On February 28, 2019 CymaBay Therapeutics, Inc. (NASDAQ: CBAY) a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported financial results and a corporate update for the quarter and year ended December 31, 2018 (Press release, CymaBay Therapeutics, FEB 28, 2019, View Source [SID1234533857]).

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"The initiation of ENHANCE, our global, Phase 3 registration study of seladelpar in primary biliary cholangitis (PBC) at the end of 2018 was a major milestone for CymaBay," said Sujal Shah, President and CEO of CymaBay. "ENHANCE was initiated on the strength of what we believe to be a very compelling and differentiated profile in Phase 2, which highlighted the potential for seladelpar to offer patients with PBC improved efficacy and better tolerability than existing second line treatment. Seladelpar has now been granted Breakthrough Therapy Designation for PBC by the FDA and PRIority MEdicine status by the EMA. In parallel, we are advancing clinical development of seladelpar in nonalcoholic steatohepatitis (NASH) and were excited earlier this month to announce the completion of enrollment in our Phase 2b study, one quarter ahead of schedule. Seladelpar is the only highly selective and potent PPARδ agonist in development for liver disease, and we believe it may be particularly well suited to treat NASH. The ability of seladelpar to lower bile acids, cholesterol and lipotoxic lipids, coupled with anti-inflammatory and anti-fibrotic actions may position it as a foundational therapy for NASH."

Recent Business Highlights

In February 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for seladelpar for the treatment of early stage PBC in combination with ursodeoxycholic acid (UDCA) in adult patients with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
In February 2019, enrollment was completed in a Phase 2b dose-ranging, paired liver biopsy study of seladelpar for the treatment of nonalcoholic steatohepatitis (NASH).
A total of 181 patients enrolled with elevated liver fat and biopsy-confirmed NASH.
Topline data on the primary efficacy outcome, the change from baseline in liver fat content at 12 weeks as measured by magnetic resonance imaging using the proton density fat fraction method (MRI-PDFF), are expected 2Q 2019.
Fourth Quarter 2018 Highlights

Initiated ENHANCE, a global, Phase 3 registration study of seladelpar for the treatment of primary biliary cholangitis (PBC).
ENHANCE is being conducted in more than 150 centers in over 20 countries. The study is intended to establish the efficacy and safety of seladelpar for the treatment of PBC to support the submission of a global registration dossier with health authorities to obtain approval.
The study is expected to be fully enrolled by the end of 2019 with the 52-week treatment period targeted to be completed by the end of 2020.
Positive data from an ongoing Phase 2 study of seladelpar in PBC were featured at late-breaking presentations during The Liver Meeting 2018 hosted by the American Association for the Study of Liver Diseases.
Sustained anti-cholestatic and anti-inflammatory effects observed with no worsening of pruritus through 52 weeks.
Results highlight the potential for seladelpar to offer patients an efficacious and safe second line treatment option.
Results suggest that seladelpar is not associated with drug-induced pruritus and may support the hypothesis that seladelpar decreases pruritus in PBC patients.
Held $178.7 million in cash, cash equivalents and marketable securities at December 31, 2018. Existing cash is expected to fund the current operating plan into 2021.
Fourth Quarter Ended December 31, 2018 Financial Results

There was no collaboration revenue in the fourth quarter of 2018 as compared to $5.2 million of revenue in the same period of 2017. Fourth quarter 2017 revenue earned was primarily due to the achievement of a $5.0 million milestone under a collaboration agreement with Kowa Pharmaceuticals America, Inc.
Research and development expenses were $16.4 million in the fourth quarter of 2018 as compared to $6.7 million in the same period of 2017. The increase was primarily driven by increases in seladelpar-related clinical trial expenses from the expansion and extension of our PBC Phase 2 clinical study, start-up activities related to our ENHANCE PBC Phase 3 clinical study, the ongoing enrollment of our NASH Phase 2b clinical study, and the execution of other NDA-enabling studies.
General and administrative expenses were $4.2 million in the fourth quarter of 2018 as compared to $2.9 million in the same period of 2017. The increase was driven primarily by employee compensation expense as we hired additional personnel to support our expanding operations.
Net loss was $19.4 million, or ($0.32) per diluted share in the fourth quarter of 2018, as compared to $5.0 million, or ($0.11) per diluted share in the same period of 2017. Net loss was higher primarily due to increased research and development expenses and decreased revenues.
Year Ended December 31, 2018 Financial Results

There was no collaboration revenue for the year ended December 31, 2018 as compared to revenue of $10.0 million in the prior year. Collaboration revenue was recognized in 2017 upon the delivery of our performance obligation under a collaboration agreement with Kowa Pharmaceuticals America, Inc.
Research and development expenses were $58.1 million in the year ended December 31, 2018 as compared to $18.9 million in the same period of 2017. The increase was primarily due to increased R&D project costs related to the expansion and extension of our PBC Phase 2 clinical study, start-up activities related to our ENHANCE PBC Phase 3 clinical study, enrollment in our NASH Phase 2b clinical study, and the execution of other NDA-enabling studies. R&D project costs also increased due to manufacturing of seladelpar to support ongoing and planned clinical trials and other development activities. Internal R&D costs also increased, primarily due to higher employee compensation related expenses as additional clinical, scientific and regulatory personnel were hired to support expanding clinical development activities.
General and administrative expenses were $14.4 million in the year ended December 31, 2018, as compared to $12.4 million in the same period of 2017. The increase was primarily due to higher compensation and consulting expenses, partially offset by a decrease in severance.
Net loss was $72.5 million, or ($1.26) per diluted share in the year ended December 31, 2018, as compared to $27.6 million, or ($0.79) per diluted share in the same period of 2017.
Conference Call Details
CymaBay management will host a conference call today at 4:30 p.m. ET to discuss fourth quarter 2018 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13687140. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On February 28, 2019 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported its financial and operational results for the year ended December 31, 2018 (Press release, Sierra Oncology, FEB 28, 2019, View Source [SID1234533856]).

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"In 2018, with our opportunistic acquisition of the Phase 3 asset, momelotinib, we transformed Sierra into a late-stage company developing a diverse portfolio of promising drug candidates. We are currently advancing discussions with regulators to determine the registration path for momelotinib and expect to report next steps in the first half of 2019. Our registration strategy envisions conducting one additional Phase 3 trial in second line myelofibrosis patients, a population with significant unmet medical needs, in order to recapitulate the meaningful clinical benefits observed in two previously completed Phase 3 trials," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We have also enrolled a substantial number of patients into the two ongoing trials for our oral Chk1 inhibitor, SRA737, and remain on track to report clinical data from these studies in the first half of 2019. In addition, our Cdc7 inhibitor, SRA141, recently delivered compelling preclinical efficacy data and has been cleared by the FDA to begin clinical trials."

2018 Highlights:

Momelotinib:

In August 2018, we acquired momelotinib, a potent, selective and orally-bioavailable JAK1, JAK2 and ACVR1 inhibitor. Momelotinib has been investigated in two completed Phase 3 trials for the treatment of myelofibrosis and has demonstrated a potentially differentiated therapeutic profile encompassing anemia-related clinical benefits, as well as achieving substantive splenic volume reduction and constitutional symptom control.

In October 2018, we hosted a Key Opinion Leader call featuring a presentation by distinguished medical oncologist Dr. Srdan Verstovsek, MD, PhD, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, Texas, who discussed momelotinib and its potential to address unmet medical needs in myelofibrosis.

In December 2018, we reported aggregated transfusion independence responses from more than 150 transfusion dependent myelofibrosis patients demonstrating robust and consistent response rates within and across the two completed SIMPLIFY Phase 3 clinical trials and a translational biology study in transfusion dependent patients with myelofibrosis. More than 44% of these patients became transfusion free for at least 12 weeks and nearly 50% were transfusion independent for at least 8 weeks. Data from the latter study were also presented in a poster at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in San Diego, California.

SRA737:

During 2018, we continued to enroll patients into the two ongoing trials for SRA737, our potent, highly selective, orally bioavailable small molecule inhibitor of Chk1. Supported by emerging clinical validation for Chk1 inhibition in high grade serous ovarian cancer (HGSOC), we prioritized enrollment of genetically defined HGSOC patients into the SRA737 monotherapy trial, while continuing to enroll patients into the trial’s other indications. The SRA737+LDG (low dose gemcitabine) trial which has been enrolling across four indications, was also modified to prioritize for the enrollment of genetically defined HGSOC patients. In April 2018, we presented preclinical data in a late-breaking poster at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting in Chicago demonstrating that SRA737 is active in both poly ADP-ribose (PARP) inhibitor resistant and CCNE1 amplified HGSOC. In November 2018, we reported preclinical data in a poster presented at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium in Dublin, Ireland demonstrating that SRA737 has impressive efficacy in highly aggressive models of ovarian cancer (CCNE1-amplified and MYCN-overexpressing HGSOC patient-derived xenograft models).

During 2018, we prepared for a potential Phase 1b/2 combination trial of SRA737 with the PARP inhibitor niraparib, in subjects with metastatic castration-resistant prostate cancer. In February 2018, we signed a supply agreement with Janssen Research & Development, LLC where they will supply niraparib for the study. We are currently evaluating the optimal timing to commence this trial within the context of our recently expanded portfolio. In April 2018, we presented supportive preclinical data at the AACR (Free AACR Whitepaper) 2018 Annual Meeting in Chicago demonstrating that SRA737 synergizes with niraparib to kill carcinoma cells via multiple cell death pathways.

In November 2018, we reported preclinical data for SRA737 combined with Immunotherapy in a poster presented at the AACR (Free AACR Whitepaper) Conference on Tumor Immunology and Immunotherapy in Miami Beach, Florida. SRA737 activated the innate immune signaling STING pathway and demonstrated significant anti-tumor activity in an immunocompetent preclinical model of small cell lung cancer (SCLC).

SRA141:

During 2018, we successfully completed the Investigational New Drug Application (IND) filing process with the U.S. Food and Drug Administration (FDA) for our novel oral Cdc7 inhibitor, SRA141, and have prepared for a potential Phase 1/2 trial of the drug candidate in patients with advanced colorectal cancer. We are currently evaluating the optimal timing to commence this trial within the context of our recently expanded portfolio.

In November 2018, we reported preclinical data for SRA141 in a poster presented at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium held in Dublin, Ireland, demonstrating that SRA141 potently and selectively inhibits Cdc7, thereby interfering with DNA replication and cell cycle dynamics within tumor cells while sparing normal cells. This unique mechanism results in significant in vitro anti-proliferative activity in a broad spectrum of tumor cell lines derived from both solid and hematologic cancers and translates into robust efficacy and tumor regressions in rodent xenograft cancer models.

Year End 2018 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $41.1 million for the year ended December 31, 2018, compared to $30.2 million for the year ended December 31, 2017. The increase was primarily due to an increase of $7.2 million in clinical trial costs mainly related to SRA737, a $3.0 million upfront fee paid to Gilead for the acquisition of our lead product candidate momelotinib and a $3.0 million increase in personnel-related and allocated overhead costs, partially offset by decreases of $1.9 million in third-party manufacturing costs related to SRA737 and SRA141 and $0.4 million in research, preclinical and other support costs. Research and development expenses included non-cash stock-based compensation of $4.5 million and $4.0 million for the year ended December 31, 2018 and 2017, respectively.

General and administrative expenses were $14.3 million for the year ended December 31, 2018, compared to $12.5 million for the year ended December 31, 2017. This increase was primarily due to a $1.7 million increase in personnel-related costs, professional fees and allocated overhead and a $0.2 million increase in business development costs. General and administrative expenses included non-cash stock-based compensation of $2.3 million and $1.9 million for the years ended December 31, 2018 and 2017, respectively.

For the year ended December 31, 2018, Sierra incurred a net loss of $53.3 million, compared to a net loss of $42.0 million for the year ended December 31, 2017.

Cash and cash equivalents totaled $106.0 million as of December 31, 2018, compared to $100.3 million as of December 31, 2017. At December 31, 2018, there were 74,365,965 shares of common stock issued and outstanding, with another 10,577,941 issuable upon exercise of stock options and warrants, and a term loan of $4.9 million.

On February 28, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the fourth quarter and full-year ended December 31, 2018 (Press release, Mirati, FEB 28, 2019, View Source [SID1234533854]).

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"Mirati made great progress in 2018 with significant advances in our sitravatinib and KRAS (MRTX849) programs. We remain focused on both programs as we anticipate enrolling second-line NSCLC patients in our Phase 3 randomized trial with sitravatinib in combination with nivolumab in the first half of 2019. We look forward to seeing data from our collaboration with BeiGene, with initial proof of concept data from the clinical trials studying sitravatinib in combination with tislelizumab, in certain tumor types, expected in the second half of 2019. We’re also excited to see MRTX849 advance in the Phase 1/2 trial toward initial clinical efficacy data this year," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "We are well funded to execute our plans following a successful financing in January and look forward to a pivotal year for Mirati."

Financial Results for the Fourth Quarter and Full Year 2018

Cash, cash equivalents, and short-term investments were $222.8 million at December 31, 2018, compared to $150.8 million at December 31, 2017. In January 2019, we completed a public equity offering with net proceeds of $107.9 million.

License and collaboration revenues for the fourth quarter of 2018 were $3.5 million and for the year ended December 31, 2018 were $12.9 million. There were no license and collaboration revenues during the same periods of 2017. License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd., which became effective January 7, 2018.

Research and development expenses for the fourth quarter of 2018 were $26.8 million, compared to $15.2 million for the same period in 2017. Research and development expenses for the year ended December 31, 2018 were $93.9 million compared to $58.1 million for the same period in 2017. The increase in research and development expenses for both periods is due to an increase in expense associated with sitravatinib and our KRAS inhibitor program, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The increase in sitravatinib expense is due to increased costs to support the expansion of existing and new clinical trials and the increase in KRAS inhibitor program expense relates primarily to increased manufacturing expenses for our lead clinical compound, MRTX849. The Company recognized research and development-related share-based compensation expense of $2.1 million during the fourth quarter of 2018 as compared to $0.7 million for same period in 2017 and $7.2 million during the year ended December 31, 2018 as compared to $3.2 million for the same period in 2017.

General and administrative expenses for the fourth quarter of 2018 were $6.4 million, compared to $3.0 million for the same period in 2017. General and administrative expenses for the year ended December 31, 2018 were $21.7 million compared to $13.5 million for the same period of 2017. The increase is due primarily to an increase in share-based compensation expense, and to a lesser extent increases in salaries and related expense, professional and consulting fees and patent filing fees. The Company recognized general and administrative-related share-based compensation expense of $2.1 million during the fourth quarter of 2018 as compared to $0.6 million for same period in 2017 and of $8.6 million during the year ended December 31, 2018 as compared to $3.6 million for the same period in 2017.

Net loss for the fourth quarter of 2018 was $28.3 million, or $0.87 per share basic and diluted, compared to net loss of $17.9 million, or $0.67 per share basic and diluted for the same period in 2017. Net loss for the year ended December 31, 2018 was $98.4 million, or $3.19 per share, compared to $70.4 million, or $2.78 per share, for the same period of 2017.

About Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial emphasizing enrollment of patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations.

About MRTX849

MRTX849 is an investigational, orally-available small molecule, that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly-identified KRAS G12C-positive advanced solid tumors.

On February 28, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the Company will host a conference call and live audio webcast on Tuesday, March 5, 2019 at 5:00 p.m. ET to report its fourth quarter and full year 2018 financial results and provide a corporate update (Press release, Fate Therapeutics, FEB 28, 2019, https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-fourth-4 [SID1234533844]).

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In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 3374407. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On February 28, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Nektar Therapeutics, FEB 28, 2019, View Source [SID1234533843]).

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Cash and investments in marketable securities at December 31, 2018 were $1.9 billion as compared to $353.2 million at December 31, 2017.

"2018 was a remarkable year for Nektar accentuated by new collaborations with leading pharmaceutical companies that validate the depth and innovation of our pipeline," said Howard W. Robin, President and Chief Executive Officer of Nektar. "We entered 2019 in an exceptionally strong financial position. We are working closely with the FDA during the ongoing review of our NDA for NKTR-181 while simultaneously preparing for a potential commercial launch later this year. We continue to design and execute on our broad registrational program for NKTR-214 (bempegaldesleukin1) with our partner Bristol-Myers Squibb. NKTR-358 is advancing in the ongoing clinical study in lupus patients and two new studies in additional auto-immune conditions are planned to start in 2019.NKTR-262, our TLR agonist is being evaluated in a Phase 1/2 study and finally, NKTR-255, our next I-O candidate is slated to move into the clinic first in patients with multiple myeloma and then in combination with CAR-T therapy."

Summary of Financial Results

Revenue for the fourth quarter of 2018 was $39.8 million as compared to $95.5 million in the fourth quarter of 2017. Revenue in the fourth quarter of 2017 included a total of $60.0 million of non-recurring revenue related to a new sublicense agreement, a contract settlement agreement and the recognition of deferred revenue from several collaboration agreements. Revenue for the year ended December 31, 2018 was $1.2 billion as compared to $307.7 million in 2017 and included the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement.

Total operating costs and expenses in the fourth quarter of 2018 were $140.1 million as compared to $119.5 million in the fourth quarter of 2017. Total operating costs and expenses for 2018 were $505.4 million as compared to $367.4 million in 2017. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

R&D expense in the fourth quarter of 2018 was $108.9 million as compared to $81.4 million for the fourth quarter of 2017. R&D expense for the year ended December 31, 2018 was $399.5 million as compared to $268.5 million in 2017. R&D expense was higher in the fourth quarter and full year 2018 as compared to the same periods in 2017 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 the NKTR-181 New Drug Application and NKTR-181 pre-commercial manufacturing, Phase 1 clinical studies of NKTR-358, the Phase 1 study of NKTR-262 in combination with bempegaldesleukin and IND-enabling activities for NKTR-255.

General and administrative (G&A) expense was $23.8 million in the fourth quarter of 2018 as compared to $12.3 million in the fourth quarter of 2017. G&A expense for 2018 was $81.4 million as compared to $52.4 million in 2017. G&A expense was higher in the fourth quarter and full year 2018 as compared to the same periods in 2017 primarily due to an increase in non-cash stock-based compensation expense.

Net loss for the fourth quarter of 2018 was $98.2 million or $0.57 basic and diluted loss per share as compared to a net loss of $33.8 million or $0.21 basic and diluted loss per share in the fourth quarter of 2017. Net income for the year ended December 31, 2018 was $681.3 million or $3.78 diluted earnings per share as compared to a net loss of $96.7 million or $0.62 basic and diluted loss per share in 2017.

2018 and Year-to-Date Business Highlights

● In February 2019, Nektar presented clinical data from first-line Stage IV urothelial carcinoma patients enrolled in the PIVOT-02 study of bempegaldesleukin with nivolumab at the 2019 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium.
● In December 2018, Nektar and Gilead entered into a research collaboration to explore the potential of NKTR-255, an IL-15 agonist, in virology. The collaboration will evaluate NKTR-255 in combination with antiretroviral therapies in Gilead’s portfolio.
● In December 2018, Nektar and Bristol-Myers Squibb initiated PIVOT-10, a potential registrational study evaluating bempegaldesleukin with nivolumab in cisplatin-ineligible urothelial carcinoma patients whose tumors express PD-L1 (Combined Positive Score < 10).
● In December 2018, Nektar and Bristol-Myers Squibb initiated PIVOT-09, a Phase 3 study of bempegaldesleukin with nivolumab versus tyrosine kinase inhibitor (TKI) monotherapy in patients with advanced metastatic renal cell carcinoma.
● In November 2018, Nektar presented data for first-line Stage IV melanoma patients from the ongoing PIVOT-02 study at the 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
● In November 2018, Nektar entered into a new clinical collaboration with Pfizer Inc. to evaluate several combination regimens in multiple cancer settings including metastatic castration-resistant prostate cancer (mCRPC) and squamous cell carcinoma of the head and neck (SCCHN). Under the collaboration, Pfizer will initiate a Phase 1b/2 clinical trial to evaluate the anti-cancer activity of the combined agents, avelumab, talazoparib and bempegaldesleukin and separately avelumab, enzalutamide and bempegaldesleukin.
● In September 2018, Nektar and Bristol-Myers Squibb initiated the Phase 3 study of bempegaldesleukin with nivolumab as compared to nivolumab monotherapy in participants with previously untreated unresectable or metastatic melanoma.
● In July 2018, the U.S. Food and Drug Administration filed and accepted a New Drug Application (NDA) for NKTR-181, a first-in-class opioid analgesic, to treat chronic low back pain in adult patients new to opioid therapy. In February 2019, Nektar received notification from the FDA that the review period for NKTR-181 has been extended by three months. The new Prescription Drug User Fee Act (PDUFA) date is now August 29, 2019. The FDA extended the action date to allow time to review data from two additional preclinical studies that Nektar conducted which were requested by the FDA early on in our review process. The new preclinical data are supportive of the company’s abuse liability package included in the NDA filing for NKTR-181.
● In June 2018, Nektar presented data from the ongoing PIVOT study for bempegaldesleukin with nivolumab at the 2018 ASCO (Free ASCO Whitepaper) Meeting. Pre-specified efficacy criteria were achieved in three tumor types: first-line melanoma, first-line renal cell carcinoma and first-line urothelial cancer.
● In May 2018, Nektar began dosing patients with systemic lupus erythematosus in a new Phase 1b multiple ascending dose study of NKTR-358, an IL-2 regulatory T cell stimulator, designed to correct the underlying immune system dysfunction found in patients with immune disorders.
● In April 2018, Nektar announced a new clinical collaboration agreement with Takeda to evaluate bempegaldesleukin with TAK-659, a dual SYK and FLT-3 inhibitor in liquid and solid tumors. The first of these studies, a Phase 1b study in patients with Non-Hodgkin Lymphoma, was initiated in January of 2019.
● In April 2018, Nektar presented preclinical data for its immuno-oncology pipeline at the 2018 AACR (Free AACR Whitepaper) Annual Meeting. Preclinical data presented by Nektar researchers and collaborators demonstrated that bempegaldesleukin combines with multiple modalities including TLR agonism and adoptive cell therapy.
● In April 2018, Nektar began dosing patients in the REVEAL Phase 1/2 study, which will evaluate NKTR-262, Nektar’s wholly-owned novel toll-like receptor 7/8 agonist, in combination with bempegaldesleukin. The dose-escalation phase of the study is continuing.
● In February 2018, Nektar and Bristol-Myers Squibb entered into a global development and commercialization agreement to evaluate the full potential of bempegaldesleukin with nivolumab in more than 20 indications in 9 tumor types.

The company also announced upcoming presentations and speaking engagements at the following scientific congresses during the first half of 2019:

ASCO-SITC Clinical Immuno-Oncology Symposium, San Francisco, CA

● Oral presentation (Abstract #28): "Phase Ib: Preliminary clinical activity and immune activation for NKTR-262 (TLR 7/8 agonist) plus NKTR-214 (CD122-biased agonist) in patients (pts) with locally advanced or metastatic solid tumors (REVEAL Phase Ib/II Trial)"
o Presenter: Dr. Adi Diab, MD Anderson Cancer Center
o Session: Oral Abstract Session B
o Session Date & Time: March 1, 2019, 1:00 p.m.-2:15 p.m. Pacific Time
26th International Molecular Medicine Tri-Conference, San Francisco, CA

● Presentation Title: "Advanced Cytokine Engineering for Immunotherapy"
o Presenter: Steven Doberstein, Ph.D., Nektar Therapeutics
o Session: Emerging Immuno-Oncology Targets Session
o Session Date & Time: March 12, 2019, at 11:25 a.m. Pacific Time
Keystone Symposia Cancer Immunotherapy: Mechanistic Insights to Improve Clinical Benefit, Whistler, BC, Canada

● Presentation Title: "Intratumoral expansion of CD8+ T cells and depletion of Tregs after treatment with NKTR-214, a first-in-class, CD122-preferential IL-2 pathway agonist"
o Presenter: Willem Overwijk, Ph.D., Nektar Therapeutics
o Session: Immune Checkpoints: Basic Mechanisms and Novel Targets
o Session Date & Time: March 13, 2019, 8:00 a.m.-11:00 a.m. Pacific Time
CHI’s Fourth Annual Immuno-Oncology Summit Europe, London, UK

● Presentation Title: "Exploratory Studies up to IND with NKTR-255, a Memory T-Cell Stimulating Cytokine"
o Presenter: Saul Kivimae, Ph.D., Nektar Therapeutics
o Session: Importance of Cytokines/Innovative Approaches with Clinical Benefit
o Session Date and Time: March 19, 2019, at 16:45 Greenwich Mean Time
ICI-IO Combinations Summit, Boston, MA

● Presentation Title: "Supercharging the Tumor Microenvironment: Lessons from NKTR-214 and OPDIVO"
o Presenter: Willem Overwijk, Ph.D., Nektar Therapeutics
o Session Date and Time: March 20, 2019, at 11:30 a.m. Eastern Time
American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, Atlanta, GA

● Abstract 2256/Poster Board 15: "Combination of neoantigen DNA plasmid vaccine VB10.NEO and NKTR-214, a CD122-biased immunostimulatory cytokine, induces strong neoantigen-specific T cell responses and sustained tumor regression in pre-clinical models," Granum, S., et al.
o Session: Clinical Research – Combination Immunotherapies 1
o Session Date and Time: April 1, 2019, 1:00 p.m.-5:00 p.m. Eastern Time
o Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 19

● Abstract 3210/Poster Board 20: "A potential immunotherapeutic approach for the treatment of osteosarcoma," Wahba, A., et al.
o Session: Immunology – Combination Immunotherapies 2
o Session Date & Time: Tuesday, April 2, 2019, 8:00 a.m.-12:00 p.m. Eastern Time
o Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 2

● Abstract 3265/Poster Board 15: "NKTR-255, a polymer-conjugated IL-15 enhances anti-tumor NK cell responses and synergizes with monoclonal antibodies to provide long-term survival in human lymphoma model," Miyazaki, T., et al.
o Session: Immunology – Novel Immunomodulatory Agents
o Session Date and Time: April 2, 2019, 8:00 a.m.-12:00 p.m. Eastern Time
o Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 25
15th Annual PEGS Boston Summit, Boston, MA

● Keynote: "Harnessing Potent Cytokine Agonist Pathways by Polymer Engineering to Develop Novel Immune Therapeutic Agents"
o Presenter: Loui Madakamutil, Ph.D., Nektar Therapeutics
o Session: Latest Developments in Agonist Immunotherapy – Cytokines and OX40 Targets
o Presentation Date and Time: Thursday, April 11, 2019 1:50 p.m. Eastern Time
6th Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference (ITOC6), Vienna, Austria

● Poster P2.12: "Mechanism of Action of NKTR-214, a first-in-class, CD122-preferential IL-2 pathway agonist"
o Presenter: Willem Overwijk, Ph.D., Nektar Therapeutics
o Session: Emerging Concepts/Novel Agents
o Session Dates and Times: April 11, 2019, at 18.20 Central European Time and April 12, 2019, from 14.00-14.30 Central European Time

Conference Call to Discuss Fourth Quarter and Year-End 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 Time today, Thursday, February 28, 2019. 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: View Source The web broadcast of the conference call will be available for replay through Thursday, March 28, 2019.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 4988768 (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.