NKTR Nektar Therapeutics

20.1
+1.58  (+9%)
Previous Close 18.52
Open 18.34
52 Week Low 15.395
52 Week High 26.75
Market Cap $3,664,168,132
Shares 182,296,922
Float 89,781,698
Enterprise Value $2,493,698,502
Volume 2,918,379
Av. Daily Volume 941,668
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Upcoming Catalysts

Drug Stage Catalyst Date
NKTR-255 and ERBITUX (cetuximab)
Head and Neck Squamous Cell Carcinoma / Colorectal Cancer
Phase 1/2
Phase 1/2
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NKTR-255
Relapsed or Refractory Non-Hodgkin Lymphoma or Multiple Myeloma
Phase 1
Phase 1
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Bempegaldesleukin (NKTR-214) and Keytruda (pembrolizumab) - (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) + 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-262 and Bempegaldesleukin (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-358
Psoriasis
Phase 1b
Phase 1b
Phase 1b trial initiation announced October 7, 2019.
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-358
Systemic lupus erythematosus (SLE)
Phase 2
Phase 2
Phase 2 trial ongoing.
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.
Inhaled Amikacin Solution (BAY41-6551T)
Gram-Negative Pneumonia (INHALE 1)
Phase 3
Phase 3
Phase 3 data released November 24, 2017. Endpoints not met.
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.
Cipro DPI
Bronchiectasis
Phase 3
Phase 3
Phase 3 second trial did not meet endpoint - April 5, 2017.

Latest News

  1. SAN FRANCISCO, May 6, 2021 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) today reported financial results for the first quarter ended March 31, 2021.

    Cash and investments in marketable securities at March 31, 2021 were approximately $1.1 billion as compared to $1.2 billion at December 31, 2020.

    "We continue to build momentum with our clinical pipeline of novel cytokine therapeutics," said Howard W. Robin, President and CEO of Nektar. "We have a robust development program for bempegaldesleukin focused on pursuing large front-line and adjuvant tumor settings. Our five registrational studies underway in melanoma, renal cell carcinoma, and bladder cancer are progressing as planned. In February, we added a sixth registrational study for bempegaldesleukin plus pembrolizumab in head and neck cancer, which we expect to initiate later this year. In addition, we remain on track to report the first data for our PROPEL study evaluating bempegaldesleukin plus pembrolizumab in patients with metastatic non-small cell lung cancer in the second half of 2021."

    "For our second cytokine program in oncology, NKTR-255, our initial efforts include two Phase 1 clinical studies in combination with ADCC antibodies, one in hematological malignancies and one in solid tumors, and we look forward to sharing data from these studies in Q4 of this year," continued Mr. Robin. "Finally, as part of the broad development program for NKTR-358, our T regulatory cell IL-2 agent, our partner Eli Lilly is conducting Phase 2 studies in both lupus and ulcerative colitis and plans to initiate additional Phase 2 studies in two different immune-mediated diseases over the next 9-12 months." 

    Summary of Financial Results

    Revenue in the first quarter of 2021 was $23.6 million as compared to $50.6 million in the first quarter of 2020. The decrease was due primarily to the recognition of the $25.0 million milestone payment from Bristol-Myers Squibb related to the initiation of the registrational trial of bempegaldesleukin plus Opdivo® in muscle-invasive bladder cancer in the first quarter of 2020.

    Total operating costs and expenses in the first quarter of 2021 were $133.0 million as compared to $184.2 million in the first quarter of 2020. Operating costs and expenses decreased 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 and a decrease in R&D expense.

    R&D expense in the first quarter of 2021 was $95.6 million as compared to $109.0 million for the first quarter of 2020. R&D expense decreased primarily due to a decrease in manufacturing costs for bempegaldesleukin.

    G&A expense was $31.7 million in the first quarter of 2021 and $26.2 million in the first quarter of 2020. G&A expense increased primarily due to an increase in pre-commercial costs for bempegaldesleukin.

    Net loss for the first quarter of 2021 was $123.0 million or $0.68 basic and diluted loss per share as compared to a net loss of $138.7 million or $0.78 basic and diluted loss per share in the first quarter of 2020.

    First Quarter 2021 and Recent 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.

    Conference Call to Discuss First Quarter 2021 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, May 6, 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 June 6, 2021.

    To access the conference call, follow these instructions:

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

    Conference ID: 9233368 (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," "plan," "expect," "project" 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 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 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; (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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2021. 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

    March 31, 2021



    December 31, 2020 1

    Current assets:







         Cash and cash equivalents

    $

    150,164



    $

    198,955

         Short-term investments

    887,152



    862,941

         Accounts receivable

    29,156



    38,889

         Inventory

    16,808



    15,292

         Other current assets

    15,771



    21,928

              Total current assets

    1,099,051



    1,138,005









    Long-term investments

    96,093



    136,662

    Property, plant and equipment, net

    58,510



    59,662

    Operating lease right-of-use assets

    124,971



    126,476

    Goodwill

    76,501



    76,501

    Other assets

    1,435



    1,461

              Total assets

    $1,456,561



    $1,538,767









    LIABILITIES AND STOCKHOLDERS' EQUITY















    Current liabilities:







         Accounts payable

    22,434



    22,139

         Accrued compensation

    23,513



    14,532

         Accrued clinical trial expenses

    41,028



    44,207

         Accrued contract manufacturing expenses

    6,057



    11,310

         Other accrued expenses

    14,833



    9,676

         Operating lease liabilities, current portion

    15,768



    13,915

              Total current liabilities

    123,633



    115,779









    Operating lease liabilities, less current portion

    134,556



    136,373

    Development derivative liability

    4,597



    -

    Liability related to the sale of future royalties, net

    195,139



    200,340

    Other long-term liabilities

    4,130



    8,980

              Total liabilities

    462,055



    461,472









    Commitments and contingencies















    Stockholders' equity:







         Preferred stock

    -



    -

         Common stock

    18



    18

         Capital in excess of par value

    3,429,734



    3,388,730

         Accumulated other comprehensive loss

    (3,121)



    (2,295)

         Accumulated deficit

    (2,432,125)



    (2,309,158)

              Total stockholders' equity

    994,506



    1,077,295

         Total liabilities and stockholders' equity

    $1,456,561



    $1,538,767





    (1)

    The consolidated balance sheet at December 31, 2020 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 March 31,

















    2021



    2020























    Revenue:



















         Product sales













    $

    4,795



    $

    3,444

         Royalty revenue 













    -



    9,719

         Non-cash royalty revenue related to sale of future royalties













    18,798



    9,895

         License, collaboration and other revenue













    54



    27,515

    Total revenue









    23,647



    50,573























    Operating costs and expenses:













         Cost of goods sold







    5,756



    3,811

         Research and development







    95,604



    108,987

         General and administrative







    31,679



    26,217

         Impairment of assets and other costs for terminated program



    -



    45,189

    Total operating costs and expenses





    133,039



    184,204























         Loss from operations







    (109,392)



    (133,631)























    Non-operating income (expense):





















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



    (13,296)



    (6,968)

         Change in fair value of development derivative liability





    (1,599)



    -

         Interest income and other income (expense), net





    1,412



    8,352

         Interest expense







    -



    (6,204)

    Total non-operating income (expense), net





    (13,483)



    (4,820)























    Loss before provision for income taxes





    (122,875)



    (138,451)























    Provision for income taxes







    92



    200

    Net loss











    $

    (122,967)



    $

    (138,651)













































    Basic and diluted net loss per share





    $

    (0.68)



    $

    (0.78)























    Weighted average shares outstanding used in computing basic and diluted net loss per share



    181,370



    177,185

     

     

    NEKTAR THERAPEUTICS

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS


    (In thousands)

    (Unaudited)



















    Three Months Ended March 31,

















    2021



    2020

    Cash flows from operating activities:











    Net loss











    $

    (122,967)



    $

    (138,651)

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









         Non-cash royalty revenue related to sale of future royalties





    (18,798)



    (9,895)

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



    13,296



    6,968

         Change in fair value of development derivative liability





    1,599



    -

         Non-cash research and development expense





    2,248



    -

         Stock-based compensation 







    23,898



    25,236

         Depreciation and amortization 





    3,543



    4,502

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



    -



    20,351

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



    2,345



    (1,289)

    Changes in operating assets and liabilities:











         Accounts receivable







    9,733



    (5,229)

         Inventory









    (1,516)



    (1,655)

         Operating leases, net







    1,541



    2,940

         Other assets 









    6,183



    1,067

         Accounts payable 







    779



    2,687

         Accrued compensation 







    8,981



    9,920

         Other accrued expenses 







    (7,345)



    7,483

         Deferred revenue 







    (605)



    (2,510)

    Net cash used in operating activities 





    (77,085)



    (78,075)























    Cash flows from investing activities:











         Purchases of investments 







    (295,314)



    (241,068)

         Maturities of investments 







    303,612



    439,735

         Sales of investments







    5,036



    -

         Purchases of property, plant and equipment 





    (2,876)



    (900)

    Net cash provided by investing activities 















    10,458



    197,767























    Cash flows from financing activities:











         Proceeds from shares issued under equity compensation plans



    17,106



    11,077

         Cash receipts from development derivative liability





    750



    -

    Net cash provided by financing activities 





    17,856



    11,077























    Effect of exchange rates on cash and cash equivalents 





    (20)



    (97)

    Net increase (decrease) in cash and cash equivalents 





    (48,791)



    130,672

    Cash and cash equivalents at beginning of period





    198,955



    96,363

    Cash and cash equivalents at end of period





    $

    150,164



    $

    227,035























    Supplemental disclosure of cash flow information:











    Cash paid for interest







    $

    -



    $

    4,951

    Operating lease right-of-use asset recognized in exchange for lease liabilities



    $

    1,057



    $

    2,133

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/nektar-therapeutics-reports-first-quarter-2021-financial-results-301286004.html

    SOURCE Nektar Therapeutics

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  2. SAN FRANCISCO, April 27, 2021 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) will announce its financial results for the first quarter 2021 on Thursday, May 6, 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, May 27, 2021.

    To access the conference call, follow these instructions:

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

    Conference ID: 9233368 (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-first-quarter-2021-on-thursday-may-6-2021-after-close-of-us-based-financial-markets-301278444.html

    SOURCE Nektar Therapeutics

    View Full Article Hide Full Article
  3. 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

     

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  4. 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

     

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  5. 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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