On November 6, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the third quarter ended September 30, 2019 (Press release, Nektar Therapeutics, NOV 6, 2019, View Source [SID1234550481]).
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Cash and investments in marketable securities at September 30, 2019 were approximately $1.7 billion as compared to $1.9 billion at December 31, 2018.
"We continue to make steady progress with our diverse portfolio of immuno-oncology and immunology programs," said Howard W. Robin, President and CEO of Nektar. "With our partner Bristol-Myers Squibb, we are conducting registrational trials evaluating the combination of bempegaldesleukin with nivolumab in melanoma, urothelial cancer and renal cell carcinoma. We are also working collaboratively with BMS to finalize the next set of registrational studies. This weekend at the SITC (Free SITC Whitepaper) Annual Meeting, we are excited to present an 18-month follow-up for patients with metastatic melanoma enrolled in our PIVOT-02 study. This follows the recent announcement of our Breakthrough Therapy Designation for the doublet which was granted by FDA in August for patients with previously untreated metastatic melanoma. For NKTR-358, we now have three separate Phase 1b clinical trials ongoing in lupus, psoriasis and atopic dermatitis with our partner Eli Lilly, with plans to add an additional autoimmune indication to the development program in 2020. And importantly, we initiated our first clinical trial for NKTR-255, our novel IL-15 agonist, in patients with non-Hodgkin lymphoma and multiple myeloma."
Revenue in the third quarter of 2019 was $29.2 million as compared to $27.8 million in the third quarter of 2018. Year-to-date revenue for 2019 was $80.8 million as compared to $1.15 billion in the first nine months of 2018. Revenue was higher in the third quarter of 2019 as compared to the same period in 2018 primarily due to non-cash royalty revenue and an increase in product sales. Revenue was lower in the first nine months of 2019 as compared to the same period in 2018 primarily because of the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement in the second quarter of 2018.
Total operating costs and expenses in the third quarter of 2019 were $128.0 million as compared to $126.4 million in the third quarter of 2018. Total operating costs and expenses in the first nine months of 2019 were $411.2 million as compared to $365.3 million in the same period of 2018. Total operating costs and expenses increased marginally in the third quarter of 2019 as compared to the third quarter of 2018 due to a decrease in research and development (R&D) expense, offset by an increase in general and administrative (G&A) expense. Total operating costs and expenses increased in the first nine months of 2019 as compared to the same period in 2018 due to increases in both R&D and G&A expense.
R&D expense in the third quarter of 2019 was $99.0 million as compared to $102.9 million for the third quarter of 2018. For the first nine months of 2019, R&D expense was $324.2 million as compared to $290.7 million in the first nine months of 2018. R&D expense was lower in the third quarter of 2019 as compared to the same period in 2018 due to decreased expense for the bempegaldesleukin program. R&D expense was higher in the first nine months as compared to the same period in 2018 primarily because of expenses for our pipeline programs, including the continued development of bempegaldesleukin in Phase 2 and registrational studies and related manufacturing costs, costs related to Phase 1 clinical studies of NKTR-358 and IND-enabling activities for NKTR-255.
G&A expense was $24.0 million in the third quarter of 2019 as compared to $18.7 million in the third quarter of 2018. G&A expense in the first nine months of 2019 was $71.6 million as compared to $57.7 million in the first nine months of 2018. G&A expense was higher in the third quarter and first nine months of 2019 as compared to the same periods in 2018 due to costs related to commercialization readiness activities for NKTR-181 and bempegaldesleukin, and increased non-cash stock-based compensation.
Net loss in the third quarter of 2019 was $98.8 million or $0.56 basic and diluted loss per share as compared to net loss of $96.1 million or $0.56 basic and diluted loss per share in the third quarter of 2018. Net loss in the first nine months of 2019 was $327.2 million or $1.87 basic and diluted loss per share as compared to net income of $779.5 million or $4.34 diluted income per share in the first nine months of 2018.
Third Quarter 2019 and Recent Business Highlights
·In September, Nektar presented clinical data from its PIVOT-02 study for bempegaldesleukin in combination with Opdivo (nivolumab) at the 2019 CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) demonstrating the promising clinical activity of the combination in patients with advanced or metastatic triple-negative breast cancer, particularly in patients with PD-L1 negative baseline tumors.
·In October, Nektar announced that its partner Eli Lilly initiated two Phase 1b studies of NKTR-358, a novel T regulatory (Treg) cell stimulator, one in patients with psoriasis and one in patients with atopic dermatitis. NKTR-358 is designed to treat autoimmune and inflammatory conditions by correcting the immune system imbalance that results from reduced numbers and impaired function of immune regulating Treg cells.
·In October, Nektar announced the initiation of a first-in-human, Phase 1 clinical study evaluating NKTR-255, an interleukin-15 (IL-15) receptor agonist, as monotherapy for patients with relapsed or refractory non-Hodgkin lymphoma or multiple myeloma (MM). The study will also combine NKTR-255 with multiple targeted antibodies that function through an antibody-dependent cell-mediated cytotoxicity mechanism to evaluate the safety and efficacy in adults with relapsed or refractory MM.
The company also announced upcoming presentations at the following scientific congresses:
2019 Society for Immunotherapy and Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, National Harbor, MD:
·Oral Presentation: "Clinical activity of BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: updated results from the phase 1/2 PIVOT-02 study"
oPresenter: Dr. Adi Diab, MD Anderson Cancer Center
oSession: Concurrent Session 310: Combination Phase 1-2 Clinical Trials
oDate: Saturday, November 9, 2019, 5:15 p.m. – 5:30 p.m. Eastern Standard Time
·Poster: "NKTR-255, a polymer-conjugated IL-15 receptor agonist, enhances efficacy of therapeutic monoclonal antibodies with ADCC activity in solid tumor models", Kivimäe, S., et al.
oSession Date and Time: Friday, November 8, 2019, 7:00 a.m. – 8:00 p.m. Eastern Standard Time
·Poster: "Bempegaldesleukin in combination with local radiation and systemic checkpoint blockade induces a robust systemic anti-tumor immunity", Pieper, A., et al.
oSession Date and Time: Friday, November 8, 2019, 7:00 a.m. – 8:00 p.m. Eastern Standard Time
·Poster: "Characterization and comparison of NKTR-255, a polymer-conjugated IL-15 versus IL-15 superagonist", Miyazaki, T., et al.
oSession Date and Time: Saturday, November 9, 2019, 7:00 a.m. – 8:00 p.m. Eastern Standard Time
·Trials in Progress Poster: "A multicenter, open-label, exploratory platform study to evaluate biomarkers and immunotherapy combinations for the treatment of patients with metastatic castration-resistant prostate cancer (PORTER)", Nissola, L., et al.
oSession Date and Time: Friday, November 8, 2019, 7:00 a.m. – 8:00 p.m. Eastern Standard Time
ACR 2019 American College of Rheumatology Annual Meeting, Atlanta, GA:
·Poster: "Selective induction of functional regulatory T-cells in healthy volunteers by NKTR-358, a novel IL-2 conjugate Treg stimulator, in development for the treatment of autoimmune diseases", Fanton, C., et al.
oSession: T Cell Biology & Targets in Autoimmune & Inflammatory Disease Poster
oDate: Sunday, November 10, 2019, 9:00 a.m. – 11:00 a.m. Eastern Standard Time
The Promise of Interleukin-2 Therapy 2019, Paris, France:
·Presentation: "NKTR-358: A polymer-conjugated IL-2 that drives the selective expansion of endogenous Tregs for the treatment of autoimmune diseases"
oPresenter: Christine Fanton, Ph.D., Nektar Therapeutics
oSession: Session V.a – Novel IL-2s
oDate: Friday, November 15, 2019, 2:00 p.m. Central European Time
·Presentation: "Bempegaldesleukin: A polymer-conjugated IL-2 prodrug for multiple immune oncology applications"
oPresenter: Loui Madakamutil, Ph.D., Nektar Therapeutics
oSession: Session VI – IL-2 in cancer therapy
oDate: Friday, November 15, 2019, 4:30 p.m. Central European Time
11th Annual PEGs Europe, Lisbon, Portugal:
·Presentation: "TLR Agonist NKTR-262 Immunotherapy Combination with Bempegaldesleukin (NKTR-214) Harnessing Innate and Adaptive Immune System for the Treatment of Solid Tumors"
oPresenter: Saul Kivimäe, Ph.D., Nektar Therapeutics
oSession: Reprogramming the Microenvironment/The Innate Immune System/Glyco-immune Checkpoints
oDate: Tuesday, November 19, 2019, 5:30 p.m. Western European Time
·Presentation: "NKTR-255: A Polymer-Conjugated IL-15 that Enhances CAR T Efficacy in Murine Models"
oPresenter: Loui Madakamutil, Ph.D., Nektar Therapeutics
oSession: TILs and Gamma Delta Therapy
oDate: Thursday, November 21, 2019, 11:15 a.m. Western European Time
Melanoma Bridge 2019, Naples, Italy:
·Presentation: "Clinical activity of BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: updated results from the phase 1/2 PIVOT-02 study"- [Encore Presentation]
oPresenter: Igor Puzanov, M.D., Roswell Park Comprehensive Cancer Center, Melanoma Bridge Co-chair
oSession: Emergent Strategies Session
oDate: Saturday, December 7, 2019, 12:00 p.m. – 12:15 p.m. Central European Time
61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, Orlando, FL:
·Poster: "Combination of NKTR-255, a Polymer Conjugated Human IL-15, with CD19 CAR T Cell Immunotherapy in a Preclinical Lymphoma Model", Chou, C., et al.
oSession: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster II
oDate: Sunday, December 8, 2019, 6:00 p.m. – 8:00 p.m. Eastern Standard Time
·Poster: "Restoring Innate and Adaptive Immune Repertoire in Multiple Myeloma for Therapeutic Application", Fernandez, R., et al.
oSession: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, Excluding Therapy: Poster III
oDate: Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. Eastern Standard Time
·Trials in Progress Poster: "A Phase 1, Open-Label, Multi-Center, Dose Escalation and Dose Expansion Study of NKTR-255 As a Single Agent in Relapsed or Refractory Hematologic Malignancies and in Combination with Daratumumab As a Salvage Regimen for Multiple Myeloma", Shah, N. et al.
oSession: 704. Immunotherapies: Poster III
oDate: Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. Eastern Standard Time
Conference Call to Discuss First Quarter 2019 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Standard Time/2:00 p.m. Pacific Standard Time, Wednesday, November 6, 2019.
This press release and a 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: View Source The web broadcast of the conference call will be available for replay through Monday, December 9, 2019.
To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Conference ID: 3079832 (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.