On May 11, 2018, DelMar Pharmaceuticals, Inc. (the "Company") presented the presentations to describe its business and preclinical program (Presentation, DelMar Pharmaceuticals, MAY 11, 2018, View Source [SID1234526539]).

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On May 11, 2018 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results for the three months ended March 31, 2018, and provided a business update (Press release, Galectin Therapeutics, MAY 11, 2018, View Source [SID1234526540]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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"Three additional analyses conducted on the results of the NASH-CX trial since we published initial, top-line trial results further support our belief that GR-MD-02 is the first compound to demonstrate clinically meaningful positive effects in patients with NASH cirrhosis without esophageal varices. First, a statistically significant correlation was identified between the decrease in portal pressure (HVPG, or hepatic venous pressure gradient) and the improvement in hepatocyte ballooning treatment with GR-MD-02 at 2 mg/Kg. Second, an ad hoc analysis examining the PK-PD (pharmacokinetics-pharmacodynamics) correlation between human data and mouse NASH model showed that the apparent lack of a dose response in the 8 mg/Kg dose group (GR8) may be due to very high levels of GR-MD-02 in the bloodstream. Finally, results from the 13C-Methacetin Breath Test, a measure of liver function, conducted as part of the trial found that results for patients without baseline varices mirrored the results for changes in HVPG. This additional analysis further supports our original report of the NASH-CX findings which demonstrated a significant improvement in HVPG in patients without varices and has been provided to the FDA as part of our proposed plan for a Phase 3 trial," said Dr. Peter Traber, CEO and Chief Medical Officer of Galectin Therapeutics.

"About half of the total population of patients with NASH cirrhosis do not have esophageal varices. In addition, endoscopy to evaluate for varices is part of the standard of care for patients with newly diagnosed NASH cirrhosis. Consequently, the sub-group of NASH patients that may

benefit from our compound is clear at initial diagnosis. Because the sub-group that had a statistically significant response to GR-MD-02 is routinely identified, we believe there is sound logic to pursue further investigation."

Summary of Key Development Programs and Updates

Since reporting the initial NASH-CX trial results in December 2017, continued analysis of the data has led to three additional findings:

The findings from the 13C-Methacetin Breath Test conducted as part of the trial found that results for patients without baseline varices mirrored the results for changes in HVPG. This further supports our findings as well as represents a significant finding in the search to discover an effective non-invasive test for liver function and NASH.

Reinforcing the positive effects of GR-MD-02, a statistically significant (p=0.04) correlation was identified between the decrease in portal pressure (HVPG) and the improvement in hepatocyte ballooning (viz., representing a decrease in liver cell death) upon treatment with GR-MD-02 at 2 mg/Kg. This suggests an important pathophysiological link between the improvement in liver biopsy and reductions in HVPG. To our knowledge, this is the first time that such a correlation has been demonstrated in a human clinical trial in patients with NASH cirrhosis.

An ad hoc analysis examining the PK-PD correlation between human data and mouse NASH model showed that the apparent lack of a dose response in the 8 mg/Kg dose group (GR8) may be due to very high levels of GR-MD-02, where excessive levels of GR-MD-02 are less effective. This was supported when a statistically significant difference was observed between the GR8 patient group with high serum drug levels (> 12,000 µg*hr/mL) and those with lower (< 12,000 µg*hr/mL) serum drug levels, where those with the lower serum drug levels had a positive response on HVPG.

The Company made an oral presentation at the International Liver Meeting in April 2018 in Paris. Dr. Naga Chalasani, one of the principal investigators on the NASH-CX clinical trial, led a session entitled, "A multicenter, randomized, double-blind, PLB-controlled trial of Galectin-3 inhibitor (GR-MD-02) in patients with NASH cirrhosis and portal hypertension."

The company continues to enroll cohort 3 (GR-MD-02 8 mg/kg) of the pembrolizumab (KEYTRUDA) combination immunotherapy clinical trial, which will include at least 10 patients with melanoma, to provide a larger group of patients to evaluate. It is hoped additional data can be reported in mid-2018, when we anticipate a decision on progressing to phase 2.
Financial Results

For the three months ended March 31, 2018, the Company reported a net loss applicable to common stockholders of $4.5 million, or $0.12 per share, compared with a net loss applicable to common stockholders of $5.2 million, or $0.15 per share, for the three months ended March 31, 2017. The decrease is largely due to lower research and development expenses as our Phase 2 clinical program is winding down, somewhat offset by higher non-cash stock-based compensation expense in the three months ended March 31, 2018.

Research and development expense for the three months ended March 31, 2018, was $2.3 million, compared with $3.8 million for first quarter of 2017. The decrease primarily relates to the winding down of the NASH-CX Phase 2b clinical trial.

General and administrative expense for the three months ended March 31, 2018, was $1.9 million, compared with $1.2 million for first quarter of 2017, with the increase primarily due to an increase in non-cash stock-based compensation expense and an increase in business development and investor relations expenses.

As of March 31, 2018, the Company had $4.0 million of non-restricted cash and cash equivalents in addition to a $10 million line of credit which has not yet been used. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through at least March 31, 2019.

On May 10, 2018 Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, reported its financial and operational results for the quarter ended March 31, 2018 (Press release, Histogenics, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348368 [SID1234526415]).

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"The preparation for top-line data and the NeoCart Biologics License Application for the U.S. Food and Drug Administration remained a key focus for Histogenics in the first quarter of 2018, and we are on track to achieve these important milestones in the third quarter," said Adam Gridley, President and Chief Executive Officer of Histogenics. "We are also actively supporting MEDINET, our NeoCart development and commercialization partner in Japan, as they prepare for the initiation of the planned confirmatory trial in Japan in the second half of 2018. We also continue to work with our surgeon investigators on our commercialization plans in both the U.S. and Japanese markets, and are pursuing additional NeoCart licensing and partnership opportunities in other major international markets. Our objective is to make NeoCart available to as many patients as possible with a goal of maximizing the clinical and commercial value of this innovative, restorative cell therapy that treats pain at the source," continued Mr. Gridley.

First Quarter 2018 and Recent Highlights

Release of NeoCart top-line Phase 3 Data and Submission of Biologics License Application on Track for Third Quarter 2018: Histogenics expects to report top-line data from its 249-patient Phase 3 randomized, controlled clinical trial of NeoCart in the third quarter of 2018. The trial is designed to show superiority of NeoCart at one year after treatment as compared to microfracture, the current standard of care. The trial will follow patients for three years and is being conducted under a Special Protocol Assessment with the United States Food and Drug Administration.

Development of Additional NeoCart Biomechanical Data to Support Potential Commercialization: As part of their Sponsored Research Agreement, Histogenics and Cornell University (Cornell) continue to build upon the robust body of evidence related to the biomechanical properties of NeoCart, with additional data that were presented at the Orthopaedic Research Society Annual Meeting in March 2018. The body of data is intended to provide additional mechanism of action and physical competence information to regulatory agencies and clinicians regarding the potential performance advantages of NeoCart when compared to other treatment alternatives. Furthermore, Histogenics and Cornell are working together in related areas including the novel testing and three-dimensional printing of cartilage tissue. Histogenics believes this work may have significant utility in identifying and supporting additional future product opportunities including the automation of certain aspects of the NeoCart manufacturing process.

Expansion and Enhancement of Board of Directors: In April 2018, Susan Washer, President and Chief Executive Officer of Applied Genetic Technologies (AGTC) joined Histogenics’ Board of Directors. Ms. Washer has served as CEO of AGTC, a company developing genetic therapies to treat patients with rare inherited conditions, since 2002. She also serves on the boards of Biotechnology Innovation Organization and the Alliance for Regenerative Medicine.

Receipt of MEDINET Licensing Agreement Proceeds and Completion of Financing: Histogenics received a $10 million up-front payment from MEDINET Co., Ltd. (MEDINET) pursuant to the terms of the license agreement with MEDINET for the development and commercialization of NeoCart in Japan. In addition, Histogenics successfully completed a registered direct offering of common stock in January 2018 that raised proceeds of $5.7 million, after deducting underwriter’s discounts and commissions, and expenses related to the offering.
Financial Results for the First Quarter of 2018

Loss from operations was $(6.1) million in the first quarter of 2018, compared to $(6.8) million in the first quarter of 2017. The decrease in operating expenses was driven by a reduction in research and development expenses which was partially offset by an increase in general and administrative expenses.

Research and development expenses were $3.3 million in the first quarter of 2018, compared to $4.5 million in the first quarter of 2017. The decrease was primarily due to a reduction in costs related to the NeoCart Phase 3 clinical trial, for which enrollment was completed in June 2017. General and administrative expenses were $2.8 million in the first quarter of 2018, compared to $2.3 million in the first quarter of 2017. The increase was primarily due to increases in salaries and consulting expenses related to increased activities to support the potential commercialization of NeoCart.

Net loss attributable to common stockholders was $(14.4) million in the first quarter of 2018, or $(0.52) per share, compared to $(5.8) million, or $(0.27) per share, in the first quarter of 2017. The increase in net loss attributable to common stockholders is primarily due to the conversion of convertible preferred stock into common stock and an increase in expense related to the fair value of the warrant liability which was partially offset by lower operating expenses.

As of March 31, 2018, Histogenics had cash, cash equivalents and marketable securities of $15.5 million, compared to $8.0 million at December 31, 2017. Histogenics believes its current cash position will be sufficient to fund its operations into the fourth quarter of 2018.

Conference Call and Webcast Information

Histogenics management will host a conference call on Thursday, May 10, 2018 at 8:30 a.m. EDT. A question-and-answer session will follow Histogenics’ remarks. To participate on the live call, please dial (877) 930-8064 (domestic) or (253) 336-8040 (international) and provide the conference ID "8376199" five to ten minutes before the start of the call.

To access a live audio webcast of the presentation on the "Investor Relations" page of the Histogenics website, please click here. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the presentation.

On May 10,2018 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the first quarter ended March 31, 2018 (Press release, Celldex Therapeutics, MAY 10, 2018, View Source [SID1234526471]).

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"Celldex has made considerable progress on an important strategic prioritization of our pipeline, following announcement in April of the METRIC study results in triple-negative breast cancer and discontinuation of the glembatumumab program across all indications," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "In 2018, we will focus primarily on continued clinical development of two company-sponsored programs—CDX-1140, a promising CD40 agonist, and CDX-3379, which blocks ErbB3, a receptor thought to play an important role in regulating cancer cell growth and survival. Development of varlilumab and CDX-301 will also continue externally through investigator-sponsored initiatives and internally through inclusion in combination studies."

"In line with this, to extend our financial resources and direct them to the advancement of the programs we believe can bring the most value to both patients and shareholders, we made significant cuts to our business operations, including executing a corporate restructuring in late April. Based on our progress to date, we believe our cash on hand combined with proceeds from our established ATM will support the continued development of our pipeline through 2020. This extended runway will provide for multiple inflection points, and we are solely focused on executing along these lines."

Pipeline Prioritization:

Celldex is focusing its efforts and resources on the continued research and development of:

CDX-1140, an agonist human monoclonal antibody targeted to CD40, a receptor expressed on dendritic cells and a key activator of immune response, currently in a Phase 1 dose-escalation study in multiple types of solid tumors. CD40 agonist antibodies have shown encouraging results in early clinical studies, but systemic toxicity associated with broad CD40 activation has limited their dosing. CDX-1140 is differentiated by potent agonist activity that is independent of Fc receptor interaction, allowing for more consistent, controlled immune activation without promoting cytokine production. Additionally, CD40 ligand binding is not blocked, allowing for potential synergistic effects near activated T cells in lymph nodes and tumors. Celldex is currently focusing its efforts on executing the Phase 1 dose-escalation activities and advancing to combination cohorts. The combination cohorts will include CDX-301, which as a dendritic cell growth factor can increase the number of cells responding to CDX-1140. In addition, combination with varlilumab, especially in lymphomas which co-express these receptors, could have significant potential.

CDX-3379, a human monoclonal antibody designed to block the activity of ErbB3 (HER3), currently in an early Phase 2 study in advanced head and neck squamous cell cancer in combination with Erbitux. The proposed mechanism of action for CDX-3379 sets it apart from other drugs in development in this class due to its ability to block both ligand-independent and ligand-dependent ErbB3 signaling by binding to a unique epitope. It has a favorable pharmacologic profile, including a longer half-life and slower clearance relative to other drug candidates in this class. CDX-3379 also has potential to enhance anti-tumor activity and/or overcome resistance in combination with other targeted and cytotoxic therapies to directly kill tumor cells. Tumor cell death and the ensuing release of new tumor antigens have the potential to serve as a focus for combination therapy with immuno-oncology approaches, even in refractory patients. Celldex intends to complete enrollment to the first stage of the Phase 2 study and will use this data to inform next decisions. In line with this, the Company continues to explore potential other opportunities in additional indications where ErbB3 is believed to play a role.

Varlilumab, an immune modulating antibody targeting CD27 designed to enhance a patient’s immune response against cancer, being studied in multiple investigator initiated research studies and currently completing a Phase 1/2 study across multiple solid tumors in combination with Opdivo. Celldex is conducting the study in collaboration with Bristol-Myers Squibb Company (BMS) and plans to present data at various medical meetings in 2018, including in an oral presentation at the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting in June. The Company intends to explore varlilumab externally through several investigator-initiated studies and internally through inclusion in combination studies.

CDX-301, a dendritic cell growth factor, currently being evaluated in an investigator-initiated pilot study with radiation therapy in patients with advanced non-small cell lung cancer (NSCLC) and planned for combination study with CDX-1140. Celldex believes CDX-301’s potential as a dendritic cell mobilizer could play an important role in immuno-oncology regimens. The Company will continue to support investigator initiated research and will seek to combine CDX-301 with CDX-1140 in its ongoing Phase 1 study of CDX-1140 in the future.

Celldex’s preclinical pipeline includes CDX-0159, which is planned to enter the clinic in 2019; the TAM program, comprised of the targets Tyro3, AXL and MerTK; and a bispecific antibody (BsAb) program. Celldex’s initial BsAb candidate couples CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway using novel, highly active anti-PD-L1 antibodies. Data from this program were presented in a poster at the AACR (Free AACR Whitepaper) 2018 Annual Meeting. The BsAb was more potent in human T cell activation and anti-tumor activity compared to the combined CD27 and PD-L1 antibodies. Enhanced efficacy has been attributed to more efficient cross-linking of the CD27 receptor, resulting in stronger T cell activation.
To conserve resources, Celldex is discontinuing development of:

Glembatumumab vedotin, a targeted antibody-drug conjugate (ADC), across all indications, as previously disclosed;
CDX-014, an ADC (which are typically more costly to develop than other therapeutics), in early Phase 1 development in renal cell and clear cell ovarian carcinomas; and
CDX-1401, an NY-ESO-1-antibody fusion protein, that was being explored in investigator-sponsored and collaborative studies.
Recent Program Highlights Presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting in April

Data from the CDX-1140 program were presented in a poster session. Building off previously presented preclinical work, CDX-1140 was further characterized showing tumor shrinkage and prolonged survival in several xenograft models. These preclinical studies support the potential of CDX-1140 having direct anti-tumor effects on CD40-positive tumors that may supplement its activity as an immune activating agent.

Data from the CDX-3379 program were presented in two poster sessions.
Data were presented from a preoperative "window of opportunity" study in 12 patients with head and neck squamous cell carcinoma (HNSCC). The study was designed to evaluate the effect of CDX-3379 on phosphorylated ErbB3 (pErbB3) and other potential biomarkers in patients with HNSCC. Patients with newly diagnosed HNSCC received two doses of CDX-3379, at a two-week interval prior to tumor resection. CDX-3379 reduced pErbB3 levels in 83% (10/12) of patient samples, with greater than or equal to 50% decreases in 58% of patients (7/12), which met the primary study objective. Stable disease was observed in 92% (11/12) of patients prior to surgery, and a patient with HPV-negative disease experienced significant tumor shrinkage (92% in primary tumor; 26% in metastatic lesion). CDX-3379 was well-tolerated, and no treatment-related adverse events were observed.
Data were presented from a study that explored the reduction of PD-L1 expression by simultaneous blockade of EGFR and ErbB3 in HNSCC. Investigators examined the effects of combining CDX-3379 and cetuximab, a monoclonal antibody targeting EGFR, in xenograft models of HNSCC. Combining CDX-3379 and cetuximab inhibited tumor growth more potently than cetuximab alone. Mechanistic studies demonstrated a reduction of PD-L1 expression from the combination.

Early promising data (n=9) from an ongoing, investigator-initiated pilot study of CDX-301 were presented in a plenary session. This Phase 2 study is evaluating the combination of CDX-301 and stereotactic body radiotherapy (SBRT) in up to 29 patients with advanced non-small cell lung cancer (NSCLC). The presentation included data from nine patients, seven of whom were previously treated with anti-PD(L)1 checkpoint inhibitors. The one-week course of treatment included subcutaneous injections of CDX-301 and SBRT directed to a single lung tumor lesion. Non-irradiated tumors were evaluated for response. Enrollment is ongoing.

Progression-free survival at four months (PFS4), the primary endpoint of the study, was achieved in 56% (5/9) of patients overall and in 100% (5/5) of patients who experienced partial responses (PRs) by PERCIST.
Notably, PRs were observed in non-irradiated tumors in 56% (5/9) of patients at two months; 3 PRs (3/9) were confirmed by immune-related response criteria (irRC).
In the patients previously treated with immune checkpoint inhibitors, 71% (5/7) experienced PRs and PFS4 versus 0% (0/2) in patients not treated with an anti-PD(L)1 therapy.
SBRT in combination with CDX-301 induced and reactivated anti-tumor immune responses in patients who had progressive disease on checkpoint inhibitors.
No dose-limiting toxicities were observed.
First Quarter 2018 Financial Highlights and Updated 2018 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2018 were $123.2 million compared to $139.4 million as of December 31, 2017. The decrease was primarily driven by first quarter cash used in operating activities of approximately $28.0 million and partially offset by the receipt of $11.7 million from sales of common stock under our Cantor agreement. At March 31, 2018, Celldex had 143.4 million shares outstanding.

Revenues: Total revenue was $4.1 million in the first quarter of 2018, compared to $1.5 million for the comparable period in 2017. The increase in revenue was primarily due to the contract manufacturing and research and development agreements with International AIDS Vaccine Initiative and Frontier Biotechnologies, Inc. signed in the second quarter of 2017.

R&D Expenses: Research and development (R&D) expenses were $21.9 million in the first quarter of 2018, compared to $25.8 million for the comparable period in 2017. The decrease in R&D expenses was primarily due to lower varlilumab, CDX-3379 and anti-KIT program product development expenses of $0.9 million, $0.7 million and $0.3 million, respectively, and lower personnel and facility costs of $1.4 million.

G&A Expenses: General and administrative (G&A) expenses were $5.6 million in the first quarter of 2018, compared to $7.2 million for the comparable period in 2017. The decrease in G&A expenses was primarily due to lower personnel expenses of $0.7 million, lower commercial planning costs of $0.4 million and lower legal, consulting and professional services expense of $0.3 million.

Changes in Fair Value Remeasurement of Contingent Consideration: The $13.6 million gain on the fair value remeasurement of contingent consideration in the first quarter of 2018 was primarily due to updated assumptions for glemba-related milestones and discount rates. The $3.4 million loss on fair value remeasurement of contingent consideration in the first quarter of 2017 was primarily due to changes in discount rates and the passage of time.

Intangible Asset and Goodwill Impairments: The Company recorded $18.7 million in non-cash impairment charges related to fully impaired glemba-related intangible assets and $91.0 million in goodwill impairment charges as the carrying value of the Company’s net assets exceeded the Company’s fair value by an amount in excess of the goodwill asset in the first quarter of 2018.

Income Tax Benefit: The Company recorded a $0.8 million non-cash income tax benefit related to the impaired glemba in-process research and development (IPR&D) assets in the first quarter of 2018.

Net Loss: Net loss was $118.1 million, or ($0.84) per share, for the first quarter of 2018, compared to a net loss of $34.3 million, or ($0.28) per share, for the comparable period in 2017.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2018, combined with the anticipated proceeds from future sales of our common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2020. This could be impacted if Celldex elects to pay Kolltan contingent milestones, if any, in cash.

Opdivo is a registered trademark of Bristol-Myers Squibb. Erbitux is a registered trademark of Eli Lilly & Co.

On May 10, 2018 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the first quarter ended March 31, 2018 (Press release, Nektar Therapeutics, MAY 10, 2018, View Source [SID1234526487]).

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Cash and investments in marketable securities at March 31, 2018 were $333.8 million as compared to $353.2 million at December 31, 2017. This does not include the $1.0 billion upfront payment and $850.0 million share purchase proceeds received on April 3, 2018, as a result of our new Bristol-Myers Squibb collaboration.

"Nektar begins 2018 in a very strong position with a major collaboration with Bristol-Myers Squibb for NKTR-214 and key advancements in our immuno-oncology and immunology pipeline," said Howard W. Robin, President and CEO of Nektar. "The PIVOT study of NKTR-214 in combination with nivolumab continues to enroll patients and we are exceptionally pleased that the preliminary data from PIVOT was accepted for an oral presentation at this year’s ASCO (Free ASCO Whitepaper) Meeting. We initiated two new clinical studies this quarter, the first with our novel I-O combination of NKTR-262 and NKTR-214 and the second with our autoimmune disease candidate, NKTR-358. Based on positive preclinical results, we entered into a clinical collaboration with Takeda to evaluate NKTR-214 with their TAK-659, a SYK/FLT inhibitor. Finally, in the area of pain, we plan to submit our NDA filing for NKTR-181 this month."

Revenue in the first quarter of 2018 was $38.0 million as compared to $24.7 million in the first quarter of 2017. Revenue in the first quarter of 2018 was higher primarily because of the recognition of $10.0 million received from Shire for the approval of Adynovi in Europe.

Total operating costs and expenses in the first quarter of 2018 were $124.8 million as compared to $79.2 million in the first quarter of 2017. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

R&D expense in the first quarter of 2018 was $99.4 million as compared to $61.1 million for the first quarter of 2017. R&D expense was higher in the first quarter 2018 as compared to the same period in 2017 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, initiation of the Phase 1 study of NKTR-262 in combination with NKTR-214 and IND-enabling activities for NKTR-255.

General and administrative expense was $18.7 million in the first quarter of 2018 as compared to $12.0 million in the first quarter of 2017 and increased primarily due to increased stock based compensation.

In the first quarter of 2018, net loss was $95.8 million, or $0.60 loss per share as compared to net loss of $63.9 million, or $0.42 loss per share in the first quarter of 2017.

2018 Business Highlights

In May, Nektar began dosing patients with systemic lupus erythematosus in a Phase 1b multiple ascending dose study of NKTR-358, a first-in-class regulatory T cell stimulator, designed to correct the underlying immune system dysfunction found in patients with immune disorders.

In April, Nektar announced a new clinical collaboration agreement with Takeda to evaluate NKTR-214 in combination with TAK-659, a dual SYK and FLT-3 inhibitor in liquid and solid tumors with the first of these studies expected to begin in the second half of 2018 in patients with Non-Hodgkin Lymphoma.

In April, Nektar presented positive preclinical data for its immuno-oncology programs at the 2018 AACR (Free AACR Whitepaper) Annual Meeting. Preclinical data presented by Nektar researchers and collaborators demonstrate how NKTR-214 synergizes with multiple modalities including TLRs, HDAC and ACT, highlighting the potential of NKTR-214 as a backbone therapy in immuno-oncology.

In April, Nektar began dosing patients in the REVEAL Phase 1/2 study, which will evaluate the safety and efficacy of NKTR-262, a novel toll-like receptor agonist, in combination with NKTR-214. This novel-novel combination is designed to engage both the innate and adaptive immune response to fight cancer and may ultimately provide another option for patients with many types of advanced or metastatic solid tumor cancers.

In February, 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 company also announced upcoming presentations at the following scientific congresses during the second quarter of 2018:

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: Wednesday, May 23, 2018, 3:40 p.m. Eastern Daylight 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: Thursday, May 24, 2018, 5:40 p.m. British Summer Time
American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting, Chicago, IL:

Oral Presentation: "NKTR-214 (CD122-biased agonist) plus nivolumab in patients with advanced solid tumors: Preliminary phase 1/2 results of PIVOT".
Abstract #3006
Presenter: Dr. Adi Diab, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Session: Developmental Therapeutics – Immunotherapy
Date: Saturday, June 2, 2018, 3:00 p.m. – 6:00 p.m. Central Daylight Time

Abstract #2567: "TAK-659 in Combination with NKTR-214 and anti-PD-1 Therapy Leads to Complete and Sustained Tumor Regression and Immune Memory In Pre-Clinical Syngeneic Models", Huck, J., et al.
Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Date: Monday, June 4, 2018, 8:00 a.m. – 11:30 a.m. Central Daylight Time

Abstract #3085: "Efficacy and immune modulation by BXCL701 a dipeptidyl peptidase inhibitor, NKTR-214 a CD122-biased immune agonist with PD1 blockade in murine pancreatic tumors", Rastelli, L., et al.
Session: Developmental Therapeutics – Immunotherapy
Date: Monday, June 4, 2018, 8:00 a.m. – 11:30 a.m. Central Daylight Time

Abstract #5582: "Efficacy and immune modulation of the tumor microenvironment in murine ovarian tumor with the PARP inhibitor rucaparib and CD122-biased immune agonist NKTR-214", Simmons, A., et al.
Session: Gynecologic Cancer
Date: Monday, June 4, 2018, 1:15 p.m. – 4:45 p.m. Central Daylight Time

Abstract #TPS3115: "PROPEL: A phase 1/2 trial of NKTR-214 (CD122-biased agonist) combined with anti-PD-1 (pembrolizumab) or anti-PD-L1 (atezolizumab) in patients (pts) with advanced solid tumors", Vaena, D., et al.
Session: Developmental Therapeutics – Immunotherapy
Date: Monday, June 4, 2018, 8:00 a.m. – 11:30 a.m. Central Daylight Time

Abstract #TPS1111: "ATTAIN: Phase 3 study of etirinotecan pegol (EP) vs. treatment of physician’s choice (TPC) in patients (pts) with metastatic breast cancer (MBC) who have stable brain metastases (BM) previously treated with an anthracycline, a taxane, and capecitabine (ATC)", Tripathy, D., et al.
Session: Breast Cancer – Metastatic
Date: Saturday, June 2, 2018, 8:00 a.m. – 11:30 a.m. Central Daylight Time

College on Problems of Drug Dependence 80th Annual Scientific Meeting (2018), San Diego, CA:

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"
Abstract #76
Presenter: Ryan Lanier, Ph.D., Analgesic Solutions
Session: The Pain and the Strain Comes Mainly from the Brain
Date: Wednesday, June 13, 2018, 1:30 p.m. – 1:45 p.m. Pacific Daylight Time

Oral Presentation: "Neuropharmacodynamic Profile of NKTR-181: Correlation to Low Abuse Potential"
Abstract #335
Presenter: Laurie Vanderveen, Ph.D., Nektar Therapeutics
Session: Basically Opioids
Date: Tuesday, June 12, 2018, 10:15 a.m. – 10:30 a.m. Pacific Daylight Time

Abstract #168: "NKTR-181 demonstrates low abuse potential in recreational opioid users in two double-blind, randomized crossover human abuse potential studies", Henningfield, J., et al.
Session: Abuse Liability
Date: Thursday, June 14, 2018, 12:00 p.m. – 2:00 p.m. Pacific Daylight Time
Conference Call to Discuss First 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, Thursday, May 10, 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, June 11, 2018.

To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 2379326 (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.