Five Prime Therapeutics Reports Second Quarter 2020 Results

On August 6, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported results for the second quarter of 2020 in addition to providing an update on the company’s recent activities (Press release, Five Prime Therapeutics, AUG 6, 2020, View Source [SID1234563114]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We remain on track to generate data from the FIGHT Phase 2 trial by year-end or early next year and have monotherapy safety and efficacy data for FPT155 in-house by year-end," said Tom Civik, Chief Executive Officer of Five Prime Therapeutics. "The team has overcome many challenges since we began working from home five months ago and has done a remarkable job keeping our clinical trials on track as we prepare for two important data readouts for our bemarituzumab and FPT155 programs."

Second Quarter 2020 Milestones

Clinical Pipeline:

Bemarituzumab (anti-FGFR2b) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) being studied in the FIGHT trial as a targeted therapy for gastric and gastroesophageal junction (GEJ) cancer that overexpresses FGFR2b.

The Phase 2 FIGHT study is expected to have a sufficient number of progression-free survival (PFS) and overall survival (OS) events to generate clinically meaningful and actionable data by the end of 2020 or in early 2021.

Converting FIGHT to a Phase 2 trial is the fastest path to generating informative data about bemarituzumab, the first agent to target FGFR2b-overexpressing gastric and GEJ cancer.

FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that directly engages CD28 and binds to CTLA-4, promoting T cell activation in the tumor microenvironment.

In the ongoing Phase 1 dose escalation study, a dose-dependent proliferation of memory T-cells has been identified, consistent with the mechanism of action of FPT155 observed in preclinical studies.

Patients with warm/hot tumor types are being enrolled with the aim of generating early clinical evidence of FPT155 single-agent activity by the end of 2020.

The first two patients have been dosed in a dose escalation of FPT155 in combination with pembrolizumab.

FPA150 (anti-B7-H4) is a first-in-class antibody being studied as a treatment for patients with B7-H4-overexpressing tumors in a Phase 1a/1b clinical trial. Five Prime is in the process of completing the Phase 1a/1b study. The company does not currently plan to independently advance the clinical development of FPA150 as either a monotherapy or in combination with pembrolizumab.

BMS-986258 (anti-TIM-3) is a fully human monoclonal antibody targeting TIM-3 (T cell immunoglobulin and mucin domain-3). It is the first clinical candidate from the discovery collaboration between Five Prime and Bristol-Myers Squibb (BMS) that includes targets in three immune checkpoint pathways. Five Prime has withdrawn its guidance that this trial may advance from Phase 1 to Phase 2 in 2020 as a result of the effect of the coronavirus pandemic on this oncology study.

2020 Corporate Highlights

The company entered into a Sales Agreement with Cowen & Company today, pursuant to which the Company may from time to time sell through at-the-market offerings, with Cowen acting as sales agent, common shares with an aggregate offering price of up to $75 million.

Summary of Second Quarter 2020 Financial Results and Cash Guidance:

Cash Position: Cash, cash equivalents and marketable securities totaled $128.6 million as of June 30, 2020 compared to $157.9 million as of December 31, 2019. This decrease was primarily attributed to quarterly operating expenses that exceeded quarterly revenues.

Revenue: Collaboration and license revenue for the second quarter of 2020 was $3.4 million, which was essentially on par with second quarter 2019 revenue of $3.3 million.

R&D Expenses: Research and development expenses for the second quarter of 2020 decreased by $16.9 million, or 57%, to $12.6 million from $29.4 million for second quarter of 2019. The decrease was primarily due to lower compensation costs resulting from the October 2019 corporate restructuring, reduced clinical and research costs, and a gain on the sale of laboratory equipment.

G&A Expenses: General and administrative expenses for the second quarter of 2020 decreased by $1.7 million, or 17%, to $8.0 million from $9.7 million for the second quarter of 2019. The decrease was primarily due to lower compensation costs, depreciation expense, and other miscellaneous general and administrative costs that were partially offset by an increase in allocated costs.

Net Loss: Net loss for the second quarter of 2020 was $16.9 million, or $0.48 per basic and diluted share, compared to a net loss of $34.4 million, or $0.99 per basic and diluted share, for the second quarter of 2019.

Shares Outstanding: Total shares outstanding were 35,481,224 as of June 30, 2020.

Cash Guidance: Five Prime expects full-year 2020 net cash used in operating activities to be between $74 and $79 million and has raised guidance to end 2020 with cash, cash equivalents and marketable securities between $80 and $85 million.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 9799664. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

NANTHEALTH REPORTS 2020 SECOND QUARTER FINANCIAL RESULTS

On August 6, 2020 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its second quarter ended June 30, 2020 (Press release, NantHealth, AUG 6, 2020, View Source [SID1234563113]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In July, we completed the strategic acquisition of the OpenNMS Group, Inc., a company with the world’s premier open source network management software platform," said Ron Louks, Chief Operating Officer, NantHealth. "This is an exciting transaction for NantHealth because it expands and diversifies our software portfolio and service offerings, enhances our AI, Cloud and SaaS capabilities, and opens market opportunities beyond healthcare.

"In response to the COVID-19 crisis, we supported the healthcare community by launching the NantHealth Cares initiative. As part of this initiative, we made our NaviNet AllPayer platform available to providers for free during the month of May. We believe it is important to do our part during the pandemic to help reduce the financial and capacity strain on hard-hit providers, even if it temporarily impacted our revenue.

"In addition, NantHealth CEO, Dr. Patrick Soon-Shiong, presented a video series exploring the science behind COVID-19. The educational series was made accessible on the NantHealth.com website and our NaviNet and Eviti platforms, which garnered more than 10,000 views – over 1,300 hours watched. In addition, NantHealth medical experts hosted two webinars designed to educate our payers, providers and partners on COVID-19. Both webinars generated considerable interest with over 900 registrants each."

Software and Services Highlights:

Clinical Decision Support (Eviti):

Implemented, through a channel partnership, Eviti Advisor clinical decision support platform with a leading non-profit medical center in New York City

In July, significantly expanded Eviti Connect across the Medicaid population of a leading U.S. health insurance company with the addition of two states

Leveraged the Eviti platform to educate users on the implications of COVID-19 for cancer care and the science behind emerging treatments through videos and instruction. Also, added a feature enabling payers to gain insights to COVID-19 testing relative to oncology treatment plans

Released enhancements to the Eviti platform, including:

Return-on-Investment (ROI) reporting: implemented cost savings dashboard enabling more robust and expedited validation of ROI for our customers

White blood cell growth factor deviation messaging: added messaging to communicate unexpected use of white blood cell growth factor when a treatment plan is entered, allowing users to make real-time corrections for faster review and approval

Payer Engagement (NaviNet):

Leveraged the NaviNet platform to enable payers to post updates to their medical policies and other key information – assisting the provider community directly impacted by the COVID-19 pandemic

Launched workflow enhancements that enable providers to update prior authorizations already on file with our payer customers. Payers that enable this option as part of their NaviNet Open services can expect to receive more prior authorization requests electronically, while streamlining the process of managing prior authorizations for their providers

Precision Medicine and Artificial Intelligence – Highlights:

In May, received notice from Molecular Diagnostic Services (MolDx) of a limited coverage determination for Omics CoreSM

In June, announced the publication of four abstracts in the developmental therapeutics session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program. In collaboration with ImmunityBio, LLC, the company presented data, gathered from its database, which was used to advance findings in molecularly targeted agents and tumor biology

In June, announced the publication of a study in JCI Insight, a peer reviewed journal dedicated to biomedical research. The study, "Transcriptomic silencing as a potential mechanism of treatment resistance," explained the importance of using both transcriptomics and genomics for patient tumor interrogation to gain actionable insights into reducing the risk of tumor treatment resistance

Business and Financial Highlights

For the 2020 second quarter:

Total net revenue was $17.6 million, which included $17.5 million of SaaS revenue. This compares with 2019 second quarter total net revenue of $20.1 million, which included $18.3 million of SaaS revenue and $1.3 million of home health care services revenue, a business the Company divested on June 7, 2019

Gross profit increased to $10.3 million, or 58% of total net revenue, compared with $11.3 million, or 56% of total net revenue, for the prior year period

Selling, general and administrative (SG&A) expenses declined to $12.0 million from $13.8 million in 2019 second quarter

Research and development (R&D) expenses increased to $4.2 million from $3.4 million, primarily due to investments in product portfolio expansion and growth in data science, machine learning and AI capabilities

Net loss from continuing operations, net of tax, was $48.3 million, or $0.44 per share, which included a non-cash loss from related party equity method investment of $29.9 million and a $6.9 million expense from our fair value bookings commitment liability. This compares with the prior-year second quarter net loss from continuing operations, net of tax, of $17.1 million, or $0.15 per share, which included loss from related party equity method investment of $2.2 million

Non-GAAP net loss from continuing operations was $7.5 million, or $0.07 per share, compared with $6.9 million, or $0.06 per share, for the second quarter of last year

At June 30, 2020, cash and cash equivalents totaled $37.5 million

Conference Call Information and Forward-Looking Statements
Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the second quarter ended June 30, 2020. The conference call will be available to interested parties by dialing 800-708-4540 from the U.S. or Canada, or 847-619-6397 from international locations, passcode 49876109. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures
This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.

Molecular Templates, Inc. Reports Second Quarter 2020 Financial Results

On August 6, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," "MTEM" or "the Company"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the second quarter of 2020 (Press release, Molecular Templates, AUG 6, 2020, View Source [SID1234563112])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Since our last quarterly update, we presented preclinical data at AACR (Free AACR Whitepaper) on four preclinical ETB programs, provided an update on the ongoing Phase I study for MT-5111, and strengthened our balance sheet through a new debt facility and our ATM," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Chief Scientific Officer. "In the second half of 2020, we expect to report interim clinical data from our three MT-3724 Phase 2 studies and additional data from the MT-5111 Phase 1 study, and also file the IND for MT-6402, our PD-L1-targeted ETB with antigen seeding."

Company Highlights, Pipeline Status, and Upcoming Milestones

Corporate

On May 22, 2020, MTEM announced it had secured a debt financing facility for up to $45 million from K2 HealthVentures, a healthcare-focused specialty finance company. MTEM received a first tranche of $15 million upon closing. Two subsequent tranches totaling $30 million will become available upon the achievement of certain milestones.
In July 2020, MTEM raised $50 million in gross proceeds from its At-The-Market Facility (ATM).
MT-3724 (CD20 ETB)

MTEM is currently conducting three Phase 2 studies with MT-3724 in relapsed/refractory diffuse large B-cell lymphoma (DLBCL): a monotherapy study that has the potential to be pivotal, a combination study with chemotherapy, and a combination study with lenalidomide.
Interim results for the study of MT-3724 in combination with lenalidomide were presented at the 25th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) virtual meeting in June 2020. This data demonstrated preliminary evidence of tolerability and efficacy with lenalidomide at standard doses and MT-3724. Among 7 evaluable subjects, 2 had CRs and 3 had PRs. While there were no permanent discontinuations due to adverse events, grade 2 capillary leak syndrome occurred at 25 mcg/kg, leading to the opening of a new cohort at 20 mcg/kg. The study now has a new schedule of therapy with MT-3724 being dosed twice rather than three times weekly for the first two cycles, and then on a weekly schedule thereafter.
MTEM expects to report updates on all three MT-3724 DLBCL studies in 2H20.
MTEM also expects to initiate Phase 2 studies for MT-3724 in follicular lymphoma and mantle cell lymphoma in 2H20.
TAK-169 (CD38 ETB)

Takeda and MTEM are conducting an ongoing Phase 1 study evaluating TAK-169 in relapsed/refractory multiple myeloma.
MT-5111 (HER2 ETB)

MTEM is conducting a Phase 1 study of MT-5111 in HER2-positive cancers.
In June 2020, MTEM provided an interim update from the first three dose cohorts of the dose escalation portion of the Phase 1 study. That update noted that 10 subjects, with a median of 5 prior lines of therapy and a median of 2 prior HER2-targeting regimens, have been treated with MT-5111 (metastatic cholangiocarcinoma n=5, metastatic breast cancer n=4, metastatic gastro-esophageal junction carcinoma n=1). Thus far, no dose limiting toxicities (DLTs) have been observed in any cohort and MT-5111 appears to be well tolerated, with no cardiotoxicity observed to date (cardiotoxicity is a known potential toxicity for HER2 targeted therapies).
Further to the June 2020 interim update, MTEM expects to provide an update on results from the subjects still on treatment as well as higher dose cohorts from the dose escalation portion of the Phase 1 study (including doses that are predicted to be clinically active based on preclinical data) in 4Q20.
Research

MTEM presented preclinical data on ETB programs targeting PD-L1, CTLA-4, SLAMF-7 and CD45 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, which took place June 22-24, 2020.
MTEM expects to file an investigational new drug (IND) application for MT-6402, its ETB targeting PD-L1 (with antigen seeding), in 2H20.
MTEM expects to file an IND application for its ETB targeting CTLA-4 in 2021.
COVID-19 Impact

The COVID-19 pandemic has resulted in a significant slowdown in the pace of site initiations and patient enrollment across our MT-3724 Phase 2 programs. Much like other sponsors with studies in patients with hematologic malignancies, we are working with sites to determine when a patient is suitable for each research study and to ensure the continued safety of all research participants.
To date, screening and enrollment for the MT-5111 Phase 1 study has been less adversely affected than the MT-3724 studies but it is enrolling at slower pace than was projected pre-COVID-19.
To date, MTEM has been able to continue to work at its cGMP manufacturing facility and laboratories without interruption from COVID-19. As a result, manufacturing of product supply for clinical trials and research activities to support advancement of our preclinical pipeline (including partnered programs) have not been adversely affected by COVID-19 to date.
Financial Results

The net loss attributable to common shareholders for the second quarter of 2020 was $31.2 million, or $0.68 per basic and diluted share. This compares with a net loss attributable to common shareholders of $9.2 million, or $0.25 per basic and diluted share, for the same period in 2019.

Revenues for the second quarter of 2020 were $6.9 million, compared to $5.4 million for the same period in 2019. Revenues for the second quarter of 2020 were comprised of revenues from collaborative research and development agreements with Takeda and Vertex, as well as grant revenue from CPRIT. Total research and development expenses for the second quarter of 2020 were $30.4 million, compared with $10.2 million for the same period in 2019. Total general and administrative expenses for the second quarter of 2020 were $6.4 million, compared with $4.6 million for the same period in 2019.

As of June 30, 2020, MTEM’s cash and investments totaled $91.0 million. With the addition of $50 million in gross proceeds raised through MTEM’s ATM facility after the end of the quarter, MTEM expects to be able to fund operations into 2H22.

XOMA Reports Second Quarter 2020 Financial Results

On August 6, 2020 XOMA Corporation (Nasdaq: XOMA), reported its second quarter 2020 royalty asset portfolio advancements and financial results (Press release, Xoma, AUG 6, 2020, View Source [SID1234563111]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With a healthy cash position, a low-cost infrastructure, and a strict discipline on capital deployment, XOMA remains in a strong position to continue executing on our royalty-aggregator strategy to create near- and long-term value for shareholders. We were pleased to expand our Board of Directors with the appointment of Natasha Hernday, Senior Vice President, Corporate Development at Seattle Genetics, who brings significant expertise in sourcing and executing licensing deals, acquisitions, and partnerships that are complementary to our business model," stated Jim Neal, Chief Executive Officer. "We recognize COVID-19 continues to impact clinical activities broadly across the industry, and while these challenges may affect the timing of potential milestone payments due to XOMA, they also could create opportunities for us to acquire interesting milestone and royalty assets.

"We commend our partners for their continued focus on advancing their therapeutic candidates in the face of COVID-19-related challenges. For example, Ology Bioservices was awarded a contract from the Department of Defense to further its anti-botulinum toxin program," Mr. Neal added. "Recently, Sesen Bio announced it signed an exclusive license agreement with Qilu Pharmaceutical for the development and commercialization of Vicineum, a locally administered fusion protein being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC), in Greater China."

Financial Results

XOMA recorded total revenues of $0.4 million for the second quarter of 2020, compared with $1.0 million recorded for the second quarter of 2019. The decrease for the three months ended June 30, 2020, as compared to the same period in 2019, was due primarily to a $0.5 million milestone recognized under our collaboration agreement with Takeda in the second quarter of 2019.

Research and development expenses were $0.04 million for the second quarter of 2020, compared to $0.7 million for the second quarter of 2019. The decrease for the three months ended June 30, 2020, compared to the same period in 2019, was due to a $0.5 million decrease in license fee expenses and a $0.2 million decrease in salary and related expenses.

General and administrative ("G&A") expenses were $3.6 million for the second quarter of 2020, compared to $4.9 million for the second quarter of 2019. The decrease of $1.3 million for the three months ended June 30, 2020, as compared to the same period of 2019, was primarily due to a $0.9 million decrease in facilities costs and a $0.3 million decrease in salary and related expenses.

In the second quarter of 2020, G&A expenses included $0.8 million in stock-based compensation, which is a non-cash expense. The Company’s net cash used in operations was $2.9 million during the second quarter of 2020.

In the second quarter of 2020, XOMA recorded $0.5 million in total interest expense, as compared to $0.4 million in the corresponding period of 2019, both of which reflect the Company’s outstanding loan balances with Silicon Valley Bank (SVB) and Novartis.

For the quarter ended June 30, 2020, XOMA reported total other income of $0.1 million, as compared to $1.1 million in the corresponding quarter of 2019. During the three months ended June 30, 2019, the Company was party to four sublease agreements resulting in $0.8 million in sublease income. The XOMA legacy leases were terminated in December 2019; it is no longer a party to any subleases, which is reflected in the total other income reported during second quarter of 2020.

Net loss for the second quarter of 2020 was $3.5 million, compared to $4.1 million for the second quarter of 2019.

On June 30, 2020, XOMA had cash and cash equivalents of $49.5 million. The Company ended December 31, 2019, with cash and cash equivalents of $56.7 million. The Company continues to believe its current cash position will be sufficient to fund XOMA’s operations for multiple years.

Nektar Therapeutics Reports Second Quarter 2020 Financial Results

On August 6, 2020 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the second quarter ended June 30, 2020 (Press release, Nektar Therapeutics, AUG 6, 2020, View Source [SID1234563110]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cash and investments in marketable securities at June 30, 2020 were approximately $1.2 billion as compared to $1.6 billion at December 31, 2019. This decrease includes the repayment of $254.8 million for Nektar’s senior secured notes and accrued interest, which occurred in the second quarter of 2020.

"During the second quarter, Nektar successfully advanced the registrational and early clinical trials across our immune-oncology portfolio which led to the opening of enrollment for the first patients into a new Phase 3 study in adjuvant melanoma for the bempegaldesleukin program," said Howard W. Robin, President and CEO of Nektar. "We now have 5 ongoing registrational trials for bempegaldesleukin, and we continue to make significant progress with our NKTR-262 and NKTR-255 clinical trials, with early data from these programs planned for presentation at this year’s Society for Immunotherapy Congress in November."

Mr. Robin continued, "In immunology, following the positive Phase 1b data in lupus patients reported at EULAR, our partner Eli Lilly continues to expand their NKTR-358 development efforts. I am pleased to announce that they are initiating investigator sites and enrolling patients into a new Phase 2 study of NKTR-358 in moderate to severe systemic lupus erythematosus. We are fortunate to be entering the second half of 2020 in a position of exceptional strength – we have built a robust pipeline in oncology and immunology with multiple registrational and earlier stage clinical trials underway and we ended Q2 in a strong financial position with $1.2 billion in cash and investments, and no debt on our balance sheet."

Summary of Q2 2020 Financial Results

Revenue in the second quarter of 2020 was $48.8 million compared to $23.3 million in the second quarter of 2019. The increase was due to the recognition of the $25.0 million milestone from Bristol-Myers Squibb related to the recent initiation of the registrational trial of bempegaldesleukin plus Opdivo in adjuvant melanoma, which opened enrollment to patients in July. Year-to-date revenue for 2020 was $99.4 million compared to $51.5 million in the first half of 2019. Revenue was higher due to the recognition of $50.0 million in total milestones from Bristol-Myers Squibb related to the start of registrational trials of bempegaldesleukin plus Opdivo in adjuvant melanoma and muscle-invasive bladder cancer.

Total operating costs and expenses in the second quarter of 2020 were $126.6 million compared to $134.3 million in the second quarter of 2019. The decrease was due to a decrease in research and development (R&D) expense. Total operating costs and expenses in the first half of 2020 were $310.8 million compared to $283.2 million in the first half of 2019. Year-to-date operating costs and expenses increased primarily as a result of impairment of assets and other costs for NKTR-181, partially offset by a decrease in R&D expense. During the first quarter of 2020, Nektar reported $45.2 million in impairment charges and additional costs related to the discontinuation of the NKTR-181 program.

R&D expense in the second quarter of 2020 was $96.4 million compared to $106.7 million for the second quarter of 2019. For the first half of 2020, R&D expense was $205.4 million compared to $225.1 million in the first half of 2019. The decrease for both the second quarter and the first half of 2020 was due primarily to pre-commercial manufacturing costs for NKTR-181 incurred during the first half of 2019.

Net loss for the second quarter of 2020 was $80.0 million or $0.45 basic and diluted loss per share compared to a net loss of $110.3 million or $0.63 basic and diluted loss per share in the second quarter of 2019. Net loss in the first half of 2020 was $218.7 million or $1.23 basic and diluted loss per share compared to a net loss of $229.9 million or $1.32 basic and diluted loss per share in the first half of 2019.

Second Quarter 2020 and Recent Business Highlights:

·In June 2020, Nektar announced the presentation of results from the Phase 1b study evaluating multiple ascending doses of NKTR-358, a first-in-class T regulatory cell stimulator, which is being developed as a potential therapeutic for a range of autoimmune disorders, including systemic lupus erythematosus (SLE). The data, which were presented during the Annual European Congress of Rheumatology (EULAR 2020) in a virtual congress format, showed that NKTR-358 was safe and well tolerated in patients with mild-to-moderate SLE and led to a marked and selective, dose-dependent expansion of regulatory T cells (Tregs) that was maintained over multiple administrations.
·In May 2020, Nektar announced the publication of clinical data from its PIVOT-02 study evaluating bempegaldesleukin in combination with nivolumab in immunotherapy-naïve patients with advanced solid tumors, including melanoma, renal cell carcinoma and non-small cell lung cancer. The data, published in Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), showed that bempegaldesleukin plus nivolumab resulted in encouraging overall response rates across multiple tumor types, independent of baseline PD-L1 expression, with responses continuing to deepen over time.
The company also announced an upcoming presentation at the following scientific congress:

Cambridge Healthtech Institute’s (CHI) 8th Annual Immuno-Oncology Virtual Summit

·Presentation: "NKTR-255: A Potent NK and CD8 Memory T Cell Mobilizer for Immunotherapy", Madakamutil, L.
o Session: Cytokines as Emerging Targets and Biotherapeutics

o Date: Thursday, October 8th, 9:40 a.m. – 10:00 a.m. Eastern Time

Conference Call to Discuss Second Quarter 2020 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, today, Thursday, August 6, 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 August 31, 2020.