NKTR Nektar Therapeutics

Item 7.01.    Regulation FD Disclosure

Nektar currently anticipates that the future cost of the Confirmatory Trial will be in the range of approximately $40 to $50 million over the next approximately 3.5 years that is currently estimated to be required to complete such trial. This cost estimate range is based on a several variables that can be difficult to estimate, including the number of clinical trial sites and the average number of patients enrolled at each site, the total time required to recruit the target number of patients to be enrolled in the Confirmatory Trial, the time required to observe the minimum number of events to support the interim and final analysis, the outcome of the pre-planned interim analysis, clinical drug supply costs, as well as numerous other factors that can impact the actual costs of a clinical trial.

Nektar plans to submit a marketing authorization application filing (the “MAA”) in June 2016 seeking conditional approval from the EMA for the use of ONZEALD in the treatment of adult patients with advanced breast cancer having brain metastases and having received prior anthracycline, taxane and capecitabine. On May 26, 2016, the Committee for Medicinal Products for Human Use (CHMP) granted the planned ONZEALD MAA filing an accelerated assessment procedure which provides for an accelerated MAA review timeline. Nektar expects the EMA review of the MAA to commence on July 14, 2016, and the CHMP review is expected to take 6-8 months with the CHMP opinion to be issued in the first quarter of 2017.

On June 1, 2016, Nektar issued a press release announcing entry into the Agreement, which is filed herewith as Exhibit 99.1 to this Current Report.  The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall such information be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise stated in such filing.

FORWARD LOOKING STATEMENTS

In this Form 8-K Nektar makes certain forward-looking statements including potential milestone payments payable by Daiichi to Nektar upon the achievement of certain specified regulatory and commercial objectives and the estimated cost of the Confirmatory Trial. These forward-looking statements involve substantial risks and uncertainties including but not limited to: (i) multi-year cost estimates, such as that provided by Nektar in this filing for the Confirmatory Trial, are based on numerous variables such as those specifically identified above and a multi-year cost estimate is by its nature subject to significant and unpredictable variability; (ii) the EMA has substantial discretion as to whether to grant conditional or final marketing approval for ONZEALD and the EMA’s final decisions are difficult to predict even after preliminary feedback from EMA representatives, and the final decisions of the EMA and EC for conditional or final approval of ONZEALD have significant financial consequences under the terms of the Agreement, including the termination payment and milestone provisions; (iii) the risk of failure of any product candidate that is in clinical development and prior to regulatory approval is high and can occur at any stage due to efficacy, safety or other factors; (iv) the failure to achieve pre-specified regulatory outcomes with the EMA could result in Nektar having to make a termination payment to Daiichi described above or result in reduced or no further milestone or royalty payments to Nektar from Daiichi, (v) the timing of the commencement or end of the Confirmatory Trial and the commercial launch of ONZEALD may be delayed or unsuccessful due to regulatory delays, required institutional review board review and approvals, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay in obtaining regulatory approval in one or more important markets; (vi) patents may not issue from Nektar’s patent applications for ONZEALD and patents that have issued may not be enforceable; (vii) potential future third-party intellectual property or licensing disputes, and (viii) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 4, 2016. Actual results could differ materially from these forward-looking statements.  Nektar undertakes no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise.

(d) Exhibits