0001213900-20-008413.txt : 20200402 0001213900-20-008413.hdr.sgml : 20200402 20200402080619 ACCESSION NUMBER: 0001213900-20-008413 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20200402 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200402 DATE AS OF CHANGE: 20200402 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEKTAR THERAPEUTICS CENTRAL INDEX KEY: 0000906709 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943134940 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24006 FILM NUMBER: 20767401 BUSINESS ADDRESS: STREET 1: 455 MISSION BAY BOULEVARD SOUTH CITY: SAN FRANCISCO STATE: CA ZIP: 94158 BUSINESS PHONE: 4154825300 MAIL ADDRESS: STREET 1: 455 MISSION BAY BOULEVARD SOUTH CITY: SAN FRANCISCO STATE: CA ZIP: 94158 FORMER COMPANY: FORMER CONFORMED NAME: INHALE THERAPEUTIC SYSTEMS INC DATE OF NAME CHANGE: 19980723 FORMER COMPANY: FORMER CONFORMED NAME: INHALE THERAPEUTIC SYSTEMS DATE OF NAME CHANGE: 19940303 8-K 1 ea120369-8k_nektartherap.htm CURRENT REPORT
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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): April 2, 2020

 

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))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading symbol(s)   Name of each exchange on which
registered
Common Stock, $0.0001 par value   NKTR   NASDAQ Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On April 2, 2020, Nektar Therapeutics, a Delaware corporation ("Nektar"), posted on its website (www.nektar.com) a communication from Nektar's Chief Executive Officer regarding COVID-19 (the "COVID-19 Communication"). A copy of the COVID-19 Communication is attached hereto as Exhibit 99.1 and incorporated into this Item 7.01 by reference.

 

The information in this Item 7.01, including the exhibit hereto, is being furnished and 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 in this Item 7.01 and in the accompanying exhibit shall not be incorporated by reference into any filing with the Securities and Exchange Commission (the "SEC") made by Nektar, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Cautionary Note Regarding Forward-Looking Statements

 

This Current Report on Form 8-K contains forward-looking statements which can be identified by words such as: "will," "anticipate," "plan," "may," "implement," "continue," "believe" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the potential impacts of the COVID-19 coronavirus pandemic on our personnel, their communities, and our business, such as delays or disruptions in our clinical trials, the anticipated timing for the completion of our clinical trials and announcement of clinical trial results, and interruptions in our manufacturing, supply chain, and research and development operations. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the potential impacts of the coronavirus pandemic on our business are based on information, guidelines, and governmental actions that are changing rapidly over time; (ii) the actions we announced to preserve the integrity of our clinical trials may not be effective and may not be fully implemented (if at all) due to circumstances beyond our control; (iii) certain clinical trials in our pipeline are sponsored and operationalized by our collaboration partners and are subject to the risks and uncertainties of those partner's policies and procedures that may continue to evolve over time to address the impact of the coronavirus pandemic; (iv) clinical development has inherent risks and the risk of failure remains high and failure can unexpectedly occur at any stage for one or more of the indications being studied prior to regulatory approval due to lack of sufficient efficacy, safety considerations or other factors that impact drug development; and (v) certain other important risks and uncertainties set forth in Nektar's Annual Report on Form 10-K filed with the SEC on February 28, 2020. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 

Item 9.01 Financial Statements and Exhibits.

 

Exhibit No.   Description
   
99.1   Communication titled "A Letter from our President & CEO, Howard Robin (updated April 1, 2020)" issued by Nektar Therapeutics on April 2, 2020.

 

1

 

 

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/ Mark A. Wilson
    Mark A. Wilson
    General Counsel and Secretary
     
  Date:   April 2, 2020

 

 

2

 

EX-99.1 2 ea120369ex99-1_nektartherap.htm COMMUNICATION TITLED "A LETTER FROM OUR PRESIDENT AND CEO, HOWARD ROBIN (UPDATED APRIL 1, 2020)" ISSUED BY NEKTAR THERAPEUTICS ON APRIL 2, 2020

Exhibit 99.1

 

A Letter from our President & CEO, Howard Robin (updated April 1, 2020)

 

This is an unprecedented time. Nektar and our partners are navigating a complex situation of new and rapidly evolving information and guidelines. The safety and well-being of our fellow employees, and the patients and healthcare providers in our clinical trial programs, are of first and foremost importance to us. We are also committed to complying with guidance from government and public health officials to stop the spread of COVID-19.

 

Continuing our Important Work on Clinical Trials

 

We have numerous ongoing clinical trials underway in cancer treatment facilities across the globe. These trials are continuing. Our primary focus now is to ensure that each of our trial investigators and their teams can continue to provide superior care and uninterrupted access to treatment to the patients fighting cancer in these studies.

 

We are not able to update any previously communicated timelines for ongoing late-stage clinical studies at this time. However, the evolving situation around COVID-19 and resulting public health guidance measures being put in place will likely delay enrollment of new patients into clinical trials and/or delay our ability to complete timely analyses of data from studies.  The impact that this will have on late-stage clinical study timelines is hard to assess because of the rapidly evolving nature of this situation.  As a result, we do not have an estimate of the length or extent of COVID-19-related delays at this time.  We also caution that regulatory agency guidance and timing of review of impact to clinical trials and data analyses related to COVID-19 is evolving and this could have further impact on timelines and these studies.

 

We currently anticipate that some planned study starts for the second half of 2020 outside oncology could be delayed by a few months depending upon how long COVID-19 precautionary measures remain in effect. In addition, any earlier stage Phase 1/2 clinical studies that are run by us or our partners and are currently enrolling patients in any therapeutic area may be paused or delayed based upon the COVID-19 situation.

 

Preserving the Integrity of Our Clinical Trials

 

In addition to our focus on the well-being of patients currently participating in our trials, we are actively working with our study sites to implement measures to prevent study protocol violations, to minimize any disruption of treatment visits, to accommodate for other patient visit delays caused by limited access to healthcare facilities, to continue monitoring and supporting patients leveraging alternative methods, and to properly record patient event data that may be related to the COVID-19 pandemic.

 

In this respect, we are also incorporating recent direction and flexibility provided by regulatory authorities, including the United States Food and Drug Administration in its March 18, 2020 Guidance (updated March 27, 2020) entitled “FDA Guidance on Conduct of Clinical Trials of Medicinal Products during COVID-19 Pandemic.”  This Guidance is continually being updated by FDA and updates can be found on the FDA’s website at www.fda.gov.  In addition, we may refer to Guidance documents from other regulatory agencies, such as, for example, the European Medicines Agency’s “Implications of coronavirus disease (COVID-19) on methodological aspect of ongoing clinical trials” found on www.ema.europe.eu, which are also continually being updated.  

 

Safeguarding Our Employees and Community

 

We believe we all play an important role in slowing the community spread of COVID-19 and as such, we are closely adhering to all county and state guidelines with respect to the operation of facilities and reinforcing shelter-in-place orders. Essential operations in research, medical and manufacturing are continuing in accordance with the permissions granted under government ordinances.

 

Supporting Our Local Healthcare Workers

 

Our team members are working with our local communities to facilitate donations of personal protective equipment, such as masks and gloves, to healthcare workers. In the San Francisco Bay Area, initial donations are being made to UCSF Medical Center and Kaiser Permanente Santa Clara Medical Center.

 

In Closing

 

We remain committed to serving the needs of our patients and advancing our mission of bringing forth novel therapies for the treatment of cancer and autoimmune disorders. Given the fluidity of the current environment, we are closely monitoring the situation to prepare for and minimize the potential impacts of the COVID-19 pandemic on our overall business.

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Cover
Apr. 02, 2020
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Apr. 02, 2020
Entity File Number 0-24006
Entity Registrant Name NEKTAR THERAPEUTICS
Entity Central Index Key 0000906709
Entity Tax Identification Number 94-3134940
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 455 Mission Bay Boulevard South
Entity Address, City or Town San Francisco
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94158
City Area Code (415)
Local Phone Number 482-5300
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.0001 par value
Trading Symbol NKTR
Security Exchange Name NASDAQ
Entity Emerging Growth Company false

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