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): June 6, 2010
NEKTAR
THERAPEUTICS
(Exact
Name of Registrant as Specified in Charter)
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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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 June
6, 2010, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued a press
release (the “Press Release”) announcing results from a Phase 2 clinical study
evaluating NKTR-102 in women with platinum-resistant/refractory ovarian
cancer. A copy of the Press Release is furnished herewith as Exhibit
99.1.
On May
20, 2010, Nektar announced that it would host an investor and analyst breakfast
on Monday, June 7, 2010, in conjunction with the 2010 ASCO Annual Meeting to
discuss results from the Phase 2 clinical trial in ovarian cancer and
perspective from clinical investigators and thought leaders in the ovarian
cancer field. This breakfast event is being webcast, and as
previously announced by Nektar, may be accessed in the Events Calendar section
on the homepage of Nektar’s website at www.nektar.com. At this
breakfast event Nektar management expects to make certain forward-looking
statements regarding the potential therapeutic benefit of NKTR-102 for ovarian
cancer patients, the future clinical development and regulatory plans for
NKTR-102, and the potential and timing for a collaboration partnership for
NKTR-102, the market potential of NKTR-102, and certain other statements
regarding the prospects and potential of Nektar’s business, technology platform
and drug candidate pipeline. These forward-looking statements involve
substantial risks and uncertainties including but not limited to: (i) 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) prior to regulatory approval due to lack of sufficient efficacy, safety
considerations or other important factors that impact drug development; (ii) the
data package required and the timing for regulatory approval of a new drug
application (NDA) is very uncertain and difficult to predict due to the broad
regulatory discretion of health authorities, changing standards of care,
available approved therapies, the size of the 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 not very unpredictable and not within the control of Nektar; (iii) approval
of a NDA by the Food and Drug Administration (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; (iv)
the expansion of the Phase 2 study in women with platinum-resistant/refractory
ovarian cancer in the Q21 dose group will necessarily change the final efficacy
(e.g. overall response rates, progression-free survival etc.) and safety (i.e.
frequency of serious adverse events) final results for the Phase 2 clinical
trial and, as such, the final results in the Q21 dose group remain subject to
change and could be materially and adversely different from the current results;
(v) the Phase 2 results for NKTR-102 in ovarian cancer described in the Press
Release remain subject to final data gathering and analysis review and
confirmation procedures and the final results for the ovarian cancer trial may
differ materially and adversely; (vi) the results from the NKTR-102 clinical
study for ovarian cancer are not necessarily indicative or predictive of the
results for future clinical trial for NKTR-102 in ovarian cancer study or the
results of NKTR-102 in any other cancer indications for which it is currently
being studied (i.e., breast and colorectal cancers); (vii) 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; (viii)
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; (ix)
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;
(x) the outcome of any existing or future intellectual property or other
litigation related to Nektar’s proprietary product candidates, including without
limitation NKTR-102, is unpredictable and could have a material adverse effect
on our business, results of operations and financial condition and the prospects
for commercialization of NKTR-102; (xi) the market potential for NKTR-102 is
based on management’s current estimates only and actual market size may differ
materially and adversely; (xii) if Nektar is unable to establish and maintain
collaboration partnerships or appropriate transaction structures relating to its
drug candidates (such as for NKTR-102) on attractive commercial terms, our
business, results of operations and financial condition could suffer; (xiii) 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 (xiv)
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. Actual results could differ materially from the
forward-looking statements contained in this press release. Nektar
undertakes no obligation to update forward-looking statements, including but not
limited to any clinical, health authority communications or other regulatory
information, 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.
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 “NKTR-102 Has High Response Rate and Sustained Clinical
Benefit in 48 Percent of Women with Platinum-Resistant/Refractory Ovarian
Cancer” issued by Nektar Therapeutics on June 6,
2010.
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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:
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June
7, 2010
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EXHIBIT
INDEX
Exhibit
No.
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Description
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99.1
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Press
release titled “NKTR-102 Has High Response Rate and Sustained Clinical
Benefit in 48 Percent of Women with Platinum-Resistant/Refractory Ovarian
Cancer” issued by Nektar Therapeutics on June 6,
2010.
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