NKTR Nektar Therapeutics

23.74
+0.12  (+1%)
Previous Close 23.62
Open 23.59
52 Week Low 13.63
52 Week High 26.75
Market Cap $4,258,924,331
Shares 179,398,666
Float 89,639,490
Enterprise Value $3,224,070,065
Volume 1,336,224
Av. Daily Volume 1,476,495
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Upcoming Catalysts

Drug Stage Catalyst Date
Bempegaldesleukin (NKTR-214) and Keytruda (PROPEL)
Solid tumors - cancer
Phase 2
Phase 2
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Bempegaldesleukin (NKTR-214) and Opdivo (nivolumab)
Melanoma
Phase 3
Phase 3
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Bempegaldesleukin (NKTR-214) and Opdivo (nivolumab)
Renal Cell Carcinoma
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Bempegaldesleukin (NKTR-214) and Keytruda (pembrolizumab)
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Phase 2/3
Phase 2/3
Phase 2/3 trial to be initiated 2H 2021.
NKTR-214 + OPDIVO (nivolumab) - PIVOT-2
Urothelial carcinoma, Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers
Phase 1/2
Phase 1/2
Phase 1/2 updated data at SITC November 9, 2019 noted ORR was 53% (20/38) with 34% (13/38) complete response (CR) rate.
NKTR-255 and cetuximab
Head and Neck Squamous Cell Carcinoma / Colorectal Cancer
Phase 1/2
Phase 1/2
Phase 1/2 initiation of dosing announced December 15, 2020.
NKTR-262 and NKTR-214 - REVEAL
Solid tumors
Phase 1/2
Phase 1/2
Phase 1 data to be presented at SITC November 11, 2020 - maximum-tolerated dose was not reached.
NKTR-255
Relapsed or Refractory Non-Hodgkin Lymphoma or Multiple Myeloma
Phase 1
Phase 1
Phase 1 data presented at SITC meeting November, 2020.
NKTR-358
Systemic lupus erythematosus (SLE)
Phase 2
Phase 2
Phase 2 trial ongoing.
NKTR-358
Psoriasis
Phase 1b
Phase 1b
Phase 1b trial initiation announced October 7, 2019.
Bempegaldesleukin
Mild COVID-19
Phase 1b
Phase 1b
Phase 1b trial to be initiated.
Bempegaldesleukin (NKTR-214)
Squamous Cell Carcinoma of the Head and Neck
Phase 1/2
Phase 1/2
Phase 1/2 initiation of dosing announced August 12, 2020.
Etirinotecan pegol NKTR-102 (BEACON)
Cancer - Metastatic Breast Cancer
Phase 3
Phase 3
Phase 3 topline data mid March 2015 did not reach primary endpoint.
ADYNOVATE
Hemophilia A
Approved
Approved
Approved November 16, 2015.
MOVANTIK (Naloxegol)
Opioid-induced constipation (OIC)
Approved
Approved
Approved September 16, 2014.
Inhaled Amikacin Solution (BAY41-6551T)
Gram-Negative Pneumonia (INHALE 1)
Phase 3
Phase 3
Phase 3 data released November 24, 2017. Endpoints not met.
Cipro DPI
Bronchiectasis
Phase 3
Phase 3
Phase 3 second trial did not meet endpoint - April 5, 2017.

Latest News

  1. SAN FRANCISCO, Feb. 25, 2021 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) today reported financial results for the fourth quarter and full year ended December 31, 2020.

    Cash and investments in marketable securities at December 31, 2020 were approximately $1.2 billion as compared to $1.6 billion at December 31, 2019.

    "This past year, Nektar made significant progress advancing our clinical pipeline of novel cytokine therapeutics," said Howard W. Robin, President and CEO of Nektar. "Our broad registrational program evaluating bempegaldesleukin (BEMPEG) plus nivolumab is progressing well with five registrational studies underway in melanoma, renal cell carcinoma and bladder cancer. We also recently added a sixth study to the registrational program to evaluate BEMPEG in combination with pembrolizumab in head and neck cancer and are pleased to be collaborating with Merck on the study. For our PROPEL study, we look forward to reporting the first data for BEMPEG plus pembrolizumab in patients with metastatic non-small cell lung cancer in the second half of 2021."

    "For our second cytokine program, NKTR-255, we were very encouraged by the early signs of clinical activity that we recently reported at the SITC 2020 meeting, and are now advancing two Phase 1 clinical studies in combination with ADCC antibodies, one in hematological malignancies and one in solid tumors," continued Mr. Robin. "Finally, our partner Eli Lilly is conducting a broad Phase 2 program for NKTR-358, our T regulatory cell IL-2 agent, with Phase 2 studies in both lupus and ulcerative colitis and plans to initiate additional Phase 2 studies in immune-mediated diseases over the next 12-18 months."

    Summary of Financial Results

    Revenue in the fourth quarter of 2020 was $23.5 million as compared to $33.9 million in the fourth quarter of 2019. Revenue for the year ended December 31, 2020 was $152.9 million as compared to $114.6 million in 2019 and was higher primarily due to the recognition of $50.0 million in total milestones from Bristol-Myers Squibb related to the start of two new registrational trials of bempegaldesleukin plus Opdivo® (nivolumab) in adjuvant melanoma and muscle-invasive bladder cancer.

    Total operating costs and expenses in the fourth quarter of 2020 were $134.2 million as compared to $143.5 million in the fourth quarter of 2019. Total operating costs and expenses for 2020 were $578.0 million as compared to $554.7 million in 2019. Total operating costs and expenses for full year 2020 increased as compared to 2019 primarily as a result of $45.2 million in impairment charges in the first quarter of 2020 resulting from the discontinuation of the NKTR-181 program, partially offset by a decrease in R&D expense.

    R&D expense in the fourth quarter of 2020 was $102.7 million as compared to $110.4 million for the fourth quarter of 2019. R&D expense for the year ended December 31, 2020 was $408.7 million as compared to $434.6 million in 2019. Excluding pre-commercial manufacturing costs for NKTR-181 incurred during 2019, research and development expense increased for the full year 2020 primarily due to the clinical development of bempegaldesleukin in five registrational trials.

    G&A expense was $27.1 million in the fourth quarter of 2020 and $27.1 million in the fourth quarter of 2019. G&A expense for 2020 was $104.7 million as compared to $98.7 million in 2019.

    Net loss for the fourth quarter of 2020 was $117.2 million or $0.65 basic and diluted loss per share as compared to a net loss of $112.2 million or $0.64 basic and diluted loss per share in the fourth quarter of 2019. Net loss for the year ended December 31, 2020 was $444.4 million or $2.49 basic and diluted loss per share as compared to net loss of $440.7 million or $2.52 basic and diluted loss per share in 2019.

    2020 and Year-to-Date 2021 Business Highlights:

    • In February 2021, Nektar announced a clinical trial collaboration and supply agreement with Merck for a Phase 2/3 study of bempegaldesleukin, Nektar's investigational IL-2 pathway agent, in combination with Merck's KEYTRUDA® (pembrolizumab) for first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1. The study is planned to start in the second half of 2021.
    • In February 2021, Nektar announced a financing and co-development collaboration with SFJ Pharmaceuticals® for the development of bempegaldesleukin plus pembrolizumab in SCCHN. SFJ has agreed to fund up to $150 million to support the planned Phase 2/3 study and manage clinical trial operations for the study. In return, Nektar agrees to pay SFJ success-based annual milestone payments over a period of seven to eight years which are contingent upon receipt of certain U.S. regulatory approvals for specified indications for bempegaldesleukin, and will begin following completion of the SCCHN study, which is projected to be completed in 2024.
    • In December 2020, Nektar sold its royalties on future sales of ADYNOVATE® and MOVANTIK® to Healthcare Royalty Management, LLC in exchange for $150 million.
    • In December 2020, Nektar announced dosing of the first patient in its Phase 1/2 study of its IL-15 agonist, NKTR-255, in combination with cetuximab in patients with relapsed or refractory head and neck squamous cell carcinoma or colorectal cancer. The study may enroll up to 80 patients at approximately 15 investigator sites in the United States and European Union.
    • In December 2020, Nektar presented preclinical data for NKTR-255 at the American Society of Hematology (ASH) 2020 Annual Meeting, underscoring the potential for NKTR-255 as an innovative immunotherapeutic agent in the treatment of multiple myeloma.
    • In November 2020, Nektar presented new data from its immuno-oncology pipeline at the virtual 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Updated clinical data from the PIVOT-02 study metastatic melanoma cohort showed that bempegaldesleukin with nivolumab resulted in a durable clinical benefit with median progression-free survival of 30.9 months. NKTR-255 showed biological activity in the first patients treated in the monotherapy dose-escalation phase of the ongoing Phase 1 study in multiple myeloma and non-Hodgkin's lymphoma. In addition, new data showed that the combination of TLR agonist candidate, NKTR-262, plus bempegaldesleukin alters the tumor micro-environment through activation of both the innate and adaptive arms of the immune system.
    • In November 2020, Nektar presented new data from its NKTR-358 program at the American College of Rheumatology (ACR) virtual meeting. Data from the Phase 1b study in patients with mild to moderate systemic lupus erythematosus (SLE) showed that NKTR-358 produced a dose-dependent increase in expression of regulatory T cell (Treg) activation markers, providing a rationale for continued development in SLE and other inflammatory indications.
    • In October 2020, Nektar initiated a Phase 1b clinical study of bempegaldesleukin in adult patients with mild COVID-19 infection. The randomized, double-blind, placebo-controlled trial is designed to assess the safety, tolerability, and pharmacokinetic and pharmacodynamic profile of bempegaldesleukin in adult patients with mild COVD-19.
    • In August 2020, Vaccibody AS and Nektar announced that the first patient had been dosed in the Phase 1/2a study evaluating bempegaldesleukin with VB10.NEO, Vaccibody's personalized neoantigen cancer vaccine, in patients with advanced squamous cell carcinoma of the head and neck.
    • In June 2020, Nektar announced the presentation of results from the Phase 1b study evaluating multiple ascending doses of NKTR-358 at the Annual European Congress of Rheumatology (EULAR 2020) virtual meeting. The data showed that treatment with NKTR-358 was safe and well tolerated in patients with mild-to-moderate SLE and led to a marked and selective, dose-dependent expansion of regulatory T cells (Tregs) that was maintained over multiple administrations.
    • In May 2020, Nektar announced the publication of clinical data from its PIVOT-02 study evaluating bempegaldesleukin in combination with nivolumab in immunotherapy-naïve patients with advanced solid tumors, including melanoma, renal cell carcinoma (RCC) and non-small cell lung cancer. The data, published in Cancer Discovery, a journal of the American Association for Cancer Research, showed that bempegaldesleukin plus nivolumab resulted in encouraging overall response rates across multiple tumor types, independent of baseline PD-L1 expression, with responses continuing to deepen over time.
    • In April 2020, Nektar repaid the principal and accrued interest of its senior notes totaling $254.8 million.
    • In February 2020, Nektar announced the publication of preclinical bempegaldesleukin data in two manuscripts in Nature Communications showing how bempegaldesleukin works synergistically with multiple immune-based therapies to enhance T-cell-mediated tumor control.
    • In January 2020, Nektar and Bristol-Myers Squibb announced a new joint development plan that expanded the ongoing registrational program for bempegaldesleukin plus Opdivo® from three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic RCC to include two additional registrational trials in adjuvant melanoma and muscle-invasive bladder cancer. In addition, the expanded development plan includes a Phase 1/2 study to evaluate bempegaldesleukin plus nivolumab in combination with a tyrosine-kinase inhibitor in first-line RCC in order to support a future registrational trial.
    • In January 2020, Nektar made the strategic business decision to withdraw its New Drug Application (NDA) for NKTR-181, an investigational opioid medicine in development for chronic pain and make no further investment into the program.

    Conference Call to Discuss Fourth Quarter and Year-End 2020 Financial Results

    Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Thursday, February 25, 2021.

    This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: https://ir.nektar.com/. The web broadcast of the conference call will be available for replay through March 25, 2021.

    To access the conference call, follow these instructions:

    Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)

    Conference ID: 3857247 (Nektar Therapeutics is the host)

    In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

    About Nektar

    Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology, and virology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements which can be identified by words such as: "may," "design," "potential," "advance," "plan" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of, and future development plans for, bempegaldesleukin, NKTR-358 and NKTR-255, and the timing of the initiation of clinical studies and the availability of clinical data for our drug candidates. 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, the economy 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 therapeutic potential of bempegaldesleukin, NKTR-358 and NKTR-255 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) bempegaldesleukin, NKTR-358 and NKTR-255 are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) bempegaldesleukin, NKTR-358 and NKTR-255 are in various stages of clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to challenges caused by the COVID-19 pandemic, regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes and competitive factors; (v) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 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.

    Contact:

    For Investors:

    Vivian Wu of Nektar Therapeutics

    628-895-0661

    For Media:

    Dan Budwick of 1AB

    973-271-6085

     

    NEKTAR THERAPEUTICS



    CONDENSED CONSOLIDATED BALANCE SHEETS



    (In thousands)



    (Unaudited)



























    ASSETS



    December 31, 2020



    December 31, 2019

    (1)

    Current assets:



















    Cash and cash equivalents







    $

    198,955



    $

    96,363





    Short-term investments







    862,941



    1,228,499





    Accounts receivable







    38,889



    36,802





    Inventory









    15,292



    12,665





    Advance payments to contract manufacturers





    3,908



    31,834





    Other current assets







    18,020



    15,387







    Total current assets







    1,138,005



    1,421,550



























    Long-term investments







    136,662



    279,119



    Property, plant and equipment, net





    59,662



    65,665



    Operating lease right-of-use assets





    126,476



    134,177



    Goodwill











    76,501



    76,501



    Other assets









    1,461



    344







    Total assets









    $

    1,538,767



    $

    1,977,356



























    LIABILITIES AND STOCKHOLDERS' EQUITY



































    Current liabilities:



















    Senior secured notes, net and interest payable





    $

    -



    $

    252,891





    Accounts payable







    22,139



    19,234





    Accrued compensation







    14,532



    11,467





    Accrued clinical trial expenses





    44,207



    32,626





    Accrued contract manufacturing expenses





    11,310



    7,304





    Other accrued expenses







    9,585



    12,338





    Operating lease liability, current portion





    13,915



    12,516





    Deferred revenue, current portion





    91



    5,517







    Total current liabilities







    115,779



    353,893



























    Operating lease liability, less current portion





    136,373



    142,730



    Liabilities related to the sales of future royalties, net



    200,340



    72,020



    Deferred revenue, less current portion





    2,464



    2,554



    Other long-term liabilities







    6,516



    768







    Total liabilities







    461,472



    571,965



























    Commitments and contingencies





































    Stockholders' equity:

















    Preferred stock









    -



    -





    Common stock









    18



    17





    Capital in excess of par value





    3,388,730



    3,271,097





    Accumulated other comprehensive loss





    (2,295)



    (1,005)





    Accumulated deficit







    (2,309,158)



    (1,864,718)







    Total stockholders' equity





    1,077,295



    1,405,391





    Total liabilities and stockholders' equity





    $

    1,538,767



    $

    1,977,356



























    (1) The consolidated balance sheet at December 31, 2019 has been derived from the audited financial statements at that date but does not include all of the information and notes required by generally accepted accounting principles in the United States for complete financial statements.

     

     

    NEKTAR THERAPEUTICS



    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS



    (In thousands, except per share information)



    (Unaudited)



















































    Three Months Ended December 31,



    Year Ended December 31,



















    2020



    2019



    2020



    2019



































    Revenue:



























         Product sales









    $

    2,884



    $

    5,815



    $

    17,504



    $

    20,117



         Royalty revenue 









    (412)



    12,214



    30,999



    41,222



         Non-cash royalty revenue related to sale of future royalties



    20,562



    8,718



    48,563



    36,303



         License, collaboration and other revenue





    428



    7,115



    55,849



    16,975



    Total revenue









    23,462



    33,862



    152,915



    114,617



































    Operating costs and expenses:























         Cost of goods sold









    4,323



    5,989



    19,477



    21,374



         Research and development







    102,724



    110,369



    408,678



    434,566



         General and administrative







    27,136



    27,142



    104,682



    98,712



         Impairment of assets and other costs for terminated program



    -



    -



    45,189



    -



    Total operating costs and expenses





    134,183



    143,500



    578,026



    554,652



































    Loss from operations







    (110,721)



    (109,638)



    (425,111)



    (440,035)



































    Non-operating income (expense):





















         Interest expense









    -



    (5,428)



    (6,851)



    (21,310)



         Non-cash interest expense on liability related to sale of future royalties



    (8,183)



    (7,191)



    (30,267)



    (25,044)



         Interest income and other income (expense), net





    1,829



    10,371



    18,282



    46,335



    Total non-operating expense, net





    (6,354)



    (2,248)



    (18,836)



    (19)



































    Loss before provision for income taxes





    (117,075)



    (111,886)



    (443,947)



    (440,054)



































    Provision for income taxes







    128



    278



    493



    613



         Net loss











    $

    (117,203)



    $

    (112,164)



    $

    (444,440)



    $

    (440,667)



































    Net loss per share:

























         Basic











    $

    (0.65)



    $

    (0.64)



    $

    (2.49)



    $

    (2.52)



         Diluted











    $

    (0.65)



    $

    (0.64)



    $

    (2.49)



    $

    (2.52)



































    Weighted average shares outstanding used in computing net loss per share:



















         Basic











    179,684



    176,130



    178,581



    174,993



         Diluted











    179,684



    176,130



    178,581



    174,993



































     

    NEKTAR THERAPEUTICS

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (In thousands)

    (Unaudited)





















    Year Ended December 31,





















    2020



    2019

    Cash flows from operating activities:















    Net loss















    $

    (444,440)



    $

    (440,667)

    Adjustments to reconcile net loss to net cash used in operating activities:









    Non-cash royalty revenue related to sale of future royalties







    (48,563)



    (36,303)

    Non-cash interest expense on liability related to sale of future royalties 



    30,267



    25,044

    Stock-based compensation 









    94,261



    99,795

    Depreciation and amortization 









    14,182



    13,156

    Impairment of advance payments to contract manufacturers and equipment for terminated program

    20,351



    -

    Accretion of premiums (discounts), net and other non-cash transactions



    3,943



    (11,394)

    Changes in operating assets and liabilities:















    Accounts receivable











    1,913



    6,411

    Inventory













    (2,627)



    (1,284)

    Operating leases, net











    2,743



    13,090

    Other assets 













    4,476



    1,190

    Accounts payable 











    2,382



    12,967

    Accrued compensation 











    4,697



    1,530

    Other accrued expenses 











    8,644



    4,349

    Deferred revenue 











    (5,516)



    (16,565)

    Net cash used in operating activities 









    (313,287)



    (328,681)



























    Cash flows from investing activities:















    Purchases of investments 









    (987,533)



    (1,380,865)

    Maturities of investments 











    1,449,304



    1,614,036

    Sales of investments 











    41,700



    -

    Purchases of property, plant and equipment 









    (7,258)



    (26,285)

    Net cash provided by investing activities 









    496,213



    206,886



























    Cash flows from financing activities:















    Proceeds from sale of future royalties, net of $3.8 million of transaction costs



    146,250



    -

    Repayment of senior notes









    (250,000)



    -

    Proceeds from shares issued under equity compensation plans







    23,396



    23,355

    Net cash provided by (used in) financing activities 







    (80,354)



    23,355

    Effect of exchange rates on cash and cash equivalents 







    20



    (102)

    Net increase (decrease) in cash and cash equivalents 







    102,592



    (98,542)

    Cash and cash equivalents at beginning of year









    96,363



    194,905

    Cash and cash equivalents at end of year









    $

    198,955



    $

    96,363



























    Supplemental disclosure of cash flow information:













    Cash paid for interest











    $

    9,742



    $

    19,199

    Cash paid for income taxes











    $

    539



    $

    555

    Right-of-use assets recognized in exchange for operating lease liabilities



    $

    2,133



    $

    57,691

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/nektar-therapeutics-reports-fourth-quarter-and-year-end-2020-financial-results-301236046.html

    SOURCE Nektar Therapeutics

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  2. SAN FRANCISCO, Feb. 18, 2021 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) will announce its financial results for the fourth quarter and year-ended December 31, 2020, on Thursday, February 25, 2021, after the close of U.S.-based financial markets. Howard Robin, President and Chief Executive Officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time.

    The press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: http://ir.nektar.com/. The web broadcast of the conference call will be available for replay through Thursday, March 25, 2021.

    To access the conference call, follow these instructions:

    Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)

    Conference ID: 3857247 (Nektar Therapeutics is the host)

    About Nektar Therapeutics

    Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology, and virology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

    Contacts:

    For Investors:

    Vivian Wu of Nektar Therapeutics

    628-895-0661

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/nektar-to-announce-financial-results-for-the-fourth-quarter-and-year-ended-2020-on-thursday-february-25-2021-after-close-of-us-based-financial-markets-301231344.html

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  3. SAN FRANCISCO, Feb. 17, 2021 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) announced today that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada) for a Phase 2/3 study of bempegaldesleukin (NKTR-214, BEMPEG), Nektar's investigational IL-2 pathway agent, in combination with Merck's KEYTRUDA® (pembrolizumab) for first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1).  The study is planned to start in the second half of 2021.

    "We are excited to advance the combination of BEMPEG plus KEYTRUDA to a Phase 2/3 study in first-line squamous cell carcinoma of the head and neck," said Jonathan Zalevsky, PhD, Chief R&D Officer at Nektar.  "Earlier studies of BEMPEG in combination with immune checkpoint inhibitors, also known as ICIs, evaluated in patients with immune-sensitive cancers have shown the potential to increase and deepen treatment responses as compared to historical rates for ICIs alone.  This collaboration with Merck will enable us to further explore the combination of BEMPEG with the leading checkpoint inhibitor therapy in the setting of advanced head and neck cancer." 

    Under the terms of the agreement, Nektar will conduct the Phase 2/3 study, which is expected to enroll 500 patients with metastatic or recurrent SCCHN with PD-L1 expressing tumors.  Patients will be randomized to receive either the combination of BEMPEG plus pembrolizumab or pembrolizumab alone.  The Phase 2 portion of the study will include an interim analysis of overall response rate (ORR) after the first 200 patients enrolled have a minimum follow up of 4 months.  If the ORR passes a prespecified futility boundary, the study will continue, and the remaining 300 patients will be enrolled to the Phase 3 portion of the study.  The primary endpoints of the trial are ORR and overall survival (OS); progression free survival (PFS) is a secondary endpoint.

    About Nektar

    Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology, and virology as well as a portfolio of approved partnered medicines.  Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India.  Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements which can be identified by words such as: "will," "develop," "may" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of bempegaldesleukin (BEMPEG) in combination with other agents (immune checkpoint inhibitors), and the availability of results from clinical studies. 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 therapeutic potential of bempegaldesleukin are based on preclinical and clinical findings and the expected therapeutic potential for bempegaldesleukin is subject to change as research and development continue; (ii) bempegaldesleukin is in clinical development 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; (iii) data reported from ongoing preclinical and clinical trials are necessarily interim data only and the final results will change based on continuing observations; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of potential new drug candidates (such as bempegaldesleukin) is therefore very uncertain and unpredictable; (v) the timing of the commencement or end of clinical studies 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, delays caused by our collaboration partners and the COVID-19 pandemic, and enrollment competition; (vi) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) certain other important risks and uncertainties set forth in Nektar's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 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.

    Contact:

    For Investors:

    Vivian Wu of Nektar Therapeutics

    628-895-0661

    For Media:

    Dan Budwick of 1AB

    973-271-6085

     

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  4. SAN FRANCISCO, Feb. 17, 2021 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cancer and auto-immune disease, today announced a financing and co-development collaboration with SFJ Pharmaceuticals to support the development of Bempegaldesleukin (BEMPEG), an investigational CD122-preferential IL-2–pathway agonist. SFJ Pharmaceuticals is a global drug development company backed by Abingworth and Blackstone Life Sciences.

    The collaboration between SFJ and Nektar will support a new Phase 2/3 registrational clinical study of BEMPEG plus pembrolizumab in patients with head and neck cancer whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). Under the terms of the agreement, SFJ has agreed to fund up to $150 million to support the study and manage clinical trial operations. Nektar will serve as the sponsor of the Phase 2/3 study.

    "This innovative collaboration with SFJ provides Nektar with substantial non-dilutive funding to broaden the registrational program for BEMPEG," said Howard Robin, President and CEO of Nektar Therapeutics. "SFJ's global drug development and clinical trial management expertise, coupled with a track record of success in accelerating and advancing late-stage development programs for global pharmaceutical companies, make them an ideal partner."

    Under the terms of the new agreement, SFJ will fund up to $150 million for the Phase 2/3 study until its completion. In return, Nektar agrees to pay SFJ success-based annual milestone payments over a period of seven to eight years, which are contingent upon receipt of certain U.S. regulatory approvals for specified indications for BEMPEG and will begin following completion of the head and neck study that is projected to be in 2024. If BEMPEG does not receive regulatory approval for one or more of the specified indications, Nektar will not owe any future payments linked to an indication that is not approved.

    "We are excited to be partnering with Nektar under this novel financing and co-development agreement," said Bob DeBenedetto, Chief Executive Officer of SFJ. "Based on the strength of the clinical data generated to date for BEMPEG in melanoma and other tumor types, and following an extensive diligence process conducted in conjunction with our partners at Blackstone Life Sciences and Abingworth, we believe that BEMPEG has great potential to help cancer patients. We look forward to supporting the Phase 3 study and working closely with the Nektar team."

    Morgan Stanley & Co. LLC acted as the sole structuring agent to Nektar on the transaction.

    About Bempegaldesleukin (BEMPEG; NKTR-214)

    Bempegaldesleukin (BEMPEG: NKTR-214) is an investigational CD122-preferential IL-2–pathway agonist that leverages the clinically validated IL-2 pathway to stimulate an antitumor immune response.1 BEMPEG was engineered to deliver a controlled, sustained, and preferential IL-2 pathway signal, with the goals of stimulating an antitumor immune response while minimizing toxicity, thereby allowing for outpatient administration.1,2 In a phase 1 trial of BEMPEG in combination with the checkpoint inhibitor nivolumab (NIVO; PIVOT-02), the combination was well tolerated and produced durable responses that deepened over time in multiple advanced solid tumor types.3

    In February of 2018, Nektar and Bristol-Myers Squibb entered into a global strategic development and commercialization collaboration for BEMPEG. Under the terms of the agreement, Nektar is eligible to receive $1.45 billion in regulatory filing and approval milestones for BEMPEG. Nektar will book revenue for worldwide sales of BEMPEG and the companies will split global profits for BEMPEG with Nektar receiving 65% and Bristol-Myers Squibb 35%. The agreement allows Nektar to develop BEMPEG with other checkpoint inhibitor therapies in tumor types outside of the Nektar-Bristol-Myers Squibb joint clinical development program for BEMPEG plus NIVO.

    In July of 2019, Bristol-Myers Squibb and Nektar announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin in combination with nivolumab for the treatment of patients with previously untreated unresectable or metastatic melanoma.

    The joint clinical development program for BEMPEG plus NIVO includes registrational and other studies of BEMPEG plus NIVO in melanoma, renal cell carcinoma or RCC, and bladder cancer. This includes a Phase 3 trial in first-line advanced melanoma (NCT03635983), a Phase 3 trial in adjuvant melanoma (NCT04410445), a Phase 3 trial in advanced RCC (NCT03729245), a Phase 3 trial in muscle-invasive bladder cancer (NCT04209114), a Phase 2 trial in cisplatin-ineligible urothelial carcinoma (NCT03785925), a Phase 1/2 trial in combination with a tyrosine kinase inhibitor in advanced RCC (NCT04540705) and a Phase 1/2 trial in children, adolescents and young adults with recurrent or treatment-resistant cancer (NCT04730349).

    BEMPEG is also being evaluated separately in the PROPEL study in combination with pembrolizumab in patients with first-line metastatic non-small cell lung cancer (NCT03138889) and in collaboration with Vaccibody in the DIRECT-01 study in combination with VB10.NEO in squamous cell carcinoma of the head and neck (NCT03548467).

    About Head and Neck Cancer

    Squamous cell carcinoma of the head and neck, which forms in the tissues of the moist, mucosal surfaces inside the mouth, nose and throat, is the sixth most common cancer worldwide. In 2020, there were more than 850,000 cases leading to 440,000 deaths, according to The Global Cancer Observatory. The incidence of SCCHN continues to rise and is expected to increase by about 40% by 2040. According to data from the SEER registry, 5-year survival rate was estimated to be 66% for patients diagnosed with SCCHN and 40% for patients with metastatic disease, during the period 2010-2016.

    About Nektar Therapeutics

    Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology and virology. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

    About the SFJ Pharmaceuticals Group

    SFJ is a global drug development company, which provides a unique and highly customized co-development partnering model for the world's top pharmaceutical and biotechnology companies. SFJ provides at-risk funding and the global clinical development management and oversight necessary for regulatory submission for some of the most promising drug development programs of Pharmaceutical and Biotechnology companies. SFJ's mission is to leverage its financial strength and global team of pharmaceutical development experts to accelerate the development of life-saving and life-enhancing drugs for the benefit of physicians and the patients they serve.

    1. Bentebibel S-E, et al. A First-in-Human Study and Biomarker Analysis of NKTR-214, a Novel IL2Rβγ -Biased Cytokine, in Patients with Advanced or Metastatic Solid Tumors. Cancer Discovery 2019;9:711-21.
    2. Charych D, et al. Modeling the receptor pharmacology, pharmacokinetics, and pharmacodynamics of NKTR-214, a kinetically controlled interleukin-2 (IL2) receptor agonist for cancer immunotherapy. PLoS ONE 2017;12.
    3. Diab A, et al. Bempegaldesleukin (NKTR-214) plus nivolumab in patients with advanced solid tumors: Phase 1 dose-escalation study of safety, efficacy and immune activation (PIVOT-02). Cancer Discovery 2020

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements which can be identified by words such as: "will," "develop," "may," "provide," "deliver" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of bempegaldesleukin (BEMPEG) in combination with other agents (such as nivolumab and pembrolizumab), the availability of results from clinical studies, and the potential benefits of co-development collaborations. 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 therapeutic potential of bempegaldesleukin are based on preclinical and clinical findings and the expected therapeutic potential for bempegaldesleukin is subject to change as research and development continue; (ii) bempegaldesleukin is in clinical development 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; (iii) data reported from ongoing preclinical and clinical trials are necessarily interim data only and the final results will change based on continuing observations; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of potential new drug candidates (such as bempegaldesleukin) is therefore very uncertain and unpredictable; (v) the timing of the commencement or end of clinical studies 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, delays caused by our collaboration partners and the COVID-19 pandemic, and enrollment competition; (vi) projected costs for completing clinical trials are estimates only and the actual costs will vary and can be higher depending on a number of factors, such as unexpected changes in healthcare costs over time, the need to increase the number of clinical trial sites, and the length of time the trial is conducted; (vii) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (viii) certain other important risks and uncertainties set forth in Nektar's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 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.

    Contact:

    For Investors:

    Vivian Wu of Nektar Therapeutics

    628-895-0661

    For Media:

    Dan Budwick of 1AB



    973-271-6085

     

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  5. SAN FRANCISCO, Jan. 6, 2021 /PRNewswire/ -- Nektar Therapeutics' (NASDAQ:NKTR) President and Chief Executive Officer, Howard Robin, is scheduled to present at the upcoming 39th Annual J.P. Morgan Virtual Healthcare Conference on Monday, January 11, 2021 at 11:50 a.m. Pacific Time. The presentation and Q&A session will be accessible via a Webcast through a link posted on the Investor Events Calendar section of the Nektar website: https://ir.nektar.com/events-and-presentations/events. This webcast will be available for replay until February 10, 2021.

    About Nektar

    Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology, and virology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

    Contact:

    For Investors:

    Vivian Wu of Nektar Therapeutics

    628-895-0661

    For Media:

    Dan Budwick of 1AB

    973-271-6085

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