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1. 25 February 2021 Nektar Therapeutics Reports Fourth Quarter and Year-End 2020 Financial Results

   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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   SOURCE Nektar Therapeutics

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2. 18 February 2021 Nektar to Announce Financial Results for the Fourth Quarter and Year-Ended 2020 on Thursday, February 25, 2021, After Close of U.S.-Based Financial Markets

   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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3. 17 February 2021 Nektar Announces Agreement for Phase 2/3 Study of IL-2 Pathway Agonist, Bempegaldesleukin, in Combination with Merck's KEYTRUDA® (pembrolizumab) in Patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN)

   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. 17 February 2021 Nektar Announces Collaboration with SFJ Pharmaceuticals® for Bempegaldesleukin in Head and Neck Cancer

   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. 06 January 2021 Nektar Therapeutics' President and CEO, Howard Robin, to Present at the 39th Annual J.P. Morgan Virtual Healthcare Conference

   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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