On February 27, 2020 Cryoport, Inc. (NASDAQ: CYRX) (NASDAQ: CYRXW) ("Cryoport" or the "Company"), a global leader in life sciences solutions, reported that the Company will report financial results for the fourth quarter and fiscal year ended December 31, 2019 on Thursday, March 5, 2020 after U.S. markets close (Press release, Cryoport, FEB 27, 2020, View Source [SID1234554942]).

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In addition to the earnings release, a document titled "Cryoport 2019 Year in Review", which will provide a review of Cryoport’s recent financial and operational performance and a general business update, will be issued by management at 4:05 pm ET on Thursday, March 5, 2020. The document is designed to be read by investors before the questions and answers conference call and can be accessed at http://ir.cryoport.com/events-and-presentations.

Cryoport management will host a conference call at 5:00 pm ET on March 5, 2020. The conference call will be in the format of a questions and answers session and will address any queries investors have regarding the Company’s reported results.

Conference Call Information

Date:

March 5, 2020

Time:

5:00 p.m. ET

Dial-in numbers:

+1 (855) 327-6837 (U.S.), +1 (631) 891-4304 (International)

Confirmation code:

Request the "Cryoport Call"

Live webcast:

‘Investor Relations’ section at www.cryoport.com or at this link. Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

An archive of the question and answer webcast will be available approximately three hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.cryoport.com for a limited time. To access the replay of the webcast, please follow this link. A dial-in replay of the call will also be available to those interested until March 12, 2020. To access the replay, dial +1 (844) 512-2921 (United States) or +1 (412) 317-6671 (International) and enter replay pin number: 10008682.

On February 27, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the fourth quarter and year ended December 31, 2019 and provided a corporate update (Press release, Jounce Therapeutics, FEB 27, 2020, View Source [SID1234554864]).

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"On the heels of a year of significant clinical progress in 2019, we have set the pace for a robust 2020 with the advancement of our vopratelimab Phase 2 studies, the ongoing EMERGE trial and the upcoming SELECT trial. The recent announcement of the TISvopra biomarker for patient selection in SELECT is a testament to our Translational Science Platform and further emphasizes our vision of bringing the right immunotherapy to the right patients," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "With two of our programs, vopratelimab and JTX-4014, in clinical trials, along with the advancement of our potential first-in-class monoclonal antibody, JTX-1811, into IND enabling activities, we are continuing to establish our differentiated approach to immunotherapy and clinical trial design. We look forward to executing on several key milestones in 2020 across our growing pipeline."

Pipeline Update and Highlights:
Vopratelimab

Established two development paths for vopratelimab program: In early 2019, Jounce announced two development paths for vopratelimab, which are now represented by two distinct and independent Phase 2 clinical trials, EMERGE and SELECT. Both trials are based on the biology related to the pharmacodynamic biomarker, ICOS hi CD4 T cells, which emerge in the blood of patients due to vopratelimab and not PD-1 inhibitors and are associated with clinical benefit.
— Enrollment on track in Phase 2 EMERGE trial: EMERGE trial enrollment in non-small cell lung cancer (NSCLC) remains on track, and Jounce expects to report preliminary efficacy and related biomarker data in the second half of 2020.
— Identified the baseline TISvopra biomarker: In February 2020, Jounce presented new data announcing the identification of the predictive biomarker associated with vopratelimab patient selection, known as TISvopra, which will be used in the upcoming SELECT trial to select patients more likely to develop ICOS hi CD4 T cells and experience clinical benefit in the presence of vopratelimab. The TISvopra biomarker is a baseline RNA signature with a threshold optimized for the prediction of the emergence of ICOS hi CD4 T cells and is expected to predict for both vopratelimab and PD-1 activity.
— Announced trial design for upcoming Phase 2 SELECT trial: In January 2020, Jounce announced the trial design for SELECT, a randomized, ex-U.S. trial that will evaluate vopratelimab and JTX-4014, a PD-1 inhibitor, in patients with second line, PD-1 inhibitor naive NSCLC. Jounce expects to enroll approximately 75 patients, who will be selected using the TISvopra biomarker. Jounce expects to initiate the Phase 2 SELECT trial in mid-2020 and report interim clinical data in 2021.
JTX-4014

Established JTX-4014 as combination agent for Phase 2 SELECT trial: Based on the results of the Phase 1 JTX-4014 trial announced in November 2019, Jounce plans to use JTX-4014 as the PD-1 inhibitor in combination with its other product candidates beginning with the upcoming Phase 2 SELECT trial.
Presented safety and preliminary efficacy data from Phase 1 trial at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting: In November 2019, Jounce presented safety and preliminary efficacy data from the Phase 1 trial of JTX-4014 at SITC (Free SITC Whitepaper) demonstrating anti-tumor activity with an overall RECIST 1.1 response rate of 16.7% (3/18), one complete response, two partial responses and a disease control rate of 44.4% (8/18) in patients with advanced refractory solid tumor malignancies and an average of over four lines of prior therapies. JTX-4014 was found to have an acceptable safety profile in this trial.
JTX-1811

Named JTX-1811 as next development candidate from Translational Science Platform: In December 2019, JTX-1811 was selected as the next development candidate to emerge from Jounce’s Translational Science Platform. JTX-1811 is a monoclonal antibody designed to selectively deplete immuno-suppressive T regulatory cells. Jounce will present additional preclinical data at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting and expects to file an Investigational New Drug (IND) application in the first half of 2021.
Research Collaborations and Partnerships:

Established research collaboration with NanoString Technologies to support the application of TISvopra in Phase 2 SELECT trial: In January 2020, Jounce entered into a new research collaboration with NanoString Technologies for the application of the TISvopra biomarker, including the optimized selection threshold in the SELECT trial. The TISvopra clinical trial assay will be implemented on the nCounter Dx Analysis System.
Updated strategic collaboration with Celgene Corporation: In July 2019, Jounce and Celgene entered into a mutual agreement to terminate their broad strategic collaboration established in 2016. As a result, Jounce owns all global rights to its current pipeline, including vopratelimab, JTX-4014, JTX-1811 and all discovery-stage assets. Separately, Celgene obtained exclusive worldwide licensing rights to JTX-8064, a potential first-in-class antibody that targets the LILRB2 receptor on macrophages. Under the terms of the new license agreement, Jounce received a $50.0 million non-refundable license fee and is eligible to receive up to $480.0 million from Celgene in development, regulatory and commercial milestone payments, as well as royalties from potential worldwide sales.
Fourth Quarter and Full Year 2019 Financial Results:

Cash position: As of December 31, 2019, cash, cash equivalents and investments were $170.4 million, compared to $195.9 million as of December 31, 2018. The decrease in cash, cash equivalents and investments was primarily due to operating costs incurred during the year, offset by the $50.0 million license fee received in July 2019 pursuant to Jounce’s JTX-8064 license agreement with Celgene.
License and collaboration revenue: No license and collaboration revenue was recognized during the fourth quarter of 2019, compared to $20.1 million for the same period in 2018. License and collaboration revenue was $147.9 million for the full year 2019, compared to $65.2 million for the full year 2018. License and collaboration revenue recognized during 2019 was comprised of $50.0 million of cash revenue related to Jounce’s JTX-8064 license agreement with Celgene and $97.9 million of non-cash revenue recognition relating to the $225.0 million upfront payment received from Celgene in July 2016. License and collaboration revenue recognized during 2018 was comprised solely of non-cash revenue recognition related to the July 2016 upfront payment.
Research and development expenses: Research and development expenses were $16.6 million for both the fourth quarter of 2019 and 2018. Research and development expenses were $67.1 million for the full year 2019, compared to $70.1 million for the full year 2018. The decrease in research and development expenses for the full year 2019 was primarily due to $6.0 million of decreased manufacturing and IND-enabling expenses as well as $0.9 million of decreased lab consumable costs. These decreases were partially offset by $3.1 million of increased employee compensation costs.
General and administrative expenses: General and administrative expenses were $6.9 million for the fourth quarter of 2019, compared to $6.6 million for the same period in 2018 and $27.9 million for the full year 2019, compared to $26.4 million for the full year 2018. The increase in general and administrative expenses for both the fourth quarter of 2019 and the full year 2019 was primarily attributable to increased employee compensation costs.
Net (loss) income: Net loss was $22.7 million for the fourth quarter of 2019, or a basic and diluted net loss per share of $0.68. Net loss was $2.0 million for the same period in 2018, or a basic and diluted net loss per share of $0.06. Net income was $56.8 million for the full year 2019, resulting in basic net income per share of $1.72 and diluted net income per share of $1.66. Net loss was $27.4 million for the full year 2018, or a basic and diluted net loss per share of $0.84. Net income recognized for the full year 2019 was primarily attributable to $147.9 million of license and collaboration revenue recognized under Jounce’s agreements with Celgene.
Financial Guidance:
Based on its current operating and development plans, Jounce expects gross cash burn on operating expenses and capital expenditures for the full year 2020 to be approximately $80.0 million to $95.0 million. Jounce will no longer provide license and collaboration revenue guidance as potential future payments under the JTX-8064 license agreement with Celgene are royalty- and milestone-based.

Given the strength of its balance sheet, Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements through the end of 2021.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 7889239. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.

On February 27, 2020 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultra-rare diseases, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions using the latest biotechnology, reported that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Crysvita (burosumab) for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors (tumor-induced osteomalacia; TIO) that cannot be curatively resected or localized (Press release, Kyowa Hakko Kirin, FEB 27, 2020, View Source [SID1234554891]). The FDA has assigned priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of June 18, 2020.

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"We appreciate the FDA’s collaboration in evaluating the data, and as a result, we are another step closer to bringing the first treatment to patients with this devastating disease in the setting of an unresectable tumor," said Camille L. Bedrosian, M.D., Chief Medical Officer of Ultragenyx. "We look forward to continuing to work closely with the FDA with the goal of bringing Crysvita to patients with TIO as quickly as possible."

"The discovery and submission of Crysvita has meant a great deal to patients and families that previously had no other treatment options," said Tomohiro Sudo, Head of Global Product Management Office of Kyowa Kirin. " "If approved, we believe Crysvita may also become a meaningful treatment option for many patients with TIO in the U.S."

The sBLA package includes data from two single-arm Phase 2 studies, a 144-week study in 14 adult patients conducted by Ultragenyx in the U.S. and an 88-week study in 13 adult patients conducted by Kyowa Kirin in Japan and South Korea.

Crysvita is approved by the U.S. FDA for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients six months of age and older, and by Health Canada and Brazil’s National Health Surveillance Agency (ANVISA) for the treatment of XLH in adult and pediatric patients one year of age and older. In Japan, it is approved by the Ministry of Health, Labor and Welfare (MHLW) for the treatment of FGF23-related hypophosphatemic rickets and osteomalacia. In Europe, Crysvita has received European conditional marketing authorization for the treatment of XLH with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons, and an application for the expanded use in adults with XLH is currently under review by the European Medicines Agency.

See below for Important Safety Information for Crysvita in X-linked hypophosphatemia.

About Tumor-Induced Osteomalacia (TIO)
TIO is caused by typically benign tumors that produce excess levels of fibroblast growth factor 23 (FGF23), causing phosphate wasting in the urine that leads to severe hypophosphatemia, osteomalacia, muscle weakness, fatigue, bone pain and fractures. The symptoms rapidly resolve if the causal tumors or lesion can be resected; however, there are cases in which resection is not feasible or recurrence of the tumor occurs after resection. In patients for whom the tumor or lesion is inoperable, the current treatment consists of oral phosphate and/or vitamin D replacement. Efficacy of this management is often limited, as it does not treat the underlying disease and its benefits must be balanced with monitoring for potential risks such as nephrocalcinosis, hypercalciuria and hyperparathyroidism. An estimated 500-1,000 people in the United States have TIO, and approximately half of all cases are inoperable.

About Crysvita
Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone FGF23. FGF23 is a hormone that reduces serum levels of phosphorus and active vitamin D by regulating phosphate excretion and active vitamin D production by the kidney. Phosphate wasting in TIO and other hypophosphatemic conditions, including XLH, is caused by excessive levels and activity of FGF23. Crysvita is designed to bind to and thereby inhibit the biological activity of FGF23. By blocking excess FGF23 in patients with TIO and XLH, Crysvita is intended to increase phosphate reabsorption from the kidney and increase the production of vitamin D, which enhances intestinal absorption of phosphate and calcium.

Kyowa Kirin and Ultragenyx have been collaborating in the development and commercialization of Crysvita globally based on the collaboration and license agreement between the parties.

INDICATION (IN THE U.S.)

Crysvita is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.

IMPORTANT SAFETY INFORMATION Crysvita should not be taken if:

• An oral phosphate supplement and/or a specific form of vitamin D supplement are taken (such as calcitriol, paricalcitol, doxercalciferol, calcifediol).

• Phosphorus levels from a blood sample are within or above the normal range for age.

• Kidney problems are present. What is the most important information to know about Crysvita?

• Some patients developed allergic reactions (rash and hives) while taking Crysvita. Doctors will monitor for symptoms of an allergic reaction while Crysvita is taken.

• High levels of phosphorus in the blood have been reported in some patients taking Crysvita. This may be related to a risk of high calcium levels in the kidneys. Doctors will collect samples to monitor levels.

• Administration of Crysvita may result in reactions at the injection site, such as hives, reddening of the skin, rash, swelling, bruising, pain, severe itching of the skin, and collection of blood outside of a blood vessel (hematoma). What are the possible side effects of Crysvita?

• The most common adverse reactions that were seen in children with XLH are: o Fever o Injection site reaction o Cough o Vomiting o Pain in arms and legs o Headache o Tooth infection o Dental cavities o Diarrhea o Decreased vitamin D levels o Toothache o Constipation o Muscle pain o Rash o Dizziness o Nausea

• The most common adverse reactions that were seen in adults with XLH are: o Back pain o Headache o Tooth infection o Restless leg syndrome o Decreased vitamin D levels o Dizziness o Muscle spasms o Constipation o Phosphorus levels increased in the blood

• Narrowing of the spaces within the spine is common in adults with XLH and pressure on the spinal cord has been reported in adults taking Crysvita. It is not known if taking Crysvita worsens the narrowing of the spaces within the spine or the pressure on the spinal cord. Before taking Crysvita, doctors should be informed about all medications (including supplements) and medical conditions, including if:

• One is taking oral phosphate and/or active vitamin D (such as calcitriol, paricalcitol, doxercalciferol, calcifediol).

• One is pregnant, thinks she may be pregnant, or plans to become pregnant. There is not enough experience to know if Crysvita may harm an unborn baby. Report pregnancies to the Kyowa Kirin, Inc. Adverse Event reporting line at 1-888-756-8657.

• One is breastfeeding or plans to breastfeed. There is not enough experience to know if Crysvita passes into breast milk. Women should talk with their doctors about the best way to feed their babies while taking Crysvita. While taking Crysvita, doctors should be informed if one experiences:

• An allergic reaction such as rash or hives

• A rash, swelling, bruising or other reaction at the injection site

• New or worsening restless leg syndrome

These are not all the possible side effects of Crysvita. Doctors should be contacted for medical advice about side effects.

Side effects may be reported to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

Side effects may also be reported to Kyowa Kirin, Inc. at 1-888-756-8657.

Please see full Prescribing Information for additional Important Safety Information.

On February 27, 2020 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Nektar Therapeutics, FEB 27, 2020, View Source [SID1234554908]).

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Cash and investments in marketable securities at December 31, 2019 were approximately $1.6 billion as compared to $1.9 billion at December 31, 2018.

"Nektar’s progress over the past year has established a strong foundation for growth, with a robust portfolio of clinical-stage immuno-oncology and immunology candidates addressing multiple therapeutic areas," said Howard W. Robin, President and CEO of Nektar. "Our amended joint development plan with Bristol-Myers Squibb for bempegaldesleukin in combination with Opdivo expands the active registrational program for the doublet to five indications, including new Phase 3 studies in the adjuvant melanoma setting and muscle invasive bladder cancer. It also provides a path forward in first-line lung cancer and enhances our ability to pursue new combinations in additional indications."

Mr. Robin continued, "We also advanced NKTR-255, a novel IL-15 agonist that stimulates NK cells and memory T cells, into the clinic in combination with ADCC therapies. With NKTR-358, we have an opportunity to address the underlying immune imbalance associated with multiple autoimmune and chronic inflammatory diseases. Our partner Eli Lilly is on track to initiate a Phase 2 study in lupus, advance ongoing Phase 1b clinical trials in psoriasis and atopic dermatitis, and start an additional Phase 2 study in a new autoimmune indication this year."

Summary of Financial Results

Revenue in the fourth quarter of 2019 was $33.9 million as compared to $39.8 million in the fourth quarter of 2018. Revenue for the year ended December 31, 2019 was $114.6 million as compared to $1.2 billion in 2018 and was lower primarily due to the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement in the second quarter of 2018.

Total operating costs and expenses in the fourth quarter of 2019 were $143.5 million as compared to $140.1 million in the fourth quarter of 2018. Total operating costs and expenses for 2019 were $554.7 million as compared to $505.4 million in 2018. Total operating costs and expenses increased primarily as a result of increases in research and development (R&D) expense and general and administrative (G&A) expense.

R&D expense in the fourth quarter of 2019 was $110.4 million as compared to $108.9 million for the fourth quarter of 2018. R&D expense for the year ended December 31, 2019 was $434.6 million as compared to $399.5 million in 2018. R&D expense was higher in 2019 as compared to 2018 primarily because of the continued clinical development of bempegaldesleukin, including the registrational studies in melanoma, bladder cancer and renal cell carcinoma, and manufacture of Phase 2 drug supply for NKTR-358, which were partially offset by lower bempegaldesleukin and NKTR-181 manufacturing costs.

G&A expense was $27.1 million in the fourth quarter of 2019 as compared to $23.8 million in the fourth quarter of 2018. G&A expense for 2019 was $98.7 million as compared to $81.4 million in 2018. G&A expense was higher in the fourth quarter and full year 2019 as compared to the same periods in 2018 primarily due to non-cash stock based compensation expense, limited commercialization readiness activities for NKTR-181, as well as other costs related to personnel, facilities and outside services.

Net loss for the fourth quarter of 2019 was $112.2 million or $0.64 basic and diluted loss per share as compared to a net loss of $98.2 million or $0.57 basic and diluted loss per share in the fourth quarter of 2018. Net loss for the year ended December 31, 2019 was $440.7 million or $2.52 diluted loss per share as compared to net income of $681.3 million or $3.78 diluted earnings per share in 2018.

2019 and Year-to-Date Business Highlights:

·In February 2020, Nektar announced the publication of preclinical bempegaldesleukin data in two manuscripts in Nature Communications showing how bempegaldesleukin works synergistically with multiple immune-based therapies to enhance T-cell-mediated tumor control.

·In January 2020, Nektar and Bristol-Myers Squibb announced a new joint development plan that expands the ongoing registrational program for bempegaldesleukin plus Opdivo (nivolumab) from three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC) to include two additional registrational trials in adjuvant melanoma and muscle-invasive bladder cancer. In addition, a Phase 1/2 study will be initiated to evaluate bempegaldesleukin plus nivolumab in combination with axitinib in first-line RCC in order to support a future registrational trial. Bristol-Myers Squibb will also independently conduct and fund a Phase 1/2 study in first-line non-small-cell lung cancer with bempegaldesleukin and nivolumab.

●In January 2020, Nektar made the strategic business decision to withdraw its New Drug Application (NDA) for NKTR-181, an investigational medicine in development for chronic pain and make no further investment into the program.

●In December 2019, Nektar presented results from preclinical studies of NKTR-255, its IL-15 agonist, at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting highlighting the candidate’s potential in the treatment of hematological malignancies by restoring both NK cell and memory CD8 T cell compartments in patients.

In November 2019, Nektar presented updated results from the first-in-human Phase 1a study of NKTR-358 at the 2019 Annual Meeting of the American College of Rheumatology supporting development of the candidate as a first-in-class T regulatory cell stimulator for the treatment of autoimmune and other chronic inflammatory conditions.

●In November 2019, Nektar presented new data from the Stage IV front-line melanoma cohort in the PIVOT-02 study at the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. At a median time of follow-up of 18.6 months, median progression free survival had not yet been reached.

●In October 2019, Nektar announced that its partner Eli Lilly initiated two Phase 1b studies of NKTR-358, one in patients with psoriasis and one in patients with atopic dermatitis.

●In October 2019, Nektar announced the initiation of a first-in-human, Phase 1 clinical study evaluating NKTR-255 as monotherapy for patients with relapsed or refractory non-Hodgkin lymphoma or multiple myeloma.

·In September 2019, Nektar presented clinical data from its PIVOT-02 study for bempegaldesleukin in combination with Opdivo (nivolumab) at the 2019 CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) demonstrating the promising clinical activity of the combination in patients with advanced or metastatic triple-negative breast cancer, particularly in patients with PD-L1 negative baseline tumors.

●In August 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for bempegaldesleukin in combination with Opdivo (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma.

●In June 2019, Nektar presented biomarker and clinical data from the ongoing PIVOT-02 study for bempegaldesleukin in combination with Opdivo (nivolumab) at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting. Clinical data presented included 12-month follow-up for the Stage IV first-line melanoma patient cohort and showed a deepening and durability of response over time.

●In April 2019, Nektar presented positive preclinical data on its immuno-oncology pipeline candidates, bempegaldesleukin and NKTR-255, at the 2019 AACR (Free AACR Whitepaper) Annual Meeting.

●In March 2019, Nektar presented preliminary immune activation, safety and clinical activity data from the ongoing dose-escalation stage of the REVEAL study at the 2019 ASCO (Free ASCO Whitepaper)-SITC Meeting. The REVEAL Phase 1/2 study is evaluating the safety and efficacy of NKTR-262, a novel TLR agonist, in combination with bempegaldesleukin.

●In February 2019, Nektar presented clinical data from first-line Stage IV urothelial carcinoma patients enrolled in the PIVOT-02 study of bempegaldesleukin with Opdivo (nivolumab) at the 2019 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium.

The company also announced upcoming presentations at the following scientific congresses:

Society of Toxicology (SOT) 59th Annual Meeting, Anaheim, CA

●Presentation: "Bempegaldesleukin (NKTR-214), a novel IL-2 based immunotherapy, demonstrates superior nonclinical safety compared to that reported for recombinant human IL-2 (rhIL-2)", Leung, S., et al.

oSession: Safety Assessment: Pharmaceutical—Drug Development
oDate: Wednesday, March 18th, 10:45 a.m. – 12:30 p.m.

●Presentation: "Toxicology Species Selection for Preclinical Safety Assessment of TLR7/8 Prodrug Agonist", Gunther, J., et al.

oSession: Safety Assessment: Pharmaceutical—Drug Development
oDate: Wednesday, March 18th, 10:45 a.m. – 12:30 p.m.

American Chemical Society National Meeting

●Presentation: "NKTR-262: Discovery of a novel TLR 7/8 agonist prodrug that demonstrates synergistic anti-tumor effect in combination with NKTR-214, a CD-122 preferential IL-2 pathway agonist", Anand, N., et al.

oSession: MEDI: Tissue Specific Delivery: TLR Agonists
oDate: Tuesday, March 24th, 10:10 a.m. – 10:45 a.m.

Conference Call to Discuss Fourth Quarter and Year-End 2019 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, Thursday, February 27, 2020.

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 March 27, 2020.

To access the conference call, follow these instructions:

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

Passcode: 2507828 (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.

On February 27, 2020 -NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company, reported two expanded programs with Eviti Connect, NantHealth’s healthcare payer solution and provider decision support software (Press release, NantHealth, FEB 27, 2020, View Source [SID1234554927]). A leading U.S. Medicaid health plan expanded its coverage and one of the largest non-profit, rural health plans in the country offering coverage for 165,000 members will continue to drive high-value oncological care with Eviti Connect.

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Eviti Connect streamlined the pre-authorization process for cancer treatments and reduced denials and appeals for this leading U.S. Medicaid health plan, while providing oncologists in their network with access to a comprehensive library of evidence-based treatment options for optimal decision making. For one of the largest non-profit rural health plans in the country, Eviti Connect improved consistency in the use of evidence-based medicine, simplified processes, and streamlined treatment approvals that enable cancer patients to begin treatment quickly and efficiently.

"Implementation of the Affordable Care Act has resulted in a much more diverse Medicaid population," said Dr. William Flood, Chief Medical Officer for Eviti at NantHealth. "Medicaid plans now must address more members and a higher prevalence of cancer. Eviti’s comprehensive evidence-based medical library and experienced oncology medical staff enables Medicaid programs to evolve and meet these new challenges quickly."

The Medicaid health plan experienced compelling results in their two-state pilot program. During the two-year pilot, which covered approximately 250,000 members, the insurer noted a significant improvement in the use of evidence-based medicine for member oncology care as a result of providers submitting treatment requests via Eviti Connect. The successful pilot led the insurer to expand the program from two to 10 U.S. states.

For Eviti Connect to continue to help assure quality, high-value care for members with cancer, the non-profit, rural health plan signed a three-year renewal agreement. Under terms of the agreement, the health plan’s provider network will continue to benefit from Eviti Connect decision support solution, which includes evidence-based treatment regimens, condition-specific clinical trial options, and the potential for more efficient preauthorization and expedited reimbursement.

"This renewal of Eviti Connect by a large health plan demonstrates our continued leadership in delivering solutions that align the priorities of physicians, patients, and payers at the moment of clinical prescribing to promote the best care for patients," said Mark Mozley, Senior Vice President, Global Sales & Marketing, NantHealth. "We are pleased to continue this relationship momentum and support our clients’ goals to exceed industry standards for the authorization of oncology care."

NantHealth’s Eviti Connect is a web-based healthcare payer solution that electronically connects health plans and oncology practices for the authorization of treatment plans in near real-time. Eviti Connect reduces the administrative time involved in obtaining authorizations at the drug level, assures appropriate reimbursement at the regimen level, and validates cancer treatment options overall. It also provides the ability to have peer-to-peer conversations between prescribing oncologists and NantHealth oncologists.