SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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|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.|
|99.1||Communication titled "A Letter from our President & CEO, Howard Robin (updated April 1, 2020)" issued by Nektar Therapeutics on April 2, 2020.|
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|
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.
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.