 BELTSVILLE, Md., Aug. 06, 2020 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 2020 financial results and provided a business update. Despite our recent announcement that we did not see sufficient clinical activity required for advancement in our initial non-small cell lung cancer and ovarian cancer Phase 2 cohorts, we remain encouraged about the NC318 single agent activity we have seen in patients with both non-small cell lung and head and neck cancers. We are working diligently in hopes of better understanding Siglec-15 biology and evaluating biomarkers that may provide a focused path forward. We anticipate having more information by the end of this year, said Michael Richman, NextCures president and chief executive officer. We recently initiated the Phase 1 portion of a Phase 12 clinical trial of NC410, our second product candidate, and expect to have initial clinical data for that trial in the second half of 2021. We remain highly committed to our goal of bringing novel immunomedicines to patients and remain focused on advancing our current clinical and preclinical programs.Business Highlights and upcoming milestones Observed one confirmed partial response in head and neck squamous cell carcinoma HNSCC, and advanced this indication to the stage 2 portion of the Simon 2-stage trial of NC318. Continued enrolling new patients in the HNSCC and triple-negative breast cancer cohorts of the NC318 monotherapy trial. Reported initial biomarker data from the Phase 1 portion of the NC318 Phase 12 monotherapy clinical trial at the virtual American Society of Clinical Oncology Annual Meeting. Initiated the Phase 1 portion of a Phase 12 clinical trial for NC410.Financial Results for Quarter Ended June 30, 2020 Cash, cash equivalents and marketable securities as of June 30, 2020 were 309.3 million, compared to 334.6 million as of December 31, 2019. The decrease of 25.3 million primarily reflects cash used to fund operations of 23.0 million and cash used to purchase fixed assets of 4.3 million. Research and development expenses were 11.1 million for the quarter ended June 30, 2020, as compared to 7.6 million for the quarter ended June 30, 2019. The increases primarily reflect an increase in headcount, clinical research costs for NC318 and NC410, and expenses for lab supplies and services for NC318, NC410, our other early stage programs and discovery activities. General and administrative expenses were 4.7 million for the quarter ended June 30, 2020, as compared to 2.7 million for the quarter ended June 30, 2019. The increase was primarily related to increases in personnel-related costs due to an increase in headcount, as well as increases in professional fees and insurance costs in connection with becoming a publicly traded company. There was no revenue recognized in the quarter ended June 30, 2020 as compared to 1.4 million in the quarter ended June 30, 2019. Revenue generated in the prior year quarter was from our former research and development agreement with Eli Lilly. Net loss was 14.5 million for the quarter ended June 30, 2020, as compared to 8.2 million for the quarter ended June 30, 2019. 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 NC318 is a first-in-class immunomedicine against S15, a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15. NextCure believes NC318 has the potential to treat multiple cancer types.About NC410 NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and dendritic cells, a type of antigen presenting cell. In preclinical research, it was observed that LAIR-1 inhibited T cell function and dendritic cell activity allowing tumor cells to grow. In preclinical studies, NC410 blocked the negative effects of LAIR-1 and promoted T cell function and dendritic cell activity. NextCure believes NC410 has the potential to treat multiple cancer types.About NextCure, Inc. NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases. Through our proprietary FIND-IOTM platform, we study various immune cells to discover and understand targets and structural components of immune cells and their functional impact in order to develop immunomedicines. Our initial focus is to bring hope and new treatments to patients who do not respond to current cancer therapies, patients whose cancer progresses despite treatment and patients with cancer types not adequately addressed by available therapies. Statements This press release contains forward-looking statements, including statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations, forecasts, assumptions and other information available to NextCure as of the date hereof. Forward-looking statements include statements regarding NextCures expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as may, will, potential, expects, believes, intends, hope, towards, forward, later and similar expressions. Examples of forward-looking statements in this press release include, among others, statements about the progress and evaluation and expected timing of results of NextCures ongoing clinical trial of NC318, expectations regarding the potential benefits, activity, effectiveness and safety of NC318, the evaluation of biomarkers, the expected timing of results of NextCures ongoing clinical trial of NC410 and NextCures plans, objectives and intentions with respect to the discovery and development of immunomedicines. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: the impacts of the COVID-19 pandemic on NextCures business, including NextCures clinical trials, third parties on which NextCure relies and NextCures operations; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCures limited operating history and no products approved for commercial sale; NextCures history of significant losses; NextCures need to obtain additional financing; risks related to clinical development, marketing approval and commercialization; the unproven approach to the discovery and development of product candidates based on NextCures FIND-IO platform; and dependence on key personnel. More detailed information on these and additional factors that could affect NextCures actual results are described in NextCures filings with the Securities and Exchange Commission the SEC, including NextCures most recent Form 10-K and subsequent Form 10-Q. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. NEXTCURE, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS unaudited, in thousands, except share and per share amounts Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Revenue: Revenue from research and development arrangement 1,402 22,378 2,759 Operating expenses: Research and development 11,130 7,643 21,708 14,156 General and administrative 4,671 2,714 8,259 4,373 Total operating expenses 15,801 10,357 29,967 18,529 Loss from operations 15,801 8,955 7,589 15,770 Other income, net 1,293 734 2,814 1,394 Net loss 14,508 8,221 4,775 14,376 Loss per share: Net loss per common sharebasic and diluted 0.53 0.61 0.17 1.92 Weighted average number of common sharesbasic and diluted 27,518,129 13,498,393 27,512,528 7,472,298 Comprehensive Loss: Net loss 14,508 8,221 4,775 14,376 Unrealized gain on marketable securities 2,478 1,935 Total comprehensive loss 12,030 8,221 2,840 14,376 NEXTCURE, INC. 