1. BELTSVILLE, Md., April 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 presented preclinical and investigational new drug (IND)-enabling data for NC762 at the American Association for Cancer Research (AACR) Annual Meeting 2021. NC762 is a humanized monoclonal antibody specific for B7-H4 and is being developed for the treatment of cancer.

    "The research presented by our team reinforces our confidence that NC762, our third program, is a novel immunomedicine with unique anti-tumor properties. We believe it has the potential to provide benefit in multiple oncology…

    BELTSVILLE, Md., April 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 presented preclinical and investigational new drug (IND)-enabling data for NC762 at the American Association for Cancer Research (AACR) Annual Meeting 2021. NC762 is a humanized monoclonal antibody specific for B7-H4 and is being developed for the treatment of cancer.

    "The research presented by our team reinforces our confidence that NC762, our third program, is a novel immunomedicine with unique anti-tumor properties. We believe it has the potential to provide benefit in multiple oncology indications, particularly in cancers where high B7-H4 expression has been observed, such as breast, ovarian and lung cancers," said Michael Richman, NextCure's president and chief executive officer. "We look forward to advancing NC762 into the clinic this quarter and continuing our efforts to broaden our pipeline of innovative immunomedicines for patients."

    Key highlights from the presentation include:

    • NC762 demonstrated specificity for human B7-H4, which is widely expressed in multiple cancers.
    • In a dose-dependent manner, NC762 inhibited tumor growth in a xenograft murine tumor model in the absence of peripheral blood mononuclear cells (PBMCs).
    • The inhibitory effect of NC762 on tumor growth was not dependent on T cells or NK cells; however, NK cells contributed to enhanced anti-tumor activity mediated by NC762.
    • Binding to Fc gamma receptors was not required for NC762 activity, suggesting a novel antibody-dependent cellular cytotoxicity (ADCC)-independent mechanism for tumor inhibition.
    • IND-enabling studies in non-human primates demonstrated a half-life of approximately 8-10 days and no safety concerns in toxicology studies or cytokine release assays were observed.

    Details of the poster presentation are as follows:

    Poster Title: Development and Functional Characterization of NC762, a Novel Therapeutic Antibody Targeting B7-H4, for the Treatment of Malignancies

    Session Title: Tumor-Immune System Interactions

    Abstract: 3193

    About NC762

    NC762 is a monoclonal antibody targeting B7-H4, a protein expressed on multiple tumor types. We believe NC762 acts by inhibiting tumor cell growth and killing tumor cells, including by enhancing immune response. In preclinical studies, NC762 inhibits the growth of human melanoma tumors in mice and inhibits tumor cell growth independently of immune cell infiltration in the tumor microenvironment. We believe that NC762 has the potential to treat multiple tumor 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-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
    
    
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    Emily Wong
    MacDougall
    (781) 235-3060
    

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  2. BELTSVILLE, Md., April 07, 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 present at the 20th Annual Needham Virtual Healthcare Conference on April 13th at 12:45 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…

    BELTSVILLE, Md., April 07, 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 present at the 20th Annual Needham Virtual Healthcare Conference on April 13th at 12:45 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
    

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  3. BELTSVILLE, Md., March 04, 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 fourth quarter and full year 2020 financial results and provided a business update.

    "Our team has worked diligently throughout 2020 to advance our programs despite the difficult environment created by the COVID-19 pandemic. We are thrilled that Dr. Han Myint has recently joined NextCure as our Chief Medical Officer and we are poised to harness his expertise in oncology product development to further advance our product pipeline. As we enter 2021, we are excited to announce the…

    BELTSVILLE, Md., March 04, 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 fourth quarter and full year 2020 financial results and provided a business update.

    "Our team has worked diligently throughout 2020 to advance our programs despite the difficult environment created by the COVID-19 pandemic. We are thrilled that Dr. Han Myint has recently joined NextCure as our Chief Medical Officer and we are poised to harness his expertise in oncology product development to further advance our product pipeline. As we enter 2021, we are excited to announce the expansion of our pipeline. We remain encouraged with the potential of NC318 given the evidence of clinical activity seen to date and are now reexploring the treatment of lung cancer through an investigator-initiated trial at Yale University," said Michael Richman, NextCure's president and chief executive officer. "In addition, the NC410 Phase 1 trial is advancing and we look forward to reporting initial data in the second half of the year and we are very excited to introduce NC762, a B7-H4 antibody expected to enter the clinic next quarter."

    Business Highlights

    • NC318
      • The two previously announced objective responder patients in the Phase 1 portion of the company's ongoing Phase 1/2 clinical trial are continuing to receive drug and remain on study at over 118 weeks and over 92 weeks.
      • The trial continues in head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer (TNBC) patients.
      • The previously announced confirmed partial response (PR) seen in the HNSCC cohort is off study after 40 weeks.
      • A confirmed PR has been observed in the TNBC cohort and the patient remains on study at over 21 weeks.
      • Given these responses in the HNSCC and TNBC cohorts, these cohorts met the criteria to advance into the stage 2 portion of the Simon 2-stage trial.
      • The NC318 Phase 2 monotherapy protocol will be revised to select S15+ patients for enrollment starting in the second quarter of this year.
      • Yale University plans to initiate in the second quarter of 2021, an investigator-initiated Phase 2 trial of NC318 as a monotherapy and in combination with pembrolizumab in patients with advanced non-small cell lung cancer.
    • NC410
      • Enrollment is on track and the company expects to announce initial clinical data from the Phase 1 portion of the trial in the second half of 2021.
    • NC762
      • An investigational new drug (IND) application has been filed with the U.S. Food and Drug Administration (FDA) for NC762, a humanized monoclonal antibody targeting B7-H4, which is upregulated in multiple solid tumor types, and which we believe is differentiated from other B7-H4-targeted antibodies.
    • Announced the appointment of Dr. Han Myint as Chief Medical Officer.

    Expected Upcoming Milestones

    • Initiate in the second quarter of 2021, the Yale University Phase 2 investigator-initiated trial of NC318 in NSCLC with anticipated initial data first half of 2022.
    • Report NC318 Phase 2 monotherapy data in the fourth quarter of 2021.
    • Initiate the NC762 Phase 1 trial in the second quarter of 2021 and report initial data in mid-2022.
    • Report NC410 initial Phase 1 data in the second half of 2021.

    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 Fourth Quarter and Full Year Ended December 31, 2020

    • Cash, cash equivalents, and marketable securities, excluding restricted cash as of December 31, 2020, were $283.4 million as compared with $334.6 million as of December 31, 2019. The decrease of $51.2 million as of December 31, 2020 as compared to December 31, 2019 primarily reflects cash used to fund operations of $44.9 million and cash used to purchase fixed assets of $7.2 million, offset by a reduction in restricted cash of $1.5 million.
    • Research and development expenses were $46.6 million and $12.1 million for the year and quarter ended December 31, 2020, respectively, as compared with $34.2 million and $11.4 million for the year and quarter ended December 31, 2019, respectively. The increase was primarily related to increase in headcount and clinical research costs related to advancing NC318 and NC410.
    • General and administrative expenses were $17.0 million and $4.1 million for the year and quarter ended December 31, 2020, respectively, as compared with $9.6 million and $2.6 million for the year and quarter ended December 31, 2019, respectively. The increase in general and administrative expenses for the year and quarter primarily related to increasing infrastructure costs and being a public company for a full year in 2020.
    • Revenue was $22.4 million for the year ended December 31, 2020. There was no revenue recognized in the quarter ended December 31, 2020, as compared with $6.3 million and $2.0 million for the year and quarter ended December 31, 2019, respectively. Revenue generated was from our former research and development agreement with Eli Lilly.
    • Net loss was $36.6 million and $15.5 million for the year and quarter ended December 31, 2020, respectively, as compared with $33.7 million and $10.9 million for the year and quarter ended December 31, 2019, respectively. The increases in net loss for the year and quarter were primarily due to increased research and development expenses and increased general and administrative expenses from an increase in headcount, offset by the recognition of the remaining deferred revenue under the former agreement with Lilly.

    Conference Call

    NextCure will host a virtual R&D update event today at 5 pm Eastern time. To participate via telephone, please dial (877) 665-6632 from the U.S. or (602) 563-8471 from outside the U.S., using the conference ID 6773907. To participate via live or replay webcast, a link is available through the Investors section of the company's website at www.nextcure.com.

    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. We believe NC762 acts by inhibiting tumor cell growth and killing tumor cells, including by enhancing immune response. We have observed in preclinical studies that NC762 inhibits the growth of human melanoma tumors in mice, and we believe that NC762 has the potential to treat multiple tumor types. Our 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

    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 progress and evaluation and expected timing of results of NextCure's ongoing clinical trial of NC318, expectations regarding the potential benefits, activity, effectiveness and safety of NC318, expectations regarding the investigator initiated trial to be launched by Yale, the expected timing of results of NextCure's ongoing clinical trial of NC410, the development plans for NC762, NextCure's financial guidance, expected upcoming milestones, 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.

    NEXTCURE, INC.

    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (in thousands, except share and per share amounts)

     

      Year Ended
      December 31, 
         2020     2019 
    Revenue:      
    Revenue from former research and development arrangement $22,378  $6,347 
           
    Operating expenses:      
    Research and development  46,554   34,216 
    General and administrative  17,049   9,613 
    Total operating expenses  63,603   43,829 
    Loss from operations  (41,225)  (37,482)
    Other income, net  4,622   3,745 
    Net loss $(36,603) $(33,737)
    Loss per share:      
    Net loss per common share—basic and diluted $(1.33) $(2.15)
    Weighted average number of common shares —basic and diluted  27,532,177   15,695,461 
    Comprehensive loss:      
    Net loss $(36,603) $(33,737)
    Unrealized gain (loss) on marketable securities  779   (38)
    Total comprehensive loss $(35,824) $(33,775)

     

     



    NEXTCURE, INC.

    BALANCE SHEETS

    (in thousands, except share and per share amounts)

     

           
      December 31, 
      2020  2019 
    Assets      
    Current assets:        
    Cash and cash equivalents $32,772  $34,091 
    Marketable securities  250,676   300,514 
    Restricted cash  1,706   1,706 
    Prepaid expenses and other current assets  2,824   3,684 
    Total current assets  287,978   339,995 
    Property and equipment, net  15,809   12,090 
    Other assets  2,857   4,083 
    Total assets $306,644  $356,168 
    Liabilities and Stockholders' Equity        
    Current liabilities:        
    Accounts payable $3,901  $1,861 
    Accrued liabilities  4,627   4,871 
    Deferred rent, current portion  130   215 
    Term loan, current portion  1,667   1,667 
    Deferred revenue, current portion     6,428 
    Total current liabilities  10,325   15,042 
    Deferred rent, net of current portion  792   359 
    Term loan, net of current portion  1,806   3,333 
    Deferred revenue, net of current portion     15,950 
    Total liabilities  12,923   34,684 
    Stockholders' equity:        
    Preferred stock, par value of $0.001 per share; 10,000,000 shares authorized at December 31, 2020 and 2019. No shares issued and outstanding at December 31, 2020 and 2019      
    Common stock, par value of $0.001 per share; 100,000,000 shares authorized at December 31, 2020 and 2019, respectively, 27,568,802 and 27,499,260 shares issued and outstanding at December 31, 2020 and 2019, respectively  28   27 
    Additional paid-in capital  410,551   402,529 
    Accumulated other comprehensive income (loss)  779   (38)
    Accumulated deficit  (117,637)  (81,034)
    Total stockholders' equity  293,721   321,484 
    Total liabilities and stockholders' equity $306,644  $356,168 


    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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  4. BELTSVILLE, Md., March 02, 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 host a Virtual R&D Update Event at 5:00 p.m. ET on Thursday, March 4.

    The event will be available via conference call and webcast. To listen to the call, please dial:

    US/CANADA Toll-Free Dial-In Number: (877) 665-6632
    International Dial-In Number: (602) 563-8471
    Conference ID: 6773907

    A live webcast of the event will be available through the Investors section of the company's website at www.nextcure.com. A replay of the webcast will be available approximately two…

    BELTSVILLE, Md., March 02, 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 host a Virtual R&D Update Event at 5:00 p.m. ET on Thursday, March 4.

    The event will be available via conference call and webcast. To listen to the call, please dial:

    US/CANADA Toll-Free Dial-In Number: (877) 665-6632

    International Dial-In Number: (602) 563-8471

    Conference ID: 6773907

    A live webcast of the event will be available through the Investors section of the company's website at www.nextcure.com. A replay of the webcast will be available approximately two hours 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. 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 progress and evaluation and expected timing of results of NextCure's 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 NextCure's ongoing clinical trial 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 NextCure's 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.



    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., Feb. 26, 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 host a Virtual R&D Update Event at 5:00 p.m. ET on Thursday, March 4.

    The event will be available via conference call and webcast. To listen to the call, please dial:

    US/CANADA Toll-Free Dial-In Number: (877) 665-6632
    International Dial-In Number: (602) 563-8471
    Conference ID: 6773907

    A live webcast of the event will be available through the Investors section of the company's website at www.nextcure.com. A replay of the webcast will be available approximately…

    BELTSVILLE, Md., Feb. 26, 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 host a Virtual R&D Update Event at 5:00 p.m. ET on Thursday, March 4.

    The event will be available via conference call and webcast. To listen to the call, please dial:

    US/CANADA Toll-Free Dial-In Number: (877) 665-6632

    International Dial-In Number: (602) 563-8471

    Conference ID: 6773907

    A live webcast of the event will be available through the Investors section of the company's website at www.nextcure.com. A replay of the webcast will be available approximately two hours 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. 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 progress and evaluation and expected timing of results of NextCure's 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 NextCure's ongoing clinical trial 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 NextCure's 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.



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  6. BELTSVILLE, Md., Jan. 14, 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 the appointment of Dr. Han Myint, MD, FACP as chief medical officer. Dr. Myint will oversee the clinical development of key products in NextCure's product pipeline, including NC318, a first-in-class immunomedicine, targeting Siglec-15 (S15), and NC410, recombinant LAIR-2 fusion protein designed to block immune suppression mediated by the immune modulator LAIR-1. Prior to joining NextCure, Dr. Myint held senior roles at both Celgene (a Bristol Myers Squibb Company) and NexImmune…

    BELTSVILLE, Md., Jan. 14, 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 the appointment of Dr. Han Myint, MD, FACP as chief medical officer. Dr. Myint will oversee the clinical development of key products in NextCure's product pipeline, including NC318, a first-in-class immunomedicine, targeting Siglec-15 (S15), and NC410, recombinant LAIR-2 fusion protein designed to block immune suppression mediated by the immune modulator LAIR-1. Prior to joining NextCure, Dr. Myint held senior roles at both Celgene (a Bristol Myers Squibb Company) and NexImmune Inc.

    "We are very excited that Han has joined the NextCure team. We believe the depth of his expertise in oncology product development will prove instrumental in the advancement of our product pipeline," said Michael Richman, NextCure's president and chief executive officer. "Han's strong industry track record is highlighted by his involvement in the development of multiple U.S. Food and Drug approved products."

    "I'm thrilled to join NextCure at this important time in the company's growth," said Dr. Myint. "I believe that the company, through its powerful discovery platform, has created a pipeline of novel immunomedicines, including NC318 and NC410, with the potential to have a significant impact in cancer treatment."

    Dr. Myint has over 20 years of experience in both academia and the biopharma industry. Before joining NextCure, he was chief medical officer at NexImmune, a clinical-stage biotechnology company developing unique approaches to T cell immunotherapies. Prior to NexImmune, he was Vice President of Global Medical Affairs and the Myeloid Diseases Lead at Celgene. His work in myeloid diseases at Celgene contributed to a number of FDA approvals, successful launches of those products and high-impact publications. Prior to joining the biopharma industry, Dr. Myint practiced medicine specializing in hematological oncology and conducted clinical and laboratory research at multiple prestigious academic institutions in the UK and USA including Rush University Medical Center in Chicago and University of Colorado, Denver. Dr. Myint, Professor of Medicine, built a FACT-accredited and Center of Excellence-Designated Stem Cell Transplant Program at the University of Colorado, Denver. He has in-depth scientific knowledge, a wealth of clinical experience and expertise in hematological malignancies and stem cell transplantation. Dr. Myint graduated from the Institute of Medicine in Yangon with a MBBS degree and subsequently emigrated to the UK to do his postgraduate training in Internal Medicine, followed by his training in Hematology. Accordingly, he was awarded as a fellow from the Royal Colleges of Physicians and Pathologists from the UK and also from the American College of Physicians.

    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 progress and evaluation and expected timing of results of NextCure's ongoing clinical trial of NC318, expectations regarding the potential benefits, activity, effectiveness and safety of NC318, the evaluation of biomarkers, future clinical trials of NC318, the hiring and onboarding of a new chief medical officer 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 or early-stage clinical trials may not be predictive of the results of later 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; 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 NextCure's 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.



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  7. BELTSVILLE, Md., Dec. 17, 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 provided an update on the clinical trial program for NC318, its first-in-class immunomedicine against Siglec15 (S15), a novel immunomodulatory target.

    "As we continue to review and analyze the available clinical and laboratory data on the NC318 program, including recently generated biomarker data, we are working to modify the clinical program to enable us to select S15-positive patients for enrollment in ongoing and future trials," said Michael Richman, NextCure's president and chief…

    BELTSVILLE, Md., Dec. 17, 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 provided an update on the clinical trial program for NC318, its first-in-class immunomedicine against Siglec15 (S15), a novel immunomodulatory target.

    "As we continue to review and analyze the available clinical and laboratory data on the NC318 program, including recently generated biomarker data, we are working to modify the clinical program to enable us to select S15-positive patients for enrollment in ongoing and future trials," said Michael Richman, NextCure's president and chief executive officer. "We remain encouraged regarding the potential of NC318 as a novel oncology treatment, given the evidence of clinical activity seen to date and recent biomarker data that continue to indicate NC318's ability to modulate immune activity. We anticipate providing additional detail in early 2021 on the next steps for the program after a new chief medical officer is on board and has had sufficient time to review the program."

    Key Updates to NC318 Clinical Program

    • The two objective responder patients in the Phase 1 portion of the company's ongoing Phase 1/2 clinical trial of NC318 are continuing to receive drug and remain on study at over 104 weeks and over 78 weeks.
    • The company is continuing to enroll head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer patients. As previously announced, a confirmed partial response (PR) has been observed in the HNSCC cohort, which supports advancing into the stage 2 portion of the Simon 2-stage trial. The patient remains on study at over 32 weeks.
    • NC318 continues to be well-tolerated, with treatment-related adverse events (TRAEs) primarily grades 1-2. The only observed grade 3-4 TRAE was an infusion reaction in one patient.
    • In the Phase 2 portion of the company's current trial, patients were selected based on tumors with a PD-L1 tumor proportion score (TPS) of less than 50%. S15 expression was analyzed retrospectively in all pretreatment biopsies successfully obtained from Phase 2 patients. Of the evaluable biopsies collected, 13% of the patients enrolled had S15-positive tumors under that criterion. Overall, the selection criterion did not result in enough S15-positive patients.
    • The ongoing Phase 2 trial is being modified for S15 selection and the company expects to begin pre-selecting patients for enrollment based on S15 expression in the first quarter of 2021 in order to assess response rates in patients selected for S15 positivity.
    • Biomarker analysis demonstrated an increase in peripheral immune modulation markers.
    • Scientific evidence supports a combination with anti-PD-1 therapy and the company is planning to study that combination in NSCLC patients. At this time, the company no longer plans to initiate a study of NC318 in combination with chemotherapy.

    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. For example, tumor types expressing S15 include non-small cell lung cancer and head and neck squamous cell carcinoma, where clinical investigators have reported responses, and ovarian and triple-negative breast 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 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 progress and evaluation and expected timing of results of NextCure's ongoing clinical trial of NC318, expectations regarding the potential benefits, activity, effectiveness and safety of NC318, the evaluation of biomarkers, future clinical trials of NC318, the hiring and onboarding of a new chief medical officer 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 or early-stage clinical trials may not be predictive of the results of later 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; 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 NextCure's 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.



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    NextCure, Inc.
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  8. BELTSVILLE, Md., Nov. 23, 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 announced that it will participate in a fireside chat at the Piper Sandler Virtual 32nd Annual Healthcare Conference on December 1st.

    An audio webcast of the pre-recorded fireside chat will be available through the Investors section of the company's website at www.nextcure.com 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…

    BELTSVILLE, Md., Nov. 23, 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 announced that it will participate in a fireside chat at the Piper Sandler Virtual 32nd Annual Healthcare Conference on December 1st.

    An audio webcast of the pre-recorded fireside chat will be available through the Investors section of the company's website at www.nextcure.com 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.



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    NextCure, Inc.
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  9. BELTSVILLE, Md., Nov. 05, 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 third quarter 2020 financial results and provided a business update.

    "We continue to enroll in our ongoing NC318 and NC410 clinical trials. In addition, we are making progress analyzing biomarker data, including Siglec-15 expression in biopsies from the NC318 Phase 2 trial," said Michael Richman, NextCure's president and chief executive officer. "We look forward to providing a clinical update and additional biomarker data on the NC318 monotherapy trial by the end of 2020 and…

    BELTSVILLE, Md., Nov. 05, 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 third quarter 2020 financial results and provided a business update.

    "We continue to enroll in our ongoing NC318 and NC410 clinical trials. In addition, we are making progress analyzing biomarker data, including Siglec-15 expression in biopsies from the NC318 Phase 2 trial," said Michael Richman, NextCure's president and chief executive officer. "We look forward to providing a clinical update and additional biomarker data on the NC318 monotherapy trial by the end of 2020 and remain committed to our goal of developing novel immunomedicines for patients who do not respond to standard treatments or existing immunotherapies."

    Business Highlights and upcoming milestones

    • Continue enrolling new patients in the head and neck squamous cell carcinoma and triple-negative breast cancer cohorts of the NC318 Phase 2 monotherapy trial.
    • Plan to report updated clinical and initial biomarker data from the Phase 1 and 2 portions of the NC318 Phase 1/2 monotherapy clinical trial by the end of 2020.
    • Continue enrolling patients in the Phase 1 portion of a Phase 1/2 clinical trial for NC410 and remain on track to report initial clinical data in the second half of 2021 as planned.
    • Two abstracts regarding pre-clinical research for the NC410 program accepted for poster presentation at the upcoming virtual 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in November.
    • Announced the appointment of John G. Houston, Ph.D., president and chief executive officer of clinical-stage biopharmaceutical company Arvinas, Inc., to NextCure's Board of Directors.

    Financial Results for Quarter Ended September 30, 2020

    • Cash, cash equivalents and marketable securities as of September 30, 2020 were $291.2 million, as compared to $334.6 million as of December 31, 2019. The decrease of $43.4 million as of September 30, 2020 as compared to as of December 31, 2019 primarily reflects cash used to fund operations of $38.6 million and cash used to purchase fixed assets of $6.2 million offset by a reduction in restricted cash of $1.1 million.
    • Research and development expenses were $12.7 million for the quarter ended September 30, 2020, as compared to $8.7 million for the quarter ended September 30, 2019. The increase was primarily related to an increase in headcount. Other significant components of the increase included clinical research costs related to advancing NC318 and NC410.
    • General and administrative expenses were $4.7 million for the quarter ended September 30, 2020, as compared to $2.6 million for the quarter ended September 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 operating as a publicly traded company.
    • There was no revenue recognized in the quarter ended September 30, 2020, as compared to $1.6 million for the quarter ended September 30, 2019. Revenue generated in the prior year quarter was from our former research and development agreement with Eli Lilly.
    • Net loss was $16.4 million for the quarter ended September 30, 2020, as compared to $8.4 million for the quarter ended September 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-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 progress and evaluation and expected timing of results of NextCure's 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 NextCure's ongoing clinical trial 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 NextCure's 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  Nine Months Ended  
      September 30,   September 30, 

     
         2020    2019    2020    2019 
    Revenue:             
    Revenue from research and development arrangement $ —  $ 1,583  $ 22,378  $ 4,342  
                  
    Operating expenses:             
    Research and development   12,740    8,663    34,448    22,819  
    General and administrative   4,659    2,622    12,918    6,995  
    Total operating expenses   17,399    11,285    47,366    29,814  
    Loss from operations   (17,399)   (9,702)   (24,988)   (25,472) 
    Other income, net   1,032    1,268    3,846    2,662  
    Net loss $ (16,367) $ (8,434) $ (21,142) $ (22,810) 
    Loss per share:             
    Net loss per common share—basic and diluted $ (0.59) $ (0.37) $ (0.77) $ (1.81) 
    Weighted average number of common shares —basic and diluted   27,547,737    22,715,567    27,524,350    12,609,219  
    Comprehensive loss:             
    Net loss $ (16,367) $ (8,434) $ (21,142) $ (22,810) 
    Unrealized gain (loss) on marketable securities   (637)   (58)   1,298    (58) 
    Total comprehensive loss $ (17,004) $ (8,492) $ (19,844) $ (22,868) 



    NEXTCURE, INC.

    CONDENSED BALANCE SHEETS

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

           
      September 30,  December 31, 
         2020    2019
    Assets      
    Current assets:        
    Cash and cash equivalents $ 22,534  $ 34,091 
    Marketable securities   268,672    300,514 
    Restricted cash   1,706    1,706 
    Prepaid expenses and other current assets   4,069    3,684 
    Total current assets   296,981    339,995 
    Property and equipment, net   15,819    12,090 
    Other assets   3,278    4,083 
    Total assets $ 316,078  $ 356,168 
    Liabilities, Preferred Stock and Stockholders' Equity        
    Current liabilities:        
    Accounts payable $ 186  $ 1,861 
    Accrued liabilities   3,754    4,871 
    Deferred rent, current portion   134    215 
    Term loan, current portion   1,667    1,667 
    Deferred revenue, current portion   —    6,428 
    Total current liabilities   5,741    15,042 
    Deferred rent, net of current portion   776    359 
    Term loan, net of current portion   2,222    3,333 
    Deferred revenue, net of current portion   —    15,950 
    Total liabilities   8,739    34,684 
    Stockholders' equity:        
    Preferred stock, par value of $0.001 per share; 10,000,000 shares authorized at September 30, 2020 and December 31, 2019. No shares issued and outstanding at September 30, 2020 and December 31, 2019   —    — 
    Common stock, par value of $0.001 per share; 100,000,000 shares authorized at September 30, 2020 and December 31, 2019, 27,553,089 and 27,499,260 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively   28    27 
    Additional paid-in capital   408,189    402,529 
    Accumulated other comprehensive income (loss)   1,298    (38)
    Accumulated deficit   (102,176)   (81,034)
    Total stockholders' equity   307,339    321,484 
    Total liabilities, preferred stock and stockholders' equity $ 316,078  $ 356,168 



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    NextCure, Inc.
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  10. BELTSVILLE, Md., Sept. 14, 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 announced the appointment of John G. Houston, Ph.D., to its board of directors as of September 10, 2020. Dr. Houston has more than 30 years of experience in the pharmaceutical and biotech industry and currently serves as president and chief executive officer of Arvinas, Inc. In addition, Judith Li has announced that she is stepping down from the company's board of directors.

    "John is an important addition to our Board of Directors. His deep expertise in discovery biology and product…

    BELTSVILLE, Md., Sept. 14, 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 announced the appointment of John G. Houston, Ph.D., to its board of directors as of September 10, 2020. Dr. Houston has more than 30 years of experience in the pharmaceutical and biotech industry and currently serves as president and chief executive officer of Arvinas, Inc. In addition, Judith Li has announced that she is stepping down from the company's board of directors.

    "John is an important addition to our Board of Directors. His deep expertise in discovery biology and product development will support NextCure as we work diligently to advance our ongoing NC318 and NC410 clinical trials, as well as our preclinical programs," said Michael Richman, NextCure's president and chief executive officer. "We are delighted to welcome him to NextCure and look forward to benefiting from his insights, which we believe will help us advance our goal of bringing novel immunomedicines to patients. We would like to thank Judith for her counsel and support since our inception," Mr. Richman added.

    In addition to his role as president and chief executive officer of Arvinas, Dr. Houston also currently serves on the boards of directors of Oerth Bio, Cybrexa Therapeutics and BioCT. Prior to Arvinas, he spent more than 18 years at Bristol Myers Squibb (BMS) in roles of increasing responsibility and had accountability for all Discovery Biology disease teams, as well as various Discovery technology departments. He was the senior vice president of Specialty Discovery and R&D Site Development at BMS and previously worked in various roles across BMS's Discovery Biology, Applied Biotechnology and Early Discovery Chemistry departments. Dr. Houston was a member of the BMS senior executive leadership team, which reviewed and approved over 200 pre-clinical candidates for progression into early development, several of which advanced into late stage clinical trials, and toward commercialization. He was also the principal architect and driver of the ‘Leveraging Technology' initiative at BMS, which led to an industry-leading integrated lead discovery and optimization process. Prior to joining BMS, he worked at Glaxo Welcome Research and Development in the UK, where he served as head of the Lead Discovery Unit.

    Dr. Houston obtained a B.Sc. in Medical Microbiology from Glasgow University and a Ph.D. in Microbial Biochemistry from Heriot-Watt University, Edinburgh.

    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 benefits of Dr. Houston as a member of NextCure's board of directors, progress 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, including NextCure's most recent Form 10-K and subsequent Forms 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.

    Investor Inquiries
    Timothy Mayer, Ph.D.
    NextCure, Inc.
    Chief Operating Officer
    (240) 762-6486
    
    
    Media Inquiries
    Shai Biran, Ph.D.
    MacDougall
    (781) 591-3481
    

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  11. BELTSVILLE, Md., Sept. 08, 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 announced that it will present at the Morgan Stanley Virtual 18th Annual Global Healthcare Conference on September 15th at 4:15 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 approximately two hours 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…

    BELTSVILLE, Md., Sept. 08, 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 announced that it will present at the Morgan Stanley Virtual 18th Annual Global Healthcare Conference on September 15th at 4:15 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 approximately two hours 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
    

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  12. 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…

    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, NextCure's president and chief executive officer. "We recently initiated the Phase 1 portion of a Phase 1/2 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 1/2 monotherapy clinical trial at the virtual American Society of Clinical Oncology Annual Meeting.
    • Initiated the Phase 1 portion of a Phase 1/2 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-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 progress and evaluation and expected timing of results of NextCure's 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 NextCure's ongoing clinical trial 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 NextCure's 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 share—basic and diluted $(0.53) $(0.61) $(0.17) $(1.92)
    Weighted average number of common shares—basic 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.

    CONDENSED BALANCE SHEETS

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

     

      June 30,  December 31, 
      2020 2019
    Assets     
    Current assets:      
    Cash and cash equivalents $25,050  $34,091 
    Marketable securities  284,285   300,514 
    Restricted cash  1,706   1,706 
    Prepaid expenses and other current assets  4,029   3,684 
    Total current assets  315,070   339,995 
    Property and equipment, net  14,831   12,090 
    Other assets  3,588   4,083 
    Total assets $333,489  $356,168 
    Liabilities, Preferred Stock and Stockholders' Equity      
    Current liabilities:      
    Accounts payable $2,435  $1,861 
    Accrued liabilities  4,118   4,871 
    Deferred rent, current portion  142   215 
    Term loan, current portion  1,667   1,667 
    Deferred revenue, current portion     6,428 
    Total current liabilities  8,362   15,042 
    Deferred rent, net of current portion  571   359 
    Term loan, net of current portion  2,639   3,333 
    Deferred revenue, net of current portion     15,950 
    Total liabilities  11,572   34,684 
    Stockholders' equity:      
    Preferred stock, par value of $0.001 per share; 10,000,000 shares authorized at June 30, 2020 and December 31, 2019. No shares issued and outstanding at June 30, 2020 and December 31, 2019      
    Common stock, par value of $0.001 per share; 100,000,000 shares authorized at June 30, 2020 and December 31, 2019, 27,520,650 and 27,499,260 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively  28   27 
    Additional paid-in capital  405,763   402,529 
    Accumulated other comprehensive income (loss)  1,935   (38)
    Accumulated deficit  (85,809)  (81,034)
    Total stockholders' equity  321,917   321,484 
    Total liabilities, preferred stock and stockholders' equity $333,489  $356,168 
             
    Investor Inquiries
    Timothy Mayer, Ph.D.
    NextCure, Inc.
    Chief Operating Officer
    (240) 762-6486
    
    
    Media Inquiries
    Shai Biran, Ph.D.
    MacDougall
    (781) 235-3060
    

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  13. BELTSVILLE, Md., Aug. 05, 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 announced that it will present at the BTIG Virtual Biotechnology Conference on August 11th at 9:30 am 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 approximately two hours 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., Aug. 05, 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 announced that it will present at the BTIG Virtual Biotechnology Conference on August 11th at 9:30 am 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 approximately two hours 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
    

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  14. BELTSVILLE, Md., July 13, 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 provided an interim update for the Phase 2 portion of its NC318 monotherapy phase 1/2 trial.

    Based on the current enrollment criteria and clinical response data, at this time the company does not plan to advance the non-small cell lung cancer (NSCLC) and ovarian cancer cohorts into the stage 2 portion of the Simon 2-stage trial. The analysis of biomarker data for these cohorts has been delayed and is not yet complete. The company will evaluate whether to pursue additional monotherapy…

    BELTSVILLE, Md., July 13, 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 provided an interim update for the Phase 2 portion of its NC318 monotherapy phase 1/2 trial.

    Based on the current enrollment criteria and clinical response data, at this time the company does not plan to advance the non-small cell lung cancer (NSCLC) and ovarian cancer cohorts into the stage 2 portion of the Simon 2-stage trial. The analysis of biomarker data for these cohorts has been delayed and is not yet complete. The company will evaluate whether to pursue additional monotherapy studies in NSCLC and ovarian cancer after a review of that information. The company continues to enroll in head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer cohorts. One confirmed partial response has been observed in HNSCC and this indication has been advanced to the stage 2 portion of the Simon 2-stage trial. The company is continuing to assess Siglec-15 (S15) biomarker data as a basis for patient selection.

    "While the monotherapy data in the NSCLC and ovarian cancer cohorts are disappointing, we continue to evaluate patient selection criteria for our ongoing NC318 clinical trials," said Michael Richman, NextCure's president and chief executive officer. "We expect to provide an NC318 clinical data update and additional biomarker data in the fourth quarter of 2020."

    NextCure also announced that Kevin N. Heller, M.D., the company's chief medical officer, has resigned, effective August 4, 2020 to pursue a new opportunity. Dr. Heller will serve as a consultant to the company. The company has initiated a search for a new chief medical officer.

    "We thank Kevin for all of his work on behalf of the company and look forward to his continued support as a clinical consultant," said Mr. Richman.

    About the Phase 2 Portion of the NC318 Phase 1/2 Clinical Trial

    The Phase 2 component of the Phase 1/2 clinical trial is designed as a single-arm trial to evaluate the efficacy of NC318 at a 400 mg dose administered every two weeks. NextCure expects to enroll up to 100 patients with NSCLC, ovarian cancer, head and neck cancer and triple-negative breast cancer. The primary endpoints are safety and tolerability, and secondary endpoints include response rate, progression-free survival, duration of response and overall survival.

    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 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 progress and evaluation and expected timing of results of NextCure's ongoing clinical trial of NC318, expectations regarding the planned combination trial of NC318, expectations regarding the potential benefits, activity, effectiveness and safety of NC318, the departure of Dr. Heller including his service as a consultant and the search for a new chief medical officer, 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 NextCure's 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.

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

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  15. BELTSVILLE, Md., July 07, 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 announced the initiation of a Phase 1/2 clinical trial for NC410, a novel immunomedicine developed to block immune suppression mediated by an immune modulator called LAIR-1.

    The Phase 1 dose-escalation portion of this open-label trial is designed to evaluate the safety and tolerability of NC410 in patients with advanced or metastatic solid tumors and determine its pharmacologically active and/or maximum tolerated dose. After a recommended dose for the Phase 2 portion of the trial is determined…

    BELTSVILLE, Md., July 07, 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 announced the initiation of a Phase 1/2 clinical trial for NC410, a novel immunomedicine developed to block immune suppression mediated by an immune modulator called LAIR-1.

    The Phase 1 dose-escalation portion of this open-label trial is designed to evaluate the safety and tolerability of NC410 in patients with advanced or metastatic solid tumors and determine its pharmacologically active and/or maximum tolerated dose. After a recommended dose for the Phase 2 portion of the trial is determined, the efficacy of NC410 will be evaluated in select tumor types.

    "We are pleased to initiate this first clinical trial of NC410, our second product candidate to reach the clinic, after a brief delay announced in April as a result of the COVID-19 pandemic. This is a significant step in building our pipeline of next-generation immunomedicines to treat cancer," said Michael Richman, NextCure's president and chief executive officer. "We are the first company to target the LAIR protein family in the clinic. NC410 is a biomimic of LAIR-2, a naturally occurring immune regulatory protein. We look forward to continuing development of both NC318 and NC410, as well as advancing our preclinical pipeline."

    Leukocyte-Associated Immunoglobulin-like Receptor 1, or LAIR-1, is a co-inhibitory receptor expressed on T cells, monocytes, macrophages and dendritic cells. LAIR-2 is a naturally occurring soluble version of LAIR-1, which binds to and blocks the inhibitory activity of LAIR-1 and thus acts as a decoy protein. NC410 is a recombinant LAIR-2 fusion protein designed to mimic the natural decoy effects of LAIR-2. Preclinical research showed that LAIR-1 inhibits T cell function and dendritic cell activity, allowing tumor cells to grow. In preclinical studies, NC410 blocked LAIR-1 mediated inhibition of T cells and dendritic cells, thus promoting their activity.

    The company anticipates initial data from the Phase 1 portion of the trial by the second half of 2021.

    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 NextCure's ongoing clinical study of NC410, NextCure's expectations regarding the potential benefits, activity, effectiveness and safety 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; and the unproven approach to the discovery and development of product candidates based on NextCure's 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. 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
    Shai Biran, Ph.D.
    MacDougall
    (781) 235-3060
    

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  16. BELTSVILLE, Md., May 29, 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 announced the presentation of biomarker data and updated clinical results from the Phase 1 portion of its ongoing Phase 1/2 monotherapy trial with NC318 at the 2020 Virtual American Society of Clinical Oncology (ASCO20) Annual Meeting. NC318 is a monoclonal antibody targeting Siglec-15 (S15), a novel immunomodulatory protein that is expressed on highly immunosuppressive cells called M2 macrophages and on tumor cells.

    "Because this is a trial in progress with limited samples, we cannot draw…

    BELTSVILLE, Md., May 29, 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 announced the presentation of biomarker data and updated clinical results from the Phase 1 portion of its ongoing Phase 1/2 monotherapy trial with NC318 at the 2020 Virtual American Society of Clinical Oncology (ASCO20) Annual Meeting. NC318 is a monoclonal antibody targeting Siglec-15 (S15), a novel immunomodulatory protein that is expressed on highly immunosuppressive cells called M2 macrophages and on tumor cells.

    "Because this is a trial in progress with limited samples, we cannot draw definitive conclusions, but we believe these early biomarker data provide additional evidence of NC318 activity," said Kevin N. Heller, M.D., NextCure's chief medical officer. "We expect to receive additional insight from the Phase 2 portion of our ongoing trial, which will include additional biomarker analyses."

    Biomarker Data and Updated Clinical Results from the Phase 1 Portion of the NC318 Clinical Trial
    As of May 11, 2020, 49 patients had been dosed across seven dose cohorts between 8 mg and 1,600 mg, administered every two weeks:

    • The early biomarker data suggest collectively the potential of NC318 to block S15-mediated immune suppression, as indicated by:
      • Increase of regulatory T cells in peripheral blood in the highest dose cohorts;
      • Increase of PD-1 expression on circulating CD4+ T cells while on treatment;
      • Expansion of peripheral T cell receptor clones while on treatment; and
      • Presence of proliferating CD8 T cells systemically and increase of proliferating lymphocytes within the tumor microenvironment while on treatment.
    • S15 and PD-L1 expression from tumor biopsies were assessed at baseline for 15 subjects. On treatment biopsies were obtained for 9 of the 15 subjects, and relative to baseline assessments, changes in S15 or PD-L1 expression were observed while on treatment with NC318 in 7 of the 9 paired biopsies.
    • As previously reported at the Society for Immunotherapy of Cancer (SITC) annual meeting in November 2019:
      • The most common tumor types enrolled included: non-small cell lung cancer (NSCLC) (13 patients), ovarian cancer (7 patients), melanoma (7 patients), breast cancer (4 patients) and colorectal cancer (3 patients).
      • All of the patients enrolled were heavily pre-treated with a median of three prior therapies.
      • All 13 NSCLC patients were PD-1 refractory, with a median of four prior therapies.
    • As of May 11, 2020, two NSCLC subjects from the Phase 1 portion of the clinical trial remain on study: a complete response and a partial response for 82 and 54 weeks, respectively. In addition, 10 subjects, including 3 NSCLC, had durable stable disease for at least 24 weeks, and progressed subsequently. All responses were based on investigator tumor assessments per RECIST v1.1.
    • Immune-related adverse events and treatment-related adverse events continued to be observed at a frequency consistent with what has been previously reported (e.g., treatment-related adverse events occurring in more than 5% of subjects were diarrhea, infusion reactions, fatigue, headaches, pruritis, and elevations in lipase and amylase). There were no new safety signals.

    The poster presented at ASCO20 further detailing these data is available on NextCure's website within the "Events and Presentations" section at http://ir.nextcure.com/events-and-presentations.

    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 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 results of NextCure's ongoing clinical study of NC318, NextCure's expectations regarding the potential benefits, activity, effectiveness and safety of NC318, 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; 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; and the unproven approach to the discovery and development of product candidates based on NextCure's 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. 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
    Shai Biran, Ph.D.
    MacDougall
    (781) 235-3060
    

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  17. BELTSVILLE, Md., May 07, 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 first quarter 2020 financial results and provided a business update.

    "Throughout the first quarter, NextCure continued to make progress on its pipeline of novel immunomedicines, and we plan to present the initial biomarker data from our Phase 1 portion of the NC318 Phase 1/2 monotherapy clinical trial at the American Society of Clinical Oncology (ASCO) Annual Meeting this month," said Michael Richman, NextCure's president and chief executive officer. "We filed an IND for our second…

    BELTSVILLE, Md., May 07, 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 first quarter 2020 financial results and provided a business update.

    "Throughout the first quarter, NextCure continued to make progress on its pipeline of novel immunomedicines, and we plan to present the initial biomarker data from our Phase 1 portion of the NC318 Phase 1/2 monotherapy clinical trial at the American Society of Clinical Oncology (ASCO) Annual Meeting this month," said Michael Richman, NextCure's president and chief executive officer. "We filed an IND for our second product candidate and received FDA clearance for clinical studies in the first quarter. In addition, we were prepared to initiate the Phase 1 portion of a Phase 1/2 clinical trial in March; however, the COVID-19 pandemic required us to temporarily delay initiating that trial and adjust some other timelines. We look forward to starting the NC410 trial when matters improve." 

    "We remain highly committed to our goal of bringing novel immunomedicines to patients by advancing our clinical and preclinical programs while leveraging our innovative FIND-IO platform," added Mr. Richman.

    Business Highlights and Upcoming Milestones

    • Filed an Investigational New Drug (IND) application for the NC410 program and received FDA clearance for clinical studies.
    • Appointed veteran oncology executive Garry Nicholson to NextCure's Board of Directors.
    • Will report initial biomarker data from the Phase 1 portion of the NC318 Phase 1/2 monotherapy clinical trial at the virtual ASCO Annual Meeting in late May 2020.
    • The following milestones were temporarily delayed by the COVID-19 pandemic and will be updated subject to further developments:
      • Initiate enrollment in the phase 1 portion of our phase 1/2 clinical trial for our second product candidate, NC410. 
      • Initiate an NC318 combination clinical trial in NSCLC with standard-of-care chemotherapies.
    • Given enrollment slowdown due to the COVID-19 pandemic, initial data reporting from the Phase 2 portion of the Phase 1/2 NC318 monotherapy clinical trial is expected to be delayed.

    Financial Results for Quarter Ended March 31, 2020

    • Cash, cash equivalents, and marketable securities, excluding restricted cash, as of March 31, 2020 were $322.1 million, as compared to $334.6 million as of December 31, 2019. The decrease of $12.5 million primarily reflects cash used to fund operations of $10.6 million and cash used to purchase fixed assets of $1.5 million.
    • Revenue was $22.4 million for the quarter ended March 31, 2020, as compared to $1.4 million for the quarter ended March 31, 2019. Revenue was generated from our former research and development agreement with Eli Lilly (Lilly), which was terminated by Lilly effective March 3, 2020, resulting in the recognition of all remaining deferred revenue related to the agreement in the first quarter of 2020.
    • Research and development expenses were $10.6 million for the quarter ended March 31, 2020 as compared to $6.5 million for the quarter ended March 31, 2019. The increases primarily reflect an increase in headcount, clinical research costs for NC318 and NC410, lab supplies and services for NC318, NC410 and our other early stage programs, and discovery activities.
    • General and administrative expenses were $3.6 million for the quarter ended March 31, 2020, as compared to $1.7 million for the quarter ended March 31, 2019. The increase was primarily related to increases in professional fees and insurance costs in connection with becoming a publicly traded company, as well as increases in personnel-related costs.
    • Net income was $9.7 million for the quarter ended March 31, 2020, resulting from the recognition of the remaining deferred revenue under the former agreement with Lilly, as compared to a net loss of $6.2 million for the quarter ended March 31, 2019.

    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-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," "forward," "progress," "continue," "momentum," "well-positioned," "upcoming" and similar expressions. Examples of forward-looking statements in this press release include, among others, statements about the progress and expected timing of NextCure's ongoing clinical trial of NC318 and planned clinical trials of NC318 and NC410, the impact of the COVID-19 pandemic on the initiation, progress or expected timing of those trials and the timing of related data, NextCure's efforts to adjust trial-related activities to address the impact of the COVID-19 pandemic, NextCure's plans for further updates related to the impact of the COVID-19 pandemic, 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 ongoing COVID-19 pandemic on NextCure's business, including NextCure's clinical trials, third parties on which NextCure relies and NextCure's operations; NextCure's limited operating history and no products approved for commercial sale; NextCure's 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 NextCure's 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 Form 10-K filed with the SEC on March 12, 2020. 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 INCOME (LOSS)
    (unaudited, in thousands, except share and per share amounts)

        Three Months Ended
      March 31,
        2020   2019
    Revenue:            
    Revenue from research and development arrangement   $  22,378   $  1,357
                 
    Operating expenses:            
    Research and development      10,578      6,513
    General and administrative      3,588      1,659
    Total operating expenses      14,166      8,172
    Income (loss) from operations      8,212      (6,815)
    Other income, net      1,521      660
    Net income (loss)   $  9,733   $  (6,155)
    Earnings (loss) per share            
    Basic   $  0.35   $  (4.46)
    Diluted   $  0.33   $  (4.46)
    Shares used in the calculation of earnings (loss) per share            
    Basic      27,506,927      1,379,444
    Diluted      29,348,615      1,379,444
    Comprehensive income (loss):            
    Net income (loss)   $  9,733   $  (6,155)
    Unrealized loss on marketable securities      (543)      —
    Comprehensive income (loss)   $  9,190   $  (6,155)



    NEXTCURE, INC.

    CONDENSED BALANCE SHEETS
    (unaudited, in thousands, except share and per share amounts)


        March 31,    December 31, 
        2020   2019
    Assets          
    Current assets:            
    Cash and cash equivalents   $  28,907   $  34,091
    Marketable securities      293,191      300,514
    Restricted cash      1,706      1,706
    Prepaid expenses and other current assets      2,860      3,684
    Total current assets      326,664      339,995
    Property and equipment, net      12,784      12,090
    Other assets      4,024      4,083
    Total assets   $  343,472   $  356,168
    Liabilities, Preferred Stock and Stockholders' Equity            
    Current liabilities:            
    Accounts payable   $  2,263   $  1,861
    Accrued liabilities      4,059      4,871
    Deferred rent, current portion      163      215
    Term loan, current portion      1,667      1,667
    Deferred revenue, current portion      —      6,428
    Total current liabilities      8,152      15,042
    Deferred rent, net of current portion      507      359
    Term loan, net of current portion      3,056      3,333
    Deferred revenue, net of current portion      —      15,950
    Total liabilities      11,715      34,684
    Stockholders' equity:            
    Preferred stock, par value of $0.001 per share; 10,000,000 shares authorized at March 31, 2020 and December 31, 2019, respectively. No shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively      —      —
    Common stock, par value of $0.001 per share; 100,000,000 shares authorized at March 31, 2020 and December 31, 2019, respectively, 27,516,402 and 27,499,260 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively      28      27
    Additional paid-in capital      403,573      402,529
    Accumulated other comprehensive loss      (543)      (38)
    Accumulated deficit      (71,301)      (81,034)
    Total stockholders' equity      331,757      321,484
    Total liabilities, preferred stock and stockholders' equity   $  343,472   $  356,168


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

    Media Inquiries
    Shai Biran, Ph.D.
    MacDougall
    (781) 235-3060

     

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  18. BELTSVILLE, Md., May 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 announced that it will present at the BofA Securities Virtual Health Care Conference on May 13th at 9:00 am 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 approximately two hours 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., May 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 announced that it will present at the BofA Securities Virtual Health Care Conference on May 13th at 9:00 am 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 approximately two hours 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 in the Risk Factors section and throughout NextCure's Form 10-K filed with the SEC on March 12, 2020. 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

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  19. BELTSVILLE, Md., April 08, 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 announced that it will present at the 19th Annual Needham Virtual Healthcare Conference on April 15th at 2:10 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 approximately two hours 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…

    BELTSVILLE, Md., April 08, 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 announced that it will present at the 19th Annual Needham Virtual Healthcare Conference on April 15th at 2:10 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 approximately two hours 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

    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," "forward," "progress," "continue," "momentum," "well-positioned," "upcoming" and similar expressions. Examples of forward-looking statements in this press release include, among others, statements about the strength of NextCure's financial position to continue advancing its product candidates, the progress and expected timing of NextCure's ongoing clinical trial of NC318, planned clinical trials of NC318 and NC410 and other research and development programs, 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: 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; and the unproven approach to the discovery and development of product candidates based on NextCure's 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 Form 10-K filed with the SEC on March 12, 2020. 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
    

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  20. BELTSVILLE, Md., March 30, 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 announced the appointment of Garry Nicholson to its board of directors. Mr. Nicholson has more than 30 years of product development and commercialization experience and previously held leadership positions at Pfizer Oncology and Eli Lilly and Company. In addition, Timothy M. Shannon, M.D. notified NextCure that he is stepping down from the company's board of directors.

    "Garry is a highly-regarded industry leader and brings deep expertise in developing and commercializing oncology products…

    BELTSVILLE, Md., March 30, 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 announced the appointment of Garry Nicholson to its board of directors. Mr. Nicholson has more than 30 years of product development and commercialization experience and previously held leadership positions at Pfizer Oncology and Eli Lilly and Company. In addition, Timothy M. Shannon, M.D. notified NextCure that he is stepping down from the company's board of directors.

    "Garry is a highly-regarded industry leader and brings deep expertise in developing and commercializing oncology products. We expect that his guidance and advice will greatly support NextCure as we continue to grow our company and advance our clinical programs," said Michael Richman, president and chief executive officer. "His deep knowledge and expertise in drug development, business development, corporate strategy and marketing will enhance our capabilities in developing and commercializing novel immunomedicines for cancer patients. We would like to thank Tim Shannon for his commitment and support as a founding Director in building NextCure from its inception," Mr. Richman added.

    Mr. Nicholson currently serves as chairman of the board for G1 Therapeutics and as a board member for Turning Point Therapeutics, Five Prime Therapeutics, Personal Genome Diagnostics and Tmunity Therapeutics. He previously served on the TESARO board prior to its acquisition by GlaxoSmithKline and as president and CEO of XTuit Pharmaceuticals. Prior to that, he was President of Pfizer Oncology, where he oversaw global commercialization and sales, clinical development, regulatory and business strategies. He has also held various leadership positions in the oncology division of Eli Lilly and Company. Mr. Nicholson holds an M.B.A. from the University of South Carolina and a B.S. in Pharmacy from the University of North Carolina at Chapel Hill.

    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
    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 in the Risk Factors section and throughout NextCure's Form 10-K filed with the SEC on March 12, 2020. 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
    
    
    Media Inquiries
    Shai Biran, Ph.D.
    MacDougall
    (781) 591-3481
    

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  21. BELTSVILLE, Md., March 12, 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 fourth quarter and full year 2019 financial results and provided a business update.

    "2019 was a momentous year for NextCure, highlighted by completing enrollment and reporting initial clinical data of the phase 1 portion of the NC318 phase 1/2 clinical trial, initiation of the phase 2 portion of the NC318 trial and two public financings," said Michael Richman, NextCure's president and chief executive officer. "Following the recent acceptance of our IND by the U.S. Food and Drug…

    BELTSVILLE, Md., March 12, 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 fourth quarter and full year 2019 financial results and provided a business update.

    "2019 was a momentous year for NextCure, highlighted by completing enrollment and reporting initial clinical data of the phase 1 portion of the NC318 phase 1/2 clinical trial, initiation of the phase 2 portion of the NC318 trial and two public financings," said Michael Richman, NextCure's president and chief executive officer. "Following the recent acceptance of our IND by the U.S. Food and Drug Administration for our second product candidate, NC410, we plan to initiate phase 1 clinical development in the second quarter of 2020. We believe we are well-positioned to continue accelerating our clinical development, advancing our preclinical programs, and growing our manufacturing capabilities as we pursue our goal of bringing novel immunomedicines to patients."

    2019 Business Highlights

    • Published a Nature Medicine paper with Yale University describing Siglec-15 (S15) as a new target for immunotherapy in March.
    • Closed initial public offering (IPO) in May, raising $86.3 million in gross proceeds.
    • Promoted Timothy Mayer, Ph.D., to Chief Operating Officer in October.
    • Initiated the phase 2 portion of the ongoing NC318 phase 1/2 monotherapy clinical trial in October.
    • Presented positive clinical data from the phase 1 portion of the NC318 phase 1/2 monotherapy clinical trial at the 34th Annual Meeting of SITC in November.
    • Closed follow-on offering in November, raising $172.2 million in gross proceeds.

    Upcoming Milestones

    • Initiate enrollment in the phase 1 portion of our phase 1/2 clinical trial for our second product candidate, NC410, in the second quarter of 2020. 
    • Initiate an NC318 combination clinical trial in NSCLC with standard-of-care chemotherapies in mid-2020.
    • Report initial data from the NC318 phase 2 monotherapy clinical trial by the end of 2020.

    Financial Results for Fourth Quarter and Full Year Ended December 31, 2019

    • Cash, cash equivalents, and marketable securities, excluding restricted cash, as of December 31, 2019 were $334.6 million, compared to $135.2 million as of December 31, 2018. This increase was primarily due to $238.4 million net proceeds from public offerings partially offset by cash used to fund operations of $35.6 million.
    • Revenue from research and development arrangement was $2.0 million and $6.3 million for the three months and the full year ended December 31, 2019, respectively. We had no revenue in 2018. All revenue was generated from our agreement with Eli Lilly (Lilly), which was terminated by Lilly effective March 3, 2020.
    • Research and development expenses were $11.4 million and $34.2 million for the fourth quarter and full year ended December 31, 2019, respectively, as compared to $6.3 million and $19.8 million for the comparable periods in 2018, respectively. The increases primarily reflect a growth in headcount, NC318 clinical research costs, lab supplies and services for NC318 and our other early stage programs and discovery activities, as well as, in the case of the increase for the full year ended December 31, 2019, a one-time license payment in connection with our IPO in the quarter ended June 30, 2019.
    • General and administrative expenses were $2.6 million and $9.6 million for the fourth quarter and full year ended December 31, 2019, respectively, as compared to $0.8 million and $3.4 million, respectively, for the comparable periods in 2018. The increases were primarily related to increases in professional fees and insurance costs in connection with becoming a publicly traded company, as well as growth in headcount and, in the case of the increase for the full year ended December 31, 2019, an unrestricted gift to an academic lab in the quarter ended June 30, 2019.
    • Net loss was $10.9 million for the fourth quarter of 2019 and $33.7 million for the year ended December 31, 2019, as compared to $6.9 million and $22.8 million, respectively, for the comparable periods in 2018.

    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 novel immunomedicine that was developed to block LAIR-1-mediated immune suppression by mimicking the natural decoy effects of LAIR-2. LAIR-1 is a co-inhibitory receptor expressed on T cells and dendritic cells. LAIR-2 is a naturally occurring soluble decoy protein for LAIR-1. 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 to promote 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-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," "forward," "progress," "continue," "momentum," "well-positioned," "upcoming" and similar expressions. Examples of forward-looking statements in this press release include, among others, statements about the strength of NextCure's financial position to continue advancing its product candidates, the progress and expected timing of NextCure's ongoing clinical trial of NC318, planned clinical trials of NC318 and NC410 and other research and development programs, 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: 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; and the unproven approach to the discovery and development of product candidates based on NextCure's 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 Form 10-K filed with the SEC on March 12, 2020. 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)

                 
        Year Ended
        December 31, 
        2019
      2018
    Revenue:            
    Revenue from research and development arrangement   $ 6,347     $  —  
                 
    Operating expenses:            
    Research and development     34,216       19,787  
    General and administrative     9,613       3,409  
    Total operating expenses     43,829       23,196  
    Loss from operations     (37,482 )     (23,196 )
    Other income, net     3,745       397  
    Net loss     (33,737 )     (22,799 )
    Net loss per common share — basic and diluted   $ (2.15 )   $ (16.64 )
    Weighted average number of common shares — basic and diluted     15,695,461       1,369,846  
    Comprehensive loss:            
    Net loss     (33,737 )     (22,799 )
    Unrealized loss on marketable securities     (38 )      
    Total comprehensive loss   $ (33,775 )   $ (22,799 )
                     



    NEXTCURE, INC.
    CONDENSED BALANCE SHEETS
    (unaudited, in thousands, except share and per share amounts)

                 
        December 31, 
        2019   2018
    Assets          
    Current assets:            
    Cash and cash equivalents   $  34,091     $  135,173  
    Marketable securities      300,514        —  
    Restricted cash      1,706        460  
    Prepaid expenses and other current assets      3,684        152  
    Total current assets      339,995        135,785  
    Property and equipment, net      12,090        11,407  
    Other assets      4,083        436  
    Total assets   $  356,168     $  147,628  
    Liabilities, Preferred Stock and Stockholders' Equity (Deficit)            
    Current liabilities:            
    Accounts payable   $  1,861     $  2,483  
    Accrued liabilities      4,871        2,411  
    Deferred rent, current portion      215        28  
    Term loan, current portion      1,667        387  
    Deferred revenue, current portion      6,428        4,989  
    Total current liabilities      15,042        10,298  
    Deferred rent, net of current portion      359        242  
    Term loan, net of current portion      3,333        73  
    Deferred revenue, net of current portion      15,950        21,736  
    Total liabilities      34,684        32,349  
    Redeemable preferred stock:            
    Series A Preferred Stock, par value of $0.001 per share; 0 and 68,181,819 shares authorized, issued and outstanding at December 31, 2019 and 2018, respectively      —        71,000  
    Series B Preferred Stock, par value $0.001 per share; 0 and 56,828,852 shares authorized at December 31, 2019 and 2018, respectively, 0 and 56,828,851 shares issued and outstanding at December 31, 2019 and 2018, respectively      —        91,223  
    Total redeemable preferred stock      —        162,223  
    Stockholders' equity (deficit):            
    Preferred stock, par value of $0.001 per share; 10,000,000 and 0 shares authorized at December 31, 2019 and 2018. No shares issued and outstanding at December 31, 2019 and 2018, respectively      —        —  
    Common stock, par value of $0.001 per share; 100,000,000 and 158,745,671 shares authorized at December 31, 2019 and 2018, respectively, 27,499,260 and 1,374,812 shares issued and outstanding at December 31, 2019 and 2018, respectively      27        1  
    Additional paid-in capital      402,529        352  
    Accumulated other comprehensive loss      (38 )      —  
    Accumulated deficit      (81,034 )      (47,297 )
    Total stockholders' equity (deficit)      321,484        (46,944 )
    Total liabilities, preferred stock and stockholders' equity (deficit)   $  356,168     $  147,628  
                     

     

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

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  22. BELTSVILLE, Md., Feb. 25, 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 announced that it will present at the 40th Annual Cowen Health Care Conference in Boston on March 4 at 8:00 am.

    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 approximately two hours 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…

    BELTSVILLE, Md., Feb. 25, 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 announced that it will present at the 40th Annual Cowen Health Care Conference in Boston on March 4 at 8:00 am.

    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 approximately two hours 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 in the Risk Factors section and throughout NextCure's Form 10-Q filed with the SEC on November 12, 2019. 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
    

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  23. BELTSVILLE, Md., Feb. 18, 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 announced that it will present at the 9th Annual SVB Leerink Global Healthcare Conference in New York on February 25 at 9:00 am.

    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 approximately two hours 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., Feb. 18, 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 announced that it will present at the 9th Annual SVB Leerink Global Healthcare Conference in New York on February 25 at 9:00 am.

    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 approximately two hours 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 in the Risk Factors section and throughout NextCure's Form 10-Q filed with the SEC on November 12, 2019. 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
    

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  24. BELTSVILLE, Md., Jan. 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 announced that the company will present at the 38th Annual J.P. Morgan Healthcare Conference being held January 13-16, 2020, in San Francisco, California.

    NextCure's President and Chief Executive Officer, Michael Richman, will present at 10:00 am (PST) on January 16, 2020. 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 approximately two hours after the event and archived on the…

    BELTSVILLE, Md., Jan. 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 announced that the company will present at the 38th Annual J.P. Morgan Healthcare Conference being held January 13-16, 2020, in San Francisco, California.

    NextCure's President and Chief Executive Officer, Michael Richman, will present at 10:00 am (PST) on January 16, 2020. 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 approximately two hours 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 "will," "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 in the Risk Factors section and throughout NextCure's Form 10-Q filed with the SEC on November 12, 2019. 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
    

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  25. BELTSVILLE, Md., Nov. 26, 2019 (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 the company will present at the Piper Jaffray 31st Annual Healthcare Conference in New York on December 3, 2019 at 2:00 pm ET.

    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 approximately two hours after the event and archived on the website for 90 days.

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

    BELTSVILLE, Md., Nov. 26, 2019 (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 the company will present at the Piper Jaffray 31st Annual Healthcare Conference in New York on December 3, 2019 at 2:00 pm ET.

    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 approximately two hours after the event and archived on the website for 90 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 "will," "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 in the Risk Factors section and throughout NextCure's Form 10-Q filed with the SEC on November 12, 2019. 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
    

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  26. BELTSVILLE, Md., Nov. 19, 2019 (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 the closing of its public offering of 4,077,192 shares of its common stock at a public offering price of $36.75 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $150 million. NextCure's common stock is listed on The Nasdaq Global Select Market under the ticker symbol "NXTC."

    Morgan Stanley, BofA Securities and Piper Jaffray & Co. acted as joint book-running managers for…

    BELTSVILLE, Md., Nov. 19, 2019 (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 the closing of its public offering of 4,077,192 shares of its common stock at a public offering price of $36.75 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $150 million. NextCure's common stock is listed on The Nasdaq Global Select Market under the ticker symbol "NXTC."

    Morgan Stanley, BofA Securities and Piper Jaffray & Co. acted as joint book-running managers for the offering. Needham & Company and BTIG acted as co-managers for the offering.

    A registration statement relating to the shares sold in the offering was declared effective by the Securities and Exchange Commission (SEC) on November 14, 2019. This offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained by visiting EDGAR on the SEC's website at www.sec.gov or from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at ; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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.

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

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  27. BELTSVILLE, Md., Nov. 14, 2019 (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 the pricing of its public offering of 4,077,192 shares of its common stock at a public offering price of $36.75 per share. NextCure also granted the underwriters a 30-day option to purchase up to an additional 611,578 shares of its common stock at the public offering price less the underwriting discounts and commissions. All of the common stock to be sold in the offering are being offered by NextCure. Gross proceeds from the offering, before deducting underwriting discounts and…

    BELTSVILLE, Md., Nov. 14, 2019 (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 the pricing of its public offering of 4,077,192 shares of its common stock at a public offering price of $36.75 per share. NextCure also granted the underwriters a 30-day option to purchase up to an additional 611,578 shares of its common stock at the public offering price less the underwriting discounts and commissions. All of the common stock to be sold in the offering are being offered by NextCure. Gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, will be approximately $150 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on or about November 19, 2019, subject to the satisfaction of customary closing conditions.

    Morgan Stanley, BofA Securities and Piper Jaffray & Co. are acting as joint book-running managers for the offering. Needham & Company and BTIG are acting as co-managers for the offering.

    A registration statement relating to the shares being sold in the offering was declared effective by the Securities and Exchange Commission (SEC) on November 14, 2019. The offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained by visiting EDGAR on the SEC's website at www.sec.gov or from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at ; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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.

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

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  28. BELTSVILLE, Md., Nov. 12, 2019 (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 a proposed public offering of 3,200,000 shares of its common stock. In addition, NextCure intends to grant the underwriters a 30-day option to purchase up to an additional 480,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the common stock to be sold in the offering will be offered by NextCure. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering…

    BELTSVILLE, Md., Nov. 12, 2019 (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 a proposed public offering of 3,200,000 shares of its common stock. In addition, NextCure intends to grant the underwriters a 30-day option to purchase up to an additional 480,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the common stock to be sold in the offering will be offered by NextCure. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

    Morgan Stanley, BofA Securities and Piper Jaffray & Co. are acting as joint book-running managers for the offering. Needham & Company and BTIG are acting as co-managers for the offering.

    A registration statement relating to the shares being sold in the offering has been filed with the Securities and Exchange Commission but has not yet become effective. The offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the offering may be obtained by visiting EDGAR on the SEC's website at www.sec.gov or from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at ; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at .

    These securities may not be sold nor may offers to buy these securities be accepted prior to the time that the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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. 

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

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  29. BELTSVILLE, Md., Nov. 12, 2019 (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 third quarter 2019 financial results and provided a business update.

    "NextCure has made important clinical and operational progress toward realizing our long-term vision of developing novel immunomedicines for patients who do not respond to standard treatments or existing immunotherapies," said Michael Richman, president and chief executive officer. "Completion of enrollment and announcement of preliminary data in the Phase 1 portion of the clinical trial with our lead program…

    BELTSVILLE, Md., Nov. 12, 2019 (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 third quarter 2019 financial results and provided a business update.

    "NextCure has made important clinical and operational progress toward realizing our long-term vision of developing novel immunomedicines for patients who do not respond to standard treatments or existing immunotherapies," said Michael Richman, president and chief executive officer. "Completion of enrollment and announcement of preliminary data in the Phase 1 portion of the clinical trial with our lead program NC318 are major milestones for NextCure. We believe that NC318 is in position to achieve further meaningful clinical endpoints as we progress into the Phase 2 portion of the trial. We remain confident in NC318's potential to be a new therapy for patients with solid tumors and low levels of PD-1 expression or who do not respond to anti-PD-1/PD-L1 treatments."

    Business Highlights

    • Presented clinical data from the Phase 1 portion of the NC318 Phase 1/2 Clinical Trial at the 34th Annual Meeting of SITC.
    • Initiated the Phase 2 portion of the ongoing Phase 1/2 clinical trial of NC318.
    • Promoted Timothy Mayer, Ph.D. to Chief Operating Officer.
    • Continued research activities under our collaboration agreement with Eli Lilly and Company ("Lilly").
    • Remain on track to submit an investigational new drug application to the U.S. Food and Drug Administration for our second product candidate, NC410, in the first quarter of 2020. NC410 is a novel immunomedicine designed to block immune suppression mediated by an immune modulator called Leukocyte‑Associated Immunoglobulin‑like Receptor 1, or LAIR‑1.

    Financial Results for Quarter Ended September 30, 2019

    • Cash, cash equivalents, and marketable securities as of September 30, 2019 were $184.1 million, compared to $135.2 million as of December 31, 2018. This increase primarily reflects net proceeds from our IPO of $77.0 million, partially offset by cash used to fund operations of $25.6 million.
    • Revenue was $1.6 million and $4.3 million for the three and nine months ended September 30, 2019, respectively. We had no revenue in 2018. Revenue to date has been generated from the Lilly agreement.
    • Research and development expenses were $8.7 million and $22.8 million for the three and nine months ended September 30, 2019, respectively, as compared to $4.9 million and $13.5 million for the three and nine months ended September 30, 2018, respectively. The increases primarily reflect an increase in headcount, NC318 clinical research costs, lab supplies and services for NC318 and our other early stage programs and discovery activities, as well as a one-time license payment in connection with our IPO in the quarter ended June 30, 2019.
    • General and administrative expenses were $2.6 million and $7.0 million for the three and nine months ended September 30, 2019, respectively as compared to $0.9 million and $2.6 million for the three and nine months ended September 30, 2018, respectively. The increase was primarily related to increases in professional fees and insurance costs in connection with becoming a publicly traded company, as well as increases in personnel-related costs and an unrestricted gift to an academic lab in the prior quarter.
    • Net loss was $8.4 million and $22.8 million for the three and nine months ended September 30, 2019, respectively, as compared to $5.7 million and $15.9 million for the three and nine months ended September 30, 2018, respectively.

    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-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," "toward," "progress," "continue," "vision," "on track" and similar expressions. Examples of forward-looking statements in this press release include, among others, statements about the strength of NextCure's financial position to continue advancing its product candidates, the progress and expected timing of NextCure's ongoing clinical trial of NC318, planned clinical trials of NC318and NC410 and other research and development programs, 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: 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; and the unproven approach to the discovery and development of product candidates based on NextCure's 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 Form 10-Q filed with the SEC on August 12, 2019. 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   Nine Months Ended
      September 30,    September 30, 
      2019     2018     2019     2018  
    Revenue:                              
    Revenue from research and development arrangement $ 1,583     $  —     $ 4,342     $  —  
                                   
    Operating expenses:                              
    Research and development   8,663       4,895       22,819       13,539  
    General and administrative   2,622       925       6,995       2,590  
    Total operating expenses   11,285       5,820       29,814       16,129  
    Loss from operations   (9,702 )     (5,820 )     (25,472 )     (16,129 )
    Other income, net   1,268       110       2,662       192  
    Net loss   (8,434 )     (5,710 )     (22,810 )     (15,937 )
    Net loss per common share—basic and diluted $ (0.37 )   $ (4.17 )   $ (1.81 )   $ (11.64 )
    Weighted average number of common shares —basic and diluted   22,715,567       1,369,212       12,609,219       1,369,212  
    Comprehensive loss:                              
    Unrealized loss on marketable securities   (58 )           (58 )      
    Total comprehensive loss $ (8,492 )   $ (5,710 )   $ (22,868 )   $ (15,937 )
                                   

    NEXTCURE, INC.
    CONDENSED BALANCE SHEETS
    (unaudited, in thousands, except share and per share amounts)

               
      September 30,    December 31, 
      2019   2018
    Assets        
    Current assets:          
    Cash and cash equivalents $ 9,935   $ 135,173
    Marketable securities   174,147    
    Restricted cash   1,289     460
    Prepaid expenses and other current assets   3,777     152
    Total current assets   189,148     135,785
    Property and equipment, net   12,031     11,407
    Other assets   3,945     436
    Total assets $ 205,124   $ 147,628
    Liabilities, Preferred Stock and Stockholders' Equity (Deficit)          
    Current liabilities:          
    Accounts payable $ 2,576   $ 2,483
    Accrued liabilities   2,582     2,411
    Deferred rent, current portion       28
    Term loan, current portion   1,250     387
    Deferred revenue, current portion   6,199     4,989
    Total current liabilities   12,607     10,298
    Deferred rent, net of current portion   434     242
    Term loan, net of current portion   3,750     73
    Deferred revenue, net of current portion   17,684     21,736
    Total liabilities   34,475     32,349
    Commitments and contingencies          
    Redeemable preferred stock:          
    Series A Preferred Stock, par value of $0.001 per share; 0 and 68,181,819 shares authorized, issued and outstanding at September 30, 2019 and December 31, 2018, respectively       71,000
    Series B Preferred Stock, par value $0.001 per share; 0 and 56,828,852 shares authorized at September 30, 2019 and December 31, 2018, respectively, 0 and 56,828,851 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively       91,223
    Total redeemable preferred stock       162,223
    Stockholders' equity (deficit):          
    Preferred stock, par value of $0.001 per share; 10,000,000 and 0 shares authorized at September 30, 2019 and December 31, 2018. No shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively      
    Common stock, par value of $0.001 per share; 100,000,000 and 158,745,671 shares authorized at September 30, 2019 and December 31, 2018, respectively, 22,739,345, and 1,374,812 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively   23     1
    Additional paid-in capital   240,791     352
    Accumulated other comprehensive loss   (58)    
    Accumulated deficit   (70,107)     (47,297)
    Total stockholders' equity (deficit)   170,649     (46,944)
    Total liabilities, preferred stock and stockholders' equity (deficit) $ 205,124   $ 147,628
               

     

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

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    • NC318 was well tolerated
    • Single agent activity observed in multiple tumor types, including a CR and a PR in NSCLC
    • Initiated Phase 2 portion of the Phase 1/2 monotherapy trial and plans for a combo trial with standard of care chemotherapies

    BELTSVILLE, Md., Nov. 09, 2019 (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 updated clinical results from the Phase 1 portion of its ongoing trial with NC318, a monoclonal antibody targeting Siglec-15 (S15), were presented at the SITC annual meeting. S15 is a novel immunomodulatory protein that is expressed on…

    • NC318 was well tolerated
    • Single agent activity observed in multiple tumor types, including a CR and a PR in NSCLC
    • Initiated Phase 2 portion of the Phase 1/2 monotherapy trial and plans for a combo trial with standard of care chemotherapies

    BELTSVILLE, Md., Nov. 09, 2019 (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 updated clinical results from the Phase 1 portion of its ongoing trial with NC318, a monoclonal antibody targeting Siglec-15 (S15), were presented at the SITC annual meeting. S15 is a novel immunomodulatory protein that is expressed on highly immunosuppressive cells called M2 macrophages and on tumor cells. In addition, NextCure announced the initiation of the Phase 2 portion of its ongoing Phase 1/2 clinical trial of NC318.

    Updated Results from the Phase 1 Portion of the Phase 1/2 Trial
    As of November 9, 2019, 49 patients had been dosed across seven dose cohorts between 8 mg and 1,600 mg, administered every two weeks:

    • The most common tumor types enrolled included: non-small cell lung cancer (NSCLC) (13 patients), ovarian cancer (seven patients), melanoma (seven patients), breast cancer (four patients) and colorectal cancer (three patients).
    • All of the patients enrolled were heavily pre-treated with a median of three prior therapies.
    • All 13 NSCLC patients were PD-1 refractory, with a median of four prior therapies.
    • Data show that NC318 was well tolerated, and the only dose-limiting toxicity was a grade 3 pneumonitis in the 1,600 mg cohort.
    • Treatment-related adverse events occurring in more than 5% of subjects were diarrhea, infusion reactions, fatigue, headaches, pruritis and elevations in lipase and amylase.   
    • Most treatment-related adverse events were easily manageable, asymptomatic or mild or moderate, except for one grade 3 episcleritis/uveitis and two cases of grade 3 pneumonitis.
    • Immune-related adverse events such as vitiligo, uveitis and pneumonitis were observed.
    • Data from the trial indicate activity in multiple tumor types including durable stable disease in patients with NSCLC, endometrial cell cancer, ovarian cancer, squamous cell carcinoma, Merkel cell cancer and head and neck cancer (ongoing for 16 to 55 weeks as of November 9, 2019).
    • Durable responses were observed in patients who received NC318, including one complete response (ongoing at 55 weeks), one partial response (ongoing at 28 weeks) and four stable diseases in NSCLC (ongoing for 16 to 40 weeks) and 14 stable diseases overall (ongoing for 16 to 42 weeks).
    • 15 patients remain on study in the Phase 1 portion of the trial, including seven patients with NSCLC.
    • All responses were based on investigator tumor assessments per RECIST v1.1.

    "NC318 has been well tolerated in the Phase 1 trial, and the only dose-limiting toxicity was a grade 3 pneumonitis in the 1,600 mg cohort," said Kevin N. Heller, M.D., NextCure's chief medical officer. "It is encouraging to see single-agent activity among NSCLC patients refractory to PD-1 therapies, including a durable complete response and a durable partial response. Given what appears to be the non-overlapping expression of PD-L1 and S15, the results to date support the potential of NC318 to block S15-mediated immune suppression among a patient population unlikely to respond to PD-1/PD-L1-directed therapies."

    "There is a real need for new treatment options for patients who do not respond to current therapies. The tolerability and initial anti-tumor activity with NC318 reinforces our belief that NC318 has the potential to be a new therapy for patients with solid tumors and low levels of PD-L1 expression or who do not respond to current anti-PD-1/PD-L1 treatments," said Michael Richman, NextCure's president and chief executive officer. "In addition, the initiation of the Phase 2 portion of the trial is an important milestone for the NC318 program and reflects NextCure's continued commitment to developing novel medicines to improve the lives of patients with cancer. We look forward to reporting initial data from the Phase 2 portion of the trial by the end of 2020. These findings also revalidate the importance of the approach of our FIND-IOTM discovery platform in identifying targets like S15 that can impact immune function."

    Slides from the SITC presentation will be posted on NextCure's website on the "Events and Presentations" tab at http://ir.nextcure.com/events-and-presentations.

    Design of NC318 Phase 1/2 Clinical Trial
    The Phase 1 component of the open-label, multicenter Phase 1/2 clinical trial is designed to assess the safety and tolerability of NC318, to define the maximum tolerable dose and/or pharmacologically active dose and to assess preliminary efficacy in patients with advanced or metastatic solid tumors. NC318 is being administered on day one of each 14-day cycle in sequential dose cohorts at increasing dose levels until the maximum tolerated dose is identified.

    The Phase 2 component of the Phase 1/2 clinical trial is designed as a single-arm trial to evaluate the efficacy of NC318 at a 400 mg dose administered every two weeks. NextCure expects to enroll approximately 100 patients with NSCLC, ovarian cancer, head and neck cancer and triple-negative breast cancer. The primary endpoints are safety and tolerability, and secondary endpoints include response rate, progression-free survival, duration of response and overall survival. Additional doses and dose administration schedules may be considered. The company expects to report initial data from the Phase 2 portion of the trial by the end of 2020.

    Phase 2 Combination Trial
    In the first half of 2020, the Company intends to initiate a Phase 2 clinical trial to evaluate NC318 in combination with standard of care chemotherapies in patients with advanced or metastatic solid tumors. This open-label trial will be designed to assess the safety and tolerability of NC318 in combination with at least two different chemotherapy regimens and to define the maximum tolerable dose of NC318 when administered with each chemotherapy. The trial will also be designed to assess preliminary efficacy of each combination in specific tumor types in a manner that can potentially support the use of such combinations in first-line therapies of advanced or metastatic solid tumors.

    Event and Webcast
    NextCure will host an event at the SITC conference to discuss these results in more detail with Dr. Kevin Heller today, November 9, 2019 at 6:30 pm ET. During the event, Dr. Heller will provide a review of the data presented at SITC by Dr. Anthony Tolcher and be available for a Q&A session. This event will be webcast live and archived for 90 days and may be accessed from the Investors section of the NextCure website at www.nextcure.com.

    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 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 pace and expected timing and results of NextCure's ongoing clinical study of NC318, NextCure's expectations regarding the potential benefits, activity, effectiveness and safety of NC318, 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: 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; and the unproven approach to the discovery and development of product candidates based on NextCure's 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 Form 10-Q filed with the SEC on August 12, 2019. 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
    Shai Biran, Ph.D.
    MacDougall
    (781) 235-3060
    

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  30. BELTSVILLE, Md., Nov. 04, 2019 (GLOBE NEWSWIRE) -- NextCure, Inc., a clinical-stage biopharmaceutical company committed to discovering and developing next-generation immunomedicines for cancer and other immune-related diseases, today announced that the company will host and webcast an event with its Chief Medical Officer at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on Saturday, November 9, 2019 at 6:30 p.m. Eastern Time at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.  At the event, NextCure will discuss updated clinical results from the Phase 1 portion of its ongoing trial with NC318 that are being presented earlier in the day at SITC.

    Institutional investors and analysts are…

    BELTSVILLE, Md., Nov. 04, 2019 (GLOBE NEWSWIRE) -- NextCure, Inc., a clinical-stage biopharmaceutical company committed to discovering and developing next-generation immunomedicines for cancer and other immune-related diseases, today announced that the company will host and webcast an event with its Chief Medical Officer at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on Saturday, November 9, 2019 at 6:30 p.m. Eastern Time at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.  At the event, NextCure will discuss updated clinical results from the Phase 1 portion of its ongoing trial with NC318 that are being presented earlier in the day at SITC.

    Institutional investors and analysts are requested to rsvp to Drew Phillips at or by phone at 443-213-0497.

    To access the live webcast and subsequent archived recording of this and other company presentations, please visit the investor section of NextCure's website at www.nextcure.com. The archived webcast will remain available for replay on NextCure's website for 90 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. For more information, please visit www.nextcure.com.

    Cautionary Statement Regarding 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," "on track" and similar expressions. Examples of forward-looking statements in this press release include, among others, statements about the sufficiency of NextCure's cash and cash equivalents, the use of proceeds from NextCure's recent initial public offering, the pace and expected timing of NextCure's ongoing clinical study of NC318 and its other research and development programs, 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: 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; and the unproven approach to the discovery and development of product candidates based on NextCure's 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 Form 10-Q filed with the SEC on August 12, 2019. 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
    

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  31. BELTSVILLE, Md., Oct. 02, 2019 (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 the promotion of Timothy Mayer, Ph.D. from Senior Vice President, Corporate Development to Chief Operating Officer.

    "I am delighted to make this announcement. Tim joined NextCure at our inception and has contributed significantly to major NextCure achievements, including our alliance with Eli Lilly & Company and our recently completed initial public offering. He has played a pivotal role on the executive management team leading corporate development, strategy, and business operations…

    BELTSVILLE, Md., Oct. 02, 2019 (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 the promotion of Timothy Mayer, Ph.D. from Senior Vice President, Corporate Development to Chief Operating Officer.

    "I am delighted to make this announcement. Tim joined NextCure at our inception and has contributed significantly to major NextCure achievements, including our alliance with Eli Lilly & Company and our recently completed initial public offering. He has played a pivotal role on the executive management team leading corporate development, strategy, and business operations and we are confident he will continue to be instrumental in the company's success," said Michael Richman, NextCure's President and Chief Executive Officer. "I look forward to continuing to work with Tim at this important and exciting time in our company's history."

    Dr. Mayer has extensive experience in the biopharmaceutical industry, including with antibody therapeutics, small molecule pharmaceuticals and molecular biology research tools. Prior to joining NextCure, he served in several positions at MacroGenics, a biopharmaceutical company focused on the treatment of cancer, where he oversaw all intellectual property matters, assisted with business development for various licensing transactions and helped facilitate MacroGenics' initial public offering. Before MacroGenics, Dr. Mayer served in several positions at Banner & Witcoff, an intellectual property law firm, where he drafted and prosecuted biotech and pharmaceutical applications and conducted patentability and freedom-to-operate searches in all areas of biotechnology and small molecule chemistry. Dr. Mayer also worked on developing cloning systems while at Life Technologies and Invitrogen. He received his Ph.D. in Microbiology and Immunology from Penn State University College of Medicine and B.S. degrees in Microbiology and Biochemistry from California Polytechnic State University.

    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

    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," "continue" and similar expressions are intended to identify forward-looking statements. Examples of forward-looking statements in this press release include, among others, statements about Dr. Mayer's future with NextCure and NextCure's plans, objectives and intentions with respect to the identification 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 in the Risk Factors section and throughout NextCure's Form 10-Q filed with the SEC on August 12, 2019. 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
     
    
    Media Inquiries
    Shai Biran, Ph.D.
    MacDougall
    (781) 235-3060
    

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  32. BELTSVILLE, Md., Oct. 01, 2019 (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 data from the Phase 1 portion of its ongoing Phase 1/2 clinical trial of NC318 in patients with advanced or metastatic solid tumors will be presented in an oral session at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) being held November 6-10, 2019 in National Harbor, Maryland.

    Presentation Details:

    Title: Single agent anti-tumor activity in PD-1 refractory NSCLC: phase 1 data from the first-in-human trial of NC318, a Siglec-15-targeted…

    BELTSVILLE, Md., Oct. 01, 2019 (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 data from the Phase 1 portion of its ongoing Phase 1/2 clinical trial of NC318 in patients with advanced or metastatic solid tumors will be presented in an oral session at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) being held November 6-10, 2019 in National Harbor, Maryland.

    Presentation Details:

    Title: Single agent anti-tumor activity in PD-1 refractory NSCLC: phase 1 data from the first-in-human trial of NC318, a Siglec-15-targeted antibody
    Abstract Number: O32
    Presentation Session: Concurrent Session 309 (Single Agent Phase 1 Clinical Trials)
    Presentation Date and Time: November 9, 2019; 4:15 pm – 4:30 pm ET
    Lead Author: Anthony Tolcher, MD, FRCPC, FACP, Director of Clinical Research, NEXT Oncology

    About NC318
    NC318 is a first-in-class immunomedicine against Siglec-15 (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 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

    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 identification of immunomedicine targets and the discovery and development of immunomedicines, NC318's potential to treat multiple tumor types, and the use of the FIND-IO platform. 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 in the Risk Factors section and throughout NextCure's Form 10-Q filed with the SEC on August 12, 2019. 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.
    SVP, Corporate Development
    (240) 762-6486
    
    
    Media Inquiries
    Shai Biran, Ph.D.
    MacDougall
    (781) 235-3060
    

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