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Delaware
|
0-24006
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94-3134940
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||
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(State
or Other Jurisdiction
of
Incorporation)
|
(Commission
File
Number)
|
(IRS
Employer
Identification
No.)
|
|
¨
|
Written communications pursuant
to Rule 425 under the Securities Act (17 CFR
230.425)
|
|
¨
|
Soliciting material pursuant to
Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
¨
|
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
|
¨
|
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
|
|
Item
2.02
|
Results
of Operations and Financial
Condition
|
|
|
1.
|
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.
|
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.
|
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.
|
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;
|
|
|
5.
|
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;
|
|
|
6.
|
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;
|
|
|
7.
|
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;
|
|
|
8.
|
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;
|
|
|
9.
|
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;
|
|
|
10.
|
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;
|
|
|
11.
|
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;
|
|
|
12.
|
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;
|
|
|
13.
|
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
|
|
|
14.
|
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.
|
|
Item 9.01
|
Financial
Statements and Exhibits
|
|
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
release titled “Nektar Therapeutics Reports Third Quarter 2010 Financial
Results” issued by Nektar Therapeutics on November 4,
2010.
|
|
|
By:
|
/s/
Gil M. Labrucherie
|
||
|
Gil
M. Labrucherie
|
|||
|
General
Counsel and Secretary
|
|||
|
Date:
|
November
4, 2010
|
||
|
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
release titled “Nektar Therapeutics Reports Third Quarter 2010 Financial
Results” issued by Nektar Therapeutics on November 4,
2010.
|
|