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OPKO Health Reports 2017 Fourth Quarter Business Highlights and Financial Results

On March 1, 2018 OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three months ended December 31, 2017 (Press release, Opko Health, MAR 1, 2018, View Source [SID1234524313]).

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Business Highlights

RAYALDEE total prescriptions reported by IMS increased 47% in Q4 2017 compared with Q3 2017: Total prescriptions were more than 3,900 during the three months ended December 31, 2017. As of January 1, 2018, more than 79% of patients have access to RAYALDEE under their insurance plans.

4Kscore utilization increased 15% in Q4 2017 compared with Q4 2016: OPKO has undertaken a number of initiatives to drive utilization of the 4Kscore test, the Company’s blood test that gives a man with elevated prostate specific androgen (PSA) levels a personalized prediction of his chance of having or developing an aggressive form of prostate cancer. OPKO launched regional television ads in the Northeast for the 4Kscore test on November 21, 2017 and expanded the television ads to Florida in February 2018.

Premarket Approval (PMA) application for Claros point-of-care (POC) PSA test submitted to FDA: On November 6, 2017, OPKO submitted a PMA for a PSA test utilizing the Claros 1 immunoassay analyzer, a novel diagnostic instrument that can provide rapid, quantitative blood test results in 10 minutes in the physician’s office with only a finger stick drop of whole blood. A second product on the same platform for testosterone is advancing toward a 510(k) submission to the FDA later this year.

Global and Japan Phase 3 and registration studies for hGH-CTP in pediatric growth hormone deficient children are making good progress in enrolling patients: The global pediatric study is a pivotal, non-inferiority design comparing a single weekly administration of hGH-CTP with daily injections of a currently marketed growth hormone product. This study is expected to complete enrollment this year. The global and Japanese pediatric studies utilize the pen device and formulation that will be launched commercially upon approval. The pediatric segment represents more than 80% of the commercial market for treatment of hGH deficiency.

Initiated a Phase 2b clinical trial for OPK88004, an orally administered selective androgen receptor modulator (SARM): In November 2017, OPKO initiated a Phase 2b dose-ranging study for the treatment of men with benign prostatic hypertrophy (BPH), or enlarged prostate. OPK88004 is expected to improve the symptoms of BPH by reducing prostate size and, on the basis of data from a previous trial in 350 men, increase muscle mass and bone strength and decrease fat mass. BPH affects approximately 50 million men in the U.S.

Initiation of four Phase 2 clinical trials anticipated in 2018:

• RAYALDEE line extension in dialysis patients with secondary hyperparathyroidism (SHPT): Together with its partners Vifor Fresenius and Japan Tobacco, OPKO is developing RAYALDEE for Stage 5 chronic kidney disease (CKD) patients with SHPT undergoing dialysis and anticipates initiating a global Phase 2 trial in dialysis centers in the second quarter of this year.
• OPK88003, a once-weekly oxyntomodulin dual GLP1-Glucagon agonist for type 2 diabetes and obesity: OPKO expects to initiate a Phase 2b dose-escalation study with OPK88003 in the second quarter of this year. In a 420-patient Phase 2 trial in patients with type 2 diabetes, OPK88003 reduced HbA1c levels similar to exenatide extended-release (Ex ER). The drug also showed statistically significantly greater weight loss and lowering of total cholesterol and triglycerides compared to once-weekly Ex ER, with a good safety profile.
• OPK88002, an NK-1 antagonist to treat pruritus (itching) in Stage 5 CKD patients undergoing dialysis: An Investigational New Drug application was submitted to the FDA and plans are being finalized to begin a single-dose Phase 2a trial of OPK88002 in dialysis patients to treat severe itching. Approximately 50% of renal dialysis patients experience difficult to control pruritus.
• OPK88001 for the treatment of Dravet Syndrome: Three clinical research centers in the United States are expected to participate in this first in human clinical study of the AntagoNAT for treatment of Dravet Syndrome.
Financial Highlights

Net loss of $213.9 during the three months ended December 31, 2017 included $147.7 million of non-recurring or non-cash items consisting of:

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$73.3 million of revenue adjustments
$13.2 million of intangible impairment related to VARUBI
$61.2 million Income tax provision
Consolidated revenues for the three months ended December 31, 2017 were $193.7 million compared to $275.5 million for the comparable period of 2016. During the three months ended December 31, 2017, revenue from services were negatively impacted by non-recurring reimbursement adjustments from commercial and federal payor programs of $73.3 million and by reduced sample volume of $9.3 million.Revenue from products included $9.1 million of revenue from RAYALDEE, including $6.2 million related to revenue previously deferred through September 30, 2017.
During the three months ended December 31, 2017, operating expenses included investment in the commercial activities supporting the launch of RAYALDEE of $7.9 million, as well as continued investment in the Company’s pharmaceutical pipeline, with R&D expense increasing to $34.2 million. In addition, fourth quarter 2017 operating expenses included a $13.2 million impairment related to our VARUBI intangible assets as a result of our licensee’s discontinuation of the IV formulation.
During the three months ended December 31, 2017, a $61.2 million income tax provision was recorded, principally as a result of the Tax Cuts and Jobs Act ($31.8 million) as well as recording a valuation allowance against our U.S. based deferred tax assets. The comparable period of 2016 includes an income tax benefit of $31.5 million.
Cash, cash equivalents and marketable securities were $91.5 million as of December 31, 2017.
OPKO strengthened its balance sheet with a $55 million private placement of convertible notes issued on February 27, 2018.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time today. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN:
866-634-2258
INTERNATIONAL DIAL-IN:
330-863-3454
PASSCODE:
1973978
WEBCAST:
View Source
For those unable to participate in the live conference call or webcast, a replay will be available beginning March 1, 2018 approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 1973978. The replay can be accessed for a period of time on OPKO’s website at View Source.

Onconova Therapeutics, Inc. to Provide Corporate Update and Full Year 2017 Financial Results

On March 1, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes, reported that the Company will release its year end 2017 financial results on March 8, 2018 before the market opens (Press release, Onconova, MAR 1, 2018, View Source [SID1234524312]).

The Company will host a conference call to discuss these results and provide an update on all rigosertib programs, including promising interim analysis for the INSPIRE trial, on March 8, 2018 at 9:00 a.m. Eastern Time.

Interested parties may access the call by dialing toll-free (855) 428-5741 from the US, or (210) 229-8823 internationally and using conference ID 2947108.

The call will also be webcast live. Please click here to access the webcast.

A replay will be available at that link until June 29, 2018.

Omeros Corporation Reports Fourth Quarter and Year-End 2017 Financial Results

On March 1, 2018 Omeros Corporation (NASDAQ: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system, reported recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2017, which include (Press release, Omeros, MAR 1, 2018, View Source;p=RssLanding&cat=news&id=2335738 [SID1234524311])

4Q 2017 total and OMIDRIA revenues were $13.8 million, a decrease of 36.5 percent from 3Q 2017, despite the fact that unit pricing and the total number of vials sold to ASCs and hospitals was unchanged from 3Q 2017. Under the company’s accounting policies, it is not able to recognize a majority of the revenue related to OMIDRIA inventories held by wholesalers at December 31 because of uncertainty around OMIDRIA reimbursement following expiration of pass-through status on January 1, 2018 and resulting reduced first quarter sell-through. In addition, a $2.4 million charge to revenue was recorded in the fourth quarter for vials that the company reserved for returns by the ASCs and hospitals anticipated in 2018.
Units sold to ASCs and hospitals by wholesalers (sell-through) for October and November 2017 were 18 percent greater than the corresponding period in 3Q.
Total year 2017 OMIDRIA revenues were $64.8 million, a 56.4 percent increase over 2016.
Net loss in 4Q 2017 was $16.6 million, or $0.34 per share, again reflecting the inability to recognize wholesaler inventories at year-end. Net loss for the full year of 2017 was $53.5 million, or $1.17 per share. Non-cash expenses for 4Q and the full year of 2017 were $4.5 million, or $0.09 per share, and $17.4 million, or $0.38 per share, respectively. The reduction in cash, cash equivalents and short-term investments from 3Q to 4Q was $3.1 million.
At December 31, 2017, the company had cash, cash equivalents and short-term investments available for operations of $83.7 million with an additional $17.1 million in accounts receivable. The company has the ability to borrow an additional $45.0 million from existing lenders through May 20, 2018.
Released compelling survival data and initiated a Phase 3 program for OMS721 in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA).
Opened enrollment in OMS721 Phase 3 trial for Immunoglobulin A (IgA) nephropathy.
Granted orphan drug designation for OMS721 in the treatment of IgA nephropathy by European Medicines Agency (EMA).
"The company’s progress during the fourth quarter of 2017 continued to build on our accomplishments earlier in the year," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Following consistently positive OMS721 data, we now have three ongoing Phase 3 clinical programs – IgA nephropathy, aHUS and, most recently, stem-cell TMA. With breakthrough therapy, fast track and orphan designations across these indications, we are continuing our interactions with FDA and European regulatory authorities to expedite approval pathways and, in the near term, to discuss accelerated and conditional approvals in stem-cell TMA. Next up is OMS527, on track to enter the clinic in mid-year for the treatment of nicotine addiction. Our frustration, shared by physicians nationwide, remains patients’ restricted access to OMIDRIA following its pass-through expiration on January 1. Congressional and administrative efforts are ongoing, and we look forward to resolving this issue soon. We are confident that OMIDRIA in 2018 will continue to fuel the advancement of our pipeline and OMS721 toward commercialization, helping to save lives."

Fourth Quarter and Recent Developments

Recent developments regarding OMIDRIA include:
OMIDRIA pass-through status expired on January 1, 2018 as scheduled, and payment for the product is included as part of the packaged payment for the associated procedure for Medicare patients. Based on first quarter 2018 data to date, Omeros believes that a substantial majority of facilities that were using OMIDRIA are awaiting resolution regarding reimbursement by the Centers for Medicare and Medicaid Services (CMS), or the company’s decision to implement an alternative sales strategy, and, therefore, sales to wholesalers during this period have been adversely affected, and Omeros expects this trend will likely continue until such uncertainty is resolved. Both legislative and administrative means are being pursued to obtain permanent separate payment or similar reimbursement for OMIDRIA and/or to extend the pass-through reimbursement period from three to five years.
In December, the FDA approved Omeros’ supplemental new drug application (sNDA) following review of efficacy and safety data from a pediatric clinical trial, expanding the indication for OMIDRIA to include use in pediatric patients (ages birth through 17 years old). The FDA also granted OMIDRIA an additional six months of U.S. market exclusivity, which is attached to the term of the drug’s patents listed in FDA’s Orange Book.
Developments regarding OMS721, Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) programs for the treatment of IgA nephropathy, HCT-TMA and atypical hemolytic uremic syndrome (aHUS), include:
In February 2018, Omeros reported new results from the ongoing Phase 2 study of OMS721 evaluating patients with HCT-TMA. The data, from a total of 19 patients, demonstrate an increase in estimated median overall survival in HCT-TMA patients treated with OMS721 compared to a matched historical control (347 days vs. 21 days, respectively, by Kaplan-Meier analysis; p < 0.0001 by log-rank test). In addition to and consistent with the survival data reported, updated assessments of platelet count, lactate dehydrogenase (LDH) and haptoglobin – all markers of TMA activity – continued to demonstrate clinically meaningful and statistically significant improvements in the HCT-TMA patients treated with OMS721.
Significant improvement in transfusion requirements was seen in the cohort of HCT-TMA patients referenced above. Eight of the 19 patients were receiving significant red blood cell and platelet transfusions at the time of study entry. The transfusions were either stopped completely or markedly reduced in seven of the eight patients. The eighth patient had ongoing acute myeloid leukemia – a malignancy of bone marrow characterized by severe red cell anemia and low production of platelets – this patient received only two doses of OMS721, discontinued the study and died shortly thereafter.
The company is scheduled to meet with FDA and is requesting meetings with regulatory bodies in the EU to discuss the most expeditious approval path, including accelerated and conditional approvals, for OMS721 in HCT-TMA.
In February 2018, the EMA granted OMS721 orphan drug designation in the treatment of IgA nephropathy. Enrollment in the Phase 3 IgA nephropathy trial is underway.
In February, Omeros extended the borrowing capacity under its existing credit facility allowing the company to borrow, at its sole discretion, up to $45.0 million through May 20, 2018 subject only to customary closing conditions.
Financial Results

Fourth Quarter 2017

For the quarter ended December 31, 2017, revenues were $13.8 million, all relating to sales of OMIDRIA. This compares to OMIDRIA revenues of $12.9 million for the same period in 2016. On a sequential quarter-over-quarter basis, OMIDRIA revenue decreased $7.9 million, or 36.5%, despite the fact that unit pricing and the total number of vials sold to ASCs and hospitals was unchanged from the quarter ended September 30, 2017. Under the company’s accounting policies, it is not able to recognize a majority of the revenue related to OMIDRIA inventories held by wholesalers at year end because of uncertainty around OMIDRIA reimbursement following expiration of pass-through status on January 1, 2018 and resulting reduced first quarter sell-through. In addition, a $2.4 million charge to revenue was recorded in the fourth quarter for vials that the company reserved for returns by the ASCs and hospitals anticipated in 2018.

Total operating costs and expenses for the three months ended December 31, 2017 were $27.9 million compared to $24.8 million for the same period in 2016. The change in the current year quarter was primarily due to higher third-party manufacturing scale up costs for our OMS721 program and higher third-party development expenses for our product candidates.

For the three months ended December 31, 2017, Omeros reported a net loss of $16.6 million, or $0.34 per share, again reflecting the inability to recognize wholesaler inventories at year end and which included non-cash expenses of $4.5 million ($0.09 per share). This compares to the prior year’s fourth quarter when Omeros reported a net loss of $19.6 million, or $0.45 per share, which included non-cash expenses of $5.2 million ($0.12 per share). The reduction in cash, cash equivalents and short-term investments from the third quarter to the fourth quarter was $3.1 million.

As of December 31, 2017, the company had $83.7 million of cash, cash equivalents and short-term investments available for operations and $5.8 million in restricted cash, with an additional $17.1 million in accounts receivable. The company also has the ability, at its sole discretion, to borrow $45.0 million from its existing lenders through May 20, 2018, subject to customary closing conditions.

Full Year 2017

Revenues for the full year 2017 were $64.8 million, a 55.8% increase compared to $41.6 million for the full year 2016. The increase was primarily attributable to an increase in both new customers and increased OMIDRIA purchases from our existing customers.

Total operating costs and expenses for the year ended December 31, 2017 were $108.7 million, an increase of $12.8 million compared to 2016. The 2017 increase related primarily to higher third-party manufacturing scale up costs for our OMS721 program, higher third-party development expenses for our product candidates, and higher legal expenses incurred in the defense of our patent infringement lawsuit against Par that was settled favorably in October 2017.

For the full year 2017, Omeros reported a net loss of $53.5 million, or $1.17 per share, including non-cash expenses of $17.4 million, or $0.38 per share. This compares to a net loss of $66.7 million, or $1.65 per share in 2016, including non-cash expenses of $16.1 million, or $0.40 per share.

Conference Call Details

Omeros’ management will host a conference call to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 1759244. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 1759244.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at www.omeros.com and select "Events" under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

Symposium and Panel Discussion on Nymox’s Fexapotide To Be Held at American Urological Association Mid-Atlantic Section Annual Meeting on March 3

On March 1, 2018 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported that a Symposium on Fexapotide Triflutate studies will be held at the Annual Meeting of the American Urological Association Mid-Atlantic Section, in Amelia Island FL March 3 (Press release, Nymox, MAR 1, 2018, View Source [SID1234524310]).

The symposium, "Long-Term Safety and Efficacy of First in Class Injectable for BPH" will be chaired by Ronald Tutrone MD FACS of Baltimore MD. The other panel members at the Symposium will be Mohamed Bidair MD of San Diego CA, James Bailen MD FACS of Louisville, KY and Richard Levin MD FACS of Baltimore MD.

The clinical trial results for Fexapotide treatment of BPH were recently published in the World Journal of Urology (View Source) in a peer review report entitled "Fexapotide Triflutate: Results of Long-Term Safety and Efficacy Trials of a Novel Injectable Therapy for Symptomatic Prostate Enlargement" which was authored by Neal Shore, MD, FACS (Carolina Urologic Research Center, Myrtle Beach, SC); Ronald Tutrone, MD, FACS (Chesapeake Urology Research Associates, Baltimore, MD); Mitchell Efros, MD, FACS (Accumed Research, Garden City, NY); Mohamed Bidair, MD (San Diego Clinical Trials, San Diego, CA); Barton Wachs, MD (Atlantic Urology Medical Group, Long Beach, CA); Susan Kalota, MD (Urological Associates of Southern Arizona, Tucson, AZ); Sheldon Freedman, MD, FACS (Freedman Urology, Las Vegas, NV); James Bailen, MD, FACS (First Urology, Louisville, KY); Richard Levin, MD, FACS (Chesapeake Urology Research Associates, Towson, MD); Stephen Richardson, MD (Jean Brown Research, Salt Lake City, UT); Jed Kaminetsky, MD, FACS (University Urology, New York, NY); Jeffrey Snyder, MD, FACS (Genitourinary Surgical Consultants, Denver, CO); Barry Shepard, MD, FACS (Urological Surgeons of Long Island, Garden City, NY); Kenneth Goldberg, MD, FACS (U T Southwestern Dept of Urology, Lewisville, TX); Alan Hay, MD, FACS (Willamette Urology, Salem, OR); Steven Gange, MD, FACS (Summit Urology Group, Salt Lake City, UT); Ivan Grunberger, MD, FACS (Brooklyn Urology, Brooklyn, NY). Please see also NCBI PubMed.gov; MDLinx; Reuters Health Information Feb 20, 2018; Medscape Urology News & Perspective; and others, re the World Journal of Urology peer review report on the Fexapotide trials.

Nymox’s lead drug Fexapotide has been in development for over 10 years and has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, and has been found after 7 years of prospective placebo controlled double blind studies of treatment of 995 U.S. men with prostate enlargement to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. The same clinical program has also shown in a long-term blinded placebo crossover group study an 82-95% reduction in the number of these patients who required surgery after they received crossover Fexapotide in the trial, as compared to patients who did not receive Fexapotide but instead received crossover conventional approved BPH treatments (p<.0001).

The Symposium will present detailed clinical data on the Phase 3 clinical trials that have been completed for Fexapotide and that have shown excellent safety and significant efficacy for the treatment of BPH. In addition, scientific data supporting the safety and efficacy from non-clinical and laboratory testing and analysis will be demonstrated. The main presentation will be followed by a panel discussion and by an interactive question and answer session with the specialist doctors in attendance.

For more information please contact [email protected] or 800-936-9669.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox’s regulatory filings, Nymox’s substantial dependence on Fexapotide, Nymox’s commercialization plans and efforts and other matters that could affect the availability or commercial potential of Fexapotide. Nymox undertakes no obligation to update or revise any forward looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox’s current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2016, and its Quarterly Reports.

Nektar Therapeutics Reports Fourth Quarter and Year-End 2017 Financial Results

On March 1,2018 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the fourth quarter and year ended December 31, 2017 (Press release, Nektar Therapeutics, MAR 1, 2018, View Source [SID1234524309]

Cash and investments in marketable securities at December 31, 2017 were $353.2 million as compared to $389.1 million at December 31, 2016. This does not include $1.85 billion in upfront payments from the new Bristol-Myers Squibb collaboration, which was announced on February 14, 2018.

"This past year was truly transformational for Nektar as we achieved a number of successes with Nektar medicines across our three key therapeutic areas of immuno-oncology, immunology and pain," said Howard W. Robin, President and Chief Executive Officer of Nektar. "In the area of pain, we completed a successful Phase 3 program for NKTR-181 in over 2,100 patients and healthy volunteers that will comprise our NDA submission in the second quarter of this year. In immunology, we entered into a major partnership with Eli Lilly for NKTR-358, a potential first-in-class T regulatory resolution therapeutic, which will be developed to treat a broad range of auto-immune disorders. Finally, in immuno-oncology, the clinical success we achieved with NKTR-214 led to a groundbreaking collaboration with Bristol-Myers Squibb that now enables us to broadly and rapidly advance NKTR-214 into over 20 registrational trials in up to 15,000 patients."

Summary of Financial Results

Revenue for the fourth quarter of 2017 was $95.5 million as compared to $37.5 million in the fourth quarter of 2016. 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, 2017 was $307.7 million as compared to $165.4 million in 2016. Revenue in 2017 included recognition of $130.1 million of the $150.0 million upfront payment from Nektar’s collaboration with Eli Lilly & Company for the development and commercialization of NKTR-358.

Total operating costs and expenses in the fourth quarter of 2017 were $119.5 million as compared to $69.6 million in the fourth quarter of 2016. Total operating costs and expenses increased primarily as a result of higher research and development (R&D) expense. Total operating costs and expenses for the year ended December 31, 2017 were $367.4 million as compared to $278.3 million in 2016.

R&D expense in the fourth quarter of 2017 was $81.4 million as compared to $50.2 million for the fourth quarter of 2016. R&D expense for the year ended December 31, 2017 was $268.5 million as compared to $203.8 million in 2016. R&D expense was higher in 2017 as compared to 2016 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, and IND-enabling activities for NKTR-262 and NKTR-255.

General and administrative (G&A) expense was $12.3 million in the fourth quarter of 2017 as compared to $12.8 million in the fourth quarter of 2016. G&A expense for the year ended December 31, 2017 was $52.4 million as compared to $44.3 million in 2016.

Net loss for the fourth quarter of 2017 was $33.8 million or $0.21 loss per share as compared to a net loss of $42.2 million or $0.28 loss per share in the fourth quarter of 2016. Net loss for the year ended December 31, 2017 was $96.7 million or $0.62 loss per share as compared to a net loss of $153.5 million or $1.10 loss per share in 2016.

2017 and Year-to-Date Business Highlights

● In February 2018, 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 first pivotal studies in melanoma and renal cell carcinoma are expected to be initiated in mid-2018.
● In December 2017, Nektar submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NKTR-262, a small molecule agonist that targets toll-like receptors (TLRs) found on innate immune cells in the body. The REVEAL Phase 1/2 study will evaluate the safety, tolerability and anti-tumor effect of NKTR-262, administered in combination with NKTR-214 (doublet) and in combination with NKTR-214 and nivolumab (triplet), in patients with locally advanced or metastatic cancers. The company plans to enroll the first patients in the REVEAL study in March of 2018.
● In November 2017, Nektar announced positive data from the dose-escalation stage of the PIVOT-02 study of NKTR-214 in combination with Opdivo at the 2017 SITC (Free SITC Whitepaper) conference. Results showed compelling response rates and favorable safety data in both PD-L1 negative and PD-L1 positive patients with melanoma, renal cell carcinoma and non-small cell lung cancer.
● In September 2017, Nektar initiated the PROPEL clinical study to evaluate the efficacy and safety of NKTR-214 in combination with approved checkpoint inhibitors, TECENTRIQ(atezolizumab) and KEYTRUDA (pembrolizumab) in patients with bladder and non-small cell lung cancer. Data from the PROPEL study is expected in the second half of 2018.
● In July 2017, Nektar and Eli Lilly announced a strategic collaboration to develop and commercialize NKTR-358, a potential first-in-class resolution therapeutic, that addresses an underlying immune system imbalance in patients with auto-immune conditions. A Phase 1 singe-ascending dose study is underway and a Phase 1/2 multiple-ascending dose study of NKTR-358 in patients with lupus is planned to begin in the second quarter of 2018.
● In July 2017, Nektar announced positive results from a Human Abuse Potential (HAP) study of NKTR-181, a first-in-class opioid analgesic.
● In May 2017, Nektar announced a new research collaboration with Takeda to explore the combination of NKTR-214 with five oncology compounds from Takeda’s cancer portfolio including a SYK-inhibitor and a proteasome inhibitor.
● In March 2017, Nektar announced positive results from the SUMMIT-07 Phase 3 efficacy study of NKTR-181 in over 600 patients with chronic low back pain. The primary efficacy endpoint of the study demonstrated significantly improved chronic back pain relief with NKTR-181 compared to placebo (p=0.0019). Key secondary endpoints of the study also achieved high statistical significance. The study demonstrated that NKTR-181 had a favorable safety profile and was well tolerated.

The company also announced upcoming presentations at the following scientific congresses during the first half of 2018:

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018, Chicago, IL:

● Abstract 3755/Poster 5: "Comprehensive antitumor immune activation by a novel TLR7/8 targeting agent NKTR-262 combined with CD122-biased immunostimulatory cytokine NKTR-214", Kivimae, S., et al.
○ Session: Immunology: Immunomodulatory Agents and Interventions 1
○ Session Date and Time: Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. Central Time
○ Location: McCormick Place South, Exhibit Hall A, Poster Section 32
● Abstract 2755/Poster 17: "NKTR-262: Prodrug pharmacokinetics in mice, rats, and dogs", Lee, M., et al.
○ Session: Immunology: Immune Mechanisms Invoked by Therapies 1
○ Session Date and Time: Monday, April 16, 2018, 1:00 p.m. – 5:00 p.m. Central Time
○ Location: McCormick Place South, Exhibit Hall A, Poster Section 33
● Abstract 123/Poster 13: "Enhanced anti-tumor activity of the combination of entinostat and NKTR-214 in renal and colon cancer tumor models", Wang, L., et al.
○ Session: Tumor Biology: Role of the Innate Immune System in Tumorigenesis
○ Session Date and Time: Sunday, April 15, 2018, 1:00 p.m. – 5:00 p.m. Central Time
○ Location: McCormick Place South, Exhibit Hall A, Poster Section 5

● Abstract 3566/Poster 4: "Enhanced expansion and tumor targeting of adoptively transferred T cells with NKTR-214", Parisi, G., et al.
○ Session: Clinical Research: Adoptive Cell Therapy 3
○ Session Date and Time: Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. Central Time
○ Location: McCormick Place South, Exhibit Hall A, Poster Section 24

Antigen-Specific Immune Tolerance Drug Development Summit 2018, Boston, MA:

● Preclinical Data Presentation: "NKTR-358: A Selective Regulatory T Cell Inducing Agent for the Treatment of Autoimmune and Inflammatory Diseases"
○ Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics
○ Date and Time: Wednesday, April 25, 2018, 4:20 p.m. Eastern Time

American Academy of Pain Medicine 34th Annual Meeting, Vancouver, BC:

● Poster: "Efficacy, safety, and tolerability of NKTR-181 in patients with moderate to severe chronic low-back pain: A Phase 3 study"
○ Presenter: John Markman, M.D., University of Rochester Medical Center
○ Session: Poster Session 2
○ Date and Time: Friday, April 27, 2018, 6:00 p.m. Pacific Time
● Poster: "Measuring withdrawal in a phase 3 study of a new analgesic, NKTR-181, in subjects with moderate-to-severe chronic low-back pain"
○ Presenter: Jack Henningfield, Ph.D., Pinney Associates
○ Session: Poster Session 2
○ Date: Friday, April 27, 2018, 6:00 p.m. Pacific Time

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 and Time: Wednesday, May 23, 2018, 3:40 p.m. Eastern Time

3rd Annual Advances in Immuno-Oncology Congress, London, U.K.:

● Presentation: "Accessing The Potential Of An Immunotherapeutic Agent"
○ Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics
○ Session: Translational Immuno-Oncology
○ Date and Time: Thursday, May 24, 2018, 5:40 p.m. London Time

College on Problems of Drug Dependence 80th Annual Scientific Meeting, San Diego, CA:

● Oral Presentation: "Neuropharmacodynamic Profile of NKTR-181: Correlation to Low Abuse Potential"
○ Presenter: Laurie VanderVeen, Ph.D., Nektar Therapeutics
○ Session: Preclinical Opioid
○ Date and Time: Tuesday, June 12, 2018, 10:15 a.m. – 10:30 a.m. Pacific Time

● 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 K. Lanier, Ph.D., Analgesic Solutions
○ Session: Pain
○ Date and Time: Wednesday, June 13, 2018, 1:30 p.m. – 1:45 p.m. Pacific Time

Conference Call to Discuss Fourth Quarter and Year-End 2017 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, March 1, 2018.

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 Monday, April 2, 2018.

To access the conference call, follow these instructions:

Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 6299239 (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..