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): January 11, 2011
NEKTAR
THERAPEUTICS
(Exact
Name of Registrant as Specified in Charter)
Delaware
|
0-24006
|
94-3134940
|
||
(State
or Other Jurisdiction
of
Incorporation)
|
(Commission
File
Number)
|
(IRS
Employer
Identification
No.)
|
455
Mission Bay Boulevard South
San
Francisco, California 94158
(Address
of Principal Executive Offices and Zip Code)
Registrant’s
telephone number, including area code: (415) 482-5300
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:
¨
|
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 8.01
|
Other
Events.
|
On
January 5, 2011, Nektar Therapeutics, a Delaware corporation (the “Company”),
announced that President and Chief Executive Officer, Howard W. Robin, will make
a presentation at the upcoming 29th Annual J.P. Morgan Healthcare Conference in
San Francisco at the Westin St. Francis Hotel on Tuesday, January 11, 2011 at
8:30 a.m. Pacific time. The presentation will be accessible via a
Webcast through a link posted on the Investor Relations, Events Calendar section
of the Nektar website: http://www.nektar.com.
During
Mr. Robin’s presentation, he expects to present information, including making
certain forward-looking statements, regarding pre-clinical and clinical
development results and the progress and potential for the Company’s proprietary
drug development programs, the planned start date time frames for future
clinical trials to be conducted by the Company and its partners (NKTR-118,
NKTR-102 and Amikacin Inhale), the timing and availability of future clinical
results, 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 estimated revenue potential for our drug candidates, and certain
other future events. This information and these forward-looking
statements involve substantial risks and uncertainties including but not limited
to:
|
1.
|
The
Company’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, manufacturing challenges or other factors that can impact
drug development.
|
|
2.
|
The
preliminary Phase 2 results for NKTR-102 in ovarian and breast cancer
remain subject to final data gathering and analysis review and audit
confirmation procedures and the final results for the ovarian and breast
cancer trials may differ materially and adversely after this review is
completed.
|
|
3.
|
The
preliminary Phase 2 results for overall survival in NKTR-102 in platinum
resistant/refractory ovarian cancer were as of January 3, 2011, and as the
study progresses (including the expansion study) and after the audit and
verification procedures are completed, the final overall survival results
may change and such change could be material and
adverse.
|
|
4.
|
The
expansion of the Phase 2 study in women with platinum-resistant/refractory
ovarian cancer could 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). 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 different from results previously
announced.
|
|
5.
|
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.
|
|
6.
|
The
preliminary clinical results from the NKTR-102 clinical trial in
metastatic breast cancer reported by the Company in a press release issued
on December 12, 2010 and that will be reviewed in Mr. Robin’s presentation
were as of October 26, 2010. As such, these data are subject to
change and the final results could be materially and adversely different
as the Phase 2 clinical trial continues and after the audit and
verification procedures are
completed.
|
|
7.
|
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. For example, the Company has experienced significant
delays in finalizing the commercial device design for Amikacin Inhale and
successful completion of this device design and commercial scale-up effort
is an important element to meeting the planned start of the Phase 3 trial
in 2011 and these activities are ongoing and remain subject to a
substantial risk of failure until such activities are successfully
completed.
|
|
8.
|
Scientific
discovery of new medical breakthroughs is an inherently uncertain process
and the future success of the application of the Company’s technology
platforms to potential new drug candidates is therefore very uncertain and
unpredictable and one or more research and development programs could
fail.
|
|
9.
|
The
Company’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.
|
|
10.
|
The
outcome of any existing or future intellectual property or other
litigation related to the Company’s proprietary product candidates or
partner product candidates where the Company has indemnification
responsibility is unpredictable and could have a material adverse effect
on our business, results of operations and financial
condition.
|
|
11.
|
The
market sizes for the Company’s proprietary and partnered product programs
are based on management’s current estimates only and actual market sizes
may differ materially and
adversely.
|
|
12.
|
Other
important risks and uncertainties set forth in the Company’s Quarterly
Report on Form 10-Q filed with the SEC on November 4, 2010 for the quarter
ended September 30, 2010.
|
Actual
results could differ materially from the forward-looking statements and the
Company undertakes no obligation to update forward-looking statements, whether
as a result of new information, future events or otherwise.
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:
|
/s/
Gil M. Labrucherie
|
|
Gil
M. Labrucherie
|
||
General
Counsel and Secretary
|
||
Date:
|
January
11, 2011
|