Item 1.01 Entry into a Material Definitive Agreement.
On September 21, 2016, Nektar Therapeutics, a Delaware corporation ("Nektar"),
entered into a Clinical Trial Collaboration Agreement (the "Agreement") with
Bristol-Myers Squibb Company, a Delaware corporation ("BMS"), pursuant to which
Nektar and BMS will collaborate to conduct Phase 1/2 clinical trials evaluating
Nektar's IL-2-based CD122-biased agonist, known as NKTR-214, and BMS's human
monoclonal antibody that binds PD-1, known as Nivolumab, as a potential
combination treatment regimen in five tumor types and seven potential
indications, and such other clinical trials evaluating the combined therapy as
may be mutually agreed upon by the parties (each, a "Combined Therapy Trial").
Under the Agreement, BMS will be responsible for 50% of all out-of-pocket costs
reasonably incurred in connection with third party contract research
organizations, laboratories, clinical sites and institutional review boards.
Each party will otherwise be responsible for its own internal costs, including
internal personnel costs, incurred in connection with each Combined Therapy
Trial. Nektar and BMS will use commercially reasonable efforts to manufacture
and supply its compound for each Combined Therapy Trial and will bear the costs
related thereto. The parties will form a joint development committee to oversee
clinical trial design, regulatory strategy, and other activities necessary to
conduct and support the Combined Therapy Trials. Nektar will act as sponsor of
each Combined Therapy Trial.
Ownership of, and global commercial rights to, NKTR-214 remain solely with
Nektar under the Agreement. If Nektar wishes to license the right to
commercialize NKTR-214 in one of certain major market territories prior to
September 30, 2018 (the "Exclusivity Expiration Date"), Nektar must first
negotiate with BMS, for a period of three months (the "Negotiation Period"), to
grant an exclusive license to develop and commercialize NKTR-214 in any of these
major market territories. If BMS and Nektar do not reach an agreement for an
exclusive license within the Negotiation Period, Nektar will be free to license
any right to NKTR-214 to other parties in any territory worldwide except that in
the event that Nektar receives a license offer from a third party during a
period of 90 calendar days after the end of the Negotiation Period, Nektar will
provide BMS ten business days to match the terms of such third-party offer.
After the Exclusivity Expiration Date, Nektar is free to license NKTR-214
without any further obligation to BMS.
Each party grants to the other party a non-exclusive, worldwide (subject to
certain exceptions in the case of the license granted by BMS), non-transferable
and royalty-free research and development license to such licensing party's
patent rights, technology and regulatory documentation to use its compound
solely to the extent necessary to discharge its obligations under the Agreement
with respect to the conduct of the Combined Therapy Trials.
The Agreement also contains certain reciprocal exclusivity provisions that run
until the Exclusivity Expiration Date. Nektar agrees not to conduct any
preclinical or clinical research with, or grant rights under its proprietary
intellectual property or relevant investigational new drug applications to,
certain restricted third parties regarding an anti-PD-1 antagonist or anti-PD-L1
antagonist together with the NKTR-214 (a "Restricted NKTR-214 Combination"), and
BMS agrees not to conduct any preclinical or clinical research with certain
restricted third parties regarding Nivolumab together with an IL2-based CD122
agonist (a "Restricted Nivolumab Combination"). Nektar and BMS remain free to
conduct any preclinical or clinical research-involving a Restricted NKTR-214
Combination in the case of Nektar and a Restricted Nivolumab Combination in the
case of BMS-on their own or in collaboration with academic or other non-profit
Subject to termination rights for breach, bankruptcy or a material safety
issue/clinical hold, the term of the Agreement will continue in effect until
completion by all centers or institutions participating in the Combined Therapy
Trials, the delivery of study data to both parties and the completion of any
then agreed upon protocol, statistical analysis and bioanalysis plan. In the
event a third party merges with or acquires Nektar, Nektar is free to assign or
transfer the Agreement without the consent of BMS.
The foregoing summary does not purport to be complete and is qualified in its
entirety by reference to the Agreement, a copy of which will be filed as an
exhibit to Nektar's Quarterly Report on Form 10-Q for the period ended September
Item 7.01 Regulation FD Disclosure.
On September 27, 2016, BMS and Nektar jointly issued a press release attached
hereto as Exhibit 99.1 ("Press Release"), announcing the entry into the
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.
Item 8.01 Other Events.
On September 27, 2016, Nektar announced that it would hold a Webcast conference
call on September 27, 2016, at 9:00 a.m. Eastern Time to review the
collaboration with BMS and give an update on the NKTR-214 development program.
This conference call is accessible through a link that is posted on the home
page and Investor Relations section of the Nektar website:
http://www.nektar.com. On this conference call, management expects to make
certain forward-looking statements regarding the therapeutic potential of
NKTR-214 both as a single agent and in combination with other cancer therapies
such as Nivolumab, the potential benefits of the BMS collaboration, plans and
expectations for the conduct and completion of future clinical studies, and
certain other forward looking statements regarding Nektar's business. These
forward-looking statements involve substantial risks and uncertainties including
but not limited to:
· NKTR-214 is in early-stage clinical development and there are substantial
risks that can unexpectedly occur for numerous reasons, including negative
safety and efficacy findings in the ongoing Phase 1/2 clinical study
notwithstanding positive findings from interim clinical results and preclinical
· The clinical observations from the ongoing Phase 1/2 clinical trial of
NKTR-214 are based on preliminary data from an ongoing clinical trial that is
still actively enrolling patients and these preliminary data may not be
representative of final results after all patients complete the trial and all
data are collected and analyzed. Further, this preliminary data is subject to
continuing audit and verification procedures that will not be complete until the
conclusion of the trial and therefore the interim data is subject to change;
· The timing of the commencement or end of clinical trials and the
availability of clinical data may be delayed or unsuccessful due to regulatory
delays, slower than anticipated patient enrollment, manufacturing challenges,
changing standards of care, evolving regulatory requirements, clinical trial
design, clinical outcomes, competitive factors, or delay or failure in
ultimately obtaining regulatory approval in one or more important markets;
· Scientific discovery of new medical breakthroughs is an inherently
uncertain process and the future success of applying our technology platform to
potential new drug candidates (such as NKTR-214) is therefore highly uncertain
and unpredictable and one or more research and development programs could fail;
· Patents may not issue from our patent applications for our drug candidates
including NKTR-214, patents that have issued may not be enforceable, or
additional intellectual property licenses from third parties may be required;
· Other important risks and uncertainties set forth in Nektar's Quarterly
Report on Form 10-Q filed with the Securities and Exchange Commission on August
4, 2016 and available at www.sec.gov.
Actual results could differ materially from the forward-looking statements made
by management during the conference call and in the Press Release. Nektar
undertakes no obligation to update forward-looking statements, whether as a
result of new information, future events or otherwise.
Item 9.01 Financial Statements and Exhibits.
99.1 Press Release titled "Bristol-Myers Squibb and Nektar Therapeutics Form
Oncology Clinical Collaboration to Evaluate the Combination of Opdivo
(nivolumab) and NKTR-214" issued on September 27, 2016.
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