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
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Phase 1/2
Phase 1/2
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NKTR-214 + TECENTRIQ + KEYTRUDA (PROPEL)
Solid tumors - cancer
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Phase 1/2
Phase 1/2
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NKTR-262 and NKTR-214 - REVEAL
Solid tumors
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Phase 1/2
Phase 1/2
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NKTR-255
Relapsed or Refractory Non-Hodgkin Lymphoma or Multiple Myeloma
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Phase 1
Phase 1
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
NKTR-358
Systemic lupus erythematosus (SLE)
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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-358
Atopic Dermatitis
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Phase 1b
Phase 1b
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Phase 1b trial initiation announced October 7, 2019.
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NKTR-214 and nivolumab
Sarcomas
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Phase 2
Phase 2
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Phase 2 data presented at ASCO June 3, 2019.
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NKTR-181
Lower back pain
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PDUFA
PDUFA
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FDA Advisory Committee voted 27-0 against recommending approval - January 14, 2020.
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NKTR-358
Psoriasis
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Phase 1b
Phase 1b
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Phase 1b trial initiation announced October 7, 2019.
|
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Inhaled Amikacin Solution (BAY41-6551T)
Gram-Negative Pneumonia (INHALE 1)
|
Phase 3
Phase 3
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Phase 3 data released November 24, 2017. Endpoints not met.
|
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Etirinotecan pegol NKTR-102 (BEACON)
Cancer - Metastatic Breast Cancer
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Phase 3
Phase 3
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Phase 3 topline data mid March 2015 did not reach primary endpoint.
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ADYNOVATE
Hemophilia A
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Approved
Approved
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Approved November 16, 2015.
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MOVANTIK (Naloxegol)
Opioid-induced constipation (OIC)
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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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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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SAN FRANCISCO, May 22, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) today announced the publication of Phase 1 clinical data for its lead immuno-oncology candidate, bempegaldesleukin (BEMPEG: NKTR-214) in combination with nivolumab, in Cancer Discovery, a journal of the American Association for Cancer Research. Previously published Phase 1 data in Cancer Discovery on BEMPEG, a CD122-preferential IL-2 pathway agonist, demonstrated that when administered as a monotherapy, it was well tolerated and showed clinical activity, including tumor shrinkage and durable disease stabilization, in heavily pretreated patients with solid tumor cancers.1 The manuscript published today presents the safety, immune-activation and efficacy results from a Phase 1 dose-escalation study conducted in 38 patients with immunotherapy-naïve, advanced solid tumors, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC).
This manuscript, entitled "Bempegaldesleukin (NKTR-214) Plus Nivolumab in Patients With Advanced Solid Tumors: Phase 1 Dose-Escalation Study of Safety, Efficacy & Immune Activation (PIVOT-02)," is published online and can be accessed here https://cancerdiscovery.aacrjournals.org/content/early/2020/05/20/2159-8290.CD-19-1510
Dr. Adi Diab, lead author, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center noted: "Our data show that BEMPEG, in combination with nivolumab, increases T-cell infiltration into the tumor microenvironment and increases PD-L1 expression on-treatment, leading to very encouraging response rates. Of equal importance, our data did not show an increase in the inflammatory T-cell subtype Th-17, which is known to play a crucial role in mediating the typical checkpoint inhibitor immune-related adverse events. In other words, BEMPEG in combination with nivolumab is well tolerated and induces meaningful tumor and immune responses in solid tumors, such as melanoma, RCC, and NSCLC."
Dr. Daniel C. Cho, Associate Professor at NYU Grossman School of Medicine, Phase 1 clinical trial director at NYU Langone Health's Perlmutter Cancer Center, one of the co-senior authors on the study, added: "While checkpoint inhibitors are effective in several tumor types, only a subset of patients derive durable response; the combination of BEMPEG plus nivolumab not only demonstrated encouraging clinical activity irrespective of baseline PD-L1 status, across tumor types, but it also deepened with additional cycles of treatment and in many cases is maintained off treatment."
Key findings are summarized below:
- Established the recommended Phase 2 dose (RP2D) of BEMPEG 0.006 mg/kg q3w plus nivolumab 360 mg q3w
- AEs were manageable and generally transient and reversible
- Combination of BEMPEG plus nivolumab increased absolute numbers and proliferation of CD8+ T- and NK cells in the peripheral blood, and increased expression of genes relating to immune activation in the tumor microenvironment, including the genes encoding the interferon gamma inflammatory response to PD-L1
- BEMPEG plus nivolumab demonstrated encouraging ORRs across multiple tumor types, independent of baseline PD-L1 expression. These responses continued to deepen over time
- Total ORR was 59.5%, CR was 18.9%, and DCR 83.8%
- ORR in PD-L1+ and PD-L1- patients was respectively 64.7% and 50.0%
- Among the 22 patients with confirmed objective responses, median TTR was 1.9 months (range 1.3-7.8) and median DOR was not reached
"These PIVOT-02 data further demonstrate the scientific and clinical rationale for combining BEMPEG with nivolumab for a range of advanced solid tumors. We are excited that this combination is now being developed in several ongoing Phase 2 and 3 registration trials. We look forward to the continued development of this promising combination treatment regimen," remarked Dr. Jonathan Zalevsky, Chief Research & Development Officer of Nektar Therapeutics.
BEMPEG in combination with nivolumab is being evaluated in multiple clinical trials including metastatic melanoma (NCT03635983), muscle-invasive bladder cancer (NCT04209114), metastatic cis-ineligible urothelial cancer (NCT03785925) and metastatic renal cell carcinoma (NCT03729245).
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," "continue," "maintain," and similar references to future periods. Examples of forward-looking statements include, among others, statements we make concerning the therapeutic potential of bempegaldesleukin ("BEMPEG"), the maintenance and deepening of responses following the administration of BEMPEG in combination with nivolumab, and our future development plans for BEMPEG. 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 partners), 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) BEMPEG 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, 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]1Bentebibel, S.E.; Hurwitz, M.E.; Bernatchez, C.; Haymaker, C.; Hudgens, C.W.; Kluger, H.M.; Tetzlaff, M.T.; Tagliaferri, M.A.; Zalevsky, J.; Hoch, U.; et al. A First-in-Human Study and Biomarker Analysis of NKTR-214, a Novel IL2Rbetagamma-Biased Cytokine, in Patients with Advanced or Metastatic Solid Tumors. Cancer Discov. 2019, 9, 711–721.
SOURCE Nektar Therapeutics
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SAN FRANCISCO, May 7, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) today reported financial results for the first quarter ended March 31, 2020.
Cash and investments in marketable securities at March 31, 2020 were approximately $1.5 billion as compared to $1.6 billion at December 31, 2019.
"Amid the challenges of the evolving COVID-19 pandemic, our Nektar team made significant progress to advance our various clinical studies for our immuno-oncology pipeline while also prioritizing the safety of the patients we serve, our employees and the physicians and staff in our clinical trial network," said Howard W. Robin, President and CEO of Nektar. "For our ongoing studies in oncology, we are working with our global study sites to ensure that patients continue to receive uninterrupted access to study treatment and that we preserve the integrity and conduct of our trials. Many of our clinical trial timelines remain intact; however, at this time, we currently expect that enrollment and study starts managed by our partners will likely be delayed from three to six months. From an operational perspective, Nektar's strong financial position coupled with decisive mitigation actions to address the potential impact to our business, provides a solid foundation for Nektar as we navigate this unprecedented time."
Summary of Q1 2020 Financial Results
Revenue in the first quarter of 2020 was $50.6 million as compared to $28.2 million in the first quarter of 2019. The increase was due primarily to the recognition of a $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.
Total operating costs and expenses in the first quarter of 2020 were $184.2 million as compared to $148.9 million in the first quarter of 2019. Total 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.
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, which was announced in January 2020. This includes $19.7 million for the impairment of advance payments to contract manufacturers for commercial batches of NKTR-181, and $25.5 million of additional costs, primarily for non-cancellable commitments to contract manufacturers and certain severance costs.
R&D expense in the first quarter of 2020 was $109.0 million as compared to $118.5 million for the first quarter of 2019. The decrease was due primarily to pre-commercial manufacturing costs for NKTR-181 incurred during the three months ended March 31, 2019.
G&A expense was $26.2 million in the first quarter of 2020 as compared to $25.0 million in the first quarter of 2019.
Net loss for the first quarter of 2020 was $138.7 million or $0.78 basic and diluted loss per share as compared to a net loss of $119.6 million or $0.69 basic and diluted loss per share in the first quarter of 2019. The loss per share for the first quarter of 2020 includes $0.25 loss per share for the impairment charges and additional costs related to the discontinuation of the NKTR-181 program.
COVID-19 Business Update and Review
Nektar remains committed to advancing its mission of bringing forth novel therapies for the treatment of cancer and autoimmune disorders. The company continues to closely monitor the evolving situation with COVID-19 to prepare for and minimize the potential impact to the business as a result of the COVID-19 pandemic.
Nektar-Sponsored Clinical Trials:
- Nektar has numerous clinical trials underway in cancer treatment facilities across the globe that are continuing to proceed. Over the past several months, Nektar deployed a strategy to allow continued enrollment and new study site initiations at facilities that have demonstrated operational readiness and are equipped to provide superior care and uninterrupted access to study treatment and patient services. For all ongoing clinical trials, Nektar is working closely with clinical trial sites to understand their needs during this time. The company is utilizing remote monitoring when possible to oversee study conduct. Nektar has adopted processes to allow for telemedicine and closer access to patient care, where and when appropriate, so it can continue all data collection processes and support patient safety. Nektar continues to monitor the evolving situation and the impact of COVID-19 for all of its clinical trials.
- Nektar also continues to monitor and support patients by leveraging alternative methods for maintaining clinical trial integrity, and to properly record patient event data that may be related to the COVID-19 pandemic, incorporating recent direction and flexibility provided by the United States Food and Drug Administration and other regulatory authorities.
- The majority of Nektar-run clinical studies in oncology have not experienced any significant delays. Nektar cautions that the evolving landscape could impact these statements and could still delay late-stage studies or enrollment of new patients into clinical trials in the future. Nektar currently believes that it could experience delays of approximately three months with respect to previously-provided timelines for earlier stage Nektar-run studies, such as the PROPEL study, where the initiation of planned new investigator sites in Europe was delayed due to the COVID-19 pandemic.
Nektar Manufacturing and Supply:
- At this time, Nektar does not anticipate any supply interruptions for manufacturing, including its preparations for scale-up of commercial supply of bempegaldesleukin, which are underway. The company has sufficient clinical trial material on hand to treat all patients in the studies for bempegaldesleukin, NKTR-262, NKTR-255 and NKTR-358, which are either underway or planned to start in 2020. Nektar and its manufacturing partners are continuing to regularly assess the situation.
Partner-Sponsored Clinical Trials:
- For Nektar's pharmaceutical partners, management practices around ongoing and planned clinical trial activities have varied during the COVID-19 situation. Based upon Nektar's current assessment of activities of its pharmaceutical partners, at this time, Nektar currently expects adjustments of timelines for projected study endpoints, study enrollment rate and study starts of between three to six months. However, this is subject to change as the situation is evolving and will depend upon how long COVID-19 precautionary measures remain in place.
First Quarter 2020 and Recent Business Highlights:
- 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 expands the ongoing registrational program for bempegaldesleukin plus Opdivo® (nivolumab) from three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC) to include two additional registrational trials in adjuvant melanoma and muscle-invasive bladder cancer. In addition, a Phase 1/2 study will be initiated to evaluate bempegaldesleukin plus nivolumab in combination with axitinib in first-line RCC in order to support a future registrational trial. Bristol-Myers Squibb will also independently conduct and fund a Phase 1/2 study in first-line non-small-cell lung cancer with bempegaldesleukin and nivolumab.
Conference Call to Discuss First 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, Thursday, May 7, 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 June 1, 2020.
To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 8288857 (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 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," "ensure," "expect," "preserve," "provide," "remain," "continue," "anticipate," and similar references to future periods. Examples of forward-looking statements include, among others, statements we make concerning estimates and predictions of the COVID-19 pandemic's impact on our business and clinical trials, the preservation of clinical trial integrity and conduct (including patient compliance with clinical trial treatment visits, scheduled patient scans and data collection), the timing of the initiation of clinical studies for our drug candidates, and future supply of 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) 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 partners), 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-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-262, 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 28, 2020. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.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
March 31, 2020
December 31, 2019(1)
Current assets:
Cash and cash equivalents
$ 227,035
$ 96,363
Short-term investments
1,118,847
1,228,499
Accounts receivable
42,031
36,802
Inventory
14,320
12,665
Advance payments to contract manufacturers
13,280
31,834
Other current assets
13,811
15,731
Total current assets
1,429,324
1,421,894
Long-term investments
185,900
279,119
Property, plant and equipment, net
62,307
65,665
Operating lease right-of-use assets
133,901
134,177
Goodwill
76,501
76,501
Total assets
$ 1,887,933
$ 1,977,356
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Senior secured notes, net and interest payable
$ 254,144
$ 252,891
Accounts payable
21,789
19,234
Accrued compensation
22,412
11,467
Accrued clinical trial expenses
38,624
32,626
Accrued contract manufacturing expenses
8,579
7,304
Other accrued expenses
11,844
11,414
Operating lease liabilities, current portion
15,613
12,516
Deferred revenue, current portion
3,007
5,517
Other current liabilities
1,459
1,692
Total current liabilities
377,471
354,661
Operating lease liabilities, less current portion
142,297
142,730
Liability related to the sale of future royalties, net
69,185
72,020
Deferred revenue, less current portion
2,554
2,554
Total liabilities
591,507
571,965
Commitments and contingencies
Stockholders' equity:
Preferred stock
-
-
Common stock
17
17
Capital in excess of par value
3,306,655
3,271,097
Accumulated other comprehensive loss
(6,877)
(1,005)
Accumulated deficit
(2,003,369)
(1,864,718)
Total stockholders' equity
1,296,426
1,405,391
Total liabilities and stockholders' equity
$ 1,887,933
$ 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 March 31,
2020
2019
Revenue:
Product sales
$ 3,444
$ 4,398
Royalty revenue
9,719
11,390
Non-cash royalty revenue related to sale of future royalties
9,895
8,230
License, collaboration and other revenue
27,515
4,204
Total revenue
50,573
28,222
Operating costs and expenses:
Cost of goods sold
3,811
5,440
Research and development
108,987
118,463
General and administrative
26,217
25,006
Impairment of assets and other costs for terminated program
45,189
-
Total operating costs and expenses
184,204
148,909
Loss from operations
(133,631)
(120,687)
Non-operating income (expense):
Interest expense
(6,204)
(5,226)
Non-cash interest expense on liability related to sale of future royalties
(6,968)
(6,065)
Interest income and other income (expense), net
8,352
12,483
Total non-operating income (expense), net
(4,820)
1,192
Loss before provision for income taxes
(138,451)
(119,495)
Provision for income taxes
200
137
Net loss
$ (138,651)
$ (119,632)
Basic and diluted net loss per share
$ (0.78)
$ (0.69)
Weighted average shares outstanding used in computing basic and diluted net loss per share
177,185
173,859
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Three Months Ended March 31,
2020
2019
Cash flows from operating activities:
Net loss
$ (138,651)
$ (119,632)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash royalty revenue related to sale of future royalties
(9,895)
(8,230)
Non-cash interest expense on liability related to sale of future royalties
6,968
6,065
Stock-based compensation
25,236
25,385
Depreciation and amortization
4,502
3,077
Impairment of advance payments to contract manufacturers and equipment for terminated program
20,351
-
Accretion of premiums (discounts), net and other non-cash transactions
(1,289)
(3,183)
Changes in operating assets and liabilities:
Accounts receivable
(5,229)
319
Inventory
(1,655)
(397)
Operating leases, net
2,940
1,168
Other assets
1,067
4,209
Accounts payable
2,687
5,156
Accrued compensation
9,920
8,434
Other accrued expenses
7,716
774
Deferred revenue
(2,510)
(4,204)
Other liabilities
(233)
164
Net cash used in operating activities
(78,075)
(80,895)
Cash flows from investing activities:
Purchases of investments
(241,068)
(368,739)
Maturities of investments
439,735
362,249
Purchases of property, plant and equipment
(900)
(5,648)
Net cash provided by (used in) investing activities
197,767
(12,138)
Cash flows from financing activities:
Proceeds from shares issued under equity compensation plans
11,077
4,894
Net cash provided by financing activities
11,077
4,894
Effect of exchange rates on cash and cash equivalents
(97)
(14)
Net increase (decrease) in cash and cash equivalents
130,672
(88,153)
Cash and cash equivalents at beginning of period
96,363
194,905
Cash and cash equivalents at end of period
$ 227,035
$ 106,752
Supplemental disclosure of cash flow information:
Cash paid for interest
$ 4,951
$ 4,805
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-first-quarter-2020-financial-results-301055246.htmlSOURCE Nektar Therapeutics
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SAN FRANCISCO, April 28, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) will announce its financial results for the first quarter 2020 on Thursday, May 7, 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 Monday, June 1, 2020.
To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Conference ID: 8288857 (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-first-quarter-2020-on-thursday-may-7-2020-after-close-of-us-based-financial-markets-301048772.htmlSOURCE Nektar Therapeutics
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