Unassociated Document
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 2, 2010
NEKTAR
THERAPEUTICS
(Exact
Name of Registrant as Specified in Charter)
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Delaware
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0-24006
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94-3134940
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(State
or Other Jurisdiction
of
Incorporation)
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(Commission
File
Number)
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(IRS
Employer
Identification
No.)
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201
Industrial Road
San
Carlos, California 94070
(Address
of Principal Executive Offices and Zip Code)
Registrant’s
telephone number, including area code: (650) 631-3100
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:
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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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¨
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item 2.02
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Results
of Operations and Financial
Condition
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On March
2, 2010, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued a press
release (the “Press Release”) announcing its year-end 2009 financial
results. A copy of the Press Release is furnished herewith
as Exhibit 99.1.
On
February 23, 2010, Nektar announced that management would hold a conference call
on March 2, 2010 to review its 2009 year-end financial results and provide an
update on Nektar’s business. On this conference call, management
expects to make certain forward-looking statements regarding certain
pre-clinical and clinical development results and progress for certain of
Nektar’s proprietary drug development programs, the value of Nektar’s pegylation
and advanced polymer chemistry technology platform, the timing and availability
of future clinical development program results, potential future revenues that
may be realized in the future under certain of the Nektar’s collaboration
agreements, and management’s financial guidance for 2010. These
forward-looking statements involve substantial risks and uncertainties including
but not limited to: (i) Nektar’s proprietary drug candidates, including
NKTR-118, NKTR-102 and NKTR-105, are in early to mid-stage clinical development
and the risk of failure remains high and can unexpectedly occur at any stage
prior to regulatory approval due to lack of efficacy, safety issues or other
factors; (ii) the preliminary Phase 2 results for NKTR-102 in ovarian cancer
patients in stage 1 announced by Nektar in January 2010 represent preliminary
data only and this data remains subject to final data gathering and analysis
review procedures; (iii) the preliminary results from stage 1 of the NKTR-102
clinical study for ovarian cancer are not necessarily indicative or predictive
of the future results from stage 2 of this clinical study or the results of
NKTR-102 in any of other cancer indications for which it is currently being
studied (i.e. breast and colorectal cancers), (iv) the amount and timing of
future payments that may become payable to Nektar under the license agreement
with AstraZeneca for NKTR-118 and NKTR-119 is subject to a number of
development, regulatory and commercial risks such as the risk of failure to
obtain regulatory approval for NKTR-118 and/or NKTR-119 based on
safety, efficacy or other issues, the risk of a lack of government or private
insurance reimbursement limiting commercial potential, the risk of competition
from alternative competing therapies, and other important risks and
uncertainties described or incorporated by reference herein; (v) the timing or
success of the commencement or end of clinical trials and commercial launch of
new drugs may be delayed or unsuccessful due to regulatory delays, clinical
trial design, slower than anticipated patient enrollment, drug manufacturing
challenges, changing standards of care, clinical outcomes, or delay or failure
in obtaining regulatory approval in one or more important
markets; (vi) scientific discovery of new medical breakthroughs is an
inherently uncertain process and the future success of the application of
Nektar’s technology platforms to potential new drug candidates is therefore very
uncertain and unpredictable and one or more research and development programs
could fail; (vii) management’s financial projections for the Nektar’s 2010
annual revenue, cash used in operations and year-end cash position are subject
to the significant risk of unplanned revenue short-falls and unplanned expenses,
which could adversely affect Nektar’s actual 2010 annual financial results and
end of year cash position; (viii) Nektar’s patent applications for its
proprietary or partner product candidates may not issue, patents that have
issued may not be enforceable, or intellectual property licenses from third
parties may be required in the future; (ix) the outcome of any existing or
future intellectual property or other litigation related to Nektar’s proprietary
product candidates or partner product candidates where Nektar has
indemnification responsibility; (x) the market sizes for Nektar’s proprietary
and partnered product programs are based on management’s current estimates only
and actual market sizes may differ materially and adversely; (xi) if Nektar is
unable to establish and maintain collaboration partnerships (such as for
NKTR-102 in 2010) on attractive commercial terms, our business, results of
operations and financial condition could suffer; (xii) the
timing of any new collaboration partnerships is difficult to predict due to
availability of clinical data, the number of potential partners that need to
complete due diligence and approval processes, and numerous other unpredictable
factors that can delay, impede or prevent partnering transactions; and
(xiii) certain other important risks and uncertainties set forth in Nektar’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
2009. Actual results could differ materially from the forward-looking
statements made by management during the conference call and in the press
release attached as Exhibit 99.1 hereto. Nektar undertakes no
obligation to update forward-looking statements, whether as a result of new
information, future events or otherwise
The
information in this report, including the exhibit hereto, is being furnished and
shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, or otherwise subject to the liabilities
of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933,
as amended. The information contained herein and in the accompanying
exhibit shall not be incorporated by reference into any filing with the
Securities and Exchange Commission made by Nektar Therapeutics, whether
made before or after the date hereof, regardless of any general
incorporation language in such filing.
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Item 9.01
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Financial
Statements and Exhibits
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Exhibit
No.
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Description
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99.1
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Press
release titled “Nektar Therapeutics Reports Year-End 2009 Financial
Results” issued by Nektar Therapeutics on March 2,
2010.
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SIGNATURES
Pursuant
to the requirement of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
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By:
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/s/
Gil M. Labrucherie
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Gil
M. Labrucherie
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General
Counsel and Secretary
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| Date: March
2,
2010 |
EXHIBIT
INDEX
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Exhibit
No.
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Description
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99.1
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Press
release titled “Nektar Therapeutics Reports Year-End 2009 Financial
Results” issued by Nektar Therapeutics on March 2,
2010.
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