiction
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(Commission File No.)
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(IRS Employer
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of Incorporation)
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Identification No.)
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7000 Shoreline Court,
Suite 270, South San Francisco, California
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94080
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(Address
of principal executive offices)
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(Zip
Code)
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(650) 583-3774
(Registrants 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 Companys 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 Companys
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.
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Poniard Pharmaceuticals, Inc.
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Dated: March 25, 2010
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By:
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/s/ Gregory L. Weaver
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Name: Gregory L. Weaver
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Title: Chief Financial Officer
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3
EXHIBIT
INDEX
Exhibit No.
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|
Description
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99.1
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Press Release dated March 24, 2010
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4
EX-99.1
2
a10-7027_1ex99d1.htm
EX-99.1
Exhibit 99.1
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 drugs value proposition and what we believe
makes it an attractive development candidate.
In the Companys 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 Companys
plan to refocus its resources on developing pivotal clinical strategies for
picoplatin in a number of cancer indications, the Companys plan to explore
strategic alternatives, and the Companys 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 Companys business, including, the Companys
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
Companys 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 Companys ability to retain key personnel; competition from third
parties; the Companys ability to preserve and protect its intellectual
property rights; the Companys 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
Companys current and periodic reports filed with the Securities and Exchange
Commission (SEC), including the Companys 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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