NKTR Nektar Therapeutics
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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NKTR-214 + OPDIVO (nivolumab) - PIVOT-2
Urothelial carcinoma, Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers
|
Phase 1/2
Phase 1/2
|
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|
|
NKTR-214 + TECENTRIQ + KEYTRUDA (PROPEL)
Solid tumors - cancer
|
Phase 1/2
Phase 1/2
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NKTR-262 and NKTR-214 - REVEAL
Solid tumors
|
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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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
NKTR-358
Atopic Dermatitis
|
Phase 1b
Phase 1b
|
Phase 1b trial initiation announced October 7, 2019.
|
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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.
|
|
NKTR-358
Systemic lupus erythematosus (SLE)
|
Phase 1b
Phase 1b
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Phase 1b data presented June 4, 2020 at EULAR - safe and well tolerated.
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|
NKTR-181
Lower back pain
|
PDUFA
PDUFA
|
FDA Advisory Committee voted 27-0 against recommending approval - January 14, 2020.
|
|
NKTR-358
Psoriasis
|
Phase 1b
Phase 1b
|
Phase 1b trial initiation announced October 7, 2019.
|
|
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.
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ADYNOVATE
Hemophilia A
|
Approved
Approved
|
Approved November 16, 2015.
|
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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
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OSLO, Norway and SAN FRANCISCO, Aug. 12, 2020 /PRNewswire/ -- Vaccibody AS and Nektar Therapeutics (NASDAQ:NKTR) today announced that the first patient has been dosed in the combination therapy of the Phase 1/2a study evaluating bempegaldesleukin (bempeg), Nektar's CD122-preferential IL-2 pathway agonist, with VB10.NEO, Vaccibody's personalized neoantigen cancer vaccine, in patients with advanced squamous cell carcinoma of the head and neck (SCCHN).
"We're pleased to advance our collaboration with Vaccibody to evaluate the potential of bempeg given with a personalized vaccine, VB10.NEO, in patients with advanced head and neck cancer," said Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar. "The rationale for this clinical study is supported by our promising preclinical data which demonstrated how a personalized cancer vaccine and a T cell proliferator can work synergistically to induce maximal expansion of vaccine-induced T cell clones, provide deep and durable responses and, at the same time, offer specific anti-tumor immunity."
VB10.NEO is designed to specifically activate a patient's immune system to tumor-specific antigens, called neoantigens, while bempeg is designed to expand and proliferate tumor antigen-specific T cells in the periphery and in the tumor microenvironment. Addition of bempeg to VB10.NEO is intended to drive maximal expansion of vaccine-induced neoantigen-specific T cells for the treatment of cancer.
At the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting, Vaccibody presented interim data for VB10.NEO in a group of patients with various solid tumor types who had all received multiple lines of prior anti-cancer therapy and had been treated with at least one checkpoint inhibitor (CPI) (nivolumab or pembrolizumab) for a range of 5 to 32 months. The data presented showed that 50 percent (7/14) of patients treated with VB10.NEO achieved clinical responses, including four patients with SCCHN. Clinical response was defined as either >10% reduction in the target lesions (as identified at screening) or converting progressive lesions into stable lesions (<20% increase, up to 37 weeks follow-up).
"We are pleased that our initial data with VB10.NEO demonstrated that the vaccine induced strong neoantigen-specific T cell responses and clinical benefit, particularly in patients who did not respond to checkpoint inhibitor monotherapy," said Agnete Fredriksen, President and Chief Scientific Officer of Vaccibody and continued: "We believe combining bempeg, a T cell stimulator, with VB10.NEO can further drive the expansion of VB10.NEO elicited neoantigen-specific T cells and potentially deepen and broaden anti-tumor activity. Siri Torhaug, Chief Medical Officer of Vaccibody added, "We are happy to announce the first patient dosed with the combined therapy of VB10.NEO and bempegaldesleukin and look forward to seeing the first read outs from this unique approach in patients with head and neck cancer."
Preclinical studies evaluating the combination of VB10.NEO and bempeg demonstrated the synergy of the two mechanisms to elicit greater breadth and depth of neoantigen-specific T cell responses as compared to each agent individually. In preclinical models of solid tumors, the combination induced strong immunogenic CD8+ T cell responses, and when combined with anti-PD-1, induced rapid, complete and durable tumor regression of small tumors, and long-lasting disease control of large tumors.1
About VB10.NEO
VB10.NEO, is Vaccibody's proprietary therapeutic DNA vaccine which uses the patient's own neoantigens for the personalized treatment of cancer patients. A phase 1/2a neoantigen clinical trial is currently enrolling patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial cancer or squamous cell carcinoma of the head and neck. In clinical trials, VB10.NEO has demonstrated induction of strong neoantigen-specific immune responses which led to clinical responses in patients with locally advanced or metastatic disease.About Bempegaldesleukin (NKTR-214)
Bempegaldesleukin is designed to stimulate cancer-killing immune cells in the body by targeting CD122 receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells.2 In clinical and preclinical studies, treatment with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment.3,4About Vaccibody
Vaccibody is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies. The Company is a leader in the rapidly developing field of individualized cancer neoantigen vaccines and is using the Vaccibody technology to generate best-in-class therapeutics to treat cancers with a high unmet medical need. Further, the Company has initiated research on infectious diseases.Vaccibody is developing cutting-edge, targeted DNA vaccines for clinical use, based on a deep understanding of immunological principles. Vaccibody's vaccines specifically target Antigen Presenting Cells (APC), which are essential for inducing rapid, strong and specific immune responses and elicit efficacious clinical responses. By intelligent design, Vaccibody's vaccines can be tailored to induce the desired immune response profile correlating with protection for each specific disease with any given antigen. Hence, the Vaccibody vaccine platform has the potential to address many disease areas with a high unmet medical need such as cancer and infectious diseases. In addition, Vaccibody has collaborations with Roche and Nektar Therapeutics.
Vaccibody's lead product candidates are VB10.NEO, a personalized therapeutic cancer neoantigen vaccine currently being evaluated in a Phase I/IIa clinical trial, and VB10.16, a therapeutic cancer vaccine against HPV16-related cancers that is currently being tested in a Phase IIa clinical trial.
Vaccibody's shares are traded on NOTC, a marketplace for unlisted shares managed by NOTC AS, which is owned 100% by Oslo Børs ASA, the Oslo Stock Exchange.
Further information about the Company may be found at http://www.vaccibody.com
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology and immunology 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," "can," "developing," "design," "intend," and similar references to future periods. Examples of forward-looking statements include, among others, statements we make concerning the therapeutic potential of bempegaldesleukin in combination with VB10.NEO, the future development plans for bempegaldesleukin in combination with VB10.NEO, and the availability of results and outcomes from clinical studies of bempegaldesleukin in combination with VB10.NEO. 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) the extent and duration of the impact of the COVID-19 pandemic on our business, regulatory efforts, research and development, clinical trials (including those being led by us and our partner), and corporate development activities will depend on future developments that are highly uncertain and cannot be accurately predicted, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, as well as the effectiveness of actions taken globally to contain and treat the disease; (ii) both bempegaldesleukin and VB10.NEO are investigational agents and continued research and development for these drug candidates (both alone and in combination) 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) 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, decisions and policies of our partner, 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; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future regulatory approval of potential new drug candidates (such as bempegaldesleukin and VB10.NEO) is therefore very uncertain and unpredictable; (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 August 7, 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.
Nektar Contacts:
For Investors:
Vivian Wu of Nektar Therapeutics
628-895-0661For Media:
Dan Budwick of 1AB
973-271-6085
[email protected]Vaccibody Contact:
CEO Michael Engsig of Vaccibody AS
Cell: +45 6173 1509
[email protected]- Granum, S., et al. Combination of neoantigen DNA plasmid vaccine VB10.NEO and bempegaldesleukin (NKTR-214) induces strong neoantigen-specific T cell responses and sustained tumor regression in pre-clinical models. In: Proceedings: AACR Annual Meeting 2019; March 29-April 3, 2019; Atlanta (GA); AACR 2019. Abstract nr 2256
- Boyman, J., et al., Nature Reviews Immunology, 2012, 12, 180-190.
- Charych, D., et al., Clin Can Res; 22(3) February 1, 2016
- Diab, A., et al., Journal for ImmunoTherapy of Cancer 2016, 4(Suppl 1): P369
SOURCE Nektar Therapeutics
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SAN FRANCISCO, Aug. 6, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) today reported financial results for the second quarter ended June 30, 2020.
Cash and investments in marketable securities at June 30, 2020 were approximately $1.2 billion as compared to $1.6 billion at December 31, 2019. This decrease includes the repayment of $254.8 million for Nektar's senior secured notes and accrued interest, which occurred in the second quarter of 2020.
"During the second quarter, Nektar successfully advanced the registrational and early clinical trials across our immune-oncology portfolio which led to the opening of enrollment for the first patients into a new Phase 3 study in adjuvant melanoma for the bempegaldesleukin program," said Howard W. Robin, President and CEO of Nektar. "We now have 5 ongoing registrational trials for bempegaldesleukin, and we continue to make significant progress with our NKTR-262 and NKTR-255 clinical trials, with early data from these programs planned for presentation at this year's Society for Immunotherapy Congress in November."
Mr. Robin continued, "In immunology, following the positive Phase 1b data in lupus patients reported at EULAR, our partner Eli Lilly continues to expand their NKTR-358 development efforts. I am pleased to announce that they are initiating investigator sites and enrolling patients into a new Phase 2 study of NKTR-358 in moderate to severe systemic lupus erythematosus. We are fortunate to be entering the second half of 2020 in a position of exceptional strength – we have built a robust pipeline in oncology and immunology with multiple registrational and earlier stage clinical trials underway and we ended Q2 in a strong financial position with $1.2 billion in cash and investments, and no debt on our balance sheet."
Summary of Q2 2020 Financial Results
Revenue in the second quarter of 2020 was $48.8 million compared to $23.3 million in the second quarter of 2019. The increase was due to the recognition of the $25.0 million milestone from Bristol-Myers Squibb related to the recent initiation of the registrational trial of bempegaldesleukin plus Opdivo® in adjuvant melanoma, which opened enrollment to patients in July. Year-to-date revenue for 2020 was $99.4 million compared to $51.5 million in the first half of 2019. Revenue was higher due to the recognition of $50.0 million in total milestones from Bristol-Myers Squibb related to the start of registrational trials of bempegaldesleukin plus Opdivo® in adjuvant melanoma and muscle-invasive bladder cancer.
Total operating costs and expenses in the second quarter of 2020 were $126.6 million compared to $134.3 million in the second quarter of 2019. The decrease was due to a decrease in research and development (R&D) expense. Total operating costs and expenses in the first half of 2020 were $310.8 million compared to $283.2 million in the first half of 2019. Year-to-date operating costs and expenses increased primarily as a result of impairment of assets and other costs for NKTR-181, partially offset by a decrease in R&D expense. During the first quarter of 2020, Nektar reported $45.2 million in impairment charges and additional costs related to the discontinuation of the NKTR-181 program.
R&D expense in the second quarter of 2020 was $96.4 million compared to $106.7 million for the second quarter of 2019. For the first half of 2020, R&D expense was $205.4 million compared to $225.1 million in the first half of 2019. The decrease for both the second quarter and the first half of 2020 was due primarily to pre-commercial manufacturing costs for NKTR-181 incurred during the first half of 2019.
Net loss for the second quarter of 2020 was $80.0 million or $0.45 basic and diluted loss per share compared to a net loss of $110.3 million or $0.63 basic and diluted loss per share in the second quarter of 2019. Net loss in the first half of 2020 was $218.7 million or $1.23 basic and diluted loss per share compared to a net loss of $229.9 million or $1.32 basic and diluted loss per share in the first half of 2019.
Second Quarter 2020 and Recent Business Highlights:
- In June 2020, Nektar announced the presentation of results from the Phase 1b study evaluating multiple ascending doses of NKTR-358, a first-in-class T regulatory cell stimulator, which is being developed as a potential therapeutic for a range of autoimmune disorders, including systemic lupus erythematosus (SLE). The data, which were presented during the Annual European Congress of Rheumatology (EULAR 2020) in a virtual congress format, showed that 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 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.
The company also announced an upcoming presentation at the following scientific congress:
Cambridge Healthtech Institute's (CHI) 8th Annual Immuno-Oncology Virtual Summit
- Presentation: "NKTR-255: A Potent NK and CD8 Memory T Cell Mobilizer for Immunotherapy", Madakamutil, L.
- Session: Cytokines as Emerging Targets and Biotherapeutics
- Date: Thursday, October 8th, 9:40 a.m. – 10:00 a.m. Eastern Time
Conference Call to Discuss Second Quarter 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, today, Thursday, August 6, 2020.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 August 31, 2020.
To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 7858867 (Nektar Therapeutics is the host)About Nektar
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology and immunology 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," "can," "develop," "progress," "will," "continue," "ensure," "preserve," "advance," "potential" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make concerning the potential therapeutic benefits of and future development plans for our investigational products (including bempegaldesleukin, NKTR-262, NKTR-255 and NKTR-358), our ability to safely advance and maintain the integrity of our clinical trials during the COVID-19 pandemic, and the strength of our financial position to develop our pipeline of our investigational products. 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) the extent and duration of the impact of the COVID-19 pandemic on our business, regulatory efforts, research and development, clinical trials (including those being led by us and our partner), and corporate development activities will depend on future developments that are highly uncertain and cannot be accurately predicted, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, as well as the effectiveness of actions taken globally to contain and treat the disease; (ii) bempegaldesleukin, NKTR-262, NKTR-255 and NKTR-358 are investigational agents and continued research and development efforts for these drug candidates are subject to substantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) 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, decisions and policies of our partners, 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; (iv) 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 (v) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 8, 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
628-895-0661For Media:
Dan Budwick of 1AB
973-271-6085
[email protected]Opdivo is a registered trademark of Bristol-Myers Squibb Company.
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
ASSETS
June 30, 2020
December 31, 2019 (1)
Current assets:
Cash and cash equivalents
$ 58,206
$ 96,363
Short-term investments
980,191
1,228,499
Accounts receivable
47,245
36,802
Inventory
12,584
12,665
Advance payments to contract manufacturers
15,972
31,834
Other current assets
37,770
15,387
Total current assets
1,151,968
1,421,550
Long-term investments
172,166
279,119
Property, plant and equipment, net
61,372
65,665
Operating lease right-of-use assets
131,458
134,177
Goodwill
76,501
76,501
Other assets
1,413
344
Total assets
$ 1,594,878
$ 1,977,356
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Senior secured notes, net and interest payable
$ -
$ 252,891
Accounts payable
19,246
19,234
Accrued compensation
22,548
11,467
Accrued clinical trial expenses
42,794
32,626
Accrued contract manufacturing expenses
11,050
7,304
Other accrued expenses
11,424
12,338
Operating lease liabilities, current portion
15,139
12,516
Deferred revenue, current portion
1,757
5,517
Total current liabilities
123,958
353,893
Operating lease liabilities, less current portion
141,633
142,730
Liability related to the sale of future royalties, net
68,284
72,020
Deferred revenue, less current portion
2,524
2,554
Other long-term liabilities
2,239
768
Total liabilities
338,638
571,965
Commitments and contingencies
Stockholders' equity:
Preferred stock
-
-
Common stock
18
17
Capital in excess of par value
3,338,876
3,271,097
Accumulated other comprehensive income (loss)
715
(1,005)
Accumulated deficit
(2,083,369)
(1,864,718)
Total stockholders' equity
1,256,240
1,405,391
Total liabilities and stockholders' equity
$ 1,594,878
$ 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 June 30,
Six Months Ended June 30,
2020
2019
2020
2019
Revenue:
Product sales
$ 5,485
$ 4,346
$ 8,929
$ 8,744
Royalty revenue
9,403
7,343
19,122
18,733
Non-cash royalty revenue related to sale of future royalties
7,684
9,091
17,579
17,321
License, collaboration and other revenue
26,275
2,535
53,790
6,739
Total revenue
48,847
23,315
99,420
51,537
Operating costs and expenses:
Cost of goods sold
5,773
5,018
9,584
10,458
Research and development
96,436
106,686
205,423
225,149
General and administrative
24,347
22,581
50,564
47,587
Impairment of assets and other costs for terminated program
-
-
45,189
-
Total operating costs and expenses
126,556
134,285
310,760
283,194
Loss from operations
(77,709)
(110,970)
(211,340)
(231,657)
Non-operating income (expense):
Interest expense
(647)
(5,231)
(6,851)
(10,457)
Non-cash interest expense on liability related to sale of future royalties
(6,691)
(5,975)
(13,659)
(12,040)
Interest income and other income (expense), net
5,191
11,989
13,543
24,472
Total non-operating income (expense), net
(2,147)
783
(6,967)
1,975
Loss before provision for income taxes
(79,856)
(110,187)
(218,307)
(229,682)
Provision for income taxes
144
99
344
236
Net loss
$ (80,000)
$ (110,286)
$ (218,651)
$ (229,918)
Basic and diluted net loss per share
$ (0.45)
$ (0.63)
$ (1.23)
$ (1.32)
Weighted average shares outstanding used in computing basic and diluted net loss per share
178,327
174,549
177,755
174,206
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Six Months Ended June 30,
2020
2019
Cash flows from operating activities:
Net loss
$ (218,651)
$ (229,918)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash royalty revenue related to sale of future royalties
(17,579)
(17,321)
Non-cash interest expense on liability related to sale of future royalties
13,659
12,040
Stock-based compensation
48,607
49,907
Depreciation and amortization
7,692
6,132
Impairment of advance payments to contract manufacturers and equipment for terminated program
20,351
-
Accretion of premiums (discounts), net and other non-cash transactions
(782)
(6,329)
Changes in operating assets and liabilities:
Accounts receivable
(10,443)
5,914
Inventory
81
(1,807)
Operating leases, net
4,245
8,415
Other assets
(27,214)
15,818
Accounts payable
425
3,480
Accrued compensation
12,469
9,773
Other accrued expenses
8,952
15,794
Deferred revenue
(3,790)
(6,715)
Net cash used in operating activities
(161,978)
(134,817)
Cash flows from investing activities:
Purchases of investments
(543,631)
(603,702)
Maturities of investments
860,330
634,145
Sales of investments
41,700
-
Purchases of property, plant and equipment
(3,594)
(17,291)
Net cash provided by investing activities
354,805
13,152
Cash flows from financing activities:
Proceeds from shares issued under equity compensation plans
19,120
12,200
Repayment of Senior Notes
(250,000)
-
Net cash provided by (used in) financing activities
(230,880)
12,200
Effect of exchange rates on cash and cash equivalents
(104)
(16)
Net decrease in cash and cash equivalents
(38,157)
(109,481)
Cash and cash equivalents at beginning of period
96,363
194,905
Cash and cash equivalents at end of period
$ 58,206
$ 85,424
Supplemental disclosures of cash flow information:
Cash paid for interest
$ 9,742
$ 9,455
Operating lease right-of-use asset recognized in exchange for lease liabilities
$ 2,133
$ 1,289
View original content:http://www.prnewswire.com/news-releases/nektar-therapeutics-reports-second-quarter-2020-financial-results-301108006.htmlSOURCE Nektar Therapeutics
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SAN FRANCISCO, July 28, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) will announce its financial results for the second quarter 2020 on Thursday, August 6, 2020, 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 Tuesday, September 1, 2020.
To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Conference ID: 7858867 (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 and immunology 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
View original content:http://www.prnewswire.com/news-releases/nektar-to-announce-financial-results-for-the-second-quarter-2020-on-thursday-august-6-2020-after-close-of-us-based-financial-markets-301101639.htmlSOURCE Nektar Therapeutics
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SAN FRANCISCO, June 4, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) today announced the presentation of results from the Phase 1b study evaluating multiple ascending doses of NKTR-358, a first-in-class T regulatory cell stimulator, which is being developed as a potential therapeutic for a range of autoimmune disorders, including systemic lupus erythematosus (SLE).
The data, which were presented during the Annual European Congress of Rheumatology (EULAR 2020) in a virtual congress format, show that 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.
NKTR-358 is designed to correct an underlying immune system imbalance in patients with autoimmune conditions, which is associated with reduced numbers and impaired function of powerful inhibitory immune cells, known as T regulatory (Treg) cells. NKTR-358 works by targeting the interleukin-2 (IL-2) receptor complex in the body to stimulate proliferation of the body's own Treg cells and increase their suppressive functional activity.
NKTR-358 was discovered by Nektar and is being co-developed in partnership with Eli Lilly and Company.
"The results in patients with lupus presented at this year's EULAR Congress further support the potential of NKTR-358, through its stimulation of immune-inhibitory Treg cells, to restore normal self-tolerance mechanisms that are out of balance in patients with systemic lupus erythematosus," said Brian Kotzin, Senior Vice President, Clinical Development and Head of Immunology at Nektar. "Based upon these data, Nektar and our partner Lilly are advancing NKTR-358 into a Phase 2 study in patients with moderate to severe SLE, which will be initiated this summer."
The randomized, double-blind, multiple-ascending dose Phase 1b study being presented at 2020 EULAR evaluated safety, pharmacokinetics (PK) and pharmacodynamics (PD) in a total of 48 SLE patients across 4 separate ascending dose cohorts who received subcutaneous Q2W doses of NKTR-358 (n=9 per cohort) or placebo (n=3 per cohort). Subjects were treated for a total of six weeks.
Key highlights from today's data presentation include:
- NKTR-358 was safe and well tolerated in patients with mild-to-moderate SLE
- Safety profile was similar between single and repeat administrations
- Data show dose-proportional pharmacokinetics and prolonged exposure, with a half-life of 10–13 days
- NKTR-358 elicited a marked and selective, dose-dependent expansion of CD25bright Tregs in patients with mild-to-moderate SLE, which was maintained through multiple administrations
- Similar extent and magnitude of induction as observed in the SAD study in healthy volunteers
Nektar will host a call tomorrow for analysts and investors to review the data presented at EULAR 2020. Details of the call are as follows:
Date and Time: Friday, June 5, 2020 at 11:00 a.m. Eastern Daylight Time
Dial- in: (877) 881-2183 (toll-free) or (970) 315-0453 (access code 1170058)
Investors and analysts can also view slides and listen to the live audio webcast of the presentation at https://edge.media-server.com/mmc/p/aaf3wx35. The event will also be available for replay for two weeks on the company's website, www.nektar.com.
About NKTR-358 (LY3471851*)
Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. NKTR-358 is a potential first-in-class resolution therapeutic that may address this underlying immune system imbalance in people with different autoimmune and inflammatory conditions. It targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance. Nektar entered into a strategic collaboration with Lilly in 2017 to develop and commercialize NKTR-358.
NKTR-358 is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases. It is currently being evaluated in two separate Phase 1b studies in patients with atopic dermatitis (NCT04081350) and psoriasis (NCT04119557).
About Nektar
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology and immunology 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," "can," "develop," "design," "will," and similar references to future periods. Examples of forward-looking statements include, among others, statements we make concerning the therapeutic potential of NKTR-358, and future development plans for this drug candidate. 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) the extent and duration of the impact of the COVID-19 pandemic on our business, regulatory efforts, research and development, clinical trials (including those being led by us and our partner), and corporate development activities will depend on future developments that are highly uncertain and cannot be accurately predicted, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, as well as the effectiveness of actions taken globally to contain and treat the disease; (ii) NKTR-358 is an investigational agent and continued research and development for this drug candidate 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) 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, decisions and policies of our partner, 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; (iv) 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 (v) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 8, 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
View original content:http://www.prnewswire.com/news-releases/data-presented-from-phase-1b-study-of-nktr-358-a-novel-t-regulatory-cell-stimulator-at-annual-european-congress-of-rheumatology-eular-2020-301071068.htmlSOURCE Nektar Therapeutics
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SAN FRANCISCO, May 29, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) announced today that it will webcast an analyst and investor conference call on Friday, June 5, 2020 at 11:00 a.m. EDT during EULAR 2020. The event will follow Thursday's virtual poster presentation of the data from a Phase 1b multiple ascending dose study of NKTR-358, a first-in-class investigational regulatory T cell stimulator, in patients with systemic lupus erythematosus.
Analyst Call Details
Date and Time: Friday, June 5, 2020 at 11:00 a.m. Eastern Daylight Time
Dial- in: (877) 881-2183 (toll-free) or (970) 315-0453 (access code 1170058)
Investors and analysts can also view slides and listen to the live audio webcast of the presentation at https://edge.media-server.com/mmc/p/aaf3wx35. The event will also be available for replay for two weeks on the company's website, www.nektar.com.
Poster Presentation Details
The virtual poster presentation will be made available on-demand via the EULAR 2020 E-Congress site and on Nektar's website beginning on Thursday, June 4, 2020 through the duration of the conference. Additional details are as follows:
Session Title: Adaptive immunity (T cells and B cells) in rheumatic diseases
Abstract Title: "NKTR-358, a Novel IL-2 Conjugate, Stimulates High Levels of Regulatory T cells in Patients with Systemic Lupus Erythematosus"
Abstract: THU0054About NKTR-358 (LY3471851*)
Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. NKTR-358 is a potential first-in-class resolution therapeutic that may address this underlying immune system imbalance in people with different autoimmune and inflammatory conditions. It targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance. Nektar entered into a strategic collaboration with Lilly in 2017 to develop and commercialize NKTR-358.
NKTR-358 is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases.
About Nektar
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology and immunology 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*NKTR-358 is referred to as LY3471851 under Lilly-sponsored studies.
View original content:http://www.prnewswire.com/news-releases/nektar-therapeutics-to-host-webcast-conference-call-for-analysts--investors-during-2020-virtual-european-congress-of-rheumatology-eular-2020-301067982.htmlSOURCE Nektar Therapeutics
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