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Delaware
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0-24006
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94-3134940
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||||
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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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||||
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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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(i)
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NKTR-102
is in early stage clinical development and the risk of failure remains
high, and failure can unexpectedly occur at any stage for one or more of
the cancer indications being studied (i.e., ovarian cancer, breast cancer,
and colorectal cancer) due to lack of sufficient efficacy, safety concerns
or other important factors that impact drug development and regulatory
approval;
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(ii)
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the
Phase 2 results for NKTR-102 in breast cancer described in the Press
Release and presented by Nektar management at the Jefferies conference
remain subject to data audit confirmation procedures, and the
reported results may change materially and adversely after such
review is completed;
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(iii)
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the
initial preliminary RECIST response data for the NKTR-102 clinical trial
in breast cancer reported in the Press Release and to be discussed at the
Jefferies conference is subject to substantial change and such substantial
change could be material and adverse—in particular, there is no way to
predict whether unconfirmed responses will become confirmed responses as
the clinical trial progresses;
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(iv)
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additional
important data will be reported by Nektar in the future regarding the
NKTR-102 clinical study in breast cancer including but not limited to
confirmed/unconfirmed RECIST response rates, progression-free survival,
overall survival and further safety information regarding the frequency
and severity of adverse events observed, and therefore the complete and
final results for the Phase 2 breast cancer trial may differ materially
and adversely from the results reported in the Press Release and at the
Jefferies conference;
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(v)
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the
initial results from the NKTR-102 clinical study in breast cancer are not
necessarily indicative or predictive of the future results of NKTR-102 in
any other cancer indications for which it is currently being studied
(i.e., ovarian and colorectal
cancers);
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(vi)
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the
data package required and the timing for regulatory approval of a new drug
application (NDA) by the Food and Drug Administration (FDA) is very
uncertain and difficult to predict due to broad regulatory discretion,
changing standards of care, available approved therapies, the size of
completed clinical trials and the statistical significance of the results,
the potential need for comparative clinical studies against approved
therapies, and other important factors that are very unpredictable and not
within Nektar’s control;
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(vii)
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approval
of an NDA by the FDA almost always requires the sponsor to conduct Phase 3
clinical studies prior to consideration and approval of an NDA and, as a
result, approval of an NDA by the FDA based on Phase 2 results prior to
completion of Phase 3 clinical studies is highly
unlikely;
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(viii)
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the
expansion of the Phase 2 study in women with platinum-resistant/refractory
ovarian cancer in the Q21 dose group, which Nektar announced on Monday,
June 7, 2010 at a webcast breakfast meeting, will necessarily result in
changes to the final efficacy (e.g., overall response rates,
progression-free survival, overall survival) and safety (i.e., frequency
and severity of adverse events) results for the Phase 2 clinical trial in
ovarian cancer, and, as such, the complete and final results in the Q21
dose group remain subject to change and could be materially and adversely
different from the results previously announced by Nektar in a press
release furnished on Exhibit 99.1 to the Current Report on Form 8-K filed
with the Securities and Exchange Commission on June 7,
2010;
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(ix)
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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;
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(x)
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scientific
discovery of new medical breakthroughs is an inherently uncertain process,
and the future success of the application of Nektar’s technology platform
to potential new drug candidates is therefore very uncertain and
unpredictable and one or more research and development programs could
fail;
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(xi)
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Nektar’s
patent applications for its proprietary or partner product candidates may
not issue, patents that have issued may not be enforceable, or additional
intellectual property licenses from third parties may be required in the
future;
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(xii)
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the
outcome of any existing or future intellectual property or other
litigation related to Nektar’s proprietary product candidates, including
without limitation NKTR-102, NKTR-118, NKTR-105 and other of Nektar’s drug
candidates, is unpredictable and could have a material adverse effect on
our business, results of operations and financial condition and the
prospects for commercialization of one or more of Nektar’s drug
candidates;
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(xiii)
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the
market potential for NKTR-102, NKTR-118, NKTR-105 and other of Nektar’s
drug candidates is based on management’s current estimates only, and
actual market size may differ materially and
adversely;
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(xiv)
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if
Nektar is unable to establish and maintain collaboration partnerships or
appropriate transaction structures relating to its drug candidates (e.g.,
NKTR-102) on attractive commercial terms, our business, results of
operations and financial condition could suffer;
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(xv)
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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 from being consummated;
and
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(xvi)
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certain
other important risks and uncertainties set forth in Nektar’s Quarterly
Report on Form 10-Q for the quarter ended March 31, 2010 filed on May 6,
2010, and the Annual Report on Form 10-K for the year ended December 31,
2009, filed on March 3, 2010.
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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
|
|
Press
release titled “Nektar Therapeutics Announces Positive Initial Results
from Phase 2 Study of NKTR-102 in Metastatic Breast Cancer” issued by
Nektar Therapeutics on June 9,
2010.
|
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By:
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/s/ Gil M. Labrucherie | |
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Gil
M. Labrucherie
General
Counsel and Secretary
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|||
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Date:
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June 9, 2010 | ||
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Exhibit
No.
|
|
Description
|
|
99.1
|
|
Press
release titled “Nektar Therapeutics Announces Positive Initial Results
from Phase 2 Study of NKTR-102 in Metastatic Breast Cancer” issued by
Nektar Therapeutics on June 9,
2010.
|