Full Press Release Details
Nektar Therapeutics Reports Financial Results for the First Quarter of 2018
SAN FRANCISCO, May 10, 2018 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results
for the first quarter ended March 31, 2018.
Cash and investments in marketable securities at March 31, 2018 were $333.8 million as compared to $353.2
million at December 31, 2017. This does not include the $1.0 billion upfront payment and $850.0 million share purchase
proceeds received on April 3, 2018, as a result of our new Bristol-Myers Squibb collaboration.
"Nektar begins 2018 in a very strong position with a major collaboration with Bristol-Myers Squibb for NKTR-214 and key advancements
in our immuno-oncology and immunology pipeline," said Howard W. Robin, President and CEO of Nektar. "The PIVOT study
of NKTR-214 in combination with nivolumab continues to enroll patients and we are exceptionally pleased that the preliminary data
from PIVOT was accepted for an oral presentation at this year's ASCO Meeting. We initiated two new clinical studies this quarter,
the first with our novel I-O combination of NKTR-262 and NKTR-214 and the second with our autoimmune disease candidate, NKTR-358.
Based on positive preclinical results, we entered into a clinical collaboration with Takeda to evaluate NKTR-214 with their TAK-659,
a SYK/FLT inhibitor. Finally, in the area of pain, we plan to submit our NDA filing for NKTR-181 this month."
Revenue in the first quarter of 2018 was $38.0 million as compared to $24.7 million in the first quarter
of 2017. Revenue in the first quarter of 2018 was higher primarily because of the recognition of $10.0 million received from
Shire for the approval of Adynovi in Europe.
Total operating costs and expenses in the first quarter of 2018 were $124.8 million as compared to $79.2 million in
the first quarter of 2017. Total operating costs and expenses increased primarily as a result of increased research and development
R&D expense in the first quarter of 2018 was $99.4 million as compared to $61.1 million for the first
quarter of 2017. R&D expense was higher in the first quarter 2018 as compared to the same period in 2017 primarily because
of expenses for our pipeline programs, including the completion of Phase 3 clinical studies for NKTR-181, Phase 1/2 clinical studies
of NKTR-214 and NKTR-358, initiation of the Phase 1 study of NKTR-262 in combination with NKTR-214 and IND-enabling activities
General and administrative expense was $18.7 million in the first quarter of 2018 as compared to $12.0 million in
the first quarter of 2017 and increased primarily due to increased stock based compensation.
In the first quarter of 2018, net loss was $95.8 million, or $0.60 loss per share as compared to net loss of $63.9
million, or $0.42 loss per share in the first quarter of 2017.
2018 Business Highlights
In May, Nektar began dosing patients with systemic lupus erythematosus in a
Phase 1b multiple ascending dose study of NKTR-358, a first-in-class regulatory T cell stimulator, designed to correct the underlying
immune system dysfunction found in patients with immune disorders.
In April, Nektar announced a new clinical collaboration agreement with Takeda
to evaluate NKTR-214 in combination with TAK-659, a dual SYK and FLT-3 inhibitor in liquid and solid tumors with the first of these
studies expected to begin in the second half of 2018 in patients with Non-Hodgkin Lymphoma.
In April, Nektar presented positive preclinical data for its immuno-oncology
programs at the 2018 AACR Annual Meeting. Preclinical data presented by Nektar researchers and collaborators demonstrate how NKTR-214
synergizes with multiple modalities including TLRs, HDAC and ACT, highlighting the potential of NKTR-214 as a backbone therapy
In April, Nektar began dosing patients in the REVEAL Phase 1/2 study, which
will evaluate the safety and efficacy of NKTR-262, a novel toll-like receptor agonist, in combination with NKTR-214. This novel-novel
combination is designed to engage both the innate and adaptive immune response to fight cancer and may ultimately provide another
option for patients with many types of advanced or metastatic solid tumor cancers.
In February, Nektar and Bristol-Myers Squibb entered into a global development
and commercialization agreement to evaluate the full potential of NKTR-214 plus Opdivo (nivolumab) in more than 20 indications
in 9 tumor types including melanoma, renal cell carcinoma, non-small cell lung cancer, bladder and triple negative breast cancer.
The company also announced upcoming presentations at the following scientific congresses during the second quarter of 2018:
Treg Directed Therapy for Autoimmune Disorders Meeting, Boston, MA:
Preclinical Data Presentation: "NKTR-358: An IL-2 Pathway Agonist
that Selectively Expands and Activates Regulatory T cells for the Treatment of Allergy and Autoimmune Disease"
Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics
Session: Enhanced Treg-based therapy with the use of IL-2
Date: Wednesday, May 23, 2018, 3:40 p.m. Eastern Daylight Time
3rd Annual Advances in Immuno-Oncology Congress, London, U.K.:
Presentation: "Accessing The Potential Of An Immunotherapeutic
Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics
Session: Translational Immuno-Oncology
Date: Thursday, May 24, 2018, 5:40 p.m. British Summer
American Society for Clinical Oncology (ASCO) 2018 Annual Meeting, Chicago, IL:
Oral Presentation: "NKTR-214 (CD122-biased agonist) plus nivolumab
in patients with advanced solid tumors: Preliminary phase 1/2 results of PIVOT".
Presenter: Dr. Adi Diab, Assistant Professor, Department of
Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Session: Developmental Therapeutics - Immunotherapy
Date: Saturday, June 2, 2018, 3:00 p.m. - 6:00 p.m. Central Daylight Time
Abstract #2567: "TAK-659 in Combination with NKTR-214 and anti-PD-1
Therapy Leads to Complete and Sustained Tumor Regression and Immune Memory In Pre-Clinical Syngeneic Models", Huck, J., et
Session: Developmental Therapeutics - Clinical Pharmacology and Experimental
Date: Monday, June 4, 2018, 8:00 a.m. - 11:30 a.m. Central Daylight Time
Abstract #3085: "Efficacy and immune modulation by BXCL701 a dipeptidyl
peptidase inhibitor, NKTR-214 a CD122-biased immune agonist with PD1 blockade in murine pancreatic tumors", Rastelli, L., et
Session: Developmental Therapeutics - Immunotherapy
Date: Monday, June 4, 2018, 8:00 a.m. - 11:30 a.m. Central Daylight
Abstract #5582: "Efficacy and immune modulation of the tumor microenvironment
in murine ovarian tumor with the PARP inhibitor rucaparib and CD122-biased immune agonist NKTR-214", Simmons, A., et al.
Session: Gynecologic Cancer
Date: Monday, June 4, 2018, 1:15 p.m. - 4:45 p.m. Central Daylight Time
Abstract #TPS3115: "PROPEL: A phase 1/2 trial of NKTR-214 (CD122-biased
agonist) combined with anti-PD-1 (pembrolizumab) or anti-PD-L1 (atezolizumab) in patients (pts) with advanced solid tumors",
Session: Developmental Therapeutics - Immunotherapy
Date: Monday, June 4, 2018, 8:00 a.m. - 11:30 a.m. Central Daylight Time
Abstract #TPS1111: "ATTAIN: Phase 3 study of etirinotecan pegol
(EP) vs. treatment of physician's choice (TPC) in patients (pts) with metastatic breast cancer (MBC) who have stable brain metastases
(BM) previously treated with an anthracycline, a taxane, and capecitabine (ATC)", Tripathy, D., et al.
Session: Breast Cancer - Metastatic
Date: Saturday, June 2, 2018, 8:00 a.m. - 11:30 a.m. Central Daylight
College on Problems of Drug Dependence 80th Annual Scientific Meeting (2018), San Diego, CA:
Oral Presentation: "Assessment of Drug Abuse-Related Events with
MADDERS in SUMMIT-07: A Phase-3 Study of NKTR-181 in Patients with Moderate to Severe Chronic Low-Back Pain"
Presenter: Ryan Lanier, Ph.D., Analgesic Solutions
Session: The Pain and the Strain Comes Mainly from the Brain
Date: Wednesday, June 13, 2018, 1:30 p.m. - 1:45 p.m. Pacific
Oral Presentation: "Neuropharmacodynamic Profile of NKTR-181: Correlation
to Low Abuse Potential"
Presenter: Laurie Vanderveen, Ph.D., Nektar Therapeutics
Session: Basically Opioids
Date: Tuesday, June 12, 2018, 10:15 a.m. - 10:30 a.m. Pacific Daylight Time
Abstract #168: "NKTR-181 demonstrates low abuse potential in recreational
opioid users in two double-blind, randomized crossover human abuse potential studies", Henningfield, J., et al.
Session: Abuse Liability
Date: Thursday, June 14, 2018, 12:00 p.m. - 2:00 p.m. Pacific Daylight
Conference Call to Discuss First Quarter 2018 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