NXTC NextCure Inc.

7.2
+0.06  (+1%)
Previous Close 7.14
Open 7.42
52 Week Low 6.82
52 Week High 14.3999
Market Cap $198,791,014
Shares 27,609,863
Float 25,965,611
Enterprise Value $-73,843,650
Volume 627,318
Av. Daily Volume 286,774
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NC410
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NC762
Phase 1/2
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Latest News

  1. BELTSVILLE, Md., July 06, 2021 (GLOBE NEWSWIRE) -- NextCure, Inc. (NASDAQ:NXTC), a clinical-stage biopharmaceutical company discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the initiation of a Phase 1/2 clinical trial for NC762, a humanized B7-H4 monoclonal antibody.

    "We are pleased to have initiated the clinical trial of our third product candidate," said Michael Richman, NextCure's president and chief executive officer. "This represents an important expansion of our pipeline of novel immunomedicines designed to treat patients who are not adequately addressed by currently available therapies. We look forward to reporting initial data from this trial in mid-2022…

    BELTSVILLE, Md., July 06, 2021 (GLOBE NEWSWIRE) -- NextCure, Inc. (NASDAQ:NXTC), a clinical-stage biopharmaceutical company discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the initiation of a Phase 1/2 clinical trial for NC762, a humanized B7-H4 monoclonal antibody.

    "We are pleased to have initiated the clinical trial of our third product candidate," said Michael Richman, NextCure's president and chief executive officer. "This represents an important expansion of our pipeline of novel immunomedicines designed to treat patients who are not adequately addressed by currently available therapies. We look forward to reporting initial data from this trial in mid-2022."

    "NC762 is an innovative immunomedicine that directly inhibits tumor growth by a unique, T cell independent mechanism," said Han Myint, M.D., NextCure's chief medical officer. "As B7-H4 is widely expressed on multiple tumor types, including non-small cell lung cancer, ovarian cancer and breast cancer, we believe NC762 has the potential to provide benefit in multiple cancer indications."

    The Phase 1 dose-escalation portion of this open-label trial is designed to evaluate the safety and tolerability of NC762 in patients with advanced or metastatic solid tumors and to determine its pharmacologically active and/or maximum tolerated dose. After a recommended dose for the Phase 2 portion of the trial is determined, NC762 will be evaluated in select tumor types. A B7-H4 Immunohistochemistry (IHC) assay has been successfully developed and will be used for patient selection in Phase 2.

    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-IO™ 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. www.nextcure.com

    Forward-Looking 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 NextCure's 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 development plans for NC762 and expected upcoming milestones, the potential benefits of NC762, and NextCure's 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 NextCure's business, including NextCure's clinical trials, third parties on which NextCure relies and NextCure's operations; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure's limited operating history and no products approved for commercial sale; NextCure's history of significant losses; NextCure's 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 NextCure's FIND-IO platform; and dependence on key personnel. More detailed information on these and additional factors that could affect NextCure's actual results are described in NextCure's filings with the Securities and Exchange Commission (the "SEC"), including in Item 1A of NextCure's most recent Form 10-K and elsewhere in the Company's filings with the SEC. 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.



    Investor Inquiries
    Timothy Mayer, Ph.D.
    NextCure, Inc.
    Chief Operating Officer
    (240) 762-6486
    
    
    Media Inquiries
    Emily Wong
    MacDougall
    (781) 235-3060
    

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  2. BELTSVILLE, Md., June 21, 2021 (GLOBE NEWSWIRE) -- NextCure, Inc. (NASDAQ:NXTC), a clinical-stage biopharmaceutical company discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the publication of preclinical data in the online journal eLife establishing NC410 as a novel immunomedicine targeting immune-excluded regions of collagen-rich tumors and enabling normalization of the tumor immune microenvironment. NC410, currently being evaluated in a Phase 1/2 clinical trial in patients with advanced or metastatic solid tumors, is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and…

    BELTSVILLE, Md., June 21, 2021 (GLOBE NEWSWIRE) -- NextCure, Inc. (NASDAQ:NXTC), a clinical-stage biopharmaceutical company discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the publication of preclinical data in the online journal eLife establishing NC410 as a novel immunomedicine targeting immune-excluded regions of collagen-rich tumors and enabling normalization of the tumor immune microenvironment. NC410, currently being evaluated in a Phase 1/2 clinical trial in patients with advanced or metastatic solid tumors, is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and myeloid cells, including dendritic cells.

    "The blockade of LAIR-1 binding to collagen in the tumor microenvironment (TME) by NC410 represents a novel mechanism for targeting immune-excluded regions of tumors, including those with poor response to immunotherapy due to dense regions of collagen in tumors," said Michael Richman, NextCure's president and chief executive officer. "We believe NC410 is a valuable asset in NextCure's growing pipeline of innovative immunomedicines, and we look forward to continuing to evaluate NC410 in our Phase 1/2 clinical study as well as reporting initial clinical data in the second half of this year."

    "The interaction between immune cells expressing LAIR-1 in collagen rich regions of a tumor suppresses immune activation and prevents immune cells from entering the parenchyma of the tumors, therefore preventing anti-tumor immunity," said Dallas Flies, Ph.D., NextCure's Vice President of Discovery Research. "This immune-excluded phenotype is common in multiple cancer indications that are not adequately addressed by checkpoint immunotherapy. Data from our preclinical studies revealed that NC410 promotes T cell mediated anti-tumor immunity as well as infiltration and localized activity of T cells in the TME, suggesting its potential as a cancer monotherapy or combination therapy with checkpoint inhibitors particularly for immune-excluded, collagen-rich tumors."

    The publication titled, "Cancer immunotherapy by NC410, a LAIR-2 Fc protein blocking LAIR-collagen interaction," details the preclinical development and characterization of NC410. It also highlights preclinical data from a series of murine xenograft efficacy studies demonstrating anti-tumor activity and the promotion of T cell expansion and infiltration in the TME by NC410.

    NC410 is a dimeric LAIR-2 Fc fusion protein that is designed to act as a LAIR-1 decoy by binding with higher affinity to tumoral collagens than human LAIR-1, preventing LAIR-1-mediated immune suppression. This publication demonstrated that NC410 binding was most notable in collagen-rich tumors, such as gastric, ovarian, lung and head and neck, and in regions where immune cells were being excluded. As a result of T cell activation and effector function, NC410 induces specific collagen degradation products that may relate to the enhanced infiltration of immune cells in the tumor and have the potential to be used as clinical biomarkers.

    The paper was published in collaboration with Linde Meyaard, Ph.D., principal investigator at the Center for Translational Immunology, University Medical Center Utrecht, and an Oncode Investigator at Oncode Institute, who identified the inhibitory immune receptor LAIR-1 and has been working on it for over 20 years. The paper can be accessed from eLife's website at http://www.elifesciences.org.

    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 myeloid cells, including dendritic cells, a type of antigen presenting cell. In preclinical research, it has been observed that LAIR-1 inhibited T cell function and myeloid activity. In preclinical studies, NC410 blocked the negative effects of LAIR-1 and promoted T cell function and myeloid cell activity. NextCure believes NC410 has the potential to treat multiple cancer types.

    About NC410 Phase 1/2 Clinical Study

    The NC410 Phase 1/2 study is a multi-center, first in human, open-label, single-armed study to determine the safety and tolerability, define maximum tolerated dose (MTD) and/or pharmacologically active dose, assess preliminary efficacy, and explore predictive and pharmacodynamic biomarkers of NC410 in patients with advanced or metastatic solid tumors. Phase 1 is a classic 3+3 dose escalation design to determine the safety, tolerability, MTD and recommended phase 2 dose (RP2D). Ongoing exploratory analyses include the assessment of predictive biomarkers associated with treatment benefit, and pharmacodynamic markers associated with study drug activity. Phase 2 is going to enroll NSCLC, ovarian, colorectal, pancreatic, gastric and other cancers depending on biomarker data available from the Phase 1 part of the study. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04408599). 

    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-IO™ 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. www.nextcure.com

    Forward-Looking 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 NextCure's 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 development plans for NC410 and expected upcoming milestones, the potential benefits of NC410, and NextCure's 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 NextCure's business, including NextCure's clinical trials, third parties on which NextCure relies and NextCure's operations; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure's limited operating history and no products approved for commercial sale; NextCure's history of significant losses; NextCure's 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 NextCure's FIND-IO™ platform; and dependence on key personnel. More detailed information on these and additional factors that could affect NextCure's actual results are described in NextCure's filings with the Securities and Exchange Commission (the "SEC"), including in Item 1A of NextCure's most recent Form 10-K and elsewhere in the Company's filings with the SEC. 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.



    Investor Inquiries
    Timothy Mayer, Ph.D.
    NextCure, Inc.
    Chief Operating Officer
    (240) 762-6486
    
    
    Media Inquiries
    Emily Wong
    MacDougall
    (781) 235-3060
    

    Primary Logo

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  3. BELTSVILLE, Md., June 10, 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 announced that it will participate in a fireside chat at the JMP Securities Life Sciences Conference on June 17th at 1:30 pm Eastern time.

    A live audio webcast will be available through the Investors section of the company's website at www.nextcure.com. A replay of the webcast will be available after the event and archived on the website for 30 days.

    About NextCure, Inc.
    NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class…

    BELTSVILLE, Md., June 10, 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 announced that it will participate in a fireside chat at the JMP Securities Life Sciences Conference on June 17th at 1:30 pm Eastern time.

    A live audio webcast will be available through the Investors section of the company's website at www.nextcure.com. A replay of the webcast will be available after the event and archived on the website for 30 days.

    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-IO™ 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. http://www.nextcure.com

    Cautionary Statement Regarding Forward-Looking Statements

    Statements made in this press release that are not historical facts are forward-looking statements. Words such as "expects," "believes," "intends," "hope," "forward" and similar expressions are intended to identify forward-looking statements. Examples of forward-looking statements in this press release include, among others, statements about NextCure's plans, objectives and intentions with respect to the discovery of immunomedicine targets and 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: our limited operating history and no products approved for commercial sale; our history of significant losses; our need to obtain additional financing; risks related to clinical development, marketing approval and commercialization; and the unproven approach to the discovery and development of product candidates based on our FIND-IO platform. More detailed information on these and additional factors that could affect NextCure's actual results are described in NextCure's filings with the Securities and Exchange Commission (the "SEC"), including NextCure's most recent Form 10-K and subsequent Form 10-Q. You should not place undue reliance on any forward-looking statements. NextCure assumes no obligation to update any forward-looking statements, even if expectations change.



    Investor Inquiries
    Timothy Mayer, Ph.D.
    NextCure, Inc.
    Chief Operating Officer
    (240) 762-6486
    

    Primary Logo

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  4. BELTSVILLE, Md., May 19, 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 announced that clinical trial investigator, Martin Gutierrez, M.D., Director, Phase 1 Program and Co-Chair of Thoracic Oncology at Hackensack University Medical Center, will present a Trials in Progress poster for NC410 at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

    "NC410 targets a unique mechanism in the tumor microenvironment (TME) and represents an innovative approach for patients who do not respond to current available therapies by targeting tumors with…

    BELTSVILLE, Md., May 19, 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 announced that clinical trial investigator, Martin Gutierrez, M.D., Director, Phase 1 Program and Co-Chair of Thoracic Oncology at Hackensack University Medical Center, will present a Trials in Progress poster for NC410 at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

    "NC410 targets a unique mechanism in the tumor microenvironment (TME) and represents an innovative approach for patients who do not respond to current available therapies by targeting tumors with collagen-rich areas where LAIR-1+ immune cells localize," said Dr. Gutierrez. "LAIR-1 expression on immune cells in the TME inhibits T cell responses, through binding to collagen therefore leading to tumor growth. NC410 is designed to act as a LAIR-1 decoy to prevent LAIR-1 mediated immunosuppression. This leads to restoration of immune function as evidenced by increased production of several cytokines, and anti-tumor responses in preclinical models. I look forward to a continued collaboration with NextCure to advance this product through the clinic."

    "We are excited to discuss our rationale for developing NC410 as a first-in-class cancer therapeutic targeting the LAIR pathway as well as our Phase 1/2 clinical trial strategy with the clinical oncology community at ASCO," said Han Myint, M.D., NextCure's chief medical officer. "NC410 demonstrates anti-tumor activity in preclinical models, and we believe it has significant potential across multiple tumor types, including gastric, ovarian, lung head and neck. We look forward to continuing to evaluate NC410 in first-in-human trials and reporting initial clinical data in the second half of 2021."

    Collagens are a primary component of the extracellular matrix (ECM) in the TME and are functional ligands for the inhibitory immune receptor leukocyte associated immunoglobulin-like receptor (LAIR)-1. LAIR-1 binding to collagens suppresses anti-tumor immunity through the inhibition of key stimulatory signaling pathways. NC410 is designed as a fusion protein of LAIR-2, a soluble homolog of LAIR-1 fused to human IgG1 Fc domain, and it acts as a LAIR-1 decoy by binding collagen with higher affinity than LAIR-1 to prevent LAIR-1 mediated immunosuppression and promoting anti-tumor response. Because NC410 binds to collagen rich areas, it also induces alterations in the ECM to promote immune cell infiltration and function in the TME. LAIR-1 expression has been observed across tumor types, including non-small lung cancer (NSCLC), gastric, colorectal, pancreatic, ovarian and head & neck cancers. In this trial we plan to evaluate the measurement of collagen fragments in serum as potential biomarkers to non-invasively interrogate cell reactivity in the TME and predict response to treatment, which may be important for patient stratification for the Phase 2 portion of the study.

    Details of the poster presentation are as follows:

    Poster Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors

    Session Title: Developmental Therapeutics—Immunotherapy

    Abstract #: TPS2659

    The abstract is available through the ASCO Meeting Library at https://meetinglibrary.asco.org/.

    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 monocyte activity allowing tumor cells to grow. In preclinical studies, NC410 blocked the negative effects of LAIR-1 and promoted T cell function and monocyte cell activity. NextCure believes NC410 has the potential to treat multiple cancer types.

    About NC410 Phase 1/2 Clinical Study

    The NC410 Phase 1/2 study is a multi-center, first in human, open-label, single-armed study to determine the safety and tolerability, define maximum tolerated dose (MTD) and/or pharmacologically active dose, assess preliminary efficacy, and explore predictive and pharmacodynamic biomarkers of NC410 in patients with advanced or metastatic solid tumors. Phase 1 is a classic 3+3 dose escalation design to determine the safety, tolerability, MTD and recommended phase 2 dose (RP2D). Ongoing exploratory analyses include the assessment of predictive biomarkers associated with treatment benefit, and pharmacodynamic markers associated with study drug activity. Phase 2 is going to enroll NSCLC, ovarian, colorectal, pancreatic, and gastric cancers and other tumors depending on biomarker data available from the Phase 1 part of the study. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04408599). 

    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-IO™ 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. www.nextcure.com

    Forward-Looking 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 NextCure's 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 development plans for NC762 and expected upcoming milestones, the potential benefits of NC762, and NextCure's 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 NextCure's business, including NextCure's clinical trials, third parties on which NextCure relies and NextCure's operations; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure's limited operating history and no products approved for commercial sale; NextCure's history of significant losses; NextCure's 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 NextCure's FIND-IO platform; and dependence on key personnel. More detailed information on these and additional factors that could affect NextCure's actual results are described in NextCure's filings with the Securities and Exchange Commission (the "SEC"), including in Item 1A of NextCure's most recent Form 10-K and elsewhere in the Company's filings with the SEC. 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.



    Investor Inquiries
    Timothy Mayer, Ph.D.
    NextCure, Inc.
    Chief Operating Officer
    (240) 762-6486
    
    
    Media Inquiries
    Emily Wong
    MacDougall
    (781) 235-3060
    

    Primary Logo

    View Full Article Hide Full Article
  5. BELTSVILLE, Md., May 06, 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 first quarter 2021 financial results and provided a business update.

    "We are highly focused on advancing our three clinical programs and broadening our pipeline of novel immunomedicines this year. We are committed to continuing to evaluate NC318 in multiple indications in our Phase 2 monotherapy trial as well as the Phase 2 investigator-initiated clinical trial at Yale University that recently commenced," said Michael Richman, NextCure's president and chief executive officer…

    BELTSVILLE, Md., May 06, 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 first quarter 2021 financial results and provided a business update.

    "We are highly focused on advancing our three clinical programs and broadening our pipeline of novel immunomedicines this year. We are committed to continuing to evaluate NC318 in multiple indications in our Phase 2 monotherapy trial as well as the Phase 2 investigator-initiated clinical trial at Yale University that recently commenced," said Michael Richman, NextCure's president and chief executive officer. "The NC410 program continues to advance and we will be sharing a trial in progress poster at the upcoming American Society of Clinical Oncology Virtual Annual Meeting. With encouraging preclinical and IND-enabling data for NC762 presented at AACR, we look forward to advancing the asset into the clinic this quarter."

    Business Highlights and Upcoming Milestones

    • Commenced the Yale University Phase 2 investigator-initiated clinical trial of NC318 in combination with pembrolizumab in patients with advanced non-small cell lung cancer with anticipated initial data in the first half of 2022.
    • Presented preclinical and investigational new drug (IND)-enabling data for NC762 at the American Association for Cancer Research Annual Meeting 2021.
    • On track to initiate the NC762 Phase 1 clinical trial in the second quarter of 2021 and report initial data in mid-2022.
    • On track to report NC318 Phase 2 monotherapy update in the fourth quarter of 2021.
    • Continue enrolling patients in the Phase 1 portion of a Phase 1/2 clinical trial for NC410 and on track to report initial clinical data in the second half of 2021.
    • Present trial in progress poster for NC410 at the upcoming 2021 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting.

    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 March 31, 2021

    • Cash, cash equivalents, and marketable securities, excluding restricted cash as of March 31, 2021, were $268.2 million as compared with $283.4 million as of December 31, 2020. The decrease of $15.2 million reflects cash used to fund operations of $13.9 million and cash used to purchase fixed assets of $0.8 million.
    • Research and development expenses were $12.4 million for the quarter ended March 31, 2021 as compared to $10.6 million for the quarter ended March 31, 2020. The increase was primarily related to increase in personnel-related costs.
    • General and administrative expenses were $4.8 million for the quarter ended March 31, 2021, as compared to $3.6 million for the quarter ended March 31, 2020. The increase was primarily related to increase in personnel-related costs.
    • Revenue was not recognized in the quarter ended March 31, 2021, as compared to $22.4 million for the quarter ended March 31, 2020. Revenue generated in the first quarter of 2020 was from our former research and development agreement with Eli Lilly.
    • Net loss was $16.5 million for the quarter ended Mach 31, 2021, as compared with net income of $9.7 million for the quarter ended March 31, 2020. The change to a loss from the previous year's quarter were primarily due to the recognition in the prior year of the remaining deferred revenue under the former agreement with Eli Lilly and increased personnel-related costs in both research and development expenses and general and administrative expenses.

    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 NC762

    NC762 is a monoclonal antibody that binds specifically to B7-H4, a protein expressed on multiple tumor types. NextCure believes NC762 acts by inhibiting tumor cell growth and killing tumor cells, including by enhancing immune response. The company has observed in preclinical studies that NC762 inhibits the growth of human melanoma tumors in mice, and believes that NC762 has the potential to treat multiple tumor types. NextCure's research indicates that NC762 inhibits tumor cell growth independently of immune cell infiltration in the tumor microenvironment.

    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-IO™ 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. www.nextcure.com

    Forward-Looking Statements

    Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to our plans, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans regarding our immunomedicines and upcoming milestones. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "continue," "could," "should," "due," "estimate," "expect," "intend," "hope," "may," "objective," "plan," "predict," "potential," "positioned," "seek," "target," "towards," "forward," "later," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language.

    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 (including the emergence of variant strains) on NextCure's business, including NextCure's clinical trials, third parties on which NextCure relies and NextCure's operations; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure's limited operating history and no products approved for commercial sale; NextCure's history of significant losses; NextCure's 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 NextCure's FIND-IO platform; and dependence on key personnel. More detailed information on these and additional factors that could affect NextCure's actual results are described under the heading "Risk Factors" in NextCure's most recent Annual Report on Form 10-K and in the Company's other filings with the Securities and Exchange Commission. 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  
      March 31,  
         2021     2020  
    Revenue:       
    Revenue from former research and development arrangement $  $22,378  
            
    Operating expenses:       
    Research and development  12,386   10,578  
    General and administrative  4,848   3,588  
    Total operating expenses  17,234   14,166  
    (Loss) income from operations  (17,234)  8,212  
    Other income, net  701   1,521  
    Net (loss) income $(16,533) $9,733  
    (Loss) earnings per share:       
    Basic $(0.60) $0.35  
    Diluted $(0.60) $0.33  
            
    Shares used in the calculation of (loss) earnings per share:       
    Basic  27,597,426   27,506,927  
    Diluted  27,597,426   29,348,615  
    Comprehensive (loss) income:       
    Net (loss) income $(16,533) $9,733  
    Unrealized loss on marketable securities  (600)  (543) 
    Total comprehensive (loss) income $(17,133) $9,190  

    NEXTCURE, INC.

    CONDENSED BALANCE SHEETS

    (unaudited, in thousands, except share and per share amounts)

      March 31,  December 31, 
         2021

        2020
    Assets      
    Current assets:        
    Cash and cash equivalents $36,527  $32,772 
    Marketable securities  231,709   250,676 
    Restricted cash  1,706   1,706 
    Prepaid expenses and other current assets  3,109   2,824 
    Total current assets  273,051   287,978 
    Property and equipment, net  15,470   15,809 
    Other assets  2,438   2,857 
    Total assets $290,959  $306,644 
    Liabilities and Stockholders' Equity        
    Current liabilities:        
    Accounts payable $2,017  $3,901 
    Accrued liabilities  4,295   4,627 
    Deferred rent, current portion  209   130 
    Term loan, current portion  1,667   1,667 
    Total current liabilities  8,188   10,325 
    Deferred rent, net of current portion  2,223   792 
    Term loan, net of current portion  1,389   1,806 
    Total liabilities  11,800   12,923 
    Stockholders' equity:        
    Preferred stock, par value of $0.001 per share; 10,000,000 shares authorized at March 31, 2021 and December 31, 2020; no shares issued and outstanding at March 31, 2021 and December 31, 2020      
    Common stock, par value of $0.001 per share; 100,000,000 shares authorized at March 31, 2021 and December 31, 2020; 27,604,417 and 27,568,802 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively  28   28 
    Additional paid-in capital  413,122   410,551 
    Accumulated other comprehensive income  179   779 
    Accumulated deficit  (134,170)  (117,637)
    Total stockholders' equity  279,159   293,721 
    Total liabilities and stockholders' equity $290,959  $306,644 


    Investor Inquiries
    Timothy Mayer, Ph.D.
    NextCure, Inc.
    Chief Operating Officer
    (240) 762-6486
    
    
    Media Inquiries
    Emily Wong
    MacDougall
    (781) 235-3060
    

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