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): March 2, 2009
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.)
|
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:
|
¨
|
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
7.01. Regulation FD Disclosure
On
March 2, 2009, Nektar Therapeutics issued a press release (the “Press Release”)
entitled “Nektar Announces Positive Results from Phase 2 Study of Oral NKTR-118
in Patients with Opioid-Induced Constipation (OIC).” A copy of the
Press Release is furnished herewith as Exhibit 99.1.
On
February 24, 2009, the company announced that it would hold a conference call on
March 2, 2009 to review its financial results for the quarter and year ended
December 31, 2008. On this conference call, management expects to
make certain forward-looking statements regarding the market potential and
revenue potential to the company for partnered product programs, the clinical
development status and certain pre-clinical and clinical results from its
proprietary product development programs including Phase 2 results for NKTR-118,
and management’s financial guidance for 2009. These forward-looking
statements involve substantial risks and uncertainties including but not limited
to: (i) NKTR-118 is in mid-stage clinical development and the risk of
failure remains high and failure can unexpectedly occur at any stage prior to
regulatory approval due to efficacy, safety or other factors; (ii) the
preliminary Phase 2 results for NKTR-118 presented in the Press Release and
further discussed on the conference call by management remain subject to change
based on completion of the final data gathering and analysis; (iii) 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; (iv) the
timing or success of the commencement or end of clinical trials and commercial
launch of partnered products may be delayed or unsuccessful due to slower than
anticipated patient enrollment, drug manufacturing challenges, changing
standards of care, clinical trial design, clinical outcomes, or delay or failure
in obtaining regulatory approval in one or more important markets; (v) clinical
trials are long, expensive and uncertain processes and the risk of failure of
any drug candidate that is in clinical development and prior to regulatory
approval remains high and can occur at any stage due to efficacy, safety or
other factors; (vi) management’s financial projections for the company’s 2009
revenue, cash used in operations and year-end cash position are subject to the
significant risk of unplanned revenue short-falls or unplanned expenses, which
could adversely affect the company’s actual 2009 financial results and end of
year cash position; (vii) the company’s patent applications for its proprietary
or partner product candidates may not issue, patents that have issued may not be
enforceable, or intellectual property licenses from third parties may be
required in the future; (viii) the outcome of any existing or future
intellectual property or other litigation related to the company’s proprietary
product candidates; (ix) the market sizes and revenue potential of the company’s
proprietary and partnered product programs are management’s current estimates
only and actual market sizes may differ materially; (x) the overall market size
for the partnered product programs and revenue and profit contribution potential
to the company will depend upon successful sales and marketing efforts by our
partners, competition from competing therapies (if any), government and private
insurance reimbursement, changing standards of care, commercial product profile
and final product pricing; and (xi) certain other important risks and
uncertainties set forth in the company’s Annual Report on Form 10-K filed with
the Securities and Exchange Commission on February 29, 2008 and the company’s
most recent Quarterly Report on Form 10-Q to be filed on November 7,
2008. Actual results could differ materially from the forward-looking
statements contained in the Press Release and made by management during the
conference call. The company undertakes no obligation to update
forward-looking statements, whether as a result of new information, future
events or otherwise.
The information in Item 7.01 of this report 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
|
Financial
Statements and Exhibits
|
|
Exhibit
Number
|
|
Description
|
|
99.1
|
|
Press
Release issued on March 2, 2009 by Nektar Therapeutics entitled “Nektar
Announces Positive Results from Phase 2 Study of Oral NKTR-118 in Patients
with Opioid-Induced Constipation
(OIC).”
|
SIGNATURES
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:
|
|
March
2, 2009
|