Earnings release
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NextCure NextCure Reports Second Quarter 2021 Financial Results August 5 , 2021 BELTSVILLE , Md . , Aug. 05 , 2021 ( GLOBE NEWSWIRE ) -- NextCure , Inc. ( Nasdaq : NXTC ) , a clinical - stage biopharmaceutical company committed to discovering and developing novel , first - in - class immunomedicines to treat cancer and other immune - related diseases , today reported second quarter 2021 financial results and provided a business update . " We have made notable progress across all of our clinical programs including several enhancements to the ongoing NC318 Phase 2 monotherapy trial . Clinical sites can now select for S15 + patients , through screening biopsies in a CLIA certified laboratory . In addition , we have resumed enrolling non - small cell lung cancer ( NSCLC ) adenocarcinoma patients in the ongoing NC318 monotherapy trial and have revised the NC318 dosing regimen to increase overall drug exposure to NC318 , " said Michael Richman , NextCure's president and chief executive officer . " We expect to provide a data update from our ongoing Phase 2 monotherapy trial of NC318 , as well as to report Phase 1 data for NC410 by year - end . We have initiated clinical development of our third program , NC762 targeting B7 - H4 , with anticipated initial Phase 1 data mid - 2022 . " Business Highlights and Upcoming Milestones • NC318 • Clinical Laboratory Improvement Amendments ( CLIA ) validated assay available for S15 + patient selection to effectively evaluate NC318 activity in patients with S15 + tumors . o Resumed enrollment of a non - small cell lung cancer ( NSCLC ) adenocarcinoma cohort in the ongoing Phase 2 monotherapy trial . • Revised dosing regimen to 800 mg weekly to increase overall drug exposure . • On track to report Phase 2 monotherapy update in the fourth quarter of 2021 . o In the second quarter of 2021 , Yale University commenced a Phase 2 investigator - initiated clinical trial of NC318 in combination with pembrolizumab in patients with advanced NSCLC with anticipated initial data in the first half of 2022 . • NC410 • Presented trial in progress poster at the 2021 American Society of Clinical Oncology ( ASCO ) Virtual Annual Meeting . • Published preclinical data demonstrating that NC410 promoted T cell mediated anti - tumor immunity , enhanced infiltration and increased localized activity of T cells in the tumor microenvironment . o On track to report initial clinical data in the fourth quarter of 2021 . • NC762 • Started the Phase 1 portion of a Phase 1/2 clinical trial in patients with advanced or metastatic solid tumors . • Initial data anticipated to be available in mid - 2022 . Financial Guidance Based on its current research and development plans , NextCure expects its existing cash , cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditure requirements into the second half of 2023 . Financial Results for Quarter Ended June 30 , 2021 • Cash , cash equivalents and marketable securities as of June 30 , 2021 were $ 249.5 million , compared to $ 283.4 million as of December 31 , 2020. The decrease of $ 33.9 million primarily reflects cash used to fund operations , cash used to purchase fixed assets , and repayments on a term loan . • Research and development expenses were $ 11.9 million for the quarter ended June 30 , 2021 , as compared to $ 11.1 million for the quarter ended June 30 , 2020. The increase was driven primarily by clinical - related costs , partially offset by timing of clinical supply costs . • General and administrative expenses were $ 6.0 million for the quarter ended June 30 , 2021 , as compared to $ 4.7 million for the quarter ended June 30 , 2020. The increase was driven primarily by personnel - related costs . • Net loss was $ 18.0 million for the quarter ended June 30 , 2021 , as compared to $ 14.5 million for the quarter ended June 30 , 2020. The increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses from an increase in headcount . About NC318