On August 5, 2021 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company’s management will participate in the following conferences in August (Press release, MacroGenics, AUG 5, 2021, View Source [SID1234585888]):

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BTIG Virtual Biotechnology Conference 2021. MacroGenics’ management is scheduled to participate in a fireside chat on Tuesday, August 10, 2021, at 9:30 am ET live via webcast to conference attendees (not available for replay). Management will also participate in one-on-one meetings.
12th Annual Wedbush PacGrow Healthcare Conference. MacroGenics’ President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in a panel discussion, ADCs – Take Me to Your Tumor, on Wednesday, August 11, 2021, at 2:20 pm ET. Management will also participate in one-on-one meetings.
A webcast of the August 11, 2021 panel discussion may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company maintains archived replays of webcasts on its website for 30 days after each conference.

On August 5, 2021 Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, reported that financial results for the second quarter ending June 30, 2021 and provided an update on clinical and corporate activities (Press release, NewLink Genetics, AUG 5, 2021, View Source [SID1234585887]).

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"The enhancement of Lumos Pharma’s leadership team and encouraging recent trends in screening and enrollment for both OraGrowtH210 and OraGrowtH212 Trials are exciting developments for the Company," commented Rick Hawkins, Chairman and CEO of Lumos Pharma. "John McKew, David Karpf, and Mark Bach each bring significant clinical development and management expertise to their new roles with the Company, strengthening our ability to execute on our clinical and corporate strategy. The majority of our trial sites are now open, and we continue to work to bring the remainder online. Additionally, as children return to school this fall and regular pediatrician visits resume, we believe these factors should lead to increased referrals and an acceleration of enrollment in our trials."

Corporate Update:

John McKew, PhD, Chief Operating Officer & Chief Scientific Officer, Promoted to President

Our Chief Operating Officer and Chief Scientific Officer, John McKew, was recently promoted to President of Lumos Pharma effective August 1, 2021 as part of a planned succession process. Dr. McKew has nearly 30 years of experience developing novel therapeutics during which he successfully advanced multiple therapies through preclinical and into clinical development, both at the NIH and in the pharmaceutical industry. Dr. McKew has served as Chief Operating Officer of Lumos Pharma since April 2020 and as Chief Scientific Officer since he joined the Company in 2016.

David B. Karpf, MD, Experienced Endocrinologist and Pharma Executive, Named Chief Medical Officer

Pharma industry veteran and academician, David B. Karpf, MD, joined Lumos Pharma as Chief Medical Officer on August 3, 2021. Dr. Karpf is an Adjunct Clinical Professor in the Division of Endocrinology at Stanford University School of Medicine with over 35 years of expertise in all aspects of clinical endocrinology. He is also an accomplished executive with 30 years of experience in the development of biopharmaceuticals and small molecular weight drugs in the areas of endocrinology and rare diseases, among others. Most recently, Dr. Karpf served as Vice President, Clinical Development for Ascendis Pharma where he was responsible for several compounds in clinical development, including TransCon GH, long-acting growth hormone for once weekly treatment of growth hormone deficiency, and TransCon PTH. Dr. Karpf has held leadership positions at several biopharmaceutical and pharma companies, including Merck where he originally gained experience with Lumos Pharma’s oral growth hormone secretagogue, LUM-201.

Pediatric Endocrinologist and Biopharma Executive, Mark Bach, MD, PhD, Joins Advisory Board

Mark Bach, MD, PhD, pediatric endocrinologist and seasoned pharmaceutical executive, joined Lumos Pharma’s Clinical Scientific Advisory Board on July 15, 2021. Dr. Bach is currently the Chief Medical Officer for ShouTi Inc., having recently joined from Ascendis Pharma where he served as Senior Vice President, Endocrine Medical Sciences. Dr. Bach is a pediatric endocrinologist with 30 years of clinical research and pharmaceutical development experience. Prior to Ascendis, Dr. Bach held successive leadership roles in research and development at both Johnson & Johnson and Merck. While at Merck, he conducted extensive clinical and preclinical research on growth hormone, IGF-1 and LUM-201 (MK-0677).

Clinical Update:

OraGrowtH210 Trial of LUM-201 in PGHD

As the Company announced on July 21, 2021, given the slower pace of site initiation and enrollment of the Phase 2 OraGrowtH210 Trial of LUM-201 in PGHD primarily due to the impact of COVID, the 6-month primary outcome data for OraGrowtH210 is now anticipated in the second half of 2023. The treatment period for this trial has been extended to 12 months to capture additional data for future regulatory filings and to meet FDA requirements to initiate our proposed 3-year long-term extension study, the OraGrowtH211 Trial. We do not anticipate these protocol changes, on a stand-alone basis, to extend the time to initiation of our Phase 3 clinical trial. The primary outcome for the Phase 2 OraGrowtH210 Trial continues to be the preliminary validity of our Predictive Enrichment Marker (PEM) strategy with the goal of selecting the optimal dose for a pivotal Phase 3 study in PGHD.

PK/PD OraGrowtH212 Trial of LUM-201 in PGHD Initiated Q2 2021

The OraGrowtH212 Trial was initiated in June and is currently enrolling patients. This study will evaluate the PK/PD effects of LUM-201 in PGHD patients at two dose levels, 1.6 and 3.2 mg/kg/day, to confirm prior clinical data illustrating the increased pulsatile release of endogenous growth hormone unique to LUM-201 and its potential for this mechanism of action to contribute to efficacy in PGHD. This open-label trial will be extended from six months to twelve months to capture additional PK/PD and height velocity data. The PD pulsatility assessment will continue to occur at six months on therapy as planned.

Pipeline Expansion

We have been conducting an assessment of the range of disease areas where LUM-201 would have medical utility for purposes of prioritizing our next indication and longer-term life cycle planning. These assessments reinforce our conviction that LUM-201 represents a pipeline-in-a-product and look forward to advancing the next phase of LUM-201 opportunities. In addition, with a heightened sensitivity toward value creation, we continue to evaluate select rare disease assets under consideration to add to our product portfolio.

Financial Results for the Quarter Ended June 30, 2021

Cash Position – Lumos Pharma ended the second quarter on June 30, 2021, with cash and cash equivalents totaling $107.7 million compared to $98.7 million on December 31, 2020. Cash on hand as of the end of Q2 2021 is expected to support operations through the primary outcome data readout from OraGrowtH210 Trial in the second half of 2023 and the OraGrowtH212 Trial.
R&D Expenses – Research and development expenses were $4.1 million, an increase of $1.4 million for the three months ended June 30, 2021 compared to the same period in 2020, primarily due to increases of $1.8 million in clinical trial and contract manufacturing expenses, offset by a decrease of $0.4 million in personnel-related and operating expenses for insurance, rent, supplies and depreciation.
G&A Expenses – General and administrative expenses were $4.6 million, an increase of $0.4 million for the three months ended June 30, 2021, compared to the same period in 2020, primarily due to increases of $0.6 million in personnel-related expenses, of which $0.9 million relates to severance expense recorded for the departure of our former CFO, Carl W. Langren on June 30, 2021 and $0.5 million in stock compensation expenses, of which $0.4 million relates to the accelerated vesting of all non-vested equity awards held by Mr. Langren upon his departure. These increases were offset by a $0.4 million decrease in legal and consulting expenses and a $0.3 million reduction in operating expenses for insurance, rent, supplies, and depreciation.
Net Loss – The net loss for the second quarter ended June 30, 2021 was $8.7 million compared to net loss of $5.4 million for the same period in 2020.
Lumos Pharma ended Q2 2021 with 8,357,391 shares outstanding.
Conference Call and Webcast Details

The Company has scheduled a conference call and webcast for 11:00 a.m. ET today to discuss its financial results and to give an update on clinical and business development activities. There will also be a question-and-answer session following management’s prepared remarks.

Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link to the webcast can be accessed through the Lumos Pharma website at View Source in the "Investors & Media" section under "Events and Presentations" or through this link: View Source To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 8050625. The replay will be available for two weeks from the date of the call.

On August 5, 2021 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three months ending June 30, 2021 (Press release, Quanterix, AUG 5, 2021, View Source [SID1234585886]).

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"The past quarter has proven to be a pivotal time for our company as we continue to make immense strides with our strategic expansion in the diagnostics space," said Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix. "With drug advances taking place for neurodegenerative diseases, there is a heightened focus to diagnose and detect cognitive conditions like Alzheimer’s Disease as early as possible and then to monitor disease progression in the patient once a drug agent is deployed. We are a leader in this area and improving outcomes and helping advance methodologies to enhance coverage with evidence for payers will change the way disease is studied, drugs are approved and ultimately how care is delivered economically and effectively."

Second Quarter 2021 Financial Highlights

Key financial results for the second quarter of 2021 are shown below:

Q2 GAAP total revenue, which includes grant revenue of $0.9M, was $25.4M versus prior year Q2 of $13.1M, an increase of 93%;
Q2 non-GAAP total revenue was $24.4M versus prior year Q2 of $13.1M, an increase of 86%;
Q2 GAAP product revenue was $18.7M versus prior year Q2 of $6.8M, an increase of 175%;
Q2 GAAP service and other revenue was $5.6M versus prior year Q2 of $6.3M, a decrease of 11%;
Q2 GAAP gross margin was 54.7% versus prior year Q2 of 39.7%, an increase of 1,500 bps; Q2 non-GAAP gross margin was 55.1% versus prior year Q2 of 44.1%, an increase of 1,100 bps
1H 2021 Financial Highlights

Key financial results for the first half of 2021 are shown below:

1H GAAP total revenue, which includes grant revenue of $3.2M, was $52.6M versus prior year 1H of $28.9M, an increase of 82%;
1H non-GAAP total revenue was $49.3M versus prior year 1H of $28.9M, an increase of 71%;
1H GAAP product revenue was $36.9M versus prior year 1H of $16.6M, an increase of 122%;
1H GAAP service and other revenue was $12.1M, consistent with prior year 1H of $12.1M;
1H GAAP gross margin was 57.5% versus prior year 1H of 41.7%; 1H non-GAAP gross margin was 56.8% versus prior year 1H of 46.5%, an increase of 1,030 bps
For additional information on the non-GAAP financial measures included in this press release, please see "Use of Non-GAAP Financial Measures" and "Reconciliation of Non-GAAP Financials" below.

Second Quarter 2021 Business Highlights

Record Product Revenue of $18.7M for Q2 2021, an increase of 175% versus prior year Q2.
FDA approval of Biogen’s Aducanamab underscores potential of plasma-based neuro biomarkers in drug development and diagnostics.
Quanterix’ Simoa technology powered the largest and most diverse global investigation of the role of plasma neurofilament light (NfL) in dementia diagnosis, published in Nature Communications. The research marks the most robust effort to date to assess the use of NfL in blood to screen for neurodegeneration as a cause of cognitive symptoms; differentiate among neurodegenerative disorders and distinguish psychiatric disorders; and derive age-related concentration cutoffs that may help to maximize plasma NfL’s usefulness in a clinical setting.
Delivered a virtual presentation at the Goldman Sachs 42nd Annual Global Healthcare Conference on June 10 and appeared on the June 3 episode of The Bio Report, a leading podcast that focuses on the intersection of biotechnology and business, science, and policy to discuss the implications of biomarkers on the future of drug development and diagnostics.
Hosted the webinar: Recent Advancements in Neurodegenerative Biomarkers: Progress Towards a Diagnostic Blood Test for Alzheimer’s Disease that featured leading industry experts to discuss neurological advancements related to the ultra-sensitive quantification of pTau181, pTau217, pTau231, and other neurological biomarkers.
Welcomed Masoud Toloue, an industry expert from PerkinElmer, to the position of President of Quanterix and Diagnostics to lead Quantertix’ growing diagnostics business and assume responsibility for the Company’s Accelerator Lab Services, strategic partnerships and corporate development.
Appointed Michael Doyle, a strong financial executive with deep public company experience to the position of Chief Financial Officer (CFO) and Treasurer.
Quanterix Simoa technology was highlighted in 130 new publications, bringing total Simoa-specific inclusions to more than 1,300 publications.
Conference Call
In conjunction with this announcement, Quanterix Corporation will host a conference call on August 5 at 4:30pm EDT. Individuals interested in listening to the conference call may do so by dialing 833-686-9351 for domestic callers, or 612-979-9890 for international callers. Please reference the following conference ID: 2299526.

A live webcast will also be available at: View Source The webcast will be available on the Company’s website, View Source, for one year following completion of the call.

Financial Highlights (in thousands)

Use of Non-GAAP Financial Measures
To supplement the Company’s financial statements presented on a GAAP basis, the Company has provided certain non-GAAP financial measures, including non-GAAP revenue and non-GAAP gross margin. Management uses these non-GAAP measures to evaluate the Company’s operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends in its business. Management believes that such measures are important in comparing current results with prior period results and are useful to investors and financial analysts in assessing the Company’s operating performance. The non-GAAP financial information presented here should be considered in conjunction with, and not as a substitute for, the financial information presented in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measures to their most directly comparable GAAP financial measures set forth below.

On August 5, 2021 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Harpoon Therapeutics, AUG 5, 2021, View Source [SID1234585885]).

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"The clinical data emerging for our proprietary TriTAC portfolio continues to be encouraging as HPN424, HPN536 and HPN328 have shown cancer target engagement, significant treatment duration, and either tumor size reductions or stable disease," said Jerry McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "Looking ahead into to the second half of 2021, we remain focused on increasing dose levels across all four programs and providing additional interim clinical pipeline data by year end."

Second Quarter 2021 Business Highlights and Other Recent Developments

•In June 2021, Harpoon presented interim clinical data from the ongoing dose-escalation portion of the Phase 1/2a trial for HPN424—a TriTAC targeting prostate-specific membrane antigen (PSMA)—in patients with metastatic castration-resistant prostate cancer (mCRPC) at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. At the time of the ASCO (Free ASCO Whitepaper) presentation data cutoff, 89 patients had been treated in 13 cohorts. Key findings include:
•HPN24 was active and generally well-tolerated.
•Antitumor activity included a confirmed PR per RECIST, PSA declines and circulating tumor cell reductions.
•Cytokine release syndrome (CRS) has been transient and manageable with 4% of patients experiencing Grade 3 CRS.
•CRS events observed most often in Cycle 1, with diminished frequency and severity in subsequent cycles.
•Introduction of step dose regimens has allowed for the administration of higher target doses, which had reached 300ng/kg at the time of the update.
•Expanding on the data presented at ASCO (Free ASCO Whitepaper), with a May 31 data cutoff date, 19 patients had been enrolled in the 300 ng/kg step dose cohort, which includes patients treated with different step regimens to obtain the target dose of 300 ng/kg. Four of 19 patients in this cohort showed PSA declines, including two PSA30.

Dose escalation is ongoing, and we have recently opened a 450 ng/kg step dose cohort. The first patient has successfully reached the target dose of 450 ng/kg.

•In June 2021, Harpoon provided a corporate pipeline update. In addition to reiterating and expanding upon HPN424 data presented at ASCO (Free ASCO Whitepaper)21, Harpoon provided updates on the following TriTAC clinical programs:
•HPN 536 (mesothelin TRiTAC) – Phase 1/2a clinical trial continues dose escalation for treating late-stage ovarian, pancreatic, and peritoneal and pleural mesothelioma cancers. Findings demonstrated that 11 of 20 relapsed/refractory ovarian cancer patients showed stability of target lesions, including three with target lesion shrinkage. Additionally, five of 27 ovarian cancer patients had a duration of treatment of greater than 24 weeks. As of the May 31, 2021 data cutoff date, two DLTs had been observed, which did not limit escalation. An MTD has not been identified and escalation to higher doses is underway. We recently opened and are actively recruiting a 1800 ng/kg cohort.
•HPN 217 (BCMA TriTAC) – Dose escalation for Phase 1/2 clinical trial is progressing. Relapsed/refractory multiple myeloma patients (N=20) have been treated across eight fixed dose cohorts of 5 to 2150 µg weekly, reflecting rapid dose expansion since the trial began, and HPN 217 has been well tolerated. Pharmacokinetic analysis shows half-life extension to support at least once weekly dosing.

•HPN328 (DLL3 TriTAC) – Dose escalation for Phase 1/2 clinical trial initiated in late 2020 and has shown rapid progress. The first single patient cohort began with a flat dose of 15µg of HPN328 administered once weekly by intravenous infusion and has proceeded to the fourth cohort at a dose of 405µg. Eligible patients include small cell lung cancer patients who have relapsed after platinum chemotherapy and patients with other tumors associated with DLL3 expression. One SCLC patient previously treated with chemotherapy enrolled in the 45µg cohort, demonstrated a 38% reduction in target lesion, consistent with an unconfirmed partial response. A subsequent scan indicated stable disease as best response. MTD has not been identified and escalation to higher doses is underway. We recently opened a 3.6 mg flat dose cohort and have successfully treated the first patient in that dose cohort.

•In addition, Harpoon provided an update on HPN601 (EpCAM ProTriTAC), a conditionally active T cell engager. IND-enabling studies for HPN601 are progressing as planned. EpCAM is expressed in a broad range of solid tumors, including gastrointestinal cancers, potentially enabling HPN601 to address multiple indications with high unmet medical need.

Second Quarter 2021 Financial Results

•Harpoon ended the second quarter of 2021 with $175.2 million in cash, cash equivalents, and marketable securities compared to $150.0 million as of December 31, 2020. The cash balance at the end of the second quarter includes Harpoon’s follow-on financing that closed on January 11, 2021 resulting in net proceeds of approximately $107.6 million.

•Revenue for the second quarter ended June 30, 2021 was $5.8 million compared to $2.8 million for the quarter ended June 30, 2020. For the six months ended June 30, 2021, revenue was $14.8 million compared to $6.1 million for the six months ended June 30, 2020. For the second quarter ended June 30, 2021, the increase in revenue was primarily due to an increase in revenue recognized related to Harpoon’s Development and Option Agreement with AbbVie, for research and development services performed. For the six months ended June 30, 2021,the increase in revenue was primarily due to an increase in revenue recognized due to the delivery of the second initial target under Harpoon’s Amended and Restated Discovery Collaboration Agreement with AbbVie, where all remaining deferred revenue associated with that target was recognized as we had no further continuing performance obligations, as well as an increase in revenue recognized related to Harpoon’s Development and Option Agreement with AbbVie, for research and development services performed.

• Research and development expense for the second quarter ended June 30, 2021, was $18.3 million compared to $11.9 million for the quarter ended June 30, 2020. For the six months ended June 30, 2021, R&D expense was $34.5 million compared to $24.4 million for the six months ended June 30, 2020. The increase for both periods, primarily arose from higher clinical development and personnel-related expense, which included conducting preclinical studies and the continuation and preparation of the clinical trials for HPN424, HPN536, HPN217 and HPN328.

• General and administrative expense for the second quarter ended June 30, 2021 was $4.3 million compared to $3.9 million for the quarter ended June 30, 2020. For the six months ended June 30, 2021, G&A expense was $8.9 million compared to $7.9 million for the six months ended June 30, 2020. The increase for both periods was primarily attributable to an increase in personnel-related expenses due to an increase in headcount and other professional services to support Harpoon’s operations as a public company.

•Net loss for the second quarter ended June 30, 2021 was $16.8 million compared to $12.7 million for the quarter ended June 30, 2020. The net loss for the six months ended June 30, 2021 was $78.5 million compared to $25.2 million in the first six months of the prior year.

Anticipated 2021 Milestones

•HPN424 – initiate a dose expansion cohort of the Phase 1/2a trial by year end 2021
•HPN536 – present interim data from the dose escalation phase of the trial by year end 2021 and initiate a dose expansion cohort of the ongoing Phase 1/2 trial in the second half of the year
•HPN217 – present interim data from the dose escalation phase of the trial by year end 2021 and initiate a dose expansion cohort of the ongoing Phase 1/2 trial in the second half of the year
•HPN328 – present interim data from the dose escalation phase of the trial by year end 2021
COVID-19 Business Update

In response to the ongoing COVID-19 pandemic, Harpoon has established testing and other protocols for personnel access to its headquarter offices and laboratory although the majority of the company’s employees continue to telecommute. Harpoon is currently continuing its clinical trials, and has not yet experienced any material delays or impacts as a result of the COVID-19 pandemic. In addition, Harpoon’s third-party contract manufacturers continue to operate at or near normal levels. Harpoon continues to assess the potential impact of the COVID-19 pandemic on its business and operations, including its programs, expected timelines, expenses, manufacturing activities and preclinical and clinical trials. The full extent to which the COVID-19 pandemic may have a negative impact on Harpoon’s business, assets, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted.

On August 5, 2021 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the second quarter ended June 30, 2021 (Press release, Nektar Therapeutics, AUG 5, 2021, View Source [SID1234585884]).

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Cash and investments in marketable securities at June 30, 2021 were approximately $1.1 billion as compared to $1.2 billion at December 31, 2020.

"We continue to execute on our clinical development strategy, setting the stage for a steady cadence of upcoming data readouts that will highlight the value of our novel cytokine portfolio," said Howard W. Robin, President and CEO of Nektar. "For bempegaldesleukin plus nivolumab, the first three of our five registrational studies in melanoma, renal cell carcinoma and bladder cancer remain on track for top line data in the first half of 2022. We are also evaluating the combination of bempegaldesleukin plus pembrolizumab and look forward to presenting data from the PROPEL study in patients with metastatic non-small cell lung cancer in the second half of 2021."

Mr. Robin continued, "We also have a robust development program for NKTR-255, our second major cytokine candidate in oncology. Our initial efforts include two Phase 1 clinical studies in combination with ADCC antibodies, one in hematological malignancies and one in solid tumors, and we look forward to sharing data from these studies before the end of the year. Finally, as part of the broad development program for NKTR-358, our T regulatory cell IL-2 agent, our partner Eli Lilly is conducting Phase 2 studies in both lupus and ulcerative colitis and plans to initiate additional Phase 2 studies in two different immune-mediated diseases."

Summary of Financial Results

Revenue in the second quarter of 2021 was $28.3 million as compared to $48.8 million in the second quarter of 2020. The decrease in revenue relative to 2020 was due to the recognition in the second quarter of 2020 of the $25.0 million milestone from Bristol-Myers Squibb for the initiation of the registrational trial of bempegaldesleukin plus Opdivo in adjuvant melanoma. Revenue for the first half of 2021 was $52.0 million as compared to $99.4 million in the first half of 2020. Revenue was lower relative to 2020 due to the recognition in the first half of 2020 of $50.0 million in total milestones from Bristol-Myers Squibb for the initiation 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 2021 were $138.5 million as compared to $126.6 million in the second quarter of 2020. The increase was due to increases in research and development (R&D) expense and general and administrative (G&A) expense in the second quarter of 2021. Total operating costs and expenses in the first half of 2021 were $271.6 million as compared to $310.8 million in the first half of 2020. Operating costs and expenses decreased relative to 2020 primarily due to the recording of $45.2 million in impairment charges in the first quarter of 2020 resulting from the discontinuation of the NKTR-181 program.

R&D expense in the second quarter of 2021 was $101.3 million as compared to $96.4 million for the second quarter of 2020. For the first half of 2021, R&D expense was $196.9 million as compared to $205.4 million in the first half of 2020.

G&A expense was $29.6 million in the second quarter of 2021 and $24.3 million in the second quarter of 2020. For the first half of 2021, G&A expense was $61.2 million compared to $50.6 million in the first half of 2020. G&A expense increased primarily due to an increase in pre-commercial costs for bempegaldesleukin.

Net loss for the second quarter of 2021 was $125.5 million or $0.69 basic and diluted loss per share as compared to a net loss of $80.0 million or $0.45 basic and diluted loss per share in the second quarter of 2020. Net loss in the first half of 2021 was $248.5 million or $1.37 basic and diluted loss per share as compared to a net loss of $218.7 million or $1.23 basic and diluted loss per share in the first half of 2020.

Second Quarter 2021 and Recent Business Highlights:

In May 2021, Nektar announced the first publication of preclinical data for NKTR-358 in the Journal of Translational Autoimmunity. The published data demonstrate that NKTR-358, a first-in-class composition of stable PEG conjugates of IL-2, has the ability to elicit sustained and preferential proliferation and activation of T regulatory cells in vivo without corresponding increases in T effector cells, supporting its potential in a broad range of autoimmune and inflammatory disorders. Nektar’s partner, Eli Lilly & Co., is conducting a Phase 2 study in patients with systemic lupus erythematosus, a Phase 2 study in patients with ulcerative colitis, as well as two separate Phase 1b studies in patients with atopic dermatitis and psoriasis.
In May 2021, Nektar announced the first publication of preclinical data from its second major immuno-oncology cytokine program, NKTR-255, in the Journal for ImmunoTherapy of Cancer. NKTR-255 is a novel recombinant human Interleukin-15 (rhIL-15) receptor agonist designed to activate the IL-15 pathway to expand both natural killer cells and memory CD8+ T cell populations. The published data demonstrate that NKTR-255 retains the full spectrum of IL-15 biology, but with improved pharmacologic properties and anti-tumor activity versus other rhIL-15 agonists.
Nektar also announced upcoming presentations at the following scientific congress:

2021 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper)
September 16-21, 2021 (Virtual)

Poster Presentation: "Evaluation of concordance between PD-L1 immunohistochemistry 28-8 and 22C3 pharmDx assays in metastatic urothelial carcinoma (mUC) in PIVOT-10", Siefker-Radtke, A., et al.
Trial in Progress Poster: "A Phase 1b/2, open-label, multicenter, dose-escalation and dose-expansion study of NKTR-255 plus cetuximab as a salvage regimen in patients with solid tumors", Altan, M., et al.
Conference Call to Discuss Second Quarter 2021 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, August 5, 2021.

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 September 5, 2021.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (International)
Conference ID: 4576644 (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 this press release, or explained on the conference call, related information will be made available on the Investors section of the Nektar website as soon as practical after the conclusion of the conference call.