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EX-99.1 - NEKTAR THERAPEUTICS | v200996_ex99-1.htm |
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): November 4, 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
November 4, 2010, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued
a press release (the “Press Release”) announcing its financial results for
the quarter ended September 30, 2010. A copy of the Press
Release is furnished herewith as Exhibit 99.1.
On
October 28, 2010, Nektar announced that its management would hold a conference
call on November 4, 2010 to review its financial results for the quarter ended
September 30, 2010. On this conference call, management expects to
make certain forward-looking statements regarding pre-clinical and clinical
development results and progress for certain of Nektar’s proprietary drug
development programs, the value and potential of Nektar’s advanced polymer
chemistry technology platform, the timing and availability of future results
from clinical development programs, the potential for submitting a New Drug
Application (“NDA”) on an accelerated basis to the Food and Drug Administration
(“FDA”) pending the outcome of future results from an expanded Phase 2 clinical
study which is currently in progress for NKTR-102 in
platinum-resistant/refractory ovarian cancer, the progress of Nektar’s programs
currently in the clinic, the timing for the anticipated start of clinical
trials, the timing and potential for completion of a partnership transaction for
NKTR-102, the commercial potential of drug candidates, potential future revenues
that may be realized under one or more of Nektar’s collaboration agreements, and
financial guidance for 2010. These forward-looking statements involve
substantial risks and uncertainties including but not limited to:
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1.
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Nektar’s
proprietary drug candidates, including NKTR-118, NKTR-102, Amikacin
Inhale, 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,
maufacturing challenges or other factors that can impact drug
development;
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2.
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The
Phase 2 results for NKTR-102 in ovarian previously announced by Nektar in
2010 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;
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3.
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The
expansion of the Phase 2 study in women with platinum-resistant/refractory
ovarian cancer will necessarily change the efficacy results (e.g. overall
response rates, progression-free survival etc.) and safety observations
(i.e. frequency and severity of serious adverse events) and, as such, the
previously announced results from the Phase 2 study for ovarian cancer
remain subject to change and the final results could be materially and
adversely;
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4.
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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, review and/or approval of an NDA by the FDA based on Phase 2
results for NKTR-102 in platinum-resistant/refractory ovarian cancer prior
to completion of Phase 3 clinical studies would be unusual and is highly
unlikely;
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5.
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The
initial preliminary RECIST response data for the NKTR-102 clinical trial
in metastatic breast cancer reported by Nektar in a press release issued
on June 9, 2010 is subject to substantial change as the trial continues to
progress since that date and such substantial change could be material and
adverse;
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6.
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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;
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7.
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The
timing of any new collaboration partnerships or other similar transactions
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 significant
transactions;
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8.
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The
timing and/or success of the commencement or end of clinical trials,
including without limitation the anticipated Phase 3 commencement for
NKTR-118 and Amikacin Inhale, may be delayed or unsuccessful due to
regulatory delays, clinical trial design (and regulatory concurrence for
design), slower than anticipated patient enrollment, manufacturing
challenges, changing standards of care or clinical
outcomes;
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9.
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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 platforms
to potential new drug candidates is therefore very uncertain and
unpredictable and we expect numerous research and development programs to
fail;
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10.
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Management’s
financial projections for 2010 revenue and year-end cash position are
subject to significant risks of unplanned revenue and/or cash short-falls
and unplanned expenses, which could adversely affect Nektar’s actual 2010
annual financial results and year-end cash
position;
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11.
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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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12.
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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 is
unpredictable and could have a material adverse effect on our business,
results of operations and financial
condition;
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13.
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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;
and
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14.
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Other
important risks and uncertainties set forth in Nektar’s Quarterly Report
on Form 10-Q filed with the SEC for the quarter ended June 30,
2010.
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Actual
results could differ materially from the forward-looking statements made by
management during the conference call and in the Press
Release. 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.
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 Third Quarter 2010 Financial
Results” issued by Nektar Therapeutics on November 4,
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.
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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November
4, 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 “Nektar Therapeutics Reports Third Quarter 2010 Financial
Results” issued by Nektar Therapeutics on November 4,
2010.
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