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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Washington, D.C.&nbsp;20549</B></P>

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<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>FORM 8-K</B></P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>CURRENT REPORT</B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Pursuant to Section&nbsp;13 or 15(d)
of the Securities Exchange Act of 1934</B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Date of report&nbsp;(Date of earliest event
reported): June 5, 2012</P>

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<P STYLE="font: 24pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>NEKTAR THERAPEUTICS</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Exact Name of Registrant as Specified
in Charter)</B></P>

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    <TD STYLE="vertical-align: top; padding-right: 0.8pt; font-size: 10pt; font-weight: bold; text-align: center">Delaware</TD>
    <TD STYLE="vertical-align: bottom; padding-right: 0.8pt; font-size: 10pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="vertical-align: top; padding-right: 0.8pt; font-size: 10pt; font-weight: bold; text-align: center">0-24006</TD>
    <TD COLSPAN="2" STYLE="vertical-align: bottom; padding-right: 0.8pt; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; padding-right: 0.8pt; font-size: 10pt; font-weight: bold; text-align: center">94-3134940</TD></TR>
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    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0; text-align: center"><B>(State or Other Jurisdiction</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0; text-align: center"><B>of Incorporation)</B></P></TD>
    <TD STYLE="vertical-align: bottom; padding-right: 0.8pt; font-size: 10pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0; text-align: center"><B>(Commission</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0; text-align: center"><B>File Number)</B></P></TD>
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        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0; text-align: center"><B>(IRS Employer</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0; text-align: center"><B>Identification No.)</B></P></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>455 Mission Bay Boulevard South</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>San Francisco, California 94158</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Address of Principal Executive Offices
and Zip Code)</B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Registrant&rsquo;s telephone number, including
area code: (415) 482-5300</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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:</P>

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    <TD STYLE="width: 96%; padding-right: 0.8pt; font-size: 10pt">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</TD></TR>
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    <TD STYLE="width: 4%; font: 10pt Wingdings; padding-right: 0.8pt">&uml;</TD>
    <TD STYLE="width: 96%; padding-right: 0.8pt; font-size: 10pt">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</TD></TR>
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    <TD STYLE="width: 96%; padding-right: 0.8pt; font-size: 10pt">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</TD></TR>
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    <TD STYLE="width: 96%; padding-right: 0.8pt; font-size: 10pt">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</TD></TR>
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    <TD STYLE="width: 10%; padding-right: -28.35pt; font-size: 10pt; font-weight: bold">Item&nbsp;8.01</TD>
    <TD STYLE="width: 90%; padding-right: 0.8pt; font-size: 10pt; font-weight: bold">Other Events</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">On May 30, 2012, Nektar
Therapeutics, a Delaware corporation (&ldquo;Nektar&rdquo;), announced that its President and Chief Executive Officer, Howard W.
Robin, is scheduled to present at the Jefferies 2012 Global Healthcare Conference at The Grand Hyatt New York on Tuesday, June
5, 2012 at 11:30 a.m. Eastern Time. This 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. This webcast will be available for replay until July 5, 2012.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">During his presentation Mr. Robin expects
to make certain forward-looking statements regarding Nektar&rsquo;s business including but not limited to: (i) statements regarding
the commercial and financial potential of certain of Nektar&rsquo;s collaboration partner programs (e.g. estimates of peak market
revenue and potential royalty revenue to Nektar); (ii) Nektar&rsquo;s future pre-clinical and clinical development plans, the potential
medical benefit and commercial potential for certain of Nektar&rsquo;s drug candidates and those of its collaboration partners;
(iii) the value and potential of Nektar&rsquo;s technology platform; (iv) the potential timing of clinical study plans and regulatory
filings for naloxegol or NKTR-118 (partnered with AstraZeneca), Amikacin Inhale (partnered with Bayer Healthcare), BAX 855 (partnered
with Baxter Healthcare), NKTR-102, NKTR-181 and NKTR-192; (v) the timing and availability of future clinical results for one or
more of our drug candidates and those of Nektar&rsquo;s collaboration partners; (vi) financial guidance for 2012; (vii) and certain
other future events and opportunities related to Nektar&rsquo;s business. These forward-looking statements involve substantial
risks and uncertainties including but not limited to:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify; text-indent: 0.25in">&nbsp;</P>

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<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>Nektar&rsquo;s drug candidates and those of its collaboration partners, including nolexegol (or NKTR-118), BAX 855, Amikacin
Inhale, NKTR-102, NKTR-181, and NKTR-192 are in clinical development and the risk of failure remains high and can unexpectedly
occur at any time due to lack of efficacy, frequency or severity of adverse safety events, manufacturing challenges, drug shortages,
regulatory delays, changes in regulatory requirements (e.g., additional or expanded clinical studies), or other factors that can
negatively impact drug development.</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>The timing or success of the commencement or end of clinical trials, including without limitation the potential start of the
Phase 3 clinical study for Amikacin Inhale, the Phase 3 clinical study for BAX 855, or the Phase 2 clinical study for NKTR-181,
may be delayed or unsuccessful due to regulatory delays, clinical trial design or the need to obtain regulatory concurrence for
such designs, manufacturing challenges, required clinical trial administrative actions (e.g. clinical research organization contracting
matters or institutional review board approvals at study sites), slower than anticipated patient enrollment, changing standards
of care, clinical outcomes, or financial constraints. For example, Nektar has experienced several significant delays in finalizing
the commercial device design for Amikacin Inhale and successful completion of the manufacturing of clinical study devices and related
stability testing is an essential element to enabling the future start of the planned Phase 3 clinical trial &mdash; these activities
are ongoing and remain subject to a substantial risk of failure until such activities are successfully completed.</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>Acceptance and approval of a new drug application (NDA) by the United States Food and Drug Administration (FDA) almost always
requires the sponsor to conduct comparative Phase 3 clinical studies prior to acceptance, review or approval of a NDA. As a result,
acceptance for review or approval of a NDA submitted to the FDA based on overall response rate from our single-arm Phase 2 study
in platinum-resistant/refractory ovarian cancer would be unusual and is highly unlikely&mdash;therefore we are not expecting the
FDA to accept or approve an accelerated NDA based on our expanded Phase 2 clinical study in platinum resistant/refractory ovarian
cancer. The FDA has significant discretion to determine what constitutes a high unmet medical need, what therapies should be considered
available to patients regardless of which therapies are approved or typically used in a particular setting, the relevance of certain
efficacy end points (e.g. overall response rate, progression free survival and overall survival), and the number of patients required
to be studied to demonstrate sufficient therapeutic benefit and safety profile. One or more of such determinations by the FDA could
impair Nektar&rsquo;s ability to submit an accelerated NDA for platinum resistant/refractory ovarian cancer patients, and even
if submitted, whether the FDA would accept it for review or approve the NDA.</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>Scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application
of Nektar&rsquo;s technology platforms to potential new drug candidates is therefore very uncertain and unpredictable and one or
more research and development programs could fail.</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>Nektar&rsquo;s patent applications for its proprietary or partner product candidates may not issue or may issue with narrow
coverage, our patents that have issued may not be enforceable, or additional intellectual property licenses from third parties
may be required in the future.</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>The outcome of any intellectual property or other litigation related to Nektar&rsquo;s proprietary drug candidates (or partnered
drug candidates where Nektar has indemnification responsibility) is unpredictable and could have a material adverse effect on Nektar&rsquo;s
business, results of operations and financial condition.</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: left; margin-bottom: 0pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: left; margin-bottom: 0pt"></P>

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<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>The market sizes for Nektar&rsquo;s proprietary and partnered product programs are based on management&rsquo;s current estimates
(and in some cases estimates communicated to us by our collaboration partners or published by financial analysis) only and actual
market sizes may differ materially and adversely.</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>Estimates of Nektar&rsquo;s potential future royalty revenue opportunity are based on peak market estimates and are not discounted
for risks associated with such programs, including important risks such as clinical failure, failure to obtain regulatory approval,
or failure of the product to achieve market sales equivalent to current peak market estimates.</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>Nektar has conducted various experiments using laboratory and home-based chemistry techniques that to date have been unable
to convert NKTR-181 into a more rapidly-acting, more abusable opioid.&nbsp;&nbsp;In the future, an alternative chemistry technique,
process or method of administration may be discovered to enable the conversion of NKTR-181 into a more abusable opioid which would
significantly and negatively impact the potential of NKTR-181.</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>Management&rsquo;s financial projections for 2012 are subject to the significant risk of unplanned revenue shortfalls, unplanned
expenses, and expenses being higher than planned, any of which could significantly and adversely affect Nektar&rsquo;s actual 2012
annual financial results.</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>Other important risks and uncertainties set forth in Nektar&rsquo;s Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on May 4, 2012.</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Actual results could differ materially from the forward-looking
statements and Nektar undertakes no obligation to update forward-looking statements, whether as a result of new information, future
events or otherwise.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in">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.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in">&nbsp;</P>

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<TR>
    <TD STYLE="vertical-align: top; padding-right: 0.8pt">By:</TD>
    <TD STYLE="border-bottom: black 1pt solid; vertical-align: bottom; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="border-bottom: black 1pt solid; vertical-align: top; padding-right: 0.8pt">/s/ Gil M. Labrucherie</TD></TR>
<TR>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-right: 0.8pt; text-align: center">Gil M. Labrucherie</TD></TR>
<TR>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-right: 0.8pt; font-style: italic; text-align: center">General Counsel and Secretary</TD></TR>
<TR>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-right: 0.8pt; font-style: italic; text-align: center">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; padding-right: 0.8pt">Date:</TD>
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[{"type": "8-K", "sequence": "1", "filename": "v315274_8k.htm", "description": "FORM 8-K", "secsgml_size_bytes": 25951}]
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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 5, 2012
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 May 30, 2012, Nektar
Therapeutics, a Delaware corporation ("Nektar"), announced that its President and Chief Executive Officer, Howard W.
Robin, is scheduled to present at the Jefferies 2012 Global Healthcare Conference at The Grand Hyatt New York on Tuesday, June
5, 2012 at 11:30 a.m. Eastern Time. This 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. This webcast will be available for replay until July 5, 2012.
During his presentation Mr. Robin expects
to make certain forward-looking statements regarding Nektar's business including but not limited to: (i) statements regarding
the commercial and financial potential of certain of Nektar's collaboration partner programs (e.g. estimates of peak market
revenue and potential royalty revenue to Nektar); (ii) Nektar's future pre-clinical and clinical development plans, the potential
medical benefit and commercial potential for certain of Nektar's drug candidates and those of its collaboration partners;
(iii) the value and potential of Nektar's technology platform; (iv) the potential timing of clinical study plans and regulatory
filings for naloxegol or NKTR-118 (partnered with AstraZeneca), Amikacin Inhale (partnered with Bayer Healthcare), BAX 855 (partnered
with Baxter Healthcare), NKTR-102, NKTR-181 and NKTR-192; (v) the timing and availability of future clinical results for one or
more of our drug candidates and those of Nektar's collaboration partners; (vi) financial guidance for 2012; (vii) and certain
other future events and opportunities related to Nektar's business. These forward-looking statements involve substantial
risks and uncertainties including but not limited to:
·
Nektar's drug candidates and those of its collaboration partners, including nolexegol (or NKTR-118), BAX 855, Amikacin
Inhale, NKTR-102, NKTR-181, and NKTR-192 are in clinical development and the risk of failure remains high and can unexpectedly
occur at any time due to lack of efficacy, frequency or severity of adverse safety events, manufacturing challenges, drug shortages,
regulatory delays, changes in regulatory requirements (e.g., additional or expanded clinical studies), or other factors that can
negatively impact drug development.
·
The timing or success of the commencement or end of clinical trials, including without limitation the potential start of the
Phase 3 clinical study for Amikacin Inhale, the Phase 3 clinical study for BAX 855, or the Phase 2 clinical study for NKTR-181,
may be delayed or unsuccessful due to regulatory delays, clinical trial design or the need to obtain regulatory concurrence for
such designs, manufacturing challenges, required clinical trial administrative actions (e.g. clinical research organization contracting
matters or institutional review board approvals at study sites), slower than anticipated patient enrollment, changing standards
of care, clinical outcomes, or financial constraints. For example, Nektar has experienced several significant delays in finalizing
the commercial device design for Amikacin Inhale and successful completion of the manufacturing of clinical study devices and related
stability testing is an essential element to enabling the future start of the planned Phase 3 clinical trial — these activities
are ongoing and remain subject to a substantial risk of failure until such activities are successfully completed.
·
Acceptance and approval of a new drug application (NDA) by the United States Food and Drug Administration (FDA) almost always
requires the sponsor to conduct comparative Phase 3 clinical studies prior to acceptance, review or approval of a NDA. As a result,
acceptance for review or approval of a NDA submitted to the FDA based on overall response rate from our single-arm Phase 2 study
in platinum-resistant/refractory ovarian cancer would be unusual and is highly unlikely—therefore we are not expecting the
FDA to accept or approve an accelerated NDA based on our expanded Phase 2 clinical study in platinum resistant/refractory ovarian
cancer. The FDA has significant discretion to determine what constitutes a high unmet medical need, what therapies should be considered
available to patients regardless of which therapies are approved or typically used in a particular setting, the relevance of certain
efficacy end points (e.g. overall response rate, progression free survival and overall survival), and the number of patients required
to be studied to demonstrate sufficient therapeutic benefit and safety profile. One or more of such determinations by the FDA could
impair Nektar's ability to submit an accelerated NDA for platinum resistant/refractory ovarian cancer patients, and even
if submitted, whether the FDA would accept it for review or approve the NDA.
·
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 one or
more research and development programs could fail.
·
Nektar's patent applications for its proprietary or partner product candidates may not issue or may issue with narrow
coverage, our patents that have issued may not be enforceable, or additional intellectual property licenses from third parties
may be required in the future.
·
The outcome of any intellectual property or other litigation related to Nektar's proprietary drug candidates (or partnered
drug candidates where Nektar has indemnification responsibility) is unpredictable and could have a material adverse effect on Nektar's
business, results of operations and financial condition.
·
The market sizes for Nektar's proprietary and partnered product programs are based on management's current estimates
(and in some cases estimates communicated to us by our collaboration partners or published by financial analysis) only and actual
market sizes may differ materially and adversely.
·
Estimates of Nektar's potential future royalty revenue opportunity are based on peak market estimates and are not discounted
for risks associated with such programs, including important risks such as clinical failure, failure to obtain regulatory approval,
or failure of the product to achieve market sales equivalent to current peak market estimates.
·
Nektar has conducted various experiments using laboratory and home-based chemistry techniques that to date have been unable
to convert NKTR-181 into a more rapidly-acting, more abusable opioid.  In the future, an alternative chemistry technique,
process or method of administration may be discovered to enable the conversion of NKTR-181 into a more abusable opioid which would
significantly and negatively impact the potential of NKTR-181.
·
Management's financial projections for 2012 are subject to the significant risk of unplanned revenue shortfalls, unplanned
expenses, and expenses being higher than planned, any of which could significantly and adversely affect Nektar's actual 2012
annual financial results.
·
Other important risks and uncertainties set forth in Nektar's Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on May 4, 2012.
Actual results could differ materially from the forward-looking
statements and Nektar undertakes no obligation to update forward-looking statements, whether as a result of new information, future
events or otherwise.
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:
June 5, 2012