On November 7, 2018 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, reported third quarter 2018 financial results (Press release, OncoGenex Pharmaceuticals, NOV 7, 2018, View Source [SID1234531181]).

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Recent Highlights

The United States Adopted Name Council, or USAN, adopted cytisinicline as the nonproprietary (generic) name for the substance also known as cytisine

Announced initiation of the first trial in the ORCA (Ongoing Research of Cytisinicline for Addiction) Program. This Phase 2b optimization study will evaluate approximately 250 smokers in the U.S.

Reported results of a clinical study evaluating the effect of food on the bioavailability of a new formulation for cytisinicline

Closed registered direct offering for gross proceeds of $5.6 million

Announced positive cytisinicline data published in the International Journal of Drug Policy

Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences commented, "We are pleased with our continued progress made in the third quarter, particularly the initiation of the ORCA-1 trial that will provide critical insights to inform our Phase 3 program expected to initiate in the second-half of 2019."

"Cytisinicline" Designated as New Generic Name for Cytisine

The United States Adopted Names (USAN) Council adopted cytisinicline as the nonproprietary (generic) name in Q3 2018. USAN is responsible for selecting simple, informative, and unique generic drug names. The USAN Council establishes logical nomenclature classifications based on pharmacological and/or chemical relationships.

Initiated Phase 2b "ORCA-1"Optimization Trial

ORCA-1 is the first in Achieve’s ORCA (Ongoing Research of Cytisinicline for Addiction) Program that aims to evaluate the effectiveness of cytisinicline for smoking cessation and potentially other indications. This Phase 2b trial will evaluate both the 1.5mg and 3mg doses of cytisinicline on a declining titration schedule over 25 days, as well as three times daily dosing. The trial is randomized and blinded to compare the effectiveness of the cytisinicline doses and schedules to respective placebo groups. The primary efficacy endpoint is reduction in the number of cigarettes smoked during treatment with secondary analyses to be conducted on smoking cessation rates, safety, and compliance. ORCA-1 is being conducted at eight centers across the U.S. and results are expected in mid-2019.

Announced Study Results for New Formulation

The study evaluated the bioavailability of a new formulation of cytisinicline under fed and fasted conditions in 12 healthy volunteer smokers. Results demonstrated bioequivalence when cytisinicline was administered with or without food and that the 3mg dose of this new formulation was well tolerated.

Completed $5.6M Financing

Achieve announced the closing of a registered direct offering that raised total gross proceeds of $5.6 million and after deducting approximately $0.6 million in placement agent fees and offering expenses, receiving net proceeds of $5.0 million.

Publication of New Cytisinicline Data in the International Journal of Drug Policy

Results of an observational study comparing the effectiveness of cytisinicline and nicotine replacement therapy (NRT) as an aid to smoking cessation in the Russian Federation determined that smokers in the cytisinicline group were approximately three times more likely to achieve 90-days abstinence compared to those who attempted to quit with NRT (p=0.011). The authors concluded the findings support previous trial evidence indicating that cytisinicline is superior to NRT for achieving short- and long-term abstinence and should be considered a first-line pharmacologic treatment for smoking cessation.

Financial Results

As of September 30, 2018, the company’s cash, cash equivalents, short-term investments and restricted cash were $13.2 million. Total operating expenses for the three and nine months ended September 30, 2018 were $3.3 million and $9.1 million, respectively. Total net loss for the three and nine months ended September 30, 2018 was $3.2 million and $9.1 million, respectively

As of November 7, 2018 Achieve had 6,721,103 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30 p.m. Eastern time today, Wednesday, November 7, 2018, to provide an update on the cytisinicline clinical development program and announce third quarter 2018 financial results. To access the webcast, log on to the Investor Relations page of the Achieve website at View Source Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 9922429. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

On November 7, 2018 Bausch Health Companies Inc. (NYSE/TSX: BHC) reported that Joseph C. Papa, chairman and chief executive officer, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Stifel 2018 Healthcare Conference in New York on Nov. 14, 2018 at 11:00 a.m. ET (Press release, Valeant, NOV 7, 2018, View Source [SID1234531177]).

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A live webcast and audio archive of the event will be available on the Investor Relations page of the Bausch Health Companies Inc. web site at: View Source

On November 7, 2018 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported financial results for the quarter ended September 30, 2018 (Press release, MacroGenics, NOV 7, 2018, View Source [SID1234531176]).

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"During the third quarter, MacroGenics made tremendous progress in advancing its portfolio of immuno-oncology product candidates towards multiple near-term data read-outs," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Given the Company’s substantial pipeline progress over the past several months, we believe that the next twelve months are poised to be transformative for MacroGenics, during which we expect to continue to advance our core mission of developing breakthrough biologics that may become life-changing medicines for patients."

Key Pipeline Updates
Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody (mAb) that targets the human epidermal growth factor receptor 2, or HER2, include:
• Fully Enrolled Phase 3 Metastatic Breast Cancer Study. The Company has completed enrollment of 530 relapsed/refractory HER2-positive metastatic breast cancer patients in its pivotal SOPHIA study. MacroGenics anticipates disclosure of topline PFS data in the first quarter of 2019. In anticipation of a potential future product launch, MacroGenics is progressing its U.S. commercial planning and actively exploring ex-U.S. development and commercialization partnership opportunities.
• Phase 2 Gastric Cancer Study Demonstrated Antitumor Activity. At the 2018 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October, MacroGenics presented updated interim clinical data from a Phase 2 study of margetuximab plus an anti-PD-1 agent in patients with HER2-positive gastroesophageal adenocarcinoma. This chemotherapy-free combination, designed to coordinately engage innate and adaptive immunity, demonstrated antitumor activity in patients with advanced gastric cancer. The Company recently completed enrollment of 25 additional gastric cancer patients and expects to present data from this ongoing portion of the study in the first quarter of 2019.

PD-1 Franchise. MacroGenics is advancing multiple PD-1-directed programs to provide further differentiation from existing PD-1-based treatment options and enable a broad set of combination opportunities across the Company’s portfolio. Recent program highlights include:

Exhibit 99.1
• MGA012 Achieves Development Milestones. This anti-PD-1 mAb, also known as INCMGA0012, was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. MacroGenics retains the rights to develop MGA012 in combination with its pipeline assets. MGA012 met certain clinical proof-of-concept criteria, triggering a total of $15 million in milestones from Incyte, $10 million of which has been recognized in the third quarter and $5 million of which is expected to be recognized in the fourth quarter. Incyte plans to present updated data from the cohort expansion portion of the Phase 1 study of MGA012 in a poster session at the upcoming Society for Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Incyte has announced its intention to pursue monotherapy development of MGA012 in MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer through registration-directed studies with initial data anticipated in 2020. In addition, across both Incyte and MacroGenics, multiple studies have been initiated which will feature various combination regimens with MGA012.
• MGD013 Dose Expansion Initiated. This first-in-class DART molecule provides co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of solid tumors and hematological malignancies. MacroGenics recently established the dose and schedule for MGD013 administration and has initiated dose expansion in up to nine tumor types in a Phase 1 study.
• MGD019 IND Cleared. This DART molecule is designed to provide co-blockade of both PD-1 and CTLA-4, two immune checkpoint inhibitors, on T cells. MacroGenics’ Investigational New Drug (IND) application for MGD019 was cleared by the FDA and the Company is currently engaged in Phase 1 study startup.
B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. Recent program highlights include:
• Enoblituzumab Oral Presentation at SITC (Free SITC Whitepaper): Clinical data from MacroGenics’ study of this Fc-optimized mAb that targets B7-H3 combined with an anti-PD-1 mAb was selected for oral presentation at the upcoming SITC (Free SITC Whitepaper) Annual Meeting. Like the combination of margetuximab and anti-PD-1, enoblituzumab and anti-PD-1 is designed to leverage Fc-optimization and checkpoint blockade to coordinately engage innate and adaptive immunity, the two major components of the immune response. As an update of the recently released abstract, the combination of enoblituzumab and anti-PD-1 demonstrated antitumor activity in checkpoint inhibitor-naïve patients who had squamous cell carcinoma of the head and neck (SCCHN) and in checkpoint inhibitor-naïve patients with non-small cell lung cancer (NSCLC) with tumor PD-L1 expression of <1%. In these two cohorts, objective responses occurred in 6/18 (33%) response-evaluable SCCHN patients and in 5/14 (36%) response-evaluable NSCLC patients. Additional details will be provided at SITC (Free SITC Whitepaper).
• Orlotamab Studies Ongoing: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 monotherapy study in multiple tumor types. In addition, a combination study of orlotamab and MGA012 is ongoing.
• MGC018 Phase 1 Startup Initiated: MacroGenics’ IND submission for this anti-B7-H3 antibody-drug conjugate (ADC) was cleared by the FDA and the Company is initiating a Phase 1 study. This first-in-man study is designed to study MGC018 both as monotherapy and in combination with MGA012 in patients with solid tumors.
Flotetuzumab. Recent highlights of the Company’s bispecific, humanized DART molecule that recognizes both CD123 and CD3, include:
• Oral Presentations at ASH (Free ASH Whitepaper). MacroGenics plans to present both updated clinical data as well as gene signature data from its completed acute myeloid leukemia (AML) dose expansion cohort in two oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting next month. The Company’s collaborator, Servier, has development and commercialization rights outside North America, Japan, Korea and India for flotetuzumab, also known as S80880.

Exhibit 99.1
• Combination Study with MGA012 Planned. MacroGenics has previously presented data supporting the rationale for using checkpoint blockade as an approach to potentially enhance the anti-leukemic activity of flotetuzumab and plans to commence a combination study with MGA012.

Third Quarter 2018 Financial Results
• Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2018, were $260.1 million, compared to $305.1 million as of December 31, 2017.
• Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $20.8 million for the quarter ended September 30, 2018, compared to $1.7 million for the quarter ended September 30, 2017. This increase was primarily due to revenue recognized under the Incyte MGA012 collaboration. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year.
• R&D Expenses: Research and development expenses were $46.2 million for the quarter ended September 30, 2018, compared to $41.0 million for the quarter ended September 30, 2017. This increase was primarily due to the initiation of combination studies of MGA012, continued enrollment in multiple ongoing studies, increased development/manufacturing costs related to MGA012, which were partially reimbursed by Incyte, and increased headcount to support expanded manufacturing and development activities.
• G&A Expenses: General and administrative expenses were $9.6 million for the quarter ended September 30, 2018, compared to $8.4 million for the quarter ended September 30, 2017. This increase was primarily due to increased patent-related expenses and consulting and other costs incurred related to the implementation of the Company’s new enterprise resource planning (ERP) system.
• Net Loss: Net loss was $34.0 million for the quarter ended September 30, 2018, compared to net loss of $47.0 million for the quarter ended September 30, 2017.
• Shares Outstanding: Shares outstanding as of September 30, 2018 were 42,248,075.

Conference Call Information

MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended September 30, 2018 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 6548008.

The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On November 7, 2018 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), a research and clinical development oncology company focused on biomarker-defined cancers, reported its third quarter 2018 financial results for the period ended September 30, 2018 and provided a strategic update (Press release, Merrimack, NOV 7, 2018, View Source [SID1234531175]).

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"Following a comprehensive review of our drug candidate pipeline, we have determined that a corporate restructuring provides the best path forward to reduce operational costs and maximize value. Naturally, this step was the result of an extremely difficult decision and we regret its impact on the affected members of our team, to whom we remain grateful for their contributions to Merrimack," said Richard Peters, M.D., Ph.D., President and Chief Executive Officer. "Going forward, we remain committed to the efficient development of targeted therapies for biomarker-defined cancers, as we are now focused on our clinical development program for MM-310, for which we anticipate providing another safety update in Q1 2019, and our emerging preclinical candidates, MM-401 and MM-201."

Strategic Update

The Company conducted an internal review of its pipeline, the results of which are outlined below:

Corporate: Reflective of its updated development plans, Merrimack is initiating a corporate restructuring intended to maximize value and preserve its ability to capture outstanding milestones from Ipsen, which the Company intends to pass through to shareholders, net of any taxes owed and subject to there being sufficient surplus at that time. This restructuring includes a workforce reduction of approximately 60%, including the elimination of all open positions, to be initiated immediately and completed by February 2019. This restructuring, together with other restructuring and cost cutting measures that the Company could implement in the future, provide the Company with the potential to extend its cash runway into at least the second half of 2022. In parallel, Merrimack has retained external advisors to explore strategic alternatives.

MM-121: Based on the results of the interim analysis of its randomized Phase 2 SHERLOC study that were announced on October 19, 2018, Merrimack is discontinuing development of all ongoing MM-121 programs, including terminating the SHERBOC study, its companion Phase 2 clinical trial evaluating MM-121 in metastatic breast cancer.

MM-310: After treating the first 14 patients in the first dose-escalating regimen in Merrimack’s Phase 1 clinical trial of MM-310 in solid tumors, the study has been amended to test an alternative dosing schedule. Early data from the every three week dosing schedule regimen showed signs of encouraging antitumor activity in four patients, including two non-small cell lung cancer patients, one soft tissue sarcoma patient and one ovarian cancer patient who additionally had a 70% reduction of CA-125, an associated tumor marker. However, emerging cumulative grade 3 peripheral neuropathy following multiple cycles of treatment was observed in three patients. Pharmacokinetic and preclinical data indicate that lengthening the time between dosing may improve tolerability of MM-310. Patients are now being screened under an every four week schedule amendment and will be dosed starting at the highest dose level reached in the prior regimen. Merrimack plans to provide an additional safety update from the study in Q1 2019.

Preclinical Programs: Merrimack is narrowing the scope of its preclinical efforts to prudently advance its two most promising programs, which are MM-401, its previously undisclosed immuno-oncology program, an agonistic antibody targeting a novel immuno-oncology target, TNFR2, and MM-201, a highly stabilized agonist-Fc fusion protein targeting death receptors 4 and 5. The Company will feature data from the MM-401 program at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on November 14, 2018 in a poster titled, "Targeting TNFR2 – A Key Regulator of the Tumor Immunosuppressive Microenvironment," which highlights robust responses to MM-401 as a monotherapy in multiple mouse tumor models, including in PD-1 antibody-resistant tumors, as well as in combination with checkpoint inhibition.

Third Quarter 2018 Financial Results

In the third quarter and more recently, Merrimack received three ONIVYDE-related milestone payments:

$18.0 million resulting from the sale of ONIVYDE in two additional major European countries, which was received and announced in August 2018;

$5.0 million resulting from the sale of ONIVYDE in the first major non-European, non-Asian country, which was received and announced in September 2018; and

$5.0 million of the $10.0 million milestone for the first patient dosed in a pivotal clinical trial of ONIVYDE in an indication other than pancreatic cancer, which was received in October 2018, subsequent to the end of the third quarter. Merrimack received $5.0 million triggered by the commencement of a multi-part study that Ipsen and Servier are conducting in small cell lung cancer (SCLC). The remaining $5.0 million would be paid if and when a decision is made to progress to the randomized part of the study focused on efficacy.

The following summarizes Merrimack’s financial results for the quarter ended September 30, 2018:

Research and development expenses for the third quarter ended September 30, 2018 were $13.0 million, compared to $13.6 million for the comparable period of 2017. Research and development spending for the third quarter of 2018 was lower versus the comparable period in 2017 primarily due to the phasing of clinical development programs;

General and administrative expenses for the third quarter ended September 30, 2018 were $3.8 million, compared to $3.4 million for the comparable period of 2017. General and administrative spending for the third quarter of 2018 was higher versus the comparable period in 2017 primarily due to the timing of external corporate expenses;

Net loss for the third quarter ended September 30, 2018 from continuing operations was $12.3 million, or $0.92 per share, compared to a net loss of $5.4 million from continuing operations, or $0.40 per share, for the comparable period of 2017. The comparable period of 2017 included a one-time non-cash gain of approximately $10.8 million related to the deconsolidation of a subsidiary; and

As of September 30, 2018, Merrimack had 13.3 million shares of common stock, $0.01 par value per share, outstanding.

Financial Outlook

As a result of the corporate restructuring, Merrimack believes that its cash, cash equivalents and marketable securities of $84.8 million as of September 30, 2018, plus the $5.0 million ONIVYDE milestone received in October but excluding any potential additional milestone payments, together with other restructuring and cost cutting measures that Merrimack could implement in the future, provide Merrimack with the potential to fund its operations into at least the second half of 2022.

Merrimack remains eligible to receive additional milestone payments resulting from the Company’s asset sale to Ipsen in 2017:

Merrimack is entitled to receive up to $5.0 million in milestone payments triggered by Ipsen’s and Servier’s decision to progress their ongoing multi-part clinical trial evaluating ONIVYDE in SCLC into the randomized part of the study focused on efficacy. This milestone payment is excluded from the Company’s cash runway guidance until achieved; and

Merrimack is entitled to receive an aggregate of $450.0 million in regulatory-based milestones from Ipsen, which Merrimack has said it expects to pass through to stockholders, net of any taxes owed and subject to there being sufficient surplus at that time, consisting of:

$225.0 million upon approval by the FDA of ONIVYDE for the first-line treatment of metastatic adenocarcinoma of the pancreas, subject to certain conditions;

$150.0 million upon approval by the FDA of ONIVYDE for the treatment of small cell lung cancer after failure of first-line chemotherapy; and

$75.0 million upon approval by the FDA of ONIVYDE for an additional indication unrelated to those described above.

Conference Call and Webcast

Merrimack will host a live conference call and webcast today, Wednesday, November 7, 2018 at 8:30 am ET, to provide an update on the Company, including the results of its portfolio review, and a summary of these financial results.

Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 4685885. A listen-only webcast of the call can be accessed in the Investors section of Merrimack’s website, investors.merrimack.com, and a replay of the call will be archived there for six weeks following the call.

On November 7, 2018 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the third quarter ended September 30, 2018 (Press release, Nektar Therapeutics, NOV 7, 2018, View Source [SID1234531174]).

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Cash and investments in marketable securities at September 30, 2018 were $2.0 billion as compared to $353.2 million at December 31, 2017.

"We have made tremendous progress advancing our portfolio of immuno-oncology, immunology and pain programs in 2018," said Howard W. Robin, President and CEO of Nektar. "We are implementing the broad joint development plan for NKTR-214 with partner Bristol-Myers Squibb across a range of tumor types, with the first Phase 3 trial in melanoma initiated in September and the next seven trials in renal cell carcinoma, urothelial cancer and non-small cell lung cancer starting over the next several months. In addition, our new collaboration with Pfizer underscores the promise of NKTR-214 as a backbone therapy in multiple cancer treatment regimens. NKTR-358 continues to advance with the ongoing clinical study in lupus patients and NKTR-181 is continuing through the NDA review process with the FDA. Finally, we are in an exceptionally strong financial position to execute on our strategy, ending the quarter with $2.0 billion in cash."

Revenue in the third quarter of 2018 was $27.8 million as compared to $152.9 million in the third quarter of 2017. Year-to-date revenue for 2018 was $1.2 billion as compared to $212.2 million in the first nine months of 2017 and included the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement. Revenue in the third quarter of 2017 included recognition of $127.6 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 third quarter of 2018 were $126.4 million as compared to $83.4 million in the third quarter of 2017. Year-to-date total operating costs and expenses in 2018 were $365.3 million as compared to $247.9 million for the same period in 2017. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

Research and development expense in the third quarter of 2018 was $102.9 million as compared to $65.7 million in the third quarter of 2017. Year-to-date R&D expense for 2018 was $290.7 million as compared to $187.0 million for the same period in 2017. R&D expense was higher in the third quarter and first nine months as compared to the same periods in 2017 primarily because of expenses for our pipeline programs, including the continued development of NKTR-214 in Phase 1/2 studies and Phase 3 preparatory activities 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 NKTR-214 and IND-enabling activities for NKTR-255.

General and administrative (G&A) expense was $18.7 million in the third quarter of 2018 as compared to $12.1 million in the third quarter of 2017. G&A expense in the first nine months of 2018 was $57.7 million as compared to $40.0 million for the same period in 2017. G&A expense was higher in the third quarter and first nine months of 2018 as compared to the same periods in 2017 primarily due to an increase in non-cash stock based compensation expense.

Net loss in the third quarter of 2018 was $96.1 million or $0.56 basic and diluted loss per share as compared to net income of $60.9 million or $0.37 diluted earnings per share in the third quarter of 2017. Net income in the first nine months of 2018 was $779.5 million or $4.34 diluted earnings per share as compared to net loss of $62.9 million or $0.41 basic and diluted loss per share in the first nine months of 2017.

Third Quarter 2018 and Recent Business Highlights

·In November, Nektar entered into an oncology 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 new collaboration, Pfizer will initiate a Phase 1b/2 clinical trial to evaluate the anti-cancer activity of the combined agents, avelumab, talazoparib and NKTR-214, as well as avelumab, enzalutamide and NKTR-214.

·In October, Nektar appointed Karin Eastham as an independent director to its Board of Directors. Ms. Eastham brings more than 35 years of experience as both an executive and independent director in the biotechnology industry, with particular expertise in finance and operations.

·In September, Nektar and Bristol-Myers Squibb initiated a Phase 3 study of NKTR-214 combined with nivolumab versus nivolumab in participants with previously untreated unresectable or metastatic melanoma.

·In July, the U.S. Food and Drug Administration accepted Nektar’s New Drug Application (NDA) for NKTR-181, a first-in-class opioid investigational drug candidate, to treat chronic low back pain in adult patients new to opioid therapy. The NDA has been assigned a PDUFA (Prescription Drug User Fee Act) target action date of May 29, 2019 by the FDA.

The Company also announced the following upcoming presentations through year-end 2018:

2018 Society for Immunotherapy and Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, Washington D.C.:

· Oral Presentation: "Immune monitoring after NKTR-214 plus nivolumab (PIVOT-02) in previously untreated patients with metastatic Stage IV melanoma"
o Session: Cytokines Reinvented
o Presenter: Dr. Adi Diab, MD Anderson Cancer Center
o Date: Friday, November 9, 2018, 5:05 p.m. – 6:30 p.m. Eastern Standard Time

Poster Presentations:

Session: Combination Therapy

· Abstract #P348: "Survival and immune modulation in homologous recombination deficient murine ovarian tumors using the PARP inhibitor, rucaparib and immune agonist, NKTR-214", Charych, D., et al.
o Date: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

· Abstract #P364: "Systemic anti-tumor immunity and immune memory formation by a novel TLR7/8 targeting agent NKTR-262 combined with CD122-biased immunostimulatory cytokine NKTR-214", Kivimae, S., et al.
o Date: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

· Abstract #P368: "Combination of a Dipeptidyl Peptidase Inhibitor BXCL701 and Biased CD122 Agonist NKTR-214 with Anti-PD1 Provides Functional Immunological Memory through Inflammatory Cell Death", MacDougall, J., et al.
o Date: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

· Abstract #P378: "NKTR-214 (CD122-biased agonist) and NKTR-262 (TLR7/8 agonist) combination treatment pairs local innate immune activation with systemic CD8+ T cell expansion to enhance anti-tumor immunity", Rolig, A., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

Session: Cytokines in Anti-Tumor Immunity

·Abstract #P418: "Pre-clinical investigation of NKTR-255, a polymer-conjugated IL-15 with a potent NK cell dependent anti-tumor efficacy", Miyazaki, T., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

·Abstract #P419: "NKTR-214 in combination with radiation produces a potent in situ vaccine in the syngeneic B78 melanoma model", Sondel, P., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

·Abstract #P422: "A polymer-associated human IL-15 (NKTR-255) has optimized biological activity and unique mechanisms of action on CD8 T Cells and NK Cells", Robinson T., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

·Abstract #P424: "NKTR-214, an engineered IL-2, selectively depletes intratumoral Tregs and expands immunotherapy-induced effector T cell responses", Sharma, M., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

Session: Mechanisms of Resistance to Immunotherapy

·Abstract #P557: "Overcoming genetically-based resistance mechanisms to PD-1 blockade", Torrejon, D., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, San Diego, CA;

·Publication #2952: "Pharmacokinetic and Pharmacodynamic Study of NKTR-255, a Polymer-Conjugated Human IL-15, in Cynomolgus Monkey", Miyazaki, T., et al.
oSession 625: Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster II
oDate: Sunday, December 2nd from 6:00 p.m. – 8:00 p.m. Pacific Time
oLocation: San Diego Convention Center, Hall GH

Conference Call to Discuss Third 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 Time today, Wednesday, November 7, 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, December 10, 2018.

To access the conference call, follow these instructions:

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

Passcode: 9395678 (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.